Pharmacokinetic and pharmacodynamic effects of prasugrel in healthy Korean males

Journal of Cardiovascular Pharmacology

Volumn 62, Issue 1, 2013, Pages 72-77

  Yu, Kyung Sang ^a   Park, Kyung Woo ^b   Kelly, Ronan P ^c   Gu, Namyi ^a   Payne, Christopher ^d   Small, David S ^d   Choi, Hyunah C ^d   Kawakatsu, Eiji ^e   Pinton, Philippe ^d  

^a Seoul National University   (South Korea)

^b Seoul National University Hospital   (South Korea)

^c NATIONAL UNIVERSITY OF SINGAPORE   (Singapore)

^d ELI LILLY AND COMPANY   (United States)

^e DAIICHI SANKYO CO   (Japan)

Author keywords

inhibition of platelet aggregation; Koreans; pharmacodynamics; pharmacokinetics; prasugrel

Indexed keywords

ADENOSINE DIPHOSPHATE; ANTITHROMBOCYTIC AGENT; PRASUGREL; R 138727; UNCLASSIFIED DRUG;

ADULT; AREA UNDER THE CURVE; ARTICLE; ASIAN; BLOOD SAMPLING; CONTROLLED STUDY; CONTUSION; DIZZINESS; DRUG BLOOD LEVEL; DRUG DISPOSITION; DRUG EFFICACY; DRUG EXPOSURE; DRUG FATALITY; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; ENZYME INHIBITION; EPISTAXIS; HOT FLUSH; HUMAN; HUMAN EXPERIMENT; KOREA; LIQUID CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY TANDEM MASS SPECTROMETRY; LOADING DRUG DOSE; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; RHINORRHEA; TANDEM MASS SPECTROMETRY; THORAX PAIN; THROMBOCYTE AGGREGATION; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADENOSINE DIPHOSPHATE; ADULT; AREA UNDER CURVE; ASIAN CONTINENTAL ANCESTRY GROUP; BIOTRANSFORMATION; BLOOD PLATELETS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HUMANS; MALE; MASS SPECTROMETRY; PIPERAZINES; PLATELET AGGREGATION; PLATELET AGGREGATION INHIBITORS; RECEPTORS, PURINERGIC P2Y12; THIOPHENES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84880573335     PISSN: 01602446     EISSN: 15334023     Source Type: Journal    
DOI: 10.1097/FJC.0b013e318290d9e1     Document Type: Article

References (15)

1. Kushner FG, Hand M, Smith SC Jr, et al. 2009 focused updates: ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction (updating the 2004 guideline and 2007 focused update) and ACC/AHA/SCAI guidelines on percutaneous coronary intervention (updating the 2005 guideline and 2007 focused update) a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2009;54:2205-2241.
2. Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS), European Association for Percutaneous Cardiovascular Interventions (EAPCI), Wijns W, et al. Guidelines on myocardial revascularization. Eur Heart J. 2010;31:2501-2555.
3. Wallentin L. P2Y(12) inhibitors: differences in properties and mechanisms of action and potential consequences for clinical use. Eur Heart J. 2009;30:1964-1977.
4. Wiviott SD, Braunwald E, McCabe CH, et al; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007;357:2001-2015.
5. Small DS, Payne CD, Kothare P, et al. Pharmacodynamics and pharmacokinetics of single doses of prasugrel 30 mg and clopidogrel 300 mg in healthy Chinese and white volunteers: an open-label trial. Clin Ther. 2010;32:365-379.
6. Small DS, Li YG, Ernest CS II, et al. Integrated analysis of pharmacokinetic data across multiple clinical pharmacology studies of prasugrel, a new thienopyridine antiplatelet agent. J Clin Pharmacol. 2010;51: 321-332.
7. Small DS, Kothare P, Yuen E, et al. The pharmacokinetics and pharmacodynamics of prasugrel in healthy Chinese, Japanese, and Korean subjects compared with healthy Caucasian subjects. Eur J Clin Pharmacol. 2010;66:127-135.
8. Farid NA, McIntosh M, Garofolo F, et al. Determination of the active and inactive metabolites of prasugrel in human plasma by liquid chromatography/ tandem mass spectrometry. Rapid Commun Mass Spectrom. 2007;21:169-179.
9. Smith BP, Vandenhende FR, DeSante KA, et al. Confidence interval criteria for assessment of dose proportionality. Pharm Res. 2000;17:1278-1283.
10. Malinin A, Pokov A, Swaim L, et al. Validation of a VerifyNow-P2Y12 cartridge for monitoring platelet inhibition with clopidogrel. Methods Find Exp Clin Pharmacol. 2006;28:315-322.
11. Jernberg T, Payne CD, Winters KJ, et al. Prasugrel achieves greater inhibition of platelet aggregation and a lower rate of non-responders compared with clopidogrel in aspirin-treated patients with stable coronary artery disease. Eur Heart J. 2006;27:1166-1173.
12. Ge J, Zhu J, Hong BK, et al. Prasugrel versus clopidogrel in Asian patients with acute coronary syndromes: design and rationale of a multi-dose, pharmacodynamic, phase 3 clinical trial. Curr Med Res Opin. 2010;26:2077-2085.
13. Chin CT, Roe MT, Fox KA, et al; TRILOGY ACS Steering Committee. Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial. Am Heart J. 2010;160:16-22.
14. Roe MT, Armstrong PW, Fox KA, et al. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med. 2012;367:1297-1309.
15. Jakubowski JA, Li YG, Small DS, et al. A comparison of VerifyNow P2Y12 point-of-care device and light transmission aggregometry to monitor platelet function with prasugrel and clopidogrel: an integrated analysis. J Cardiovasc Pharmacol. 2010;56:29-37.