Heart drug scrutiny after rise in mortality risk
Last week the European Medicines Agency (EMA) announced a review of the drug 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 treatment, patients received up to 10mg ivabradine twice daily, which is higher than the approved maximum daily dose of 7.5mg twice daily.
However, preliminary results found an increased risk of cardiovascular death or non-fatal MI with the medicine in the subgroup of patients who had symptomatic angina.
A spokesperson for the