Category Archives: Preventative Medicine

Preventive health care is not a magic bullet that is the responsibility of the Health Ministry alone. The paradigm shift from a sick to a sick free society needs all stakeholders to be persuasive advocates to elevate Malaysias status to a healthy nation.

For decades, health care support was aboutcuring an ailing society and not about effectively keeping people out of hospitals. This is the right time for health care reform to fix what is broken and build on what works.

The health of a nation is measured through three key components mental and physical health, health infrastructure and the availability of preventative care.

The management costs of cancer, cardiovascular disease, and diabetes exceeds RM9.65 billion yearly. Some of these disease can be prevented with successful intervention in early detection, as well as with investments in prevention and wellness programmes.

The institutionalisation in health care reform is an ongoing process, where programmes and policies become an ongoing routine. It will only become sustainable with the coordination and cooperation of all stakeholders, and with integration prevention modules in long term policies.

The White Paper on Health will be an exercise for our own existential reform with a fundamental shift from a curative model to a preventive one. We will focus on public health surveillance, policy development, research, regulation, monitoring, and evaluation, said Health Minister Khairy Jamaluddin at the recent Health Policy Summit 2022.

Better integration between the public and private health care sectors would reduce pressure on public facilities to seamlessly endorse prevention whether in the public, private, or non-profit sector.

It is indeed going to be a long road when you consider that even hospitals have fast food outlets as cheaper and easier options, indicating what fuels a ballooning epidemic of obesity, diabetes, andvarious other health issues.

According to the National Health andMorbidity Survey (2019), one in two Malaysian adults are overweight or obese, three in 10 adults have hypertension, while in four in 10 adults have elevated cholesterol levels.

In 2020. the World Health Organization (WHO) reported that coronary heart deaths in Malaysia reached 36,729 or 21.86 per cent of total deaths. Heart diseases kill about 17.9 million people in the world annually, and Malaysia ranks 61st.

For starters, food quality regulators, advertisers, and schools should be mindful of the pervasive marketing schemesof school sport events that are sponsored by companies that manufacture junk food, fizzy drinks, and sweets.

Exercise as a medicine or as therapy has been prescribed both in mental and chronic diseases.

Town planners should designate parks for children within every housing estate. The present trend of cutting down trees to approve high rise condominiums should be monitored.

In place,thereought be well-designed and equipped playgrounds, football fields, and safe cycling lanes. Such facilities should be attractive enough to draw children away from their smartphones.

Schools should delegate more hours for sports and physical activities to diffuse the stressful environment of examinations and grades.

Essentially, it will be the efforts of the Ministries of Sports, Education, and Housing and Development, and the institutionalisation of all agencies to push the prevention agenda.

For workers, there should be schemes to appraise the health risk through the Employment Provident Fund, social security, and the Employment Insurance System.

Getting an annual health check-up is the most reliable test of our health.

The Health Ministry will screen about 1.5 million people who had never undergone health screening, including tests for colorectal cancer and breast cancer at public and private clinics, said Khairy.

The National Health Service in the United Kingdom offers free testing once every five years for the 40 to 74 age group without a pre-existing condition, and a discussion with a health care professional. Health risk assessments can help people get care they need before problems escalate.

A hallmark of Malaysias health care system should be subsidised and affordable check-ups for preventable ailments for the poor.No one should be denied a medical test or examination that can prevent or detect disease at an early stage.

As it is, our limited national expenditure on health infrastructure means that many cannot receive intensive care in public hospitals, unless they can afford exorbitant private hospital fees.

This will also have a tremendous impact on congested hospital services to be freed up to focus oncomplex curative cases.

It is more effective to have a preventive model than injecting money to maintain curing the sick. The curative model is becoming increasingly expensive for the majority of the population. It is not financially viable, and is never-ending.

I want to increase the annual budgetary allocation for public health care to 5 per cent of gross domestic product (GDP) over the next few years. And that increase must be ring-fenced in every subsequent budget, Khairy affirmed.

However, health care allocation as a percentage of GDP has not moved much over the last decade. In 2011, the health care allocation, which comprised both development and operating expenditures, worked out to 2.4 per cent of GDP.

By 2022, health care made up only 2.59 per cent of GDP.

The White Paper on Healthcare Reform will be tabled in November, covering wide-ranging proposed changes to health care financing, among other issues, spanning a 15-year period. It is recommended that a Health Reform Commission supervises the reform.

The government is considering gradually increasing the health care budget up to targeted levels over a number of years while working out funding structures to make the system more sustainable and progressive., said Khairy.

Khairy advocated using science, data, and technology to identify and intervene proactively and help people sustain their health and wellbeing.

Part of this work requires the sharing of patient records across facilities and providers, and initiatives to pilot and scale up electronic medical records will be critical, he explained.

Finally, it is about the people. We cannot reimagine a world of good health unless we play a major role in the prevention process.

As consumers, it is important for us to get to know the different types of products that are available in the market, whatever the marketing might tell us. Market logic cannot be all legitimate when profit is the bottom line.

A simple measure for us is to read labels on how much fat, salt, or sugar each food product contains, and how do we process this information.

Most importantly, getting an annual health check-up for everyone above 40 is the most reliable test of our health.

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Cure Is An Absolute, But Prevention Is The Ideal Vasanthi Ramachandran - CodeBlue

Board-Certified Pediatrician Provides Tips for Parents to Help Their Kids Prepare for Back-to-School

SANTA MONICA, Calif., Aug. 16, 2022 /PRNewswire/ --

BACKGROUND:

For parents of kids of all ages, back-to-school season is the perfect time to take stock of your child's physical and mental health to help prepare them for a successful school year. Starting in a new school or classroom can be an exciting or stressful experience for kids. Parents should recognize not all stressful emotions are bad and dealing with stress is an important step in a child's developmental growth.

Experience the full interactive Multichannel News Release here: https://www.multivu.com/players/English/9060251-goodrx-board-certified-pediatrician-provides-tips-back-to-school/

TIPS ON PREPARING FOR A HEALTHY SCHOOL YEAR:

Dr. Preeti Parikh, Executive Medical Directorat GoodRx and a board-certified pediatrician in New York City, shared tips parents can use to prepare their children for a healthy school year. Dr. Parikh also discussed why staying ahead of stress by practicing mindfulness techniques with children can help avoid it manifesting into worrisome physical symptoms.

For more information please visit:www.goodrx.com/health

MORE ABOUT DR. PREETI PARIKH:

Dr. Preeti Parikh is the Executive Medical Director at GoodRx. She is a board-certified pediatrician practicing at Westside Pediatrics, is an Assistant Clinical Professor at the Mount Sinai School of Medicine and is an American Academy of Pediatrics spokesperson.

Dr. Parikh graduated from Columbia University and Rutgers Robert Wood Johnson Medical School, and she completed postgraduate training at the Mount Sinai School of Medicine. Dr. Parikh combines her passions of preventative medicine, advocacy, and patient education to empower people to achieve their optimal health. She has contributed to media outlets including Bump.com, Parents.com, CBSNews, and many others.

Produced for: GoodRx

SOURCE GoodRx

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GET PREPPED FOR A HEALTHY AND PRODUCTIVE SCHOOL YEAR - PR Newswire

FINDINGS

In single pollutant models and within a 20-year period, 10 out of 29 reviewed pesticides were associated with thyroid cancer, including several of the most widely used ones in the U.S. These included paraquat dichloride, glyphosate and oxyfluorfen.

Additionally, the risk of thyroid cancer increased proportionally to the total number of pesticides subjects were exposed to 20 years before diagnosis or the research interview. In all models, paraquat dichloride was associated with thyroid cancer.

The study appears in The Journal of Clinical Endocrinology & Metabolism.

CONCLUSION

The authors say this study provides the first evidence supporting the hypothesis that residential pesticide exposure from agricultural use is associated with an increased risk of thyroid cancer.

BACKGROUND

Thyroid cancer incidence has increased substantially in the U.S. during the past 30 years, rising by 3% annually. Some experts attribute the increase to better detection methods, but other reports suggest environmental, genetic and lifestyle risk factors may also explain the upward trend. Few studies have examined environmental exposures on thyroid cancer occurrence, except those focusing on radiation exposure. Previous studies found higher risks for those working in the leather, wood and paper industries, as well as those exposed to environmental solvents, flame retardants and pesticides.

Certain pesticides are established mutagens or have been shown to induce tumor growth and chromosomal abnormalities in vitro. These include glyphosate the active ingredient in widely used herbicides and 19 pesticides that induce DNA cell damage in vitro. Pesticides also can alter thyroid hormone production, which has been associated with thyroid cancer risk.

