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Panel to Ponder Fate of Qnexa Weight-Loss Pill

Posted: February 18, 2012 at 1:46 am

Once Rejected Over Safety, Qnexa Again Before FDA Panel

Feb. 17, 2012 -- Once rejected by the FDA over safety concerns, the weight loss pill Qnexa on Wednesday will get a second chance before an FDA advisory committee.

Will the second time around be the charm? Qnexa maker Vivus Inc. hopes so. And the company will be showing off new safety data from patients who took Qnexa for a second year after completing a one-year clinical trial.

Whether that will sway the panel -- and, ultimately, the FDA -- is a tough call.

Qnexa combines two currently approved drugs. One is the appetite suppressant phentermine, the safer "phen" part of the infamously unsafe fen-phen diet drug.

The other half of Qnexa is the seizure/migraine drug topiramate. The topiramate label lists some scary side effects: eye problems, decreased sweating and increased body temperature, acidic body fluids, suicidal thoughts and behaviors, and fetal toxicity.

But Vivus' new data suggests that the FDA's main safety concerns, heart risk and birth defects, were not a big issue in the follow-up study. Neither were worries about increased suicide risk, mental dulling, or too much acid in body fluids.

These may not have been major issues in the clinical trials, but troubling safety issues persist. In the FDA's analysis of Qnexa safety, there were some ominous comments:

There was indeed evidence of increased heart rate and acidic body fluids in people taking Qnexa. The FDA states that "only a long-term" study can tell whether Qnexa increases the risk of heart disease in obese people already at high heart risk. One question before the panel is whether Vivus must conduct such a study. A disturbing number of women in the clinical trials got pregnant, even though they had agreed to be on birth control and had regular pregnancy checks. One of the ingredients in Qnexa is linked to birth defects, although none were seen in the clinical trial. Since 36% of U.S. women are obese, the FDA worries that a lot of pregnant women will be exposed to Qnexa.

 

Does Qnexa Benefit Outweigh Qnexa Risk?

While the argument over Qnexa approval isn't about efficacy, not everyone taking the drug loses a significant amount of weight:

On average, people taking the dose of Qnexa proposed for approval lost 6.6% of their body weight. For approval, the FDA requires that a drug result in average loss of at least 5% of body weight. In one study, 62% of obese and overweight people taking Qnexa lost at least 5% of their body weight -- about three times as many as in the placebo group. The FDA standard is that 35% of people must lose 5% of body weight. In a follow-up study, people continuing to take Qnexa for a second year regained some of the weight they lost the first year. They did not regain as much weight as people taking a placebo.

Since Qnexa exceeds the FDA's minimum effectiveness requirement, the question is whether the new safety data will sway the new FDA panel.

The last panel voted 10 to 6 against approval. But a lot of those voting said it was a close call.

This year, there are 22 panel members scheduled to vote. Twelve of them were on the last panel. Last time, seven of them voted "no" to approval, and five voted "yes."

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Panel to Ponder Fate of Qnexa Weight-Loss Pill

Want to Lose Weight? Try Teamwork

Posted: February 18, 2012 at 1:46 am

Weight Loss Influenced by Team Support, Researchers Say

Feb. 17, 2012 -- Weight loss may be influenced by joining a team.

A new study shows that people who shed at least 5% of their initial body weight during a weight loss competition were likely to be on the same teams. Those who said their teammates played a large role in their weight loss were more likely to lose a significant amount of weight.

The findings appear in Obesity.

Shows like The Biggest Loser often have team-, family-, or couples-based competitions that harness the power of peer influence when it comes to weight loss.

“People around us affect our health behaviors,” says researcher Tricia Leahey, PhD. She is with The Miriam Hospital’s Weight Control and Diabetes Research Center and is an assistant professor of psychiatry and human behavior at Alpert Medical School of Brown University in Providence, R.I.

This is true for healthy and unhealthy behaviors. “It could be quite beneficial if a bunch of friends that choose to lose weight make healthy food choices together, and hold each other accountable to those choices,” she says.

