This international multi-center, double-blind, placebo-controlled study enrolled 1,507 overweight or obese patients from 60 medical centers in Europe and the United States.
Patients were randomized to receive for one year either a low daily, fixed dose of 5 mg of Acomplia, a higher dose of 20 mg of Acomplia, or a placebo.
Throughout the study, calorie intakes were reduced by 600 calories per day.
The primary objective was to assess weight loss over one year, while secondary objectives were to look at weight loss and weight maintenance over two years, risk factors associated with obesity (blood pressure, dyslipidemia), and glucose tolerance status.
Patients on the higher dose of Acomplia were far more successful in losing weight than patients on the lower dose or in the placebo control group.
Nearly 70% of patients treated for one year with the higher dose of Acomplia lost more than 5 percent of their body weight compared to 44.2% of those on the low dose of Acomplia and 30.5% of patients in the control group.
Moreover, 39.0% of patients treated for one year with the higher dose of Acomplia lost more than 10 percent of their body weight compared to 15.3% of patients on the low dose of Acomplia and 10.4% of patients in the control group.
Patients treated for one year with the higher dose of Acomplia lost an average of 19 pounds compared to just over 10 pounds for those on the low dose of Acomplia and 8 pounds for patients in the control group.
The researchers also reported that patients treated for a year with the higher dose of Acomplia reduced their waist circumference by an average of 3.4 inches compared to just over 2 inches for those on the low dose of Acomplia and 1.8 inches for patients in the control group.
The researchers also reported that those treated with the higher dose of Acomplia increased their HDL cholesterol (good cholesterol) by 27 percent compared to 19 percent for those on the low dose of Acomplia and 17.3 percent for those in the control group.
At the same time, patients treated with the higher dose of Acomplia lowered their triglycerides by 10.6 percent, while the triglyceride levels of those on the low dose of Acomplia and those in the control group both went up about 5 percent.
For those patients with metabolic syndrome at the outset of the study, more than half of those taking the higher dose of Acomplia no longer had this problem after one year.
“The findings of the RIO-Europe trial are totally consistent with those of the RIO-Lipids trial announced earlier this year at the American College of Cardiology meeting," said Dr. Luc Van Gaal, associate professor of endocrinology at University Hospital in Antwerp and a lead researcher on the study.
"“We are looking forward to the full 2 year findings of the RIO-Europe trial to see if these impressive results are maintained,” he added.
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