INDIANAPOLIS and TOKYO, Aug. 26,
2012 /PRNewswire/ -- Daiichi Sankyo Company, Limited
(TSE: 4568) and Eli Lilly and Company (NYSE: LLY) today announced
data from the TRILOGY ACS study, a phase III trial comparing
prasugrel plus aspirin to clopidogrel plus aspirin in patients with
unstable angina (UA) or non-ST elevation myocardial infarction
(NSTEMI), who were managed medically without an artery-opening
procedure. At 30 months, 13.9 percent of prasugrel patients
vs. 16.0 percent of clopidogrel patients experienced the combined
primary endpoint of heart attack, stroke or cardiovascular (CV)
death in patients under 75 years of age, the primary analysis
population (HR=0.91; 95% CI: 0.79-1.05).(1) This outcome was not
statistically significant (P=0.21). Different from other
large-scale trials, TRILOGY ACS (TaRgeted platelet
Inhibition to cLarify the Optimal
strateGy to medicallY manage Acute
Coronary Syndromes) prospectively studied only the
UA/NSTEMI population medically managed without revascularization
(percutaneous coronary intervention (PCI) or coronary artery bypass
graft (CABG) surgery).(2) Results of this study were published in
the New England Journal of Medicine and also presented
during a late-breaking session at the ESC Congress 2012 (European
Society of Cardiology) in Munich,
Germany.
From a safety perspective, TRILOGY ACS showed that rates of TIMI
major bleeding events (including life-threatening or fatal bleeds)
did not differ significantly between the prasugrel plus aspirin and
clopidogrel plus aspirin treatment groups in patients less than 75
years of age or in the overall study population.(1) In patients
under age 75, non-CABG TIMI major bleeding occurred in 2.1 percent
of prasugrel patients versus 1.5 percent of clopidogrel patients
(HR=1.31, 95% CI: 0.81-2.11, P=0.27).(1) However, the rates of TIMI
major or minor bleeding were higher in patients treated with
prasugrel (3.3 percent of prasugrel patients versus 2.1 percent of
clopidogrel patients; HR=1.54; 95% CI: 1.06-2.23; P=0.02).(1)
"TRILOGY ACS was designed to evaluate dual oral antiplatelet
therapy in UA/NSTEMI patients who are managed medically without
revascularization," said E. Magnus
Ohman, M.D., Duke Clinical Research Institute and
Chairperson of the TRILOGY ACS trial. "While the study did not
demonstrate prasugrel was superior to clopidogrel in these
patients, TRILOGY ACS provided some additional observations in this
previously understudied population. The delayed treatment effect
beyond 12 months observed in TRILOGY ACS had not been seen in
earlier studies of shorter duration."
An analysis performed to account for multiple recurrent ischemic
events suggested a lower risk among participants
