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Expert Opinion on Drug Safety Volume 4, 2005 - Issue 6
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Review

Celecoxib and cardiovascular risks

James M Brophy McGill University Health Centre, Divisions of Cardiology and Clinical Epidemiology, Room R4.12, Royal Victoria Hospital, 687 Pine Avenue West, Montréal, Québec, H3A 1A1, Canada. [email protected]
Pages 1005-1015 | Published online: 28 Oct 2005

Bibliography

  • BRESALIER RS, SANDLER RS, QUAN H et al THE ADENOMATOUS POLYP PREVENTION ON VIOXX (APPROVE) TRIAL INVESTIGATORS: Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl. J. Med. (2005) 352:1092–1102.
  • •The fmal study which led to the withdrawal of rofecoxib.
  • BOMBARDIER C, LAINE L, REICIN A et al.: Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR study group. N Engl. J. Med. (2000) 343:1520–1528.
  • GRAHAM DJ, CAMPEN D, HUI R et al: Risk of acute myocardial infarction 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) 365:475–481.
  • RAY WA, STEIN CM, HALL K, DAUGHERTY JR, GRIFFIN MR: Non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease: an observational cohort study. Lancet (2002) 359:118–123.
  • SOLOMON DH, SCHNEEWEISS S, GLYNN RJ et al.: Relationship between selective cyclooxygenase-2 inhibitors and acute myocardial infarction in older adults. Circulation (2004) 109:2068–2073.
  • TOPOL EJ: Arthritis medicines and cardiovascular events-'house of coxibs'. "AMA (2005) 293:366–368.
  • TOPOL EJ: Failing the public health-rofecoxib, Merck, and the FDA. N Engl. J. Med. (2004) 351:1707–1709.
  • •Interesting editorial examining the roles of the main players (Merck and the FDA) in the rofecoxib issue.
  • TOPOL EJ, FALK GW: A coxib a day won't keep the doctor away. Lancet (2004) 364:639–640.
  • SINGH G: Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am. J. Med. (1998) 105:31S–38S.
  • SIMON LS, WEAVER AL, GRAHAM DYet al.: Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis: a randomized controlled trial. JAMA (1999) 282(20):1921–1928.
  • MOORE RA, DERRY S, MAKINSON GT, MCQUAY HJ: Tolerability and adverse events in clinical trials of celecoxib in osteoarthritis and rheumatoid arthritis: systematic review and meta-analysis of information from company clinical trial reports. Arthritis Res. Ther. (2005) 7:R644–R665.
  • SILVERSTEIN FE, FAICH G, GOLDSTEIN JL et al.: Gastrointestinal toxicity with celecoxib versus nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: A randomized controlled trial. Celecoxib long-term arthritis Safety study. "AMA (2000) 284:1247–1255.
  • CHAN FK, HUNG LC, SUEN BY et al: Celecoxib versus diclofenac and omeprazole in reducing the risk of recurrent ulcer bleeding in patients with arthritis. N. Engl. J. Med. (2002) 347:2104–2110.
  • MAMDANI M, ROCHON PA, JUURLINK DN et al: Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs. Br. Med. J. (2002) 325:624.
  • BOGATY P, BROPHY JM, NOEL M et al: Impact of prolonged cyclooxygenase-2 inhibition on inflammatory markers and endothelial function in patients with ischemic heart disease and raised C-reactive protein: a randomized placebo-controlled study. Circulation (2004) 110(8):934–939.
  • CIPOLLONE F, PRONTERA C, PINI B et al: Overexpression of functionally coupled cyclooxygenase-2 and prostaglandin E synthase in symptomatic atherosclerotic plaques as a basis of prostaglandin E(2)-dependent plaque instability. Circulation (2001) 104:921–927.
  • 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) 111:334–342.
  • ROSS R: Atheroscelerosis- an inflammatory disease. N Engl. J. Med. (1999) 340:115–126.
  • RABAUSCH K, BRETSCHNEIDER E, SARBIA M et al.: Regulation of thrombomodulin expression in human vascular smooth muscle cells by COX-2-derived prostaglandins. Circ. Res. (2005) 96:el-e6.
  • FARKOUH M, 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) 364:675–684.
  • SOWERS JR, WHITE WB, PITT B et al. AND FOR THE CELECOXIB ROFECOXIB EFFICACY AND SAFETY IN COMORBIDITIES EVALUATION TRIAL (CRESCENT) INVESTIGATORS: The effects of cyclooxygenase-2 inhibitors and nonsteroidal anti-inflammatory therapy on 24-hour blood pressure in patients with hypertension, osteoarthritis, and Type 2 diabetes mellitus. Arch. Intern. Med. (2005) 165(2):161–168.
