Investigation Uncovers Data Inaccuracies in Key Studies of Heart Medication Ticagrelor

Recent investigations by The BMJ have raised serious concerns regarding the integrity of pivotal studies that supported the approval of the popular antiplatelet drug ticagrelor (Brilinta/Brilique). This drug, widely recommended for patients suffering from acute coronary syndrome—a condition marked by sudden and reduced blood flow to the heart—has recently come under scrutiny for inaccuracies in its foundational clinical trials.

Ticagrelor has been a mainstay in emergency heart care for over ten years, following its approval based largely on the landmark PLATO trial. However, a follow-up inquiry revealed significant issues with data reporting in two crucial platelet studies that AstraZeneca cited to explain the drug’s efficacy. Specifically, the primary endpoint results presented in the journal Circulation were found to be inaccurate, and over 60 of 282 readings from platelet analysis machines were missing from the FDA datasets, calling into question the validity of the trial outcomes.

Complicating the matter, some investigators involved in these studies were either unreachable, declined interviews, or in one case, an investigator never listed as a study author despite active participation. Critic Victor Serebruany emphasized the potential risks, noting that fluctuations in platelet activity following ticagrelor use could lead to serious complications like thrombosis or bleeding—risks that could have been better understood had the data been transparently reported.

AstraZeneca and the Circulation journal have yet to respond to requests for comment. These revelations have reignited concerns about the robustness of the evidence supporting ticagrelor’s widespread use and cast doubt on the oversight processes of regulatory agencies.

As generic versions of ticagrelor are prepared for launch, the medical community faces the challenge of reassessing the drug’s safety and efficacy profile, underscoring the importance of data transparency in clinical research. The ongoing controversy highlights the need for rigorous scrutiny and verification in the approval of medications that affect millions of lives.

For additional information, refer to the article: Ticagrelor doubts: inaccuracies uncovered in key studies for AstraZeneca's billion-dollar drug, The BMJ (2025). [DOI: 10.1136/bmj.r1201]

Source: https://medicalxpress.com/news/2025-06-inaccuracies-key-blockbuster-heart-drug.html