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news.Results from a two-year phase III study of obesity drug rimonabant, which Sanofi-Aventis hopes to market as Acomplia, showed the drug to help with weight loss and maintain heart risk improvements, but had serious side effect issues.
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The study showed that the improvements in cardiovascular risk factors achieved with rimonabant 20mg/day at the end of the first year of treatment were maintained in the second year. The study also demonstrated the safety and tolerability profile of rimonabant versus placebo.
The two-year findings of the trial, named RIO-Europe, are consistent with those of the other two-year trial in the rimonabant phase III program, RIO-North America, results of which were announced in November 2004.
“The RIO-Europe findings demonstrated that in addition to maintaining body weight loss, two-year treatment with rimonabant 20mg/day compared with placebo reduced waist circumference, improved metabolic profile and reduced the number of patients meeting the NCEP criteria for metabolic syndrome,” said Professor Luc Van Gaal, professor of diabetology, metabolism and clinical nutrition at University Hospital of Antwerp, and principal investigator of the study.
The drug does have some drawbacks, however, as not all of the weight lost was kept off in the second year of the study and most side effects were more frequent in rimonabant than placebo. For example, the frequency of nausea was 13.7% for 20mg/day, compared to just 5.2% for placebo.