Previous studies of pesticides and thyroid cancer have been inconsistent or had methodology limitations, including self-reporting of exposures, little or no information on specific pesticides and small sample sizes.

California ranks first among U.S. states in agricultural production. Moreover, agricultural pesticide use in California in 2008 totaled 162 million pounds, about 25% of all U.S. usage. Meanwhile, the state has seen increasing rates of advanced thyroid cancer.

This study examines the association between exposure to pesticides, including 19 that were found to cause DNA cell damage, and the risk of thyroid cancer. The researchers hypothesized that pesticide exposure may be a missing link requiring further investigation.

METHODS

The authors performed a case-controlled study using thyroid cancer cases from the California Cancer Registry (1999-2012) and controls sampled in a population-based manner. Study participants were diagnosed with thyroid cancer, lived in the study area when diagnosed and were age 35 or older. Control subjects were recruited from the same geographic area and were eligible if age 35 or older and had been living in California for at least five years before the research interview. The study sample included 2067 thyroid cancer cases and 1003 control participants.

The researchers examined residential exposure to 29 agricultural-use pesticides known to cause DNA damage or endocrine disruption. They utilized a validated geographic information-based system to generate exposure estimates for each study participant.

EXPERT COMMENTS

The incidence of thyroid cancer has been increasing exponentially over the course of the last few decades, said Dr. Avital Harari, corresponding author and principal investigator for the study. Additionally, the risk of advanced thyroid cancers, which can increase risk of mortality and cancer recurrence, has been found to be higher in the state of California as compared to other states. Therefore, it is essential to elucidate risk factors for getting thyroid cancer and understand potentially alterable causes of this disease in order to decrease risks for future generations.

Our research suggests several novel associations between pesticide exposure and increased risk of thyroid cancer, she added. Specifically, exposure to the pesticide paraquat is positively associated with thyroid cancer risk.

Additionally, exposure to other pesticides, in combination with paraquat in multipollutant models, also suggests an increased risk of thyroid cancer, she explained, and exposure to a greater number of unique pesticides over a 20-year period proportionately increased the risk.

Harari, an Associate Professor of Endocrine Surgery at UCLA Health, said additional research is needed. Our study warrants further investigation to confirm these findings and better evaluate the actual mechanisms of action.

DOI: 10.1210/clinem/dgac413

AUTHORS

Corresponding author and principal investigator Avital Harari is a UCLA physician-researcher in the Department of Surgery. Co-first author Negar Omidakhsh and Chenxiao Ling are researchers with the Fielding School of Public Health at UCLA. The late Jerome M. Hershman was a UCLA physician-researcher with the Department of Medicine. Co-first author Julia E. Heck is with the College of Health and Public Service at the University of North Texas. Myles Cockburn is with the Department of Preventative Medicine at Keck School of Medicine and Department of Geography at USC.

FUNDING

This research was supported by the University of California Cancer Research Coordinating Committee Relation of pesticide exposure to thyroid cancer incidence and stage distribution. Grant # CRN-15-380517.

DISCLOSURES:

The authors had no disclosures.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Researchers examine link between pesticides and thyroid cancer risk in Central California area - EurekAlert

When you hear the word potassium, bananas probably come to mind. It's fairthey are a great source of potassium, after allbut this is often where common knowledge starts and stops as far as potassium is concerned. Unfortunate, seeing as potassium is both a super important mineral (and electrolyte) for a bunch of bodily functions, and only around three percent of adults in the U.S. get enough potassium, says Bonnie Taub-Dix, RDN, registered dietitian and author of Read It Before You Eat ItTaking You from Label to Table.

"Potassium is essential for the communication between cells and nerve connections; this is important for muscle contractions and kidney function," says Taub-Dix. "Some folks don't realize just how important potassium is for the body and how much they need. People are familiar with sodium, protein, vitamin C, even antioxidants, for instance, but many are not as familiar with potassium." This is why, according to Taub-Dix, many foods are starting to list potassium on their packaging.

Potassium is part of every cell in the body," says Kaustubh Dabhadkar, MD, MPH, MBA, FACC, a North Carolina-based cardiologist with a specialization in preventative care. "It is necessary for proper functioning of muscles and nerves; low potassium levels hamper muscle and nerve functioning."

Clearly, getting enough potassium is super important for maintaining your heart health, muscles contractions, and even neurological function. "And while most Americans could stand to get more potassium into their diets, keep in mind that it's far easier to lose potassium when you exercise because it's closely related to hydration levels," adds Taub-Dix. This is even more true when spending time outdoors in warm weather.

Here are some signs your body is telling you you need more potassium to keep an eye out for this summer (and all year-round), according to Taub-Dix and Dr. Dabhadkar.

"If you've been working out, exercising, or sweating in the sun, it's possible you need to re-up on potassium," says Taub-Dix. The U.S. National Library of Medicine states that slight drops in potassium may have specific symptoms that might resemble dehydration (think thirst, dry mouth, and headache), however, non-severe drops in potassium can manifest differently depending on the person.

"You may have an irregular heartbeat or palpitation because potassium has to do with how muscles function," says Taub-Dix. "If you ever feel a funny heart sensation, it may be the result of low potassium." As for most matters of heart health, if you experience sharp pains, arm pain, or any other acute heart-related symptoms, it's best to seek emergency medical care as soon as possible.

Low potassium levels can induce additional heart beats, which can lead to palpitations, says Dr. Dabhadkar. Additionally, potassium helps relax blood vessels and thus, low potassium level causes high blood pressure in the long term.

"Cramps, muscle weakness, and muscle spasms are a telltale sign of low potassium," says Taub-Dix. That charlie horse that wakes you up in the middle of the night or the back spasm that throws you out of commission when you lean to pick up a sock could be a sign that you need more potassium. This is because, according to Taub-Dix, when your muscle cells dont have enough of this mineral, they dont facilitate your muscles push and pull as easily as they would when they have enough potassium.

Believe it or not, this muscular impact of low potassium is also why low potassium can also cause constipation. With low potassium levels, the small muscle in intestine doesn't contract appropriately, says Dr. Dabhadkar. Having enough of this mineral allows your digestive system to squeeze and releasewhich is how it moves stool from your stomach, through your body, and out.

Keep in mind that severe calcium deficiency can lead to a condition known as hypokalemia, however this is very unusual among healthy folks with normal kidney functioning and is rarely caused by low dietary potassium intake alone. Hypokalemia is typically caused of the use of diuretics and other medications,but it can result from diarrhea due to potassium losses in the stool.

According to Taub-Dix, general malaise can also be tied to low potassium levels. In absence of adequate potassium, large muscles fail to contract optimally, says Dr. Dabhadkar. This means that when youre low on potassium, your muscles cant work as effectively as they normally would which can leave you feeling weaker than usual.

If you're feeling fatigued or not quite like yourself, the first step is to see a healthcare provider before trying to diagnose yourself with potassium deficiency. That being said, it's always a good idea to fit more electrolytes and potassium-rich foods into your diet.

I really recommend trying to get your potassium from food, rather than one supplement of potassium, because you can get a bunch of nutrients at once from foods, says Taub-Dix. This is particularly useful for a nutrient like potassium that needs other minerals to do its job.

The good news is that there are so many delicious sources of potassium to choose from. "Potatoes, cooked spinach, carrots, avocadoes, milk, peas, beans, peanut butter, salmon, cooked lean beef, and seaweed are all excellent sources of potassium. Believe it or not, a baked potato has about twice the potassium content as a banana," Taub-Dix says. The more you know!

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5 Ways Your Body Is Telling You That You Need More Potassium, According to a Cardiologist and a Dietitian - Well+Good

AUSTIN, Texas--(BUSINESS WIRE)--Restore Hyper Wellness (Restore), the leading provider of proactive wellness services, announced its business performance results for the first half of 2022, with system-wide sales surpassing $60 million, an increase of 84% year-over-year. Same-store sales grew 28% year-over-year, a reflection of Restores growing momentum with consumers that want to take a proactive approach to their wellness. Restore expanded its retail footprint, opening 32 new studios in the first half of 2022, outpacing virtually any other U.S. retailer in new store openings. Restore now has more than 150 locations around the U.S. Most importantly, Restore delivered over 1 million Hyper Wellness services to clients to help them feel their best and do more of what they love.

