Expert position paper on the use of proton pump inhibitors in patients with cardiovascular disease and antithrombotic therapy

European Heart Journal

Volumn 34, Issue 23, 2013, Pages

  Agewall, Stefan ^a   Cattaneo, M ^b   Collet, J P ^c   Andreotti, F ^d   Lip, G Y H ^e   Verheugt, F W A ^f   Huber, K ^g   Grove, E L ^h   Morais, J ⁱ   Husted, S ^h   Wassmann, S ^j   Rosano, G ^k   Atar, D ^a   Pathak, A ^l   Kjeldsen, K ^m   Storey, R F ⁿ  

^a OSLO UNIVERSITY HOSPITAL   (Norway)

^b UNIVERSITY OF MILAN   (Italy)

^c INSERM   (France)

^d CATHOLIC UNIVERSITY   (Italy)

^e UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^f Onze Lieve Vrouwe Gasthuis ^*  (Netherlands)

^g WILHELMINEN HOSPITAL   (Austria)

^h AARHUS UNIVERSITY HOSPITAL   (Denmark)

ⁱ Centro Hospitalar Leiria Pombal   (Portugal)

^j Medizinische Klinik   (Germany)

^k IRCCS SAN RAFFAELE PISANA   (Italy)

^l Université de Toulouse   (France)

^m AALBORG UNIVERSITY   (Denmark)

ⁿ UNIVERSITY OF SHEFFIELD   (United Kingdom)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACENOCOUMAROL; ACETYLSALICYLIC ACID; APIXABAN; BLOOD CLOTTING FACTOR 10A INHIBITOR; CLOPIDOGREL; DABIGATRAN; ESOMEPRAZOLE; HISTAMINE H2 RECEPTOR ANTAGONIST; LANSOPRAZOLE; OMEPRAZOLE; PANTOPRAZOLE; PHENPROCOUMON; PRASUGREL; PROTON PUMP INHIBITOR; RABEPRAZOLE; RIVAROXABAN; TICAGRELOR; WARFARIN;

ACUTE HEART INFARCTION; ANTICOAGULANT THERAPY; AREA UNDER THE CURVE; BLEEDING; CARDIAC PATIENT; CARDIOVASCULAR DISEASE; COMPETITIVE INHIBITION; CORONARY STENT; DRUG ABSORPTION; DRUG EFFICACY; DRUG EXPOSURE; DRUG HALF LIFE; DRUG METABOLISM; DRUG POTENCY; DRUG SOLUBILITY; DYSPEPSIA; HEART INFARCTION; HIGH RISK PATIENT; HUMAN; HYPERTENSION; INTERNATIONAL NORMALIZED RATIO; ISCHEMIC HEART DISEASE; MAXIMUM PLASMA CONCENTRATION; OUTCOME ASSESSMENT; PLATELET REACTIVITY; PRIORITY JOURNAL; PROTHROMBIN TIME; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; ST SEGMENT ELEVATION; STENT THROMBOSIS; STOMACH PH; THROMBOCYTE AGGREGATION; UNSTABLE ANGINA PECTORIS;

ADENOSINE; ASPIRIN; BENZIMIDAZOLES; BETA-ALANINE; CARDIOVASCULAR DISEASES; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; FIBRINOLYTIC AGENTS; HUMANS; PIPERAZINES; PLATELET AGGREGATION INHIBITORS; PROTON PUMP INHIBITORS; PURINERGIC P2Y RECEPTOR ANTAGONISTS; THIOPHENES; TICLOPIDINE; WARFARIN;

EID: 84879068693     PISSN: 0195668X     EISSN: 15229645     Source Type: Journal    
DOI: 10.1093/eurheartj/eht042     Document Type: Review

References (51)

1. Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, WijnsW, Zahger D; ESC Committee for Practice Guidelines, Bax JJ, Auricchio A, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Knuuti J, Kolh P, McDonagh T, Moulin C, Poldermans D, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Torbicki A, Vahanian A, Windecker S; Document Reviewers, Windecker S, Achenbach S, Badimon L, Bertrand M, Bøtker HE, Collet JP, Crea F, Danchin N, Falk E, Goudevenos J, Gulba D, Hambrecht R, Herrmann J, Kastrati A, Kjeldsen K, Kristensen SD, Lancellotti P, Mehilli J, Merkely B, Montalescot G, Neumann FJ, Neyses L, Perk J, Roffi M, Romeo F, Ruda M, Swahn E, Valgimigli M, Vrints CJ, Widimsky P. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: the Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J 2011;32:2999-3054.
2. Steg PG, James SK, Atar D, Badano LP, Lundqvist CB, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Valgimigli M, Van't Hof A, Widimsky P, Zahger D; ESC Committee for Practice Guidelines (CPG), Bax JJ, Baumgartner H, Ceconi C, Dean V, Deaton C, Fagard R, Funck-Brentano C, Hasdai D, Hoes A, Kirchhof P, Knuuti J, Kolh P, McDonagh T, Moulin C, Popescu BA, Reiner Z, Sechtem U, Sirnes PA, Tendera M, Torbicki A, Vahanian A, Windecker S; Document Reviewers, Hasdai D, Astin F, Aström-Olsson K, Budaj A, Clemmensen P, Collet JP, Fox KA, Fuat A, Gustiene O, Hamm CW, Kala P, Lancellotti P, Maggioni AP, Merkely B, Neumann FJ, Piepoli MF, Van de Werf F, Verheugt F, Wallentin L. ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: the Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC). Eur Heart J 2012;33:2569-2619.
3. Abraham NS, Hlatky MA, Antman EM, Bhatt DL, Bjorkman DJ, Clark CB, Furberg CD, Johnson DA, Kahi CJ, Laine L, Mahaffey KW, Quigley EM, Scheiman J, Sperling LS, Tomaselli GF; ACCF/ACG/AHA. ACCF/ACG/AHA 2010 expert consensus document on the concomitant use of proton pump inhibitors and thienopyridines: a focused update of the ACCF/ACG/AHA 2008 expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use. J Am Coll Cardiol 2010;56:2051-2066.
4. Gilard M, Arnaud B, Le Gal G, Abgrall JF, Boschat J. Influence of omeprazol on the antiplatelet action of clopidogrel associated to ASA. J Thromb Haemost 2006;4: 2508-2509.
5. O'Donoghue ML, Braunwald E, Antman EM, Murphy SA, Bates ER, Rozenman Y, Michelson AD, Hautvast RW, Ver Lee PN, Close SL, Shen L, Mega JL, Sabatine MS, Wiviott SD. Pharmacodynamic effect and clinical efficacy of clopidogrel and prasugrel with or without a proton-pump inhibitor: an analysis of two randomised trials. Lancet 2009;374:989-997.
6. Charlot M, Grove EL, Hansen PR, Olesen JB, Ahlehoff O, Selmer C, Lindhardsen J, Madsen JK, Køber L, Torp-Pedersen C, Gislason GH. Proton pump inhibitor use and risk of adverse cardiovascular events in ASA treated patients with first time myocardial infarction: nationwide propensity score matched study. BMJ 2011;342: d2690.
7. Würtz M, Grove EL, Kristensen SD, Hvas AM. The antiplatelet effect of ASA is reduced by proton pump inhibitors in patients with coronary artery disease. Heart 2010;96:368-371.
8. Adamopoulos AB, Sakizlis GN, Nasothimiou EG, Anastasopoulou I, Anastasakou E, Kotsi P, Karafoulidou A, Stergiou GS. Do proton pump inhibitors attenuate the effect of ASA on platelet aggregation? A randomized crossover study. J Cardiovasc Pharmacol 2009;54:163-168.
