AusPAR: Ivabradine - Therapeutic Goods Administration

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AusPAR Coralan Ivabradine Servier Laboratories (Australia) Pty Ltd PM-2010-03269-3-3 Final 31 October 2012 Therapeutic Goods Administration reduction of 15% on which the sample size was calculated. However, when the components of the primary composite endpoint were analysed separately as secondary endpoints in the RS population, only the relative risk reduction for the endpoint of hospitalisation for worsening heart failure was statistically significant (26%, p
AusPAR Coralan Ivabradine Servier Laboratories (Australia) Pty Ltd PM-2010-03269-3-3 Final 31 October 2012 Therapeutic Goods Administration respectively). However, analyses of the 3 secondary endpoints relating to mortality (death from any cause, cardiovascular death and death from heart failure) in the RS population showed that there was a statistically significant relative risk reduction in the ivabradine group compared to the placebo group only in the disease-specific endpoint of death from heart failure (relative risk reductions of 26% [p=0.014]). Analyses of the 3 secondary endpoints relating to hospitalisation (hospitalisation for any cause, hospitalisation for cardiovascular reason, and hospitalisation for worsening heart failure) in the RSBBdose population showed that there were statistically significant relative risk reductions in the ivabradine group compared to the placebo group only in the disease-specific endpoints of hospitalisation for cardiovascular reason, and hospitalisation for worsening heart failure (relative risk reductions of 12% [p=0.0464], 19% [p=0.0211], respectively). Analyses of the 3 secondary endpoints relating to mortality (death from any cause, cardiovascular death, and death from heart failure) in the RSBBdose population showed that the differences between treatment groups in all 3 endpoints were not statistically significant. Subgroup analysis of the secondary endpoints relating to mortality (death from any cause, cardiovascular death and death from heart failure) in the RS population showed an effect in favour of ivabradine in all the pre specified subgroups except in the subgroup of “baseline HR
Page 1 and 2: Australian Public Assessment Report
Page 3 and 4: Contents AusPAR Coralan Ivabradine
Page 5 and 6: Product background AusPAR Coralan I
Page 7 and 8: AusPAR Coralan Ivabradine Servier L
Page 17 and 18: Table 1. Analysis Sets and Subsets
Page 25 and 26: Table 6. Causes of deaths by treatm
Page 27: Analyses performed across trials (p
Page 31 and 32: Table 10. (ii) Pre-specified subgro
Page 37 and 38: Patient exposure AusPAR Coralan Iva
Page 39 and 40: Treatment-related adverse events (a
Page 41 and 42: Table 15. Continued AusPAR Coralan
Page 49 and 50: Clinical summary and conclusions Fi
Page 63 and 64: Table 25. Incidence of TEAEs by age
Page 65 and 66: Second round benefit-risk assessmen
Page 67 and 68: Safety specification AusPAR Coralan
Page 69 and 70: CL3-067 (Follow up Measure; Ophthal
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AusPAR Coralan Ivabradine Servier L
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Risk management plan AusPAR Coralan
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Table 35 AusPAR Coralan Ivabradine
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Therapeutic Goods Administration PO
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AusPAR: Ivabradine - Therapeutic Goods Administration

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