Critical review of prasugrel for formulary decision makers

Journal of Managed Care Pharmacy

Volumn 15, Issue 4, 2009, Pages 335-343

  Schafer, Jeremy A ^a,c   Kjesbo, Nicole K ^a   Gleason, Patrick P ^a,b  

^a Prime Therapeutics LLC   (United States)

^b UNIVERSITY OF MINNESOTA   (United States)

^c Prime Therapeutics   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ATORVASTATIN; CLOPIDOGREL; EPTIFIBATIDE; FIBRINOGEN RECEPTOR ANTAGONIST; HEPARIN; HIRULOG; HISTAMINE H2 RECEPTOR ANTAGONIST; KETOCONAZOLE; LANSOPRAZOLE; LOW MOLECULAR WEIGHT HEPARIN; PRASUGREL; PURINERGIC P2Y12 RECEPTOR;

ACUTE CORONARY SYNDROME; AREA UNDER THE CURVE; ARTERY BYPASS; ARTICLE; BLEEDING; BRAIN HEMORRHAGE; CARDIOVASCULAR RISK; DECISION MAKING; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG COST; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG EXCRETION; DRUG FORMULATION; DRUG HALF LIFE; DRUG INFORMATION; DRUG METABOLISM; DRUG RECEPTOR BINDING; DRUG SAFETY; DRUG USE; FOOD AND DRUG ADMINISTRATION; GASTROINTESTINAL HEMORRHAGE; HEALTH INSURANCE; HEART INFARCTION; HIGH RISK PATIENT; HUMAN; INTRACARDIAC THROMBOSIS; LOADING DRUG DOSE; MAXIMUM PLASMA CONCENTRATION; MORTALITY; PERCUTANEOUS CORONARY INTERVENTION; REPEATED DRUG DOSE; RISK BENEFIT ANALYSIS; STROKE; TREATMENT OUTCOME; UNSTABLE ANGINA PECTORIS;

EID: 66849131585     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: 10.18553/jmcp.2009.15.4.335     Document Type: Article

References (29)

1. Lloyd-Jones D, Adams R, Carnethon M, et al. Heart disease and stroke statistics - 2009 update: a report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation. 2009;119(3):480-86. Available at: http://circ.ahajournals.org/cgi/reprint/119/3/ 480. Accessed April 24, 2009.
2. King SB 3rd, Smith SC Jr, Hirshfeld JW Jr, et al. 2007 focused update of the ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2008;117(2):261-95. Available at: http://circ.ahajournals.org/cgi/reprint/117/2/261. Accessed April 24, 2009.
3. Antman EM, Hand M, Armstrong PW, et al. 2007 focused update of the ACC/AHA 2004 guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2008;117(2):296-330. Available at: http://circ.ahajournals.org/cgi/reprint/117/ 2/296. Accessed April 21, 2009.
4. Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction:. a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing committee to revise the 2002 guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction). J Am Coll Cardiol. 2007;50(7):e1-e157. Available at: http://content.onlinejacc.org/cgi/reprint/50/ 7/e1.pdf. Accessed April 21, 2009.
5. Goodman SG, Menon V, Cannon CP, et al. Acute ST-segment elevation myocardial infarction. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest. 2008;133(6 Suppl):708S-775S.
6. Harrington RA, Becker RC, Cannon CP, et al. Antithrombotic therapy for non-ST-segment elevation acute coronary syndromes: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th edition). Chest. 2008;133(6 Suppl):670S-707S.
7. National Center for Health Statistics. HIST290A: deaths for selected causes by 10-year age groups, race, and sex: death registration states, 1900-32, and United States, 1933-98. Available at: http://www.cdc.gov/nchs/datawh/ statab/unpubd/mortabs/hist290a.htm. Accessed April 24, 2009.
8. National Center for Health Statistics. GMWK292F: deaths for 358 selected causes by 5-year age groups, race, and sex: United States, 1999-2004. Available at: http://www.cdc.gov/nchs/datawh/statab/unpubd/mortabs/gmwk292-10.htm. Accessed April 24, 2009.
9. DeFrances CJ, Lucas CA, Buie VC, Golosinskiy A. 2006 National Hospital Discharge Survey. Natl Health Stat Rep. 2008;5:1-20.
10. U.S. Food and Drug Administration. Cardiovascular and Renal Drug Advisory Committee briefing document on prasugrel for ACS. February 3, 2009. Available at: http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4412b1-01-FDA.pdf. Accessed April 24, 2009.
11. Bhatt DL, Roe MT, Peterson ED. Utilization of early invasive management strategies for high-risk patients with non-ST-segment elevation acute coronary syndromes. JAMA. 2004;292(17):2096-2104
12. Farid NA, Smith RL, Gillespie TA, et al. The disposition of prasugrel, a novel thienopyridine, in humans. Drug Metab Dispos. 2007;35(7):1096-1104
13. U.S. Food and Drug Administration. Plavix (clopidogrel). NDA no. 020-839/S-038. Approved November 17, 1997. Available at: http://www.fda.gov/ cder/foi/label/2007/020839s038lbl.pdf. Accessed April 14, 2009.
14. Riley AB, Tafreshi MJ, Haber SL. Prasugrel: a novel antiplatelet agent. Am J Health Syst Pharm. 2008;65(11):1019-1028
15. 12 receptor antagonist activity. Semin Thromb Hemost. 2005;31(2):184-194
16. 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(4):600-607
17. 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 Clopdiogrel for Inhibition of Platelet Activation and Aggregation Thrombolysis in Myocardial Infarction 44 trial. Circulation. 2007;116(25):2923-32. Available at: http://circ. ahajournals.org/cgi/reprint/116/25/2923. Accessed April 24, 2009.
18. Ho PM, Maddox TM, Wang L, et al. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA. 2009;301(9):937-944
19. 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(4):475-484
20. 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(8):2251-2257
21. 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(12):1483-1494
22. 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(5):735-741
23. Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007;357(20):2001-15. Available at: http://content.nejm.org/cgi/reprint/357/20/2001.pdf. Accessed April 24, 2009.
24. Yusuf S, Zhao F, Mehta SR, et al. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001;345(7):494-502. Available at: http://content.nejm.org/cgi/ reprint/345/7/494.pdf. Accessed April 21, 2009.
25. Sabatine MS, et al. Effect of clopidogrel pretreatment before percutaneous coronary intervention in patients with ST-elevation myocardial infarction treated with fibrinolytics: the PCI-CLARITY study. JAMA 2005;294(10):1224-1232
26. Montalescot G, Wiviott SD, Braunwald E, et al. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomized controlled trial. Lancet. 2009;373(9665):723-731
27. U.S. Food and Drug Administration. Summary minutes of the Cardiovascular and Renal Drugs Advisory Committee February 3, 2009. Available at: http://www.fda.gov/ohrms/dockets/ac/09/minutes/2009-4412m1-Final.pdf. Accessed April 24, 2009.
28. U.S. National Institutes of Health. Clinical trial search for prasugrel. Available at: http://www.clinicaltrials.gov/ct2/results?term=prasugrel. Accessed April 21, 2009.
29. Jackson MA, Fairman KA, Curtiss FR. Prior authorization and clopiodgrel use: the truth lies in the details. J Manag Care Pharm. 2009;15(1):71-77. Available at: http://www.amcp.org/data/jmcp/071-077.pdf.