A new analysis of the PLATO trial presented at the American Heart Association’s Emerging Science Series seminar suggests that patients who took AstraZeneca’s Brilinta (ticagrelor) with low-dose aspirin were 16-percent less likely to have a heart attack or stroke, or to die within a year than those who took Sanofi and Bristol-Myers Squibb’s Plavix (clopidogrel) with low-dose aspirin.
However, patients who took Brilinta with a higher dose of aspirin of more than 300 milligrams had worse outcomes than those who took Plavix in combination with high-dose aspirin.
In July, an FDA panel voted 7-1 in favour of approving Brilinta for patients undergoing angioplasty or stenting procedures, but raised some concerns about data suggesting that study participants in the US and Canada did worse on Brilinta than people in other parts of the world.
Mahaffey noted that "while the regional interaction could arise from chance alone, two independently performed analyses identified a statistical interaction with aspirin maintenance dose that may explain the regional difference," adding that no definite biological rationale explains the finding.
The FDA is expected to make a decision on Brilinta by July 20, after extending the review process several times. Analysts suggest that if approved, the drug could generate $1.17 billion by 2014.