title: [Ticagrelor in acute coronary syndrome. Explaining the inexplicable].
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.
authors.affiliation: Servicio de Clínica Médica, Hospital Alemán, Buenos Aires, Argentina. E-mail: jmcriniti@gmail.com.
authors.forename: Juan Martín
authors.initials: JM
authors.lastname: Criniti
authors.forename: Ariel
authors.initials: A
authors.lastname: Izcovich
authors.forename: Federico
authors.initials: F
authors.lastname: Popoff
authors.forename: Juan Ignacio
authors.initials: JI
authors.lastname: Ruiz
authors.forename: Hugo N
authors.initials: HN
authors.lastname: Catalano
mesh_terms: D054058:Acute Coronary Syndrome / Q000188:drug therapy*; D000241:Adenosine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000941:ethics*; D016265:Conflict of Interest / Q000191:economics; D019317:Evidence-Based Medicine / Q000941:ethics; D005378:Financial Support / Q000941:ethics; D006801:Humans; D017594:Publication Bias; D012307:Risk Factors; D000077486:Ticagrelor; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000077486:Ticagrelor; D000241:Adenosine
keywords: PLATO; acute coronary syndrome; ticagrelor