We set ambitious goals for 2022, and Im thrilled with the progress weve made the first half of the year towards our mission of making Hyper Wellness accessible and affordable for everyone, said Jim Donnelly, Restores CEO and Co-Founder. Providing our innovative wellness experience in more than 150 locations to date proves that proactive wellness is a growing focus for people of all walks of life. Our team is proud to have achieved a strong national footprint and a foothold to continue to grow and help more people feel their best and do more of what they love.

Restores Wellness Experience

With its innovative experience and direct-to-consumer membership model, Restore is creating a new category of careHyper Wellness. Hyper Wellness is Restores framework for living a proactive, healthy lifestyle that helps you feel your best, so you can do more of what you love.

Hyper Wellness is grounded in 9 Elements everyone should incorporate into their daily life both inside and outside of Restores four walls: oxygen, hydration, nourishment, cold, heat, light, movement, rest and connection. Restore offers 12 innovative modalities under one roofeach modality supporting one or more of these 9 Elements.

Cryotherapy and IV Drip Therapy are the two most popular services offered at Restore. NAD+ IV Drips and Mild Hyperbaric Oxygen Therapy are growing in awareness and popularity, as more clients feel the results and share their experience. Restore has delivered more than 1 million whole body cryotherapy sessions, over 900,000 wellness IV drips and over 140,000 mild hyperbaric oxygen therapy sessions since its founding in 2015.

Through its Hyper Wellness approach, Restore is creating an entirely new wellness experience and category that its members love. It is proactive, effective, transparent, social and funvalidated by Restores industry-leading 85 net promoter score (NPS).

Our direct-to-consumer, membership-based wellness model allows Restore to offer a better health care experience and develop a closer relationship with its members, said Steve Welch, Co-Founder and Executive Chairman. Members visit Restore three times per month on average, whereas half the U.S. population visits their doctor once a year or less. Our deep relationship with clients allows Restore to partner with them more closely to achieve their wellness goals.

Medical Advisory Board

Restore also announced today the official launch of its Medical Advisory Board, which provides medical oversight and direction of current and future modalities offered at Restore. The Board works with Restores medical leadership team, seven medical directors, over thirty nurse practitioners and over 750 registered nurses providing medical services in Restores wellness studios. The new Board members bring a wealth of clinical knowledge and experience that align with Restores priorities of offering a wellness experience that is proactive, effective and transparent with the safest protocols possible across all its wellness studios.

Jonathan Hemmert, MD, serves as Restores Head Medical Director. Dr. Hemmert is Board Certified in Emergency Medicine by the American Board of Emergency Medicine. He is also a World Health Ambassador working in St. Vincent and the Grenadines as an international physician volunteer. Dr. Hemmert received his Doctor of Medicine Degree from University of Chicago Pritzker School of Medicine and completed his Residency in Emergency Medicine at Indiana University School of Medicine.

Alexandra Siojo, MSN, FNP-C serves as Restores Chief Nursing Officer. Alexandra is an experienced nurse practitioner in the areas of trauma, neurosurgery, emergency medicine and family-centric general health care. As a Family Nurse Practitioner, Alexandra performed preventative, diagnostic and treatment procedures for a variety of acute and chronic diseases, conditions, and injuries. Alexandra earned her Bachelor of Science in Registered Nursing and her Masters of Science in Nursing from University of Mary Hardin-Baylor. She is currently a MBA candidate at Baylor University.

Richard Joseph, MD is the founder of VIM Medicine, a clinical model that integrates preventive medical care with health and fitness services, a practicing clinician in the Center for Weight Management and Wellness at Brigham and Womens Hospital in Boston, MA, and a faculty member at Harvard Medical School. He completed his residency in primary care/internal medicine at Brigham and Women's Hospital after receiving his medical and business degrees from Stanford University. Dr. Joseph is a longtime personal trainer and fitness expert, currently conducts group-based lifestyle programs, and is a coauthor of The Lifestyle Medicine Handbook: An Introduction to the Power of Healthy Habits.

John Day, MD is a cardiologist specializing in the treatment of atrial fibrillation and other abnormal heart rhythm conditions at St. Marks Hospital in Salt Lake City, Utah. Dr. Day is the author of over 100 clinical studies that have been published in many of the most prestigious scientific and medical journals. And, he is the author of two Amazon best-selling books, The Longevity Plan and The AFib Cure. He also is the founding editor-in-chief of the Innovations in Cardiac Rhythm Management medical journal. He previously served as the president of the Heart Rhythm Society. Dr. Day received his medical degree from John Hopkins and completed his residency and fellowships in cardiovascular medicine and cardiac electrophysiology at Stanford University. Dr. John Day is board certified in cardiology and cardiac electrophysiology.

Peter Weiss, MD is a leading OB/GYN who has dedicated his life to providing women with a level of care thats unrivaled in Beverly Hills, California. He co-founded the Rodeo Drive Womens Health Center in 2004, where he has served as the Medical Director. Dr. Weiss helps women of all ages in southern California with his expertise in advanced therapies for menopausal health, such as Mona Lisa Touch Laser. Dr. Weiss has advised legislators on both sides of the aisle on how to advance womens health care issues. He was a national health care advisor for Senator John McCains (R) 2008 presidential campaign. Dr. Weiss graduated with honors in Gynecology from the University of Michigan School of Medicine. He has been an Assistant Clinical Professor of Obstetrics and Gynecology at the UCLA Geffen School of Medicine for 30 years.

We are pleased to welcome Dr. Joseph, Dr. Day and Dr. Weiss to our Medical Advisory Board, said Dr. Jonathan Hemmert, Restores Head Medical Director. These physicians bring a wealth of clinical experience improving peoples lives in their medical practices. Their knowledge will help us continue to scale our operations to more locations and people in the safest and most effective way possible.

Retail Expansion and Franchising

In addition to its 150+ currently open locations, Restore has over 600 locations under development in the U.S. It sold over 80 franchise territories in the first half of 2022.

For more information about Restore Hyper Wellness, its innovative experience and franchising opportunities, please visit restore.com.

About Restore Hyper Wellness

Launched in Austin, Texas in 2015, Restore Hyper Wellness (Restore) is the award-winning creator of an innovative new category of careHyper Wellness. Restore delivers expert guidance and an extensive array of cutting-edge wellness modalities integrated under one roof. These modalities include biomarker assessments, IV drip therapy, intramuscular (IM) shots, mild hyperbaric oxygen therapy, whole body and localized cryotherapy, infrared sauna, red light therapy, compression, HydraFacial, Circadia and Cryoskin. Restores mission is to make Hyper Wellness accessible and affordable so people can feel their best and do more of what they love.

*Medical services available to clients of Restore are provided by an independently owned physician practice.

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Restore Hyper Wellness Announces First Half of 2022 Performance Results with Over $60M in System-Wide Sales & Official Announcement of its Medical...

New test panel follows a Quest Diagnostics Health Trends study with the CDC that revealed less than half of pregnant people are screened for hepatitis C as recommended under guidelines

SECAUCUS, N.J., Aug. 17, 2022 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today announced the launch of a new obstetrics laboratory test panel designed to enable physicians to screen all eligible pregnant people easily and reliably for hepatitis C (HCV) with other laboratory tests typically ordered during early pregnancy.

The company developed the new test panel to include HCV antibody testing with reflex to quantitative real-time PCR in response to findings from a Quest Diagnostics Health Trends study published inObstetrics & Gynecology in June 2022. This peer reviewed study found that less than 41% of pregnant people were screened for HCV in 2021, based on Quest Diagnostic's laboratory testing of more than 5 million pregnant patients. The study also found that individuals with Medicaid health insurance were screened at rates 25-35% lower than those with commercial insurance.

"Our Health Trends research revealed that despite guidelines recommending HCV screening in pregnancy, many people are not receiving the testing they need. Individuals in underserved communities are most likely to experience this gap in care," said Damian "Pat" Alagia, MD, Senior Medical Director, Women's Health, Quest Diagnostics. "Screening for HIV, HBV and syphilis is already standard in obstetric panels, and it is no coincidence that screening rates for these diseases during pregnancy are more than double the current rate as for HCV. By adding HCV screening to our obstetrics panel, physicians will be more likely to deliver guideline-based carethat reduces HCV infection during pregnancy and fosters a positive outcome for the patient and their newborn."

"Our new test service is a prime example of how Quest Diagnostics illuminates care gaps from its uniquely large laboratory dataset and then creates solutions to improve patient care and public health," said Harvey W. Kaufman, MD, Senior Medical Director, Head of the Health Trends Research Program for Quest Diagnostics, and a lead of the study published in Obstetrics & Gynecology.

