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Optimizing Lipid Pattern by Adding a Combined Nutraceutical or Pravastatin to Fenofibrate Treatment in Hypertriglyceridemic Subjects: Single Site, Randomized, Open-Label, Post-Market Clinical Investigation

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Abstract

Introduction

Fenofibrate is an effective and safe treatment for hypertriglyceridemia. However, after TG reduction a residual dyslipidemia could appear and require further treatment.

Aim

To comparatively evaluate the short-term tolerability and efficacy of a combined lipid-lowering nutraceutical and pravastatin 40 mg in fenofibrate treated patients.

Method

We prospectively enrolled 40 patients well-tolerating treatment with micronized fenofibrate 145 mg/day and with residual dyslipidemia (LDL-C > 115 mg/dL and TG > 150 mg/dL). Exclusion criteria have been type 2 diabetes, Familial Hypercholesterolemia, previous cardiovascular diseases and severe chronic kidney disease. Then, we have randomly assigned the patients to treatment with pravastatin 40 mg or a combined lipid-lowering nutraceutical (Armolipid Plus®, containing monacolin 3 mg and berberine 500 mg).

Results

After 8 weeks of treatment, 80% of pravastatin treated patients (N. 16/20) and 75% of those treated with Armolipid Plus® (N. 15/20) reached the desired LDL-C target, while 50% of pravastatin treated patients (N. 10/20) and 80% of the Armolipid Plus® treated ones reached the desired TG target (N. 16/20). No one adverse event has been registered during Armolipid Plus®, while 1 patient claimed myalgia and 1 reported significant increase of CPK (> 3 ULN) during pravastatin treatment. Both patients were then treated with Armolipid Plus® with resolution of symptoms and CPK increase, respectively.

Conclusion

In hypertriglyceridemic patients treated with fenofibrate, the association with a combined lipid lowering nutraceutical seem to be more effective in optimizing residual hypertriglyceridemia than pravastatin 40 mg, while being more tolerable and having similar effect on LDL-C plasma level.

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Authors and Affiliations

  1. Atherosclerosis Research Unit, Medical and Surgical Sciences Department, Sant’Orsola-Malpighi Hospital, Alma Mater Studiorum University of Bologna, Via Albertoni, 15, 40138, Bologna, Italy

    Arrigo F. G. Cicero, Federica Fogacci, Marilisa Bove, Fulvio Ventura, Marina Giovannini & Claudio Borghi

Authors
  1. Arrigo F. G. Cicero
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  2. Federica Fogacci
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  3. Marilisa Bove
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  4. Fulvio Ventura
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  5. Marina Giovannini
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  6. Claudio Borghi
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Corresponding author

Correspondence to Arrigo F. G. Cicero.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Conflict of interest

Dr. Cicero has spoken in Mylan SpA sponsored meetings. Other authors have no direct nor indirect conflict of interest in the publication of this paper.

Additional information

This article is part of the topical collection on Nutraceuticals in Hypertension & Cardiovascular Prevention.

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Cicero, A.F.G., Fogacci, F., Bove, M. et al. Optimizing Lipid Pattern by Adding a Combined Nutraceutical or Pravastatin to Fenofibrate Treatment in Hypertriglyceridemic Subjects: Single Site, Randomized, Open-Label, Post-Market Clinical Investigation. High Blood Press Cardiovasc Prev 25, 355–359 (2018). https://doi.org/10.1007/s40292-018-0277-9

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  • DOI: https://doi.org/10.1007/s40292-018-0277-9

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