"Extended-Release Niacin or Laropiprant and Vascular Outcomes". The New England Journal of Medicine. 2014. DOI:10.1056/NEJMoa1300955.

Clinical Question

Does the addition of extended-release niacin with laropiprant to statin-based LDL cholesterol-lowering therapy reduce the risk of major vascular events in patients with atherosclerotic vascular disease?

Bottom Line

Among patients with atherosclerotic vascular disease, the addition of extended-release niacin with laropiprant to statin-based LDL cholesterol–lowering therapy did not significantly reduce the risk of major vascular events but did increase the risk of serious adverse events.

Major Points

Guidelines

As of the last knowledge update, this trial's findings support recommendations against the routine use of niacin in combination with laropiprant for the purpose of reducing cardiovascular risk in patients already on statin therapy.

Design

- Multicenter, randomized, double-blind, placebo-controlled trial
- N=25,673
- Extended-release niacin with laropiprant (n=12,838)
- Placebo (n=12,835)
- Median follow-up: 3.9 years
- Setting: 245 sites in the United Kingdom, Scandinavia, and China

Population

Adults aged 50 to 80 years with a history of myocardial infarction, cerebrovascular disease, peripheral arterial disease, or diabetes with symptomatic coronary disease. There were no specific lipid level criteria for entry.

Interventions

- Extended-release niacin (2 g daily) with laropiprant (40 mg daily) vs. placebo
- Prerandomization run-in phase with LDL cholesterol–lowering therapy using statins

Outcomes

- Primary Outcome: First major vascular event (nonfatal myocardial infarction, death from coronary causes, stroke, or arterial revascularization).

Criticisms

- High discontinuation rate of the medication due to side effects, which could impact the evaluation of its efficacy.
- The study cannot determine the separate effects of niacin and laropiprant.
- The results might not be generalizable to niacin formulations not combined with laropiprant.

Funding

This trial was funded by Merck, the U.K. Medical Research Council, the British Heart Foundation, Cancer Research U.K., and a grant from the British Heart Foundation Centre of Research Excellence, Oxford.

Further Reading