Ticagrelor: Study Flaws & Heart Drug Concerns

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STEP 1: ANALYSIS

primarykeywords: ticagrelor, Brilinta, heart drug, platelet studies, data integrity, acute coronary syndrome
audience: Healthcare professionals, medical researchers, patients with heart conditions, investors in pharmaceutical companies
tone: Investigative, critical, factual, concerned
datelinelocation: WASHINGTON
evergreenbackgroundtopics: drug safety, clinical trials, FDA approval process, pharmaceutical regulation
originalbrandterms: medicalxpress.com, British Medical Journal, BMJ

STEP 2: REWRITE & OPTIMISE

WASHINGTON – A new investigation has raised concerns about the accuracy of key platelet studies used in the approval of the blockbuster drug ticagrelor,a medication generating billions in revenue.

ticagrelor (marketed as Brilinta in the US and Brilique in Europe) has been widely prescribed for over a decade too patients suffering from acute coronary syndrome, a condition characterized by reduced blood flow to the heart.

The investigation follows previous reporting that revealed critically important data integrity issues within the pivotal PLATO clinical trial, which supported ticagrelor’s global approval. These issues cast doubt on whether the drug offers a real advantage over less expensive alternatives.

As generic versions of ticagrelor are poised to enter the market, the probe focused on two key platelet studies cited by AstraZeneca to justify ticagrelor’s effectiveness in treating acute coronary syndrome.

The investigation revealed that the “primary endpoint” results, the core measurement of the clinical trials, were reported inaccurately in the journal Circulation. Furthermore, over 60 out of 282 readings from platelet analysis machines used in the trials were absent from the data submitted to the US Food and Drug Administration (FDA).

The investigation also found that one active trial investigator was not credited as a study author. Another author stated he had no involvement in the trial. Most investigators, including the principal investigator, could not be reached or declined to comment.

According to Victor Serebruany, an adjunct faculty member at Johns Hopkins University and a prominent critic of ticagrelor, “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, thay would never have started using ticagrelor.”

Neither Circulation nor AstraZeneca responded to requests for comment.

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.”