Obstetric panels are typically performed early in pregnancy and include guideline-recommended tests, such as complete blood count (CBC), blood typing, hepatitis B, syphilis, and rubella, to help guide clinical decisions affecting the pregnancy and mother's health.i Inrecent years, hepatitis C infections have risen in pregnant people and other populations in the United States, largely due to increased intravenous drug use. Between 2020-2021, the United States Preventative Services Task Force, American College of Obstetricians and Gynecologists, and the Society of Maternal-Fetal Medicine issued practice guidance recommending one-time hepatitis C screening during pregnancyii,iiiwhile the CDC issued guidance recommending HCV screening for all pregnant people except in settings where the prevalence of HCV infection is less than 0.1%.iv

Hepatitis C is the most common bloodborne infection in the United States and is a leading cause of liver-related morbidity and mortality.v An estimated 1,700 infants were born with HCV infection (acquired in utero) each year between 2011 and 2014.vi

About Quest Diagnostics Health TrendsQuest Diagnostics Health Trends is a series of scientific reports that provide insights into health topics, based on analysis of HIPAA-compliant, objective clinical laboratory data, to empower better patient care, population health management and public health policy. The reports are based on the Quest Diagnostics database of 60 billion deidentified laboratory test results, believed to be the largest of its kind in healthcare. Health Trends has yielded novel insights to aid the management of allergies and asthma, prescription drug misuse, diabetes, Lyme disease, heart disease, influenza and workplace wellness. Quest Diagnostics also produces the Drug Testing Index (DTI), a series of reports on national workplace drug positivity trends based on the company's employer workplace drug testing data.

About Quest DiagnosticsQuest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest annually serves one in three adult Americans and half the physicians and hospitals intheUnited States, and our 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives.www.QuestDiagnostics.com

iAmerican College of Obstetricians and Gynecologists. Routine Tests During Pregnancy. https://www.acog.org/womens-health/faqs/routine-tests-during-pregnancy. Accessed July 26, 2022.ii U.S. Preventative Services Task Force. Hepatitis C virus infection in adolescents and adults: screening: United States Preventative Services Task Force statement.JAMA. 2020;323(10):970975.https://doi.org/10.1001/jama.2020.1123.iii ACOG Practice Advisory: Routine Hepatitis C Virus Screening in Pregnant Individuals (opqic.org)Schillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC recommendations for hepatitis C screening among adults United States, 2020.MMWR Recomm Rep. 2020;69(RR-2):117.https://doi.org/10.15585/mmwr.rr6902a1.ivSchillie S, Wester C, Osborne M, Wesolowski L, Ryerson AB. CDC Recommendations for Hepatitis C Screening Among Adults United States, 2020. MMWR Recomm Rep 2020;69(No. RR-2):117.vSeo S, Silverberg MJ, Hurley LB, et al. Prevalence of spontaneous clearance of hepatitis C virus infection doubled from 1998 to 2017.J Clin Gastroenterol Hepatol. 2020;18(2):511513.https://doi.org/10.1016/j.cgh.2019.04.035.viRoberts EA, Yeung L. Maternal-infant transmission of hepatitis C virus infection. Hepatology. 2002;36(5 Suppl 1):S106-13.

SOURCE Quest Diagnostics

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Quest Diagnostics Aims to Close Gaps in Maternal Healthcare with New Obstetrics Test Panel that Includes Hepatitis C Screening - PR Newswire

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All levels of government, businesses, whether they be health care or tomato picking, seem to be of one mindset. Hire foreign-trained workers, increase immigration be damned if we dont have adequate housing, medical services, this is what will be the cure all. A Band-Aid measure at best. Training should begin at home, at the early stages of education. Wasted on me was five years of forced French language instruction, streaming me into an academic system when I belonged in a technical one. Any trade, profession is a good one, but there seems to be a collective lack of effort to encourage, showcase, anything but a basic regurgitation of worn, outdated curriculum, nothing hands on. Time to take control of our own job resources, train those already living in Canada, put more people in careers that best suit them, and stop the madness that is being driven by those woken socialists that believe some deserve a free lunch while others toil to provide that meal.

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Bill Vernon

(Those that come here want to contribute and work. The issue are the politicians that meddle in the system trying to score points by implementing ridiculous policies that help no one)

YOU GET WHAT YOU DESERVE

Re Trudeau returns from vacation, ignores problems we face at airports (Brian Lilley, Aug. 15): Of course, our entitled PM skips all the airport crises he created with his ArriveCan duplication, testing, layoffs, and lockdowns. Who really believes he follows all the mandates he imposes on us? With homage to that old Tiny Tim shrill song Tip Toe Thru the Tulips With Me, he free-floats in his loafers past all of us peasants especially those who stupidly voted for his not-at-all-liberal party (and the complicit-by-support NDP). Now, sing along, Tip toe past Pearson, over Ottawa, with meeee To quote early American president Thomas Jefferson, The government you elect is the government you deserve. That goes for Canada too. Canadians are now living their choices.

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Dyan CrossOttawa

(Sad but true)

TAX IMPACT

There is a lesson for our Liberal government in the Aug. 14 editorial regarding the U.S. rejection of a national carbon tax in favour of massive tax credits for green energy and increased support for off-shore drilling rights. Its probably too late, but I wish that Ministers Guilbeault and Wilkinson had shown a similar understanding of what is required to meet GHG emissions, as the U.S. has, before they became victims of the onerous anti-energy policies of the Liberal government and the ineffective carbon tax. The carbon tax will have zero impact on global GHG emissions, and as for relief for Canadian taxpayers, even the PBO disputes the purported rebate percentage to taxpayers of the carbon tax.

Duane SharpMississauga

(Exactly it will have no impact other than in our pocket books. The Trudeau/NDP government dont care for anything other than a good talking point)

HEAL UP

If Ontario has a medical crisis, why are we still practicing reactionary medicine and not proactive preventative medicine. Early detection through annual check-ups by either a doctor or trained medical nurse/practitioner can substantially reduce hospital care and crowding. Do the math.

William DivitcoffToronto

(The system is such a mess they probably dont even think this way)

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Letters to the Editor, Aug. 19, 2022 - Toronto Sun

Flu and viral: If you are down with the flu, you must isolate yourself to limit spread

A viral infection is known as influenza. It targets the respiratory system, including the nose, throat, and lungs. Although influenza is frequently referred to as the flu, it differs from stomach "flu" viruses that cause vomiting and diarrhoea. The flu often goes away on its own for most people. But occasionally, influenza and its side effects might be fatal.

Understanding the flu, its symptoms, prevention, and treatment can help you better deal with it. In this article, we discuss some of the most frequently asked questions regarding the flu.

1. How are flu virals spread?

Flu virals can spread in various ways. They may spread through airborne respiratory droplets (coughs or sneezes), touching a contaminated surface, saliva (kissing or shared drinks), skin-to-skin contact (handshakes or hugs), etc.

2. What causes flu spike in monsoon?

The sudden change in weather and fluctuation in temperature can cause influenza. Low immunity is also a reason. The best time for pathogenic microorganisms to reproduce is regarded to be the monsoon season, also referred to as the flu season.

The monsoon season has greater rates of disease than other times of the year because of the humidity, dirt, and standing water that function as a breeding ground for many viruses and bacteria. At this time of year, adopting a healthy lifestyle and improving living conditions can be effective preventative measures.

3. How can we prevent getting virals?

Physician Dr. Balamurugan suggests, The best way to prevent the flu is through annual vaccinations. Each flu shot protects against three to four different influenza viruses within that year's flu season.

Other ways to prevent spreading this disease include washing hands regularly, avoiding large crowds specifically during a flu outbreak, covering mouth and nose when cough or sneeze, staying home. Adds Dr. Balamurugan.

4. Should viral patients isolate? If yes, for how long?

Yes, 4 to 5 days after the onset of symptoms. The virus is transmissible and can transfer from one sick person to the other. Make sure to isolate and stay at home to reduce the spread.

5. Do flu virals cause long-term damage to us?

The flu can have some long-term effects, like increased risk of heart attack and stroke. And can worsen long-term medical conditions, like congestive heart failure, asthma, or diabetes. Mentions Dr. Balamurugan. Hence, it is ideal to seek the necessary vaccine and medication. Prevention is better than cure. You are encouraged to follow necessary preventive measures.

6. How to treat flu virals?

Dr. Balamurugan suggests, Flu is primarily treated with rest and fluid intake to allow the body to fight the infection on its own. Decongestant, Cough medicine, Nonsteroidal anti-inflammatory drug, Analgesic, and Antiviral drug. An annual vaccine can help prevent the flu and limit its complications.

