Combination Naltrexone plus Bupropion for Weight Loss: CV Risks Are Still Unknown

This obesity drug's cardiovascular outcomes trial was terminated prematurely because of leaked interim results.

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…

Reviewing Author

Thomas L. Schwenk, MD

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Thomas L. Schwenk, MD

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Combination Naltrexone plus Bupropion for Weight Loss: CV Risks Are Still Unknown

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