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Jun 28

FDA OKs drug for long-term weight loss

The Food and Drug Administration has approved Arena Pharmaceuticals anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in more than a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDAs endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.

Obesity Society President Patrick O'Neil said hes encouraged by the drugs approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.

This is good news because it tells us that the FDA is indeed treating obesity seriously, said Mr. ONeil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. On the other hand, its not the answer to the problem or even a big part of the answer.

Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.

The way these things tend to work is you have some people who do extremely well and other people dont lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field, said Dr. Louis Aronne, director of the weight-loss program at Weill-Cornell Medical College.

The FDA denied approval for Arenas drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight-loss treatments.

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FDA OKs drug for long-term weight loss


Jun 28

FDA approves first diet prescription pill in 13 years

by Associated Press

KING5.com

Posted on June 27, 2012 at 12:16 PM

Updated today at 4:59 PM

WASHINGTON -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.

The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.

But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by FDA.

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FDA approves first diet prescription pill in 13 years


Jun 28

Belviq: First New Weight-Loss Pill Approved By FDA In Decade

WASHINGTON The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.

Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.

"This is good news because it tells us that the FDA is indeed treating obesity seriously," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. "On the other hand, it's not the answer to the problem or even a big part of the answer."

Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.

"The way these things tend to work is you have some people who do extremely well and other people don't lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.

The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.

Link:
Belviq: First New Weight-Loss Pill Approved By FDA In Decade


Jun 28

FDA clears first new prescription weight-loss pill in 13 years

by Associated Press

KING5.com

Posted on June 27, 2012 at 2:33 PM

Updated today at 2:33 PM

WASHINGTON -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.

The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

"The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition," said FDA's drug center director, Dr. Janet Woodcock, in a statement.

Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.

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FDA clears first new prescription weight-loss pill in 13 years


Jun 28

FDA Approves First Weight-Loss Drug In 13 Yrs.

WASHINGTON (AP) -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.

Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.

The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.

Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.

"This is good news because it tells us that the FDA is indeed treating obesity seriously," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. "On the other hand, it's not the answer to the problem - or even a big part of the answer."

Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.

"The way these things tend to work is you have some people who do extremely well and other people don't lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.

The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.

Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.

With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.

Read more here:
FDA Approves First Weight-Loss Drug In 13 Yrs.


Jun 27

Stepped-care intervention results in weight loss, at lower cost

Public release date: 26-Jun-2012 [ | E-mail | Share ]

Contact: Patricia Lomando White laer@pitt.edu 412-624-9101 JAMA and Archives Journals

CHICAGO Although a standard behavioral weight loss intervention among overweight and obese adults resulted in greater average weight loss over 18 months, a stepped care intervention resulted in clinically meaningful weight loss that cost less to implement, according to a study in the June 27 issue of JAMA.

"Most weight loss programs are intensive during the initial weeks of treatment, become less intensive over time, and maintain a fixed contact schedule for participants irrespective of treatment success or failure. Intensive weight loss programs are costly and require substantial time commitments from the participants, making them impractical in many circumstances. An alternative is a stepped-care approach. It involves an initially low-intensity intervention that is increased if weight loss milestones are not achieved at fixed time points. Stepped care has been effective for treatment of other health conditions. In theory, stepped care could result in better weight loss than conventional therapy because treatment intensity is escalated if weight loss goals are not met during the treatment period," according to background information in the article. "If shown to be an effective and a lower cost alternative to traditional in-person programs, a stepped-care approach could prove to be a cost-effective means for obesity treatment."

John M. Jakicic, Ph.D., of the University of Pittsburgh, and colleagues examined whether a stepped-care weight loss intervention (STEP) would result in greater weight loss compared with a standard behavioral weight loss intervention (SBWI). The clinical trial included 363 overweight and obese adults (body mass index: 25-<40; age: 18-55 years, 33 percent nonwhite, and 83 percent female) who were randomized to SBWI (n = 165) or STEP (n=198). Participants were enrolled between May 2008 and February 2010 and data collection was completed by September 2011. All participants were placed on a low-calorie diet, prescribed increases in physical activity, and attended group counseling sessions ranging from weekly to monthly during an 18-month period. The SBWI group was assigned to a fixed program. Counseling frequency, type, and weight loss strategies could be modified every 3 months for the STEP group in response to observed weight loss as it related to weight loss goals.

Of the 363 study participants, 260 (71.6 percent) provided a measure of weight at the 18-month assessment. The researchers found that weight loss at 18 months was -7.6 kg (16.8 lbs.) in the SBWI group compared with -6.2 kg (13.7 lbs.) in the STEP group. The percentage change in weight from baseline to 18 months was -8.1 percent in the SBWI group compared with -6.9 percent in the STEP group.

