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Assistant Professor, Xavier University, 407 Bienville Street, Natchitoches, Louisiana 71457
Captain, USAF, BSC, Chief, Inpatient Pharmacy Services, Offutt Air Force Base, Nebraska
Published Online, April 25, 2006. www.theannals.com, DOI 10.1345/aph.1G713
The purpose of RIO-Europe was to examine the relationship between rimonabant administration and subsequent weight loss and improvement in cardiovascular risk factors in over 1500 overweight or obese subjects.2 Weight loss maintenance after treatment was also evaluated. The trial compared 2 fixed doses of rimonabant (5 and 20 mg/day) with placebo over a 2 year period. Subjects were randomized to double-blind treatment consisting of placebo (n = 305), rimonabant 5 mg/day (n = 603), and rimonabant 20 mg/day (n = 599). Results revealed a significant weight loss in subjects receiving rimonabant versus placebo. After one year, subjects lost an average of 3.4 kg with rimonabant 5 mg/day (p = 0.002 vs placebo) and 6.6 kg with rimonabant 20 mg/day (p < 0.001 vs placebo), while those receiving placebo lost an average of only 1.8 kg. A significantly greater number of subjects in the rimonabant groups were able to lose 5% or greater of their weight from baseline compared with the placebo group (p < 0.001). However, rimonabant 20 mg/day yielded a greater likelihood of a 10% or greater weight loss from baseline versus placebo (p < 0.001). Treatment with rimonabant was able to increase high-density lipoprotein cholesterol (HDL-C), decrease triglycerides, decrease non-HDL-C, and improve cardiovascular risk factors. Treatment with rimonabant was generally well tolerated, and adverse effects were mild and transient.
The RIO -Lipids trial investigated the effects of rimonabant on metabolic risk factors in overweight or obese persons with untreated dyslipidemia.3 Subjects were randomized to receive either a daily fixed dose of rimonabant or placebo. Those treated with rimonabant 20 mg/day lost significantly more weight (8.6 kg) than those treated with placebo (2.3 kg) (p < 0.001). More importantly, rimonabant 20 mg/day yielded a 38.9% absolute reduction of 5% of body weight and a 25.4% absolute reduction of 10% of body weight. Rimonabant 20 mg/day affected HDL-C by an absolute increase of 11.4% over placebo (p < 0.001). The most clinically significant result was the 28.2% absolute reduction of metabolic syndrome compared with placebo (p < 0.001), which contributed to a waist reduction and increase in HDL-C. At baseline, 54% of the subjects met the criteria for the diagnosis of metabolic syndrome. This diagnosis was cut to 25.8% in those treated with rimonabant 20 mg/day. The most frequent adverse events leading to discontinuation of treatment included depression (2.9%) and anxiety (1.7%).
Although rimonabant alone will not eradicate obesity, the RIO - Lipids3 and RIO-Europe2 trials provide significant insight into the future medical management of cardiovascular disease and offer a potential tool in assisting people to lose weight. The overall testing results of rimonabant's effectiveness continue to be positive, but investigation into its safety and tolerability is warranted.
References
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