The health news world has been buzzing with stories about a study in the medical journal The Lancet: as CBS News put it, "Big news for big people: in a new drug company-funded study, high doses of the weight loss drug Qnexa helped patients lose an average of 22 pounds over the course of a year." But some observers are questioning both the drug's effectiveness and its safety, in light of the fact that the Food and Drug Administration recently decided not to approve it. Here's more from The Los Angeles Times:
The diet drug Qnexa helps obese people with weight-related medical conditions to lose more weight than those who take a dummy pill and could allow some to scale back on medications for diabetes, high blood pressure or cholesterol, according to a new study published online in the Lancet.
Only this study is not so new -- and its findings may be less weighty than might be concluded with its publication in this respected medical journal. Qnexa -- an investigational weight-loss drug that combines the anticonvulsant topiramate with the short-term diet drug phentermine -- was denied FDA approval last October. At that time, the FDA asked Vivus, the company sponsoring Qnexa's application for market approval, to conduct further research on the drug's safety.
This newly published article details one of two clinical trials that were evaluated by the FDA before the agency decided to deny approval for Qnexa in October 2010. When the FDA's staff scientists combined the results of this study with a second study (both funded by Vivus, of Mountain View, Calif.) -- they concluded that the weight-loss difference between those taking Qnexa and those taking a placebo was "of nominal statistical significance."
Read the full story at The Los Angeles Times.
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