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Eli Lilly Releases Data From Two Retrospective Studies

Daiichi Sankyo and Eli Lilly and Company (NYSE: LLY) today announced new 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), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

The first study evaluated the rate of rehospitalization 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.[1] 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 rehospitalization for AMI than Plavix-treated patients (n=74,163) at 30 days (Odds Ratio [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 rehospitalization 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).[2]

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.[3] 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 (+ or - $2,548) and $17,139 (+ or - $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 rehospitalization 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 Company. "The findings of these studies expand on data from clinical studies and previous health outcomes research."

Posted-In: News FDA

 

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