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Medicina (B.Aires) ; 74(3): 239-244, jun. 2014.
Article in Spanish | LILACS, BINACIS | ID: biblio-1165182

ABSTRACT

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.


Subject(s)
Humans , Adenosine/analogs & derivatives , Clinical Trials as Topic/ethics , Publication Bias , United States , United States Food and Drug Administration , Financial Support/ethics , Adenosine/therapeutic use , Risk Factors , Conflict of Interest/economics , Treatment Outcome , Evidence-Based Medicine/ethics , Acute Coronary Syndrome/drug therapy , Ticagrelor
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