October 2012 Australian Public Assessment Report for Ivabradine Proprietary Product Name: Coralan Sponsor: Servier Laboratories
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In its pre-ACPM response, the sponsor is requested to provide a short summary of the safety in the sub-group of the study population with an LVEF of 20% or less, particularly with regard to the 4 TEAEs of interest (AF, asymptomatic bradycardia, symptomatic bradycardia and blood pressure inadequately controlled).In patients with LVEF 20% at baseline (N = 613), the incidence of emergent adverse events (EAEs) reported on treatment was similar in the ivabradine group (79.3%) and in the placebo group (79.6%). EAEs related to cardiac failure were less frequent with ivabradine (34.1%) than with placebo (38.2%). EAEs related to bradycardia were more frequent with ivabradine than with placebo: (asymptomatic: 5.4% versus 1.6% and symptomatic: 3.3% versus 0.3%), atrial fibrillation (9.4% versus 6.4%) and blood pressure inadequately controlled (3.7% versus 2.9%) were more frequent with ivabradine (Table 34). Table 34 
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