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Medicina (B.Aires) ; 74(3): 239-244, jun. 2014.
Artículo en Español | LILACS, BINACIS | ID: biblio-1165182

RESUMEN

The PLATO study evaluated the efficacy of adding ticagrelor, instead of clopidogrel, to aspirin in patients with acute coronary syndrome, which showed surprisingly positive results making the drug acceptable to regulatory agencies and specialty societies worldwide. Notwithstanding the aforementioned success, contradictory information supplied by critical analysis was submitted by the sponsor. The controversial findings revealed several aspects that are difficult to explain, threatening the veracity of the study’s conclusions. Mortality rate pattern, excessive benefit not comparable to prior studies, unexplained loss of follow-up development and inconsistency in findings in accordance with the country, the type of events arbitrator and monitoring committee are some of the most questionable issues. Dubious reaction to this trial is based on the fact that the information could not be found in published articles. This complex situation poses a challenge to the critical analysis of the text and raises questions as to how far the conflicts of financial interest influenced the development of the study, the communication of its results and probably, acceptance of the drug for commercial use.


Asunto(s)
Humanos , Adenosina/análogos & derivados , Ensayos Clínicos como Asunto/ética , Sesgo de Publicación , Estados Unidos , United States Food and Drug Administration , Apoyo Financiero/ética , Adenosina/uso terapéutico , Factores de Riesgo , Conflicto de Intereses/economía , Resultado del Tratamiento , Medicina Basada en la Evidencia/ética , Síndrome Coronario Agudo/tratamiento farmacológico , Ticagrelor
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