Both groups had significant and comparable improvements in resting heart rate, blood pressure level, and fitness.

"From the payer perspective, the mean cost per participant was $358 for the STEP group and $494 for the SBWI group. Costs from the participant perspective also were lower in the STEP group ($427) per participant compared with the SBWI group ($863). From the societal perspective (i.e., the sum of payer and participant), the average cost for STEP was $785. This was significantly less expensive than the average cost for SBWI, which was estimated to be $1,357," the authors write.

The researchers add that using the base-case cost estimates, they found that from the societal perspective, relative to status quo, the incremental cost-effectiveness ratio for STEP was $127 per 1 kg (2.2 lbs.) of weight lost. "The incremental cost-effectiveness ratio for SBWI, relative to the less expensive STEP, was $409 per 1 kg of weight lost. From the payer perspective, the incremental cost-effectiveness ratios were reduced to $58 per 1 kg of weight lost for STEP and $97 per 1 kg of weight lost for SBWI."

"Among overweight and obese adults, the use of SBWI resulted in a greater mean weight loss than STEP over 18 months. STEP resulted in clinically meaningful weight loss that cost less to implement than SBWI. Whether this weight loss results in improved health-related outcomes warrants further investigation," the authors conclude.

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Stepped-care intervention results in weight loss, at lower cost


Jun 27

Study compares effect of 3 common diets on energy expenditure following weight loss

Public release date: 26-Jun-2012 [ | E-mail | Share ]

Contact: Keri Stedman keri.stedman@childrens.harvard.edu 617-919-3114 JAMA and Archives Journals

CHICAGO In an examination of the effect on energy expenditure and components of the metabolic syndrome of 3 types of commonly consumed diets following weight loss, decreases in resting energy expenditure and total energy expenditure were greatest with a low-fat diet, intermediate with a low-glycemic index diet, and least with a very low-carbohydrate diet, suggesting that a low-fat diet may increase the risk for weight regain compared to the other diets, according to preliminary research published in the June 27 issue of JAMA.

"Many people can lose weight for a few months, but most have difficulty maintaining clinically significant weight loss over the long term. According to data from the National Health and Nutrition Examination Survey (1999-2006), only 1 in 6 overweight and obese adults report ever having maintained weight loss of at least 10 percent for 1 year," according to background information in the article. One explanation for the poor long-term outcome is that weight loss elicits biological adaptationsspecifically a decline in energy expenditure and an increase in hungerthat promote weight. According to the authors, the effect of dietary composition on energy expenditure during weight-loss maintenance has not been studied.

Cara B. Ebbeling, Ph.D., of Children's Hospital Boston, and colleagues conducted a study to evaluate the effects of 3 weight-loss maintenance diets on energy expenditure, hormones, and components of the metabolic syndrome. The study, conducted between June 2006 and June 2010, included 21 overweight and obese young adults. After achieving 10 percent to 15 percent weight loss while consuming a run-in diet, participants consumed an isocaloric low-fat diet (60 percent of energy from carbohydrate, 20 percent from fat, 20 percent from protein; high glycemic load), low-glycemic index diet (40 percent from carbohydrate, 40 percent from fat, and 20 percent from protein; moderate glycemic load), and very low-carbohydrate diet (10 percent from carbohydrate, 60 percent from fat, and 30 percent from protein; low glycemic load) in random order, each for 4 weeks. The primary outcome measured was resting energy expenditure (REE), with secondary outcomes of total energy expenditure (TEE), hormone levels, and metabolic syndrome components.

The researchers found that energy expenditure during weight-loss maintenance differed significantly among the 3 diets. The decrease in REE from pre-weight-loss levels, measured by indirect calorimetry in the fasting state, was greatest for the low-fat diet (average relative to baseline, -205 kcal/d), intermediate with the low-glycemic index diet (-166 kcal/d), and least for the very low-carbohydrate diet (-138 kcal/d). The decrease in TEE also differed significantly by diet (average -423 kcal/d for low fat; -297 kcal/d for low glycemic index; and -97 kcal/d for very low carbohydrate).

"Hormone levels and metabolic syndrome components also varied during weight maintenance by diet (leptin; 24-hour urinary cortisol; indexes of peripheral and hepatic insulin sensitivity; high-density lipoprotein [HDL] cholesterol; non-HDL cholesterol; triglycerides; plasminogen activator inhibitor 1; and C-reactive protein), but no consistent favorable pattern emerged," the authors write.

