Oral antiplatelet therapy in diabetes mellitus and the role of prasugrel: An overview

Vascular Health and Risk Management

Volumn 7, Issue 1, 2011, Pages 445-459

  Hillegass, William B ^a   Brott, Brigitta C ^b   Dobbs, James C ^b   Papapietro, Silvio E ^b   Misra, Vijay K ^b   Zoghbi, Gilbert J ^b  

^a Interventional Cardiovascular Section University of Alabama at Birmingham ^*

^b UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

Author keywords

Acute coronary syndromes; Antithrombotic agents; Diabetes mellitus; Percutaneous coronary intervention; Prasugrel

Indexed keywords

ANTITHROMBOCYTIC AGENT; PIPERAZINE DERIVATIVE; PRASUGREL; THIOPHENE DERIVATIVE;

BLOOD; CARDIOVASCULAR DISEASE; CORONARY ARTERY DISEASE; DIABETES MELLITUS; DRUG COMBINATION; DRUG RESISTANCE; HEART INFARCTION; HUMAN; MORTALITY; ORAL DRUG ADMINISTRATION; PATHOPHYSIOLOGY; REVIEW; STROKE; THROMBOSIS; TIME; TRANSLUMINAL CORONARY ANGIOPLASTY; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ANGIOPLASTY, BALLOON, CORONARY; CARDIOVASCULAR DISEASES; CORONARY ARTERY DISEASE; DIABETES MELLITUS; DRUG RESISTANCE; DRUG THERAPY, COMBINATION; HUMANS; MYOCARDIAL INFARCTION; PIPERAZINES; PLATELET AGGREGATION INHIBITORS; STROKE; THIOPHENES; THROMBOSIS; TIME FACTORS; TREATMENT OUTCOME;

EID: 80054978441     PISSN: 11766344     EISSN: 11782048     Source Type: Journal    
DOI: 10.2147/VHRM.S4746     Document Type: Review

References (78)

