AusPAR: Ivabradine - Therapeutic Goods Administration

AusPAR Coralan Ivabradine Servier Laboratories (Australia) Pty Ltd PM-2010-03269-3-3
Final 31 October 2012
Therapeutic Goods Administration
(asymptomatic and symptomatic) or arrhythmias in this subgroup and hence assist in
determining the profile of CHF patient population for which ivabradine should be
indicated in terms of concomitant use of beta blockers.
Evaluator’s overall conclusions on clinical safety
Overall, the incidence of TEAEs and SAEs was comparable between the 2 treatment
groups. However, the incidences of treatment-related TEAEs and treatment-related SAEs
were higher in the ivabradine group than in the placebo group (17.8% versus 8.3% and
2.0% versus 1.3%, respectively) (Table 17).
Table 17. Overall summary of safety results. All clinical events on treatment (Safety Set)
The most commonly occurring treatment-related TEAEs in the ivabradine group were
known adverse effects of ivabradine stated in the currently approved PI.
In the section on SAEs in the proposed PI, it is stated that “the most frequently reported
SAEs with ivabradine were Cardiac disorders, where the only SAE reported with a ≥1%
incidence was unstable angina (1.5%)”. Results in the SHIFT study showed that the most
frequently reported treatment-related SAEs by SOC in the ivabradine group was also
cardiac disorders (1.7% versus 0.6% in the ivabradine and placebo groups, respectively).
All treatment-related SAEs by preferred term occurred at an incidence rate of < 0.5%, the
commonest being cardiac failure (0.4% versus 0.3% in the ivabradine and placebo groups,
respectively), symptomatic bradycardia (0.4% versus