7. How helpful is the influenza vaccine?

Flu vaccination can reduce the risk of flu-associated hospitalization. Flu vaccination has been shown in several studies to reduce the severity of illness in people who get vaccinated but still get sick. It is an important preventive tool for people with certain chronic health conditions. Vaccination helps protect pregnant people during and after pregnancy and may even be lifesaving in children.

In conclusion, proper care and isolation can help lower the spike in flu cases this monsoon. Proper vaccines and medication help eradicate the flu without causing severe damage to our bodies.

Disclaimer: This content including advice provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. NDTV does not claim responsibility for this information.

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Flu Viral: Here Are The Most Common Queries Answered - NDTV

By: Nyima Sillah

Covid-19 vaccine has immensely contributed to the immunization of the most vulnerable which includes pregnant women, children and the elderly.

Gibril Gando Baldeh, a senior health communications officer at the Ministry of Health highlighted the importance of the Covid-19 vaccine on children, pregnant women, and elderly persons, saying that the Covid-19 vaccine is a preventative medicine that is meant to ensure that these children, pregnant women, and elderly persons are protected from the pandemic.

However, the health official said that there has been increased coverage of the number of people who are vaccinated and this applies to an increase in the number of people who are protected and prevented from the pandemic.

There is a link between children, pregnant women, and the elderly when it comes to the Covid-19 transmission and disease. First of all, children are very energetic and they go about a lot, so getting children vaccinated will go a long way. It will not only prevent kids from the disease or from the virus but also will prevent them from hospitalization.

For pregnant mothers, it is very important since they are vulnerable it is important for them to receive the Covid-19 vaccine to avoid any complications due to the pandemic as we all know pregnant women have low immunity due to their pregnancy, so getting the vaccine will improve their immunity and will improve their health status especially when it regards to Covid-19, he said.

Finally, the elderly, are the most vulnerable when it comes to Covid-19 vaccination. The vaccination first targeted the elders because they mostly with low immunity and most of them are confronted with diabetes, hypertension, asthma, etc, these are the co-mobility which increase the risk of getting Covid-19 and also increased their chances of hospitalization, he added.

He confirmed that injecting children with the vaccine is not only going to improve their immunity but prevent them from Covid-19 or severe symptoms of Covid-19 but it also goes a long way by cutting down the chain of transmission which is very key.

He added that children are very active they can spread the virus to their parents and grandparents who will be at disadvantage due to their low immunity or due to the fact that they are having co-mobility diseases like diabetes, hypertension, and others that they are confronted with, so if the kids are not vaccinated the chances of transmission of diabetes and others will be high.

Considering the vulnerability of the pregnant women, children, and elderly, the Ministry of Health is appealing to the general public, especially to parents to ensure that since they are vaccinated to complete the cycle of prevention, they have to try and get their kids to be vaccinated.

It is very important for elders to get boosted. Not only receiving one shoot but it is important for elders to get a second dose or third dose which we refer to as boosters dose so that it will increase their immune system and prevent them from having a severe form of the disease, he revealed.

According to him, The Gambia started using the Covid-19 vaccine in 2021 March/ April until 2022, they reached all the vaccines that they were using for Covid-19, and they have people who are above the age of 18 and now since the arrival of the new Covid-19 vaccine which is Pfizer, they have been cleared by WHO to be used on children of 12 years and above.

Aminata Sambou, a pregnant woman said she took the Covid-19 J&J vaccination during her two months of pregnancy, adding that it happened at a time when pregnant women are more vulnerable to miscarriages.

She added that as she took the courage for the jab vaccination, she said nothing has happened to her except a common side effect that almost everyone that took the vaccine experienced which is a little bit of headache.

Aboubacarr Saidykan, a 67year old man also revealed that he took the jab vaccine since the introduction of the AstraZeneca which has boosted his immune system. The vaccine also showed a reduction in many of my severe illnesses. I felt some side effects on the first day but aside from that, I am fine and my health status is normal, he confirmed.

Furthermore, a mother of a 13-year-old child also explained the importance of the vaccine on his child and how it protected their old mother who is staying with them. I never hesitated for my child to get vaccinated, because I am 7 months pregnant and her grandmother is 69 years, so the risk of not getting vaccinated was high but now we all in good health, she confirmed.

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Gambia: How Covid-19 vaccine contributes to the immunization of the most vulnerable - - Voice Gambia Newspaper

Peter MA Calverley,1 Alberto Papi,2 Clive Page,3 Paola Rogliani,4 Roberto W Dal Negro,5 Mario Cazzola,4 Arrigo F Cicero,6 Jadwiga A Wedzicha7

1Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK; 2Respiratory Medicine, University of Ferrara, Ferrara, Italy; 3Sackler Institute of Pulmonary Pharmacology, Institute of Pharmaceutical Science, Faculty of Life Sciences and Medicine, Kings College, London, UK; 4Respiratory Medicine Unit, Department of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy; 5National Centre for Respiratory Pharmacoeconomics and Pharmacoepidemiology, Verona, Italy; 6Medical and Surgical Department, University of Bologna, Bologna, Italy; 7Respiratory Division, National Heart and Lung Institute, Imperial College London, London, UK

Correspondence: Peter MA Calverley, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK, Tel +44 1515295886, Fax +44 1515295888, Email [emailprotected]

Purpose: To explore the effect of erdosteine on COPD exacerbations, health-related quality of life (HRQoL), and subjectively assessed COPD severity.Patients and methods: This post-hoc analysis of the RESTORE study included participants with COPD and spirometrically moderate (GOLD 2; post-bronchodilator forced expiratory volume in 1 second [FEV1] 5079% predicted; n = 254), or severe airflow limitation (GOLD 3; post-bronchodilator FEV1 3049% predicted; n = 191) who received erdosteine 300 mg twice daily or placebo added to usual maintenance therapy for 12 months. Antibiotic and oral corticosteroid use was determined together with patient-reported HRQoL (St Georges Respiratory Questionnaire, SGRQ). Patient and physician subjective COPD severity scores (scale 04) were rated at baseline, 6 and 12 months. Data were analyzed using descriptive statistics for exacerbation severity, COPD severity, and treatment group. Comparisons between treatment groups used Students t-tests or ANCOVA as appropriate.Results: Among GOLD 2 patients, 43 of 126 erdosteine-treated patients exacerbated (7 moderate-to-severe exacerbations), compared to 62 of 128 placebo-treated patients (14 moderate-to-severe exacerbations). Among those with moderate-to-severe exacerbations, erdosteine-treated patients had a shorter mean duration of corticosteroid treatment (11.4 days vs 13.3 days for placebo, P = 0.043), and fewer patients required antibiotic treatment with/without oral corticosteroids (71.4% vs 85.8% for placebo, P < 0.001). Erdosteine-treated GOLD 2 patients who exacerbated showed significant improvements from baseline in SGRQ total scores and subjective disease severity scores (patient- and physician-rated), compared with placebo-treated patients regardless of exacerbation severity. Among GOLD 3 patients, there were no significant differences between treatment groups on any of these measures.Conclusion: Adding erdosteine to the usual maintenance therapy of COPD patients with moderate airflow limitation reduced the number of exacerbations, the duration of treatment with corticosteroids and the episodes requiring treatment with antibiotics. Additionally, treatment with erdosteine improved HRQoL and patient-reported disease severity.

Keywords: antibiotic, chronic obstructive pulmonary disease, erdosteine, COPD exacerbation, health-related quality of life, systemic corticosteroid

People with chronic obstructive pulmonary disease (COPD) can experience episodes of worsening symptoms (cough, breathlessness) of differing severity (mild, moderate, or severe exacerbations), and may need to be treated with antibiotics and/or oral steroids. We looked at the effects of adding an oral drug (erdosteine) to usual daily therapy for 12 months on exacerbation events, severity, treatment, and patient health status. We found that patients with moderate COPD had fewer exacerbations when taking erdosteine and that this was associated with a better health status. The patients with moderate-to-severe exacerbations were also less likely to require treatment with antibiotics or oral steroids. Patients with severe COPD did not show these effects when erdosteine was added to their usual therapy. Our results suggest that regular treatment with erdosteine may reduce exacerbations and improve the health status of some patients with COPD.

