Resumen estudio tritón timi 38

TRITON-TIMI 38 ECONOMIC SUBSTUDY: Cost-Effectiveness of Prasugrel vs. Clopidogrel from a Prospective Randomized Trial of Patients with ACS Undergoing PCI

Summary
In patients with acute coronary syndrome and planned PCI, treatment with prasugrel was more cost-effective compared to clopidogrel.

Background
The TRITON-TIMI 38 trial randomized 13,608 patients with ACS with and withoutST-segment elevation undergoing PCI to receive clopidogrel or prasugrel. The main trial found that prasugrel was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding.

Given the higher cost of prasugrel, the current analysis was a pre-specified economic substudy to identify the optimal patientpopulation and treatment duration with prasugrel.

Study Design
The current analysis included all patients from eight countries and applied the healthcare system model of the United States. Medical resource utilization was tracked for all patients from randomization through last follow-up visit. Hospitalization and physician cost was derived from Medicare data. Study drug costs based on netwholesale price as of August 2009 (clopidogrel = $4.62/day; prasugrel = $5.45/day).

Results and Conclusions
Treatment with prasugrel was associated with 36 fewer re-hospitalizations for PCI per 1000 patients as compared with clopidogrel. However, it was associated with 11 more re-hospitalizations for bleeding per 1000 patients as compared with clopidogrel.

Including index hospitalization,re-hospitalization, and drug cost, total cost per patient for prasugrel was $26,067 as compared with $26,288 for brand clopidogrel, a saving of $221.
Compared to the projected cost of generic clopidogrel (approximately $1/day), prasugrel was more cost-effective during the first 30 days but was less cost-effective (by ~$800/pt) beyond the first 30 days.

Clopidogrel optimal loading dose Usage toReduce Recurrent EveNTs-Organization to Assess Strategies in Ischemic Syndromes (CURRENT OASIS 7 — Presented at ESC and TCT 2009)

Description
The goal of the trial was to evaluate the efficacy and safety of a high daily dose of aspirin compared to a low dose of aspirin, and to compare standard dose clopidogrel with double dose clopidogrel, among patients with ST-elevation myocardial infarction(STEMI) or nonST-segment elevation acute coronary syndrome (NSTE-ACS).

Drugs/Procedures Used
Patients were randomized in an open-label manner to a high daily dose of aspirin (300-325 mg) or to a low dose of aspirin (75-100 mg), and were followed for 30 days. Patients were also randomized in 2x2 factorial design to a clopidogrel high-dose regimen (600 mg loading dose on day 1 followed by 150 mgonce daily on days 2-7, followed by 75 mg once daily on days 8-30) compared with the standard-dose regimen (300 mg loading dose on day 1, followed by 75 mg once daily on days 2-30).

Principal Findings
Percutaneous coronary intervention (PCI) was performed in 70% of patients in the trial. The reason no PCI was performed was no significant coronary artery disease (15%), coronary artery bypassgrafting (CABG) (7%), and other reasons despite presence of coronary artery disease (10%). Type of ACS was unstable angina/NSTEMI in 70.8% of patients and STEMI in 29.2%.

For the primary efficacy endpoint of the trial, there was a significant interaction with the factorial randomization in the trial between low-dose and high-dose aspirin and standard-dose and double-dose clopidogrel (p = 0.043). Inthe high-dose aspirin group, the primary efficacy event rate was lower in the double-dose clopidogrel versus the standard-dose clopidogrel group (4.6% vs 3.8%, relative risk 0.83, 95% confidence interval 0.70-0.99, p = 0.036). However, there was no difference between the double-dose clopidogrel versus the standard-dose clopidogrel group in the low-dose aspirin cohort (4.2% vs 4.5%, RR 1.07, 95%...