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March 31, 2008 (Chicago) -- An experimental weight loss drug helped dieters shed an average of 14.5 pounds over the course of one year.
Researchers studied more than 800 overweight and obese people on a diet and exercise program; 28% of those given the drug taranabant lost more than 10% of their body weight compared with 8% of those taking placebo.
"Even losing just 5% of your body weight is important to your health," says researcher Louis Aronne, MD, clinical professor of medicine at Weill-Cornell Medical College and director of the comprehensive weight control program at New York Presbyterian Hospital.
"It will help you lower your risk factors of cardiovascular disease," he tells WebMD.
The findings were presented at the 57th annual scientific session of the American College of Cardiology.
The one-year study involved 414 patients randomly assigned to take 2 milligrams of taranabant daily and 417 patients given placebo.
Results showed that patients reached their lowest weight about nine months into the study. They were then able to maintain that weight for the rest of the year, Aronne says.
Patients taking taranabant also experienced a rise in levels of HDL"good" cholesterol and a drop in triglyceride levels.
The most common side effects were nausea and diarrhea, but less than 2% of patients dropped out because of these problems.
Taranabant is a member of the same class of drugs as Zimulti. Taranbant helps people resist food cravings by partially shutting down the cannabinoid system.
Zimulti recently failed to win approval from an FDA advisory panel, mainly because of fears that it could lead to depression and suicidal thoughts in some patients. The drug was previously known as Acomplia.
But at the 2-milligram dose, taranabant was not associated with an increased risk of depression or suicidal thoughts, Aronne says. People taking the drug were also no more likely to suffer from crying, tearfulness, or anxiety than those on placebo.
In fact, irritability was the only psychiatric symptom experienced by more patients taking the 2-milligram dose of taranabant compared with placebo, says Noreen Verbrugge, a spokesperson for Merck Research Laboratories. Merck makes taranabant and sponsored the study.
The study also included patients given a higher dose of taranabant. But due to a high rate of side effects, only the 2-milligram dose will be studied further, she says.
American Heart Association President Dan Jones, MD, dean of the University of Mississippi School of Medicine in Jackson, tells WebMD that much more study is needed. "Weight loss is highly complex," he says, and "every we have tried to attack it with has been associated with substantial side effects.
"These were all people that were highly motivated to lose weight," Jones says. "I worry that adverse events will be even higher in the real world."
Merck hopes to file an application with the FDA for drug approval in 2008, according to Verbrugge.