"The results of our study challenge the notion that a calorie is a calorie from a metabolic perspective," the researchers write. "TEE differed by approximately 300 kcal/d between these 2 diets [very low-carbohydrate vs. low-fat], an effect corresponding with the amount of energy typically expended in 1 hour of moderate-intensity physical activity."

"These findings suggest that a strategy to reduce glycemic load rather than dietary fat may be advantageous for weight-loss maintenance and cardiovascular disease prevention. Ultimately, successful weight-loss maintenance will require behavioral and environmental interventions to facilitate long-term dietary adherence. But such interventions will be most effective if they promote a dietary pattern that ameliorates the adverse biological changes accompanying weight loss," the researchers conclude.

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Study compares effect of 3 common diets on energy expenditure following weight loss


Jun 27

Effect of three common diets on energy expenditure following weight loss detailed

ScienceDaily (June 26, 2012) In an examination of the effect on energy expenditure and components of the metabolic syndrome of 3 types of commonly consumed diets following weight loss, decreases in resting energy expenditure and total energy expenditure were greatest with a low-fat diet, intermediate with a low-glycemic index diet, and least with a very low-carbohydrate diet, suggesting that a low-fat diet may increase the risk for weight regain compared to the other diets, according to preliminary research published in the June 27 issue of JAMA.

"Many people can lose weight for a few months, but most have difficulty maintaining clinically significant weight loss over the long term. According to data from the National Health and Nutrition Examination Survey (1999-2006), only 1 in 6 overweight and obese adults report ever having maintained weight loss of at least 10 percent for 1 year," according to background information in the article. One explanation for the poor long-term outcome is that weight loss elicits biological adaptations -- specifically a decline in energy expenditure and an increase in hunger -- that promote weight. According to the authors, the effect of dietary composition on energy expenditure during weight-loss maintenance has not been studied.

Cara B. Ebbeling, Ph.D., of Children's Hospital Boston, and colleagues conducted a study to evaluate the effects of 3 weight-loss maintenance diets on energy expenditure, hormones, and components of the metabolic syndrome. The study, conducted between June 2006 and June 2010, included 21 overweight and obese young adults. After achieving 10 percent to 15 percent weight loss while consuming a run-in diet, participants consumed an isocaloric low-fat diet (60 percent of energy from carbohydrate, 20 percent from fat, 20 percent from protein; high glycemic load), low-glycemic index diet (40 percent from carbohydrate, 40 percent from fat, and 20 percent from protein; moderate glycemic load), and very low-carbohydrate diet (10 percent from carbohydrate, 60 percent from fat, and 30 percent from protein; low glycemic load) in random order, each for 4 weeks. The primary outcome measured was resting energy expenditure (REE), with secondary outcomes of total energy expenditure (TEE), hormone levels, and metabolic syndrome components.

The researchers found that energy expenditure during weight-loss maintenance differed significantly among the 3 diets. The decrease in REE from pre-weight-loss levels, measured by indirect calorimetry in the fasting state, was greatest for the low-fat diet (average relative to baseline, -205 kcal/d), intermediate with the low-glycemic index diet (-166 kcal/d), and least for the very low-carbohydrate diet (-138 kcal/d). The decrease in TEE also differed significantly by diet (average -423 kcal/d for low fat; -297 kcal/d for low glycemic index; and -97 kcal/d for very low carbohydrate).

"Hormone levels and metabolic syndrome components also varied during weight maintenance by diet (leptin; 24-hour urinary cortisol; indexes of peripheral and hepatic insulin sensitivity; high-density lipoprotein [HDL] cholesterol; non-HDL cholesterol; triglycerides; plasminogen activator inhibitor 1; and C-reactive protein), but no consistent favorable pattern emerged," the authors write.

"The results of our study challenge the notion that a calorie is a calorie from a metabolic perspective," the researchers write. "TEE differed by approximately 300 kcal/d between these 2 diets [very low-carbohydrate vs. low-fat], an effect corresponding with the amount of energy typically expended in 1 hour of moderate-intensity physical activity."

"These findings suggest that a strategy to reduce glycemic load rather than dietary fat may be advantageous for weight-loss maintenance and cardiovascular disease prevention. Ultimately, successful weight-loss maintenance will require behavioral and environmental interventions to facilitate long-term dietary adherence. But such interventions will be most effective if they promote a dietary pattern that ameliorates the adverse biological changes accompanying weight loss," the researchers conclude.

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Effect of three common diets on energy expenditure following weight loss detailed


Jun 25

Mercy Health System targets bariatric patients with Health eCooking weight loss video recipes

WASHINGTON CROSSING, Pa.--(BUSINESS WIRE)--

For thousands of obese Philadelphians, Mercy Bariatrics website is a resource for weight loss recipes, fitness tips, bariatric support and a link to weight loss surgeons.

