Contrave, A New Weight Loss Pill Combines Anti-Addiction Medication And An Antidepressant.
An maven bulletin panel recommended on Tuesday that Contrave, a further weight-loss cure that combines an antidepressant with an anti-addiction medication, be approved by the US Food and Drug Administration. The 13-7 opinion in favor of Contrave came amongst agency concerns that the sedative might raise blood pressure in some patients and increase the jeopardy of heart attacks and strokes among some users, according to the Associated Press bowtrolcoloncleanse. But panelists voted 11-8 earlier in the daytime that those developing health risks could be studied after Contrave was approved.
The FDA does not have to follow the opinion of its advisory committees, but it typically does. The action is expected to make a decision on Contrave by Jan 31, 2011, the wire ceremony 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 protection concerns, according to the AP. Last July, a writing-room funded by Orexigen and published in The Lancet found that Contrave helped users doff pounds when captivated along with a sturdy assembly and exercise.
People who took the drug for more than a year lost an common of 5 percent or more of body weight, depending on the dose used, the pair said. However, the regimen did come with side effects, and about half of memorize participants dropped out before completing a year of treatment. Contrave is federation of two well-known drugs, naltrexone (Revia, occupied to fight addictions) and the antidepressant bupropion (known by a sum of names, including Wellbutrin).
The drug appears to boost majority loss by changing the workings of the body's central nervous system, the researchers said. The work enrolled men (15 percent) and women (85 percent) from around the country, ranging in stage from 18 to 65. They were all either pudgy or overweightm, with turbulent blood fat levels or high blood pressure.
The participants were told to feed-bag less and exercise, and they were randomly assigned to annihilate a twice-daily placebo or a combination 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 portion of naltrexone irremediable 5 percent of their preponderance or more, while only 16 percent of those who took placebos did.
However, about 30 percent of those taking Contrave knowing nausea, the office authors say, and other interest effects included headache, constipation, dizziness, vomiting and wearying mouth. Still, Contrave may give plebeians struggling to lose weight a unique option, the researchers contended.
The Lancet findings echo those of studies into other slim drugs such as Meridia, Xenical and Alli, said Lona Sandon, an subordinate 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, humble amounts of power drubbing are achieved. One rare thing to note is the study drop-out rate of 50 percent. This may have been due to squad effects of medications, the reality that it is hard to stick to dietary changes for 56 weeks, or the fait accompli that slow and only modest weight loss did not meet participant expectations".
Cynthia Sass, a New York City-based nutritionist and author, added that drugs worn to to addiction also appear to help with heft control, supporting "the notion that food can be addictive for many people". An accompanying Lancet column noted that one be germane to is that blood pressure did not drop as much as expected in the higher weight-loss group vito mol. "More evidence are needed to get a better overall assessment of cardiovascular risk of this otherwise hopeful combination therapy for obesity," wrote Professor Arne Astrup, a nutrition superb at the University of Copenhagen, Denmark.
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