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Lipid-modifying efficacy and tolerability of extended-release niacin/laropiprant in patients with primary hypercholesterolaemia or mixed dyslipidaemia
Merck Research Laboratories, Cardiovascular Disease, Merck and Co., Inc., 126 East Lincoln Avenue, RY34A-204, Rahway, NJ 07065, United States, Merck Research Laboratories, Rahway, NJ, United States.
Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, United States.
Linköping University, Faculty of Health Sciences. Linköping University, Department of Medicine and Health Sciences, Internal Medicine . Östergötlands Läns Landsting, Centre for Medicine, Department of Endocrinology and Gastroenterology UHL.
Regional Clinical Research, Inc., Endwell, NY, United States.
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2008 (English)In: International journal of clinical practice (Esher), ISSN 1368-5031, Vol. 62, no 12, 1959-1970 p.Article in journal (Refereed) Published
Abstract [en]

Background: Improving lipids beyond low-density lipoprotein cholesterol (LDL-C) lowering with statin monotherapy may further reduce cardiovascular risk. Niacin has complementary lipid-modifying efficacy to statins and cardiovascular benefit, but is underutilised because of flushing, mediated primarily by prostaglandin D2 (PGD2). Laropiprant (LRPT), a PGD 2 receptor (DP1) antagonist that reduces niacin-induced flushing has been combined with extended-release niacin (ERN) into a fixed-dose tablet. Methods and results: Dyslipidaemic patients were randomised to ERN/LRPT 1 g (n = 800), ERN 1 g (n = 543) or placebo (n = 270) for 4 weeks. Doses were doubled (2 tablets/day, i.e. 2 g for active treatments) for 20 weeks. ERN/LRPT 2 g produced significant changes vs. placebo in LDL-C (-18.4%), high-density lipoprotein cholesterol (HDL-C, 20.0%), LDL-C:HDL-C (-31.2%), non-HDL-C (-19.8%), triglycerides (TG, -25.8%), apolipoprotein (Apo) B (-18.8%), Apo A-I (6.9%), total cholesterol (TC, -8.5%), TC:HDL-C (-23.1%) and lipoprotein(a) (-20.8%) across weeks 12-24. ERN/LRPT produced significantly less flushing than ERN during initiation (week 1) and maintenance (weeks 2-24) for all prespecified flushing end-points (incidence, intensity and discontinuation because of flushing). Except for flushing, ERN/LRPT had a safety/tolerability profile comparable with ERN. Conclusion: Extended-release niacin/LRPT 2 g produced significant, durable improvements in multiple lipid/lipoprotein parameters. The improved tolerability of ERN/LRPT supports a simplified 1 g?2 g dosing regimen of niacin, a therapy proven to reduce cardiovascular risk. © 2008 Merck & Co.

Place, publisher, year, edition, pages
2008. Vol. 62, no 12, 1959-1970 p.
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Medical and Health Sciences
URN: urn:nbn:se:liu:diva-45988DOI: 10.1111/j.1742-1241.2008.01938.xOAI: diva2:266884
Available from: 2009-10-11 Created: 2009-10-11 Last updated: 2011-01-10

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Olsson, Anders
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Faculty of Health SciencesInternal Medicine Department of Endocrinology and Gastroenterology UHL
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