CV deaths spark TGA drug review

The European Medicines Agency (EMA) announced a review of the drug earlier this month after preliminary findings from the SIGNIFY clinical trial revealed a small, but significant increase, in the combined risk of cardiovascular death and non-fatal MI in a subgroup of patients.

The trial, which recruited 19,000 patients worldwide, including 116 patients in Australia, was evaluating the efficacy of ivabradine in preventing cardiovascular events in patients with coronary heart disease without heart failure.

On top of their usual