camm j, et al. on behalf of the shift gothenburg, cardiac safety of selective heart rate reduction...
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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
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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
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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
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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
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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
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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.