Could Diabetes Drug Metformin Help Keep People Slim?

New research suggests a first-line drug for treating type 2 diabetes   'metformin'  may help people with pre-diabetes maintain long-term weight loss.

People who lost weight while taking metformin maintained a loss of about 6% of their body weight for six to 15 years. People who lost weight through lifestyle changes -- eating healthily and exercising regularly -- managed to keep off just under 4% of their initial body weight for the same period, the study found.

Metformin doesn't seem to be particularly helpful for shedding pounds in the first place, though. In fact, an earlier phase of the study found that people were much more likely to lose 5% or more of their body weight through lifestyle changes -- healthy eating and exercising -- than by using metformin.

"Although lifestyle changes were superior for inducing weight loss early on, metformin was better for long-term weight maintenance," said senior study author Dr. Kishore Gadde. He's a professor in heart disease prevention at the Pennington Biomedical Research Center in Baton Rouge, La.

Not everyone is convinced that metformin can keep you slim, however. After reviewing the findings, Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in New York City, said, "This study was very well done, but it doesn't show metformin is effective for everyone. The ones on metformin who did lose weight only regained a little less weight."

He added that metformin isn't well-tolerated by a lot of people. It can cause digestive problems, such as nausea and diarrhoea.

An  effective intervention for losing weight and maintaining that loss is clearly needed. Nearly three-quarters of the American population is overweight or obese -- a major risk factor for type 2 diabetes, according to the U.S. Centers for Disease Control and Prevention.

Losing a significant amount of weight more than 5% of your body weight  seems to help prevent pre-diabetes from turning into type 2 diabetes, and can help delay the progression of type 2 diabetes.

The latest study was a continuation of the three-year diabetes prevention clinical trial that compared three different groups of people with pre-diabetes to see what type of intervention would help prevent type 2 diabetes from developing. One group was given metformin, another was coached on intensive lifestyle changes, and the third group was given a placebo.

This study found that lifestyle changes led to the greatest initial weight loss, followed by the metformin group, according to Gadde.

From the original study group -- more than 3,000 people -- just over 1,000 lost more than 5% of their body weight.

The researchers followed this group for as long as 15 years to see who maintained their weight loss.

People taking metformin had the greatest weight loss from years six to 15, according to the study. The study also found that being older and losing a greater amount of weight in the first year were consistent predictors of lasting weight loss, the study authors said.

Gadde said it's not exactly clear why the metformin group was better at maintaining weight loss. "Metformin does reduce food intake a little bit, but it's not a dramatic effect. And, from what we know, it doesn't significantly alter energy expenditure."

He said other recent research suggests that metformin may alter the body's microbiome (the healthy bacteria in your gut). It also seems that metformin may have some effects on muscle function. But Gadde said, more research is necessary to know for sure.

Could Diabetes Drug Metformin Help Keep People Slim?

Long-Term Antibiotic Use May Up Women's Odds for Heart Trouble

Antibiotics can be lifesaving, but using them over a long period might raise the odds of heart disease and stroke in older women, a new study suggests.

Researchers tracked the health of nearly 36,500 U.S. women over an average follow-up of nearly eight years. During that time, more than a thousand developed heart disease.

The study found that women aged 60 and older who used antibiotics for two months or longer were 32% percent more likely to develop heart disease than those who did not use antibiotics.

Women aged 40 to 59 who took antibiotics for longer than two months had a 28% higher risk than those who did not take the drugs, said a team led by Lu Qi. He directs the Tulane University Obesity Research Center in New Orleans.

Said another way, the results mean that for older women who take antibiotics for two months or more, 6 per 1,000 would go on to develop heart disease, compared with 3 in 1,000 among those who did not take the drugs.

There was no increased risk of heart disease among women aged 20 to 39 who took antibiotics, according to the study published April 24 in the European Heart Journal.

"This is an observational study and so it cannot show that antibiotics cause heart disease and stroke, only that there is a link between them," Qi said in a journal news release. "It's possible that women who reported more antibiotic use might be sicker in other ways that we were unable to measure, or there may be other factors that could affect the results that we have not been able take account of."

However, the researchers did take into account other factors, including age, race, sex, diet and lifestyle, reasons for antibiotic use, overweight or obesity, other diseases and medication use.

The most common reasons for antibiotic use among women in the study were respiratory infections, urinary tract infections and dental problems.

So what could be the link between antibiotics and heart risk?

One possible reason could lie in the fact that antibiotics do alter the balance of gut microbes, destroying good bacteria and increasing the proportion of viruses, bacteria or other microbes that can cause disease, Qi suggested.

