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

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

James McKenney, Harold Bays, Michael Koren, Christie M. Ballantyne, John F. Paolini, Yale Mitchel, Abigaile Betteridge, Olga Kuznetsova, Aditi Sapre, Christine McCrary Sisk and Darbie Maccubbin

Journal of Clinical Lipidology, 2010, 4(2), 105-112. DOI: 10.1016/j.jacl.2010.02.002

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 ≥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 (∼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.

ASCI-ID: 2746-136

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