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.