1. Acetylsalicylic acid reduces niacin extended-release-induced flushing in patients with dyslipidemia.
- Author
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Thakkar RB, Kashyap ML, Lewin AJ, Krause SL, Jiang P, and Padley RJ
- Subjects
- Administration, Oral, Adult, Aged, Aspirin administration & dosage, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Drug Therapy, Combination, Female, Humans, Hypolipidemic Agents administration & dosage, Hypolipidemic Agents therapeutic use, Male, Middle Aged, Niacin administration & dosage, Niacin therapeutic use, Vasodilator Agents administration & dosage, Aspirin therapeutic use, Dyslipidemias drug therapy, Flushing chemically induced, Flushing drug therapy, Hypolipidemic Agents adverse effects, Niacin adverse effects, Vasodilator Agents therapeutic use
- Abstract
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 (ClinicalTrials.gov 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.
- Published
- 2009
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