Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial

New England Journal of Medicine

Volumn 352, Issue 11, 2005, Pages 1092-1102

  Bresalier, Robert S ^a   Sandler, Robert S ^b   Quan, Hui ^c   Bolognese, James A ^c   Oxenius, Bettina ^c   Horgan, Kevin ^c   Lines, Christopher ^c   Riddell, Robert ^d   Morton, Dion ^e   Lanas, Angel ^f   Konstam, Marvin A ^g   Baron, John A ^h  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^c MERCK RESEARCH LABORATORIES   (United States)

^d MOUNT SINAI HOSPITAL   (Canada)

^e UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^f HOSPITAL CLÍNICO UNIVERSITARIO LOZANO BLESA   (Spain)

^g TUFTS MEDICAL CENTER   (United States)

^h DARTMOUTH MEDICAL SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ROFECOXIB;

ADULT; AGED; ARTERY THROMBOSIS; ARTICLE; CARDIOVASCULAR RISK; CEREBROVASCULAR ACCIDENT; CHEMOPROPHYLAXIS; CLINICAL TRIAL; COLORECTAL ADENOMA; CONFIDENCE INTERVAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HEART FAILURE; HEART INFARCTION; HUMAN; LUNG EDEMA; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; MORTALITY; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SUDDEN DEATH; TRANSIENT ISCHEMIC ATTACK; UNSTABLE ANGINA PECTORIS; VEIN THROMBOSIS;

ADENOMATOUS POLYPS; ADULT; AGED; AGED, 80 AND OVER; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ASPIRIN; CARDIOVASCULAR DISEASES; COLORECTAL NEOPLASMS; CYCLOOXYGENASE INHIBITORS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INCIDENCE; LACTONES; MALE; MIDDLE AGED; PROPORTIONAL HAZARDS MODELS; RECURRENCE; RISK; SINGLE-BLIND METHOD; SULFONES; THROMBOSIS;

EID: 19744380776     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJMoa050493     Document Type: Article

References (29)

1. Dannenberg AJ, Subbaramaiah K. Targeting cyclooxygenase-2 in human neoplasia: rationale and promise. Cancer Cell 2003;4:431-6.
2. 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 2000;43:4-13.
3. Howard PA, Delafontaine P. Nonsteroidal anti-inflammatory drugs and cardiovascular risk. J Am Coll Cardiol 2004;43:519-25.
4. Konstam MA, Weir MR, Reicin A, et al. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation 2001;104:2280-8.
5. Weir MR, Sperling RS, Reicin A, Gertz BJ. Selective COX-2 inhibition and cardiovascular effects: a review of the rofecoxib development program. Am Heart J 2003;146: 591-604.
6. Solomon DH, Glynn RJ, Levin R, Avorn J. Nonsteroidal anti-inflammatory drug use and acute myocardial infarction. Arch Intern Med 2002;162:1099-104.
7. Solomon DH, Schneeweiss S, Glynn RJ, et al. Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation 2004;109:2068-73.
8. Strand V, Hochberg MC. The risk of cardiovascular thrombotic events with selective cyclooxygenase-2 inhibitors. Arthritis Rheum 2002;47:349-55.
9. 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 2004;363:1751-6.
10. 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 2001; 8:85-95. [Erratum, Am J Ther 2001;8:220.]
11. 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 2002;90: 959-63.
12. Egan KM, Wang M, Lucitt MB, et al. Cyclooxygenases, thromboxane, and atherosclerosis: plaque destabilization by cyclooxygenase-2 inhibition combined with thromboxane receptor antagonism. Circulation 2005;111:334-42.
13. 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 2000;343:1520-8.
14. Rahme E, Pilote L, LeLorier J. Association between naproxen use and protection against acute myocardial infarction. Arch Intern Med 2002;162:1111-5. [Erratum, Arch Intern Med 2002;162:1858.]
15. Watson DJ, Rhodes T, Cai B, Guess HA. Lower risk of thromboembolic cardiovascular events with naproxen among patients with rheumatoid arthritis. Arch Intern Med 2002;162:1105-10. [Erratum, Arch Intern Med 2002;162:1779.]
16. Farkouh ME, Kirshner H, Harrington RA, et al. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial. Lancet 2004;364:675-84.
17. Reicin AS, Shapiro D, Sperling RS, Barr E, Yu Q. Comparison of cardiovascular thrombotic events in patients with osteoarthritis treated with rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs (ibuprofen, diclofenac, and nabumetone). Am J Cardiol 2002;89:204-9.
18. 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 2003;163:481-6.
19. Ray WA, Stein CM, Daugherty JR, Hall K, Arbogast PG, Griffin MR. COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease. Lancet 2002;360:1071-3.
20. Graham DJ, Campen D, Hui R, et al. Risk of acute myocardial infraction and sudden cardiac death in patients treated with cyclo-oxygenase 2 selective and non-selective non-steroidal anti-inflammatory drugs: nested case-control study. Lancet 2005;365:475-81.
21. Juni P, Nartey L, Reichenbach S, Sterchi R, Dieppe PA, Egger M. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet 2004;364:2021-9.
22. Baron JA, Cole BF, Sandler RS, et al. A randomized trial of aspirin to prevent colorectal adenomas. N Engl J Med 2003;348: 891-9.
23. 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. [Erratum, BMJ 1994;308:1540.]
24. Guess HA, Lydick EG, Small RD, Miller LP. Epidemiologic programs for computers and calculators: exact binomial confidence intervals for the relative risk in follow-up studies with sparsely stratified incidence density data. Am J Epidemiol 1987;125:340-7.
25. McAdam BF, Catella-Lawson F, Mardini IA, Kapoor S, Lawson JA, FitzGerald GA. Systemic biosynthesis of prostacyclin by cyclooxygenase (COX)-2: the human pharmacology of a selective inhibitor of COX-2. Proc Natl Acad Sci U S A 1999;96:272-7.
26. Fitzgerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med 2001;345:433-42.
27. Kimmel SE, Berlin JA, Reilly M, et al. Patients exposed to rofecoxib and celecoxib have different odds of nonfatal myocardial infarction. Ann Intern Med 2005;142:157-64.
28. Nussmeier NA, Whelton AA, Brown MT, et al. Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl J Med 2005;352:1081-91.
29. Solomon SD, McMurray JJV, Pfeffer MA, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005;352: 1071-80.