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The STRATUS-US Study
 

This clinical trial enrolled 787 smokers in a double-blind, placebo-controlled study, conducted at 11 sites throughout the United States.

Patients enrolled in the study smoked 23 cigarettes/day on average, were motivated to quit, and had, previously failed to quit on an average of four prior attempts.

Patients were randomly assigned to receive weekly counseling accompanied by either a higher dose of rimonabant (20 mg), a lower dose of rimonabant (5 mg) or a placebo.

Participants in the trial were treated for 10 weeks. During the first two weeks of the study, patients were allowed to smoke while initiating treatment but were given a target quit date at day 15.

Patients on the higher dose of rimonabant were far more successful in quitting smoking than patients on the lower dose, who did about the same as patients in the placebo control group.

Study results showed that 36.2 percent of patients given the higher dose of rimonabant who completed the study quit smoking compared to 20.6 percent of patients who received the placebo and 20.2 percent of patients given the lower dose of rimonabant.

On average patients given the higher dose of rimonabant also lost about a half pound while those on the placebo gained about two and a half pounds. The weight loss occurred mostly among patients who were overweight or obese. Patients of normal weight did not lose weight during their treatment with rimonabant.

Researchers said the study raised no cardiovascular safety concerns for Acomplia and no differences were observed in the three groups with regard to depression and anxiety scores as measured by the Hospital Anxiety and Depression (HAD) scale.

"Smoking is one of the leading modifiable risk factors for heart disease and we have very few medications available to help people stop smoking," said Dr. Robert Anthenelli, principal researcher for the STRATUS-US trial and associate Professor of Psychiatry at the University of Cincinnati College of Medicine.

"STRATUS-US suggests that Acomplia may have a distinctive dual effect that could prove to be critical in helping patients to quit smoking while reducing the likelihood of weight gain," Anthenelli said.

 

 

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Last Updated: 03/05/2008