A quantitative evaluation of the regulatory assessment of the benefits and risks of rofecoxib relative to naproxen: An application of the incremental net-benefit framework

Pharmacoepidemiology and Drug Safety

Volumn 19, Issue 11, 2010, Pages 1172-1180

  Lynd, Larry D ^a,b   Marra, Carlo A ^a,b   Najafzadeh, Mehdi ^a,b   Sadatsafavi, Mohsen ^a,b  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

^b CENTRE FOR HEALTH EVALUATION AND OUTCOME SCIENCES   (Canada)

Author keywords

Arthritis; Benefit risk analysis; Naproxen; Rofecoxib

Indexed keywords

NAPROXEN; ROFECOXIB;

ARTICLE; DIGESTIVE SYSTEM PERFORATION; DRUG FATALITY; DYSPEPSIA; GASTROINTESTINAL HEMORRHAGE; HEALTH STATUS; HEART INFARCTION; HUMAN; INCREMENTAL NET BENEFIT ANALYSIS; MONTE CARLO METHOD; OUTCOME ASSESSMENT; PRIORITY JOURNAL; PROBABILITY; QUALITY ADJUSTED LIFE YEAR; QUANTITATIVE ANALYSIS; RHEUMATOID ARTHRITIS; RISK BENEFIT ANALYSIS; SENSITIVITY ANALYSIS; SIDE EFFECT; SIMULATION; SUDDEN DEATH;

COMPUTER SIMULATION; CYCLOOXYGENASE 2 INHIBITORS; CYCLOOXYGENASE INHIBITORS; HUMANS; LACTONES; MODELS, BIOLOGICAL; MONTE CARLO METHOD; NAPROXEN; QUALITY-ADJUSTED LIFE YEARS; SULFONES;

EID: 78049258320     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1994     Document Type: Article

References (40)

