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Safety of the Combination of Intensive Cholesterol-Lowering Therapy with Oral Anticoagulation Medication in Elderly Patients with Atrial Fibrillation

A Randomized, Double-Blind, Placebo-Controlled Study

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Abstract

Background

The incidence of atrial fibrillation (AF) is very high in the elderly, and often oral anticoagulation (OAC) is indicated to prevent thromboembolism.

Objective

The aim of this study was to evaluate the safety of combining intensive cholesterol-lowering therapy with OAC in elderly patients with AF.

Methods

In a randomized, double-blind trial, 34 patients received OAC plus atorvastatin 40 mg/day and ezetimibe 10 mg/day versus placebo over 1 year. Dose adjustments of OAC served as an indicator of an interaction between HMG-CoA reductase inhibitors (statins) and OAC. Safety was evaluated by the occurrence of bleeding and a rise in AST, ALT and creatine phosphokinase.

Results

Compared with a 6-month pre-intervention period, the mean daily dose±standard error of OAC was 4.4±1.5% lower in the treatment group (p=0.003) and virtually the same in the placebo group (change from baseline: −0.1±1.3%, p=0.96). The mean daily dose of OAC stabilized after 3 months. In the 6-month post-intervention period, OAC dosing showed no statistically significant change from baseline: −1.9±1.9% in the placebo arm and −2.6±2.1% in the intervention arm.

Conclusion

We conclude that in elderly AF patients treated with OAC, intensive cholesterol-lowering therapy (atorvastatin 40 mg/day and ezetimibe 10 mg/day) is well tolerated. No increased risk in bleeding was found.

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Acknowledgements

No funds other than research funds from the Department of Cardiology of the University Medical Center, Radboud, the Netherlands, were used to assist in the conduct of this study or preparation of this article. The authors have no conflicts of interest that are directly relevant to the content of this study.

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Authors and Affiliations

  1. Heart Lung Center, St Radboud University Medical Centre, P.O. Box 9101, 6500 HB, Nijmegen, the Netherlands

    Morteza Enajat, Janet T. van Kuilenburg, Freek W. A. Verheugt & Gheorghe A. M. Pop

  2. Department of Epidemiology, Biostatistics, and Health Technology Assessment, St Radboud University Medical Centre, Nijmegen, the Netherlands

    Steven Teerenstra

  3. Anticoagulation Outpatient Clinic, Nijmegen, the Netherlands

    Aty H. N. van Sorge-Greve & Marjo T. H. Albers-Akkers

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  1. Morteza Enajat
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  2. Steven Teerenstra
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Correspondence to Morteza Enajat.

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Enajat, M., Teerenstra, S., van Kuilenburg, J.T. et al. Safety of the Combination of Intensive Cholesterol-Lowering Therapy with Oral Anticoagulation Medication in Elderly Patients with Atrial Fibrillation. Drugs Aging 26, 585–593 (2009). https://doi.org/10.2165/10558450-000000000-00000

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  • DOI: https://doi.org/10.2165/10558450-000000000-00000

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