Mixed
In overweight or obese patients with cardiovascular risk factors, naltrexone-bupropion treatment does not increase the risk of major adverse cardiovascular events (MACE) compared to placebo, although noninferiority was not formally proven due to early trial termination.
For patients with obesity and heart risk factors, naltrexone-bupropion does not appear to increase the risk of heart attacks or strokes compared to placebo, based on interim data. However, the study was stopped early, so doctors cannot yet definitively say it is safe for all purposes. It requires careful monitoring and is part of a broader weight management program.
Among overweight or obese patients at increased cardiovascular risk, based on the interim analyses performed after 25% and 50% of planned events, the upper limit of the 95% CI of the HR for MACE for naltrexone-bupropion treatment, compared with placebo, did not exceed 2.0. However, because of the unanticipated early termination of the trial, it is not possible to assess noninferiority for the prespecified upper limit of 1.4. Accordingly, the cardiovascular safety of this treatment remains uncertain and will require evaluation in a new adequately powered outcome trial.
Why this rating
Large randomized controlled trial (n=8910) but terminated early, preventing definitive noninferiority conclusion and leaving uncertainty.
Source
Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors
Steven E. Nissen et al. · JAMA · 2016
DOI 10.1001/jama.2016.1558
Related findings · Mixed
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