In less than a year, Mercy Health Systems program has identified hundreds of new bariatric patients in the Philadelphia region using a marketing campaign that focuses on web, email and social media. This digital campaign is fueled with bariatric recipes and articles from Baldwin Publishing.

The first quarter delivered 134 calls to the call center asking for appointments, and almost 30 appointment requests came from the website, says Gabrielle DeTora, Interim Vice President of Marketing for Mercy Health System.

Weight loss surgery patients need to make drastic dietary changes following surgery. Health eCooking video recipes teach them how to prepare low calorie bariatric recipes. Web articles on weight loss procedures; nutrition advice and fitness build relationships through social sharing on Mercys Bariatric Facebook page.

A bariatric eNewsletter, also from Baldwin Publishing, engages people considering the procedure and showcases Mercys long-term relationships with bariatric patients. An integrative campaign including radio, print and billboards across the city send thousands of web visits to http://www.mercybariatrics.org/.

Baldwin's bariatric recipes and articles are an easily accessible marketingtool that helps weight loss surgery patients succeed. Baldwin Publishing's holistic approach to bariatric marketing is extremely valuable, says DeTora.

About Mercy Health System

Mercy Health System is the largest Catholic healthcare system serving the Delaware Valley and is a member of Catholic Health East, a multi-institutional Catholic health system co-sponsored by9 religious congregations and Hope Ministries. Mercy Health System is comprised of more than 6,500 caring, highly skilled employees focused on creating an outstanding patient-care experience. As a market leader for quality clinical outcomes Mercy Health System is a significant force in creating an environment where competence and compassionate care meet.

About Baldwin Publishing

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Mercy Health System targets bariatric patients with Health eCooking weight loss video recipes


Jun 25

Kate Middleton Weight Loss 2012 Kate Middleton Diet Programs

Kate Middleton Weight Loss 2012 Kate Middleton Diet Programs - Isn't amazing how all of the celebrities you see have a celebrity diet plan for weight loss to maintain their weight. Some of them are shapely and healthy looking, and look good on camera. Others look like they haven't eaten in weeks, like they just got back from the famine in Ethiopia for a few weeks. Like they had been starving themselves to lose weight, and that is probably what they have been doing. You see it in all the tabloids, this person lost 100 pounds again, this one gained 100 pounds, and then lost 150 pounds. Some are not as dramatic; this one lost 40 pounds and is a television spokesperson, because the previous celebrity diet spokesperson gained the weight back. The fact is they may be starving themselves to lose weight, fasting like they are going through a famine.

Celebrities make dieting look so easy, don't they? One month they're on the cover of US Weekly for gaining too much weight and the next they're headlining the "sexiest beach bods" story. It is true that seriously overweight people can lose large amounts of fat in a quick amount of time, because of the large fat content in their cells. But those that are only a few pounds overweight, losing 40 pounds in a month, is not only starvation, it is malnutrition and can have serious side effects. Our body weight can fluctuate day to day and the best diets take the weight off gradually, the way it came on.

Researches indicate that individuals who indulge in a weight loss program by taking prepared meals end up losing an additional 31% weight as against those who cook their own meals. With help, losing weight is made easier and at times much faster as against doing it on your own.Diet delivery is gaining popularity in a big way as it is fairly affordable by even the common man, roughly around $20 a day with an increasing variety to choose from. A few of which include: Zone-compliant meal, low carbs plan, veggie meals, and gourmet too.

"Click Here to Watch Weird VIDEO About The 5 Foods that KILL Abdominal Fat!"

With the rapidly increasing epidemic of obesity and increasing BMI levels, there is an array of products and diet plan to aid in combating obesity. Celebrity slim diet, the basic idea is to educate people and not to depict food as an enemy. Like a lot of famous diets in Hollywood, if your body thinks you are starving, it is going to hold on to every calorie you take in to keep you from starving to death instead of burning them for energy. When you follow a properly balanced weight loss diet, your metabolism will hardly notice the decrease in calories and continue to burn fat it doesn't need to store. This is a more long-term weight loss strategy.

Celebrities do not have secrets about dieting. They are normal people like the rest of us but, unlike most of us, they have people working for them such as diet advisors and personal trainers. Celebrity diets involve a level of commitment and dedication which we struggle with. The best celebrity diets involve eating sensibly and limiting our calorie intake. Having these factors in mind will allow you to have safe and easy weight loss that will provide you with short term and long term consistent results.

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Kate Middleton Weight Loss 2012 Kate Middleton Diet Programs



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