Journal
CLINICAL RESEARCH IN CARDIOLOGY
Volume 101, Issue 5, Pages 365-373Publisher
SPRINGER HEIDELBERG
DOI: 10.1007/s00392-011-0402-4
Keywords
Ivabradine; Beta-blocker; Coronary artery disease; Angina pectoris; Heart rate; Quality of life
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Funding
- Clinical Research GmbH, Munich
- Servier Deutschland GmbH, Munich
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Several clinical trials have demonstrated the antianginal and anti-ischemic efficacy of ivabradine in combination with beta-blocker in patients with stable angina pectoris. The ADDITIONS (PrActical Daily efficacy anD safety of Procoralan (R) In combinaTION with betablockerS) study evaluated the efficacy, safety, and tolerability of ivabradine added to beta-blocker, and its effect on angina symptoms and quality of life in routine clinical practice. This non-interventional, multicenter, prospective study included 2,330 patients with stable angina pectoris treated with a flexible dose of ivabradine twice daily in addition to beta-blocker for 4 months. The parameters recorded included heart rate, number of angina attacks, nitrate consumption, tolerance, and quality of life. After 4 months ivabradine (mean dose 12.37 +/- 2.95 mg/day) reduced heart rate by 19.4 +/- 11.4 to 65.6 +/- 8.2 bpm (p < 0.0001). The number of angina attacks was reduced by 1.4 +/- 1.9 per week (p < 0.0001), and nitrate consumption by 1.9 +/- 2.9 U per week (p < 0.0001). At baseline (i.e., on beta-blocker), half of the patients (51%) were classified as Canadian Cardiovascular Society (CCS) grade II; 29% were CCS grade I. After 4 months' treatment with ivabradine, most of the patients were CCS grade I (68%). The EQ-5D index improved by 0.17 +/- 0.23 (p < 0.0001). The overall efficacy of ivabradine was considered by the physicians as very good (61%) or good (36%) in most patients. Suspected adverse drug reactions were documented in 14 patients; none were severe. In daily clinical practice, combining ivabradine with beta-blocker not only reduces heart rate, number of angina attacks, and nitrate consumption, but also improves the quality of life in patients with stable angina pectoris.
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