FDA to investigate PLATO trial for Brilinta

The U.S. Justice Department's civil division is to investigate the PLATO study related to Brilinta/Brilique (ticagrelor) from AstraZeneca, requesting documents and information on the study. The PLATO study has been subjected to criticism from James DiNicolantonio, Pharm.D., and Dr. Ales Tomek, of Charles University in Prague. They raised serious questions about the study results in a report published in the International Journal of Cardiology. They reported concerns that study results reviewed by an independent CRO demonstrated a worse outcome for ticagrelor than the clopidogrel arm compared to the positive results reported by the investigators. They also reported that almost half of the favourable results for Brilinta were drawn from just two Eastern European countries, Hungary and Poland.

Reporting on cardiovascular events appeared to favour Brilinta and "an estimated 23 definite or possible cardiovascular events or deaths on ticagrelor (Brilinta) were either not submitted for adjudication, inactivated, deleted or were downgraded to 'softer' endpoints ."

Lars Wallentin ,lead investigator of the PLATO trial responded that " unfortunately, DiNicolantonio and Victor Serebruany, M.D., Ph.D., a co-author one of the papers report selected data derived from various sources using improper statistics. The data provided in the commentary are a biased selection of an extensively peer-reviewed and published series of articles".