Pharmacokinetic evaluation of prasugrel for the treatment of myocardial infarction

Bibliography

• O'Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines. J Am Coll Cardiol 2013;61(4):e78-e140
   PubMed Web of Science ®Google Scholar
• Go AS, Mozaffarian D, Roger VL, et al.; on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2013 update: a report from the American Heart Association. Circulation 2013;127:e6-e245
   PubMed Web of Science ®Google Scholar
• The Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med 2001;345:494-502
   PubMed Web of Science ®Google Scholar
• Steinhubl SR, Berger PB, Mann JT, et al. for the CREDO Investigators. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention. JAMA 2002;288:2411-20
   PubMed Web of Science ®Google Scholar
• Wiviott SD, Braunwald E, McCabe CH, et al.; for the TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2007;357:2001-15
   PubMed Web of Science ®Google Scholar
• Wallentin L, Becker RC, Budaj A, et al. for the PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med 2009;361:1045-57
   PubMed Web of Science ®Google Scholar
• Andersen JL, Adams CD, Antman EM, et al. 2012 ACCF/AHA focused update incorporated in to the ACCF/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;61(23):e179-347
   PubMed Web of Science ®Google Scholar
• Frelinger AL, Bhatt DL, Lee RD, et al. Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet function. J Am Coll Cardiol 2013;61:872-9
   PubMed Web of Science ®Google Scholar
• Mega JL, Close SL, Wiviott SD, et al. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med 2009;360:354-62
   PubMed Web of Science ®Google Scholar
• Hulot JS, Collet JP, Silvain J, et al. Cardiovascular risk in clopidogrel-treated patients according to cytochrome P450 2C19*2 loss-of-function allele or proton pump inhibitor coadministration: a systematic meta-analysis. J Am Coll Cardiol 2010;56:134-43
   PubMed Web of Science ®Google Scholar
• Mega JL, Simon T, Collet J, et al. Reduced-function CYP2C19 genotype and risk of adverse clinical outcomes among patients treated with clopidogrel predominantly for PCI. JAMA 2010;304(16):1821-30
   PubMed Web of Science ®Google Scholar
• Scott SA, Sangkuhl K, Garner EE, et al. Clinical pharmacogenetics implementation consortium guidelines for cytochrome P450-2C19 (CYP2C19) genotype and clopidogrel therapy. Clin Pharmacol Ther 2011;90(2):328-32
   PubMed Web of Science ®Google Scholar
• Silvain J, Montalescot G. Rapid P2Y12 inhibition: still an unmet medical need. Circ Cardiovasc Interv 2012;5:328-31
   PubMed Web of Science ®Google Scholar
• Welsh RC, Rao SV, Zeymer U, et al. on behalf of the INNOVATE-PCI Investigators. A randomized, double-blind, active-controlled phase 2 trial to evaluate a novel selective and reversible intravenous and oral P2Y12 inhibitor elinogrel versus clopidogrel in patients undergoing nonurgent percutaneous coronary intervention. Circ Cardiovasc Interv 2012;5:336-46
   PubMed Web of Science ®Google Scholar
• Bhatt DL, Stone GW, Mahaffey KW, et al. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med 2013;368:1303-13
   PubMed Web of Science ®Google Scholar
• Tricoci P, Huang Z, Held C, et al. for the TRACER Investigators. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med 2012;366:20-33
   PubMed Web of Science ®Google Scholar
• Effient [package insert]. Eli Lilly and Co., Indianapolis, IN; 2012
   Google Scholar
• Dobesh PP. Pharmacokinetics and pharmacodynamics of prasugrel, a thienopyridine P2Y12 inhibitor. Pharmacotherapy 2009;29(9):1089-102
   PubMed Web of Science ®Google Scholar
