Abstract:
OBJECTIVES:Our goal was to compare the safety and initial efficacy of AZD6140, the first reversible oral adenosine diphosphate receptor antagonist, with clopidogrel in patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS). BACKGROUND:AZD6140 achieves higher mean levels of platelet inhibition than clopidogrel in patients with stable coronary artery disease. METHODS:A total of 990 patients with NSTE-ACS, treated with aspirin and standard therapy for ACS, were randomized in a 1:1:1 double-blind fashion to receive either twice-daily AZD6140 90 mg, AZD6140 180 mg, or clopidogrel 300-mg loading dose plus 75 mg once daily for up to 12 weeks. RESULTS:The primary end point, the Kaplan-Meier rate of major or minor bleeding through 4 weeks, was 8.1% in the clopidogrel group, 9.8% in the AZD6140 90-mg group, and 8.0% in the AZD6140 180-mg group (p = 0.43 and p = 0.96, respectively, vs. clopidogrel); the major bleeding rates were 6.9%, 7.1%, and 5.1%, respectively (p = 0.91 and p = 0.35, respectively, vs. clopidogrel). Although not statistically significant, favorable trends were seen in the Kaplan-Meier rates of myocardial infarction (MI) over the entire study period (MI: 5.6%, 3.8%, and 2.5%, respectively; p = 0.41 and p = 0.06, respectively, vs. clopidogrel). In a post-hoc analysis of continuous electrocardiograms, mostly asymptomatic ventricular pauses >2.5 s were more common, especially in the AZD6140 180-mg group (4.3%, 5.5%, and 9.9%, respectively; p = 0.58 and p = 0.01, respectively, vs. clopidogrel). CONCLUSIONS:This initial experience with AZD6140 in patients with ACS showed no difference in major bleeding but an increase in minor bleeding at the higher dose with encouraging results on the secondary end point of MI. This agent is currently being studied in a large outcomes trial in 18,000 patients with ACS.
journal_name
J Am Coll Cardioljournal_title
Journal of the American College of Cardiologyauthors
Cannon CP,Husted S,Harrington RA,Scirica BM,Emanuelsson H,Peters G,Storey RF,DISPERSE-2 Investigators.doi
10.1016/j.jacc.2007.07.053subject
Has Abstractpub_date
2007-11-06 00:00:00pages
1844-51issue
19eissn
0735-1097issn
1558-3597pii
S0735-1097(07)02634-4journal_volume
50pub_type
杂志文章,多中心研究,随机对照试验abstract:OBJECTIVES:The aim of this study was to determine whether the release of nitric oxide (NO) from the ischemic heart increases during exercise in patients with effort angina. BACKGROUND:Myocardial ischemia increases NO production in the canine heart, but no such increase has been demonstrated in the ischemic human heart...
journal_title:Journal of the American College of Cardiology
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journal_title:Journal of the American College of Cardiology
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journal_title:Journal of the American College of Cardiology
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更新日期:2003-02-05 00:00:00
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journal_title:Journal of the American College of Cardiology
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journal_title:Journal of the American College of Cardiology
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更新日期:2004-04-07 00:00:00