The results of the RIO-North America trial with Sanofi-Aventis' rimonabant were published in the Journal of the American Medical Association (February 14 issue), evaluating two-year treatment with the drug in overweight or obese patients, many of whom were at increased risk for diabetes and heart disease through the presence of additional risk factors including increased waist circumference, elevated blood pressure or abnormal lipid levels. The findings showed that patients treated with rimonabant 20mg once-daily experienced significant reduction of their waist circumference and body weight as well as improvements in multiple cardiometabolic risk factors, including high-density lipoprotein cholesterol, triglycerides and an estimate of insulin sensitivity.
"The RIO-North America trial results indicate that rimonabant 20mg once-daily produced sustained clinically-meaningful weight loss and improvements in associated risk factors during two years of treatment," said Xavier Pi-Sunyer, chief of the division of endocrinology, Saint Luke's - Roosevelt Hospital Center, Columbia University, New York, USA, and principal investigator of the RIO-North America trial.
However, there was also some evidence of psychiatric side effects with the drug: 6.1% of patients on 20mg rimonabant experienced anxiety, compared with 2.1% on placebo; and 5.2% suffered "depressed mood."
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