Safety of celecoxib compared with placebo and non-selective NSAIDs: cumulative meta-analysis of 89 randomized controlled trials

Bibliography

• Hochberg MC, Altman RD, April KT, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken) 2012;64:455-74
   PubMed Web of Science ®Google Scholar
• Mallen SR, Essex MN, Zhang R. Gastrointestinal tolerability of NSAIDs in elderly patients: a pooled analysis of 21 randomized clinical trials with celecoxib and nonselective NSAIDs. Curr Med Res Opin 2011;27:1359-66
   PubMed Web of Science ®Google Scholar
• Niculescu L, Li C, Huang J, et al. Pooled analysis of GI tolerability of 21 randomized controlled trials of celecoxib and nonselective NSAIDs. Curr Med Res Opin 2009;25:729-40
   PubMed Web of Science ®Google Scholar
• 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. JAMA 2000;284:1247-55
   PubMed Web of Science ®Google Scholar
• Kearney PM, Baigent C, Godwin J, et al. 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;332:1302-8
   PubMed Web of Science ®Google Scholar
• McGettigan P, Henry D. Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. JAMA 2006;296:1633-44
   PubMed Web of Science ®Google Scholar
• McGettigan P, Henry D. Cardiovascular risk with non-steroidal anti-inflammatory drugs: systematic review of population-based controlled observational studies. PLoS Med 2011;8:e1001098
   PubMed Web of Science ®Google Scholar
• Solomon DH, Glynn RJ, Rothman KJ, et al. Subgroup analyses to determine cardiovascular risk associated with nonsteroidal antiinflammatory drugs and coxibs in specific patient groups. Arthritis Rheum 2008;59:1097-104
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. COX-2 selective (includes Bextra, Celebrex, and Vioxx) and non-selective non-steroidal anti-inflammatory drugs (NSAIDs). 2005. Available from: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm [Last accessed 9 March 2012]
   Google Scholar
• Patrignani P, Tacconelli S, Bruno A, et al. Managing the adverse effects of nonsteroidal anti-inflammatory drugs. Expert Rev Clin Pharmacol 2011;4:605-21
   PubMedGoogle Scholar
• Antman EM, Bennett JS, Daugherty A, et al. Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation 2007;115:1634-42
   PubMed Web of Science ®Google Scholar
• Bensen WG, Fiechtner JJ, McMillen JI, et al. Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: a randomized controlled trial. Mayo Clin Proc 1999;74:1095-105
   PubMed Web of Science ®Google Scholar
• 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;325:619
   PubMed Web of Science ®Google Scholar
• Kivitz AJ, Moskowitz RW, Woods E, et al. Comparative efficacy and safety of celecoxib and naproxen in the treatment of osteoarthritis of the hip. J Int Med Res 2001;29:467-79
   PubMed Web of Science ®Google Scholar
• McKenna F, Borenstein D, Wendt H, et al. Celecoxib versus diclofenac in the management of osteoarthritis of the knee. Scand J Rheumatol 2001;30:11-18
   PubMed Web of Science ®Google Scholar
• Pincus T, Koch G, Lei H, et al. Patient Preference for Placebo, Acetaminophen (paracetamol) or Celecoxib Efficacy Studies (PACES): two randomised, double blind, placebo controlled, crossover clinical trials in patients with knee or hip osteoarthritis. Ann Rheum Dis 2004;63:931-9
   PubMed Web of Science ®Google Scholar
• Singh G, Fort JG, Goldstein JL, et al. Celecoxib versus naproxen and diclofenac in osteoarthritis patients: SUCCESS-I Study. Am J Med 2006;119:255-66
   PubMed Web of Science ®Google Scholar
• Williams HJ, Ward JR, Egger MJ, et al. Comparison of naproxen and acetaminophen in a two-year study of treatment of osteoarthritis of the knee. Arthritis Rheum 1993;36:1196-206
