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Although phase III trials showed that combination naltrexone plus bupropion led to weight loss in obese patients (NEJM JW Gen Med Oct 1 2010 and Lancet 2010; 376:595), the drug's approval was deferred because of cardiovascular (CV) safety concerns. Thus, the FDA required the manufacturer to conduct a placebo-controlled, noninferiority, CV-outcomes trial of this combination; ≈8900 overweight or obese patients with or at elevated risk for CV disease participated. Prespecified interim analysis after accrual of 25% of predicted CV events (i.e., CV-related death, nonfatal myocardial infarction, nonfatal stroke) revealed fewer events with active treatment than with placebo (35 vs. 59; hazard ratio, 0.59).
The 25% interim data were to be kept confi…