Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia

Am J Cardiovasc Drugs. 2009;9(2):69-79. doi: 10.1007/BF03256578.


Background: Niacin extended-release (NER) is safe and effective for treatment of dyslipidemia. However, some patients discontinue NER treatment because of flushing, the most common adverse event associated with niacin therapy.

Objective: To evaluate the effect of daily oral acetylsalicylic acid (ASA) on NER-induced flushing in patients with dyslipidemia.

Methods: A randomized, double-blind, placebo-controlled, multicenter, 5-week study was conducted ( identifier: NCT00626392). Patients (n = 277) were randomly assigned to one of six treatment arms and received a 1-week run-in with ASA 325 mg or placebo followed by 4 weeks of ASA 325 mg or placebo 30 minutes before NER at a starting dose of 500 mg or 1000 mg; all patients were titrated to NER 2000 mg at week 3. The primary endpoint was the maximum severity of flushing events during week 1.

Results: In week 1, ASA run-in, ASA pretreatment, and a lower starting dosage of NER (500 mg/day) resulted in reductions in mean maximum severity of flushing; 48% fewer patients who received ASA experienced flushing episodes of moderate or greater intensity relative to placebo (absolute rates 15% vs 29%; p = 0.01). Over 4 weeks, ASA reduced the number of flushing episodes/patient/week by 42% relative to placebo. The discontinuation rate due to flushing was lower in the ASA group compared with placebo (1.8% vs 9.4%; p = 0.007). Overall safety was not different between groups.

Conclusion: These data suggest that a clinically meaningful reduction in the severity and incidence of NER-induced flushing may be achieved with ASA use.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Aspirin / administration & dosage
  • Aspirin / therapeutic use*
  • Delayed-Action Preparations
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Dyslipidemias / drug therapy*
  • Female
  • Flushing / chemically induced*
  • Flushing / drug therapy*
  • Humans
  • Hypolipidemic Agents / administration & dosage
  • Hypolipidemic Agents / adverse effects*
  • Hypolipidemic Agents / therapeutic use
  • Male
  • Middle Aged
  • Niacin / administration & dosage
  • Niacin / adverse effects*
  • Niacin / therapeutic use
  • Vasodilator Agents / administration & dosage
  • Vasodilator Agents / therapeutic use*


  • Delayed-Action Preparations
  • Hypolipidemic Agents
  • Vasodilator Agents
  • Niacin
  • Aspirin

Associated data