Safety issues with prasugrel: the latest from TRITON-TIMI 38
TRITON-TIMI 38 is one of the biggest phase III clinical trials on prasugrel, a new thienopyridine from Lilly/Daiichi Sankyo. The trial was designed as multicenter, randomized, double-blind, and parallel-group. Over 13000 patients from different countries were enrolled based on the main inclusion criterion of having moderate- to high-risk ACS and undergoing PCI. Of these, about 73% had unstable angina/non-ST-segment elevation MI and 37% ST-segment elevation MI [1, 2].
The participants were randomized to either prasugrel or the comparator clopidogrel. Clopidogrel combined with aspirin is the first line antiplatelet therapy for the prevention of thrombotic complications of PCI. Prasugrel is said to be less variable and achieves a higher level of platelet inhibition than the comparator. The primary end point of the trial is the time of the first event of cardiovascular death, MI, or stroke [1, 2].
The latest results from the trial as reported in the latest issue of NEJM [3] show good efficacy profile but fall short in terms of safety. Prasugrel significantly reduced cardiovascular events compared to clopidogrel. However, the incidence of bleeding in prasugrel patients was significantly higher. The risk of bleeding is especially elevated in patients who have had CABG or cerebrovascular problems [3]. Safety concerns in terms of bleeding were actually reported already last year at the World Congress of Cardiology in Barcelona, Spain [4].
Abbreviations:
TRITON_TIMI 38: TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet InhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38.
ACS: acute coronray syndrome
PCI: percutaneous coronary intervention
MI: myocardial infarction
CABG: coronary artery bypass graft
Sources:
- TIMI homepage
- American Heart Journal 152(4):627-635, October 2006
- NEJM 357:2001-2015 November 2007.
- Heartwire 21 September 2006
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