Biotech Tracker News - Obesity Drugs Disappoint
April 08, 2003, Data presented at the recently concluded 2003 Annual Meeting of the Society for Clinical Pharmacology and Therapeutics verify that long-term treatment with Roche’s (Swiss: ROG) Xenical (orlistat) or sibutramine formulations (such as Abbott’s [NYSE: ABT] Meridia) results in weight loss averaging less than 5% of body weight. These abysmal outcomes are expected, furthering the hypothesis that, for the foreseeable future, pharmacologic management will not become the treatment of choice for the vast majority of overweight and obese people. The presentations come on the heels of recently released data highlighting Regeneron’s (NASDAQ: REGN) Axokine’s long-term therapeutic inadequacies.  Dr. Raj Padwal (University of Toronto) and colleagues performed a systematic review designed to assess the effectiveness and safety of orlistat and sibutramine for the long-term promotion of weight loss. 8 controlled orlistat and 3 controlled sibutramine clinical trials lasting at least 12 months were reviewed. Orlistat administration produced a mean incremental weight loss, versus placebo, of 2.7 kilograms, approximately 2.9% of the initial body weight. Sibutramine administration provided a mean incremental weight loss, versus placebo, of 4.3 kilograms, approximately 4.6% of initial body weight. The percentage of phamacologically managed patients achieving at least 10% better weight loss than achieved with placebo was clinically inadequate, with 3% of orlistat recipients and 15% of sibutramine recipients achieving this mark.  The usual high attrition rates that plague both experimental and real-world overweight and obesity management scenarios were observed in this systematic review – 33% in the orlistat studies and 48% in the sibutramine studies. Moreover, small but significant increases in systolic blood pressure (mean increase, 0.8 mm Hg) and diastolic blood pressure (2.2 mm Hg) were observed, predominately for sibutramine recipients. Given that a goal of anti-overweight and obesity management is decreasing blood pressure and mitigating against cardiovascular risk, these data continue to call into question the value of these drugs.
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