Heart patients taking AstraZeneca Plc (AZN)’s Brilinta blood-thinner and more than 300 milligrams of aspirin fared worse than those taking Sanofi and Bristol-Myers Squibb Co. (BMY)’s Plavix, according to a new analysis of a study.
When taken with lower doses of aspirin, Brilinta beat Plavix in preventing heart attacks, strokes and early death, according to the research presented today at the Dallas-based American Heart Association’s Emerging Science Series seminar. The analysis found no systematic errors in the analyzed trial, called Plato.
The U.S. Food and Drug Administration in December asked for additional analysis of Plato, which compared Brilinta, also known as ticagrelor, with Plavix. Brilinta won the backing of an FDA advisory panel on July 28. All committee members had expressed concern that study participants in the U.S. and Canada did worse on Brilinta than people in other parts of the world. Many North American patients were also receiving high-dose aspirin, AstraZeneca said.
“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,” said the researchers, led by Kenneth Mahaffey of the Duke Clinical Research Institute in Durham, North Carolina, in the study’s abstract.
No definite biological rationale explains the finding, the researchers said. U.S. patients in the study had a lower rate of drug compliance and a higher rate of discontinuation than in other parts of the world, they found.
The medicine, which won European approval last year to be sold as Brilique, is still under FDA review. The regulator is expected to make a decision on the pill by July 20.
Brilinta may generate $1.17 billion by 2014, according to the average estimate of 12 analysts surveyed by Bloomberg. AstraZeneca, the U.K.’s second-biggest drugmaker, needs new products as patents expire on its three best-selling medicines, which generated a combined $16 billion in revenue last year.
To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
http://www.bloomberg.com/news/2011-06-27/astrazeneca-s-brilinta-worse-with-high-dose-aspirin-in-analysis.html
When taken with lower doses of aspirin, Brilinta beat Plavix in preventing heart attacks, strokes and early death, according to the research presented today at the Dallas-based American Heart Association’s Emerging Science Series seminar. The analysis found no systematic errors in the analyzed trial, called Plato.
The U.S. Food and Drug Administration in December asked for additional analysis of Plato, which compared Brilinta, also known as ticagrelor, with Plavix. Brilinta won the backing of an FDA advisory panel on July 28. All committee members had expressed concern that study participants in the U.S. and Canada did worse on Brilinta than people in other parts of the world. Many North American patients were also receiving high-dose aspirin, AstraZeneca said.
“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,” said the researchers, led by Kenneth Mahaffey of the Duke Clinical Research Institute in Durham, North Carolina, in the study’s abstract.
No definite biological rationale explains the finding, the researchers said. U.S. patients in the study had a lower rate of drug compliance and a higher rate of discontinuation than in other parts of the world, they found.
The medicine, which won European approval last year to be sold as Brilique, is still under FDA review. The regulator is expected to make a decision on the pill by July 20.
Brilinta may generate $1.17 billion by 2014, according to the average estimate of 12 analysts surveyed by Bloomberg. AstraZeneca, the U.K.’s second-biggest drugmaker, needs new products as patents expire on its three best-selling medicines, which generated a combined $16 billion in revenue last year.
To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
http://www.bloomberg.com/news/2011-06-27/astrazeneca-s-brilinta-worse-with-high-dose-aspirin-in-analysis.html
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