A blockbuster diabetes drug significantly reduced the risk of hospitalization and death in people with all types of heart failure, according to a large international study led by a researcher at Brigham and Womens Hospital.

The clinical trial found that AstraZenecas drug Farxiga reduced cardiovascular death or worsening heart failure by 18 percent when compared with a placebo in 6,000 patients followed for a median of 2.3 years in 20 countries. Farxiga was first approved in 2014 for the treatment of type 2 diabetes and generated $1 billion in quarterly sales in the first three months of 2022.

Dr. Scott D. Solomon, a professor of medicine at Harvard Medical School and Brigham and Womens, and principal investigator for the study, said a separate meta-analysis he helped conduct of more than 12,000 patients confirmed that Farxiga and a rival drug called Jardiance, sold by Boehringer Ingelheim and Eli Lilly and Co., decreases the number deaths, as well as urgent trips to hospitals.

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We now have really very definitive evidence that regardless of what type of heart failure a patient has, they would benefit from being on this class of drugs, said Solomon. The studies were published in the New England Journal of Medicine, The Lancet, and Nature Medicine. Solomon helped present the findings at the European Society of Cardiology Congress in Barcelona over the weekend.

Heart failure, sometimes known as congestive heart failure, occurs when the heart muscle doesnt pump blood as well as it should. Blood often backs up, and fluid can build up in the lungs, causing shortness of breath, fatigue, and swelling in the legs. The condition, which becomes more common with age, is the leading cause of hospitalization in people over 65 years old, according to the US Food and Drug Administration. It affects more than 650,000 in the United States each year.

Both Farxiga and Jardiance are known as SGLT2 inhibitors and cause the body to excrete sugar in urine. For reasons not entirely understood by scientists, Solomon said, the drugs also appear to slow the progression of heart failure. And thats true for the two main groups of patients: those whose heart muscles dont contract properly, and those whose muscles contract properly but whose chambers dont relax. Both forms of the disease can diminish blood flow.

In February, the FDA allowed Jardiance, which had previously been approved for those patients whose heart muscles dont contract properly, to be prescribed to all of them. Solomon said AstraZeneca has requested similar approval for Farxiga, which is only cleared for the first subset of heart failure patients. He expected the FDA to make a decision in the first half of 2023.

Heart failure remains one of the leading causes of death worldwide with high unmet need for some 64 million people, Mene Pangalos, AstraZenecas executive vice president overseeing research and development of biopharmaceuticals, said in a statement.

Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.

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Brigham and Womens researchers say diabetes drug helps reduce heart failure - The Boston Globe

Investigators have identified at least 2 new risk factors for liver-related mortality in patients with hepatitis C virus (HCV).

A team, led by Nobuhiro Hattori, Department of Internal Medicine, Division of Gastroenterology and Hepatology, St. Marianna University School of Medicine, identified the risk factors linked to liver-related and non-liver-related mortality in patients with HCV following sustained virologic response to direct-acting antiviral agents.

In the retrospective, single-center cohort, the investigators examined 330 patients with HCV cured by DAAs. There was a median follow-up of 3.38 years. Each patient was administered IFN-free DAA treatment between September 2014 and January 2021 at the St. Marianna University Hospital. In addition, the patients with a history of hepatocellular carcinoma (HCC) did not have active HCC at the time of initiation of their final DAA therapy.

The study included 1481 person-years of follow-up, with 25 patients dying during the course of the study.

The investigators also collected data on age, sex, HCV genotype, history of HCC, previous DAA treatment, diabetes mellitus (DM), and hypertension history.

The team also collected laboratory test results, including aspartate aminotransferase (AST), alanine aminotransferase (ALT), albumin, total bilirubin, platelet, alpha-fetoprotein (AFP), and mac-2 binding protein glycan isomer (M2BPGi) before the final DAA treatment and at 12weeks after the end of treatment.

The investigators sought primary outcomes of the incidence and predictors of liver-related and non-liver-related deaths of patients with HCV cured by IFN-free DAA treatment.

