FDA approves ticagrelor for use in ACS

The FDA has announced the approval of ticagrelor for the reduction of MI and CV death in patients with acute coronary syndromes, according to a press release.

FDA officials noted that the adenosine diphosphate receptor antagonist ticagrelor (Brilinta, Astra Zeneca) was more effective than clopidogrel (Plavix, Sanofi Aventis/Bristol-Meyers Squibb) in the prevention of MI and CV death in patients with ACS. The drug’s efficacy, however, diminished when used with doses of aspirin above 100 mg/d.

“In clinical trials, [ticagrelor] was more effective at preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses 75 mg to 100 mg once daily,” Norman Stockbridge, MD, PhD, director of the division of CV and Renal Products in the Center for Drug Evaluation and Research at FDA, said in the press release.

Box warnings that accompany the approval indicate that blood-thinners such as ticagrelor are associated with increased bleeding rates — and occasionally fatal bleeding — particularly if used with higher doses of aspirin.

The drug was also approved with a Risk Evaluation and Mitigation Strategy to be implemented by the manufacturer that includes educational outreach to physicians regarding the risks of using ticagrelor with higher doses of aspirin, as well as patient medication guides that would be distributed at each medication refill.

This is a major advance in the treatment of acute coronary syndromes. The reduction in CV mortality seen in the overall PLATO trial results is impressive given that ticagrelor went head-to-head against clopidogrel, which itself has substantial efficacy versus placebo.

– Deepak L. Bhatt, MD

Cardiology Today Editorial Board member

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