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Prasugrel: Indications of an additional benefit for some patients, but also of greater harm
Date:9/15/2011

with ASA monotherapy were not available, which is why the final report cannot draw any conclusions on advantages and disadvantages of prasugrel in patients with STEMI.

No proof, but indication of a benefit

In patients with a "minor" heart attack or unstable angina, i.e. patients with a "non-ST-segment-elevation myocardial infarction" (UA/NSTEMI), IQWiG found indications of a potential advantage of prasugrel plus ASA versus clopidogrel plus ASA. In the TRITON study, patients taking prasugrel suffered fewer (renewed) non-fatal heart attacks or strokes, or required fewer interventions with a balloon catheter for dilatation of the coronary vessels.

IQWiG does not interpret these results as proof, but only as an indication of an advantage of prasugrel, as the study participants only received the medications some time after the occurrence of heart attack symptoms. As prasugrel generally has a more rapid onset of effect, clopidogrel was presumably systematically disadvantaged by the study design. "The rules for a fair comparison were broken here," says Thomas Kaiser, Head of IQWiG's Drug Assessment Department, "We cannot exclude the possibility that the result would have been different if both drugs had been given earlier."

Moreover, regarding the prevention of a stroke, the indication of an additional benefit of prasugrel only applies to certain patients, as such indications were only found in the studies in patients without a known history of vascular disease.

Also indication of harm

At the same time, IQWiG also found indications of greater harm, as major bleeding events occurred more often with prasugrel plus ASA than with clopidogrel plus ASA. This included, for example, bleeding events that required a blood transfusion.

Neoplasia (benign and malignant tumours) were also diagnosed more often in patients treated with prasugrel. However, due to the more common occurrence of bleeding, patie
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Contact: Dr. Anna-Sabine Ernst
info@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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