Rofecoxib and cardiovascular adverse events in adjuvant treatment of colorectal cancer

New England Journal of Medicine

Volumn 357, Issue 4, 2007, Pages 360-369

  Kerr, David J ^a   Dunn, Janet A ^b   Langman, Michael J ^b   Smith, Justine L ^a   Midgley, Rachel S J ^b   Stanley, Andrew ^c   Stokes, Joanne C ^a   Julier, Patrick ^a   Iveson, Claire ^a   Duvvuri, Ravi ^a   McConkey, Christopher C ^b  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b UNIVERSITY OF WARWICK   (United Kingdom)

^c CITY HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

DICLOFENAC; MELOXICAM; NONSTEROID ANTIINFLAMMATORY AGENT; PLACEBO; ROFECOXIB;

ADJUVANT THERAPY; ADULT; AGED; ARTICLE; BRAIN ARTERY ANEURYSM RUPTURE; BRAIN HEMORRHAGE; BRAIN ISCHEMIA; CANCER PATIENT; CANCER STAGING; CARDIOVASCULAR DISEASE; CAUSE OF DEATH; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG FATALITY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; GASTROINTESTINAL PAIN; HEART DEATH; HEART FAILURE; HEART INFARCTION; HEARTBURN; HUMAN; HYPERTENSION; KIDNEY DYSFUNCTION; LUNG EMBOLISM; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; THROMBOSIS; TRANSIENT ISCHEMIC ATTACK; TREATMENT DURATION; TREATMENT INDICATION; TREATMENT OUTCOME; UNSTABLE ANGINA PECTORIS; VEIN THROMBOSIS;

EID: 34547148986     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa071841     Document Type: Article

References (22)

1. Midgley RS, Kerr DJ. ABC of colorectal cancer: adjuvant therapy. BMJ 2000; 321:1208-11.
2. QUASAR Collaborative Group. Comparison of fluorouracil with additional levamisole, higher-dose folinic acid, or both, as adjuvant chemotherapy for colorectal cancer: a randomised trial. Lancet 2000;355:1588-96.
3. QUASAR Collaborative. QUASAR: a randomized study of adjuvant chemotherapy (CT) vs observation including 3238 colorectal cancer patients. J Clin Oncol 2004;22:Suppl 14:3501a. abstract.
4. Sargent DJ, Wieand HS, Haller DG, et al. Disease-free survival versus overall survival as a primary end point of adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomised trials. J Clin Oncol 2005;23:8664-70.
5. Oshima M, Murai N, Kargman S, et al. Chemoprevention of intestinal polyposis in the Apcdelta716 mouse by rofecoxib, a specific cycooxygenase-2 inhibitor. Cancer Res 2001;61:1733-40.
6. Sheehan KM, Sheahan K, O'Donoghue DP, et al. The relationship between cyclooxygenase-2 expression and colorectal cancer. JAMA 1999;282:1254-7. [Erratum, JAMA 2000;283:1427.]
7. Fenwick SW, Toogood GJ, Lodge PA, Hull MA. The effect of the selective cyclooxygenase-2 inhibitor rofecoxib on human colorectal cancer liver metastases. Gastroenterology 2003;125:716-29.
8. Giovannucci E, Rimm EG, Stampfer MJ, Colditz GA, Ascherio A, Willett WC. Aspirin use and the risk of colorectal cancer and adenoma in male health professionals. Ann Intern Med 1994;121:241-6.
9. Thun MJ, Namboodiri MM, Calle EE, Flanders DW, Heath CW Jr. Aspirin use and risk of fatal cancer. Cancer Res 1993;53:1322-7.
10. Langman MJS, Cheng KK, Gilman EA, Lancashire RJ. Effect of anti-inflammatory drugs on overall risk of common cancer: case-control study in general practice research database. BMJ 2000;320:1642-6.
11. Langman MJ, Jensen DM, Watson DJ, et al. Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs. JAMA 1999;282:1929-33.
12. Bresalier RS, Sandler RS, Quan H, et al. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005;352:1092-102. [Erratum, N Engl J Med 2006;355:221.]
13. 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.
14. Kearney PM, Baigent C, Goodwin J, Halla H, Emberson JR, Patrono C. Do selective cyclo-oxygenase-2 inhibitors and traditional non-steroidal anti-inflammatory drugs increase the risk of atherothrombosis? Meta-analysis of randomised trials. BMJ 2006;332:1302-5.
15. 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.]
16. Lagakos SW. Time-to-event analyses for long-term treatments - the APPROVe trial. N Engl J Med 2006;355:113-7.
17. Johnsen SP, Larsson H, Tarone RE, et al. Risk of hospitalization for myocardial infarction among users of rofecoxib, celecoxib, and other NSAIDs: a populationbased case-control study. Arch Intern Med 2005;165:978-84.
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. Andersohn F, Suissa S, Garbe E. Use of first- and second-generation cyclooxygenase-2-selective drugs and risk of acute myocardial infarction. Circulation 2006;113:1950-7.
20. McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA 2006;296:1633-44.
21. Public CHMP assessment report for medicinal products containing non-selective non-steroidal anti-inflammatory drugs (NSAIDs). London: European Medicines Agency, November 7, 2006. (Accessed July 2, 2007, at http://www.emea.europa.eu/pdfs/human/opiniongen/44213006en.pdf.)
22. Moussa O, Yordy JS, Abol-Enein H, et al. Prognostic and functional significance of thromboxane synthase gene overexpression in invasive bladder cancer. Cancer Res 2005;65:11581-7.