Randomized controlled trial of different aspirin regimens for reduction of niacin-induced flushing

Abstract

Purpose: Results of a study to test the hypothesis that taking niacin simultaneously with different forms of aspirin would reduce the occurrence of niacin-induced flushing are reported.

Methods: Traditionally, taking enteral absorbed aspirin 30 minutes before a niacin dose has been shown to reduce flushing by 30-50% relative to nonuse of aspirin. The objective of the study was to evaluate the efficacy of enteral absorbed and orally dissolved aspirin, taken at the same time as niacin, in reducing the frequency of moderate-to-severe flushing. In a prospective, double-blind, placebo-controlled crossover trial, healthy adult male and female volunteers were asked to take aspirin or a placebo (both agents were taken in both orally dissolved and swallowed formulations) immediately before niacin administration. Subjects then self-evaluated flushing symptoms on a validated scale.

Results: Simultaneous administration of swallowed aspirin and niacin reduced moderate-to-severe flushing events by a mean of 36.1%, from 2.35 to 1.5 events per subject (p = 0.003), relative to event rates with use of niacin alone. In a subset of subjects who had experienced moderate-to-severe flushing symptoms despite taking swallowed aspirin, flushing in response to subsequent niacin use was decreased by 20.5% (p = 0.05) with coadministration of orally dissolved aspirin and by 18.0% with a regimen containing both orally dissolved and swallowed aspirin (p = 0.03).

Conclusion: Novel regimens of niacin and aspirin, including orally dissolved aspirin, were effective in reducing niacin-induced flushing in a small sample of healthy adult volunteers.

Keywords: anticholesterolemic agents; aspirin; flushing; niacin.