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Background: Niacin extended-release (NER) is safe and effective for treatment of dyslipidemia. However, some patients discontinueNER 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: Arandomized, double-blind, placebo-controlled,multicenter, 5-week study was conducted (Clinical- Trials.gov identifier: NCT00626392). Patients (n = 277) were randomly assigned to one of six treatment arms and received a 1-week run-in with ASA 325mg or placebo followed by 4 weeks of ASA 325mg or placebo 30 minutes before NER at a starting dose of 500mg or 1000 mg; all patients were titrated to NER 2000mg at week 3. The primary endpoint was the maximum severity of flushing events during week 1. Results: In week 1, ASArun-in,ASA pretreatment, and a lower starting dosage ofNER(500mg/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 NERinduced flushing may be achieved with ASA use. [ABSTRACT FROM AUTHOR]