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Treatment of stable angina pectoris by ivabradine in every day practice: the REDUCTION study
Ralf Köster1, Jan Kaehler, Thomas Meinertz
1University Heart Center Hamburg, Clinic for Cardiology and Angiology, Martinistrasse 52, Hamburg, Germany. rkoester@uke.uni-hamburg.de
Insights
Ivabradine effectively reduces heart rate and angina symptoms in patients with coronary artery disease. This study confirms its efficacy and safety in real-world clinical practice, mirroring controlled trial results.
Area of Science:
- Cardiology
- Pharmacology
Background:
- Controlled clinical trials on ivabradine's antianginal efficacy have strict patient selection criteria.
- A discrepancy may exist between controlled trial results and routine clinical practice.
- This study aimed to evaluate ivabradine's efficacy and safety in everyday practice.
Purpose of the Study:
- To assess the real-world effectiveness of ivabradine in patients with stable angina pectoris.
- To evaluate the safety and tolerability of ivabradine in a broad patient population.
- To compare routine practice outcomes with findings from controlled clinical trials.
Main Methods:
- A multicenter study involving 4,954 patients with stable angina pectoris.
- Patients received ivabradine in a routine clinical setting with a 4-month follow-up.
- Evaluated parameters included heart rate, angina attacks, nitrate consumption, overall efficacy, and tolerance.
Main Results:
- Ivabradine significantly reduced heart rate (HR) by 12.4 bpm (P < .0001).
- Weekly angina attacks decreased from 2.4 to 0.4 (P < .0001), and nitrate use reduced significantly (P < .0001).
- Physicians rated efficacy and tolerance as "excellent/very good" for 97% and 98% of patients, respectively, with low adverse event rates (nausea, dizziness).
Conclusions:
- Ivabradine is highly effective and well-tolerated for treating symptomatic coronary artery disease in routine practice.
- The drug significantly reduces heart rate and angina symptoms.
- Real-world data supports the findings of controlled clinical trials across a diverse patient group.
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.
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