Pharmacodynamic effects of standard dose prasugrel versus high dose clopidogrel in non-diabetic obese patients with coronary artery disease

Thrombosis and Haemostasis

Volumn 111, Issue 2, 2013, Pages 258-265

  Darlington, Andrew ^a   Tello Montoliu, Antonio ^a   Rollini, Fabiana ^a   Ueno, Masafumi ^a   Ferreiro, José Luis ^a   Patel, Ronakkumar ^a   Desai, Bhaloo ^a   Guzman, Luis A ^a   Bass, Theodore A ^a   Angiolillo, Dominick J ^a  

^a UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

Author keywords

Clopido grel; Coronary artery disease; Obesity; Platelet function; Prasugrel

Indexed keywords

CLOPIDOGREL; PRASUGREL; VASODILATOR STIMULATED PHOSPHOPROTEIN;

ADULT; ARTICLE; CLINICAL ARTICLE; COMPARATIVE STUDY; CORONARY ARTERY DISEASE; DRUG MEGADOSE; FEMALE; HUMAN; LOADING DRUG DOSE; MALE; MIDDLE AGED; OBESITY; PLATELET REACTIVITY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTE AGGREGATION; THROMBOCYTE FUNCTION ANALYZER;

CLOPIDOGREL; CORONARY ARTERY DISEASE; OBESITY; PLATELET FUNCTION; PRASUGREL;

ASPIRIN; BIOLOGICAL MARKERS; BLOOD PLATELETS; BODY MASS INDEX; CELL ADHESION MOLECULES; CORONARY ARTERY DISEASE; DRUG THERAPY, COMBINATION; FEMALE; FLORIDA; HUMANS; MALE; MICROFILAMENT PROTEINS; MIDDLE AGED; OBESITY; PHOSPHOPROTEINS; PHOSPHORYLATION; PIPERAZINES; PLATELET ACTIVATION; PLATELET ADHESIVENESS; PLATELET AGGREGATION; PLATELET AGGREGATION INHIBITORS; PLATELET FUNCTION TESTS; PROSPECTIVE STUDIES; RECEPTORS, PURINERGIC P2Y12; THIOPHENES; TICLOPIDINE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84893171392     PISSN: 03406245     EISSN: None     Source Type: Journal    
DOI: 10.1160/TH13-07-0529     Document Type: Article

References (47)

1. Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, et al. Variability in individual responsiveness to clopidogrel: clinical implications, management, and future perspectives. J Am Coll Cardiol 2007; 49: 1505-1516.
2. Ferreiro JL, Angiolillo DJ. Clopidogrel response variability: current status and future directions. Thromb Haemost 2009; 102: 7-14.
3. Bonello L, Tantry US, Marcucci R, et al. For the Working Group on High On-Treatment Platelet Reactivity. Consensus and future directions on the definition of high on-treatment platelet reactivity to adenosine diphosphate. J Am Coll Cardiol 2010; 56: 919-933.
4. Gaglia MA Jr, Torguson R, Pakala R, et al. Relation of body mass index to on-treatment (clopidogrel + aspirin) platelet reactivity. Am J Cardiol 2011; 108: 766-771.
5. Breet NJ, van Donkersgoed HE, van Werkum JW, et al. Is platelet inhibition due to thienopyridines increased in elderly patients, in patients with previous stroke and patients with low body weight as a possible explanation of an increased bleeding risk? Neth Heart J 2011; 19: 279-284.
6. Zhu B, Effron MB, Kulkarni M P, et al. The onset of inhibition of platelet aggregation with prasugrel compared with clopidogrel loading doses using gatekeep-ing analysis of integrated clinical pharmacology data. J Cardiovasc Pharmacol 2011; 57: 317-324.
7. 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: 169-174.
8. Bonello-Palot N, Armero S, Paganelli F, et al. Relation of body mass index to high on-treatment platelet reactivity and of failed clopidogrel dose adjustment according to platelet reactivity monitoring in patients undergoing percutaneous coronary intervention. Am J Cardiol 2009; 104: 1511-1515.
9. Sibbing D, von Beckerath O, Schomig A, et al. Impact of body mass index on platelet aggregation after administration of a high loading dose of 600 mg of clopidogrel before percutaneous coronary intervention. Am J Cardiol 2007; 100: 203-205.
10. Hochholzer W, Trenk D, Bestehorn H P, et al. Impact of the degree of peri-inter-ventional platelet inhibition after loading with clopidogrel on early clinical outcome of elective coronary stent placement. J Am Coll Cardiol 2006; 48: 1742-1750.
11. Bonello L, Berbis J, Laine M, et al. Biological efficacy of a 600 mg loading dose of clopidogrel in ST-elevation myocardial infarction. Thromb Haemost 2012; 108: 101-106.
12. Cayla G, Cuisset T, Silvain J, et al. Prasugrel monitoring and bleeding in real world patients. Am J Cardiol 2013; 111: 38-44.
13. Alexopoulos D, Xanthopoulou I, Perperis A, et al. Factors Affecting Residual Platelet Aggregation in Prasugrel Treated Patients. Curr Pharm Des 2013; 19: 5121-5126.
14. Cuisset T, Quilici J, Morange PE, et al. Predictors of long-term high on-treat-ment platelet reactivity in clopidogrel-treated patients undergoing coronary stenting for acute coronary syndrome. Int J Cardiol 2013; 168: 1565-1566.
15. Gremmel T, Steiner S, Seidinger D, et al. Obesity is associated with poor response to clopidogrel and an increased susceptibility to protease activated re-ceptor-1 mediated platelet activation. Transl Res 2013; 161: 421-429.
16. Zürn CS, Geisler T, Gawaz M. ADP-receptor blockade: A case for personalised pharmacotherapy? Thromb Haemost 2010; 103: 496-506.
17. Mokdad AH, Ford ES, Bowman BA, et al. Prevalence of obesity, diabetes, and obesity-related health risk factors, 2001. J Am Med Assoc 2003; 289: 76-79.
18. Angiolillo DJ, Badimon JJ, Saucedo J, et al. A Pharmacodynamic comparison of prasugrel vs. high-dose clopidogrel in patients with type 2 diabetes mellitus and coronary artery disease: results of the Optimising anti-Platelet Therapy in diabetes MellitUS (OPTIMUS)-3 Trial. Eur Heart J 2011; 32: 838-846.
19. 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: 2430-2435.
20. Ueno M, Ferreiro JL, Tomasello SD, et al. Functional profile of the platelet P2Y12 receptor signalling pathway in patients with type 2 diabetes mellitus and coronary artery disease. Thromb Haemost 2011; 105: 730-732.
21. Erlinge D, Varenhorst C, Braun O, et al. Patients with poor responsiveness to thienopyridine treatment and those with diabetes have lower levels of circulating active metabolites but their platelets respond normally to the active metabolite added ex-vivo. J Am Coll Cardiol 2008; 52: 1968-1977.
22. 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: 849-856.
23. Brar SS, ten Berg J, Marcucci R, et al. Impact of platelet reactivity on clinical outcomes after percutaneous coronary intervention. A collaborative meta-analysis of individual participant data. J Am Coll Cardiol. 2011; 58:1945-1954.