   PubMed Web of Science ®Google Scholar
• Emery P, Zeidler H, Kvien TK, et al. Celecoxib versus diclofenac in long-term management of rheumatoid arthritis: randomised double-blind comparison. Lancet 1999;354:2106-11
   PubMed Web of Science ®Google Scholar
• Simon LS, Weaver AL, Graham DY, et al. Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis: a randomized controlled trial. JAMA 1999;282:1921-8
   PubMed Web of Science ®Google Scholar
• Barkhuizen A, Steinfeld S, Robbins J, et al. Celecoxib is efficacious and well tolerated in treating signs and symptoms of ankylosing spondylitis. J Rheumatol 2006;33:1805-12
   PubMed Web of Science ®Google Scholar
• Dougados M, Behier JM, Jolchine I, et al. Efficacy of celecoxib, a cyclooxygenase 2-specific inhibitor, in the treatment of ankylosing spondylitis: a six-week controlled study with comparison against placebo and against a conventional nonsteroidal antiinflammatory drug. Arthritis Rheum 2001;44:180-5
   PubMed Web of Science ®Google Scholar
• Sieper J, Klopsch T, Richter M, et al. Comparison of two different dosages of celecoxib with diclofenac for the treatment of active ankylosing spondylitis: results of a 12-week randomised, double-blind, controlled study. Ann Rheum Dis 2008;67:323-9
   PubMed Web of Science ®Google Scholar
• Foeldvari I, Szer IS, Zemel LS, et al. A prospective study comparing celecoxib with naproxen in children with juvenile rheumatoid arthritis. J Rheumatol 2009;36:174-82
   PubMed Web of Science ®Google Scholar
• Derry S, Moore RA. Single dose oral celecoxib for acute postoperative pain in adults. Cochrane Database Syst Rev 2012;3:CD004233
   PubMedGoogle Scholar
• Frampton JE, Keating GM. Celecoxib: a review of its use in the management of arthritis and acute pain. Drugs 2007;67:2433-72
   PubMed Web of Science ®Google Scholar
• Daniels S, Robbins J, West CR, et al. Celecoxib in the treatment of primary dysmenorrhea: results from two randomized, double-blind, active- and placebo-controlled, crossover studies. Clin Ther 2009;31:1192-208
   PubMed Web of Science ®Google Scholar
• Chuang-Stein C, Beltangady M. Reporting cumulative proportion of subjects with an adverse event based on data from multiple studies. Pharm Stat 2011;10:3-7
   PubMed Web of Science ®Google Scholar
• Crowe BJ, Xia HA, Berlin JA, et al. Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team. Clin Trials 2009;6:430-40
   PubMed Web of Science ®Google Scholar
• Agresti A, Hartzel J. Strategies for comparing treatments on a binary response with multi-centre data. Stat Med 2000;19:1115-39
   PubMed Web of Science ®Google Scholar
• Singh G, Triadafilopoulos G, Agrawal NM, et al. Upper and lower gastrointestinal safety profile of celecoxib: patient-level pooled analysis of 51,048 patients in randomized, double-blinded, parallel-group clinical trials [abstract]. Gastroenterology 2010;138(5):S-44
   Google Scholar
• White WB, West CR, Borer JS, et al. Risk of cardiovascular events in patients receiving celecoxib: a meta-analysis of randomized clinical trials. Am J Cardiol 2007;99:91-8
   PubMed Web of Science ®Google Scholar
• Solomon SD, Pfeffer MA, McMurray JJ, et al. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation 2006;114:1028-35
   PubMed Web of Science ®Google Scholar
• Maddrey WC, Maurath CJ, Verburg KM, et al. The hepatic safety and tolerability of the novel cyclooxygenase-2 inhibitor celecoxib. Am J Ther 2000;7:153-8
   PubMedGoogle Scholar
• Richy F, Bruyere O, Ethgen O, et al. Time dependent risk of gastrointestinal complications induced by non-steroidal anti-inflammatory drug use: a consensus statement using a meta-analytic approach. Ann Rheum Dis 2004;63:759-66
