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 2. Estimate of treatment effect on primary composite endpoint in the RS -Sensitivity
and prognostic factors analyses
Kaplan-Meier survival curves showed a divergence between the treatment groups in
favour of ivabradine by approximately 3 months after randomisation (Figure 4).
Figure 4. Kaplan-Meier survival graphs for the primary composite endpoint, RS population
Results for other efficacy outcomes
Sensitivity and prognostic factors analyses on primary composite endpoint in the RS
population were analysed. The sensitivity analysis tested the superiority of ivabradine
over placebo using an unadjusted Cox proportional hazards model (in contrast with the
main primary efficacy analysis, where the primary endpoint was analysed using Cox
proportional hazards model that was adjusted for beta blocker intake at randomisation).
The results yielded the same estimates of the hazard ratio (95% CI) of 0.82 (0.75, 0.90) as
the main analysis, with a same p-value of < 0.0001.
The prognostic factors analysis consisted of a superiority test based on a Cox proportional
hazards model adjusted for the prognostic factors of beta blocker intake at randomisation,
NYHA class, LVEF, aetiology of CHF, age, systolic blood pressure, heart rate and estimated
glomerular filtration rate. The treatment effect observed in the prognostic factors analysis
was similar to that observed in the main analysis, with an estimate of hazard ratio (95%
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