A randomized trial to assess the pharmacodynamics and pharmacokinetics of a single dose of an extended-release aspirin formulation

Postgraduate Medicine

Volumn 127, Issue 6, 2015, Pages 573-580

  Patrick, Jeff ^a   Dillaha, Larry ^a   Armas, Danielle ^b   Sessa, William C ^c  

^a New Haven Pharmaceuticals   (United States)

^b CELERION   (United States)

^c YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Acetylsalicylic acid; Aspirin; Extended release; Platelets; Thromboxane

Indexed keywords

11 OXOTHROMBOXANE B2; ACETYLSALICYLIC ACID; ALANINE AMINOTRANSFERASE; ARACHIDONIC ACID; ASPARTATE AMINOTRANSFERASE; SALICYLIC ACID; THROMBOXANE B2; THROMBOXANE B2 DERIVATIVE; ANTITHROMBOCYTIC AGENT; DELAYED RELEASE FORMULATION; MICROCAPSULE;

ADULT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; DRUG SAFETY; FEMALE; GAMMA GLUTAMYL TRANSFERASE BLOOD LEVEL; HEADACHE; HUMAN; HYPERTRANSAMINASEMIA; ID50; MALE; MAXIMUM DRUG EFFECT; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; THROMBOCYTE AGGREGATION; TIME TO MAXIMUM PLASMA CONCENTRATION; ADOLESCENT; CLINICAL TRIAL; CROSSOVER PROCEDURE; DELAYED RELEASE FORMULATION; DOSE RESPONSE; DRUG EFFECTS; MICROCAPSULE; MIDDLE AGED; PHASE 1 CLINICAL TRIAL; THERAPEUTIC EQUIVALENCE; YOUNG ADULT;

ADOLESCENT; ADULT; AREA UNDER CURVE; ASPIRIN; CAPSULES; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; MALE; MIDDLE AGED; PLATELET AGGREGATION; PLATELET AGGREGATION INHIBITORS; THERAPEUTIC EQUIVALENCY; YOUNG ADULT;

EID: 84942237593     PISSN: 00325481     EISSN: 19419260     Source Type: Journal    
DOI: 10.1080/00325481.2015.1050341     Document Type: Article

References (23)

1. Vandvik PO, Lincoff AM, Gore JM, Gutterman DD, Sonnenberg FA, Alonso-Coello P, et al. Primary and secondary prevention of cardiovascular disease: antithrombotic therapy and prevention of thrombosis, 9th Ed: American College Of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141:E637s–68s.
2. Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC, et al. American Heart Association Stroke Council, Council On Cardiovascular Nursing, Council On Clinical Cardiology, And Interdisciplinary Council On Quality Of Care And Outcomes Research. Guidelines For The Prevention Of Stroke In Patients With Stroke Or Transient Ischemic Attack: A Guideline For Healthcare Professionals From The American Heart Association/American Stroke Association. Stroke 2011;42:227–76.
3. Patrono C, García Rodríguez LA, Landolfi R, Baigent C. Low-dose aspirin for the prevention of atherothrombosis. N Engl J Med 2005;353:2373–83.
4. Ricciotti E, Fitzgerald GA. Prostaglandins and inflammation. Arterioscler Thromb Vasc Biol 2011;31:986–1000.
5. Wallace JL. Prostaglandins, NSAIDs, and gastric mucosal protection: why doesn’t the stomach digest itself? Physiol Rev 2008;88:1547–65.
6. Graham DY, Smith JL. Aspirin and the stomach. Ann Intern Med 1986;104:390–8.
7. Kelly JP, Kaufman DW, Jurgelon JM, Sheehan J, Koff RS, Shapiro S. Risk of aspirin-associated major upper-gastrointestinal bleeding with enteric-coated or buffered product. Lancet 1996;348:1413–16.
8. Awtry EH, Loscalzo J. Aspirin. Circulation 2000;101:1206–18.
9. Sørensen HT, Mellemkjaer L, Blot WJ, Nielsen GL, Steffensen FH, McLaughlin JK, Olsen JH. Risk of upper gastrointestinal bleeding associated with use of low-dose aspirin. Am J Gastroenterol 2000;95:2218–24.
10. Rocca B, Petrucci G. Variability in the responsiveness to low-dose aspirin: pharmacological and disease-related mechanisms. Thrombosis 2012;2012:376721.
11. Gasparyan AY, Watson T, Lip GY. The role of aspirin in cardiovascular prevention: implications of aspirin resistance. J Am Coll Cardiol 2008;51:1829–43.
12. Wurtz M, Grove EL. Interindividual variability in the efficacy of oral antiplatelet drugs: definitions, mechanisms and clinical importance. Curr Pharm Des 2012;18:5344–61.
13. Capodanno D, Patel A, Dharmashankar K, Ferreiro JL, Ueno M, Kodali M, et al. Pharmacodynamic effects of different aspirin dosing regimens in type 2 diabetes mellitus patients with coronary artery disease. Circ Cardiovasc Interv 2011;4:180–7.
14. Rocca B, Santilli F, Pitocco D, Mucci L, Petrucci G, Vitacolonna E, et al. The recovery of platelet cyclooxygenase activity explains interindividual variability in responsiveness to low-dose aspirin in patients with and without diabetes. J Thromb Haemost 2012;10:1220–30.
15. Grove EL, Hvas AM, Mortensen SB, Larsen SB, Kristensen SD. Effect of platelet turnover on whole blood platelet aggregation in patients with coronary artery disease. J Thromb Haemost 2011;9:185–91.
16. Grove EL, Hvas AM, Kristensen SD. Immature platelets in patients with acute coronary syndromes. Thromb Haemost 2009;101:151–6.
17. Schnell O, Erbach M, Hummel M. Primary and secondary prevention of cardiovascular disease in diabetes with aspirin. Diab Vasc Dis Res 2012;9:245–55.
18. Brown N, May JA, Wilcox RG, Allan LM, Wilson AM, Kiff PS, Heptinstall S. Comparison of antiplatelet activity of microencapsulated aspirin 162.5 Mg (Caspac Xl), with enteric coated aspirin 75 Mg And 150 Mg in patients with atherosclerosis. Br J Clin Pharmacol 1999;48:57–62.
19. Frontroth JP. Light transmission aggregometry. In Monagle P, editor. Haemostasis methods and protocols. New York, NY: Humana Press; 2013. pp 227–40.
20. Clarke RJ, Mayo G, Price P, FitzGerald GA. Suppression of thromboxane A2 but not of systemic prostacyclin by controlled-release aspirin. N Engl J Med 1991;325:1137–41.
21. Simpson SH, Abdelmoneim AS, Omran D, Featherstone TR. Prevalence of high on-treatment platelet reactivity in diabetic patients treated with aspirin. Am J Med 2014;127:95.E1–9.
22. Martin JF, Kristensen SD, Mathur A, Grove EL, Choudry FA. The causal role of megakaryocyte-platelet hyperactivity in acute coronary syndromes. Nat Rev Cardiol 2012;9:658–70.
23. Patrignani P, Tacconelli S, Piazuelo E, Di Francesco L, Dovizio M, Sostres C, et al. Reappraisal of the clinical pharmacology of low-dose aspirin by comparing novel direct and traditional indirect biomarkers of drug action. J Thromb Haemost 2014;12:1320–30.