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Camm J, et al. On Behalf of The SHIFT Gothenburg, Cardiac safety of selective heart rate reduction with Ivabradine in chronic heart failure. Poster, Heart Failure Congress; 2011 May.
Hot Topic from Gothenburg heart failure congress
Insights from the SHIFT ECG-Holter Substudy
Cardiac Safety of Selective Heart
Rate Reduction with Ivabradine
in Chronic Heart Failure
Rational & objective
• The results of the SHIFT study showed that the addition of ivabradine to
guideline-based treatment significantly reduced the primary end point of
cardiovascular death and hospitalization for heart failure with an excellent safety
profile.1
• To complete the safety assessment, it was investigated whether specific heart
rate lowering with ivabradine was associated with effects on the heart rhythm
safety profile; this was explored over a 24-hour period in a prespecified ECG
Holter ancillary study of the SHIFT study.2
1- Swedberg K, Komajda M, Böhm M, et al. Ivabradine and outcomes in chronic heart failure (SHIFT): a randomised placebo-controlled study. Lancet. 2010;376:875-885. 2 - Camm. J, et al. On Behalf of The SHIFT Gothenburg, Cardiac safety of selective heart rate reduction with Ivabradine in chronic heart failure. Poster, Heart Failure Congress. 2011 May.
ECG-Holter
Holter ECG analysis was performed at baseline and after 8 months
Run-in7 to 30 days
D014D014 D028D028ASSEASSE
HR and tolerabilityIvabradine 5 mg, bid
Matching placebo, bid
Run-in7 to 30 days
D014D014 D028D028ASSEASSE
Ivabradine 2.5, 5 or 7.5 mg bid according to
M008
Holter ECG
D000
Holter ECG
M004
ECG-Holter
Heart rate reduction with ivabradine compared with placebo at baseline and at month
Heart rate reduction with ivabradine tends to be greater during the waking hours than at night
24-hour heart rate control with ivabradine
ECG-Holter
Heart rate reduction with ivabradine at night and during the day, at month 8 compared with baseline
Camm J et al. Eur of HF supplements 2011; 10(51), S134; abstract P797
Ivabradine offers good cardiac safety
Table I. Results from ambulatory 24-hour electrocardiographic Holter monitoring after 8 months of treatment.
ECG-Holter
Camm J et al. Eur of HF supplements 2011; 10(51), S134; abstract P797
Conclusion
• The electrocardiographic safety profile of ivabradine in chronic heart
failure patients treated with recommended therapy, including β-blockers
is confirmed.
Ivabradine provides effective heart rate reduction over 24
hours with good cardiac safety.
• Those results are reassuring with respect to use of ivabradine in clinical
practice and complement the wide cardiac safety assessment of
ivabradine.