9. Inarrea P, Esteva F, Cornudella R, Lanas A. Omeprazole does not interfere with the antiplatelet effect of low-dose ASA in man. Scand J Gastroenterol 2000;35: 242-246.
10. Kazui M, Nishiya Y, Ishizuka T, Hagihara K, Farid NA, Okazaki O, Ikeda T, Kurihara A. Identification of the human cytochrome P450 enzymes involved in the two oxidative steps in the bioactivation of clopidogrel to its pharmacologically active metabolite. Drug Metab Dispos 2009;38:92-99.
11. Hagihara K, Nishiya Y, Kurihara A, Kazui M, Farid NA, Ikeda T. Comparison of human cytochrome P450 inhibition by the thienopyridines prasugrel, clopidogrel, and ticlopidine. Drug Metab Pharmacokinet 2008;23:412-420.
12. Li X-Q, Andersson TB, Ahlström M, Weidolf L. Comparison of inhibitory effects of the proton pump-inhibiting drugs omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole on human cytochrome P450 activities. Drug Metab Dispos 2004;32:821-827.
13. Angiolillo DJ, Gibson CM, Cheng S, Ollier C, Nicolas O, Bergougnan L, Perrin L, LaCreta FP, Hurbin F, Dubar M. 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;89:65-74.
14. Rassen JA, Choudhry NK, Avorn J, Schneeweiss S. Cardiovascular outcomes and mortality in patients using clopidogrel with proton pump inhibitors after percutaneous coronary intervention or acute coronary syndrome. Circulation. 2009; 120:2322-2329.
15. Sarafoff N, Sibbing D, Sonntag U, Ellert J, Schulz S, Byrne RA, Mehilli J, Schömig A, Kastrati A. Risk of drug-eluting stent thrombosis in patients receiving proton pump inhibitors. Thromb Haemost 2010;104:626-632.
16. Tentzeris I, Jarai R, Farhan S, Brozovic I, Smetana P, Geppert A, Wojta J, Siller-Matula J, Huber K. Impact of concomitant treatment with proton pump inhibitors and clopidogrel on clinical outcome in patients after coronary stent implantation. Thromb Haemost 2010;104:1211-1218.
17. Bhatt DL, Cryer BL, Contant CF, Cohen M, Lanas A, Schnitzer TJ, Shook TL, Lapuerta P, Goldsmith MA, Laine L, Scirica BM, Murphy SA, Cannon CP. COGENT Investigators. Clopidogrel with or without Omeprazole in Coronary Artery Disease. N Engl J Med 2010;363:1909-1917.
18. Grove EL, Würtz M, Schwarz P, Jørgensen NR, Vestergaard P. Gastrointestinal events with clopidogrel: a nationwide population-based cohort study. J Gen Intern Med 2012; (in press) DOI: 10.1007/s11606-012-2208-0.
19. Juurlink DN, Gomes T, Ko DT, Szmitko PE, Austin PC, Tu JV, Henry DA, Kopp A, Mamdani MM. A population-based study of the drug interaction between proton pump inhibitors and clopidogrel. CMAJ 2009;180:713-718.
20. Stockl KM, Le L, Zakharyan A, Harada AS, Solow BK, Addiego JE, Ramsey S. Risk of rehospitalization for patients using clopidogrel with a proton pump inhibitor. Arch Intern Med 2010;170:704-710.
21. Siller-Matula JM, Jilma B, Schror K, Christ G, Huber K. Effect of proton pump inhibitors on clinical outcome in patients treated with clopidogrel: a systematic review and meta-analysis. J Thromb Haemost 2010;8:2624-2641.
22. Hulot JS, Collet JP, Silvain J, Pena A, Bellemain-Appaix A, Barthélémy O, Cayla G, Beygui F, Montalescot G. Cardiovascular risk in clopidogrel-treated patients according to cytochrome P450 2C19*2 loss-of-funtion allele or proton pump inhibitor co-administration: A systematic meta-analysis. J Am Coll Cardiol 2010;56: 134-143.