• Wallentin L, Varenhorst C, James S, et al. Prasugrel achieves greater and faster P2Y12 receptor-mediated platelet inhibition than clopidogrel due to more efficient generation of its active metabolite in aspirin-treated patients with coronary artery disease. Eur Heart J 2008;29(1):21-30
   PubMed Web of Science ®Google Scholar
• Wiviott SD, Trenk D, Frelinger AL, et al. Prasugrel compared with high loading- and maintenance-dose clopidogrel in patients with planned percutaneous coronary intervention: the prasugrel in comparison to clopidogrel for inhibition of platelet activation and aggregation-thrombolysis in myocardial infarction 44 trial. Circulation 2007;116(25):2923-32
   PubMed Web of Science ®Google Scholar
• Angiolillo DJ, Saucedo JF, DeRaad R, et al. Increased platelet inhibition after switching from maintenance clopidogrel to prasugrel in patients with acute coronary syndromes. J Am Coll Cardiol 2010;56(13):1017-23
   PubMed Web of Science ®Google Scholar
• Price MJ, Walder JS, Baker BA, et al. Recovery of platelet function after discontinuation of prasugrel or clopidogrel maintenance dosing in aspirin-treated patients with stable coronary disease. J Am Coll Cardiol 2012;59(25):2338-43
   PubMed Web of Science ®Google Scholar
• Erlinge D, ten Berg J, Foley D, et al. Reduction in platelet reactivity with prasugrel 5 mg in low-body-weight patients is noninferior to prasugrel 10 mg in higher-body-weight patients. J Am Coll Cardiol 2012;60:2032-40
   PubMed Web of Science ®Google Scholar
• Erlinge D, Gurbel PA, James S, et al. Prasugrel 5 mg in the very elderly attenuates platelet inhibition but maintains noninferiority to prasugrel 10 mg in nonelderly patients. J Am Coll Cardiol 2013;62:577-83
   PubMed Web of Science ®Google Scholar
• Alexopoulos D, Xanthopoulou I, Gkizas V, et al. Randomized assessment of ticagrelor versus prasugrel antiplatelet effects in patients with ST-segment-elevation myocardial infarction. Circ Cardiovasc Interv 2012;5:797-804
   PubMed Web of Science ®Google Scholar
• Alexopoulos D, Galati A, Xanthopoulou I, et al. Ticagrelor versus prasugrel in acute coronary syndrome patients with high on-clopidogrel platelet reactivity following percutaneous coronary intervention. J Am Coll Cardiol 2012;60:193-9
   PubMed Web of Science ®Google Scholar
• Hagihara K, Kazui M, Ikenaga H, et al. Comparison of formation of thiolactones and active metabolites of prasugrel and clopidogrel in rats and dogs. Xenobiotica 2009;39(3):218-26
   PubMed Web of Science ®Google Scholar
• Farid NA, Smith RL, Gillespie TA, et al. The disposition of prasugrel, a novel thienopyridine, in humans. Drug Metab Dispos 2007;35:1096-104
   PubMed Web of Science ®Google Scholar
• Rehmel JL, Eckstein JA, Farid NA, et al. Interactions of two major metabolites of prasugrel, a thienopyridine antiplatelet agent, with the cytochromes P450. Drug Metab Dispos 2006;34:600-7
   PubMed Web of Science ®Google Scholar
• Hagihara K, Kazui M, Kazui M, et al. Biotransformation of prasugrel, a novel thienopyridine antiplatelet agent, to the pharmacologically active metabolite. Drug Metab Dispos 2010;38:898-904
   PubMed Web of Science ®Google Scholar
• Farid NA, Payne CD, Small DS, et al. Cytochrome P450 3A inhibition by ketoconazole affects prasugrel and clopidogrel pharmacokinetics and pharmacodynamics differently. Clin Pharmacol Ther 2007;81:735-41
   PubMed Web of Science ®Google Scholar
• Small DS, Farid NA, Li YG, et al. Effect of ranitidine on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel. Curr Med Res Opin 2008;24:2251-7
   PubMed Web of Science ®Google Scholar