Team members can motivate one another to stay the course. “If someone is doing really well, it could influence the whole group,” Leahey says.

The findings are based on the results of the 2009 Shape Up Rhode Island campaign, a 12-week statewide, online weight loss competition. Participants competed against other teams for weight loss, physical activity, and the number of steps taken. The weight loss arm included 3,330 overweight or obese people on 987 teams. The teams had between five and 11 members.

Two of the study’s co-authors, Rajiv Kumar, MD and Brad M. Weinberg, MD, are co-founders of ShapeUp, Inc.

There Is No ‘I’ in Team

People who lost at least 5% of their body weight, which is an amount that is thought to be significant in improving health, tended to be on the same teams. Those who reported a higher level of social influence by their teammates increased their odds of significant weight loss by 20%. 

“This is really quite powerful,” Leahey tells WebMD. "We were surprised by the magnitude of the effect."

Team captains lost more weight than team members. This may be because they were more motivated and engaged in the contest.

Kevin Sloan is the acting psychology director at Beaumont Weight Control Center in Royal Oak, Mich. The findings mirror what he sees in his practice. “We find that when couples begin their weight loss journey together, they tend to do better. There is a lot of credence to the buddy concept,” he says.

Not everyone is a team player. “It is important to do a self-assessment before signing up, but this a good approach for some people who are joiners and do much better as part of a group,” he says.

Weight Loss Is Contagious

“People do better in a group because of the peer pressure,” says Louis Aronne, MD, founder and director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center.

And “virtual” weight loss works, too. Groups can get together via the web. “Social support helps people to do better, and there are a variety of ways to accomplish it,” Aronne says.

Still, group dynamics can backfire. "When someone is not doing very well, sometimes that person gets pulled along and sometimes they don’t,” he says.

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Want to Lose Weight? Try Teamwork

Hey, dieters, research indicates you should eat dessert with breakfast

Posted: February 17, 2012 at 7:01 pm

If you're reading this at breakfast, it's our pleasure to bring you good tidings of great joy: You may eat cake.

Dig in. Have a cookie. Have some chocolate mousse or ice cream.

If that sounds insane, let us turn your attention to a counter-intuitive new study from a team of researchers at Tel Aviv University. They've stumbled onto some earthshaking evidence that suggests adding dessert to a balanced 600-calorie breakfast that includes proteins and carbohydrates can help dieters shed weight and keep it off in the long run.

Here's the skinny:

Researchers split 193 clinically obese, nondiabetic adults into two groups. The groups were assigned nearly identical low-carb diets of 1,400 calories a day for women and 1,600 calories a day for men, similar to the popular Atkins diet. But one group was given a low-carb 300-calorie breakfast and the other was given a 600-calorie breakfast that was high in protein and carbohydrates and always included a dessert.

Weight loss was about equal for the two groups at 16 weeks. But after 32 weeks, those who added a cookie or cake or ice cream to breakfast had lost an average of 40 pounds more than those who ate the lighter, low-carb breakfast, according to the findings published in the journal Steroids.

Shocking, right? How on earth does that work?

We reached the lead researcher in Tel Aviv.

"What you eat for breakfast does not make you fat," said professor Daniela Jakubowicz, part of the Sackler Faculty of Medicine

and the Diabetes Unit at Wolfson Medical Center.

She explained that breakfast provides energy for the day, revs the body's metabolism and aids brain function. What you consume early is fuel. If a low-calorie diet restricts carbohydrates at breakfast, metabolism goes down and the body makes compensatory changes that encourage weight gain if you eat carbohydrates later. And you will, because by lunchtime you'll be super hungry.

"Breakfast increases metabolism and decreases hunger," she said.

And adding the sweet to breakfast reduces the desire to eat the sweet later in the day.

Serotonin, a neurotransmitter popularly thought to be a contributor to feelings of happiness, is high in the morning but falls in the afternoon, she said. When you eat chocolate in the afternoon, serotonin increases and has an antidepressive effect; it makes you happier. That ups the likelihood that you'll reach for it the next afternoon when your serotonin levels drop.

