US lawyers investigate trial that secured license for AstraZeneca’s antiplatelet drug

The US Department of Justice is investigating the UK drug company AstraZeneca over a clinical trial that was used to gain marketing approval for its antiplatelet drug ticagrelor (marketed in the United States as Brilinta and in the European Union as Brilique).

The US authorities have asked for documents and information about the Platelet Inhibition and Patient Outcomes (PLATO) trial, published in the New England Journal of Medicine in September 2009.1

This 18 000 participant trial, conducted in 43 countries, reported that ticagrelor with aspirin, when compared with clopidogrel with aspirin, significantly reduced the rate of a composite of deaths from vascular causes, myocardial infarction, or stroke (death rate 9.8% versus 11.7% (hazard ratio 0.84 (95% confidence interval 0.77 to 0.92)).

AstraZeneca said it …