They also identified the cumulative all-cause, liver-related, and non-liver-related mortality using Kaplan-Meier methods and univariate and multivariate Cox proportional hazard models to identify the predictors of liver-related and non-liver-related deaths.

The results show a cumulative liver-related or non-liver-related mortality rate of 0.00 or 1.29% at year 1, compared to 2.87 or 3.60% at year 3 and 5.10 or 9.46% at year 5.

For liver-related deaths, 90% (n = 9) were from liver cancer, while the most common cause of non-liver-related deaths was malignancy.

After conducting a multivariate analysis using the Cox proportional hazard model, the investigators found diabetes mellitus (HR, 13.1; 95% CI, 2.8161.3) and a history of hepatocellular carcinoma (HR, 12.8; 95% CI, 2.7659.2), independently predicted liver-related death. There were no variables linked to non-liver-related death.

Our findings suggest that DM and a history of HCC are risk factors for liver-related mortality of HCV patients cured by DAAs, the authors wrote. These results indicate that early management of HCV and HCC surveillance of diabetic patients after SVR are important to increase the chance of survival. Further studies are needed to confirm the association of DM and HCC history with survival.

The study, Risk factors for liver-related mortality of patients with hepatitis C virus after sustained virologic response to direct-acting antiviral agents, was published online in JGH Open.

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Diabetes Mellitus, HCC Linked to Liver-Related Mortality in HCV Patients - MD Magazine

Controlling blood sugar levels is important for people with diabetes to avoid health complications. While persistent high blood sugar levels (hyperglycaemia) can affect your heart, nerves, kidney over a period of time, low glucose levels (hypoglycaemia) on the other hand can cause confusion, dizziness and even coma or death. If your blood sugar is lower that 70 mg/dl, then you must immediately take steps to correct it. If your blood glucose levels fall too low, there will be telltale signs from intense hunger, feeling of anxiety, mood changes, difficulty in concentration and clumsiness. (Also read: Are you at risk of diabetes? Factors that increase your chances of getting the disease)

In case you are experiencing low sugar levels, you can quickly have a simple sugar source, such as glucose tablets, hard candy or fruit juice. If you are feeling confusion or dizziness, you must immediately inform your friends or family members.

"As a person living with diabetes, you know how important it is to reduce blood sugar when it is too high, a phenomenon called hyperglycaemia. But blood sugar that is too low, or hypoglycaemias, is equally critical to avoid This decrease in blood sugar levels can cause both short-term complications, like confusion and dizziness, as well as more serious issues, including seizures, coma," writes Karishma Shah, nutritionist and wellness expert in her recent Instagram post.

Shah also talked about signs of low blood sugar levels in her post.

1. Ravenous hunger

If you suddenly, inexplicably feel as if you are starving your body is signalling that it's experiencing a blood sugar drop. A good starting point is to eat between 15 & 20 grams (g) of carbohydrates with each snack and between 40 and 65 gm at each meal.

2. Feeling of anxiety

When glucose levels fall too low your body releases the hormones epinephrine (also called adrenaline) and cortisol which signals the liver to release more sugar into the blood. This can lead to anxiety and its associated symptoms.

3. Emotional instability

Mood swings and sudden emotional episodes not typical of your normal behaviour are among the neurological symptoms of hypoglycaemia and can include irritability, stubbornness, and feelings of depression.

4. Difficulty concentrating

The brain relies on blood sugar for energy, so if there's a drop in glucose, your brain may not function properly. That can make it difficult to concentrate on one thing at a time.

5. Slurred speech and clumsiness

Your sugar-starved brain may change the way your sound. Slurred speech is a common symptom associated with blood sugar levels that drop below 40mg/dL.

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Diabetes: Signs that your blood glucose levels are too low - Hindustan Times

ORLANDO, Fla., Aug. 29, 2022 /PRNewswire/ -- Touched by Type 1 hosted its 5th Annual Conference on Saturday, August 27, 2022 to over 400 individuals Touched by Type 1 Diabetes at the Portofino Bay Hotel at Universal. This milestone is a major move for Touched by Type 1 on its mission to elevate awareness of Type 1 Diabetes.

