Better Results With Higher Dose
All three groups had some improvement in waist size, cholesterol, triglycerides, and metabolic syndrome. Those changes were significant with Acomplia compared with changes produced with the placebo, say the researchers.
"Treatment with [Acomplia] over one year led to sustained, clinically meaningful weight loss, reduction in waist circumference, and associated improvements with several cardiovascular and metabolic risk factors," says the study.
The lower dose of Acomplia did not have significant effects on these risk factors compared with the placebo except for weight and waist size. The higher Acomplia dose outpaced both other groups in all categories.
Acomplia did not affect blood pressure, says the study.
Mood disorders were more frequent in the high-dose group. There were nine people in the high-dose group (1.5%) who had psychiatric disorders during the study, compared with two on the lower dose (0.3%) and one taking the placebo (0.3%).
All three groups had similar drop-out rates due to this adverse effect, says the study.
Acomplia is not currently available for use. However, the drug's maker, Sanofi-Aventis, has been making presentations about Acomplia to investment firms, the company's web site shows.
Van Gaal's study was funded by Sanofi-Aventis. Several of the researchers have received travel awards and honoraria from the drug company to attend scientific meetings or present trial results, says the journal.