Cardiovascular and Renal Drugs Advisory (CRDAC)
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Overview of the 2010 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee meeting regarding ticagrelor.
Landmark clinical trials established the benefit of the thienopyridine clopidogrel, an irreversibly binding inhibitor of the platelet P2Y12 receptor, in the setting of acute coronary syndromes (ACS).1–3 Clopidogrel has thus become a key component of the current standard of care for antiplatelet therapy in the setting of ACS.4,5 Evidence has emerged, however, regarding the inherent limitations o...
متن کاملSpecial Report Overview of the 2010 Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee Meeting Regarding Ticagrelor
Landmark clinical trials established the benefit of the thienopyridine clopidogrel, an irreversibly binding inhibitor of the platelet P2Y12 receptor, in the setting of acute coronary syndromes (ACS).1–3 Clopidogrel has thus become a key component of the current standard of care for antiplatelet therapy in the setting of ACS.4,5 Evidence has emerged, however, regarding the inherent limitations o...
متن کاملNew Drugs and Technologies
1287 Patients with a history of heart disease are at increased risk for future cardiovascular events, including myocardial infarction (MI), stroke, and death resulting from cardiovascular disease. Although coronary artery disease remains the leading cause of mortality worldwide, advancements in medical therapy, particularly antithrombotic agents, have improved patient outcomes. Although the tre...
متن کاملAtypical hypertrophic cardiomyopathy of the left lateral wall leading to ventricular tachycardia.
vascular outcomes in large simple RCTs. Clin Trials 2009;6:239–251. 11. Alexander JH, Levy E, Lawrence J, Hanna M, Waclawski AP, Wang J, Califf RM, Wallentin L, Granger CB. Documentation of study medication dispensing in a prospective large randomized clinical trial: experiences from the ARISTOTLE Trial. Am Heart J 2013;166:559–565.e1. 12. EMA. Reflection Paper on Risk-based Quality Management ...
متن کاملAgainst TREATing all patients alike: lessons from an FDA Advisory Committee Meeting.
On October 18, 2010, the Food and Drug Administration (FDA) convened a Cardiovascular and Renal Drug Advisory Committee (CRDAC) meeting to discuss the risks and benefits of darbepoetin or, more broadly, erythropoiesis-stimulating agents (ESAs) for the treatment of anemia in patients with chronic kidney disease (CKD), a subject that was recently debated in JASN.1,2 Dr. Emil Paganini, a nephrolog...
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