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Modified-Policosanol Does Not Reduce Plasma Lipoproteins in Hyperlipidemic Patients When Used Alone or in Combination with Statin Therapy

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Lipids

Abstract

Policosanol is a poorly absorbed nutritional supplement used primarily for cholesterol management. Findings from previous trials evaluating the effects of policosanol are mixed with early data reporting positive lipid effects while more recent studies indicate negligible efficacy. We hypothesized that re-formulating policosanol would result in an improvement in major lipoproteins and possibly provide some explanation for previously conflicting trial data. Our primary objectives were to assess the efficacy and safety of modified-policosanol (MP) on the major lipoproteins among hyperlipidemic subjects receiving background statin therapy or as monotherapy. This 8-week clinical trial consisted of 3 arms. Subjects receiving chronic statin therapy (N = 36) were randomized in a double-blind design to MP 20 mg daily or placebo. In the third arm, subjects not receiving statin therapy (N = 18) were assigned open-label MP 20 mg daily. The utilization of MP when added to background statin therapy or as monotherapy resulted in no significant changes in major lipoproteins (all p > 0.05). The MP therapy was well tolerated with no major adverse events reported. Consistent with recent clinical trial data, MP demonstrated an excellent safety profile but produced no significant effects on major lipoproteins when used as monotherapy or when given with concomitant statin therapy.

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Abbreviations

ANOVA:

Analysis of variance

ATP-III:

Adult Treatment Panel III

CHD:

Coronary heart disease

HDL-C:

High-density lipoprotein cholesterol

HMG CoA:

Hydroxymethylglutaryl Coenzyme A

HRT:

Hormone replacement therapy

LDL-C:

Low-density lipoprotein cholesterol

Lp(a):

Lipoprotein a

MP:

Modified policosanol

NCEP:

National Cholesterol Education Program

SPSS:

Statistical Package for the Social Sciences

VLDL:

Very low-density lipoprotein cholesterol

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Acknowledgments

This study was supported by the University of Kansas General Research Fund allocation #23011083 and by Marcor Development Corporation (Carlstadt, NJ). We would also like to express our sincere gratitude to David Mueller, R.Ph., for his diligence and expertise in pharmaceutical compounding and Roger Rajewski Ph.D. for his expertise and assistance in product formulation.

Conflict of interest

Drs. Backes, Gibson, Ruisinger and Moriarty––all report no conflicts of interest with submitted material.

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Authors and Affiliations

  1. Schools of Pharmacy and Medicine, The University of Kansas Medical Center, Kansas, USA

    James M. Backes & Janelle F. Ruisinger

  2. Atherosclerosis and LDL-Apheresis Center, University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS, 66160-7231, USA

    James M. Backes & Patrick M. Moriarty

  3. Department of Internal Medicine, The University of Kansas Medical Center, Kansas, USA

    Cheryl A. Gibson

  4. Department of Internal Medicine, Division of Clinical Pharmacology, The University of Kansas Medical Center, Kansas, USA

    Patrick M. Moriarty

Authors
  1. James M. Backes
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  2. Cheryl A. Gibson
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  3. Janelle F. Ruisinger
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  4. Patrick M. Moriarty
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Correspondence to James M. Backes.

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Backes, J.M., Gibson, C.A., Ruisinger, J.F. et al. Modified-Policosanol Does Not Reduce Plasma Lipoproteins in Hyperlipidemic Patients When Used Alone or in Combination with Statin Therapy. Lipids 46, 923–929 (2011). https://doi.org/10.1007/s11745-011-3591-8

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  • DOI: https://doi.org/10.1007/s11745-011-3591-8

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