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FDA approves first new weight-loss pill in decade

Posted: June 27, 2012 at 9:19 pm

By MATTHEW PERRONE AP Health Writer

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 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.

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.

In a rare move, the FDA explicitly stated in a press release that Belviq "does not appear to activate" a chemical pathway that was linked to the heart problems seen with fen-phen.

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Weight Loss Success Jaime Medina Gave Up Fast Food And Lost 115 Pounds

Posted: June 27, 2012 at 9:19 pm

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

Posted: June 27, 2012 at 8:16 am

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

Posted: June 27, 2012 at 8:16 am

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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Smart ways to lose weight – Video

Posted: June 27, 2012 at 8:16 am

25-06-2012 18:24 Reporter Susan Hendricks tells us about how to lose weight quickly but safely - up to 2 pounds a week. For more CNN videos, check out our YouTube channel at Or visit our site at

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Subliminal Weight Loss – lose weight with Subliminal MP3 – Video

Posted: June 27, 2012 at 8:16 am

26-06-2012 12:46 Subliminal Weight Loss Subliminal MP3s can help with your Weight loss system. They will help you to destroy your negative beliefs about your weight issues and help you to believe that Weight loss comes naturally to you, you are losing weight consistently, you are losing weight safely and naturally, your are extremely motivated to lose weight and that you have a strong level of willpower. Click the link for more info and to sign up for your three free albums worth over $40

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Weight Loss Bully – How to Lose Weight Fast! – Video

Posted: June 27, 2012 at 8:16 am

26-06-2012 19:30 Weight loss bully : How 1 man Lost 50 Pounds by doing things the "weight loss gurus" forbid you to! weight loss bully weight loss bully review weight loss diet bully weight loss bully manual lose weight quickly fast weight loss weight loss diet rapid weight loss quick weight...

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Jessica Simpson And Aishwarya Rai Baby Weight Scrutiny Reflects Hefty Expectations Of Celebrity Moms

Posted: June 27, 2012 at 8:16 am

In Hollywood, new moms are feeling greater pressure than ever before to lose their baby weight -- and quickly. It seems that as soon as a starlet gives birth, tabloids and even legitimate publications are on round-the-clock weight-loss watch, and the public invariably eats it up.

This year, two high-profile women became the target of cruel gossip both during and after their pregnancies.

Bollywood sensation Aishwarya Rai has been the target of critical attention around her post-baby body, and the scrutiny has helped open up a dialogue about the unhealthy standards imposed on women.

The 38-year-old stunner, who was crowned Miss World in 1994 and frequently named the world's most beautiful woman, gave birth to a daughter in November of 2011. Since then, she has faced public and media scrutiny about her weight that borders on harassment. Videos such as FAT Aishwarya Rai Attends Mukesh Ambani Party and SHOCKING! FAT Aishwarya Rai hit the web and incited an onlsaught of comments - some supportive, some not so much.

"She's absolutely beautiful. She's gained weight, so what? She's gorgeous," wrote one YouTube user in response to the latter video.

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Others weren't so generous.

"Let's be REAL AND HONEST. She used to be gorgeous, now she is ugly. 'Fat' doesn't 'suit' everybody," said a meaner-spirited commenter.

Jessica Simpson's expanding belly became the butt of jokes well before she gave birth - and the criticism has not subsided since she welcomed baby Maxwell into the world May 1.

In March TMZ announced that Simpson signed a $4 million deal with Weight Watchers to lose all of her baby weight - but in order to cash in, Simpson must lose the weight in five months. The headline on the TMZ story? "Jessica Simpson -Professional Fat Person."

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Obese adults should get counseling, federal task force says

Posted: June 26, 2012 at 1:19 pm

In a move that could significantly expand insurance coverage of weight-loss treatments, a federal health advisory panel on Monday recommended that all obese adults receive intensive counseling in an effort to rein in a growing health crisis in America.

The U.S. Preventive Services Task Force urged doctors to identify patients with a body mass index of 30 or more currently 1 in 3 Americans and either provide counseling themselves or refer the patient to a program designed to promote weight loss and improve health prospects.

Under the current healthcare law, Medicare and most private insurers would be required to cover the entire cost of weight-loss services that meet or exceed the task force's standards.

That could all change Thursday, when the U.S. Supreme Courtis expected to rule on the constitutionality of President Obama's healthcare law, which requires adoption of certain recommendations from the task force, such as this one on obesity.

Few private health insurers now reimburse physicians for weight-loss counseling or pay for programs that patients seek out on their own. A growing number, in fact, charge obese patients more for coverage a policy that some public health officials have denounced as punitive and ineffective.

The task force concluded after a review of the medical literature that the most successful programs in improving patients' health were "intensive, multicomponent behavioral interventions." They involve 12 to 26 counseling sessions a year with a physician or community-based program, the panel said.

Successful programs set weight-loss goals, improve knowledge about nutrition, teach patients how to track their eating and set limits, identify barriers to change (such as a scarcity of healthful food choices near home) and strategize on ways to maintain lifestyle changes, the panel found.

In some cases, programs include exercise sessions as well.

The recommendation, published online in the Annals of Internal Medicine, does not apply to the roughly one-third of Americans who are considered overweight, those with a BMI from 25 to 29.9.

It follows a November decision by Medicare to reimburse physicians for providing "intensive weight counseling" to the roughly 14 million obese Americans insured by the government program.

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Diabetes: Weight-Loss Surgery May Not Reverse Disease

Posted: June 25, 2012 at 10:10 pm

Diabetes can be shed like so many unwanted pounds thanks to the advent of weight-loss surgery. However, according to a recent study, these procedures may not a permanent solution to their problem. In about one-fifth of the individuals who elected to have the surgery, diabetes returned within about three to five years. This, of course, is definitely bad news for those folks who endured the many side effects in hopes that the procedure would give them a new lease on life.

In order to determine just how frequently the disease returns, researchers poured over the medical records of nearly 72 obese patients who were living with Type 2 diabetes at the time of their gastric bypass surgery. The results are a tad alarming.

Following the procedure, 66 patients soon said goodbye to their diabetes. Unfortunately, 14 of these individuals saw the disease return within five years time. However, those who did not experience another round of diabetes contributed their good luck to losing more weight following the procedure. These folks also kept a lower average weight than their counterparts.

The study also found that people who had diabetes for an extended period of time before embarking down the path of weight-loss surgery were more likely to see the disease return than those who had it for a much shorter period. As such, the sooner obese individuals address their weight and diabetes problems with weight-loss surgery, the higher the chance that they wont see the disease return years later.

Providers and patients need to be aware of this information, to have a better idea of the expected outcome and be able to make an informed decision about pursuing gastric bypass surgery, lead author Dr. Yessica Ramos explained.

The study was recently presented at the Endocrine Societys annual meeting in Houston, Texas. Until the these findings have been published in a peer-reviewed journal, they should be considered as preliminary.

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