Comparing the safety of ticagrelor versus clopidogrel: Insights from the FDA reports

Therapeutic Advances in Cardiovascular Disease

Volumn 7, Issue 1, 2013, Pages 5-9

  Dinicolantonio, James J ^a   Serebruany, Victor L ^b  

^a Wegmans Pharmacy   (United States)

^b JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ATORVASTATIN; CARBAMAZEPINE; CLOPIDOGREL; CYCLOSPORIN; CYTOCHROME P450 3A4; DEXAMETHASONE; DIGOXIN; ESTRADIOL; MEVINOLIN; MULTIDRUG RESISTANCE PROTEIN; PHENOBARBITAL; PHENYTOIN; QUINIDINE; RIFAMPICIN; SIMVASTATIN; TICAGRELOR; VERAPAMIL;

ACUTE CORONARY SYNDROME; AREA UNDER THE CURVE; ARTERIAL THROMBOEMBOLISM; BLEEDING; BRADYCARDIA; BRAIN HEMORRHAGE; CARDIOVASCULAR RISK; CAUCASIAN; CEREBROVASCULAR ACCIDENT; CORONARY ARTERY BYPASS GRAFT; DEATH; DEEP VEIN THROMBOSIS; DRUG EFFICACY; DRUG EXPOSURE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FOOD AND DRUG ADMINISTRATION; GENDER; GYNECOMASTIA; HEART ATRIUM ARRHYTHMIA; HEART INFARCTION; HEART VENTRICLE ARRHYTHMIA; HUMAN; JAPANESE; KIDNEY FAILURE; LOADING DRUG DOSE; LUNG EMBOLISM; MAXIMUM PLASMA CONCENTRATION; OUTCOME ASSESSMENT; PERIPHERAL VASCULAR DISEASE; POSTOPERATIVE COMPLICATION; PRIORITY JOURNAL; RACE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SIDE EFFECT; THROMBOCYTE ACTIVATION; TRANSITIONAL BLINDNESS; VENOUS THROMBOEMBOLISM;

ADENOSINE; CARDIOVASCULAR DISEASES; HUMANS; PURINERGIC P2Y RECEPTOR ANTAGONISTS; TICLOPIDINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84873588027     PISSN: 17539447     EISSN: 17539455     Source Type: Journal    
DOI: 10.1177/1753944712468627     Document Type: Editorial

References (6)

1. EMA (2010) Ticagrelor (Brilique) Summary of product characteristics. European Medicines Agency. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001241/WC500100494.pdf (accessed 10 May 2012).
2. FDA (2011) Complete response review. Drug approval package. US Food and Drug Administration. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022433Orig1s000TOC.cfm (accessed 5 November 2012).
3. FDA (2012) Ticagrelor Advisory Committee Briefing Document. US Food and Drug Administration. Available at: http://www.fda.gov/downloads/AdvisoryCommitteesMeetingMaterials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM220197.pdf (accessed 10 May 2012).
4. James S. Budaj A. Aylward P. Buck K. Cannon C. Cornel J. et al. (2010) Ticagrelor versus clopidogrel in acute coronary syndromes in relation to renal function: results from the Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation 122: 1056–1067.
5. Levine G. Bates E. Blankenship J. et al (2011) ACCF/AHA/SCAI guidelines for percutaneous coronary intervention: a report of the American College of Cardiology Foundation / American Heart Association task force on practice guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation 124: e574–e651.
6. Wallentin L. Becker R. Budaj A. Cannon C. Emanuelsson H. Held C. et al.; the PLATO Investigators (2009) Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 61: 1045–1057.