CAPRIE ÇALIŞMASI VE İLK SONUÇLARI

CAPRIE çalışması dopidogrel isimli yeni bir antiplatelet ilacın kullanıldığı en geniş klinik çalışma olup, iskemik strok, miyokard infarktüsü ve periferik vasküler hastalık gibi risk olan hastalıklarından biri bulunan hastalarda aspirinden daha etkili olduğunu göstermiştir. Uç yıl devam eden çalışmada önceden iskemik strok, Ml veya PAH geçiren 19,185 hastanın 9,599'unda 75 mg/ gün dopidogrel, 9,586'undil ise 325 mg/gün aspirin 16 ülkeden 400 merkezde kullanılmıştır. Clopidogrel kullanılan hastalarda hematolojik yan etkilere rastlanmamış, aspirin ile farksız oranlarda nötropeni ve minor belirtiler (diare, kırmızılık ve kaşmtı) izlenmiştir. Gastrointestinal kanama oluşmamıştır.

THE CAPRIE STUDY: AN OVERVIEW

The CAPRIE (Clopidogrel versusu Aspirin in Patienls at Risk of lschemic Event) study, the largest dinical trial ever conducted on any medicine in development, shows that a new antiplatelet agent, dopidogrel, is significantly more effective than aspirin at reducing the likelihood of ischemic stroke, heart attack or vascular death in at-risk patients. CAPRIE was a three-year, randomized, triple-blind international dinical study which enrolled 19,185 patients who had previously suffered an ischemic stroke, heart attack, or claudication. Patients received either 75 mg once daily of dopidogrel or 325 mg per day of aspirin. The study was conducted by investigators at almost 400 elinical centres in 16 countries araund the world. The CAPRIE study demonstrated that_ treatment with clopidogrel provided an overall relative risk reduction in ischemic stroke, myocardial infarctlon, or peripheral wıscular disease of 8,7% amongst the 9,599 patients treated with dopidogrel compared with the 9,586 patients trealed with aspirin (p=0,043). This study showed no evidence of any adverse haematological effects with clopidogrel. Specifically, there was no difference in the ineidence of neutropenia between the group treated wit aspirin (0.17%) and that treated with dopidogrel (0.09%). The patients treated with clopidogrel were significcmtly less likely to suffer from severe gastrointestinal bleeding than those treated with aspirin. There was an increase in some minor adverse event~ (diarrhea, rash and itching) in those patients receiving dopidogrel com pa red with aspirin, but the observed differences of about 0.1% are considered clinically unimportant.