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07.04.2014
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A new weight-loss pill that many doctors consider the most effective of a new generation of anti-obesity drugs got the approval of the Food and Drug Administration on Tuesday.
The pill, called Qsymia, was approved for patients who are overweight or obese and also have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol. The drug offers hope for those who have failed to lose weight in other ways, but its path to approval also underscores how difficult it has been for drugmakers to find obesity treatments that are safe and effective.
The drug's maker, Vivus Inc., said it plans to bring the drug to market in the fourth quarter of this year.
In testing, the drug made led patients to lose more weight than two other weight-loss pills recently review by the FDA.
Despite its impressive performance in clinical trials, Qsymia is not exactly a scientific breakthrough. Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss.
Researchers say the innovation of Qsymia lies in targeting more than one of the brain signals that drive people to overeat. Qsymia is the second weight-loss drug approved by the FDA in less than a month, following Arena Pharmaceutical's pill Belviq in late June.
The FDA's approvals of Qsymia and Belviq suggest a new willingness to make weight-loss medications available, even in the face of lingering safety issues. The FDA initially rejected Vivus' drug in 2010 over concerns that it can cause birth defects if taken by pregnant women. The agency also said patients with recent or unstable heart disease or stroke aren't good candidates for the drug because its effect on heart rates in those patients is not known. Analysts estimate the new pill could garner more than $1 billion in sales by 2016, though Mountain View, Calif.-based Vivus plans a slow rollout. Throughout the years, scientists and manufacturers have designed thousands of weight-loss pills, supplements and devices designed to help obese or overweight people shed pounds. The study was conducted on two different groups of people: one group was given a placebo, while the other one was given the actual pill. The study was performed on 128 overweight or obese people who were instructed to take the pill before dinner and lunch, along with 17 ounces of water. This innovative weight-loss pill was created by Gelesis, a company seeking FDA approval for the product and to start marketing it right away.
Nonetheless, the results of the study are still being debated, and professionals have not yet had time to analyze them properly.


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Product Description L-Carnitine ,herbal slimming ,lose weight pills L-carnitine, also known as vitamin BT, is a type of vitamin, red meat is the main food source for carnitine. 2011 Hot Lose Weight Diet Pills- 1 Day Diet Slimming Capsule 1 Day Diet Loss Weight Pills give you the chance! A new diet pill called the Obalon inflates inside your stomach to mimic the results of weight loss surgery.
The pill's maker, Obalon Therapeutics, claims overweight and obese patients can lose up to 20 pounds in three months because it helps you feel full, so you eat less.
Though not all experts are convinced that the Obalon is effective, the idea is part of a growing trend to find alternatives to weight loss surgery, which can be expensive and risky.
Some procedures, like stunning the stomach and intestinal lining with the cosmetic drug Botox to reduce hunger pangs or chemically scarring the intestine to slow digestion, haven't quite panned out, said Dr. Two Brazilian investigations followed more than 100 moderately-to-severely overweight patients who had the inflatable device endoscopically implanted.
Pryor said the balloons can be easily removed and the biggest risk seems to be unintentional deflation. Morgan Liscinsky, a spokeswoman for the agency, said the FDA does not comment on its ongoing approval processes for medical devices. Another weight loss method the ASMBS is following closely is the EndoBarrier, a long, flexible tube resembling a plastic bag. The EndoBarrier was approved in Europe, South America and Australia in 2006 and is expected to be approved for use in the U.S. Pryor noted that one of the more controversial devices on the ASMBS emerging technology list is the AspireAssist pump, which works by sucking the food right out of the stomach so that only about a third of the calories are absorbed by the body. Calories not digested are calories not absorbed, which, in theory, Pryor said, should lead to weight loss.
Available in select regions of Europe, including Sweden, since 2011, the AspireAssist is still undergoing trials in the United States, with no word when it may be approved for use in this country. Pryor pointed out that the most current Centers for Disease Control and Prevention statistics put the percentage of Americans who are overweight or obese at nearly 70 percent, so new and novel approaches to weight loss are certainly needed. You have read and agree to the Global Shipping Program terms and conditions - opens in a new window or tab. Import charges previously quoted are subject to change if you increase you maximum bid amount. The slimming pills can reduce the compound and absorption of fat, dilute and burn the fat effectively, accelerate metabolism and delay skin caducity by antioxidant. The drug is actually a combination of two older drugs long known to help with weight loss: phentermine and topirimate.
Topiramate is an anticonvulsant, sold by Johnson & Johnson as Topamax, that makes people feel more satisfied after eating. The cocktail of phentermine and fenfluramine was a popular weight-loss combination prescribed by doctors, though it was never approved by the FDA. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased risks for heart attack and stroke. The agency laid out a risk-management plan Tuesday specifically designed to minimize the chance of the women becoming pregnant while using the drug. Company executives say their initial marketing efforts will focus on obesity specialists, not general doctors. However, FDA regulators ordered the company to change the name to avoid potential confusion with similar-sounding drugs.
One of the newest and most controversial inventions in terms of weight loss is the capsule that temporarily swells up in your digestive tract, thus making you feel fuller than you actually are.


