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New investigation questions AstraZeneca's ticagrelor approval, citing discrepancies in key trial data.
A new investigation by The BMJ raises concerns about the clinical trial that approved AstraZeneca's anti-platelet drug ticagrelor.
Despite the 2009 PLATO trial showing ticagrelor reduced deaths from vascular causes compared to clopidogrel, the FDA approved it over objections from its own medical officer.
Since approval, other studies failed to replicate the PLATO results, and The BMJ found discrepancies in death reporting, questioning the drug's efficacy and approval process.
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Nueva investigación cuestiona la aprobación de ticagrelor de AstraZeneca, citando discrepancias en los datos clave de los ensayos.