Exponent's Catherine Rogers Murray, Dustin Burns, Heather Watson, Jeff Swaney, Samuel Spevack, Emma Moynihan, and David Dore, along with co-authors, have published a study evaluating the long-term cardiovascular (CV) safety of the antiobesity medication (AOM) naltrexone/bupropion (NB-ER). The research utilized linked electronic health records (EHRs), health insurance claims, and mortality data from U.S. health systems.
The study compared the rate of major adverse CV events over an average of 4.7 years of follow-up between 12,475 recipients of NB-ER and 12,171 recipients of lorcaserin, another AOM. The findings indicated that recipients of NB-ER were not at an increased risk of major adverse CV events, such as CV death, nonfatal myocardial infarction, or nonfatal stroke.
This research, published after the FDA approved NB-ER in 2014, highlights Exponent's capabilities in real-world evidence (RWE) generation and drug safety assessment. The firm's expertise in data sciences and biomedical engineering provides critical insights for pharmaceutical companies and regulatory bodies in understanding the long-term safety profiles of medications.
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