Excess of Solid Cancers After Prasugrel: The Food and Drug Administration Outlook

American Journal of Therapeutics
Victor L SerebruanyDerek Chew

Abstract

The TRITON-TIMI 38 was a head-to-head trial to assess the efficacy and safety of the experimental antiplatelet agent prasugrel versus standard care with clopidogrel on top of aspirin. Besides some early ischemic protection at the expense of growing over time overwhelming bleeding disadvantage, prasugrel-treated patients experienced significantly higher cancer rates. Recently, the Food and Drug Administration (FDA) issued a Prasugrel Second Review, a detailed 357-page document presenting realistic outlook on various aspects of the TRITON trial including distributions of different cancers between treatment arms. The comprehensive FDA analysis revealed that some preclinical but especially human data overwhelmingly indicate excessive cancer risks after prasugrel. Indeed, despite excellent baseline balance, prasugrel-treated patients experienced extra cancer-related deaths, 27% higher risks for new cancers occurrences, and 36.8% increase of new solid malignant cancers. The FDA report concluded that cancer risks after prasugrel are real, especially high in women, and after 4 months of therapy at least for solid highly metastatic cancers. These unexpected findings may be explained by disruption of tumor-platelet aggregates by chronic ...Continue Reading

Citations

Nov 16, 2013·PloS One·Yanhua WangJunling Liu
Sep 3, 2011·Cardiovascular Therapeutics·Joseph A JakubowskiDavid Erlinge
Oct 6, 2016·Expert Review of Cardiovascular Therapy·Ashan GunarathneAnthony H Gershlick
Sep 29, 2011·Journal of Environmental Science and Health. Part A, Toxic/hazardous Substances & Environmental Engineering·Bárbara RincónRafael Borja
Aug 2, 2018·Cancers·Annalisa BrunoPaola Patrignani

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