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 Research and Therapy

Volumn 7, Issue 3, 2005, Pages R644-R665

  Moore, R Andrew ^a   Derry, Sheena ^a   Makinson, Geoffrey T ^b   McQuay, Henry J ^a  

^a UNIVERSITY OF OXFORD   (United Kingdom)

^b PFIZER GLOBAL RESEARCH AND DEVELOPMENT   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CELECOXIB; CREATININE; DICLOFENAC; HEMOGLOBIN; IBUPROFEN; LOXOPROFEN; NAPROXEN; PARACETAMOL; PLACEBO; ROFECOXIB; NONSTEROID ANTIINFLAMMATORY AGENT; PYRAZOLE DERIVATIVE; SULFONAMIDE;

ABDOMINAL PAIN; ARTICLE; BLEEDING; CAUSAL ATTRIBUTION; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); CREATININE BLOOD LEVEL; DIARRHEA; DISEASE ASSOCIATION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG EXPOSURE; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; EDEMA; GASTROINTESTINAL DISEASE; HEART FAILURE; HEART INFARCTION; HEMATOCRIT; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERTENSION; META ANALYSIS; NAUSEA; OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; RISK ASSESSMENT; SYSTEMATIC REVIEW; TREATMENT DURATION; TREATMENT OUTCOME; ULCER; VOMITING; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DRUG INDUSTRY; DRUG TOLERANCE; RANDOMIZED CONTROLLED TRIAL; REVIEW;

ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; ARTHRITIS, RHEUMATOID; DRUG INDUSTRY; DRUG TOLERANCE; GASTROINTESTINAL DISEASES; HUMANS; OSTEOARTHRITIS; PYRAZOLES; RANDOMIZED CONTROLLED TRIALS; SULFONAMIDES;

EID: 24944463735     PISSN: 14786354     EISSN: 14786362     Source Type: Journal    
DOI: 10.1186/ar1704     Document Type: Article

References (50)

