The BEAUTIFUL study: randomized trial of ivabradine in patients with stable coronary artery disease and left ventricular systolic dysfunction - baseline characteristics of the study population.
OBJECTIVE
Ivabradine is a selective heart rate-lowering agent that acts by inhibiting the pacemaker current If in sinoatrial node cells. Patients with coronary artery disease and left ventricular dysfunction are at high risk of death and cardiac events, and the BEAUTIFUL study was designed to evaluate the effects of ivabradine on outcome in such patients receiving optimal medical therapy. This report describes the study population at baseline.


METHODS
BEAUTIFUL is an international, multicentre, randomized, double-blind trial to compare ivabradine with placebo in reducing mortality and cardiovascular events in patients with stable coronary artery disease and left ventricular systolic dysfunction (ejection fraction <40%).


RESULTS
A total of 10,917 patients were randomized. At baseline, their mean age was 65 years, 83% were male, 98% Caucasian, 88% had previous myocardial infarction, 37% had diabetes, and 40% had metabolic syndrome. Mean ejection fraction was 32% and resting heart rate was 71.6 bpm. Concomitant medications included beta-blockers (87%), renin-angiotensin system agents (89%), antithrombotic agents (94%), and lipid-lowering agents (76%).


CONCLUSIONS
Main results from BEAUTIFUL are expected in 2008, and should show whether ivabradine, on top of optimal medical treatment, reduces mortality and cardiovascular events in this population of high-risk patients.
Royal Brompton Hospital, London, UK.
Ferrari
R
R
Ford
I
I
Fox
K
K
Steg
P G
PG
Tendera
M
M
D000368:Aged; D001552:Benzazepines / Q000627:therapeutic use*; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D003324:Coronary Artery Disease / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D048909:Diabetes Complications; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D000077550:Ivabradine; D008297:Male; D024821:Metabolic Syndrome / Q000150:complications; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy / Q000209:etiology
D001552:Benzazepines; D002317:Cardiovascular Agents; D000077550:Ivabradine