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Consistency of Extended-Release Niacin/Laropiprant Effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 Ratio Across Patient Subgroups

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Abstract

Background

According to prior analyses, extended-release niacin/laropiprant (ERN/LRPT) consistently reduces low-density lipoprotein cholesterol (LDL-C) and triglycerides (TG) and increases high-density lipoprotein cholesterol (HDL-C) levels across a wide range of dyslipidemic patient subgroups.

Objectives

This analysis examined ERN/LRPT’s consistency across four phase III, randomized, double-blind trials in improving other lipid/lipoprotein parameters associated with cardiovascular risk, across several key dyslipidemic patient subgroups.

Methods

In three of the studies, the randomized population included patients with primary hypercholesterolemia or mixed hyperlipidemia; in the remaining study, the population included patients with type 2 diabetes mellitus. The lipid-altering consistency of ERN/LRPT’s efficacy was evaluated versus the predefined comparator (placebo or active control) among key subgroups of sex, race (White, non-White), region (US, ex-US), baseline age (<65 years, ≥65 years), use of statin therapy (yes, no), coronary heart disease (yes, no), risk status (low, multiple, high), and type of hyperlipidemia (primary hypercholesterolemia, mixed dyslipidemia), as well as across baseline LDL-C, HDL-C, and TG levels. The consistency of the treatment effects on lipoprotein(a) [Lp(a)], apolipoprotein B (ApoB), non-HDL-C, ApoA1, and ApoB/ApoA1 ratio was evaluated by examining treatment difference estimates of the percentage change from baseline with 95% confidence intervals.

Results

Treatment with ERN/LRPT produced significantly greater improvements in Lp(a), ApoB, non-HDL-C, ApoA1, and ApoB/ApoA1 ratio compared with placebo/active comparator in each study. These effects were generally consistent across key subgroups within each study.

Conclusion

ERN/LRPT produced lipid-altering efficacy on the parameters evaluated in four controlled studies; these effects were generally consistent across all examined subgroups. ERN/LRPT represents an effective and reliable therapeutic option for the treatment of dyslipidemia in a wide range of patient types.

Clinical Trial Registration

Registered as Clinicaltrials.gov NCT00269204, NCT00269217, NCT00479388, and NCT00485758.

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Acknowledgments

This analysis was funded and supported by Merck & Co., Inc., Whitehouse Station, NJ, USA.

These data were presented at National Lipid Association 2011 and European Atherosclerosis Society 2011 meetings.

Harold E. Bays has received research grants and consultant/speaker’s honoraria from Merck. Arvind Shah, Jianxin Lin, and Christine McCrary Sisk are employees of Merck and may hold stock/stock options in the company. Darbie Maccubbin and Qian Dong are former employees of Merck and may hold stock/stock options in the company.

All authors contributed to the design, conduct, and interpretation of results for at least one of the studies evaluated in the present analysis, and all authors meet the ICMJE (International Committee of Medical Journal Editors) requirements for authorship. All have contributed to the development of this manuscript and approved the submission for publication.

The authors would like to thank Kathleen Newcomb and Jennifer Rotonda, Merck Sharp & Dohme Corp., for editorial assistance in the preparation of this manuscript.

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Authors and Affiliations

  1. Louisville Metabolic and Atherosclerosis Research Center Inc. (L-MARC), 3288 Illinois Avenue, Louisville, Kentucky, KY 40213, USA

    Harold E. Bays MD, FACP, FACE, FLNA (Medical Director/President)

  2. Merck Sharp & Dohme Corp., Whitehouse Station, New Jersey, USA

    Arvind Shah, Jianxin Lin, Christine McCrary Sisk, Qian Dong & Darbie Maccubbin

Authors
  1. Harold E. Bays MD, FACP, FACE, FLNA
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  2. Arvind Shah
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  3. Jianxin Lin
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  4. Christine McCrary Sisk
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  5. Qian Dong
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  6. Darbie Maccubbin
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Corresponding author

Correspondence to Harold E. Bays MD, FACP, FACE, FLNA.

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Bays, H.E., Shah, A., Lin, J. et al. Consistency of Extended-Release Niacin/Laropiprant Effects on Lp(a), ApoB, non-HDL-C, Apo A1, and ApoB/ApoA1 Ratio Across Patient Subgroups. Am J Cardiovasc Drugs 12, 197–206 (2012). https://doi.org/10.2165/11631530-000000000-00000

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