That's what happened to the group eating the lower-carb breakfast, those who didn't eat a balanced breakfast with dessert. They craved sweets later in the day, when indulging is worse, and they cheated on their diet.

"When serotonin goes down, you become sad and the chocolate makes you happy," she said. "It's like a vicious cycle."

So we should eat sweets in the morning?

"Chocolate in the morning maintains the serotonin levels during the day, so you don't feel depressed," Jakubowicz said. "When you think of the chocolate you ate in the morning, you don't remember that it made you happy because when you ate it your serotonin level was up. The dependence on the chocolate begins to decrease."

The study shows that the group that ate dessert at breakfast was far more successful at maintaining the diet in the long run.

We ran this by Dr. Denise Edwards, director of the Healthy Weight Clinic at the University of South Florida. She said the study made sense because people often fail at very restrictive diets and engage in "emotional eating," indulging on foods that give pleasure.

The best plan is one that strikes a balance, she said, so don't think you can just eat sweets and lose weight.

Excerpt from:
Hey, dieters, research indicates you should eat dessert with breakfast

A Calorie Is a Calorie Is a Calorie: All Diets Work if You Stick to Them

Posted: February 17, 2012 at 7:01 pm

Adherence seems to be the hardest part of dieting, but if you can follow through with basic calorie restriction, you will lose the weight.

Strict adherence to eating a certain proportion of carbs, fat, and protein may not be as effective for weight loss as strict adherence to eating fewer calories from all sources, according to a new study that compared four diet regimens.

In the Pounds Lost trial, researchers at Pennington Biomedical Research Center in Baton Rouge, Louisiana, set out to study whether the composition of a weight loss diet affected the loss of lean body mass, total body fat, visceral fat, liver, or abdominal fat. Over 400 overweight or obese men and women were randomly assigned to follow one of four diets: average protein, low fat, higher carbs; high protein, low fat, higher carbs; average protein, high fat, lower carbs; or high protein, high fat, lower carbs.

Low fat was defined as 20 percent of calories coming from fat, while the high fat diets derived 40 percent of their calories from fat. High protein diets had 25 percent of calories from protein while low protein diets were defined as 20 percent of calories from protein. Average protein was considered 15 percent of calories from protein.

All of the diets were designed to be low in saturated fat and cholesterol, high in fiber, include low-glycemic carbohydrates, and reduce intake by 750 calories per day. Each participant was offered both group and individual counseling over the two years of the study.

After six months, the people in the study had lost more than nine pounds of total body fat and five pounds of lean body mass on average, but after two years had regained some of this. Comparing all four of the diet groups, there was no difference in fat loss or muscle loss. Neither did the proportion of carbohydrate, fat, or protein affect the amount of abdominal, visceral, or liver fat lost. People were able to maintain a weight loss of nearly nine pounds at the two-year mark, including a nearly three-pound loss of abdominal fat.

According to Dr. George Bray, a researcher who worked on the study, the major predictor for weight loss was adherence. The people who adhered to their assigned diet lost more weight than those who did not.

Adherence was a problem in this study. Many of the study participants did not complete the study, and the diets of those who did stick with it weren't exactly what they were supposed to be. Researchers hoped to see two of the diet groups adhere to the average-protein diet (15 percent) and the other two groups stick with the high-protein diet (25 percent). However, all four groups ate about 20 percent of their calories from protein over the two years of the study.

The take home message from this study is that any "diet" can work if total calories are consistently reduced. People will be more successful at losing weight if they choose a healthy diet plan that is easy for them to adhere to for the long haul, and they stick with it.

A breakdown of the meal plans used for the four diets in this study can be located here.

The study was published online January 18, 2012, in the American Journal of Clinical Nutrition.

Image: italianestro/Shutterstock.

This article originally appeared on TheDoctorWillSeeYouNow.com, an Atlantic partner site.