   PubMed Web of Science ®Google Scholar
• Schaffer D, Florin T, Eagle C, et al. Risk of serious NSAID-related gastrointestinal events during long-term exposure: a systematic review. Med J Aust 2006;185:501-6
   PubMed Web of Science ®Google Scholar
• Dahlberg LE, Holme I, Hoye K, et al. A randomized, multicentre, double-blind, parallel-group study to assess the adverse event-related discontinuation rate with celecoxib and diclofenac in elderly patients with osteoarthritis. Scand J Rheumatol 2009;38:133-43
   PubMed Web of Science ®Google Scholar
• Essex MN, O'Connell P, Bhadra PB. Response to nonsteroidal anti-inflammatory drugs in African Americans with osteoarthritis of the knee. J Int Med Res 2012;40:2251-66
   PubMed Web of Science ®Google Scholar
• Chan FK, Lanas A, Scheiman J, et al. Celecoxib versus omeprazole and diclofenac in patients with osteoarthritis and rheumatoid arthritis (CONDOR): a randomised trial. Lancet 2010;376:173-9
   PubMed Web of Science ®Google Scholar
• Essex MN, Bhadra P, Sands GH. Efficacy and tolerability of celecoxib versus naproxen in patients with osteoarthritis of the knee: a randomized, double-blind, double-dummy trial. J Int Med Res 2012;40:1357-70
   PubMed Web of Science ®Google Scholar
• Cryer B, Li C, Simon LS, et al. GI-REASONS: a novel 6-month, prospective, randomized, open-label, blinded endpoint (PROBE) Trial. Am J Gastroenterol 2013; Published online 12 Feb; doi:10.1038/ajg.2012.467
   PubMedGoogle Scholar
• Cheung R, Cheng TT, Dong Y, et al. Incidence of gastroduodenal ulcers during treatment with celecoxib or diclofenac: pooled results from three 12-week trials in Chinese patients with osteoarthritis or rheumatoid arthritis. Int J Rheum Dis 2010;13:151-7
   PubMed Web of Science ®Google Scholar
• Goldstein JL, Bello AE, Spalding W, et al. Cyclooxygenase-2 specific inhibitors and upper gastrointestinal tolerability in patients with osteoarthritis receiving concomitant low dose aspirin: pooled analysis of 2 trials. J Rheumatol 2005;32:111-17
   PubMed Web of Science ®Google Scholar
• Kivitz AJ, Espinoza LR, Sherrer YR, et al. A comparison of the efficacy and safety of celecoxib 200 mg and celecoxib 400 mg once daily in treating the signs and symptoms of psoriatic arthritis. Semin Arthritis Rheum 2007;37:164-73
   PubMed Web of Science ®Google Scholar
• Emery P, Koncz T, Pan S, et al. Analgesic effectiveness of celecoxib and diclofenac in patients with osteoarthritis of the hip requiring joint replacement surgery: a 12-week, multicenter, randomized, double-blind, parallel-group, double-dummy, noninferiority study. Clin Ther 2008;30:70-83
   PubMed Web of Science ®Google Scholar
• Ekman EF, Berger M, Bhadra P. Determine whether perioperative celecoxib administration would reduce opioid consumption and provide effective pain relief in patients undergoing arthroscopic knee surgery. Arthroscopy 2006;22:804
   PubMed Web of Science ®Google Scholar
• Cheung R, Krishnaswami S, Kowalski K. Analgesic efficacy of celecoxib in postoperative oral surgery pain: a single-dose, two-center, randomized, double-blind, active- and placebo-controlled study. Clin Ther 2007;29(Suppl):2498-510
   PubMed Web of Science ®Google Scholar
• Cardenas-Estrada E, Oliveira LG, Abad HL, et al. Efficacy and safety of celecoxib in the treatment of acute pain due to ankle sprain in a Latin American and Middle Eastern population. J Int Med Res 2009;37:1937-51
   PubMed Web of Science ®Google Scholar
• Schumacher HR, Berger MF, Li-Yu J, et al. Efficacy and tolerability of celecoxib in the treatment of acute gouty arthritis: a randomized controlled trial. J Rheumatol 2012;39:1859-66
   PubMed Web of Science ®Google Scholar