1. Champion GD. Therapeutic usage of the non-steroidal anti-inflammatory drugs. Med J Aust 1988; 149(4): 203, 6-10, 12-13.
2. Laine L, Connors LG, Reicin A, et al. Serious lower gastrointestinal clinical events with nonselective NSAID or coxib use. Gastroenterology 2003; 124(2): 288-292.
3. Rostom A, Muir K, Dube C, et al. Gastrointestinal safety of cyclooxygenase-2 inhibitors: a Cochrane Collaboration systematic review. Clin Gastroenterol Hepatol 2007; 5(7): 818-828.
4. Watson DJ, Harper SE, Zhao PL, Quan H, Bolognese JA, Simon TJ. Gastrointestinal tolerability of the selective cyclooxygenase-2 (COX-2) inhibitor rofecoxib compared with nonselective COX-1 and COX-2 inhibitors in osteoarthritis. Arch Intern Med 2000; 160(19): 2998-3003.
5. Whitney E. Rofecoxib and the risk of adverse upper gastrointestinal effects. J Am Med Assoc 2000; 283(15): 1960.
6. 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(21): 1520-1528.
7. 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. Celecoxib Long-term Arthritis Safety Study. J Am Med Assoc 2000; 284(10): 1247-1255.
8. U.S. Food and Drug Administration. Bextra (valdecoxib) Tablets. 2001. Available from: [updated 2001; cited 24 March 2008].
9. U.S. Food and Drug Administration. Vioxx (Rofecoxib) tablets. 1999. Available from: [updated 1999; cited 2008 March 24].
10. Chen LC, Ashcroft DM. Risk of myocardial infarction associated with selective COX-2 inhibitors: meta-analysis of randomised controlled trials. Pharmacoepidemiol Drug Saf 2007; 16(7): 762-772.
11. Srensen R, Abildstrom SZ, Torp-Pedersen C, et al. Use of selective cyclooxygenase-2 inhibitors and nonselective nonsteroidal antiinflammatory drugs in high doses increases mortality and risk of reinfarction in patients with prior myocardial infarction. J Cardiovasc Nurs 2008; 23(1): 14-19.
12. Health Canada Expert Advisory Panel. Report of the Expert Advisory Panel on the safety of COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDS). Health Canada, Ottawa, 6 July 2005.
13. US Food and Drugs Administration. Analysis and recommendations for agency action regarding non-steroidal anti-inflammatory drugs and cardiovascular risk. Available from: [6 April 2005; cited 24 March 2008].
14. Glasziou PP, Irwig LM. An evidence based approach to individualising treatment. Br Med J 1995; 311(7016): 1356-1359.
15. Minelli C, Abrams KR, Sutton AJ, Cooper NJ. Benefits and harms associated with hormone replacement therapy: clinical decision analysis. Br Med J 2004; 328(7436): 371.
16. Lynd LD, O'Brien BJ. Advances in risk-benefit evaluation using probabilistic simulation methods: an application to the prophylaxis of deep vein thrombosis. J Clin Epidemiol 2004; 57: 795-803.
17. Geusens PP, Truitt K, Sfikakis P, et al. A placebo and active comparator-controlled trial of rofecoxib for the treatment of rheumatoid arthritis. Scand J Rheumatol 2002; 31(4): 230-238.
18. Konstam MA, Weir MR, Reicin A, et al. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation 2001; 104(19): 2280-2288.
19. Abraham NS, El-Serag HB, Hartman C, Richardson P, Deswal A. Cyclooxygenase-2 selectivity of non-steroidal anti-inflammatory drugs and the risk of myocardial infarction and cerebrovascular accident. Aliment Pharmacol Ther 2007; 25(8): 913-924.
20. Spiegel BM, Chiou CF, Ofman JJ. Minimizing complications from nonsteroidal antiinflammatory drugs: cost-effectiveness of competing strategies in varying risk groups. Arthritis Rheum 2005; 53(2): 185-197.
21. Collantes E, Curtis SP, Lee KW, et al. A multinational randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis. BMC Fam Pract 2002; 3: 10.
22. Maetzel A, Krahn M, Naglie G. The cost effectiveness of rofecoxib and celecoxib in patients with osteoarthritis or rheumatoid arthritis. Arthritis Rheum 2003; 49(3): 283-292.
23. Drummond M, Sculpher M, Torrance G, O'Brien B, Stoddart G. Methods for economic evaluation of health programs (3rd edn). Oxford University Press: New York, NY, 2005.
24. Marra CA, Marion SA, Guh DP, et al. Not all "quality-adjusted life years" are equal. J Clin Epidemiol 2007; 60(6): 616-624.
25. Critchfield GC, Willard KE, Connelly DP. Probabilistic sensitivity analysis methods for general decision models. Comput Biomed Res 1986; 19: 254-265.
26. Varas-Lorenzo C, Maguire A, Castellsague J, Perez-Gutthann S. Quantitative assessment of the gastrointestinal and cardiovascular risk-benefit of celecoxib compared to individual NSAIDs at the population level. Pharmacoepidemiol Drug Saf 2007; 16(4): 366-376.
27. Rahme E, Nedjar H. Risks and benefits of COX-2 inhibitors vs non-selective NSAIDs: does their cardiovascular risk exceed their gastrointestinal benefit? A retrospective cohort study [see comment]. Rheumatology 2007; 46(3): 435-438.
28. Committee for Medical Products for Human Use. Report of the CHMP working group on benefit-risk assessment models and methods. Report No.: EMEA/CHMP/15404/2007. European Medicines Agency, London, UK, 19 January 2007.
29. Committee on the Assessment of the US Drug Safety System. The future of drug safety: promoting and protecting the health of the public. National Academies Press: Washington, DC, 2006.
30. Lynd LD, Colley L, Najafazedeh M, et al. Quantitative risk-benefit analysis of alosetron in irritable bowel syndrome: a patient-level meta-cohort analysis. Pharmacoepidemiol Drug Saf 2007; 16 (Suppl 2): S183.
31. Spiegel BMR, Targownik L, Dulai GS, Gralnek IM. The cost-effectiveness of cyclooxygenase-2 selective inhibitors in the management of chronic arthritis. Ann Intern Med 2003; 138(10): 795-806.
32. Moore A, Phillips C, Hunsche E, Pellissier J, Crespi S. Economic evaluation of etoricoxib versus non-selective NSAIDs in the treatment of osteoarthritis and rheumatoid arthritis patients in the UK [see comment]. Pharmacoeconomics 2004; 22(10): 643-660.
33. National Institute for Health and Clinical Excellence. The Guidelines Manual. National Institute for Health and Clinical Excellence: London, UK, 2007 April.
34. Buxton MJ, Drummond MF, Van Hout BA, et al. Modelling in economic evaluation: an unavoidable fact of life. Health Econ 1997; 6(3): 217-227.
35. Kamath CC, Kremers HM, Vanness DJ, O'Fallon WM, Cabanela RL, Gabriel SE. The cost-effectiveness of acetaminophen, NSAIDs, and selective COX-2 inhibitors in the treatment of symptomatic knee osteoarthritis. Value Health 2003; 6(2): 144-157.
36. Pellissier JM, Straus WL, Watson DJ, Kong SX, Harper SE. Economic evaluation of rofecoxib versus nonselective nonsteroidal anti-inflammatory drugs for the treatment of osteoarthritis. Clin Ther 2001; 23(7): 1061-1079.
37. van Staa TP, Leufkens HG, Zhang B, Smeeth L. A comparison of cost effectiveness using data from randomized trials or actual clinical practice: selective cox-2 inhibitors as an example. PLoS Med 2009; 6(12): e1000194.
38. Rahme E, Watson DJ, Kong SX, Toubouti Y, LeLorier J. Association between nonnaproxen NSAIDs, COX-2 inhibitors and hospitalization for acute myocardial infarction among the elderly: a retrospective cohort study. Pharmacoepidemiol Drug Saf 2007; 16(5): 493-503.
39. 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(4): 481-486.
40. Guidry UC, Evans JC, Larson MG, Wilson PW, Murabito JM, Levy D. Temporal trends in event rates after Q-wave myocardial infarction: the Framingham Heart Study. Circulation 1999; 100(20): 2054-2059.