Acute episodes of symptomatic deterioration (exacerbations) have long been recognized as clinically important events for patients with chronic obstructive pulmonary disease (COPD) and were first used as a clinical trial endpoint over 20 years ago in the Inhaled Steroids in Obstructive Lung Disease in Europe (ISOLDE) study.1 Subsequent analyses of interventional and observational studies showed that exacerbations led to sustained worsening of health-related quality of life (HRQoL) and contributed to disease progression.2,3 Prolonged recovery from an exacerbation was associated with a poorer HRQoL and increased risk of further exacerbations.4 Treatment of COPD aims to prevent exacerbations and/or shorten their frequency, severity, and/or duration.5,6

A pragmatic definition of exacerbations based on worsening symptoms and increased use of treatment was developed for use in clinical trials and has subsequently been applied more widely.7,8 Moderate episodes were considered to require treatment with antibiotics and/or systemic corticosteroids while severe events require hospitalization. Using this definition, it was shown that long-acting inhaled bronchodilators alone9 or in combination with inhaled corticosteroids (ICS) could decrease the rate of exacerbations and that this was associated with improvements in health status.10 Recent data highlight the heterogeneity of these events11 with differential responses to preventative therapy12 and differing in clinical courses.13 The symptomatic episodes managed solely by increases in existing medication were harder to define and required daily diary card monitoring to characterize properly. Nonetheless, these milder events are associated with more health care utilization,14 and worse health status even in individuals who have yet to develop airflow obstruction.15 Whether treatment that reduces the number of mild exacerbations also improves patient health status is still unclear.

Erdosteine is a mucoactive drug with additional pharmacological properties (anti-inflammatory, antioxidant, bacterial anti-adhesiveness) that is commonly used in the treatment of COPD.16 The Reducing Exacerbations and Symptoms by Treatment with Oral Erdosteine in COPD (RESTORE) study showed that COPD patients treated with erdosteine with a history of moderate or severe exacerbations had a decreased exacerbation rate and shortened duration of events without alterations in lung function.16 In a further analysis of these data, we showed that the principal benefits of erdosteine treatment occurred in patients with less severe disease defined spirometrically and where more mild exacerbations occurred. In fact, in these patients there was a 58.3% reduction in the mild exacerbation rate with erdosteine, compared to placebo, irrespective of concurrent treatment with ICS.17

In this manuscript, we have further explored these data to better characterize the effect of erdosteine on the moderate-to-severe exacerbations, to determine whether the decrease in exacerbations in moderate COPD led to changes in health status, and whether this was the case for both mild and moderate-to-severe exacerbation events.

The RESTORE study (NCT01032304) was a Phase III multinational, randomized, double-blind, placebo-controlled study conducted in 10 European countries. Full details of the study design, inclusion and exclusion criteria, ethical approval, and results have been reported elsewhere.16 Briefly, after a 2-week run-in period with their usual COPD therapy to confirm clinical stability, 467 COPD patients with moderate or severe airflow limitation (grade II/III, GOLD 2007 classification) were randomized to receive either oral erdosteine at a standard approved dose (300 mg twice daily, n = 228) or placebo (n = 239) for 12 months as add-on therapy to their usual COPD treatment. Participants were outpatients aged 4080 years, current or ex-smokers (10 pack-years), on a stable therapeutic regimen for 8 weeks prior to inclusion, and who had experienced 2 acute COPD exacerbations requiring medical intervention in the previous 12 months, but with no exacerbations in the preceding 2 months.

The study protocol was approved by local ethics committees as outlined in the primary report and subsequent data analysis.16,17 In the UK, this was done by the South Sefton Research Ethics Committee. Each participant provided written informed consent prior to study enrolment and the trial was conducted in accordance with the Declaration of Helsinki.

In this post-hoc analysis we reclassified patients participating in the RESTORE study using the spirometry criteria from the GOLD 2022 guidelines.8 Thus, COPD patients with moderate airflow limitation (GOLD 2) were defined as having a post-bronchodilator forced expiratory volume in one second (FEV1) between 50% and 79% predicted, and patients with severe airflow limitation (GOLD 3) had a post-bronchodilator FEV1 between 30% and 49% predicted; both subgroups had a post-bronchodilator fixed ratio FEV1/forced vital capacity [FVC] <0.70.

A COPD exacerbation was defined as a worsening of symptoms beyond normal day-to-day variation that required a change in regular medication and/or health care resource utilization.7 Exacerbations were confirmed by the investigators from the variation in daily symptom (dyspnea, cough, sputum) scores, changes in regular medication, use of additional medication or emergency hospitalization for COPD, as recorded in the patient diary. Exacerbation severity was graded as mild, moderate, or severe (Supplementary Table 1) and patients were grouped as having mild or moderate-to-severe exacerbations. Patients may have had more than one exacerbation during the 12-month treatment period: those in the moderate-to-severe exacerbations subgroup may also have had mild exacerbations, but patients in the mild exacerbations subgroup did not have moderate-to-severe exacerbations during the 12 months of treatment. Use of oral corticosteroids and/or antibiotics, and the duration of such treatment for an acute exacerbation was determined from data recorded in the daily diary. All use of oral corticosteroids was converted to prednisolone equivalent doses (Supplementary Table 2).

HRQoL was self-assessed by patients at baseline and after 6 and 12 months of treatment using the St. Georges Respiratory Questionnaire (SGRQ), a validated 76-item questionnaire developed to measure health status in patients with chronic airflow limitation.18 The questionnaire has three domains measuring symptoms, activity limitation, and impact on daily life. The total score is calculated from the domain scores and ranges from 0 (no effect) to 100 (maximum effect), with lower scores corresponding to a better health status. A change of 4 points is considered the minimal clinically important difference (MCID) relevant to the patient.19

Subjects and Physicians Global Assessment of Disease Severity was assessed at baseline and after 6 and 12 months of treatment. Subjects were asked: Overall, on a scale 04, how troublesome is your lung problem today? Responses were graded as: 0 = not troublesome at all; 1 = a little troublesome; 2 = moderately troublesome; 3 = very troublesome; 4 = unbearably troublesome. At the same visits, investigators were asked to respond to the following question: Based on clinical examination and patient interview, how would you rate patients COPD? Responses were graded as: 0 = subject with stable COPD, none or minimal symptoms; 1 = subject with stable COPD, occasional symptoms, fully functional; 2 = subject with stable COPD, recurring symptoms, slight functional impact; 3 = subject with stable COPD, frequent moderate to severe symptoms, functionality limited; 4 = subject with stable COPD, constant severe symptoms, functional impairment.

All post-hoc efficacy analyses were conducted using intention-to-treat (ITT) principles on randomized patients who received at least one dose of study treatment and had at least one available post-baseline efficacy evaluation.

Baseline characteristics are reported using descriptive statistics (means and standard deviations [SD] or percentages). Comparisons between treatment groups were performed using the Chi-squared test followed by Fishers exact test. Comparisons between COPD severity groups (GOLD 2 vs GOLD 3) were performed using Students t-tests for unpaired samples (if normal distribution) or MannWhitney U-tests.

SGRQ total scores and patient and physician subjective disease severity scores at baseline, 6 months, and 12 months in patients who experienced exacerbations are presented as mean (95% confidence intervals [CI]) by COPD severity (GOLD 2 or GOLD 3), exacerbation severity (mild or moderate-to-severe), and treatment group (erdosteine or placebo). Changes in trend over time for each treatment group were analyzed using Residual Maximum Likelihood (REML) or least squares method. Comparisons between treatment groups were based on an analysis of covariance (ANCOVA) model including the fixed effects of treatment. The percentage of people showing a decrease in SGRQ total score of at least 4 points was calculated for the GOLD 2 group by exacerbation severity and treatment group.

The percentage of patients with moderate-to-severe exacerbations who used antibiotics and/or oral corticosteroids are reported by COPD severity and treatment group. Comparisons between treatment groups were performed using the Chi-squared test followed by Fishers exact test. Oral corticosteroid doses are presented as mean (SD) prednisolone-equivalent daily dose and as total dose over 12 months, and comparisons between treatment groups used Students t-tests for unpaired samples. Duration of oral corticosteroid treatment was determined by COPD severity, exacerbation severity, and treatment group. Comparisons between treatment groups was based on an ANCOVA model including fixed effects of treatment.

Statistical analyses were performed using SPSS version 21.0 (IBM, Armonk, NY, USA). A two-sided p-value <0.05 was considered nominally significant for all tests.

In this post-hoc analysis of data from the RESTORE study, 254 patients had COPD with moderate airflow limitation (GOLD 2; post-bronchodilator FEV1 5079% predicted) and 191 patients had COPD with severe airflow limitation (GOLD 3; post-bronchodilator FEV1 3049% predicted). Of the GOLD 2 patients, 126 received erdosteine and 128 received placebo. In the GOLD 3 subgroup, 89 received erdosteine and 102 received placebo. Figure 1 shows the flow of patients considered in this analysis (ITT population).