"Antibiotic use is the most critical factor in altering the balance of microorganisms in the gut," he said, and "previous studies have shown a link between alterations in the microbiotic environment of the gut and inflammation and narrowing of the blood vessels, stroke and heart disease."

Study first author Yoriko Heianza is a research fellow at Tulane University. She noted that, as the women in the study aged, "they were more likely to need more antibiotics, and sometimes for longer periods of time, which suggests a cumulative effect may be the reason for the stronger link in older age between antibiotic use and cardiovascular disease."

According to Qi, the take-home message from the new study is that "antibiotics should be used only when they are absolutely needed. Considering the potentially cumulative adverse effects, the shorter time of antibiotic use, the better."

Dr. Eugenia Gianos directs Women's Heart Health at Lenox Hill Hospital in New York City. She wasn't involved in the new research, but said the findings are "interesting and warrant further analysis."

Gianos agreed that the study couldn't prove cause and effect. "It is very possible that patients who require antibiotics for an infection have a worse underlying infectious or inflammatory process, and that the systemic effects of these diseases are what cause cardiovascular disease," she reasoned.

But the interplay between antibiotics, the gut's "microbiome" and the cardiovascular system could be important as well, Gianos said.

Long-Term Antibiotic Use May Up Women's Odds for Heart Trouble 

FDA Approves Kalydeco (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age

In continuation of my update on Kalydeco (ivacaftor) 

Vertex Pharmaceuticals Incorporated  announced the U.S. Food and Drug Administration (FDA) approved Kalydeco (ivacaftor) for use in children with cystic fibrosis (CF) ages six months to less than 12 months who have at least one mutation in their cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to Kalydeco based on clinical and/or in vitro assay data. Kalydeco is already approved in the U.S., Canada and EU for the treatment of CF in patients ages 12 months and older.

“Today’s approval for Kalydeco allows physicians to begin treating the underlying cause of CF in eligible infants as young as six months of age for the first time, with the potential to modify the course of the disease,” said Margaret Rosenfeld, M.D., MPH, Seattle Children’s Research Institute and Department of Pediatrics, University of Washington School of Medicine.

This FDA approval is based on data from a 24-week Phase 3 open-label safety cohort (ARRIVAL) of 11 children with CF aged six months to less than 12 months who have one of 10 mutations in the CFTR gene (G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, G1349D or R117H). The study demonstrated a safety profile similar to that observed in previous Phase 3 studies of older children and adults; most adverse events were mild or moderate in severity, and no patient discontinued therapy due to adverse events. The most common adverse events (≥30%) were cough (64%), nasal congestion (36%) and rhinorrhea (36%). Three serious adverse events, all considered unrelated to study treatment by the investigators, were observed in three patients.

Mean baseline sweat chloride for the children in this cohort was 101.5 mmol/L (n=11). Following 24 weeks of treatment with Kalydeco, the mean sweat chloride level was 43.1 mmol/L (n=6). In the six subjects with paired sweat chloride samples at baseline and week 24, there was a mean absolute change of -58.6 mmol/L (95% CI; -75.9, -41.3).

Results of this study were presented at the 32nd Annual North American Cystic Fibrosis Conference in October 2018.

“The manifestations of CF are often present at birth, which underscores our relentless commitment to reach the youngest CF patients possible in our clinical trials,” said Reshma Kewalramani, M.D., Executive Vice President and Chief Medical Officer at Vertex. “As an important outcome of these efforts, we are now able to treat infants with cystic fibrosis as early as six months of age with Kalydeco.”

Kalydeco was first approved in 2012 in the U.S. and is now available in more than 40 countries with more than 5,000 patients on therapy. For more information on Kalydeco, prescribing information, or patient assistance programs, visit Kalydeco.com or VertexGPS.com.

https://en.wikipedia.org/wiki/Ivacaftor

FDA Approves Kalydeco (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants with CF as Early as Six Months of Age

Veggies, Fruits and Grains Keep Your Heart Pumping

  

As if you needed any more proof that fruits, vegetables and whole grains are good for you, a new study finds they may cut your chances of heart As if you needed any more proof that fruits, vegetables and whole grains are good for you, a new study finds they may cut your chances of heart failure by 41%.

Conversely, the so-called Southern diet, which focuses on meats, fried and processed foods and lots of sweet tea, was tied to a 72% increased risk of heart failure.

"Eat more plants, limit red and processed meat," said lead researcher Dr. Kyla Lara, a cardiology fellow at the Mayo Clinic in Rochester, Minn.

Lara cautioned that this study cannot prove different diets cause or prevent heart failure, only that they are linked.

Nearly 6 million American adults suffer from heart failure, and that number is expected to rise with the aging population. The condition occurs when the heart does not pump blood sufficiently to meet the body's needs.

