Diet drug Acomplia (rimonabant) failed to meet its primary goal in a study of its use in slowing progression of coronary artery disease and it also significantly raised the risk of anxiety and depression in patients taking it, according to a report in the April 2 issue of the Journal of the American Medical Association.

The STRADIVARIUS study, which involved 839 abdominally obese patients with coronary disease and metabolic risk factors at 112 centers, sought to determine whether rimonabant might help slow progression of atherosclerotic disease, often commonly known as “hardening” of the arteries.

The researchers reported that the study failed to meet its main goal of reducing the Percent Atheroma Volume (PAV), a measure of plaque in a cross-section of the arteries, although it did reduce the Total Atheroma Volume (TAV), a measurement of total plaque in the coronary artery.

“Because the current study failed to achieve a statistically significant effect for the primary efficacy measure, additional studies will be required to further define the role of rimonabant in the treatment of abdominally obese patients with coronary disease and metabolic risk factors," the researchers concluded.

But even more disappointing to many was the report by researchers that more than 40 percent of patients who took rimonabant in the STRADIVARIUS trial developed psychiatric problems and one committed suicide.

While Acomplia is sold in European Union countries and some other nations as an obesity treatment, Sanofi Aventis pulled back its U.S. application last year after an FDA advisory panel recommended against approval of rimonabant because of concerns over psychiatric risks.

The researchers in the STRADIVARIUS study included patients with a history of psychiatric problems, and 43.4 percent of patients who got Acomplia suffered psychiatric side effects such as depression and anxiety compared to 28.4 percent of patients in the control group, according to the researchers.

Dr. John Rumsfeld of the Denver Veterans Affairs Medical Center and Dr. Brahmajee Nallamothu of the University of Michigan, in a commentary in the medical journal, observed that while the promise of Acomplia remains, "it certainly has faded.

"The potential benefits are offset by the very real risks of depression and anxiety," they added.

The results of the trial were released a day ahead of the journal's normal publication to coincide with a presentation at the annual conference of the American College of Cardiology currently underway in Chicago.