Figure 1 Flow chart of patients in the analysis by treatment group, severity of COPD, exacerbation status, and severity of exacerbations (ITT population). All numbers refer to numbers of patients.

Abbreviations: COPD, chronic obstructive pulmonary disease; GOLD, global initiative for chronic obstructive lung disease; ITT, intention-to-treat.

The baseline demographic and clinical characteristics of the patients did not differ between treatment groups within each subgroup by COPD severity or for the total RESTORE population (Table 1). As expected, the GOLD 2 subgroup had significantly higher FEV1 and FVC values and significantly fewer patients were using ICS, compared with the GOLD 3 subgroup.

Table 1 Demographic and Baseline Characteristics of Patients (ITT Population)

In the GOLD 2 subgroup (n = 254), there were 127 exacerbations in 105 patients during the 12 months of treatment with erdosteine or placebo: 38 were moderate-to-severe exacerbations in 21 patients (7 patients in the erdosteine group and 14 patients in the placebo group), and 89 were mild exacerbations in 84 patients (36 patients in the erdosteine group and 48 patients in the placebo group). In the GOLD 3 subgroup (n = 191), there were 330 exacerbations in 161 patients: 133 moderate-to-severe exacerbations in 119 patients (55 patients in erdosteine group and 64 patients in placebo group), and 197 mild exacerbations in 42 patients (20 patients in erdosteine group and 22 patients in placebo group). The baseline demographic and clinical characteristics of patients with GOLD 2 and GOLD 3 COPD who experienced exacerbations by observed exacerbation severity are shown in Supplementary Tables 3 and 4.

In the GOLD 2 subgroup, the baseline mean SGRQ total score for those erdosteine-treated patients who experienced exacerbations during follow-up was 38.5 (SD 10.9): the scores were 33.3 (SD 9.0) for those with mild exacerbations and 44.4 (SD 12.3) for those with moderate-to-severe exacerbations. In the corresponding GOLD 2 placebo group, the baseline mean SGRQ total score was 38.8 (SD 11.4) for those who experienced exacerbations: 33.4 (SD 11.2) for those with mild exacerbations and 43.8 (SD 11.8) for those with moderate-to-severe exacerbations. The baseline mean SGRQ total scores for patients with GOLD 3 COPD (all exacerbations) were 50.7 (SD 17.3) and 49.2 (SD 16.7) for the erdosteine and placebo groups, respectively (Supplementary Table 5).

The mean SGRQ total score decreased significantly from baseline over 12 months of treatment with erdosteine but not with placebo in GOLD 2 patients who experienced exacerbations; the decrease in SGRQ total score and between-treatment comparisons were significant regardless of exacerbation severity (Figure 2, Supplementary Table 5). There were no significant changes from baseline in SGRQ total score or between-treatment difference among GOLD 3 patients who experienced exacerbations or for all RESTORE patients with exacerbations (Supplementary Table 5). Of the GOLD 2 patients who exacerbated during 12 months of follow-up, a 4-point decrease in SGRQ score was seen for 13.9% of erdosteine-treated patients and 4.6% of placebo-treated patients. For those with moderate-to-severe exacerbations, this MCID occurred in a higher proportion of erdosteine recipients (28.5%) than in those taking placebo (7.2%; P < 0.001). Among the GOLD 2 patients with mild exacerbations, a 4-point decrease in SGRQ score was seen for 11.1% of erdosteine-treated patients and 6.3% of placebo-treated patients (P = 0.003).

Figure 2 Mean SGRQ total score for GOLD 2 patients with moderate COPD who experienced exacerbations in each treatment group (erdosteine or placebo) and for the subgroups by exacerbation severity (mild or moderate-to-severe). A lower score represents a better HRQoL. Patients may have experienced more than one exacerbation, but those in the mild exacerbations subgroup only experienced mild exacerbations, while those in the moderate-to-severe exacerbations subgroup may also have experienced mild exacerbations. The n value for each treatment group is the number of patients with exacerbations. There were 127 exacerbations overall (89 mild exacerbations and 38 moderate-to-severe exacerbations). Analysis was conducted in the ITT population and based on ANCOVA model including fixed effects of treatment. P values given above the columns are for significant changes in trend over time for each treatment and for the treatment comparison; they were analyzed using the Residual Maximum Likelihood or least squares method. *P < 0.05 versus placebo at each timepoint.

Abbreviations: ANCOVA, analysis of covariance; COPD, chronic obstructive pulmonary disease; GOLD, global initiative for chronic obstructive lung disease; HRQoL, health-related quality of life; ITT, intention-to-treat; SGRQ, St Georges respiratory questionnaire.

The scores from the patients assessment of disease severity (Table 2) show that erdosteine-treated GOLD 2 patients experiencing exacerbations reported a significant reduction in mean disease severity score over time (1.49 at baseline to 1.25 at 12 months, P = 0.021) that was significantly different from the scores reported by the placebo group (1.50 at baseline and 1.54 at 12 months, P < 0.001 for treatment group comparison). The significant reduction in patient perception of disease severity in erdosteine-treated GOLD 2 patients was seen regardless of the severity of exacerbation. GOLD 3 patients with exacerbations did not report improved subjective severity scores over time or differences between treatment groups (Table 2). Similar results were found for the physician global assessment of disease severity (Supplementary Table 6).

Table 2 Patient Subjective Assessment of Disease Severity Over Time by COPD Severity, Exacerbation Severity and Treatment Group

Systemic corticosteroids were used by 89% (125/140) of the RESTORE population to manage exacerbations irrespective of the spirometric severity of their disease. In the GOLD 2 subgroup, systemic corticosteroids were used by a significantly lower proportion of patients receiving erdosteine (85.7%) compared with placebo (92.9%, P < 0.05), while 89% of GOLD 3 patients in both treatment groups were treated with oral corticosteroids. Different centers used different corticosteroids (see prednisolone-equivalent doses in Supplementary Table 2). Figure 3 shows the pattern of antibiotic use for moderate-to-severe exacerbation treatment in the RESTORE population. Significantly fewer GOLD 2 patients with moderate-to-severe exacerbations were treated with antibiotics oral corticosteroids when they were taking erdosteine (71.4%) as compared to placebo (85.8%, P < 0.05). This difference in antibiotic use oral corticosteroids between treatment groups was also seen in GOLD 3 patients (84.5% in erdosteine group vs 89.6% in placebo group, P < 0.05).

Figure 3 Proportion of patients with moderate-to-severe exacerbations who used antibiotics alone and with oral corticosteroids by disease severity (GOLD 2 or 3) and treatment group. The percentage value in italics above each stacked bar is the total percentage of patients treated with antibiotics (with or without oral corticosteroids); the remaining patients with moderate-to-severe exacerbations received oral corticosteroids alone. The P values above the columns are for the comparisons of erdosteine versus placebo for the total percentage of patients treated with antibiotics. The asterisks between columns represent *P < 0.05 for erdosteine versus placebo groups within each antibiotic treatment group (antibiotic + oral corticosteroid or antibiotic alone). Analysis used a Chi-square test followed by Fishers exact test.

Abbreviation: GOLD, global initiative for chronic obstructive lung disease.

In the GOLD 2 subgroup, the number of patients was similar in the erdosteine and placebo groups (Table 1). Among those GOLD 2 patients who experienced moderate-to-severe exacerbations, the mean total dose of oral corticosteroids over the 12-month study period was significantly lower for erdosteine-treated patients (251.9 mg) versus those receiving placebo (320.5 mg, P < 0.001), although the mean daily dose of oral corticosteroid treatment over the same time period did not differ between the groups (Table 3). The difference in total corticosteroid dose between the erdosteine and placebo groups was due to a significantly shorter treatment duration with oral corticosteroids for moderate-to-severe exacerbations (mean 11.4 days vs 13.3 days, P = 0.043). In the GOLD 3 subgroup, the oral corticosteroid dose (total dose or average daily dose) and treatment duration did not differ between the erdosteine and placebo groups.

