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In a follow-up investigation into the multibillion-dollar drug ticagrelor, The BMJ has uncovered contemporary considerations, this time in key platelet research utilized in its FDA approval.
For greater than a decade, ticagrelor (Brilinta within the US and Brilique in Europe) has been beneficial for sufferers with acute coronary syndrome—a variety of circumstances associated to sudden decreased blood circulate to the guts.
Final December, an investigation by The BMJ discovered severe information integrity issues within the landmark medical trial (PLATO) that was used to achieve worldwide approval for ticagrelor, calling into query the drug’s benefit over cheaper rivals.
Now, as generic variations of the drug put together to launch this 12 months, The BMJ has expanded its investigation, taking a look at two key platelet research that AstraZeneca claimed defined ticagrelor’s skill to deal with acute coronary syndrome efficiently.
It finds that the “primary endpoint” outcomes (the trial’s key measurement) for each medical trials had been inaccurately reported within the journal Circulation, and divulges that greater than 60 of 282 readings from platelet machines used within the trials weren’t current within the US Meals and Drug Administration (FDA) datasets.
What’s extra, one lively trial investigator by no means turned a research creator, whereas one creator advised The BMJ he was not concerned within the trial, and most investigators, together with the principal investigator, had been unreachable or declined to be interviewed.
Victor Serebruany, an adjunct college member at Johns Hopkins College and ticagrelor’s most famed critic, advised The BMJ that “there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor, making patients prone to thrombosis or bleeding. If doctors had known what happened in these trials, they would never have started using ticagrelor.”
Circulation and AstraZeneca didn’t reply to a request for remark.
Serebruany added, “It’s been obvious for years that there is something wrong with the data. That the FDA’s leadership could look past all these problems—on top of the many problems their own reviewers identified and are now being discovered by The BMJ—is unconscionable. We all need to know how and why that happened.”
Extra info:
Ticagrelor doubts: inaccuracies uncovered in key research for AstraZeneca’s billion greenback drug, The BMJ (2025). DOI: 10.1136/bmj.r1201
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Inaccuracies present in key research for blockbuster coronary heart drug ticagrelor (2025, June 19)
retrieved 19 June 2025
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