The sponsor is asked to respond to the suggestion that the adverse event of ‘blood pressure inadequately controlled’ needs some discussion and clarification in the PI. See DO
The incidence rates and hazard ratio of the EAE ‘blood pressure inadequately controlled’ for patients in the ivabradine and placebo groups aged 65 years, 70 years, 75 years compared to the overall population demonstrates that the incidence rates do not consistently increase with increasing age in ivabradine patients (Table 33). The incidence rate in ivabradine treated patients aged 75 years was smaller (7.4%) compared to those aged 65 years (8.3%) and 70 years (8.3%), compared to the overall population (ivabradine 7.1%). Incidence between age groups is similar.
This EAE ‘blood pressure inadequately controlled’ will be included in the relevant table in the Adverse Event section of the PI however Servier believed that further discussion and clarification in the PI was unwarranted.
Table 33. Time to first emergent “blood pressure inadequate controlled” on treatment according to age. Estimate of treatment effect by age strata.
CI=confidence interval; HR=hazard ratio; N=number of patients in the sub group. N=number of patients with a least one EAE or SEAE in the considered sub group, % of patients with at least one TEAE or STEAE in the considered sub group.
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