Contrave, A New Weight Loss Pill Combines Anti-Addiction Medication And An Antidepressant.
An pro admonitory panel recommended on Tuesday that Contrave, a supplementary weight-loss pill that combines an antidepressant with an anti-addiction medication, be approved by the US Food and Drug Administration. The 13-7 come out in favor of Contrave came amid agency concerns that the knock out might raise blood pressure in some patients and increase the risk of heart attacks and strokes mid some users, according to the Associated Press. But panelists voted 11-8 earlier in the daylight that those potential health risks could be studied after Contrave was approved.
The FDA does not have to follow the advice of its advisory committees, but it typically does. The activity is expected to make a decision on Contrave by Jan 31, 2011, the wire usefulness reported. Contrave is manufactured by Orexigen Therapeutics Inc. In October, the FDA voted against approving two other weight-loss drugs, Arena Pharmaceuticals' lorcaserin and Vivus' Qnexa, because of safeness concerns, according to the AP. Last July, a survey funded by Orexigen and published in The Lancet found that Contrave helped users abandon pounds when taken along with a beneficial diet and exercise.
People who took the drug for more than a year lost an average of 5 percent or more of body weight, depending on the quantity used, the team said. However, the regimen did come with side effects, and about half of think over participants dropped out before completing a year of treatment. Contrave is combination of two famous drugs, naltrexone (Revia, used to fight addictions) and the antidepressant bupropion (known by a few of names, including Wellbutrin).
The drug appears to boost weight loss by changing the workings of the body's medial nervous system, the researchers said. The study enrolled men (15 percent) and women (85 percent) from around the country, ranging in grow old from 18 to 65. They were all either paunchy or overweightm, with high blood fat levels or high blood pressure.
The participants were told to dine less and exercise, and they were randomly assigned to take a twice-daily placebo or a consortium of the two drugs at one of two levels. After 56 weeks, only about half (870) of the more than 1700 participants initially enrolled remained in the study. Almost half (48 percent) of those who took the highest measure of naltrexone irremediable 5 percent of their weight or more, while only 16 percent of those who took placebos did.
However, about 30 percent of those taking Contrave au fait nausea, the study authors say, and other inconsequential effects included headache, constipation, dizziness, vomiting and dry mouth. Still, Contrave may give commoners struggling to lose weight a new option, the researchers contended.
The Lancet findings duplicate those of studies into other diet drugs such as Meridia, Xenical and Alli, said Lona Sandon, an underling professor of clinical nutrition at the University of Texas Southwestern Medical Center in Dallas and spokeswoman for the American Dietetic Association. "When these are combined with a modestly reduced calorie diet, meek amounts of tonnage loss are achieved. One striking gismo to note is the study drop-out rate of 50 percent. This may have been due to side effects of medications, the certainty that it is hard to stick to dietary changes for 56 weeks, or the fact that slow and only modest load loss did not meet participant expectations".
Cynthia Sass, a New York City-based nutritionist and author, added that drugs utilized to treat addiction also appear to help with weight control, supporting "the whimsy that food can be addictive for many people". An accompanying Lancet editorial noted that one anxiety is that blood pressure did not drop as much as expected in the higher weight-loss group testosterone. "More data are needed to get a better overall assessment of cardiovascular chance of this otherwise promising combination therapy for obesity," wrote Professor Arne Astrup, a nutrition authority at the University of Copenhagen, Denmark.
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