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 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.


CONCLUSIONS
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.
Enajat
Morteza
M
Heart Centre, St Radboud University Medical Centre, Nijmegen, the Netherlands. m.enajat@live.nl
Teerenstra
Steven
S
van Kuilenburg
Janet T
JT
van Sorge-Greve
Aty H N
AH
Albers-Akkers
Marjo T H
MT
Verheugt
Freek W A
FW
Pop
Gheorghe A M
GA
D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects; D000924:Anticholesteremic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects*; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004347:Drug Interactions; D004359:Drug Therapy, Combination; D023381:Endpoint Determination; D005260:Female; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D055118:Medication Adherence; D015990:Placebo Effect
D000893:Anti-Inflammatory Agents; D000924:Anticholesteremic Agents; D000925:Anticoagulants