"To have the ability to host a FREE, high quality day of education to those that need it most in the diabetes community, is simply a dream come true," says Elizabeth Forrest, Founder of Touched by Type 1. "For the first time ever, we provided an entire track in Spanish - something you will not find elsewhere in the type 1 diabetes world."

The 2022 Conference Featured:

The Touched by Type 1 Annual Conference is a conference for individuals of all ages and backgrounds. The goal is to educate, encourage, and empower all lives touched by Type 1 diabeteswhether they have Type 1 or a connection to someone who does. The annual conference provides the unique opportunity to be surrounded by the nation's top experts related to thriving despite diabetes.

Touched by Type 1: Elevates awareness of Type 1 Diabetes, raises funds to find a cure and inspires those with diabetes to thrive. For more information: http://www.TouchedbyType1.org.

Elizabeth ForrestTouched by Type 1407-474-4686[emailprotected]

SOURCE Touched by Type 1

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Touched by Type 1 Annual Conference - Educate, Encourage, and Empower all lives Touched by Type 1 Diabetes - PR Newswire

On Sept. 1, the nonprofit Blue Circle Health will partner with up to 15 Federally Qualified Health Centers across the state of Florida to launch diabetes support coaching services while it continues to build a team and infrastructure to offer more support and care focused on Type 1 Diabetes (T1D).

In a recent blog post, Leonard DAvolio, Ph.D., Blue Circles CEO, described how in the fall of 2021, a group of T1D experts was gathered by the Leona M. and Harry B. Helmsley Charitable Trust for a two-day meeting to begin answering the question: If we could create a healthcare delivery system for people with T1D unconstrained by tradition or reimbursement concerns what would it look like? In other words, how exactly should T1D care be designed? It was the first meeting for what would become Blue Circle Health, a healthcare delivery system for people with T1D living in under-resourced communities. It is funded by the Helmsley Charitable Trust.

DAvolio said the organizations goal is to build a St. Judes-like program specifically for T1D that cares for patients regardless of their ability to pay. But he added that how exactly to do that what services to offer, where, when, and to whom introduces an enormous number of decisions, each one of which carries consequences.

He explained the decision to partner with FQHCs by mentioning that they typically focus on primary care but do not have T1D specialists on staff. Working with FQHCs will allow us to connect to the people we hope to serve while also ensuring that they have access to critically important primary care, he said.

DAvolio also noted that to become a model, one needs to be able to demonstrate not just improved outcomes but the ability to do so cost efficiently. Of all of the things we will measure, the ratio of improved outcomes to the cost of achieving improvement is among the most important, he wrote.

Blue Circle Health stresses that an important foundation for trust is a single, accessible point of contact. For this reason, our care model centers on trained diabetes support coaches. The coach serves as the primary point of contact the guide for those we serve throughout their journey. They can be accessed when theyre needed in whatever modality makes the most sense for the individual with T1D, DAvolio wrote.

Its a model learned from the ECHO Diabetes program led by Drs. Michael Haller, Ashby Walker, David Maahs and others and also informed by Dr. Michael Harris of OHSU and his NICHE program. Both proved the importance of a trained peer as a friend, mentor, and guide for supporting people with chronic conditions.

In fact, he added, the first wave of coaches will be transitioned from the Diabetes ECHO program at the University of Florida as that research project draws to a conclusion. Each of the coaches hired are from the same communities as the people Blue Circle serves, speaks the same language, and lives with T1D.

DAvolio said care would escalate from coaches to members of a multidisciplinary team that includes nurses, advanced practice nurses, registered dietitians, pharmacists, insurance navigators, behavioral health specialists, social workers, and endocrinologists with experience supporting people with T1D. In addition, connections will be made with ancillary providers through the patients primary care group to include podiatrists, optometrists and ophthalmologists, nephrologists, cardiologists, ob/gyns and others.

He also said one of the top priorities is to build an infrastructure that allows Blue Circle to gather data and learn without placing undue burden on the care team or patients. Progress to date includes access to feeds of continuous glucose monitor data from several manufacturers and validated predictive models able to anticipate dangerous situations before they become acute (e.g., rising A1c and diabetic ketoacidosis), he noted. However, there is much work to be done as todays electronic health records are designed more for billing than for learning, and few useful population health tools for people with T1D exist.

