Once again, diet drug Acomplia (rimonabant) is the subject of a breathless news story on WebMD based on a rehash by researchers of the four main clinical trial studies of Acomplia that have been reported on ad nauseam over the past two years.
"The latest Acomplia headlines," WebMD reports, "appear online in The Cochrane Library" and reveal (gasp) that only the higher dose of Acomplia results in significant weight loss (the lower trial dose has long since been abandoned), and that shaving 600 calories a day off your diet helps (duh).
The reviewers reached these conclusions based on an analysis of results of the four Phase III clinical trials that were part of the Rimonabant In Obesity (RIO) program. All of these trials have been reported on extensively, both at scientific meetings and in peer-reviewed professional journals.
These trials formed the basis of Acomplia's submission to the FDA for approval almost a year and a half ago. The highly anticipated diet drug has been stalled at the FDA since this past February for reasons that developer Sanofi Aventis has never made clear.
"The use of rimonabant after one year produces modest weight loss of approximately 5 percent" of body weight, reported reviewers led by Cintia Curioni of the State University of Rio de Janeiro. "Compared with placebo, a 20-milligram pill produced a 4.9 kilogram (just under 11 pound) greater reduction in body weight in trials with one-year results."
Her report appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care.
For those new to Acomplia, Curioni and her fellow researchers described the weight-loss pattern thus:
"After the 36th week, the level of weight loss decreased and the body weight was maintained practically until the end of the studies." One study evaluated data after two years: "Patients who stayed on 20 mg rimonabant seemed to maintain their weight loss, while those who were re-randomized to placebo gained significant weight."
People on the larger dose (the 20 mg dose approved in Europe and currently pending before the U.S. FDA) lost an average 1.5 inches on their waistlines, showed a slight dip in blood pressure, had significantly lowered blood lipids (fats) and increased high-density lipoprotein ("good" cholesterol).
Side effects included nausea, dizziness, headache, joint pain and diarrhea, they reported. More serious side effects included psychiatric and nervous system disorders.
"Every time a new drug comes along, it gets a lot of attention. The natural course is that people who want it will try it, and people with have some lackluster results," said Kelly Brownell, Ph.D., director of the Rudd Center for Food Policy and Obesity at Yale University.
"Few people lose enough weight to make themselves happy, more lose enough weight to get some medical benefit but overall results for most treatments for obesity are disappointing," Brownell said.
Curioni's team also compared the Acomplia results to a previous review of Xenical (orlistat) and Meridia (silbutramine), the only drugs approved in the United States for long-term treatment of obesity.
"The weight loss associated with rimonabant was slightly greater compared to that related to silbutramine use, with more positive impact on cardiometabolic risk. The effects compared with orlistat appear to be greater weight loss and less frequent adverse effects," the researchers reported.
The researchers noted that the four reviewed Acomplia studies were all sponsored by Sanofi. With the French drugmaker sponsoring all reviewed studies, Brownell said results "probably represent a best-case scenario."
Incidentally, at the very bottom of the WebMD article comes the final sentence: "Sanofi-Aventis is a WebMD sponsor."
Sanofi-Aventis is NOT a sponsor of the Acomplia Report. |