A new trial did not find any evidence that the drug actually slowed disease progression, although it did show a decrease in one measure of plaque build-up in arteries.
Still, Dr. Suzanne Steinbaum, director of Women and Heart Disease at Lenox Hill Hospital in New York City, who was not involved with the study, said: “I think it’s important for us to understand that this wasn’t a negative trial. It’s very important that we look at this more closely. What decrease in blood pressure and cholesterol as parameters are needed, or really how much decrease in obesity is needed for us to see a change in atherosclerosis volume? It might pan out to show something beneficial. We just don’t know.”
The study was funded by Sanofi Aventis, which makes Acomplia.
Data on a second anti-obesity drug, taranabant, also presented at the conference, also showed a high rate of psychiatric problems, although the medication did show some promise helping patients lose weight.
In the United States, two-thirds of adults are overweight, and more than one-third are obese. People with weight concentrated in their midsection have a higher risk of type 2 diabetes, high blood pressure and other risk factors for atherosclerotic cardiovascular disease or disease related to the build-up of plaque in the arteries.
Not for lack of effort, researchers have yet to happen on a “magic” treatment for obesity and its attendant problems.
One drug that has shown some promise, Acomplia (rimonabant), has been approved for use in Europe but not in the United States. Last June, the U.S. Food and Drug Administration did not recommend approval of the drug, pending more information on psychiatric side effects.
The drug works by inhibiting the cannabinoid type 1(CB1) receptors, which are involved in regulating food ingestion.
For the new study, 839 patients at 112 centers in Australia, Europe and North America were randomly selected to receive either Acomplia or a placebo. All participants, who also had coronary disease, received dietary counseling as well.
Coronary intravascular ultrasonography (IVUS) at the end of 18 months revealed a 0.25 percent increase in percent atheroma volume (PAV) in those taking rimonabant, compared to 0.51 percent in the placebo group. And change in normalized total atheroma volume (TAV) decreased in the Acomplia group but increased in the placebo group. PAV and TAV are basically two ways to measure how clogged an artery is.
Those taking Acomplia also saw other benefits: They lost more weight (9.5 pounds versus 1.1 pounds in the placebo group); their waist circumference went down more (1.77 inches versus 0.39 inches); their HDL or “good” cholesterol increased more (22.4 percent versus 6.9 percent) and triglyceride levels went down further (20.5 percent versus 6.2 percent). But LDL or “bad” cholesterol levels and blood pressure stayed about the same in both groups.
More worrisome, 43.4 percent of those in the Acomplia group experienced psychiatric problems, most notably anxiety and depression, compared to 28.4 percent in the placebo group.