1. Brieger D, Fox KA, Fitzgerald G, et al. Predicting freedom from clinical events in non-ST-elevation acute coronary syndromes. The Global Registry of Acute Coronary Events. Heart. 2009.
2. Anderson HV, Shaw RE, Brindis RG, et al. A contemporary overview of percutaneous coronary interventions. The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR). J Am Coll Cardiol. 2002;39(7):1096-1103.
3. Brown JR, Edwards FH, O'Connor GT, Ross CS, Furnary AP. The diabetic disadvantage: historical outcomes measures in diabetic patients undergoing cardiac surgery-the pre-intravenous insulin era. Semin Thorac Cardiovasc Surg. 2006;18(4):281-288.
4. Donahoe SM, Stewart GC, McCabe CH, et al. Diabetes and mortality following acute coronary syndromes. JAMA. 2007;298(7):765-775.
5. Machecourt J, Danchin N, Lablanche JM, et al. Risk factors for stent thrombosis after implantation of sirolimus-eluting stents in diabetic and nondiabetic patients: the EVASTENT Matched-Cohort Registry. J Am Coll Cardiol. 2007;50(6):501-508.
6. Schafer A, Bauersachs J. Endothelial dysfunction, impaired endogenous platelet inhibition and platelet activation in diabetes and atherosclerosis. Curr Vasc Pharmacol. 2008;6(1):52-60.
7. Mina A, Favaloro EJ, Koutts J. Hemostatic dysfunction associated with endocrine disorders as a major risk factor and cause of human morbidity and mortality: a comprehensive meta-review. Semin Thromb Hemost. 2007;33(8):798-809.
8. Natarajan A, Zaman AG, Marshall SM. Platelet hyperactivity in type 2 diabetes: role of antiplatelet agents. Diab Vasc Dis Res. 2008;5(2): 138-144.
9. El Haouari M, Rosado JA. Platelet signalling abnormalities in patients with type 2 diabetes mellitus: a review. Blood Cells Mol Dis. 2008;41(1):119-123.
10. Sudic D, Razmara M, Forslund M, Ji Q, Hjemdahl P, Li N. High glucose levels enhance platelet activation: involvement of multiple mechanisms. Br J Haematol. 2006;133(3):315-322.
11. Rajendran S, Chirkov YY. Platelet hyperaggregability: impaired responsiveness to nitric oxide ("platelet NO resistance") as a therapeutic target. Cardiovasc Drugs Ther. 2008;22(3):193-203.
12. Anfossi G, Russo I, Trovati M. Resistance to aspirin and thienopyridines in diabetes mellitus and metabolic syndrome. Curr Vasc Pharmacol. 2008;6(4):313-328.
13. Corrado E, Camarda P, Coppola G, et al. Prognostic role of endothelial dysfunction and carotid intima-media thickness in patients undergoing coronary stent implantation. Int Angiol. 2009;28(1):12-19.
14. Irace C, Tschakovsky ME, Carallo C, Cortese C, Gnasso A. Endothelial dysfunction or dysfunctions? Identification of three different FMD responses in males with type 2 diabetes. Atherosclerosis. 2008;200(2):439-445.
15. Meigs JB, Mittleman MA, Nathan DM, et al. Hyperinsulinemia, hyperglycemia, and impaired hemostasis: the Framingham Offspring Study. JAMA. 2000;283(2):221-228.
16. Juhan-Vague I, Alessi MC, Vague P. Thrombogenic and fibrinolytic factors and cardiovascular risk in non-insulin-dependent diabetes mellitus. Ann Med. 1996;28(4):371-380.
17. Schneider DJ, Nordt TK, Sobel BE. Attenuated fibrinolysis and accelerated atherogenesis in type II diabetic patients. Diabetes. 1993;42(1):1-7.
18. McGill JB, Schneider DJ, Arfken CL, Lucore CL, Sobel BE. Factors responsible for impaired fibrinolysis in obese subjects and NIDDM patients. Diabetes. 1994;43(1):104-109.
19. Nordt TK, Bode C. Impaired endogenous fibrinolysis in diabetes mellitus: mechanisms and therapeutic approaches. Semin Thromb Hemost. 2000;26(5):495-501.
20. Serebruany VL, Malinin A, Ong S, Atar D. Patients with metabolic syndrome exhibit higher platelet activity than those with conventional risk factors for vascular disease. J Thromb Thrombolysis. 2008;25(2):207-213.
21. Serebruany V, Pokov I, Kuliczkowski W, Chesebro J, Badimon J. Baseline platelet activity and response after clopidogrel in 257 diabetics among 822 patients with coronary artery disease. Thromb Haemost. 2008;100(1):76-82.
22. Steiner M, Reinhardt KM, Krammer B, Ernst B, Blann AD. Increased levels of soluble adhesion molecules in type 2 (non-insulin dependent) diabetes mellitus are independent of glycaemic control. Thromb Haemost. 1994;72(6):979-984.
23. Massucco P, Mattiello L, Russo I, et al. High glucose rapidly activates the nitric oxide/cyclic nucleotide pathway in human platelets via an osmotic mechanism. Thromb Haemost. 2005;93(3):517-526.
24. Varughese GI, Patel JV, Tomson J, Blann AD, Hughes EA, Lip GY. Prognostic value of plasma soluble P-selectin and von Willebrand factor as indices of platelet activation and endothelial damage/dysfunction in highrisk patients with hypertension: a sub-study of the Anglo-Scandinavian Cardiac Outcomes Trial. J Intern Med. 2007;261(4):384-391.
25. Henn V, Slupsky JR, Grafe M, et al. CD40 ligand on activated platelets triggers an inflammatory reaction of endothelial cells. Nature. 1998;391(6667):591-594.