• Small DS, Farid NA, Payne CD, et al. Effects of the proton pump inhibitor lansoprazole on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel. J Clin Pharmacol 2008;48:475-84
   PubMed Web of Science ®Google Scholar
• Farid NA, Small DS, Payne CD, et al. Effect of atorvastatin on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel in healthy subjects. Pharmacotherapy 2008;28:1483-94
   PubMed Web of Science ®Google Scholar
• Niemi M, Backman JT, Fromm MF, et al. Pharmacokinetic interactions with rifampicin: clinical relevance. Clin Pharmacokinet 2003;42:819-50
   PubMed Web of Science ®Google Scholar
• Farid NA, Jakubowski JA, Payne CD, et al. Effect of rifampin on the pharmacokinetics and pharmacodynamics of prasugrel in healthy male subjects. Curr Med Res Opin 2009;25:1821-9
   PubMed Web of Science ®Google Scholar
• Knox TA, Oleson L, von Moltke LL, et al. Ritonavir greatly impairs CYP3A activity in HIV infection with chronic viral hepatitis. J Acquir Immune Defic Syndr 2008;49:358-68
   PubMed Web of Science ®Google Scholar
• Hesse LM, von Moltke LL, Shader RI, et al. Ritonavir, efavirenz, and nelfinavir inhibit CYP2B6 activity in vitro: potential drug interactions with bupropion. Drug Metab Dispos 2001;29:100-2
   PubMed Web of Science ®Google Scholar
• Ancrenaz V, Deglon J, Samer C, et al. Pharmacokinetic interaction between prasugrel and ritonavir in healthy volunteers. Basic Clin Pharmacol Toxicol 2013;112:132-7
   PubMed Web of Science ®Google Scholar
• Daali Y, Ancrenaz V, Bosilkovska M, et al. Ritonavir inhibits the two main prasugrel bioactivation pathways in vitro: a potential drug–drug interaction in HIV patients. Metabolism 2011;60:1584-9
   PubMed Web of Science ®Google Scholar
• Farid NA, Payne CD, Ernest CS, et al. Prasugrel, a new thienopyridine antiplatelet drug, weakly inhibits cytochrome P450 2B6 in humans. J Clin Pharmacol 2008;48:53-9
   PubMed Web of Science ®Google Scholar
• Bhatt DL, Cryer BL, Contant CF, et al. Clopidogrel with or without omeprazole in coronary artery disease. N Engl J Med 2010;363:1909-17
   PubMed Web of Science ®Google Scholar
• Wiviott SD, Antman EM, Winters KJ, et al. Randomized comparison of prasugrel (CS-747, LY640315), a novel thienopyridine P2Y12 antagonist, with clopidogrel in percutaneous coronary intervention: results of the Joint Utilization of Medications to Block Platelets Optimally (JUMBO-TIMI 26 trial). Circulation 2005;111:3366-73
   PubMed Web of Science ®Google Scholar
• Roe MT, Armstrong PW, Fox KAA, et al. for the TRILOGY ACS Investigators. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med 2012;367:1297-309
   PubMed Web of Science ®Google Scholar
• Montalescot G, Bolognese L, Dudek D, et al.; for the ACCOAST Investigators. Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes. N Engl J Med 2013;369:999-1010
   PubMed Web of Science ®Google Scholar
• Antman EM, Wiviott SD, Murphy SA, et al. Early and late benefits of prasugrel in patients with acute coronary syndromes undergoing percutaneous coronary intervention. J Am Coll Cardiol 2008;51:2028-33
   PubMed Web of Science ®Google Scholar
• Wiviott SD, Braunwald E, Angiolillo DJ, et al. for the TRITON-TIMI 38 Investigators. Greater clinical benefit of more intense oral antiplatelet therapy with prasugrel in patients with diabetes mellitus in the trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel: thrombolysis in myocardial infarction 38. Circulation 2008;118:1626-36
   PubMed Web of Science ®Google Scholar
• Roe MT, Goodman SG, Ohman EM, et al. Elderly patients with acute coronary syndromes managed without revascularization. Circulation 2013;128:823-33
   PubMed Web of Science ®Google Scholar
