How Does Naltrexone/Bupropion Impact Heart Health?

Naltrexone/bupropion extended release (NB-ER) is prescribed to adults with obesity in combination with a reduced-calorie diet and increased physical activity to support weight loss. Because anti-obesity medications (AOMs) are typically used long-term, regulators, clinicians, and patients seek evidence of their cardiovascular safety. Although NB-ER had been approved for weight management, a prior cardiovascular outcomes trial ended early for reasons unrelated to safety concerns, leaving some uncertainty about long-term cardiovascular risk. To address this gap, a team of health scientists from Exponent and co-authors conducted a real-world evidence study to assess whether NB-ER is associated with an increased risk of major adverse cardiovascular events (MACE) and its components: nonfatal acute myocardial infarction, nonfatal stroke, and cardiovascular death.

In this cohort study, which followed patients for an average of 4.7 years, the team used electronic medical records and health insurance claims to compare MACE incidence between patients starting NB-ER and those starting lorcaserin (another oral AOM) in routine clinical practice.

Finding similar rates of cardiovascular outcomes across both treatment groups, the researchers concluded that NB-ER was not associated with an increased risk of MACE or its components. Definitive causal conclusions regarding NB-ER cardiovascular safety would require further prospective, randomized, blinded, controlled clinical trials; however, these findings support the continued intended safe use of NB-ER for weight loss.

"Our findings suggest that patients initiating NB-ER were not at an increased risk of MACE or its components compared to patients initiating lorcaserin."