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A Calorie Is a Calorie Is a Calorie: All Diets Work if You Stick to Them

Diet drug may cause long-term health problems, FDA says

Posted: February 17, 2012 at 7:01 pm

U.S. health officials say they still have safety concerns about experimental diet pill Qnexa, from drugmaker Vivus Inc., as the company prepares to make a second attempt to convince experts of the drug's safety next week.

Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus.

All three companies are in the process of resubmitting their products.

The FDA had rejected the diet pill Qnexa in October 2010. Vivus has resubmitted the drug with additional follow-up information, hoping for a more favorable ruling.

But in documents posted online Friday, the FDA reiterated concerns about two safety issues that plagued the pill the time first around: Potential heart problems and birth defects in women who become pregnant while taking the drug.

Final decision on Qnexa in April

On Wednesday the FDA will ask experts at a public meeting to weigh in on those issues, specifically risks of cleft lip defects associated with one of the ingredients in Qnexa. The experts will also discuss increased blood pressure and higher heart rates reported for patients taking the drug.

The panel of doctors will take a final vote on whether the drug appears safe and effective. The group's recommendation is not binding, and the FDA is expected to make its final decision in April.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. But none of the three medicines before the FDA represents a breakthrough in research.

Qnexa is a combination of two older drugs. The amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anticonvulsant drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

High weight loss reported in company studies

Many analysts had picked Qnexa as the most promising contender of the new potential diet pills because of the high level of weight loss reported in company studies. On average, patients lost more than 10 per cent of their total body mass.

But at Qnexa's first FDA panel in 2010, experts assembled by the food and drug regulator voted 10-6 to not recommend the drug's approval. Panelists said the drug was associated with a number of dangerous side effects, including suicidal thoughts, heart palpitations, memory lapses and birth defects.

On Wednesday, Vivus will offer to conduct a follow-up study to monitor patients for any heart problems, if Qnexa is approved. Experts will consider whether the company should be required to conduct that study before FDA gives approval. The company will also offer a plan to make sure women who are likely to become pregnant do not use the drug. One of the two ingredients in Qnexa, topirimate, is known to more than double the risk of birth defects.

Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.

Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is not widely used because of modest weight loss results.

Here is the original post:
Diet drug may cause long-term health problems, FDA says

FDA raises safety concerns for Vivus diet pill

Posted: February 17, 2012 at 7:01 pm

WASHINGTON (AP) — Federal health officials say they still have safety concerns about an experimental diet pill from drugmaker Vivus Inc., as the company prepares to make a second attempt to convince experts of the drug's safety next week.

Vivus, based in Mountain View, Calif., is one of three small drugmakers racing to bring the first new prescription weight loss drug to market in more than a decade. In the past two years the Food and Drug Administration has rejected pills from all three: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA had rejected the diet pill Qnexa in October 2010. Vivus has resubmitted the drug with additional follow-up information, hoping for a more favorable ruling.

But in documents posted online Friday, the FDA reiterated concerns about two safety issues that plagued the pill the time first around: Potential heart problems and birth defects in women who become pregnant while taking the drug.

On Wednesday the FDA will ask experts at a public meeting to weigh in on those issues, specifically risks of cleft lip defects associated with one of the ingredients in Qnexa. The experts will also discuss increased blood pressure and higher heart rates reported for patients taking the drug.

The panel of doctors will take a final vote on whether the drug appears safe and effective. The group's recommendation is not binding, and the FDA is expected to make its final decision in April.

With U.S. obesity rates nearing 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. But none of the three medicines before the FDA represents a breakthrough in research.

Qnexa is a combination of two older drugs. The amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anticonvulsant drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

Many analysts had picked Qnexa as the most promising contender of the new potential diet pills because of the high level of weight loss reported in company studies. On average, patients lost more than 10 percent of their total body mass.

But at Qnexa's first FDA panel in 2010, experts assembled by the food and drug regulator voted 10-6 to not recommend the drug's approval. Panelists said the drug was associated with a number of dangerous side effects, including suicidal thoughts, heart palpitations, memory lapses and birth defects.