24. Price MJ, Angiolillo DJ, Teirstein PS, et al. Platelet reactivity and cardiovascular outcomes after percutaneous coronary intervention: a time-dependent analysis of the Gauging Responsiveness with a VerifyNow P2Y12 assay: Impact on Thrombosis and Safety (GRAVITAS) trial. Circulation 2011; 124: 1132-1137.
25. 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: 2923-2932.
26. Jernberg T, Payne C, Winters K, et al. Prasugrel achieves greater inhibition of platelet aggregation and a lower rate of non-responders compared with clopido-grel in aspirin- treated patients with stable coronary artery disease. Eur Heart J 2006; 27: 1166-1173.
27. Ferreiro JL, Angiolillo DJ. Diabetes and antiplatelet therapy in acute coronary syndrome. Circulation 2011; 123: 798-813.
28. Hanley MJ, Abernethy DR, Greenblatt DJ. Effect of obesity on the pharmacoki-netics of drugs in humans. Clin Pharmacokinet. 2010; 49: 71-87.
29. Santilli F, Vazzana N, Liani R, et al. Platelet activation in obesity and metabolic syndrome. Obes Rev 2012; 13: 27-42.
30. Gandhi A, Moorthy B, Ghose R. Drug disposition in pathophysiological conditions. Curr Drug Metab 2012; 9: 1327-1344.
31. Kotlyar M, Carson SW. Effects of obesity of the cytochrome p450 system. Int J Clin Pharmacol Ther 1999; 1: 8-19.
32. Rocca B, Santilli F, Pitocco D, et al. The recovery of platelet cyclooxygenase activity explains inter-individual variability in responsiveness to low-dose aspirin in patients with and without diabetes. J Thromb Haemost 2012; 7: 1220-1230.
33. Takaya J, Iwamoto Y, Higashino H, et al. Altered intracellular calcium and phor-bol 12,13-dibutyrate binding to intact platelets in young obese subject. J Lab Clin Med 1997; 129: 245-250.
34. Scherrer U, Nussberger J, Torriani S, et al. Effect of weight reduction in moderately overweight patients on recorded ambulatory blood pressure and free cy-tostolic platelet calcium. Circulation 1991; 83: 552-558.
35. Anfossi G, Russo I, Trovati M. Platelet resistance to the anti-aggregating agents in the insulin resistant states. Curr Diabetes Rev 2006; 4: 409-430.
36. 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: 21-30.
37. Wrishko RE, Ernest CS, Small DS, et al. Population pharmacokinetic analyses to evaluate the influence of intrinsic and extrinsic factors on exposure of prasugrel active metabolite in TRITON-TIMI 38. J Clin Pharmacol 2009; 49: 984-998.
38. Erlinge D, Ten Berg J, Foley D, et al. Reduction in platelet reactivity with prasu-grel 5 mg in low-body-weight patients is noninferior to prasugrel 10 mg in higher-body-weight patients: results from the FEATHER trial. J Am Coll Car-diol 2012; 60: 2032-2040.
39. Ernest CS, Small DS, Rohatagi S, et al. Population pharmacokinetics and pharma-codynamics of prasugrel and clopidogrel in aspirin-treated patients with stable coronary artery disease. J Pharmacokinet Pharmacodyn 2008; 35: 593-618.
40. Payne CD, Li YG, Small DS, et al. Increased active metabolite formation explains the greater platelet inhibition with prasugrel compared to high-dose clopidogrel. J Cardiovasc Pharmacol 2007; 50: 555-562.
41. Wiviott S, Antman E, Winters K, et al. Randomized Comparison of Prasugrel (CS-747, LY640315), a Novel Thienopyridine P2Y 12 Antagonist, With Clopi-dogrel in Percutaneous Coronary Intervention: Results of the Joint Utilisation of Medications to Block Platelets Optimally (JUMBO)-TIMI 26 Trial. Circulation 2005; 111: 3366-3373.
42. Angiolillo DJ, Gibson CM, Cheng S, et al. Differential effects of omeprazole and pantoprazole on the pharmacodynamics and pharmacokinetics of clopidogrel in healthy subjects: randomized, placebo-controlled, crossover comparison studies. Clin Pharmacol Ther 2011; 1: 65-74.
43. Linden M, Furman M, Frelinger A, et al. Indices of platelet activation and the stability of coronary artery disease. J Thromb Haemost 2007; 4: 761-765.
44. Hochholzer W, Trenk D, Frundi D, et al. Time dependence of platelet inhibition after a 600-mg loading dose of clopidogrel in a large, unselected cohort of candidates for percutaneous coronary intervention. Circulation 2005; 111:2560-2564.
45. Zhu B, Effron MB, Kulkarni M P, et al. The onset of inhibition of platelet aggregation with prasugrel compared with clopidogrel loading doses using gatekeep-ing analysis of integrated clinical pharmacology data. J Cardiovasc Pharmacol 2011; 57: 317-324.
46. Jakubowski JA, Li YG, Small DS, et al. A comparison of the 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.
47. Montalescot G, Sideris G, Meuleman C, et al.; ALBION Trial Investigators. A randomized comparison of high clopidogrel loading doses in patients with non-ST-segment elevation acute coronary syndromes: the ALBION (Assessment of the Best Loading Dose of Clopidogrel to Blunt Platelet Activation, Inflammation and Ongoing Necrosis) trial. J Am Coll Cardiol 2006; 48: 931-938.