Microsoft word - sample clinical summary

Rimonabant
Synopsis of RIO-Lipids Reprint
Publication Information
Title: Effects of Rimonabant on Metabolic Risk Factors in Overweight Patients with Dyslipidemia
Authors: Després J-P, Golay A, Sjöström L, for the Rimonabant in Obesity-Lipids Study Group
Journal: N Engl J Med 2005;353:2121-34
Objective
To study the effects of rimonabant on metabolic risk factors, including adiponectin levels, in high-risk patients who are overweight or obese and have untreated dyslipidemia Design
› Randomized, double-blind, placebo-controlled, multicenter study › Patients randomized to receive placebo, rimonabant 5 mg, or rimonabant 20 mg (1:1:1 ratio, › Single blind, 4-week placebo run-in period with mildly hypocaloric diet (600 kcal/day deficit) that Patient Population
› Presence of untreated dyslipidemia: triglycerides > 150-700 mg/dL (1.69-7.90 mmol/L), or ratio of cholesterol to high-density lipoprotein cholesterol (HDL-C) of > 4.5 in women and > 5 in men Endpoints
› Primary: Change in body weight › Secondary: Changes in levels of HDL-C, triglycerides, glucose, insulin (during an oral glucose tolerance test), metabolic syndrome, waist circumference, leptin, adiponectin, and relevant biochemical cardiovascular markers (for example, C-reactive protein); and assessment of safety Results
› Weight change: Rimonabant 20 mg induced significant weight loss compared with placebo: -19 lb (-8.6 kg) rimonabant 20 mg vs. -5.1 lb (-2.3 kg) placebo using the repeated-measures (RM) model for completers (which provided a better estimate of the true effect of the drug than last observation carried forward [LOCF]); with the LOCF analysis, weight loss was -15.2 lb (-6.9 kg) rimonabant 20 mg vs. -3.3 lb (-1.5 kg) placebo (P < 0.001) FOR SALES EDUCATION ONLY. NOT FOR PROMOTIONAL USE. DO NOT DUPLICATE, DISTRIBUTE, OR USE IN DETAILING.
Rimonabant
› Waist circumference: Rimonabant 20 mg induced a significant decrease in waist circumference compared with placebo: -9.1 cm with rimonabant 20 mg vs. -3.4 cm with placebo (P < 0.001) using RM; and -7.1 cm vs. -2.4 cm using LOCF › Triglycerides: Levels decreased -15.8% with rimonabant 20 mg vs. -3.6% with placebo (P < 0.001) using RM; -12.6 vs. -0.2 using LOCF › HDL-C: Levels increased 23.4% with rimonabant 20 mg vs. 12.2% with placebo (P < 0.001) using › Plasma adiponectin: Levels of plasma adiponectin increased by 57.7% with rimonabant 20 mg using RM and 46.2% using LOCF (P < 0.001), a change that was partly independent of weight loss › Other factors: Rimonabant 20 mg also showed significant improvement over placebo in changes in low-density lipoprotein particle size, glucose tolerance, fasting and post-challenge insulin levels, C-reactive protein levels, and the proportion of patients with metabolic syndrome › Safety profile: The rates of completion for the study were similar among those receiving placebo and rimonabant 5 mg and 20 mg. The most frequent adverse events causing discontinuation were depression, anxiety, and nausea Conclusions
› CB1-receptor blockade with rimonabant significantly reduces body weight and waist circumference and improves a number of metabolic risk factors in overweight or obese patients who have atherogenic dyslipidemia › The adverse-event profile in this study was similar to that in the RIO-Europe study › The weight-loss-independent effect of rimonabant on plasma adiponectin levels is consistent with rimonabant's in vitro effect on adiponectin production by adipocytes FOR SALES EDUCATION ONLY. NOT FOR PROMOTIONAL USE. DO NOT DUPLICATE, DISTRIBUTE, OR USE IN DETAILING.

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