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ACOMPLIA - new weight loss drug shown effective in trial
Acomplia, a drug intended to promote weight loss, continues
to show good safety and efficacy at the 2-year mark in a
late-stage clinical trial, according to data presented here
at the American Heart Association's annual meeting.
Patients on active treatment lost an average of 19 pounds
during the course of the trial and more importantly, lead
investigator Dr. F. Xavier Pi-Sunyer said, patients had a
significant reduction in waist circumference. Abdominal
obesity is strongly linked to heart disease.
The clinical trial involved 3040 obese patients, average age
45 years, more than 80 percent of whom were women. The
participants were randomly assigned to a low or high dose of
Acomplia (known technically as rimonabant) or an inactive
placebo compound. They were also prescribed a
reduced-calorie diet.
In addition to the average 19-pound weight loss after 2
years on the high dose of rimonabant, Pi-Sunyer reported
that waist circumference was reduced by 3.1 inches on the
high dose, 1.9 inches with the low dose and 1.5 inches with
placebo. The Columbia University investigator said that 63
percent of patients on the higher dose lost more than 5
percent of their total body weight and that 33 percent lost
more than 10 percent.
He said that another important finding was that metabolic
parameters improved significantly with higher-dose Acomplia.
HDL ("good") cholesterol rose 25 percent, triglycerides
dropped by 10 percent and insulin sensitivity increased
significantly. The lower dose of the drug and placebo
resulted in less marked degrees of improvement. Adverse
effects were mild in all groups and included depression,
anxiety and nausea.
Sanofi-Aventis of Paris, France, is planning to apply for
FDA approval of Acomplia in the second quarter of 2005.
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