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Safety of extended-release niacin/laropiprant in patients with dyslipidemia.

Author(s): McKenney J, Bays H, Koren M, Ballantyne CM, Paolini JF, Mitchel Y, Betteridge A, Kuznetsova O, Sapre A, Sisk CM, Maccubbin D

Affiliation(s): National Clinical Research Inc., 2809 Emerywood Parkway, Suite 140, Richmond, VA 23294, USA. jmckenney@ncrinc.net

Publication date & source: 2010-03, J Clin Lipidol., 4(2):105-112.e1. Epub 2010 Feb 12.

Publication type: Clinical Trial, Phase II; Clinical Trial, Phase III; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: To evaluate the safety profile of extended-release niacin/laropiprant (ERN/LRPT), pooling data from studies in the clinical development program. METHODS: Data were pooled from three active- or placebo-controlled phase 3 studies and three 1-year extensions of phase 2 studies that ranged from 12 to 52 weeks (N = 4747): ERN/LRPT = 2548; ERN or Niaspan(R) (ERN-NSP = 1268); or simvastatin or placebo (SIMVA-PBO = 931). RESULTS: The safety and tolerability profile for ERN/LRPT was similar to that of ERN-NSP, except for fewer flushing-related adverse experiences and discontinuations with ERN/LRPT than ERN-NSP. The incidence of consecutive >/=3x the upper limit of normal increases in alanine aminotransferase and/or aspartate aminotransferase was numerically (but not statistically) greater with ERN/LRPT (1.0%) than ERN-NSP (0.5%) and similar to SIMVA-PBO (0.9%). Elevations were reversible with therapy discontinuation and not associated with clinical hepatotoxicity. There was no evidence that ERN/LRPT administered alone or concurrently with a statin had adverse effects on muscle. ERN/LRPT and ERN-NSP produced small median increases in fasting blood glucose levels ( approximately 4 mg/dL) after 24 weeks of treatment, consistent with known effects of niacin. CONCLUSION: The favorable safety and tolerability profile of ERN/LRPT for up to 1 year supports the use of LRPT to achieve improved therapeutic dosing of niacin, an agent with comprehensive lipid-modifying efficacy and shown to reduce cardiovascular risk. Copyright (c) 2010. Published by Elsevier Inc.

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