April 14, 2005 -- A new weight loss drug called looks promising, say European researchers.
They studied 1,500 people with obese or overweight body mass index (BMI). Participants who took Acomplia for a year -- while also cutting 600 calories from their daily intake -- lost more weight than their dieting peers who got a placebo.
The dose mattered. Those who took 20 milligrams of Acomplia fared best. They lost more weight and had greater improvements in waist size, cholesterol, triglycerides (a blood fat link to diabetes and heart disease risk), insulin resistance, and prevalence of (abnormalities that greatly raise the risk of heart disease and diabetes).
The findings appear in The Lancet's April 16 edition.
First, all participants had their calories cut by the researchers, who included Luc Van Gaal of Belgium's University Hospital Antwerp.
Next, participants were assigned to one of three treatment groups. One group took five milligrams of Acomplia per day. The second group took 20 milligrams of Acomplia. The third group got a placebo pill.
Meanwhile, everyone kept dieting. Their calories were limited throughout the study.
A year later, all groups had lost at least some weight. More weight was lost with Acomplia compared with the placebo.
After one year the average weight loss was about 14 pounds (6.6 kilograms) with 20 milligrams per day of Acomplia, 7.5 pounds with 5 milligrams per day of Acomplia, and about 4 pounds with the placebo, says the study.
Here's how the results look for people who completed the study:
- Weight loss of 5% or more: 67% with 20 milligrams of Acomplia, 44% with 5 milligrams of Acomplia, 30% with the placebo.
- Weight loss of 10% or more: 39% with 20 milligrams of Acomplia, 15% with 5 milligrams of Acomplia, and 12% with the placebo.
Weight loss with Acomplia appeared to be sustained for up to 36-40 weeks, says the study. "How this finding will translate into prolonged weight loss in clinical practice has yet to be determined," the researchers write.
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.