While the placebo group only managed to lose approximately 4% of their weight throughout the three-month study, the group that was given the real pill managed to lose approximately 6% of their body weight, thus partially proving the efficacy of this pill. Not only were they instructed on how to take the pill, but their diets were also slightly changed, as they were switched to a lower-calorie diet.
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Once you swallow the pill, the device can stay in your stomach up to three months before it is removed. You can swallow up to three balloons in a 12-week period to speed up weight loss, according to the company.
But you can buy it Austria, Belgium, Germany, Italy, Luxembourg, the Netherlands and Spain. The American Society for Metabolic and Bariatric Surgery tracks alternative weight loss procedures that may one day provide a viable alternative to going under the knife. They found that the patients lost an average of 20 percent of their body weight after six months. They are available in many parts of the world but the Food and Drug Administration has not yet approved them for use in the U.S. The device attaches to the bottom of the stomach and snakes through the first two feet of the small intestine so that food does not come into contact with the intestine itself. Holly Wyatt, an endocrinologist with the School of Medicine at the University of Colorado, will oversee one of the 25 FDA EndoBarrier trials of more than 500 people beginning later this year.
Patients wait 20 minutes after eating, then empty 30 percent of their stomach contents into the toilet through a small, handheld device that connects to a skin-port discretely embedded on the outside of the abdomen.
In a one-year trial of 24 obese patients, on average, patients lost 49 percent of excess weight, the equivalent of about 45 pounds. She said it's unlikely any one procedure will work for everyone and that any and all of these devises may eventually find their place in the arsenal in the fight against obesity.
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The company said patients on the strongest formulation tested lost nearly 11 percent of their weight. But a long line of prescription diet pills have been associated with dangerous side effects, particularly heart problems.
It recommends that women of childbearing age test negative for pregnancy before starting the drug and take a monthly pregnancy test while taking it.
A third California drugmaker, Orexigen Therapeutics Inc., is still running clinical trials of its product, Contrave, and is working toward an FDA approval date in 2014. The chief executive of the pill’s manufacturer claims that the difference between the placebo group and the other group would have been significantly higher if the subjects continued to take the pill for an extended period of time, and if the trial had been longer. She said the device is based on the same premise as gastric bypass but doesn't make permanent changes to the stomach's anatomy, thereby avoiding many of the risks. He added that in foreign clinical trials, average weight loss was 20 percent of body weight in 12 months or less and many patients were also able to reach healthy blood sugar levels and reduce or eliminate the use of anti-diabetes medications. Astrup, the head of the Nutrition, Sports and Exercise Department at the University of Copenhagen, claims, this pill can actually be safer and more efficient than many other weight-loss drugs on the market given the fact that it contains no chemicals that influence appetite whatsoever.



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