Procoralan ivabradine: Phase III data

In the double-blind, international Phase III SHIFT trial in 6,558 patients with moderate to severe CHF, poor left-ventricular ejection function and a heart rate >=70 bpm, Procoralan met the composite primary endpoint of significantly reducing the incidence of CV death or hospital admission for worsening heart failure vs. placebo at a median follow-up of 23 months (24% vs. 29%, p<0.0001). Additionally, Procoralan significantly reduced hospital admissions for worsening heart failure (16% vs. 21%, p<0.0001) and deaths due to heart failure vs. placebo (3% vs. 5%, p=0.014).

A significantly greater proportion of patients treated with Procoralan had increased symptomatic bradycardia (5% vs. 1%, p<0.0001) and visual side effects vs. placebo (3% vs. 1%, p<0.0001). Patients received up to 7.5 mg twice-daily Procoralan or placebo in addition to their standard CHF therapy. Data were presented at the European Society of Cardiology meeting in Stockholm and published in The Lancet. ...