Review of prasugrel for the secondary prevention of atherothrombosis

Journal of Managed Care Pharmacy

Volumn 15, Issue 5, 2009, Pages 383-395

  Spinler, Sarah A ^a   Rees, Catherine ^b  

^a UNIVERSITY OF THE SCIENCES   (United States)

^b Adis Communications ^*

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CLOPIDOGREL; PRASUGREL; ANTITHROMBOCYTIC AGENT; DRUG DERIVATIVE; PIPERAZINE DERIVATIVE; THIOPHENE DERIVATIVE; TICLOPIDINE;

ACUTE CORONARY SYNDROME; ARTERY DISEASE; ATHEROTHROMBOSIS; BARE METAL STENT; BLEEDING; BLOOD CLOT LYSIS; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CORONARY ARTERY DISEASE; DRUG COST; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG ELUTING STENT; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; HEART INFARCTION; HUMAN; LOADING DRUG DOSE; PERCUTANEOUS CORONARY INTERVENTION; RANDOMIZED CONTROLLED TRIAL; REVIEW; SECONDARY PREVENTION; THROMBOCYTE ACTIVATION; THROMBOCYTE AGGREGATION; THROMBOSIS; ATHEROSCLEROSIS; COMPARATIVE STUDY; RISK FACTOR; TRANSLUMINAL CORONARY ANGIOPLASTY;

ACUTE CORONARY SYNDROME; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; ATHEROSCLEROSIS; HUMANS; PIPERAZINES; PLATELET AGGREGATION INHIBITORS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RISK FACTORS; THIOPHENES; THROMBOSIS; TICLOPIDINE;

EID: 67649981100     PISSN: 10834087     EISSN: None     Source Type: Journal    
DOI: 10.18553/jmcp.2009.15.5.383     Document Type: Review

References (71)

1. Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ. 2002;324(7329):71-86. (Pubitemid 34073138)
2. Yeghiazarians Y, Braunstein JB, Askari A, Stone PH. Unstable angina pectoris. N Engl J Med. 2000;342(2):101-114
3. Inoue T, Sohma R, Miyazaki T, et al. Comparison of activation process of platelets and neutrophils after coronary stent implantation versus balloon angioplasty for stable angina pectoris. Am J Cardiol. 2000;86(10):1057-1062 (Pubitemid 30802211)
4. Steg PG, Bhatt DL, Wilson PW, et al. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA. 2007;297(11):1197-1206 (Pubitemid 46465728)
5. 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. (Pubitemid 32758501)
6. 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): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007;116(7):e148-304.
7. ECC Committee, Subcommittees and Task Forces of the American Heart Association. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2005;112(24 Suppl):1V1-203.
8. 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: developed in collaboration With the Canadian Cardiovascular Society endorsed by the American Academy of Family Physicians: 2007 Writing Group to Review New Evidence and Update the ACC/AHA 2004 Guidelines for the Management of Patients With ST-Elevation Myocardial Infarction, Writing on Behalf of the 2004 Writing Committee. Circulation. 2008;117(2):296-329.
9. Becker RC, Meade TW, Berger PB, et al. The primary and secondary prevention of coronary artery disease: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):776S-814S. (Pubitemid 351894917)
10. Hirsh J, Guyatt G, Albers GW, Harrington R, Schunemann HJ. Executive summary: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133(6 Suppl):71S-109S. (Pubitemid 351892961)
11. King SB, III, Smith SC, Jr., Hirshfeld JW, Jr., et al. 2007 Focused Update of the ACC/AHA/SCA1 2005 Guideline Update for Percutaneous Coronary Intervention: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines: 2007 Writing Group to Review New Evidence and Update the ACC/AHA/SCA1 2005 Guideline Update for Percutaneous Coronary Intervention, Writing on Behalf of the 2005 Writing Committee. Circulation. 2008;117(2):261-295
12. U.S. Food and Drug Administration. Cardiovascular and Renal Drug Advisory Committee briefing document: Questions, prasugrel for ACS. February 3, 2009. Available at: http://www.fda.gov/ohrms/dockets/ac/09/briefing/2009-4412b1-01- FDA.pdf. Accessed May 18, 2009.
13. Leon MB, Baim DS, Popma JJ, et al. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators. N Engl J Med. 1998;339(23):1665-1671
14. Hankey GJ, Sudlow CL, Dunbabin DW. Thienopyridines or aspirin to prevent stroke and other serious vascular events in patients at high risk of vascular disease? A systematic review of the evidence from randomized trials. Stroke. 2000;31(7):1779-1784 (Pubitemid 30437537)
15. Love BB, Biller J, Gent M. Adverse haematological effects of ticlopidine. Prevention, recognition and management. Drug Saf. 1998;19(2):89-98.
16. Smith SC, Jr., Allen J, Blair SN, et al. AHA/ACC guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update: endorsed by the National Heart, Lung, and Blood Institute. Circulation. 2006;113(19):2363-2372
17. Sanmuganathan PS, Ghahramani P, Jackson PR, Wallis EJ, Ramsay LE. Aspirin for primary prevention of coronary heart disease: safety and absolute benefit related to coronary risk derived from meta-analysis of randomised trials. Heart. 2001;85(3):265-271 (Pubitemid 32973555)
18. Patrono C, Bachmann F, Baigent C, et al. Expert consensus document on the use of antiplatelet agents. The task force on the use of antiplatelet agents in patients with atherosclerotic cardiovascular disease of the European society of cardiology. Eur Heart J. 2004;25(2):166-181
19. Bassand JP, Hamm CW, Ardissino D, et al. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes. Eur Heart J. 2007;28(13):1598-1660
20. Bhatt DL, Flather MD, Hacke W, et al. Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial. J Am Coll Cardiol. 2007;49(19):1982-1988 (Pubitemid 46694290)
21. 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. Available at: http://circ. ahajournals.org/cgi/reprint/116/25/2923. Accessed May 19, 2009. (Pubitemid 350291199)
22. 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(25):3366-73. Available at: http://circ.ahajournals.org/ cgi/reprint/111/25/3366. Accessed May 19, 2009. (Pubitemid 40931949)
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 May 18, 2009. (Pubitemid 350106708)
24. Antman EM, Wiviott SD, Murphy SA, et al. Early and late benefits of prasugrel in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a TRITON-TIMI 38 (TRial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet InhibitioN with Prasugrel- Thrombolysis In Myocardial Infarction) analysis. J Am Coll Cardiol. 2008;51(21):2028-2033 (Pubitemid 351689056)