23. Ho PM, Maddox TM, Wang L, Fihn SD, Jesse RL, Peterson ED, Rumsfeld JS. Risk of adverse outcomes associated with concomitant use of clopidogrel and proton pump inhibitors following acute coronary syndrome. JAMA 2009;301:937-944.
24. Roe MT, Armstrong PW, Fox KA, White HD, Prabhakaran D, Goodman SG, Cornel JH, Bhatt DL, Clemmensen P, Martinez F, Ardissino D, Nicolau JC, Boden WE, Gurbel PA, Ruzyllo W, Dalby AJ, McGuire DK, Leiva-Pons JL, Parkhomenko A, Gottlieb S, Topacio GO, Hamm C, Pavlides G, Goudev AR, Oto A, Tseng CD, Merkely B, Gasparovic V, Corbalan R, Cinteza? M, McLendon RC, Winters KJ, Brown EB, Lokhnygina Y, Aylward PE, Huber K, Hochman JS, Ohman EM; TRILOGY ACS Investigators. Prasugrel versus clopidogrel for acute coronary syndromes without revascularization. N Engl J Med 2012; 367:1297-1309.
25. Small DS, Farid NA, Payne CD, Weerakkody GJ, Li YG, Brandt JT, Salazar DE, Winters KJ. Effects of the proton pump inhibitor lansoprazole on the pharmacokinetics and pharmacodynamics of prasugrel and clopidogrel. J Clin Pharmacol 2008;48:475-484.
26. Seiler D, Doser K, Salem I. Relative bioavailability of prasugrel free base in comparison to prasugrel hydrochloride in the presence and in the absence of a proton pump inhibitor. Arzneimittelforschung 2011;61:247-251.
27. Aradi D, Kuliczkowski W, Atar D, Serebruany VL. Inter-patient variability and impact of proton pump inhibitors on platelet reactivity after prasugrel. Thromb Haemost 2012;107:338-345.
28. Teng R. Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Profile of the Oral Antiplatelet Agent Ticagrelor. Clin Pharmacokinet 2012;51: 305-318.
29. Storey RF, Angiolillo D, Patil S, Desai B, Ecob R, Husted S, Emanuelsson H, Cannon C, Becker R,Wallentin L. Inhibitory effects of ticagrelor compared to clopidogrel on platelet function in patients with acute coronary syndromes: the PLATO PLATELET substudy. J Am Coll Cardiol 2010;56:1456-1462.
30. Goodman SG, Clare R, Pieper KS, Nicolau JC, Storey RF, Cantor WJ, Mahaffey KW, Angiolillo DJ, Husted S, Cannon CP, James SK, Kilhamn J, Steg PG, Harrington RA, Wallentin L. Association of proton pump inhibitor use on cardiovascular outcomes with clopidogrel and ticagrelor/clinical perspective. Circulation 2012;125:978-986.
31. Sauvet P, Schouler L. Omeprazole and liver functions. Rev Med Interne 1992;13: 359-363.
32. Jung JW, Kang HR, Kwon JW, Kim TE, Lee SH, Hong KS, Yu KS, Cho SH. The potential inhibitory effect of revaprazan, an acid pump antagonist, on anticoagulation with warfarin. Tohoku J Exp Med 2011;224:293-300.
33. Julkunen RJ. The absorption of warfarin from the rat stomach in situ. Med Biol 1976;54:260-263.
34. Goldstein JA. Clinical relevance of genetic polymorphisms in the human CYP2C subfamily. Br J Clin Pharmacol 2001;52:349-355.
35. Wu AHB. Drug metabolizing enzyme acitivites versus genetic variances for drug of clinical pharmacogenomic relevance. Clin Proteomics 2011;8:12.
36. Vakily M, Lee RD, Wu J, Gunawardhana L, Mulford D. Drug interaction studies with dexlansoprazole modified release (TAK-390MR), a proton pump inhibitor with a dual delayed-release formulation: results of four randomized, double-blind, crossover, placebo-controlled, single-centre studies. Clin Drug Investig 2009;29: 35-50.
37. Steinijans VW, Huber R, Hartmann M, Zech K, Bliesath H, WurstW, Radtke HW. Lack of pantoprazol drug interactions in man: an updated review. Int J Clin Pharmacol Ther 1996;34:243-262.
