Naltrexone/bupropion increases risk of serious AEs
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Naltrexone/bupropion increases risk of serious AEs Naltrexone/bupropion (Mysimba) reduces bodyweight in obese patients but increases the risk of serious adverse events (AEs), according to findings of a systematic review and meta-analysis of data from clinical study reports (CSRs) published in the British Journal of Clinical Pharmacology. Investigators searched European Medicines Agency (EMA) and US FDA websites up until May 2016 to identify pivotal phase III placebo-controlled trials on naltrexone/bupropion used to gain market approval, searched for further information on PubMed and Clinicaltrials.gov, and obtained CSRs on unpublished trial data. Between July 2016 and August 2018, they received 31 batches of CSRs from four trials in a total of 4536 patients. The rate of reduction in bodyweight of 5% or greater was significantly greater with naltrexone/bupropion than with placebo (relative risk [RR] 2.1; 95% CI 1.35, 3.28; p=0.001). However, naltrexone/bupropion significantly increased the risk of AEs (RR 1.11; 95% CI 1.05, 1.18; p=0.0004), serious AEs (RR 1.70; 95% CI 1.38, 2.1; p
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