title: Ticagrelor vs. clopidogrel in Japanese, Korean and Taiwanese patients with acute coronary syndrome -- randomized, double-blind, phase III PHILO study.
abstract: BACKGROUND
  Few data on the relative efficacy and safety of new P2Y12inhibitors such as prasugrel and ticagrelor in Japanese, Taiwanese and South Korean patients with acute coronary syndromes (ACS) exist.
  
  
  RESULTS
  The multicenter, double-blind, randomized PHILO trial compared the safety and efficacy of ticagrelor vs. clopidogrel in 801 patients with ACS (Japanese, n=721; Taiwanese, n=35; South Korean, n=44; unknown ethnicity, n=1). All were planned to undergo percutaneous coronary intervention and randomized within 24 h of symptom onset. Primary safety and efficacy endpoints were time to first occurrence of any major bleeding event and to any event from the composite of myocardial infarction, stroke or death from vascular causes, respectively.At 12 months, overall major bleeding occurred in 10.3% of ticagrelor-treated patients and in 6.8% of clopidogrel-treated patients (hazard ratio (HR), 1.54; 95% confidence interval (CI): 0.94-2.53); the composite primary efficacy endpoint occurred in 9.0% and in 6.3% of ticagrelor- and clopidogrel-treated patients, respectively (HR, 1.47; 95% CI: 0.88-2.44). For both analyses, the difference between groups was not statistically significant.
  
  
  CONCLUSIONS
  In ACS patients from Japan, Taiwan and South Korea, event rates of primary safety and efficacy endpoints were higher, albeit not significantly, in ticagrelor-treated patients compared with clopidogrel-treated patients. This observation could be explained by the small sample size, imbalance in clinical characteristics and low number of events in the PHILO population.
authors.affiliation: Department of Medicine (Cardiology), Tokai University School of Medicine.
authors.forename: Shinya
authors.initials: S
authors.lastname: Goto
authors.forename: Chien-Hua
authors.initials: CH
authors.lastname: Huang
authors.forename: Seung-Jung
authors.initials: SJ
authors.lastname: Park
authors.forename: Håkan
authors.initials: H
authors.lastname: Emanuelsson
authors.forename: Takeshi
authors.initials: T
authors.lastname: Kimura
mesh_terms: D054058:Acute Coronary Syndrome / Q000097:blood / Q000175:diagnosis / Q000208:ethnology / Q000401:mortality / Q000628:therapy*; D000241:Adenosine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D000368:Aged; D044466:Asian People; D000077144:Clopidogrel; D004311:Double-Blind Method; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000401:mortality; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D010979:Platelet Function Tests; D056910:Republic of Korea; D012307:Risk Factors; D020521:Stroke / Q000209:etiology; D013624:Taiwan; D000077486:Ticagrelor; D013988:Ticlopidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D010975:Platelet Aggregation Inhibitors; D000077144:Clopidogrel; D000077486:Ticagrelor; D000241:Adenosine; D013988:Ticlopidine