Questions are being raised about the PLATO study that launched the antiplatelet drug ticagrelor worldwide. A new investigation by Peter Doshi raised concerns about data inconsistencies and omissions in the 2009 trial originally published in The New England Journal of Medicine. AstraZeneca’s failed bid for FDA approval highlighted discrepancies in the effectiveness of ticagrelor compared to other inhibitors. The US Department of Justice investigated the trial, but no action was taken. Critics believe that there may have been data manipulation in the trial. Recommendations for ticagrelor may need to be revisited based on newer, disappointing postlicensure studies.
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