On Wednesday Vivus will offer to conduct a follow-up study to monitor patients for any heart problems, if Qnexa is approved. Experts will consider whether the company should be required to conduct that study before FDA gives approval. The company will also offer a plan to make sure women who are likely to become pregnant do not use the drug. One of the two ingredients in Qnexa, topirimate, is known to more than double the risk of birth defects.

Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.

Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is not widely used because of modest weight loss results.

Read more from the original source:
FDA raises safety concerns for Vivus diet pill

Daily diet soda tied to heart attack, stroke

Posted: February 17, 2012 at 7:01 pm

Diet soda may benefit the waistline, but a new study suggests that people who drink it every day have a heightened risk of heart attack and stroke.

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The study, which followed almost 2,600 older adults for a decade, found that those who drank diet soda every day were 44 percent more likely than non-drinkers to suffer a heart attack or stroke.

The findings, reported in the Journal of General Internal Medicine, don't prove that the sugar-free drinks are actually to blame.

There may be other things about diet-soda lovers that explain the connection, researchers say.

"What we saw was an association," said lead researcher Hannah Gardener, of the University of Miami Miller School of Medicine. "These people may tend to have more unhealthy habits."

She and her colleagues tried to account for that, Gardener told Reuters Health.

Daily diet-soda drinkers did tend to be heavier and more often have heart risk factors like high blood pressure, diabetes and unhealthy cholesterol levels.

That all suggests that people who were trying to shed pounds or manage existing health problems often opted for a diet soda over the sugar-laden variety.

But even after the researchers factored in those differences -- along with people's reported diet and exercise habits -- they found that daily diet soda was linked to a 44-percent higher chance of heart attack or stroke.

Nevertheless, Gardener said, it's impossible for a study to capture all the variables that could be at work.

The findings do build on a few recent studies that also found diet-soda drinkers are more likely to have certain cardiovascular risk factors, like high blood pressure or high blood sugar.

This is the first study, Gardener said, to look at actual "vascular events" -- that is, heart attacks, strokes and deaths from cardiovascular causes.

The findings are based on 2,564 New York City adults who were 69 years old, on average, at the outset. Over the next decade, 591 men and women had a heart attack, stroke or died of cardiovascular causes.

That included 31 percent of the 163 people who were daily diet-soda drinkers at the study's start. In contrast, 22 percent of people who rarely or never drank diet soda went on to have a heart attack or stroke.

There was no increased risk linked to less-than-daily consumption. Nor was regular soda tied to heart attacks and strokes.

If diet soda, itself, somehow contributes to health risks, it's not clear how, Gardener said.

There's research in rats suggesting that artificial sweeteners can end up boosting food intake and weight. But whether results in rodents translate to humans is unknown.

"I don't think people should change their behavior based on this study," Gardener said. "And I wouldn't advocate drinking regular soda instead."

Regular soda is high in calories, and for people who need to shed pounds, experts often suggest swapping regular soda for the diet version.

A study out this month found that the advice may be sound. Obese people who were randomly assigned to drink water or diet drinks in place of sugary ones lost about five pounds over six months.

Gardener said that further studies such as hers are still needed to confirm a connection between diet soda and cardiovascular trouble.

Ultimately, she noted, clinical trials are considered the "gold standard" for proving cause-and-effect. That would mean randomly assigning people to drink diet soda or not, and then following them over time to see if there were differences in their rates of heart problems or stroke.

A study like that, Gardener said, would be "difficult and costly" -- since it would have to follow large groups of people over many years, and rely on people to stick with their assigned beverages.

Copyright 2012 Thomson Reuters. Click for restrictions.

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Daily diet soda tied to heart attack, stroke

One man's crazy diet: Nothing but beer and water

Posted: February 17, 2012 at 7:01 pm

It may seem like a dream diet: Substitute beer for food for two weeks, and never have to worry about a hangover.

Well, it’s because you only drink three beers a day, and snack on lots of water.

