Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: Randomised controlled trial

Lancet

Volumn 364, Issue 9435, 2004, Pages 675-684

  Farkouh, Michael E ^a   Kirshner, Howard ^b   Harrington, Robert A ^c   Ruland, Sean ^d   Verheugt, Freek W A ^e   Schnitzer, Thomas J ^f   Burmester, Gerd R ^g   Mysler, Eduardo ^h   Hochberg, Marc C ⁱ   Doherty, Michael ^j   Ehrsam, Elena ^l   Gitton, Xavier ^l   Krammer, Gerhard ^l   Mellein, Bernhard ^l   Gimona, Alberto ^l   Matchaba, Patrice ^l   Hawkey, Christopher J ^k   Chesebro, James H ^m  

^a NEW YORK UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b VANDERBILT UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^d UNIVERSITY OF ILLINOIS AT CHICAGO   (United States)

^e RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^f NORTHWESTERN UNIVERSITY   (United States)

^g CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^h Buenos Aires ^*  (Argentina)

ⁱ UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^j UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^k NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST   (United Kingdom)

^l NOVARTIS PHARMA AG   (Switzerland)

^m MAYO CLINIC   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; CYCLOOXYGENASE 2 INHIBITOR; IBUPROFEN; LUMIRACOXIB; NAPROXEN; NONSTEROID ANTIINFLAMMATORY AGENT; ANTITHROMBOCYTIC AGENT; DICLOFENAC; DRUG DERIVATIVE; ORGANIC COMPOUND; PROSTAGLANDIN SYNTHASE INHIBITOR;

ADULT; AGE; AGED; ARTICLE; BLEEDING; CARDIOTOXICITY; CARDIOVASCULAR RISK; CARDIOVASCULAR SYSTEM; CLINICAL ARTICLE; CLINICAL TRIAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DATA ANALYSIS; DEEP VEIN THROMBOSIS; DOUBLE BLIND PROCEDURE; DRUG SAFETY; DRUG USE; FEMALE; FOLLOW UP; GASTROINTESTINAL TOXICITY; HEART ARREST; HEART DEATH; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HUMAN; INCIDENCE; LUNG EMBOLISM; MALE; OSTEOARTHRITIS; PATIENT COMPLIANCE; PRIORITY JOURNAL; Q WAVE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; ST SEGMENT DEPRESSION; ST SEGMENT ELEVATION; STROKE; TRANSIENT ISCHEMIC ATTACK; TREATMENT OUTCOME; UNSTABLE ANGINA PECTORIS; CEREBROVASCULAR ACCIDENT; CHEMICALLY INDUCED DISORDER; COMPARATIVE STUDY; MIDDLE AGED; MULTICENTER STUDY; RISK FACTOR;

AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ASPIRIN; CEREBROVASCULAR ACCIDENT; CYCLOOXYGENASE INHIBITORS; DICLOFENAC; DOUBLE-BLIND METHOD; FEMALE; HUMANS; IBUPROFEN; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; NAPROXEN; ORGANIC CHEMICALS; OSTEOARTHRITIS; PLATELET AGGREGATION INHIBITORS; RISK FACTORS;

EID: 4344578073     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(04)16894-3     Document Type: Article

References (33)

1. Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA. 286:2001;954-959
2. Konstam MA, Weir MR, Reicin A, et al. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation. 104:2001;2280-2288
3. Strand V, Hochberg MC. The risk of cardiovascular thrombotic events with selective cyclooxygenase-2 inhibitors. Arthritis Rheum. 47:2002;349-355
4. Mamdani M, Rochon P, Juurlink DN, et al. Effect of selective cyclooxygenase 2 inhibitors and naproxen on short-term risk of acute myocardial infarction in the elderly. Arch Intern Med. 163:2003;481-486
5. Solomon DH, Schneeweiss S, Glynn RJ, et al. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation. 109:2004;2068-2073
6. Mamdani M, Juurlink DN, Lee DS, et al. Cyclo-oxygenase-2 inhibitors versus non-selective non-steroidal anti-inflammatory drugs and congestive heart failure outcomes in elderly patients: a population-based cohort study. Lancet. 363:2004;1751-1756
7. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 343:2000;1520-1528
8. Solomon DH, Glynn RJ, Levin R, Avorn J. Nonsteroidal anti-inflammatory drug use and acute myocardial infarction. Arch Intern Med. 162:2002;1099-1104
9. Watson DJ, Rhodes T, Cai B, Guess HA. Lower risk of thromboembolic cardiovascular events with naproxen among patients with rheumatoid arthritis. Arch Intern Med. 162:2002;1105-1110
10. Rahme E, Pilote L, LeLorier J. Association between naproxen use and protection against acute myocardial infarction. Arch Intern Med. 162:2002;1111-1115
11. Van Hecken A, Schwartz JI, Depre M, et al. Comparative inhibitory activity of rofecoxib, meloxicam, diclofenac, ibuprofen and naproxen on COX-2 versus COX-1 in healthy volunteers. J Clin Pharmacol. 40:2000;1109-1120
12. Ray W, Stein M, Daugherty J, Hall K, Arbogast P, Griffin M. Cox-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet. 360:2002;1071-1073
13. Howard PA, Delafontaine P. Nonsteroidal anti-inflammatory drugs and cardiovascular risk. J Am Coll Cardiol. 43:2004;519-525
14. Crofford LJ, Lipsky PE, Brooks P, Abramson SB, Simon LS, van de Putte LB. Basic biology and clinical application of specific cyclooxygenase-2 inhibitors. Arthritis Rheum. 43:2000;4-13
15. McAdam BF, Catella LF, Mardini IA, et al. Systemic biosynthesis of prostacyclin by cyclooxygenase (COX)-2: the human pharmacology of a selective inhibitor of COX-2. Proc Natl Acad Sci USA. 96:1999;272-277
16. Woolf AD, Pfleger B. Burden of major musculoskeletal conditions. Bull World Health Organ. 819:2003;646-656
17. Singh G, Miller JD, Lee FH, Pattitt D, Russell MW. Prevalence of cardiovascular disease risk factors among US adults with self-reported osteoarthritis: data from the third national health and nutrition examination survey. Am J Manag Care. 8:2002;S383-S391
18. Brune K, Hinz B. Selective cyclooxygenase-2 inhibitors: similarities and differences. Scand J Rheumatol. 33:2004;1-6
19. Mangold JB, Gu H, Rodriguez LC, Scott G, Bonner J, Rordorf C. Pharmacokinetics and metabolism of lumiracoxib in healthy male subjects. Drug Metab Rev 2002; 34 (suppl 1): 141 (abstr 281).
20. Scott G, Rordorf C, Blood P, Branson J, Milosavljev S, Greig G. Dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of COX189 in healthy subjects. Ann Rheum Dis 2002; 61 (suppl 1): 242 (abstr FRI0300).
21. Hawkey CJ, Farkouh M, Gitton X, Ehrsam E, Huels J, Richardson P. Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET): study design and patient demographics. Aliment Pharmacol Ther. 19:2004;1-13
22. Schnitzer TJ, Burmester GR, Mysler E, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), reduction in ulcer complications: randomised controlled trial. Lancet. 364:2004;665-674
23. Grundy SM, Pasternak R, Greenland P, Smith S Jr, Fuster V. AHA/ACC scientific statement: assessment of cardiovascular risk by use of multiple-risk-factor assessment equations. J Am Coll Cardiol. 34:1999;1348-1359
24. Antiplatelet Trialists' Collaboration. 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. BMJ 1994; 308: 81-106.
25. Fisher LD, Gent M, Buller HR. Active-control trials: how would a new agent compare with placebo? A method illustrated with clopidogrel, aspirin, and placebo. Am Heart J. 141:2001;26-32
26. Capone ML, Tacconelli S, Sciulli MG, et al. Clinical pharmacology of platelet, monocyte, and vascular cyclooxygenase inhibition by naproxen and low-dose aspirin in healthy subjects. Circulation. 109:2004;1468-1471
27. Catella-Lawson F, Reilly M, et al. Cyclooxygenase inhibitors and the antiplatelet effects of aspirin. N Engl Med. 345:2001;1809-1817
28. MacDonald TM, Wei L. Effect of ibuprofen on cardioprotective effect of aspirin. Lancet. 361:2003;573-574
29. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA. 284:2000;1247-1255
30. Whelton A, Fort JG, Puma JA, Normandin D, Bello AE, Verburg KM. Cyclooxygenase-2-specific inhibitors and cardiorenal function: a randomized, controlled trial of celecoxib and rofecoxib in older hypertensive osteoarthritis patients. Am J Ther. 8:2001;85-95
31. Whelton A, White WB, Bello AE, Puma JA, Fort JG. Effects of celecoxib and rofecoxib on blood pressure and edema in patients ≥65 years of age with systemic hypertension and osteoarthritis. Am J Cardiol. 90:2002;959-963
32. Hansson L, Zanchetti A, Carruthers SG, et al. Effects of intensive blood pressure lowering and low dose aspirin in patients with hypertension: principal results of the Hypertension Optimal Treatment (HOT) randomized trial. Lancet. 351:1998;1755-1762
33. MacMahon S, Peto R, Cutler J, et al. Blood pressure stroke and coronary heart disease: part 1, prolonged differences in blood pressure - prospective regression dilution bias. Lancet. 335:1990;765-774