The organizations chief medical officer is Anne Peters, M.D., professor of medicine at the Keck School of Medicine of University of Southern California and director of the USC Clinical Diabetes Programs. Her research has focused on testing new approaches for diagnosing and treating diabetes and developing systems of care to improve outcomes in diabetic populations.

Prior to Blue Circle, DAvolio was the co-founder of Cyft, a company dedicated to helping serious illness care providers succeed in value-based care. He is also an assistant professor at Brigham and Womens Hospital and Harvard Medical School. He is an advisor to several healthcare startups. Prior to founding Cyft, he led informatics at Ariadne Labs where he helped improve childbirth across 70 clinics in India. Prior to that he created the infrastructure for the worlds largest genomic medicine cohort and embedded the first clinical trial within an electronic medical record system for the Department of Veterans Affairs.

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Nonprofit Blue Circle Health Partners With FQHCs on Type 1 Diabetes - Healthcare Innovation

Peripheral vascular disease (PVD) is chronic limb ischemia caused by atherosclerosis of the peripheral arteries. Diabetes mellitus (DM) is a risk factor for this disease. The probability of a diabetic foot ulcer (DFU) is higher in a patient with DM and PVD than in a patient without DM. Ankle-brachial-pressure index (ABPI) allows the measurement of blood flow towards the distal extremities, which could help timely diagnosis, initiate brief therapy, and minimize the risk of critical limb ischemia and loss. This study aims to determine the prevalence of peripheral vascular disease and assess its association with intima-media thickness (IMT) in diabetic patients with and without foot ulcers in India. In the present study, we included all type 2 DM patients. The assessment was conducted clinically by measuring Ankle Brachial Pressure Index (ABPI) radiologically by Duplex Ultrasonography (Samsung HS 70A machine), and Doppler (Linear probe- LA3 - 12A) and IMT were detected. In healthy adults, IMT ranges from 0.25 to 1.5mm, and values above 1.0mm are often considered abnormal and linked with atherosclerosis and significantly increased cardiovascular disease (CVD). In this study, 72 patients with DM were enrolled over the study period; 52 patients presented with DFU, and 20 presented without DFU. The prevalence of PVD was higher in males compared to females; 40% of the patient population in the age range of 40-49 years was with PVD, and 62.5% of patients with PVD showed an IMT value more than 1.0mm, whereas only 5% patients without PVD shows IMT value more than 1.0mm. In conclusion, among type 2 diabetic subjects, the prevalence of PVD is 72.2%, and IMT is strongly associated with PVD.

Diabetes Mellitus (DM) is a chronic, metabolic disease characterized by increased levels of blood glucose, which result from absolute or relative insulin deficiency in circumstances with -cell dysfunction, insulin resistance, or both[1]. It is one of the most usual and rapidly growing diseases worldwide. Diabetes is fast becoming a potential epidemic in India, with 77 million patients[2]and the vast majority still undiagnosed.

Diabetic footis a condition in which foot ulcers form in patients with DM[3]. It is a frightening disorder with extended hospitalization and expensive with chances of an amputated extremity[4]. However, it is possible to prevent amputation using educational and care strategies[5]. Diabetic foot is characterized by a classical triad of neuropathy, ischemia, and infection[4]. The risk of a person with DM having a DFU has been reported to be as high as 25%. Diabetic foot is the most frequent cause (about 30%) of hospitalization in patients with DM[2]. 15-20% of patients with such DFU require an amputation. Nearly 85% of the amputations are preceded due to DFU. Several elements for developing DFU have been proposed, the significant being peripheral sensory neuropathy followed by peripheral vascular disease (PVD).

PVD is chronic limb ischemia which is always generated by atherosclerosis of the peripheral veins. PVD is one of Type II DM's most common macrovascular complications[6]. Prevalence increases with age, about 3% in people below 60 years of age, and rises to over 20% in people over 75. Only a quarter of people with PVD are symptomatic. Apart from age, other risk factors include smoking, diabetes mellitus, hypertension, physical inactivity, and obesity. PVD is a disease affecting the veins supplying the legs, feet, kidneys, and intestines. PVD is typically more severe in patients with diabetes than in comparable nondiabetic individuals and is associated with a worse prognosis[7,8]. Patients with PVD risk myocardial infarction, stroke, and mortality[9,10]. Early detection of vascular changes helps effectively handle DM and DM complications.