26. DiMinno G, Silver MJ, Cerbone AM, Murphy S. Trial of repeated lowdose aspirin in diabetic angiopathy. Blood. 1986;68(4):886-891.
27. Sacco M, Pellegrini F, Roncaglioni MC, Avanzini F, Tognoni G, Nicolucci A. Primary prevention of cardiovascular events with low-dose aspirin and vitamin E in type 2 diabetic patients: results of the Primary Prevention Project (PPP) trial. Diabetes Care. 2003;26(12):3264-3272.
28. Ogawa H, Nakayama M, Morimoto T, et al. Low-dose aspirin for primary prevention of atherosclerotic events in patients with type 2 diabetes: a randomized controlled trial. JAMA. 2008;300(18):2134-2141.
29. Collaborative overview of randomised trials of antiplatelet therapy-I: Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. Antiplatelet Trialists' Collaboration. BMJ. 1994;308(6921):81-106.
30. A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee. Lancet. 1996;348(9038):1329-1339.
31. Bhatt DL, Marso SP, Hirsch AT, Ringleb PA, Hacke W, Topol EJ. Amplified benefit of clopidogrel versus aspirin in patients with diabetes mellitus. Am J Cardiol. 2002;90(6):625-628.
32. Serebruany VL, Malinin AI, Pokov A, Barsness G, Hanley DF. Effects of clopidogrel and aspirin in combination versus aspirin alone on platelet activation and major receptor expression in diabetic patients: the PLavix Use for Treatment Of Diabetes (PLUTO-Diabetes) trial. Am Heart J. 2008;155(1):93 e1-7.
33. Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK. 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.
34. Roffi M, Chew DP, Mukherjee D, et al. Platelet glycoprotein IIb/IIIa inhibitors reduce mortality in diabetic patients with non-ST-segment-elevation acute coronary syndromes. Circulation. 2001;104(23):2767-2771.
35. Takahashi S, Ushida M, Komine R, et al. Increased basal platelet activity, plasma adiponectin levels, and diabetes mellitus are associated with poor platelet responsiveness to in vitro effect of aspirin. Thromb Res. 2007;119(4):517-524.
36. Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, et al. Platelet function profiles in patients with type 2 diabetes and coronary artery disease on combined aspirin and clopidogrel treatment. Diabetes. 2005;54(8): 2430-2435.
37. Krasopoulos G, Brister SJ, Beattie WS, Buchanan MR. Aspirin "resistance" and risk of cardiovascular morbidity: systematic review and meta-analysis. BMJ. 2008;336(7637):195-198.
38. Angiolillo DJ, Bernardo E, Sabate M, et al. Impact of platelet reactivity on cardiovascular outcomes in patients with type 2 diabetes mellitus and coronary artery disease. J Am Coll Cardiol. 2007;50(16):1541-1547.
39. Sibbing D, Braun S, Morath T, et al. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009;53(10):849-856.
40. Bonello L, Camoin-Jau L, Arques S, et al. Adjusted clopidogrel loading doses according to vasodilator-stimulated phosphoprotein phosphorylation index decrease rate of major adverse cardiovascular events in patients with clopidogrel resistance: a multicenter randomized prospective study. J Am Coll Cardiol. 2008;51(14):1404-1411.
41. Antman EM, Morrow DA, McCabe CH, et al. Enoxaparin versus unfractionated heparin with fibrinolysis for ST-elevation myocardial infarction. N Engl J Med. 2006;354(14):1477-1488.
42. Price MJ. GRAVITAS Investigators. Primary results of GRAVITAS. AHA Scientific Sessions: Late-Breaking Clinical Trials, Nov. 17, 2010. Chicago, IL.
43. Becker RC, Moliterno DJ, Jennings LK, et al. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. Lancet. 2009;373(9667):919-928.
44. Stone GW, McLaurin BT, Cox DA, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006;355(21):2203-2216.
45. Saw J, Lincoff AM, DeSmet W, et al. Lack of clopidogrel pretreatment effect on the relative efficacy of bivalirudin with provisional glycoprotein IIb/IIIa blockade compared to heparin with routine glycoprotein IIb/IIIa blockade: a REPLACE-2 substudy. J Am Coll Cardiol. 2004;44(6):1194-1199.
46. Bittl JA, Strony J, Brinker JA, et al. Treatment with bivalirudin (Hirulog) as compared with heparin during coronary angioplasty for unstable or postinfarction angina. Hirulog Angioplasty Study Investigators. N Engl J Med. 1995;333(12):764-769.
47. Bittl JA. Comparative safety profiles of hirulog and heparin in patients undergoing coronary angioplasty. The Hirulog Angioplasty Study Investigators. Am Heart J. 1995;130(3 Pt 2):658-665.
48. Lincoff AM, Bittl JA, Harrington RA, et al. Bivalirudin and provisional glycoprotein IIb/IIIa blockade compared with heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary intervention: REPLACE-2 randomized trial. JAMA. 2003;289(7):853-863.
49. Stone GW, Witzenbichler B, Guagliumi G, et al. Bivalirudin during primary PCI in acute myocardial infarction. N Engl J Med. 2008;358(21):2218-2230.
50. 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):2923-2932.
51. Jakubowski JA, Winters KJ, Naganuma H, Wallentin L. Prasugrel: a novel thienopyridine antiplatelet agent. A review of preclinical and clinical studies and the mechanistic basis for its distinct antiplatelet profile. Cardiovasc Drug Rev. 2007;25(4):357-374.