Paul Fierro, owner of Primo’s Craft Beer in El Paso, Texas, underwent a beer and water diet, inspired by Bavarian Monks who drank only beer during their fasts in the 16th Century.

“I started to see it as a personal challenge and a personal journey when I can kind of cleanse my body, cleanse my mind and see how I would reexamine things,” said Fierro.

Fierro and his friend Albert Salinas started the diet over a week ago, drinking beers with heavy calories and carbohydrates -- one for breakfast, lunch, and dinner.

A nursing student agreed to check on Fierro’s and Salinas’ heart rate and blood pressure every other day.

“The first few days you get a big pain like in your stomach. Then after the third day it stops, but you still have mental cravings. You’re always thinking of food,” said Salinas.

On day seven, Salinas had to quit the diet as he picked up a bad cold. In total, Salinas lost 13 pounds. So far, Fierro has lost nine.

“These past few days I’ve woken up with a lot of energy. No hunger pains yet,” said Fierro, on day eight of the diet. He said that he feels great.

Dr. Marc Siegel, a general practitioner and member of the Fox News Medical A-Team, said there are no medical benefits to this diet.

“There’s no way of knowing what someone’s underlying health issues are. You don’t know if you strain the body to this extent what’s (going to) happen,” said Siegel.  

Siegel also said there are no real nutrients in beer. There is no protein and no fat.

“I would urge them, if they are going to do this crazy thing, to at least have fluids with electrolytes in it, not just plain water,” Siegal said.

Salinas said his sense for smelling became a lot stronger during his fast. At his desk job, where he works as an insurance agent, he could smell foods at a greater distance than before.

He said he also experienced what it’s like to live in an area of the world where food is not so readily available.

“[You take] food for granted and you’re realizing other things in your life you’ve taken for granted,” said Salinas. 

Fierro finished his diet on Super Bowl Sunday. He broke the fast by eating wings, burgers, and what he was most excited for--his grandmother’s cooking.

Patrick Manning is apart of the Fox News Junior Reporting Program.

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One man's crazy diet: Nothing but beer and water

Diet soda tied to heart attack, stroke risks: study

Posted: February 17, 2012 at 7:01 pm

NEW YORK (Reuters Health) - Diet soda may benefit the waistline, but a new study suggests that people who drink it every day have a heightened risk of heart attack and stroke.

The study, which followed almost 2,600 older adults for a decade, found that those who drank diet soda every day were 44 percent more likely than non-drinkers to suffer a heart attack or stroke.

The findings, reported in the Journal of General Internal Medicine, don't prove that the sugar-free drinks are actually to blame.

There may be other things about diet-soda lovers that explain the connection, researchers say.

"What we saw was an association," said lead researcher Hannah Gardener, of the University of Miami Miller School of Medicine. "These people may tend to have more unhealthy habits."

She and her colleagues tried to account for that, Gardener told Reuters Health.

Daily diet-soda drinkers did tend to be heavier and more often have heart risk factors like high blood pressure, diabetes and unhealthy cholesterol levels.

That all suggests that people who were trying to shed pounds or manage existing health problems often opted for a diet soda over the sugar-laden variety.

But even after the researchers factored in those differences -- along with people's reported diet and exercise habits -- they found that daily diet soda was linked to a 44-percent higher chance of heart attack or stroke.

Nevertheless, Gardener said, it's impossible for a study to capture all the variables that could be at work.

The findings do build on a few recent studies that also found diet-soda drinkers are more likely to have certain cardiovascular risk factors, like high blood pressure or high blood sugar.

This is the first study, Gardener said, to look at actual "vascular events" -- that is, heart attacks, strokes and deaths from cardiovascular causes.

The findings are based on 2,564 New York City adults who were 69 years old, on average, at the outset. Over the next decade, 591 men and women had a heart attack, stroke or died of cardiovascular causes.

That included 31 percent of the 163 people who were daily diet-soda drinkers at the study's start. In contrast, 22 percent of people who rarely or never drank diet soda went on to have a heart attack or stroke.

