Blood pressure-lowering effects of extended-release niacin alone and extended-release niacin/laropiprant combination: A post hoc analysis of a 24-week, placebo-controlled trial in dyslipidemic patients

• Published in: Clinical therapeutics Vol. 31; no. 1; pp. 115 - 122
• Main Authors: Bays, Harold E., MD, Maccubbin, Darbie, PhD, Meehan, Alan G., PhD, Kuznetsova, Olga, PhD, Mitchel, Yale B., MD, Paolini, John F., MD
• Format: Journal Article
• Language: English
• Published: Bridgewater, NJ EM Inc USA 2009; Elsevier; Elsevier Limited
• Subjects: Adult; Aged; Aged, 80 and over; Biological and medical sciences; Blood Pressure - drug effects; Clinical Trials, Phase III as Topic; Delayed-Action Preparations; diastolic blood pressure; Double-Blind Method; Drug Combinations; dyslipidemia; Dyslipidemias - complications; Dyslipidemias - drug therapy; Female; Humans; Hypertension - complications; Hypertension - drug therapy; Hypolipidemic Agents - administration & dosage; Hypolipidemic Agents - adverse effects; Hypolipidemic Agents - pharmacology; Indoles - administration & dosage; Indoles - pharmacology; Internal Medicine; laropiprant; Male; Medical Education; Medical sciences; Middle Aged; niacin; Niacin - administration & dosage; Niacin - adverse effects; Niacin - pharmacology; Pharmacology. Drug treatments; Randomized Controlled Trials as Topic; systolic blood pressure; Young Adult; niacin; laropiprant; diastolic blood pressure; dyslipidemia; systolic blood pressure; Human; Laropiprant; Controlled release form; Nicotinic acid; Metabolic diseases; Lipids; B-Vitamins; Pyridine derivatives; Placebo; Dosage form; Clinical trial; Arterial pressure; Blood pressure; Antagonist; Hemodynamics; Dyslipemia; Antilipemic agent
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/j.clinthera.2009.01.010

Abstract Background: Dyslipidemia and high blood pressure are both major cardiovascular disease risk factors. Niacin is an effective lipid-altering agent that has been reported to reduce the risk of cardiovascular disease. However, the more widespread use of niacin is limited, mainly due to the occurrence of flushing. Laropiprant (LRPT) is a selective antagonist of prostaglandin D2 receptor subtype 1 that reduces extended-release niacin (ERN)-induced flushing without affecting its beneficial lipid effects. While the lipid effects of ERN are well known, the blood pressure effects are unclear. Objective: The aim of this analysis was to examine the blood pressure effects of ERN and ERN/LRPT. Methods: This was a post hoc analysis of a 24-week, worldwide, multicenter, double-blind, randomized, placebo-controlled, parallel, Phase III, previously published study of dyslipidemic patients, which examined the effect of ERN and ERN/LRPT on systolic blood pressure (SBP) and diastolic blood pressure (DBP). Results: A total of 1613 men and women, aged 21 to 85 years, with primary hypercholesterolemia or mixed dyslipidemia (66% on statins), were included in the original analysis. ERN alone, or in combination with LRPT, was associated with significant reductions in SBP and DBP at 24 weeks from baseline. The placebo-adjusted mean changes from baseline at week 24 in SBP were −2.2 and −3.1 mm Hg for the ERN and ERN/LRPT groups, respectively ( P < 0.05 and P < 0.001). Similar changes in DBP were observed; −2.7 and −2.5 mm Hg in the ERN and ERN/ LRPT groups, respectively (both, P < 0.001). Conclusion: This post hoc analysis of a 24-week trial found that ERN alone, or in combination with LRPT, was associated with significant placebo-adjusted reductions from baseline in blood pressure in these hyperlipidemic hypertensive or normotensive subjects.