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SHIFT data reveal key improvements with ivabradine
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Patients with chronic HF who were treated with ivabradine had improved quality of life at 2 years and lowered heart rate at 8 months, according to results from two substudies of the SHIFT trial presented at the Heart Failure Congress 2011.
In the quality-of-life substudy, patients with chronic HF (n=1,944) were randomly assigned to either ivabradine (Procoralan, Servier; n=968) or placebo (n=976). The Kansas City Cardiomyopathy Questionnaire (KCCQ) score was determined at baseline and at 4, 12 and 24 months after randomization.
Researchers found that the difference in KCCQ overall summary score — which included clinical summary score and quality of life — for surviving patients from baseline to last assessment was nearly two times greater in the ivabradine arm (5.3 vs. 3; P<.001). Although both arms reported decreases in overall summary score when researchers included death, the least reduction was found in the ivabradine group (–2.8 vs. –6.4; P=.004).
Similar but less significant results were also reported when researchers looked at clinical summary score alone for both scores including (P=.012) or not including (P=.015) death.
“In patients with HF and systolic dysfunction who are in sinus rhythm with HR >70 bpm, heart rate reduction with ivabradine was associated with improved health-related quality of life,” Inger Ekman, PhD, study investigator and director, University of Gothenburg Centre for Person-Centred Care (GPCC), Gothenburg, Sweden, said in her presentation. “This … benefit was seen in addition to reduction in the primary endpoint of CV death or hospitalization for worsening HF.”
Also presented at the Heart Failure Congress was the SHIFT ECG-Holter substudy, which looked at 501 patients of SHIFT to better understand the heart rhythm safety profile of ivabradine. All patients were given optimized HF therapy and ivabradine (n=254) or placebo (n=247).
At 8 months, 24-hour heart rate was significantly reduced in the ivabradine arm compared with placebo (P<.0001), and higher rates of at least one episode of heart rate less than 40 bpm were also reported in the ivabradine group (P<.0001). However, rates of atrial fibrillation were slightly higher in the ivabradine group (2.4% vs. 2%), whereas rates of second- or high-degree atrioventricular block were higher with those taking placebo (3.6% vs. 1.6%).
Previous Cardiology Today coverage of the SHIFT trial can be viewed here.
For more information:
- Camm J. Abstract P797. Presented at: Heart Failure Congress 2011; May 21-24, 2011; Gothenburg, Sweden.
- Ekman I. LBCT I. Presented at: Heart Failure Congress 2011; May 21-24, 2011; Gothenburg, Sweden.
Disclosure: Dr. Ekman reports acting as a consultant for Servier.
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