The diagnosis technique further affects the magnitude of PVD[7]. A more precise assessment of PVD in DM must depend on a validated and reproducible diagnosis technique. Such a test includes the ankle-brachial index (ABI). The ABPI is the ratio of the ankle to systolic brachial pressure. It is suggested to be calculated by dividing the higher systolic pressure of the dorsalis pedis and tibialis posterior vessels at the ankle by the higher systolic pressures measured in the brachial vein[11]. ABPI is a simple and noninvasive technique. The ABPI showed to be more accurate and verified against angiographically confirmed disease and found to be 95% sensitive and nearly 100% specific[12].

There is a need for a structured evaluation of PVD in all DM patients. The information can help prepare protocols for the effective management of DM patients to limit morbidity. The present study aims to determine the prevalence of peripheral vascular disease and assess its association with ankle-brachial index in diabetic patients with and without foot ulcers in India.

A retrospective study was carried out on 72 consecutive patients with type 2 DM attending the medicine outpatient department/ward. Endocrine outpatient department/ward and diabetic foot clinic of SCB Medical College and Hospital, Bhubhaneshwar, between 2011 to 2012, as the patients were monitored for changes observed under the same categories for 10 years. All patients with type 2 diabetes mellitus were included in the study, and the patients with trauma, Buerger disease, fibromuscular dysplasia, or vasculitis were excluded. Ethical approval was obtained from the SCB Medical College Ethics Committee (1536/IEC/ SCBMCH/2022).

A detailed general, systemic, and foot examination of patients was done. The body mass index (BMI) was calculated using the formula: weight (kg)/height (m2). A fasting blood sugar (FBS), postprandial blood sugar (PPBS), hemoglobin [R1] (HB), cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL) and IMT were measured. Intima medial thickness of the popliteal vein is predictive of peripheral vascular disease, which can be detected using ABPI. ABPI was measured radiologically by Duplex Ultrasonography using an ACUSON 128 P/10 machine with a 7.5 MHz linear superficial array probe in B- mode. B-scan was used for detecting IMT, pulse wave signal for flow velocity, and color flow for site determination.

The statistical analysis of all mentioned clinical parameters was performed. The continuous variables are expressed as mean standard deviation (SD). A comparison of variables was performed using ANOVA tests. Variables with a P-value < 0.05 was considered as the level of significance.

Table1shows the demographic factors of patients (n=72) enrolled in this study. Of the total patients, it was found that 73.1% are males and 26.9% are females with PVD, whereas 60% are males and 40% are females without PVD. Age distribution was shown in table1, and here we found 40.4% of patients falling in the 40-49 years of age group are found with PVD, and 45% of patients in the age group of 50-59 years are found without PVD. In the case of the distribution of BMI, 73.1% are in the range of 18.5- 22.9 with PVD, and 70% are in the range of 18.5- 22.9 without PVD.

Out of the total patient population, 40% was in the age range of 40-49 years for patients with PVD, whereas 45% was in the age range of 50-59 years for patients without PVD. A graphical representation of the age distribution is shown in Figures1, 2.

The result of statistical analysis data, i.e., mean, standard deviation, and range for demographic, clinical, and biochemical factors for patients (n= 52) with PVD, are shown in table2.

The result of statistical analysis data, i.e., mean, standard deviation, and range for demographic, clinical, and biochemical factors for patients (n= 20) without PVD, is shown in table3.

The statistical comparison of clinical and biochemical characteristics of the study groups with PVD (n = 52) and without PVD (n =20) are shown in Table 4.