Steps to prevent heart failure include not smoking, keeping blood pressure under control, maintaining a healthy weight and eating healthy foods.

Getting people to eat healthier requires that they be educated about the benefits of plant-based diets and have access to low-cost healthy foods, Lara said.

"Animal meat is not necessary for a nutritious diet, in terms of health promotion and quality of life," she said. "Now is the time to get on board with a plant-based diet -- it's going to be the future of health."

In the study, Lara and her colleagues collected data on more than 16,000 men and women, 45 and older, who took part in a large U.S. stroke study. None of the participants had heart disease at the start of the study. Participants completed a questionnaire that asked them about their diet.

The diets were classified into five types:

Convenience, which was heavy on meats, pasta, Mexican food, pizza and fast food.

Plant-based, which included vegetables, fruits, beans and fish.

Sweets and fats, which was heavy on desserts, bread, sweet breakfast foods, chocolate and other sugars.

Southern, which was heavy on fried foods, processed meats, eggs, added fats, and sugar-sweetened drinks.

Alcohol and salads, which was heavy on wine, liquor, beer, leafy greens and salad dressing.

After nearly nine years of follow-up, 363 participants developed heart failure.

The benefit of the plant-based diet was significant, but after taking into account factors such as weight, waist size, high blood pressure and high cholesterol, the negative effect of the Southern diet was no longer statistically significant, Lara said.

It might be that the increased risk for heart failure in this group was due to obesity and excess belly fat or other factors, she said.

None of the other diets showed a statistically significant association with heart failure, and no association was seen between any diet and the type of heart failure people developed, the researchers noted.

The findings were published April 22 in the Journal of the American College of Cardiology.

"Our lifestyle, such as what we eat, if we are physically active and smoking or vaping, can contribute significantly to a poorly functioning heart, which in turn affects our quality of life and ultimately how soon we die," said Samantha Heller, a senior clinical nutritionist at New York University Medical Center in New York City.

Plant-based diets have been shown to reduce the risk of cardiovascular disease, cognitive [thinking] decline, type 2 diabetes, several cancers, depression and obesity," said Heller, who wasn't involved with the study.

For optimal health, people need to cut back on fried foods, cheese, fast food and junk foods, and processed and red meats, she said.

"It is sad and frustrating when I see patients who could quite literally save their lives by making healthier choices, but instead opt for a burger and fries," Heller said.

A cheeseburger, fries and milkshake meal sounds innocent enough, but it can add up to more than 2,600 calories, 65 grams of saturated fat and 3,400 milligrams of salt, she said.

Heller advises people to include a minimum of one high-fiber food to every meal. "Dietary fiber is only found in plant foods, such as spinach, oranges, quinoa and lentils."

Also try having meatless dinners two or three nights a week, like a grilled vegetable and black bean burrito, pasta primavera or an edamame and fresh vegetable stir fry, she suggested.failure by 41%.

Conversely, the so-called Southern diet, which focuses on meats, fried and processed foods and lots of sweet tea, was tied to a 72% increased risk of heart failure.

"Eat more plants, limit red and processed meat," said lead researcher Dr. Kyla Lara, a cardiology fellow at the Mayo Clinic in Rochester, Minn.

Lara cautioned that this study cannot prove different diets cause or prevent heart failure, only that they are linked.

Nearly 6 million American adults suffer from heart failure, and that number is expected to rise with the aging population. The condition occurs when the heart does not pump blood sufficiently to meet the body's needs.

Steps to prevent heart failure include not smoking, keeping blood pressure under control, maintaining a healthy weight and eating healthy foods.

Getting people to eat healthier requires that they be educated about the benefits of plant-based diets and have access to low-cost healthy foods, Lara said.

"Animal meat is not necessary for a nutritious diet, in terms of health promotion and quality of life," she said. "Now is the time to get on board with a plant-based diet -- it's going to be the future of health."

In the study, Lara and her colleagues collected data on more than 16,000 men and women, 45 and older, who took part in a large U.S. stroke study. None of the participants had heart disease at the start of the study. Participants completed a questionnaire that asked them about their diet.

The diets were classified into five types:

• Convenience, which was heavy on meats, pasta, Mexican food, pizza and fast food.

• Plant-based, which included vegetables, fruits, beans and fish.

• Sweets and fats, which was heavy on desserts, bread, sweet breakfast foods, chocolate and other sugars.

• Southern, which was heavy on fried foods, processed meats, eggs, added fats, and sugar-sweetened drinks.

• Alcohol and salads, which was heavy on wine, liquor, beer, leafy greens and salad dressing.

After nearly nine years of follow-up, 363 participants developed heart failure.