There was no increased risk linked to less-than-daily consumption. Nor was regular soda tied to heart attacks and strokes.

If diet soda, itself, somehow contributes to health risks, it's not clear how, Gardener said.

There's research in rats suggesting that artificial sweeteners can end up boosting food intake and weight. But whether results in rodents translate to humans is unknown.

"I don't think people should change their behavior based on this study," Gardener said. "And I wouldn't advocate drinking regular soda instead."

Regular soda is high in calories, and for people who need to shed pounds, experts often suggest swapping regular soda for the diet version.

A study out this month found that the advice may be sound. Obese people who were randomly assigned to drink water or diet drinks in place of sugary ones lost about five pounds over six months.

Gardener said that further studies such as hers are still needed to confirm a connection between diet soda and cardiovascular trouble.

Ultimately, she noted, clinical trials are considered the "gold standard" for proving cause-and-effect. That would mean randomly assigning people to drink diet soda or not, and then following them over time to see if there were differences in their rates of heart problems or stroke.

A study like that, Gardener said, would be "difficult and costly" -- since it would have to follow large groups of people over many years, and rely on people to stick with their assigned beverages.

SOURCE: http://bit.ly/widyUV Journal of General Internal Medicine, online January 27, 2012.

The rest is here:
Diet soda tied to heart attack, stroke risks: study

Vivus weight loss drug faces FDA concerns

Posted: February 17, 2012 at 7:01 pm

(CBS/AP) An experimental diet pill from drugmaker Vivus Inc. has federal health officials concerned.

Vivus, based in Mountain View, Calif., plans to convince experts of the drug's safety next week. It hopes to bring the weight loss drug to market for the first time in more than a decade.

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In the past two years, the Food and Drug Administration has rejected pills from all of the three small drugmakers with such offers: Arena Pharmaceuticals Inc., Orexigen Therapeutics Inc. and Vivus. All three companies are in the process of resubmitting their products.

The FDA rejected Vivus' pill, Qnexa, in October 2010, with concerns about two particular safety issues: potential heart problems and birth defects in women who become pregnant while taking the drug. The agency plans to ask experts to weigh in on those issues, specifically risks of cleft lip defects associated with one of the ingredients in Qnexa. The experts will also discuss increased blood pressure and higher heart rates reported for patients taking the drug.

The panel of doctors will take a final vote on whether the drug appears safe and effective. The group's recommendation is not binding, and the FDA is expected to make its final decision in April.

With U.S. obesity rates close to 35 percent among adults, doctors and public health officials say new weight-loss therapies are desperately needed. And even a modestly effective drug could have blockbuster potential. But none of the three medicines before the FDA represents a breakthrough in research.

Qnexa is a combination of two older drugs. The amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anticonvulsant drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is supposed to make patients feel more satiated.

Many analysts had picked Qnexa as the most promising contender of the new potential diet pills because of the high level of weight loss reported in studies - on average, 10 percent of total body mass.

But at Qnexa's first FDA panel in 2010, experts voted 10-6 against the drug. Panelists said the drug was associated with a number of dangerous side effects, including suicidal thoughts, heart palpitations, memory lapses and birth defects.

If Qnexa is approved, Vivus plans to offer a follow-up study to monitor patients for any heart problems. Experts will consider whether the company should be required to conduct that study before FDA gives approval. The company will also offer a plan to make sure women who are likely to become pregnant do not use the drug. One of the two ingredients in Qnexa, topirimate, is known to more than double the risk of birth defects.

Qnexa's other ingredient, phentermine, was one half of the dangerous fen-phen combination, a weight loss treatment pushed by doctors that was never approved by the FDA. The regimen was linked to heart-valve damage and lung problems in the late 1990s, and the FDA forced drugmaker Wyeth to withdraw two versions of its drug fenfluramine.

Currently there is just one prescription drug on the market for long-term weight loss: Roche's Xenical, which is not widely used because of insignificant weight loss results.

Excerpt from:
Vivus weight loss drug faces FDA concerns


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