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Niacin Extended-Release Therapy in Phase III Clinical Trials is Associated with Relatively Low Rates of Drug Discontinuation due to Flushing and Treatment-Related Adverse Events

A Pooled Analysis

  • Original Research Article
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American Journal of Cardiovascular Drugs Aims and scope Submit manuscript

Abstract

Background and Objective

Niacin is a highly effective agent for increasing low high-density lipoprotein cholesterol (HDL-C) levels. It also has beneficial effects on key pro-atherogenic lipoprotein parameters. However, the side effect of flushing can challenge patient adherence to treatment. In this study, we pooled safety data from available trials of at least 16 weeks’ duration to evaluate the impact of flushing on patient adherence to niacin extended-release (NER) therapy.

Methods

Data were pooled from eight NER studies (administered as NER with a maximum dosage of 1000, 1500, and 2000 mg/day, either as monotherapy or in combination with simvastatin 20 or 40mg/day [NER/S], or lovastatin 20 or 40 mg/day [NER/L]) to evaluate rates of study discontinuation due to flushing or any treatment-related adverse events.

Results

While 66.6% of patients experienced flushing, only 5.2% of patients discontinued treatment due to flushing. Of the total number of patients treated with NER (n = 307), NER/S (n = 912), or NER/L (n = 928), 34 (11%), 105 (11%), and 127 (14%) patients discontinued due to any treatment-related adverse event, respectively, while 14 (5%), 43 (5%), and 55 (6%) discontinued due to flushing. Discontinuation for flushing did not differ with regard to maximum dose, or to the presence or type of statin combined with NER.

Conclusion

Although flushing was common with NER treatment, discontinuation due to flushing occurred in only 5–6% of patients in this pooled analysis. This could be due to several factors, including the fact that all patients in the NER trials were educated about flushing and its management. Translation of methodology employed in these trials into clinical practice may improve long-term adherence to NER therapy, which would enhance the therapeutic benefit of NER for reducing cardiovascular risk.

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Authors and Affiliations

  1. Cardiovascular Genetics, University of Utah School of Medicine, 420 Chipeta Way, Room 1160, Salt Lake City, UT, 84108, USA

    Eliot A. Brinton

  2. Department of Veterans Affairs Healthcare System, Atherosclerosis Research Center, Long Beach, CA, USA

    Moti L. Kashyap & Anthony N. Vo

  3. Department of Medicine, University of California-Irvine, Irvine, CA, USA

    Moti L. Kashyap & Anthony N. Vo

  4. Abbott, Abbott Park, IL, USA

    Roopal B. Thakkar, Ping Jiang & Robert J. Padley

Authors
  1. Eliot A. Brinton
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  2. Moti L. Kashyap
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Correspondence to Eliot A. Brinton.

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Brinton, E.A., Kashyap, M.L., Vo, A.N. et al. Niacin Extended-Release Therapy in Phase III Clinical Trials is Associated with Relatively Low Rates of Drug Discontinuation due to Flushing and Treatment-Related Adverse Events. Am J Cardiovasc Drugs 11, 179–187 (2011). https://doi.org/10.2165/11592560-000000000-00000

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  • DOI: https://doi.org/10.2165/11592560-000000000-00000

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