• Hansen ML, Sorensen R, Clausen MT, et al. Risk of bleeding with single, dual, or triple therapy with warfarin, aspirin, and clopidogrel in patients with atrial fibrillation. Arch Intern Med 2010;170:1433-41
   PubMed Web of Science ®Google Scholar
• Doyle BJ, Rihal CS, Gastineau DA, Holmes DR Jr. Bleeding, blood transfusion, and increased mortality after percutaneous coronary intervention: implications for contemporary practice. J Am Coll Cardiol 2009;53:2019-27
   PubMed Web of Science ®Google Scholar
• Fosbol EL, Wang TY, Li S, et al. Safety and effectiveness of antithrombotic strategies in older adult patients with atrial fibrillation and non-ST elevation myocardial infarction. Am Heart J 2012;163:720-8
   PubMed Web of Science ®Google Scholar
• Sarafoff N, Martischnig A, Wealer J, et al. Triple therapy with aspirin, prasugrel, and vitamin K antagonists in patients with drug eluting stent implantation and an indication for oral anticoagulation. J Am Coll Cardiol 2013;61:2060-6
   PubMed Web of Science ®Google Scholar
• Brilinta [package insert]. AstraZeneca, LP, Wilmington, DE; 2013
   Google Scholar
• Tantry US, Bonello L, Aradi D, et al. Consensus and update on the definition of on-treatment platelet reactivity to ADP associated with ischemia and bleeding. J Am Coll Cardiol 2013;62(24):2261-73
   PubMed Web of Science ®Google Scholar
• Price MJ, Berger PB, Teirstein PS, et al. for the GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention. JAMA 2011;305(11):1097-105
   PubMed Web of Science ®Google Scholar
• Trenk D, Stone GW, Gawaz M, et al. A randomized trial of prasugrel versus clopidogrel in patients with high platelet reactivity on clopidogrel after elective percutaneous coronary intervention with implantation of drug-eluting stents: results of the TRIGGER-PCI (Testing Platelet Reactivity In Patients Undergoing Elective Stent Placement on Clopidogrel to Guide Alternative Therapy with Prasugrel) study. J Am Coll Cardiol 2012;59:2159-64
   PubMed Web of Science ®Google Scholar
• Collet J-P, Cuisset T, Range G, et al. Bedside monitoring to adjust antiplatelet therapy for coronary stenting. N Engl J Med 2012;367:2100-9
   PubMed Web of Science ®Google Scholar
• Tailored antiplatelet therapy versus recommended dose of prasugrel (ANTARCTIC). Available from: clinicaltrials.gov/show/NCT01538446 [Accessed 4 October 2013]
   Google Scholar
• Brandt JT, Close SL, Iturria SJ, et al. Common polymorphisms of CYP2C19 and CYP2C9 affect the pharmacokinetic and pharmacodynamic response to clopidogrel but not prasugrel. J Thromb Haemost 2007;5:2429-36
   PubMed Web of Science ®Google Scholar
• Shuldiner AR, O'Connell JR, Bliden KP, et al. Association of cytochrome P450 2C19 genotype with the antiplatelet effect and clinical efficacy of clopidogrel therapy. JAMA 2009;302:849-57
   PubMed Web of Science ®Google Scholar
• Sorich MJ, Vitry A, Ward MB, et al. Prasugrel vs clopidogrel for cytochrome P450 2C19-genotyped subgroups: integration of the TRITON-TIMI 38 trial data. J Thromb Haemost 2010;8:1678-84
   PubMed Web of Science ®Google Scholar
• Roberts JD, Wells GA, Le May MR, et al. Point-of-care genetic testing for personalisation of antiplatelet treatment (RAPID GENE): a prospective, randomised, proof-of-concept trial. Lancet 2012;379:1705-11
   PubMed Web of Science ®Google Scholar
• Damani SB, Topol EJ. The case for routine genotyping in dual-antiplatelet therapy. J Am Coll Cardiol 2010;56(2):109-11
   PubMed Web of Science ®Google Scholar
• Johnson JA, Roden DM, Lesko LJ, et al. Clopidogrel: a case for indication-specific pharmacogenetics. Clin Pharmacol Ther 2012;91(5):774-6
   PubMed Web of Science ®Google Scholar