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

• Published in: Drugs & aging Vol. 26; no. 7; pp. 585 - 593
• Main Authors: Enajat, Morteza, Teerenstra, Steven, van Kuilenburg, Janet T., van Sorge-Greve, Aty H. N., Albers-Akkers, Marjo T. H., Verheugt, Freek W. A., Pop, Gheorghe A. M.
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.01.2009; Adis International; Springer Nature B.V
• Subjects: Administration, Oral; Aged; Aged, 80 and over; Anti-Inflammatory Agents - administration & dosage; Anti-Inflammatory Agents - adverse effects; Anticholesteremic Agents - administration & dosage; Anticholesteremic Agents - adverse effects; Anticoagulants - administration & dosage; Anticoagulants - adverse effects; Aspirin; Atrial Fibrillation - complications; Atrial Fibrillation - drug therapy; Biological and medical sciences; Cardiac arrhythmia; Cardiac dysrhythmias; Cardiology. Vascular system; Cholesterol; Cytochrome; Disease prevention; Dose-Response Relationship, Drug; Double-Blind Method; Drug dosages; Drug Interactions; Drug Therapy, Combination; Endpoint Determination; Enzymes; Female; Geriatrics/Gerontology; Heart; Hemorrhage - etiology; High density lipoprotein; Humans; Internal Medicine; Laboratories; Lipoproteins; Liver; Magnetic resonance imaging; Male; Medical sciences; Medication Adherence; Medicine; Medicine & Public Health; Original Research Article; Patients; Pharmacology. Drug treatments; Pharmacology/Toxicology; Pharmacotherapy; Placebo Effect; Stroke; Thromboembolism; International Normalize Ratio; Atorvastatin; Warfarin; Atrial Fibrillation; Ezetimibe; Human; Drug; Arrhythmia; Toxicity; Atrial fibrillation; Oral administration; Cardiovascular disease; Anticoagulant; Review; Excitability disorder; Randomization; Treatment; Heart disease; Placebo; Double blind study; Safety; Elderly; Antilipemic agent
• ISSN: 1170-229X; 1179-1969
• DOI: 10.2165/10558450-000000000-00000

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.