Treatment of stable angina pectoris by ivabradine in every day practice: The REDUCTION Study

Background The antianginal efficacy of ivabradine was studied in controlled clinical trials. Strict patient selection criteria may cause a discrepancy between the results of highly controlled clinical trials and everyday routine practice. The objective of this study was to evaluate the efficacy and...

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Bibliographic Details
Published in:The American heart journal 2009-10, Vol.158 (4), p.e51-e57
Main Authors: Köster, Ralf, MD, Kaehler, Jan, MD, Meinertz, Thomas, MD
Format: Article
Language:English
Subjects:
Aged
Angina pectoris
Angina Pectoris - diagnosis
Angina Pectoris - drug therapy
Angina Pectoris - physiopathology
Benzazepines - administration & dosage
Cardiovascular
Coronary vessels
Cyclic Nucleotide-Gated Cation Channels
Dose-Response Relationship, Drug
Electrocardiography
Female
Follow-Up Studies
Germany
Heart attacks
Heart Rate - drug effects
Humans
Male
Nitrates
Prospective Studies
Surveys and Questionnaires
Time Factors
Treatment Outcome
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Summary:Background The antianginal efficacy of ivabradine was studied in controlled clinical trials. Strict patient selection criteria may cause a discrepancy between the results of highly controlled clinical trials and everyday routine practice. The objective of this study was to evaluate the efficacy and safety of ivabradine in everyday routine practice. Methods In this multicenter study, 4,954 patients with stable angina pectoris received ivabradine in everyday routine practice and underwent follow-up for 4 months. The heart rate (HR), angina pectoris attacks, nitrate consumption, overall efficacy, and tolerance were evaluated. Results Within 4 months of treatment with ivabradine, HR was reduced by 12.4 ± 12.2 beat/min from 82.9 ± 15.3 to 70.4 ± 9.2 beat/min ( P < .0001). Angina pectoris attacks were reduced from 2.4 ± 3.1 to 0.4 ± 1.5 per week ( P < .0001). Consumption of short-acting nitrates was reduced from 3.3 ± 4.4 to 0.6 ± 1.6 U/wk ( P < .0001). Seventy-eight cases of adverse drug reactions were reported. The most common adverse drug reactions were nausea (n = 11, 0.22%) and dizziness (n = 9, 0.18%). Efficacy and tolerance were graded by physicians as being “excellent/very good” for 97% and 98% of the patients treated. Conclusion Ivabradine reduces the HR and is highly effective and well tolerated in the treatment of patients with symptomatic coronary artery disease. The results confirm the findings of controlled clinical trials in a broad patient population in everyday routine practice.
ISSN:0002-8703
1097-6744
DOI:10.1016/j.ahj.2009.06.008