Naltrexone-bupropion (Mysimba) in management of obesity: A systematic review and meta-analysis of unpublished clinical study reports.

ABSTRACT:

Aims

To compare the benefits and harms of naltrexone-bupropion using evidence from clinical study reports.

Methods

We searched Food and Drug Administration and European Medicines Agency websites, PubMed, and Clinicaltrials.gov (May 2016) to identify pivotal trials; we then sent a freedom of information request to the European Medicines Agency (July 2016). We included pivotal, phase III placebo-controlled trials. We assessed the risks of bias using the Cochrane criteria, and the quality of the evidence using GRADE. We used a random-effects model for meta-analyses.

Results

Over a 27-month period (July 2016 to August 2018), we received 31 batches of clinical study report documents containing over 65 000 pages of data from 4 pivotal trials (n = 4536). Significantly more p

SUBMITTER: Onakpoya IJ 

PROVIDER: S-EPMC7098870 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature