Doubts over landmark heart drug trial: ticagrelor PLATO study
www.bmj.com
Jan. 26, 2025, 3:26 p.m.
When AstraZeneca developed ticagrelor in the mid-to-late 2000s, it needed to demonstrate a clear advantage over clopidogrel (Plavix), then one of the world’s best selling prescription drugs that was nearing patent expiration. The results of PLATO, a 18 624 patient randomised trial conducted across 43 countries, appeared set to actualise those hopes. PLATO investigators, writing in 2009 in the New England Journal of Medicine (NEJM), reported that at 12 months, patients assigned to ticagrelor compared with clopidogrel saw a reduction in risk of the primary endpoint—death from vascular causes, myocardial infarction, or stroke—from 11.7% to 9.8%, a 16% decrease in relative risk.Despite the results, however, the company’s first bid for FDA approval failed. A subgroup analysis found that, in the US, ticagrelor patients had poorer outcomes than those randomised to clopidogrel—a 27% higher risk of the primary endpoint.