December 6, 2012 — Daiichi Sankyo Inc. and Eli Lilly and Co. announced results of two retrospective, observational comparative effectiveness studies of U.S. hospital data comparing rates of readmission for subsequent heart attack and initial hospitalization costs among patients with acute coronary syndromes (ACS) treated with a percutaneous coronary intervention (PCI) and antiplatelet therapy, including Effient (prasugrel) or Plavix (clopidogrel). The findings were presented at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation (CRF).
The first study evaluated the rate of re-hospitalization for acute myocardial infarction (AMI) and bleeding at both 30 and 90 days after discharge for ACS-PCI patients treated with Effient compared to Plavix. Based on a cohort of 83,567 ACS-PCI patients in the PREMIER database, Effient-treated patients (n=9,404) had a significantly lower adjusted rate of re-hospitalization for AMI than Plavix-treated patients (n=74,163) at 30 days (OR: 0.89; p=0.047) and 90 days (OR: 0.90; p= 0.037) following ACS-PCI discharge. The adjusted rates of bleeding-related re-hospitalization were not different between Effient- and Plavix-treated patients at 30 days (OR: 1.04; p=0.82) or 90 days (OR: 0.92; p=0.51) post-discharge. In the pivotal randomized control trial, TRITON-TIMI 38, the risk of serious bleeding was significantly higher with Effient versus Plavix (2.2 percent versus 1.7 percent, respectively).
The second study evaluated use of healthcare resources by Effient-treated ACS-PCI patients compared to Plavix-treated patients during index hospitalization (hospitalization that qualified the patients for entry into the study), as measured by hospital costs. Based on a cohort of 84,695 ACS-PCI patients in the PREMIER database, adjusted estimates of average hospitalization costs for patients receiving Plavix (n=75,224) or Effient (n=9,471) were $17,519 (±$2,548) and $17,139 (± $2,560) respectively – a cost savings of $380 (p<0.05) for Effient-treated patients during the index hospital stay. Results were consistent across subgroups by subtype of ACS (STEMI, NSTEMI and unstable angina).
“In the current healthcare environment, it is important to understand the comparative effectiveness of antiplatelet therapies on re-hospitalization rates for subsequent events, such as heart attacks, and index hospitalization costs associated with their use in the real-world setting,” said lead study investigator Jay P. Bae, Ph.D., health economist, Health Outcomes Research, Global Health Outcomes, Eli Lilly and Co. “The findings of these studies expand on data from clinical studies and previous health outcomes research.”
The studies were conducted using the PREMIER Perspective Database, a large U.S. database of drug utilization and other aggregate hospital data on more than 45 million inpatient discharges and 210 million hospital outpatient visits from U.S. acute care facilities, ambulatory surgery centers and clinics. The PREMIER Perspective Database is selected by the Centers for Medicare and Medicaid Services (CMS) for measurement of hospital quality and commonly used for outcomes research. The data presented at TCT evaluated non-randomized ACS-PCI patients hospitalized between July 2009 and June 2011. The study endpoints were pre-specified and the analyses were blinded and conducted by the PREMIER research team. The studies included ACS-PCI patients treated with Effient who were on label or Plavix-treated patients who would have been eligible for Effient treatment per the U.S. prescribing information (i.e., patients who fit the description of the indication in the U.S. Food and Drug Administration (FDA)-approved Effient label).
“The results from the PREMIER studies provide physicians with real-world insights into the use and effectiveness of Effient in ACS-PCI patients in the United States,” said Xin Ye, Ph.D., director, Health Economics & Outcomes Research, Daiichi Sankyo Inc.
This study was adjusted for potential selection bias, including the following variables: patient age, sex, race, type of ACS diagnosis, co-morbidities and details of intervention.
The studies were conducted by researchers at Lilly and the Premier Healthcare Alliance.
For more information: www.effient.com