1. Fear J, Hillman M, Chamberlain MA, Tennant A: Prevalence of hip problems in the population aged 55 years and over: access to specialist care and future demand for hip arthroplasty. Br J Rheumatol 1997, 36:74-76.
2. Elliott AM, Smith BH, Penny KI, Smith WC, Chambers WA: The epidemiology of chronic pain in the community. Lancet 1999, 354:1248-1252.
3. Crichton B, Green M: GP and patient perspectives on treatment with non-steroidal anti-inflammatory drugs for the pain in osteoarthritis. Curr Med Res Opin 2002, 18:92-96.
4. Fraenkel L, Bogardus ST, Concato J, Wittink DR: Treatment options in knee osteoarthritis. The patient's perspective. Arch Intrn Med 2004, 164:1299-1304.
5. Scholes D, Stergachis A, Penna PM, Normand EH, Hansten PD: Nonsteroidal anti-inflammatory drug discontinuation in patients with osteoarthritis. J Rheumatol 1995, 22:708-712.
6. Moore RA, Phillips CJ: Cost of NSAID adverse effects to the NHS. J Med Econ 1999, 2:45-55.
7. Tramer MR, Moore RA, Reynolds DJ, McQuay HJ: Quantitative estimation of rare adverse effects which follow a biological progression-a new model applied to chronic NSAID use. Pain 2000, 85:169-182.
8. Henry D, Page J, Whyte I, Nanra R, Hall C: Consumption of nonsteroidal anti-inflammatory drugs and the development of functional renal impairment in elderly subjects. Results of a case-control study. Br J Clin Pharmacol 1997, 44:85-90.
9. Griffin MR, Yared A, Ray WA: Nonsteroidal antiinflamatory drugs and acute renal failure in elderly persons. Am J Epidemiol 2000, 151:488-496.
10. Page J, Henry D: Consumption of NSAIDs and the development of congestive heart failure in elderly patients: an underrecognized public health problem. Arch Intern Med 2000, 160:777-784.
11. Garcia-Rodriguez A, Hernandez-Diaz S: Nonsteroidal antiinflammatory drugs as a trigger of clinical heart failure. Epidemiology 2003, 14:240-246.
12. Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, McQuay HJ: Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996, 17:1-12.
13. Smith LA, Oldman AD, McQuay HJ, Moore RA: Teasing apart quality and validity in systematic reviews: an example from acupuncture trials in chronic neck and back pain. Pain 2000, 86:119-132.
14. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF: Improving the quality of reports of meta-analyses of randomised controlled: the QUOROM statement. Lancet 1999, 354:1896-1900.
15. Moore RA, Gavaghan D, Tramer MR, Collins SL, McQuay HJ: Size is everything-large amounts of information are needed to overcome random effects in estimating direction and magnitude of treatment effects. Pain 1998, 78:209-216.
16. White WB, Faich G, Borer JS, Makuch RW: Cardiovascular thrombotic events in arthritis trials of the cyclooxygenase-2 inhibitor celecoxib. Am J Cardiol 2003, 92:411-418.
17. Gavaghan DJ, Moore RA, McQuay HJ: An evaluation of homogeneity tests in meta-analyses in pain using simulations of individual patient data. Pain 2000, 85:415-424.
18. Sterne JA, Gavaghan D, Egger M: Publication and related bias in meta-analysis: power of statistical tests and prevalence in the literature. J Clin Epidemiol 2000, 53:1119-1129.
19. Tang J-L, Liu JLY: Misleading funnel plot for detection of bias in meta-analysis. J Clin Epidemiol 2000, 53:477-484.
20. L'Abbe KA, Detsky AS, O'Rourke K: Meta-analysis in clinical research. Ann Intern Med 1987, 107:224-233.
21. Morris JA, Gardner MJ: Calculating confidence intervals for relative risk, odds ratios and standardised ratios and rates. In Statistics with Confidence-Confidence Intervals and Statistical Guidelines Edited by: Gardner MJ, Altman DG. London: British Medical Journal; 1995:50-63.
22. Cook RJ, Sackett DL: The number needed to treat: a clinically useful measure of treatment effect. BMJ 1995, 310:452-454.
23. Langman MJ, Jensen DM, Watson DJ, Harper SE, Zhao PL, Quan H, Bolognese JA, Simon TJ: Adverse upper gastrointestinal effects of rofecoxib compared with NSAIDs. JAMA 1999, 282:1929-1933.
24. Goldstein JL, Silverstein FE, Agrawal NM, Hubbard RC, Kaiser J, Maurath CJ, Verburg KM, Geis GS: Reduced risk of upper gastrointestinal ulcer complications with celecoxib, a novel COX-2 inhibitor. Am J Gastroenterol 2000, 95:1681-1690.
25. Whelton A, Maurath CJ, Verburg KM, Geis GS: Renal safety and tolerability of celecoxib, a novel cyclooxygenase-2 inhibitor. Am J Ther 2000, 7:159-175.
26. 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, 89:204-209.
27. Garner S, Fidan D, Frankish R, Judd M, Towheed T, Wells G, Tugwell P: Rofecoxib for rheumatoid arthritis (Cochrane Review). In The Cochrane Library Issue 3 Chichester, UK: John Wiley & Sons; 2004.
