Abstract
Purpose
The anti-anginal efficacy of the selective If inhibitor ivabradine has been demonstrated in controlled clinical trials. However, there is limited information about the safety and efficacy of a combined treatment of ivabradine with beta-blockers, particularly outside of clinical trials in every day practice. This analysis from the REDUCTION study evaluated the safety and efficacy of a combined therapy of beta-blockers and ivabradine in every day practice.
Methods
In this multi-center study 4,954 patients with stable angina pectoris were treated with ivabradine in every day routine practice and underwent a clinical follow-up for 4 months. 344 of these patients received a co-medication with beta-blockers. Heart rate (HR), angina pectoris episodes, nitrate consumption, overall efficacy and tolerance were analyzed.
Results
After 4 months of treatment with ivabradine HR was reduced by 12.4 ± 11.6 bpm from 84.3 ± 14.6 to 72.0 ± 9.9 bpm, p < 0.0001. Angina pectoris episodes were reduced from 2.8 ± 3.3 to 0.5 ± 1.3 per week, p < 0.0001. Consumption of short-acting nitrates was reduced from 3.7 ± 5.6 to 0.7 ± 1.7 units per week, p < 0.0001. Five patients (1.5%) reported adverse drug reactions (ADR). The most common ADR were nausea and dizziness (<0.6% each). There was no clinically relevant bradycardia. Efficacy and tolerance were graded as ‘very good/good’ for 96 and 99% of the patients treated.
Conclusion
Ivabradine effectively reduces heart rate and angina pectoris in combination with beta-blockers and is well tolerated by patients in every day practice.
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Acknowledgments
The authors thank Dieter Schremmer from the ‘Gesellschaft für Therapieforschung’ in Munich, Germany, for his substantive support of the statistical analysis, and all investigators for their contributions to the study. The investigators participated were J. Taggeselle, L. Feß, R. Aubele, N. Hassler, K. Hofmann, V. Adelberger, T. Arnold, B. Holz, M. Hwaidi, H.-D. Kombächer, R. Meysing, S. Appel, J. Bazowski, R. Bernauer, H. Böneke, M. Braun, E. Daelmann, M. Deißner, S. Duddy, M.-A. Eisenbarth, H. Fissan, C. Freese, G. Gölz, M. Gutting, K. Hallbaum, M. Hilgedieck, J.-A. Hintze, H. Hohensee, T. Hohenstatt, O. Khan, H.-H. Knäbchen, A. Krämer, K. Krämer, R. Lange, A. Levertov, H. Littwitz, U. Meyer, K. Müller, L. Rokitzki, C. Ruhnau, K. Rybak, R. Schmitt, A. Spingler, H. Stellmach, R. Tietze, W. Türk, R. Vormann, T.-A. Wiegmann, G. Will, E. Wüstenberg, J. Zivojinovic. The list of the further investigators is available from the corresponding author. TM’s, KW’s, HE’s, GS’s and RK’s participation at scientific congresses has been supported by Servier Deutschland. The study was supported by funding from Servier, Germany.
Conflict of interest statement
TM is member of the advisory board. JK has no conflict of interest.
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Koester, R., Kaehler, J., Ebelt, H. et al. Ivabradine in combination with beta-blocker therapy for the treatment of stable angina pectoris in every day clinical practice. Clin Res Cardiol 99, 665–672 (2010). https://doi.org/10.1007/s00392-010-0172-4
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DOI: https://doi.org/10.1007/s00392-010-0172-4