  • 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. I Ther. (2001) 8:85–95.
  • 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) 90:959–963.
  • AW TJ, HAAS SJ, LIEW D, KRUM H: Meta-analysis of cyclooxygenase-2 inhibitors and their effects on blood pressure. Arch. Intern. Med. (2005) 165:490–496.
  • STEFFEL J, HERMANN M, GREUTERT H et al: Celecoxib decreases endothelial tissue factor expression through inhibition of c-Jun terminal NH2 kinase phosphorylation. Circulation (2005) 111(13):1685–1689.
  • CIPOLLONE F, TONIATO E, MARTINOTTI S et al.: A polymorphism in the cyclooxygenase 2 gene as an inherited protective factor against myocardial infarction and stroke. "AMA (2004) 291:2221–2228.
  • JUNI P, NARTEY L, REICHENBACH S, STERCHI R, DIEPPE PA, EGGER M: Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet (2004) 364:2021-2029. [27] and [44] examine largely the same body of evidence, but arrive at radically different conclusions.
  • LEVESQUE LE, BROPHY JM, ZHANG B: The risk for myocardial infarction with cyclooxygenase-2 inhibitors: a population study of elderly adults. Ann. Intern. Med. (2005) 142(7):481–489.
  • JOHNSEN SP, LARSSON H, TARONE RE et al: Risk of hospitalization for myocardial infarction among users of rofecoxib, celecoxib, and other NSAIDs: a population-based case-control study. Arch. Intern. Med. (2005) 165(9):978–984.
  • 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: 1751-1756.
  • HUDSON M, RICHARD H, PILOTE L: Differences in outcomes of patients with congestive heart failure prescribed celecoxib, rofecoxib, or non-steroidal anti-inflammatory drugs: population based study. Br. Med. J. (2005) 330(7504):1370.
  • MIETTINEN OS: The need for randomization in the study of intended effects. Stat. Med. (1983) 2:267–271.
  • HIPPISLEY-COX J, COUPLAND C: Risk of myocardial infarction in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis. BE Med. J. (2005) 330(7504):1366.
  • SHAYA FT, BLUME SW, BLANCHETTE CM, WEIR MR, MULLINS CD: Selective cyclooxygenase-2 inhibition and cardiovascular effects: an observational study of a medicaid population. Arch. Intern. Med. (2005) 165:181–186.
  • 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) 142:157–164.
  • 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) 360:1071–1073.
  • 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) 163:481–486.
  • OTT E, NUSSMEIER NA, DUKE PC et al.: Efficacy and safety of the cyclooxygenase 2 inhibitors parecoxib and valdecoxib in patients undergoing coronary artery bypass surgery./. Thorac. Cardiovasc. Surg. (2003) 125:1481–1492.
  • NUSSMEIER NA, WHELTON AA, BROWN MT et al: Complications of the COX-2 inhibitors parecoxib and valdecoxib after cardiac surgery. N Engl. I Med. (2005) 352:1081–1091.
  • MUKHERJEE D, NISSEN SE, TOPOL EJ: Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA (2001) 286:954–959.
  • SOLOMON SD, MCMURRAY JJV, PFEFFER MA et al. THE ADENOMA PREVENTION WITH CELECOXIB (APC) STUDY INVESTIGATORS: Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl. I Med. (2005) 352:1071–1080.
  • DRAZEN JEFFREY M: COX-2 inhibitors- a lesson in unexpected problems. N. Engl. J. Med. (2005) 352:1131–1132.
  • PSATY BM, FURBERG CD: COX-2 inhibitors - lessons in drug safety. N. Engl. J. Med. (2005) 352:1133–1135.
  • KONSTAM MA, WEIR MR, REICIN A et al.: Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation (2001) 104:2280–2288.
  • •[27] and [44] examine largely the same body of evidence, but arrive at radically different conclusions.

Websites

  • http://www.fda.gov/ohrms/dockets/ac/ cder05.html#DrugSafetyRiskMgmt FDA joint meeting with the drug safety and risk management advisory committee (2005).
  • http://www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b2_06_cardio.pdf FDA advisory committee. Cardiovascular safety review of rofecoxib. Rockville, Maryland FDA (2001).
  • http://www.fda.gov/ohrms/dockets/ac/ cder05.html#ArthritisDrugs FDA advisory committee (2005).

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