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
Table 4. Incidence of the primary composite endpoint and components (secondary
endpoints) in the RS-BB-dose
Subgroup analysis of the primary composite endpoint in the RSBBdose population
showed an effect in favour of ivabradine in all the pre specified subgroups except for the
subgroup “age ≥ 65 years” where the hazard ratio was 1.04. In addition, the subgroup of
“males” showed a negligible effect in favour of ivabradine (hazard ratio of 0.99). All the
interaction tests had p-values higher than 0.05 except for the subgroup of gender, showing
that the effect of ivabradine was greater in females than in males in this analysis set (p =
0.0177).
The results of the main secondary efficacy outcomes in the RS population are tabulated in
Table 5. Secondary non-composite endpoints relating to mortality showed that there was
a 26% reduction in relative risk in deaths from heart failure and this was found to be
statistically significant (p = 0.014). There was a relative risk reduction of 10% in all-cause
mortality and 9% in cardiovascular mortality but the reductions were not statistically
significant (p= 0.092 and p= 0.128, respectively). Secondary non-composite endpoints
relating to hospitalisations showed statistically significant reduction in relative risks in the
ivabradine treatment group compared to the placebo group, for hospitalisations for
worsening heart failure, for all-cause hospitalisations and for cardiovascular
hospitalisation (relative risk reduction of 26% [p