25. Murphy SA, Antman EM, Wiviott SD, et al. Reduction in recurrent cardiovascular events with prasugrel compared with clopidogrel in patients with acute coronary syndromes from the TRITON-TIMI 38 trial. Eur Heart J. 2008;29(20):2473-79. Available at: http://www.pubmedcentral.nih.gov/picrender. fcgi?artid=2567025&blobtype=pdf. Accessed May 19, 2009.
26. Wiviott SD, Braunwald E, Angiolillo DJ, et al. Greater clinical benefit of more intensive 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(16):1626-1636
27. Wiviott SD, Braunwald E, McCabe CH, et al. Intensive oral antiplatelet therapy for reduction of ischaemic events including stent thrombosis in patients with acute coronary syndromes treated with percutaneous coronary intervention and stenting in the TRITON-TIMI 38 trial: a subanalysis of a randomised trial. Lancet. 2008;371(9621):1353-1363
28. 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, randomised controlled trial. Lancet. 2009;373(9665):723-731
29. Asai F, Jakubowski JA, Naganuma H, et al. Platelet inhibitory activity and pharmacokinetics of prasugrel (CS-747) a novel thienopyridine P2Y12 inhibitor: a single ascending dose study in healthy humans. Platelets. 2006;17(4):209-217 (Pubitemid 43890792)
30. 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(12):2429-2436 (Pubitemid 350154353)
31. Brandt JT, Payne CD, Wiviott SD, et al. A comparison of prasugrel and clopidogrel loading doses on platelet function: magnitude of platelet inhibition is related to active metabolite formation. Am Heart J. 2007;153(1):66. (Pubitemid 44895531)
32. Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership. Plavix (clopidogrel bisulfate tablets) prescribing information. Bridgewater, NJ, 2009. Available at: http://products.sanofi-aventis.us/plavix/plavix.html.
33. 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 (Pubitemid 46625113)
34. 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 (Pubitemid 46956429)
35. Jakubowski JA, Payne CD, Brandt JT, et al. The platelet inhibitory effects and pharmacokinetics of prasugrel after administration of loading and maintenance doses in healthy subjects. J Cardiovasc Pharmacol. 2006;47(3):377-384 (Pubitemid 44309690)
36. Jarvis B, Simpson K. Clopidogrel: a review of its use in the prevention of atherothrombosis. Drugs. 2000;60(2):347-377 (Pubitemid 30680398)
37. Matsushima N, Jakubowski JA, Asai F, et al. Platelet inhibitory activity and pharmacokinetics of prasugrel (CS-747) a novel thienopyridine P2Y12 inhibitor: a multiple-dose study in healthy humans. Platelets. 2006;17(4):218-226 (Pubitemid 43890793)
38. Mullangi R, Srinivas NR. Clopidogrel: review of bioanalytical methods, pharmacokinetics/pharmacodynamics, and update on recent trends in drug-drug interaction studies. Biomed Chromatogr. 2009;23(1):26-41.
39. Niitsu Y, Jakubowski JA, Sugidachi A, Asai F. Pharmacology of CS-747 (prasugrel, LY640315), a novel, potent antiplatelet agent with in vivo P2Y12 receptor antagonist activity. Semin Thromb Hemost. 2005;31(2):184-194 (Pubitemid 40605193)
40. Savi P, Pereillo JM, Uzabiaga MF, et al. Identification and biological activity of the active metabolite of clopidogrel. Thromb Haemost. 2000;84(5):891-896 (Pubitemid 30946954)
41. Taubert D, Kastrati A, Harlfinger S, et al. Pharmacokinetics of clopidogrel after administration of a high loading dose. Thromb Haemost. 2004;92(2):311-316 (Pubitemid 39172312)
42. Umemura K, Furuta T, Kondo K. The common gene variants of CYP2C19 affect pharmacokinetics and pharmacodynamics in an active metabolite of clopidogrel in healthy subjects. J Thromb Haemost. 2008;6(8):1439-1441 (Pubitemid 352016331)
43. Mega JL, Close SL, Wiviott SD, et al. Cytochrome p-450 polymorphisms and response to clopidogrel. N Engl J Med. 2009;360(4):354-362
44. Sibbing D, Stegherr J, Latz W, et al. Cytochrome P450 2C19 loss-of-function polymorphism and stent thrombosis following percutaneous coronary intervention. Eur Heart J. 2009;30(8):916-922
45. Simon T, Verstuyft C, Mary-Krause M, et al. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009;360(4):363-375
46. Lau WC, Waskell LA, Watkins PB, et al. Atorvastatin reduces the ability of clopidogrel to inhibit platelet aggregation: a new drug-drug interaction. Circulation. 2003;107(1):32-37. Available at: http://circ.ahajournals.org/cgi/ reprint/107/1/32. Accessed May 19, 2009. (Pubitemid 36070929)
47. Siller-Matula JM, Lang I, Christ G, Jilma B. Calcium-channel blockers reduce the antiplatelet effect of clopidogrel. J Am Coll Cardiol 2008;52(19):1557-1563
48. Saw J, Brennan DM, Steinhubl SR, et al. Lack of evidence of a clopidogrel-statin interaction in the CHARISMA trial. J Am Coll Cardiol. 2007;50(4):291-295 (Pubitemid 47058889)
49. Saw J, Steinhubl SR, Berger PB, et al. Lack of adverse clopidogrel-atorvastatin clinical interaction from secondary analysis of a randomized, placebo-controlled clopidogrel trial. Circulation. 2003;108(8):921-24. Available at: http://circ.ahajournals.org/cgi/reprint/108/8/ 921. Accessed May 19, 2009. (Pubitemid 37048218)