Table 3 Oral Corticosteroid Total Dose and Average Daily Dose (Prednisolone-Equivalents) Over 12 Months in Patients Experiencing Moderate-to-Severe Exacerbations by COPD Severity and Treatment Group

Much of our understanding about COPD exacerbations and their prevention has been driven by the results of treatment trials and this further analysis of the RESTORE dataset contributes to this process. Early intervention in COPD patients could lead to beneficial effects on disease progression and clinical outcomes; the early treatment might be reasonable with the aim of achieving better clinical outcomes in COPD, ameliorating the decline in lung function, and improving the health status.20 Regular early treatment with erdosteine, as add-on therapy, showed a significant effect on rate and duration of exacerbations.16

Patients who had a moderate-to-severe exacerbation while taking erdosteine were less likely to receive antibiotics and had a lower requirement for oral corticosteroids than those taking placebo, especially if they had moderate airflow obstruction when stable The health status of GOLD 3 patients with severe COPD was worse than in those with GOLD 2 moderate disease and was uninfluenced by erdosteine. By contrast, erdosteine use was associated with better health status in GOLD 2 patients who experienced an exacerbation, and this was supported by the subjective global assessments of disease severity scored blinded to maintenance treatment. These observations have clinical relevance.

For many years, treatment trials and observational studies have used a health care utilization definition of exacerbation in identifying differing clinical courses of these acute episodes.13 However, it is now clear that episodes that are not treated with antibiotics and corticosteroids still impact the patients health status,14 while some preventive treatments (ICS) mainly act by decreasing episodes where corticosteroids are used15 or are less effective as airflow obstruction worsens.21,22 Anti-inflammatory therapies like ICS and the phosphodiesterase-4 inhibitor roflumilast are most effective in patients with higher blood eosinophil counts.23,24 Erdosteine has a different anti-inflammatory action and its effects on exacerbation prevention are unrelated to the blood eosinophil count.17 Erdosteine may enhance the effectiveness of co-administered antibiotics in vivo and when given as a treatment for COPD exacerbations, by a variety of mechanisms including effects on bacterial adhesiveness and increasing sputum antibiotic concentrations.2527 In our analysis, fewer patients required antibiotic treatment when they experienced an exacerbation if erdosteine was used as maintenance therapy, although the reason for this cannot be definitively addressed with the data available. The episodes treated with oral corticosteroids were managed similarly in terms of the daily dose but the overall corticosteroid exposure was reduced as the exacerbations were shorter when erdosteine was used. Decreasing the patients exposure to systemic corticosteroids is an important goal of management and the results observed with erdosteine in this study suggest that this drug could be helpful in this regard, at least in patients with less severe airflow obstruction.

The association between worse health status and a higher exacerbation frequency is well established for both reported and unreported exacerbations.14,28 The focus on episodes treated with antibiotics and/or corticosteroids has led to the impression that only these episodes are important. Our data suggest that this is not so, at least among patients with moderate COPD who experience an exacerbation. In our GOLD 2 group, where similar numbers received erdosteine or placebo, the SGRQ scores over the year differed between the exacerbators in these two groups. Among the erdosteine-treated GOLD 2 patients who had a moderate-to-severe exacerbation event, health status had improved significantly by 6 months after randomization and this change was maintained at 12 months compared to those who exacerbated while using placebo. The same was observed for patients with mild exacerbations. These findings were also supported by the subjective global assessment questions, which identified reduced disease severity in the erdosteine-treated GOLD 2 group, regardless of exacerbation severity. The health status of exacerbators taking placebo was stable in moderate disease but improved with erdosteine, with approximately 14% of erdosteine-treated GOLD 2 patients reaching and maintaining the conventional 4-point threshold of clinical significance in SGRQ score over one year. Whether this difference reflected the shorter duration of these exacerbation events or the conversion of more severe events into less severe ones cannot be resolved here. However, there was a clear difference in the behavior of the moderate and severe disease groups. In the latter, exacerbations were more frequent, involved both mild and moderate-to-severe episodes in the same individual, and showed no impact of erdosteine on patient health status. Whether these differences in the response to an exacerbation reflect differences in the triggers to exacerbation or the host response to the event requires further prospective study.

Our study has both strengths and limitations. The RESTORE population was well characterized with both diary card data and an agreed prospective classification of exacerbations based on treatment given. The lack of side effects associated with erdosteine16 helped with patient retention in the trial and there was no evidence of differential dropout, something which has complicated the interpretation of other trials.29 Although our treatment groups were well matched at baseline, we did not adjust further for potential covariates of interest given the relatively small sample size available in each arm of the study. We did not pre-specify criteria for the way in which exacerbations should be managed but left this to the clinicians usual practice. We recognize that different countries adopt different policies to the selection of antibiotics and the dose of oral corticosteroids used in exacerbation management, but we do not believe that these differences introduced a systematic bias into our data. We used the SGRQ as our principal measure of health status, although the validity of our observations of a differential effect in moderate and severe COPD are supported by the patient and physician global health assessments. Although less robustly validated, these simple clinically applicable tools showed consistency with each other and with the longer SGRQ tool, supporting the usefulness of rapid clinical assessment in evaluating patient health status. However, our study was relatively small compared with other intervention studies and the analyses performed in this manuscript were all post hoc evaluations; thus, the results presented are not conclusive and need to be interpreted with caution, but they do allow the generation of hypotheses that can be tested in future studies.

This further analysis of the RESTORE data set confirms the heterogeneity of exacerbation events which are defined by their differing needs for medical treatment. Patients who have moderate COPD not only have fewer exacerbations when taking erdosteine, but also are less likely to require antibiotic treatment in those that do occur. Furthermore, their overall exposure to systemic corticosteroids of all types is less as the events needing treatment are briefer and less frequent. Measurable improvements in health status are seen in both mild and moderate-to-severe exacerbations in patients who still go on to exacerbate and these are recognizable to both the patient and their doctors, emphasizing the need to not only reduce the number of exacerbations, but also the duration of the ones that do occur. The lack of an impact of erdosteine in patients with more severe disease also indicates that not all exacerbations are the same and that different factors drive the clinical presentation of these events at different stages in the natural history of COPD. Importantly for our understanding of COPD exacerbations, mild exacerbations do affect patient health status, and their reduction following chronic treatment with erdosteine is associated with improved health status that is noticeable to both patients and their physicians. Managing these mild-to-moderate episodes should not be neglected and our data suggest that regular treatment with erdosteine, a drug that is orally active and well tolerated may be a useful treatment in early disease.

ANCOVA, analysis of covariance; BMI, body mass index; CI, confidence interval; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; GOLD, global initiative for chronic obstructive lung disease; HRQoL, health-related quality of life; ICS, inhaled corticosteroid; ITT, intention-to-treat; MCID, minimal clinically important difference; REML, residual maximum likelihood; RESTORE, reducing exacerbations and symptoms by treatment with oral erdosteine in COPD; SD, standard deviation; SGRQ, St Georges respiratory questionnaire.

The data included in this paper are from a post hoc analysis of the RESTORE study and are not publicly available.

Medical writing assistance was provided by Deirdre Elmhirst, PhD, of Elmhirst Scientific Consultancy Limited, funded by Edmond Pharma.

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the manuscript; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Funding, medications, and investigators meeting costs for the RESTORE study were provided by Edmond Pharma. No specific funding was received regarding this manuscript.

P Calverley reports personal fees from Recipharm, during the conduct of the study; personal fees from Edmond Pharma, Novartis, Phillips Respironics, and Genentech, outside the submitted work. P Rogliani participated as a lecturer and advisor in scientific meetings sponsored by Almirall, AstraZeneca, Biofutura, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline (GSK), Menarini Group, MSD, Mundipharma, Novartis, Edmond Pharma and Roche. Her department was funded by Almirall, Boehringer Ingelheim, Chiesi Farmaceutici, Novartis, and Zambon. J Wedzicha reports grants from AstraZeneca, personal fees from Chiesi Farmaceutici, Novartis, grants, personal fees from GSK, grants from Boehringer Ingelheim, personal fees from Gilead, grants from Genentech, outside the submitted work. A Papi reports grants from Chiesi Farmaceutici, AstraZeneca, GSK, Boehringer Ingelheim, Teva, Sanofi, personal fees from Chiesi Farmaceutici, AstraZeneca, GSK, Novartis, Sanofi, IQVIA, Avillion, Elpen Pharmaceuticals, MSD, Boehringer Ingelheim, Menarini, Zambon, Mundipharma, Teva, Edmond Pharma, outside the submitted work. M Cazzola and C Page are consultants to Edmond Pharma who manufactures and markets erdosteine. C Page reports personal fees from Edmond Pharma, during the conduct of the study; equity from Verona Pharma, personal fees from Glycos Innovation, personal fees from Eurodrug, personal fees from worldwide clinical trial, outside the submitted work; and Non Executive Director of Epiendo Pharmaceuticals. AF Cicero reported personal fees from Edmond Pharma. The authors report no other conflicts of interest in this work.

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