52. 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.
53. 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.
54. Sibbing D, Morath T, Stegherr J, et al. Impact of proton pump inhibitors on the antiplatelet effects of clopidogrel. Thromb Haemost. 2009;101(4):714-719.
55. Gurbel PA, Lau WC, Tantry US. Omeprazole: a possible new candidate influencing the antiplatelet effect of clopidogrel. J Am Coll Cardiol. 2008;51(3):261-263.
56. Erlinge D, Varenhorst C, Braun OO, et al. Patients with poor responsiveness to thienopyridine treatment or with diabetes have lower levels of circulating active metabolite, but their platelets respond normally to active metabolite added ex vivo. J Am Coll Cardiol. 2008;52(24): 1968-1977.
57. Wallentin L, Varenhorst C, James S, et al. Prasugrel achieves greater and faster P2Y12receptor-mediated platelet inhibition than clopidogrel due to more efficient generation of its active metabolite in aspirintreated patients with coronary artery disease. Eur Heart J. 2008;29(1): 21-30.
58. 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 e9-16.
59. Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007;357(20):2001-2015.
60. 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.
61. Toth PP. The potential role of prasugrel in secondary prevention of ischemic events in patients with acute coronary syndromes. Postgrad Med. 2009;121(1):59-72.
62. Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, et al. Platelet aggregation according to body mass index in patients undergoing coronary stenting: should clopidogrel loading-dose be weight adjusted? J Invasive Cardiol. 2004;16(4):169-174.
63. Rinaldi MJ, Kirtane AJ, Piana RN, et al. Clinical, procedural, and pharmacologic correlates of acute and subacute stent thrombosis: results of a multicenter case-control study with 145 thrombosis events. Am Heart J. 2008;155(4):654-660.
64. 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.
65. Angiolillo DJ, Shoemaker SB, Desai B, et al. Randomized comparison of a high clopidogrel maintenance dose in patients with diabetes mellitus and coronary artery disease: results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) study. Circulation. 2007;115(6):708-716.
66. Angiolillo DJ, Capranzano P, Desai B, et al. Impact of P2Y(12) Inhibitory effects induced by clopidogrel on platelet procoagulant activity in type 2 diabetes mellitus patients. Thromb Res. 2009;124(3): 318-322.
67. Angiolillo DJ, Capranzano P, Goto S, et al. A randomized study assessing the impact of cilostazol on platelet function profiles in patients with diabetes mellitus and coronary artery disease on dual antiplatelet therapy: results of the OPTIMUS-2 study. Eur Heart J. 2008;29(18):2202-2211.
68. Lee SW, Park SW, Hong MK, et al. Triple versus dual antiplatelet therapy after coronary stenting: impact on stent thrombosis. J Am Coll Cardiol. 2005;46(10):1833-1837.
69. Han Y, Li Y, Wang S, et al. Cilostazol in addition to aspirin and clopidogrel improves long-term outcomes after percutaneous coronary intervention in patients with acute coronary syndromes: a randomized, controlled study. Am Heart J. 2009;157(4):733-739.
70. Ahn Y, Jeong MH, Jeong JW, et al. Randomized comparison of cilostazol vs clopidogrel after drug-eluting stenting in diabetic patients-clilostazol for diabetic patients in drug-eluting stent (CIDES) trial. Circ J. 2008;72(1):35-39.
71. Mardikar HM, Hiremath MS, Moliterno DJ, et al. Optimal platelet inhibition in patients undergoing PCI: data from the Multicenter Registry of High-Risk Percutaneous Coronary Intervention and Adequate Platelet Inhibition (MR PCI) study. Am Heart J. 2007;154(2):344 e1-5.
72. Mehta SR, Yusuf S, Peters RJ, et al. Effects of pretreatment with clopidogrel and aspirin followed by long-term therapy in patients undergoing percutaneous coronary intervention: the PCI-CURE study. Lancet. 2001;358(9281):527-533.
73. Steinhubl SR, Berger PB, Mann JT 3rd, et al. Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial. JAMA. 2002;288(19):2411-2420.
74. Chen ZM, Jiang LX, Chen YP, et al. Addition of clopidogrel to aspirin in 45,852 patients with acute myocardial infarction: randomised placebocontrolled trial. Lancet. 2005;366(9497):1607-1621.
75. Bhatt DL, Fox KA, Hacke W, et al. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006;354(16):1706-1717.
76. 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.
77. Markus HS, Droste DW, Kaps M, et al. Dual antiplatelet therapy with clopidogrel and aspirin in symptomatic carotid stenosis evaluated using doppler embolic signal detection: the Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis (CARESS) trial. Circulation. 2005;111(17):2233-2240.
78. Diener HC, Bogousslavsky J, Brass LM, et al. Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, doubleblind, placebo-controlled trial. Lancet. 2004;364(9431):331-337.