The benefit of the plant-based diet was significant, but after taking into account factors such as weight, waist size, high blood pressure and high cholesterol, the negative effect of the Southern diet was no longer statistically significant, Lara said.

It might be that the increased risk for heart failure in this group was due to obesity and excess belly fat or other factors, she said.

None of the other diets showed a statistically significant association with heart failure, and no association was seen between any diet and the type of heart failure people developed, the researchers noted.

The findings were published April 22 in the Journal of the American College of Cardiology.

"Our lifestyle, such as what we eat, if we are physically active and smoking or vaping, can contribute significantly to a poorly functioning heart, which in turn affects our quality of life and ultimately how soon we die," said Samantha Heller, a senior clinical nutritionist at New York University Medical Center in New York City.

Plant-based diets have been shown to reduce the risk of cardiovascular disease, cognitive [thinking] decline, type 2 diabetes, several cancers, depression and obesity," said Heller, who wasn't involved with the study.

For optimal health, people need to cut back on fried foods, cheese, fast food and junk foods, and processed and red meats, she said.

"It is sad and frustrating when I see patients who could quite literally save their lives by making healthier choices, but instead opt for a burger and fries," Heller said.

A cheeseburger, fries and milkshake meal sounds innocent enough, but it can add up to more than 2,600 calories, 65 grams of saturated fat and 3,400 milligrams of salt, she said.

Heller advises people to include a minimum of one high-fiber food to every meal. "Dietary fiber is only found in plant foods, such as spinach, oranges, quinoa and lentils."

Also try having meatless dinners two or three nights a week, like a grilled vegetable and black bean burrito, pasta primavera or an edamame and fresh vegetable stir fry, she suggested.

Veggies, Fruits and Grains Keep Your Heart Pumping 

FDA Approves Mavenclad (cladribine) Tablets for Multiple Sclerosis

In continuation of my update on cladribine

The U.S. Food and Drug Administration,    approved Mavenclad (cladribine) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease and active secondary progressive disease. Mavenclad is not recommended for MS patients with clinically isolated syndrome. Because of its safety profile, the use of Mavenclad is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS.

“We are committed to supporting the development of safe and effective treatments for patients with multiple sclerosis,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “The approval of Mavenclad represents an additional option for patients who have tried another treatment without success.”

MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communications between the brain and other parts of the body. Most people experience their first symptoms of MS between the ages of 20 and 40. MS is among the most common causes of neurological disability in young adults and occurs more frequently in women than in men.

For most people, MS starts with a relapsing-remitting course, in which episodes of worsening function (relapses) are followed by recovery periods (remissions). These remissions may not be complete and may leave patients with some degree of residual disability. Many, but not all, patients with MS experience some degree of persistent disability that gradually worsens over time. In some patients, disability may progress independent of relapses, a process termed secondary progressive multiple sclerosis (SPMS). In the first few years of this process, many patients continue to experience relapses, a phase of the disease described as active SPMS. Active SPMS is one of the relapsing forms of MS, and drugs approved for the treatment of relapsing forms of MS can be used to treat active SPMS.

The efficacy of Mavenclad was shown in a clinical trial in 1,326 patients with relapsing forms of MS who had least one relapse in the previous 12 months. Mavenclad significantly decreased the number of relapses experienced by these patients compared to placebo. Mavenclad also reduced the progression of disability compared to placebo.

Mavenclad must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. Mavenclad has a Boxed Warning for an increased risk of malignancy and fetal harm. Mavenclad is not to be used in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, health care professionals should evaluate the benefits and risks of the use of Mavenclad on an individual patient basis. Health care professionals should follow standard cancer screening guidelines in patients treated with Mavenclad. The drug should not be used in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception during treatment and for six months after the course of therapy because of the potential for fetal harm. Mavenclad should be stopped if the patient becomes pregnant.

Other warnings include the risk of decreased lymphocyte (white blood cell) counts; lymphocyte counts should be monitored before, during and after treatment. Mavenclad may increase the risk of infections; health care professionals should screen patients for infections and treatment with Mavenclad should be delayed if necessary. Mavenclad may cause hematologic toxicity and bone marrow suppression so health care professionals should measure a patient’s complete blood counts before, during and after therapy. The drug has been associated with graft-versus-host-disease following blood transfusions with non-irradiated blood. Mavenclad may cause liver injury and treatment should be interrupted or discontinued, as appropriate, if clinically significant liver injury is suspected.

The most common adverse reactions reported by patients receiving Mavenclad in the clinical trials include upper respiratory tract infections, headache and decreased lymphocyte counts. 

Ref : https://en.wikipedia.org/wiki/Cladribine

FDA Approves Mavenclad (cladribine) Tablets for Multiple Sclerosis