N/A Completed N=31,889

Real-World Evidence on the Cardiovascular Safety of CONTRAVE® in the United States (U.S.)

Obesity

Source: ClinicalTrials.gov NCT06090461 ↗

Enrolled (actual)

31,889

Serious AEs

0.5%

Results posted

Jun 2025

Primary outcomePrimary: The Incidence of Major Adverse Cardiovascular Events (MACE) Between Initiators of CONTRAVE®/MYSIMBA® or N&B and Initiators of Lorcaserin. — 26; 36; 10; 6 Events

Summary

The fixed-dose combination of naltrexone 8mg and bupropion 90mg extended-release oral tablet is marketed under the trade name CONTRAVE® in the U.S. In this protocol, the investigators propose to generate real-world evidence (RWE) from electronic health records (EHR) and linked claims data to assess the cardiovascular safety of CONTRAVE® and all combined use of naltrexone and bupropion (NB) in usual clinical practice.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Incidence of Major Adverse Cardiovascular Events (MACE) Between Initiators of CONTRAVE®/MYSIMBA® or N&B and Initiators of Lorcaserin.	26; 36; 10; 6; 5; 5	—

Eligibility Criteria

For the main objective (1.0, 1.1), patients are eligible if they meet the following Inclusion Criteria:

Have at least one prescription for NB between September 2014 and February 2020, including concurrent prescriptions (within 15 days) for naltrexone and bupropion; or have at least one prescription for lorcaserin;
Have at least 180 days of data available prior to cohort entry with no evidence of prescriptions or dispensings of NB or lorcaserin;
Have at least one BMI value available in the 180 days prior to cohort entry, inclusive of the index date;
Have documentation of at least one outpatient medical visit 180 or more days prior to cohort entry, and at least one healthcare interaction in the 180 days prior to cohort entry;
Are at least 18 years of age on the cohort entry date.

For the main objective, patients are not eligible if they have a diagnosis of any of the following conditions in the 180 days before the cohort entry date:

Epilepsy;
Bulimia;
Anorexia nervosa;
Surgical procedure for weight loss.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06090461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.