38. Humphries TJ, Merritt GJ. Review article: drug interactions with agents used to treat acid-related diseases. Aliment Pharmacol Ther 1999;13(S3):18-26.
39. Teichert M, van Noord C, Uitterlinden AG, Hofman A, Buhre PN, De Smet PA, Straus S, Stricker BH, Visser LE. Proton pump inhibitors and the risk of overanticoagulation during acenocoumarol maintenance treatment. Br J Haematol 2011; 153:379-385.
40. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD,Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 2009;361:1139-1151.
41. Schulman S, Kearon C, Kakkar AK, Mismetti P, Schellong S, Eriksson H, Baanstra D, Schnee J, Goldhaber SZ; RE-COVER Study Group. Dabigatran versus warfarin in the treatment of acute venous thromboembolism. N Engl J Med 2009;361:2342-2352.
42. Doc. Id. US Drug Substance: Dabigatran Etexilate (DE). Page 2. Boehringer Ingelheim Page 2 of 168 Dabigatran Briefing Document www.fda.gov/.../Drugs/ CardiovascularandRenalDrugsAdvisoryCommittee/UCM226009.pdf. (13 February 2013).
43. Huisman MV, Lip GY, Diener HC, Brueckmann M, van Ryn J, Clemens A. Dabigatran etexilate for stroke prevention in patients with atrial fibrillation: resolving uncertainties in routine practice. Thromb Haemost 2012;107: 838-847.
44. Liesenfeld KH, Lehr T, Dansirikul C, Reilly PA, Connolly SJ, Ezekowitz MD, Yusuf S, Wallentin L, Haertter S, Staab A. Population pharmacokinetic analysis of the oral thrombin inhibitor dabigatran etexilate in patients with nonvalvular atrial fibrillation from the RE-LY trial. J Thromb Haemost 2011;9: 2168-2175.
45. U.S. Food and Drug Administration -FDA Briefing Information, Dabigatran Etexilate Mesylate Capsules, for the September 20, 2010 Meeting of the Cardiovascular and Renal Drugs Advisory Committee. Oct 19th, 2010. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeeting Materials/Drugs/CardiovascularandRenalDrugsAdvisoryCommittee/UCM247244. (14 February 2013).
46. EINSTEIN Investigators, Baursachs R, Berkowitz SD, Brenner B, Buller HR, Decousus H, Gallus AS, Lensing AW, Misselwitz F, Prins MH, Raskob GE, Segers A, Verhamme P, Wells P, Agnelli G, Bounameaux H, Cohen A, Davidson BL, Piovella F, Schellong S. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med 2010;363:2499-2510.
47. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM.; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 2011;365: 885-891.
48. Connolly SJ, Eikelboom J, Joyner C, Diener HC, Hart R, Golitsyn S, Flaker G, Avezum A, Hohnloser SH, Diaz R, Talajic M, Zhu J, Pais P, Budaj A, Parkhomenko A, Jansky P, Commerford P, Tan RS, Sim KH, Lewis BS, Van Mieghem W, Lip GY, Kim JH, Lanas-Zanetti F, Gonzalez-Hermosillo A, Dans AL, Munawar M, O'Donnell M, Lawrence J, Lewis G, Afzal R, Yusuf S.; AVERROES Steering Committee and Investigators. Apixaban in patients with atrial fibrillation. N Engl J Med 2011;364:806-817.
49. Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L.; ARISTOTLE Committees and Investigatorsl. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981-992.
50. Stedman CA, Barclay ML. Review article: comparison of the pharmacokinetics, acid suppression and efficacy of proton pump inhibitors. Aliment Pharmacol Ther 2000;14:963-978.
51. Saini SD, Fendrick AM, Scheiman JM. Cost-effectiveness analysis: cardiovascular benefits of proton pump inhibitor co-therapy in patients using ASA for secondary prevention. Aliment Pharmacol Ther 2011;34:243-251.