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 the ivabradine group compared to the placebo group (2.0% [66/3232], 1.2%PY versus1.3% [42/3260], 0.8%PY in the ivabradine and placebo groups, respectively). The most frequently reported treatment-related SAEs by SOC in both groups were Cardiac disorders (1.7%, 1.0%PY versus 0.6%, 0.4%PY, in the ivabradine and placebo groups, respectively) and Nervous system disorders (0.1%, < 0.1%PY versus 0.2%, 0.1%PY, respectively). Treatment-related SAEs in the other SOCs occurred at an incidence rate of ≤ 0.1% in either treatment group. Treatment-related SAEs (preferred term) that were reported by ≥ 5 patients in the ivabradine group (that is, an incidence rate of >0.1%) were cardiac failure (0.4% [12/3232], 0.2%PY versus 0.3% [8/3260], 0.2%PY in the ivabradine and placebo groups, respectively), symptomatic bradycardia (0.4% [12/3232], 0.2%PY versus
AusPAR Coralan Ivabradine Servier Laboratories (Australia) Pty Ltd PM-2010-03269-3-3 Final 31 October 2012 Therapeutic Goods Administration The sponsor had combined these two categories of treatment withdrawal (permanent, and temporary without restart) in the analysis of TEAEs that led to study drug discontinuation. Results showed that the incidence rate of study drug discontinuation was higher in the ivadrabine group compared to the placebo group (14.5% [467/3232] versus 12.8% [416/3260], respectively). The most frequently reported TEAEs leading to study drug discontinuation in the ivabradine group (by SOC) were Cardiac disorders (9.4%, 5.6%PY versus 8.3%, 4.9%PY in the ivabradine and placebo groups, respectively) and Investigations (1.1%, 0.6%PY versus 0.3%, 0.2%PY, respectively). Within the SOC of Cardiac disorders, the commonest TEAEs (by preferred term) leading to study drug discontinuation in the ivabradine group were atrial fibrillation (4.2%, 2.5%PY versus 3.5%, 2.1%PY, respectively), cardiac failures (2.0%, 1.2%PY versus 2.4%, 1.4%PY, respectively) and symptomatic bradycardia (0.6%, 0.4%PY versus 0.2%, 0.1%PY, respectively). Within the SOC of investigations, the commonest TEAE (by preferred term) leading to study drug discontinuation in the ivabradine group was asymptomatic bradycardia (HR decreased) (0.9%, 0.5%PY versus 0.2%, 0.1%PY, respectively). Other studies Not applicable. Laboratory tests Liver function Pivotal study There were no clinically significant changes or differences between groups over time in the liver function tests (only AST and ALT were assessed in this study). Other studies Not applicable. Kidney function Pivotal study There were no clinically significant changes or differences between groups over time in the kidney function tests (only sodium, potassium and creatinine were assessed in this study). Other studies Not applicable. Other clinical chemistry Pivotal study There were no clinically significant changes or differences between groups over time in the total cholesterol and LDL-cholesterol levels. Other studies Not applicable. Haematology Pivotal study There were no clinically significant changes or differences between groups over time in the haematology tests. Page 43 of 101
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 and 28: 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: 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
Page 85 and 86: Risk management plan AusPAR Coralan
Page 93 and 94:
AusPAR Coralan Ivabradine Servier L
Page 95 and 96:
Table 35 AusPAR Coralan Ivabradine
Page 97 and 98:
Page 99 and 100:
Page 101:
Therapeutic Goods Administration PO
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