As per table4, the mean IMT in subjects with PVD (n = 52) was 1.12 .19mm (right) and 1.09 .18mm (left) whereas in subjects without PVD (n = 20), it 0.70 0.17mm (right) and 0.71 0.17mm (left). Values of HBA1c (p-value = 0.0001), Cholesterol (p value= 0.004), VLDL (p value= 0.0031) and IMT (p value=0.001) show significance. The distribution of IMT results in patients with PVD and without PVD is shown in table5.

The true magnitude of PVD in DM patients is challenging to measure as many patients can be asymptomatic, and some do not report their symptoms. ABPI is an excellent initial screening tool for the assessment of PVD. This study aimed to determine the prevalence of peripheral vascular disease and assess its association with ankle-brachial index in diabetic patients with and without foot ulcers in India. It was reported that DM patients with evidence of systemic atherosclerosis were found to be at risk for PVD. The prevalence of diabetes mellitus in India is 8.8% (among people between 20-79 years of age). The actual prevalence of PVD in people with DM is challenging to calculate, as most cases are asymptomatic and many cases refrain from reporting the symptoms. DFUs were found in 4.54% of patients newly diagnosed with type 2 diabetes mellitus in India[2]. Earlier estimations for the magnitude of PVD among DM subjects in the United States and Europe vary from 9.5-42%. In contrast, for the Asian region, the magnitude of DM populations has been reported to be lower than that in the western community[10].

In the present study, 72 persons with diabetes were enrolled over the study period; 52 patients presented with DFUs, and 20 patients were without DFUs. In this study, the prevalence of PVD in DM subjects was found to be 72.22%, with 52 out of 72 patients showing the presence of PVD. As reported earlier by Pradeepa R et al.[10], the prevalence of PVD is higher in DM subjects than in non-DM subjects in population-based and clinic-based studies.

The prevalence of PVD, symptomatic and asymptomatic, is higher in males than in females in this study. It was found in this study that gender-wise distribution indicates 73% of males and 27% of females with PVD, whereas 60% was male and 40% was female without PVD. Thus the magnitude of PVD in DM patients was higher in males than in females. These results contrast with Pradeepa R et al.[10], where female subjects were more likely to have PVD than male subjects.

The age-wise distribution shows that 40% of the patient population was in the age range of 40-49 years for patients with PVD, whereas 45% was in the age range of 50-59 years for patients without PVD. Like Ikem R et al.[7], age showed statistical significance in PVD risk in the present study.

The ABPI assessment was done radiologically by Duplex Ultrasonography which determines IMT. The normal IMT value ranges from 0.25 to 1.5mm in healthy adults, and values above 1.0mm are often considered abnormal[13]and are linked with atherosclerosis and increased cardiovascular disease. In present study, 62.5% patients with PVD shows IMT value more than 1.0mm, 36.5% patients shows IMT value in between 0.7- 1.0mm and 1.9% patients show IMT value below 0.7mm. In this study, 5% of patients without PVD showed an IMT value of more than 1.0mm, 60% of patients showed an IMT value between 0.7- 1.0mm, and 35% of patients showed an IMT value below 0.7mm. That means IMT is strongly associated with PVD.

The PVD prevalence is symptomatic and asymptomatic, and it is more in males than in females in this study. It is thus essential to investigate the presence of PVD in asymptomatic cases to manage the risk elements as early as possible and minimize mortality. We recommend screening for PVD while on the time of detection of DM for both timely detection and to prevent the disease.

This study concluded that type 2 diabetes patients with IMT of more than 1.0mm, increased CVD, and diabetic foot ulcers were prone to more risks of peripheral vascular disease. It also revealed that these risks increased gradually with the increase of age. This study revealed that males tend to have more risk of PVD than females. Detection of peripheral vascular disease in diabetic foot patients using Duplex Ultrasonography and ABPI together with regular clinical analysis will help to assist timely detection of critical extremities. The patients may not all be symptomatic or show clear signs of PVD though they need to be examined for the presence of PVD. The current and earlier studies have repeatedly manifested the need and advantages of investigating DM for peripheral ischemia to give better care. The care of DM subjects must be initiated with preventive actions, which is the key to avoiding further complications.

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A Study of the Peripheral Vessels in Patients With Type 2 Diabetes Mellitus With or Without Foot Involvement - Cureus