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Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors - The Light Study
Description:
The goal of the trial was to evaluate treatment with naltrexone/bupropion compared with placebo among overweight/obese individuals with diabetes and/or other cardiovascular risk factors.
Hypothesis:
Naltrexone/bupropion will not increase major adverse cardiovascular events (MACE).
Study Design
- Placebo Controlled
- Blinded
- Parallel
Patient Populations:
- Women ≥50 years of age or men ≥45 years of age
- BMI ≥27 kg/m2 and ≤50 kg/m2
- Waist circumference ≥88 cm for women or ≥102 cm for men
- History of cardiovascular disease; prior myocardial infarction, coronary/carotid/peripheral revascularization, unstable angina, positive stress test, abnormal ankle-brachial index, ≥50% coronary/carotid/peripheral stenosis, and/or
- Type 2 diabetes with at least two additional risk factors: hypertension, dyslipidemia, or smoking
- Number of enrollees: 10,400 patients
Exclusions:
- Recent myocardial infarction
- Prior stroke
- History of tachyarrhythmia
- Planned bariatric, cardiac, or coronary surgery
- History of seizures
- History of mania
- Limited life expectancy
Primary Endpoints:
- First occurrence of MACE
Drug/Procedures Used:
Overweight/obese patients with diabetes or other cardiovascular risk factors were randomized to naltrexone sustained release (SR) 32 mg/bupropion SR 360 mg daily versus placebo.
Principal Findings:
Interim analysis has revealed that naltrexone/bupropion does not increase the risk of cardiovascular events.
Interpretation:
This drug was previously denied Food and Drug Administration (FDA) approval in 2011. Based on these findings, approval of this drug will likely be sought for the summer of 2014.
Keywords: Naltrexone, Overweight, Risk Factors, Diabetes Mellitus, Smoking Cessation, Bupropion
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