- Question
- Does adding extended-release niacin with laropiprant to statin-based lipid-lowering therapy reduce major vascular events in high-risk patients with vascular disease?
- Design
- Randomized, double-blind, placebo-controlled trial with a prerandomization run-in phase to standardize statin therapy and confirm niacin tolerability. It enrolled 25673 adults, with a median follow-up of 3.9 years.
- Population
- Adults with established atherosclerotic vascular disease (coronary, peripheral arterial or cerebrovascular disease, including patients with diabetes) receiving statin-based lipid-lowering therapy.
- Intervention
- 2 g daily of extended-release niacin plus 40 mg of laropiprant, on a background of simvastatin or ezetimibe/simvastatin.
- Control
- Matching placebo, also on the same background statin therapy.
- Primary outcome
- First major vascular event: nonfatal myocardial infarction, death from coronary causes, stroke, or arterial revascularization.
- Results
- LDL cholesterol was on average 10 mg/dL lower and HDL cholesterol 6 mg/dL higher with niacin-laropiprant. Major vascular events occurred in 13.2% vs. 13.7% of participants (rate ratio 0.96; 95% CI 0.90 to 1.03; P=0.29), a nonsignificant difference.
- Safety
- Niacin-laropiprant increased serious disturbances in diabetes control (absolute excess of 3.7 percentage points) and new diabetes diagnoses (1.3 points). There were also more serious gastrointestinal, musculoskeletal and skin adverse events, as well as infections (1.4 points) and bleeding (0.7 points).
- Conclusion
- Adding extended-release niacin-laropiprant to statin therapy did not significantly reduce major vascular events and increased serious adverse events.
- Why it matters
- The trial curbed the use of niacin as an add-on to statins to raise HDL cholesterol and reinforced that modifying HDL with this drug does not translate into clinical benefit.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026