In a follow-up investigation into the multibillion-dollar drug ticagrelor, The BMJ has uncovered recent issues, 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 situations associated to sudden decreased blood stream to the center.
Final December, an investigation by The BMJ discovered critical knowledge integrity issues within the landmark scientific 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 capacity to deal with acute coronary syndrome efficiently.
It finds that the “major endpoint” outcomes (the trial’s key measurement) for each scientific 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 grew to become a examine 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 sufferers susceptible to thrombosis or bleeding. If medical doctors had recognized what occurred in these trials, they’d by no means have began utilizing ticagrelor.”
Circulation and AstraZeneca didn’t reply to a request for remark.
Serebruany added, “It has been apparent for years that there’s something unsuitable with the information. That the FDA’s management might look previous all these issues—on prime of the numerous issues their very own reviewers recognized and at the moment are being found by The BMJ—is unconscionable. All of us must know the way and why that occurred.”
Extra data:
Ticagrelor doubts: inaccuracies uncovered in key research for AstraZeneca’s billion greenback drug, The BMJ (2025). DOI: 10.1136/bmj.r1201
Quotation:
Inaccuracies present in key research for blockbuster coronary heart drug ticagrelor (2025, June 19)
retrieved 20 June 2025
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