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J Clin Lipidol. 2010 Mar-Apr;4(2):105-112.e1. doi: 10.1016/j.jacl.2010.02.002. Epub 2010 Feb 12.

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

Author information

1
National Clinical Research Inc., 2809 Emerywood Parkway, Suite 140, Richmond, VA 23294, USA. jmckenney@ncrinc.net

Abstract

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® (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 ≥3× 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 (∼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.

PMID:
21122637
DOI:
10.1016/j.jacl.2010.02.002
[Indexed for MEDLINE]

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