Methodology of a large prospective, randomised, open, Blinded Endpoint streamlined safety study of celecoxib versus traditional non-steroidal antiinflammatory drugs In Patients with osteoarthritis or rheumatoid arthritis: Protocol of the Standard care versus celecoxib Outcome Trial (SCOT)

BMJ Open

Volumn 3, Issue 1, 2013, Pages

  MacDonald, Thomas M ^a   Mackenzie, Isla S ^a   Wei, Li ^b   Hawkey, Christopher J ^c   Ford, Ian ^d  

^a UNIVERSITY OF DUNDEE   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

^c UNIVERSITY OF NOTTINGHAM   (United Kingdom)

^d UNIVERSITY OF GLASGOW   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACECLOFENAC; ACEMETACIN; ANTIDEPRESSANT AGENT; ARTHROTEC; CELECOXIB; CODEINE; DEXIBUPROFEN; DEXKETOPROFEN; DICLOFENAC; DIFLUNISAL; ETODOLAC; FENBUFEN; FENOPROFEN; IBUPROFEN; MEFENAMIC ACID; MELOXICAM; NABUMETONE; NAPROXEN; NEFOPAM; NONSTEROID ANTIINFLAMMATORY AGENT; PARACETAMOL; PIROXICAM; SULINDAC; TENOXICAM; TIAPROFENIC ACID; TRAMADOL;

ADULT; CARDIOTOXICITY; CONTROLLED STUDY; DEATH; DIGESTIVE SYSTEM ULCER; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FOLLOW UP; GASTROINTESTINAL HEMORRHAGE; HEART FAILURE; HEART INFARCTION; HOSPITALIZATION; HUMAN; KIDNEY FAILURE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OSTEOARTHRITIS; PATIENT COMPLIANCE; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REVIEW; RHEUMATOID ARTHRITIS; UNSPECIFIED SIDE EFFECT;

EID: 84873446458     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2012-002295     Document Type: Review

References (35)

1. Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004;329:15-19. (Pubitemid 38869995)
2. http://www.itqb.unl.pt/~ccr/quimicaemlinha/PDF%20files/VIOXXmerck.pdf (accessed 25 Jan 2013).
3. 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.
4. Bresalier RS, Sandler RS, Quan H, et al. Adenomatous Polyp Prevention on Vioxx (APPROVe) Trial Investigators. Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 2005;352:1092-102. (Pubitemid 40365350)
5. Solomon SD, McMurray JJ, Pfeffer MA, et al. Adenoma Prevention with Celecoxib (APC) Study Investigators. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005;352:1071-80. (Pubitemid 40365348)
6. Bertagnolli MM, Eagle CJ, Zauber AG, et al. Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med 2006;355:873-84. (Pubitemid 44315980)
7. Arber N, Eagle CJ, Spicak J, et al. Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med 2006;355:885-95. (Pubitemid 44315981)
8. Solomon SD, Wittes J, Finn PV, et al. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation 2008;117:2104-13. (Pubitemid 351572169)
9. Cannon CP, Curtis SP, Fitzgerald GA, et al. Cardiovascular outcomes with etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet 2006;368:1771-81. (Pubitemid 44739003)
10. White WB, Faich G, Borer JS, et al. Cardiovascular Thrombotic Events in Arthritis Trials of the Cyclooxygenase-2 Inhibitor Celecoxib. Am J Cardiol 2003;92:411-18. (Pubitemid 36959877)
11. Rodriguez LA Garcia, Tacconelli S, Patrignani P. Role of dose potency in the prediction of risk of myocardial infarction associated with non-steroidal anti-inflammatory drugs in the general population. J Am Coll Cardiol 2008;52:1628-36.
12. Hernandez-Diaz S, Varas-Lorenzo C, Rodriguez LA Garcia. Non-Steroidal Anti-inflammatory Drugs and the Risk of Acute Myocardial Infarction. Basic Clin Pharmacol Toxicol 2006;98:266-74.
13. 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. (Pubitemid 44511610)
14. Gislason GH, Rasmussen JN, Abildstrom SZ, et al. Increased mortality and cardiovascular morbidity associated with use of non-steroidal anti-inflammatory drugs in chronic heart failure. Arch Intern Med 2009;169:141-9.
15. Fosbol EL, Gislason GH, Jacobsen S, et al. Risk of myocardial infarction and death associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs) among healthy individuals: a nationwide cohort study. Clin Pharmacol Ther 2009;85:190-7.
16. Trelle S, Reichenbach S, Wandel S, et al. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ 2011;342:c7086.
17. Chan FKL, 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.
18. Hansson L, Hedner T, Dahlof B. Prospective randomised open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomised Open Blinded End-Point. Blood Press 1992;1:113-19.
19. Farkouh ME, 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;364:675-84. (Pubitemid 39140623)
20. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs non-steroidal 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.
21. Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20, 536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7-22.
22. Wei L, MacDonald TM, on behalf of the SCOT Study Group Collaborators. Drop-out rates in patients with and without screening period in the SCOT trial. Pharmacoepidemiol Drug Saf 2012;21(Suppl 3):87 abstract.
23. Ford I, Murray H, Shepherd J, et al. Long-term follow-up of the West of Scotland Coronary Prevention Study. N Engl J Med 2007;357:1477-86. (Pubitemid 47572633)
24. Sever PS, Dahlof B, Poulter NR, et al. Rationale, design, methods and baseline demography of participants of the Anglo-scandinavian cardiac outcomes trial. ASCOT investigators. J Hypertens 2001:1139-47. (Pubitemid 32493649)
25. Alpert JS, Thygesen K, Antman E, et al. Myocardial infarction redefined-a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol 2000;36:959-69.
26. Adams HP Jr, Adams RJ, Brott T, et al. Guidelines for the early management of patients with ischemic stroke: a scientific statement from the stroke council of the American stroke association. Stroke 2003;34:1056-83. (Pubitemid 36402991)
27. Swedberg K, Cleland J, Dargie H, et al. Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005): the task force for the diagnosis and treatment of chronic heart failure of the European Society of Cardiology. Eur Heart J 2005;26:1115-40.
28. Levey AS. Clinical practice. Non-diabetic kidney disease. N Engl J Med 2002;347:1505-11. (Pubitemid 35257591)
29. Perazella MA. Drug-induced renal failure: update on new medications and unique mechanisms of nephrotoxicity. Am J Med Sci 2003;325:349-62. (Pubitemid 36712657)
30. International Society for Pharmacoepidemiology (ISPE). Guidelines for good pharmacoepidemiology practices (GPP). 2007. http://www.pharmacoepi.org/ resources/guidelines-08027.cfm (accessed 1 Oct. 2012).
31. 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. (Pubitemid 44969347)
32. Moore RA, Derry S, Makinson GT, et al. 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:R644-65.
33. Varas-Lorenzo C, Maguire A, Castellsague J, et al. Quantitative assessment of the gastrointestinal and cardiovascular risk-benefit of celecoxib compared to individual NSAIDs at the population level. Pharmacoepidemiol Drug Saf 2007;16:366-76. (Pubitemid 46656858)
34. Becker MC, Wang TH, Wisniewski L, et al. Rationale, design, and governance of Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen (PRECISION), a cardiovascular end point trial of non-steroidal anti-inflammatory agents in patients with arthritis. Am Heart J 2009;157:606-12.
35. http://clinicaltrials.gov/ct/show/NCT00346216 (accessed 25 Jan 2013).