28. Garner S, Fidan D, Frankish R, Judd M, Shea B, Towheed T, Wells G, Tugwell P: Celecoxib for rheumatoid arthritis (Cochrane Review). In The Cochrane Library Issue 3 Chichester, UK: John Wiley & Sons; 2004.
29. Deeks JJ, Smith LA, Bradley MD: Efficacy, tolerability, and upper gastrointestinal safety of celecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. BMJ 2002, 325:1-8.
30. Edwards JE, McQuay HJ, Moore RA: Efficacy and safety of valdecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. Pain 2004, 111:286-296.
31. Clarke M, Halsey J: DICE2: a further investigation of the effects of chance in life, death and subgroup analyses. Int J Clin Pract 2001, 55:240-242.
32. Edwards IR, Aronson JK: Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000, 356:1255-1259.
33. Edwards JE, McQuay HJ, Moore RA, Collins SL: Reporting of adverse effects in clinical trials should be improved: lessons from acute postoperative pain. J Pain Symptom Manage 1999, 18:427-437.
34. Miceli-Richard C, Le Bars M, Schmidely N, Dougados M: Paracetamol in osteoarthritis of the knee. Ann Rheum Dis 2004, 63:923-930.
35. Goldstein J, Bjarnason I, Moore A, Spalding W, Cawkwell G: Comparison of hemoglobin and hematocrit changes associated with valdecoxib and nonspecific NSAIDs: pooled analysis of randomized trials in patients with OA or RA. Ann Rheum Dis 2004:372.
36. Goldstein J, Bjarnason I, Spalding W, Cawkwell G, Moore A: Long-term NSAIDs but not COX-2 specific inhibitors are associated with anemia [abstract]. Gastroenterology 2004:A1.
37. Laine L, Maller ES, Yu C, Quan H, Simon T: Ulcer formation with low-dose enteric-coated aspirin and the effect of COX-2 selective inhibition: a double-blind trial. Gastroenterology 2004, 127:395-402.
38. Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, Makuch R, Eisen G, Agrawal NM, Stenson WF, et al.: Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Longterm Arthritis Safety Study. JAMA 2000, 284:1247-1255.
39. Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, Day R, Ferraz MB, Hawkey CJ, Hochberg MC, et al.: Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000, 343:1520-1528.
40. Mamdani M, Rochon PA, Juurlink DN, Kopp A, Anderson GM, Naglie G, Austin PC, Laupacis A: Observational study of upper gastrointestinal haemorrhage in elderly patients given selective cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs. BMJ 2002, 325:624-629.
41. MacDonald TM, Morant SV, Goldstein JL, Burke TA, Pettitt D: Channelling bias and the incidence of gastrointestinal haemorrhage in users of meloxicam, coxibs, and older, non-specific non-steroidal anti-inflammatory drugs. Gut 2003, 52:1265-1270.
42. Nørgård B, Pedersen L, Johnsen SP, Tarone RE, McLaughlin JK, Friis S, Sorensen HT: COX-2-selective inhibitors and the risk of upper gastrointestinal bleeding in high-risk patients with previous gastrointestinal diseases: a population-based case-control study. Aliment Pharmacol Ther 2004, 19:817-825.
43. Arboleya LR, de la Figuera E, Soledad Garcia M, Aragon B, VICOXX Study Group: Experience of rofecoxib in patients with osteoarthritis previously treated with traditional non-steroidal anti-inflammatory drugs in Spain: results of phase 2 of the VICOXX study. Curr Med Res Opin 2003, 19:288-297.
44. Hawkey C, Laine L, Simon T, Beaulieu A, Maldonado-Cocco J, Acevedo E, Shahane A, Quan H, Bolognese J, Mortensen E: Comparison of the effect of rofecoxib (a cyclooxygenase 2 inhibitor), ibuprofen, and placebo on the gastroduodenal mucosa of patients with osteoarthritis. Arthritis Rheum 2000, 43:370-377.
45. Hawkey CJ, Laine L, Simon T, Quan H, Shingo S, Evans J, Rofecoxib Rheumatoid Arthritis Endoscopy Study Group: Incidence of gastroduodenal ulcers in patients with rheumatoid arthritis after 12 weeks of rofecoxib, naproxen, or placebo: a multicentre, randomised, double blind study. Gut 2003, 52:820-826.
46. Harley C, Wagner S: Persistence with COX-2 inhibitors in managed care: an analysis of claims data. Manag Care Interface 2003, 16:38-45.
47. Laine L, Wogen J, Yu H: Gastrointestinal health care resource utilization with chronic use of COX-2-specific inhibitors versus traditional NSAIDs. Gastroenterology 2003, 125:389-395.
48. Gøtzsche PC: Reporting of outcomes in arthritis trials measured on ordinal and interval scales is inadequate in relation to meta-analysis. Ann Rheum Dis 2001, 60:349-352.
49. Barden J: Meta-analysis to investigate methodological issues in clinical trials using pain as an exemplar. In DPhil Thesis Oxford University, Nuffield Department of Anesthetics; 2004.
50. Loke YK, Derry S: Reporting of adverse drug reactions in randomised controlled trials-a systematic survey. BMC Clin Pharmacol 2001, 1:3.