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Efficacy and safety of ivabradine in chronic heart failure across the age spectrum : insights from the SHIFT study
Tavazzi, Luigi ...
Aims: To test whether the efficacy and safety of the selective heart rate-reducing agent ivabradine changes according to age in chronic heart failure (HF) patients. Methods and results: The ...ivabradine and placebo arms of SHIFT, which enrolled 6505 chronic HF patients, were combined and age distribution was divided by quartiles to give four groups (<53 years, n= 1522; 53 to<60 years, n=1521; 60 to<69 years, n=1750; and <69 years, n= 1712). The effects of ivabradine on cardiovascular outcomes, changes in heart rate, and adverse events, particularly bradycardia, were evaluated according to age group. A subgroup (602 patients) underwent 24 h ambulatory ECG Holter monitoring. The relative risk of the primary endpoint (cardiovascular death or hospitalization for worsening HF) was reduced by ivabradine in all age groups, ranging from 38% [hazard ratio (HR) 0.62,95% confidence interval (CI) 0.50-0.78, P<0.001] in the youngest patients <53 years to 16% (HR 0.84,95% CI 0.71-0.99, P=0.035) in the oldest patients >69 years. Ivabradine up-titration reduced heart rate similarly in all age groups, by 11 b.p.m. As anticipated, bradycardia and phosphenes occurred more frequently with ivabradine, at a similar rate whatever the age. In the Holter substudy, there were no episodes of severe bradycardia and no clinically relevant pauses with ivabradine in any age group. Conclusions: Age does not limit the appropriate use of ivabradine in patients with chronic HF and systolic dysfunction. The safety and efficacy of ivabradine are comparable across all age groups.
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