Safety of Ivabradine in Patients With Coronary Artery Disease and Left Ventricular Systolic Dysfunction (from the BEAUTIFUL Holter Substudy)

The BEAUTIFUL Holter substudy explored the cardiac safety of the If inhibitor ivabradine in patients with stable coronary artery disease and left ventricular systolic dysfunction receiving optimal background therapy. The Holter substudy included 840 patients (ivabradine 5 or 7.5 mg/day, n = 421; pla...

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Bibliographic Details
Published in:The American journal of cardiology 2011-03, Vol.107 (6), p.805-811
Main Authors: Tendera, Michal, MD, Talajic, Mario, MD, Robertson, Michele, BSc, Tardif, Jean-Claude, MD, Ferrari, Roberto, MD, Ford, Ian, PhD, Steg, P. Gabriel, MD, Fox, Kim, MD
Format: Article
Language:English
Subjects:
Adrenergic beta-Antagonists - therapeutic use
Aged
Benzazepines - therapeutic use
Beta blockers
Biological and medical sciences
Cardiology
Cardiology. Vascular system
Cardiovascular
Cardiovascular disease
Coronary Artery Disease - complications
Coronary Artery Disease - drug therapy
Coronary Artery Disease - physiopathology
Coronary heart disease
Double-Blind Method
Drug Therapy, Combination
Electrocardiography
Electrocardiography, Ambulatory
Female
Heart
Heart failure, cardiogenic pulmonary edema, cardiac enlargement
Heart rate
Heart Rate - drug effects
Humans
Male
Medical sciences
Middle Aged
Patient safety
Placebos
Studies
Systole
Treatment Outcome
Ventricular Dysfunction, Left - complications
Ventricular Dysfunction, Left - drug therapy
Ventricular Dysfunction, Left - physiopathology
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Summary:The BEAUTIFUL Holter substudy explored the cardiac safety of the If inhibitor ivabradine in patients with stable coronary artery disease and left ventricular systolic dysfunction receiving optimal background therapy. The Holter substudy included 840 patients (ivabradine 5 or 7.5 mg/day, n = 421; placebo, n = 419), and the safety set consisted of 807 patients (ivabradine, n = 408; placebo, n = 399). Ambulatory 24-hour electrocardiographic Holter monitoring was performed at baseline and after 1 month and 6 months. There were no relevant between-group differences in baseline characteristics; 93% were receiving concomitant β blocker. Treatment with ivabradine was associated with a decrease in 24-hour heart rate of 6.3 ± 9.5 beats/min at last assessment versus no change with placebo (0.4 ± 7.2 beats/min, p
ISSN:0002-9149
1879-1913
DOI:10.1016/j.amjcard.2010.10.065