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

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...

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Published inDrugs & 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
LanguageEnglish
Published Cham Springer International Publishing 01.01.2009
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Springer Nature B.V
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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.
AbstractList 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.
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.
The incidence of atrial fibrillation (AF) is very high in the elderly, and often oral anticoagulation (OAC) is indicated to prevent thromboembolism. The aim of this study was to evaluate the safety of combining intensive cholesterol-lowering therapy with OAC in elderly patients with AF. 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. 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. 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.
Author Teerenstra, Steven
van Kuilenburg, Janet T.
Albers-Akkers, Marjo T. H.
Verheugt, Freek W. A.
Pop, Gheorghe A. M.
van Sorge-Greve, Aty H. N.
Enajat, Morteza
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Issue 7
Keywords 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
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Snippet Background The incidence of atrial fibrillation (AF) is very high in the elderly, and often oral anticoagulation (OAC) is indicated to prevent thromboembolism....
The incidence of atrial fibrillation (AF) is very high in the elderly, and often oral anticoagulation (OAC) is indicated to prevent thromboembolism. The aim of...
Background: The incidence of atrial fibrillation (AF) is very high in the elderly, and often oral anticoagulation (OAC) is indicated to prevent...
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StartPage 585
SubjectTerms 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
Subtitle A Randomized, Double-Blind, Placebo-Controlled Study
Title Safety of the Combination of Intensive Cholesterol-Lowering Therapy with Oral Anticoagulation Medication in Elderly Patients with Atrial Fibrillation
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https://www.ncbi.nlm.nih.gov/pubmed/19655825
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Volume 26
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