50. Flockhart DA. Drug interactions: cytochrome P450 drug interaction table. Indiana University School of Medicine, 2007. Available at: http://medicine. iupui.edu/clinpharm/ddis/table.pdf. Accessed May 21, 2009.
51. Pezalla E, Day D, Pulliadath I. Initial assessment of clinical impact of a drug interaction between clopidogrel and proton pump inhibitors. J Am Coll Cardiol. 2008;52(12):1038-1039
52. 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
53. Gilard M, Arnaud B, Cornily JC, et al. Influence of omeprazole on the antiplatelet action of clopidogrel associated with aspirin: the randomized, double-blind OCLA (Omeprazole CLopidogrel Aspirin) study. J Am Coll Cardiol. 2008;51(3):256-260
54. Siller-Matula JM, Spiel AO, Lang IM, et al. Effects of pantoprazole and esomeprazole on platelet inhibition by clopidogrel. Am Heart J. 2009;157(1):148.
55. Wood S. Possible "class effect" for proton-pump inhibitors on top of copidogrel therapy. Heartwire, May 6, 2009. Available at: http://www.theheart.org/article/967075.do. Accessed May 17, 2009.
56. The Society for Cardiovascular Angiography and Interventions. SCA1 statement on "A National Study of the Effect of Individual Proton Pump Inhibitors on Cardiovascular Outcomes in Patients Treated with Clopidogrel Following Coronary Stenting: The Clopidogrel Medco Outcomes Study." May 7, 2009. Available at: http://www.scai.org/drlt1.aspx?PAGE-ID=5870. Accessed May 19, 2009.
57. 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
58. Mega JL, Close SL, Wiviott SD, et al. Cytochrome P450 genetic polymorphisms and the response to prasugrel. relationship to pharmacokinetic, pharmacodynamic, and clinical outcomes. Circulation. 2009;9(19):2553-2560
59. Jakubowski JA, Payne CD, Weerakkody GJ, et al. Dose-dependent inhibition of human platelet aggregation by prasugrel and its interaction with aspirin in healthy subjects. J Cardiovasc Pharmacol. 2007;49(3):167-173 (Pubitemid 46579951)
60. Weerakkody GJ, Jakubowski JA, Brandt JT, et al. Comparison of speed of onset of platelet inhibition after loading doses of clopidogrel versus prasugrel in healthy volunteers and correlation with responder status. Am J Cardiol. 2007;100(2):331-336 (Pubitemid 47042002)
61. 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(10):1166-1173 (Pubitemid 43752387)
62. Serebruany VL, Midei MG, Meilman H, Malinin AI, Lowry DR. Platelet inhibition with prasugrel (CS-747) compared with clopidogrel in patients undergoing coronary stenting: the subset from the JUMBO study. Postgrad Med J. 2006;82(968):404-410 (Pubitemid 43945478)
63. The CAPTURE Investigators. Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: the CAPTURE Study. Lancet. 1997;349(9063):1429-1435
64. Platelet Receptor Inhibition in Ischemic Syndrome Management in Patients Limited by Unstable Signs and Symptoms (PRISM-PLUS) Study Investigators. Inhibition of the platelet glycoprotein IIb/IIIa receptor with tirofiban in unstable angina and non-Q-wave myocardial infarction. Platelet Receptor Inhibition in Ischemic Syndrome Management in Patients Limited by Unstable Signs and Symptoms (PRISM-PLUS) Study Investigators. N Engl J Med. 1998;338(21):1488-1497
65. The PURSUIT Trial Investigators. Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. The PURSUIT Trial Investigators. Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy. N Engl J Med. 1998;339(7):436-443
66. Hirsh J, Bhatt DL. Comparative benefits of clopidogrel and aspirin in high-risk patient populations: lessons from the CAPRIE and CURE studies. Arch Intern Med. 2004;164(19):2106-2110 (Pubitemid 39410798)
67. Wiviott SD, Antman EM, Gibson CM, et al. Evaluation of prasugrel compared with clopidogrel in patients with acute coronary syndromes: design and rationale for the TRial to assess Improvement in Therapeutic Outcomes by optimizing platelet InhibitioN with prasugrel Thrombolysis In Myocardial Infarction 38 (TRITON-TIMI 38). Am Heart J. 2006;152(4):627-35. (Pubitemid 44396884)
68. Clinicaltrials.gov. NCT 00699998. A comparision of prasugrel and cloipidogrel in acute coronary syndrome subjects (TRILOGY ACS). Available at: http://www.clinicaltrials.gov/ct2/show/NCT00699998?term=NCT00699998&rank=1. Accessed May 18, 2009.
69. Lotrionte M, Biondi-Zoccai GG, Agostoni P, et al. Meta-analysis appraising high clopidogrel loading in patients undergoing percutaneous coronary intervention. Am J Cardiol. 2007;100(8):1199-1206
70. CAPRIE Steering Committee. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). Lancet. 1996;348(9038):1329-1339 (Pubitemid 26383772)
71. Schafer JA, Kjesbo NK, Gleason PP. Critical review of prasugrel for formulary decision makers. J Manag Care Pharm. 2009;15(4):335-343 Available at: http://www.amcp.org/data/jmcp/335-343.pdf.