MedWire News: The US Food and Drug Administration (FDA) has approved the use of ticagrelor in patients with acute coronary syndromes (ACS).
The approval comes after the FDA twice postponed a decision on the drug (US brand name Brilinta), reportedly because of a discrepancy found in the treatment effect between geographic regions in the Platelet Inhibition and Patient Outcomes (PLATO) trial, published in 2009.
As reported previously by MedWire News, this trial found that the benefit of ticagrelor compared with clopidogrel did not reach significance in North American patients.
Further analysis of PLATO, conducted by Kenneth Mahaffey (Duke Clinical Research Institute, Durham, North Carolina, USA) and colleagues, revealed that a higher proportion of US patients took concomitant high-dose aspirin (median ≥300 mg/day), at 53.6%, than did patients elsewhere, at 1.7%.
They concluded that the discrepancy observed in the PLATO trial was caused by high doses of concomitant aspirin, and consequently recommended that ticagrelor be used in combination with low-dose aspirin to achieve favorable outcomes.
Accordingly, the FDA's approval of ticagrelor is accompanied by a boxed warning stating that aspirin doses above 100 mg per day decrease the medication's effectiveness.
In a press statement, Norman Stockbridge (FDA's Center for Drug Evaluation and Research) explained: "In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75-150 mg once daily."
Health Canada, which recently approved ticagrelor for the Canadian market, has also specified that the drug is to be co-administered with aspirin 75-150 mg/day.
The FDA has announced that ticagrelor will be dispensed to patients with an accompanying medication guide, which contains information on its side-effects and the risk of using high-dose aspirin with the drug.
MedWire (www.medwire-news.md) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2011
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