Main results of the SHIfT study

In the SHIFT study, ivabradine significantly reduced the risk of the primary composite endpoint of hospitalization for worsening heart failure or cardiovascular death by 18% (P<0.0001) compared with placebo (Figure 1). These benefits were observed after 3 months of treatment.

Figure 1: Effect of ivabradine on the primary composite endpoint

SHIFT also showed that administration of ivabradine to heart failure patients significantly reduced the risk of death from heart failure by 26% (P=0.014) (Figure 2) and hospitalization for heart failure by 26% (P<0.0001).

Figure 2: Effect of ivabradine on death and hospitalization for heart failure

The improvements in outcomes were observed throughout all prespecified subgroups: female and male, with or without beta-blockers at randomization, patients below and over 65 years of age, with heart failure of ischemic or non-ischemic etiology, NYHA class II or class III, IV, with or without diabetes, and with or without hypertension (Figure 3).

Figure 3: Effect of treatment on primary composite endpoint in prespecified subgroups

SHIFT was conducted in 677 centers in 37 countries and included 6505 heart failure patients for a median duration of 22.9 months and up to 41.7 months.

SHIFT is the largest morbidity-mortality study of treatment for heart failure. Adding ivabradine, the specific heart rate-lowering agent, to standard therapies (Figure 4) significantly improved morbidity and mortality in heart failure patients with a low ejection fraction and heart rate ≥70 bpm, and in sinus rhythm. The benefit of ivabradine in these patients is such that only 26 patients need to be treated for 1 year in order to avoid one primary event (cardiovascular death or hospitalization for worsening heart failure).

Figure 4: Treatment at randomization

Ivabradine was safe and well tolerated with serious adverse events occurring more frequently in the placebo group than in the ivabradine group. Over 75% of patients achieved the target dose of 7.5 mg twice daily.

The SHIFT study has answered important unmet scientific and medical needs: (1) heart rate is indeed a risk factor in heart failure patiens; and (2) 20 years after angiotensin-converting enzyme inhibitors and 10 years after beta-blockers, healthcare practitioners have a new treatment – ivabradine – to reduce the risk of mortality and morbidity in heart failure patients.

Reference: Swedberg K, et al. Lancet. 2010;DOI:10.1016/S0140-6736(10)61198-1

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