Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily: a randomised controlled trial in patients with osteoarthritis.
Fleischmann, Roy; Tannenbaum, Hyman; Patel, Neha Pet al.
[en] BACKGROUND: The efficacy, safety and tolerability of lumiracoxib, a novel selective cyclooxygenase-2 (COX-2) inhibitor, has been demonstrated in previous studies of patients with osteoarthritis (OA). As it is important to establish the long-term safety and efficacy of treatments for a chronic disease such as OA, the present study compared the effects of lumiracoxib at doses of 100 mg once daily (o.d.) and 100 mg twice daily (b.i.d.) with those of celecoxib 200 mg o.d. on retention on treatment over 1 year. METHODS: In this 52-week, multicentre, randomised, double-blind, parallel-group study, male and female patients (aged at least 40 years) with symptomatic primary OA of the hip, knee, hand or spine were randomised (1:2:1) to lumiracoxib 100 mg o.d. (n = 755), lumiracoxib 100 mg b.i.d. (n = 1,519) or celecoxib 200 mg o.d. (n = 758). The primary objective of the study was to demonstrate non-inferiority of lumiracoxib at either dose compared with celecoxib 200 mg o.d. with respect to the 1-year retention on treatment rate. Secondary outcome variables included OA pain in the target joint, patient's and physician's global assessments of disease activity, Short Arthritis assessment Scale (SAS) total score, rescue medication use, and safety and tolerability. RESULTS: Retention rates at 1 year were similar for the lumiracoxib 100 mg o.d., lumiracoxib 100 mg b.i.d. and celecoxib 200 mg o.d. groups (46.9% vs 47.5% vs 45.3%, respectively). It was demonstrated that retention on treatment with lumiracoxib at either dose was non-inferior to celecoxib 200 mg o.d. Similarly, Kaplan-Meier curves for the probability of premature discontinuation from the study for any reason were similar across the treatment groups. All three treatments generally yielded comparable results for the secondary efficacy variables and all treatments were well tolerated. CONCLUSION: Long-term treatment with lumiracoxib 100 mg o.d., the recommended dose for OA, was as effective and well tolerated as celecoxib 200 mg o.d. in patients with OA. TRIAL REGISTRATION: clinicaltrials.gov NCT00145301.
Disciplines :
General & internal medicine
Author, co-author :
Fleischmann, Roy
Tannenbaum, Hyman
Patel, Neha P
Notter, Marianne
Sallstig, Peter
Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique > Epidémiologie et santé publique
Language :
English
Title :
Long-term retention on treatment with lumiracoxib 100 mg once or twice daily compared with celecoxib 200 mg once daily: a randomised controlled trial in patients with osteoarthritis.
Burden of major musculoskeletal conditions. AD Woolf B Pfleger, Bull World Health Organ 2003 81 646 656 14710506
The prevalence and burden of arthritis. JY Reginster, Rheumatology 2002 41 Suppl 1 3 6 10.1093/rheumatology/41.suppl_1.3 12173279
EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee forInternational Clinical Studies Including Therapeutic Trials (ESCISIT). KM Jordan NK Arden M Doherty B Bannwarth JW Bijlsma P Dieppe K Gunther H Hauselmann G Herrero-Beaumont P Kaklamanis S Lohmander B Leeb M Lequesne B Mazieres E Martín-Mola K Pavelka A Pendleton L Punzi U Serni B Swoboda G Verbruggen I Zimmerman-Gorska M Dougados, Ann Rheum Dis 2003 62 1145 1155 14644851 10.1136/ard.2003.011742
The global burden of disease. A comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020. CJL Murray AD Lopez Eds, Cambridge, MA; Harvard School of Public Health on behalf of the World Health Organization and The World Bank 1996
Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. American College of Rheumatology, Arthritis Rheum 2000 43 1905 1915 10.1002/1529-0131(200009)43:9<1905::AID-ANR1>3.0.CO;2-P 11014340
The role of anti-inflammatory drugs in the treatment of osteoarthritis: a European viewpoint. M Dougados, Clin Exp Rheumatol 2001 19 Suppl 25 S9 S14 11695258
The role of anti-inflammatory drugs in the treatment of osteoarthritis: a United States viewpoint. RW Moskowitz, Clin Exp Rheumatol 2001 19 Suppl 25 S3 S8 11695248
Risk of bleeding peptic ulcer associated with individual non-steroidal anti-inflammatory drugs. MJ Langman J Weil P Wainwright DH Lawson MD Rawlins RF Logan M Murphy MP Vessey DG Colin-Jones, Lancet 1994 343 1075 1078 10.1016/S0140-6736(94)90185-6 7909103
Gastrointestinal toxicity of nonsteroidal anti-inflammatory drugs. MM Wolfe DR Lichtenstein G Singh, N Engl J Med 1999 340 1888 1899 10.1056/NEJM199906173402407 10369853
Rofecoxib shows consistent efficacy in osteoarthritis clinical trials, regardless of specific patient demographic and disease factors. LM Detora D Krupa J Bolognese RS Sperling EW Ehrich, J Rheumatol 2001 28 2494 2503 11708424
Efficacy and safety of valdecoxib for treatment of osteoarthritis and rheumatoid arthritis: systematic review of randomised controlled trials. JE Edwards HJ McQuay RA Moore, Pain 2004 111 286 296 10.1016/j.pain.2004.07.004 15363872
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. T Pincus G Koch H Lei B Mangal T Sokka R Moskowitz F Wolfe A Gibofsky L Simon S Zlotnick JG Fort, Ann Rheum Dis 2004 63 931 939 15082468 10.1136/ard.2003.020313
Efficacy of lumiracoxib in osteoarthritis: a review of nine studies. F Berenbaum J Grifka JP Brown J Zacher A Moore G Krammer D Dutta VS Sloan, J Int Med Res 2005 33 21 41 15651713
Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a prospective randomized 13-week study versus placebo and celecoxib. R Fleischmann E Sheldon J Maldonado-Cocco D Dutta S Yu VS Sloan, Clin Rheumatol 2006 25 42 53 10.1007/s10067-005-1126-5 16132165
Efficacy and tolerability of lumiracoxib 100 mg once daily in knee osteoarthritis: a 13-week, randomized, double-blind study vs. placebo and celecoxib. R Lehmann M Brzosko P Kopsa R Nischik A Kreiss H Thurston S Litschig VS Sloan, Curr Med Res Opin 2005 21 517 526 10.1185/030079905X38196 15899100
Efficacy and tolerability of lumiracoxib in the treatment of osteoarthritis of the knee: a 13-week, randomized, double-blind comparison with celecoxib and placebo. E Sheldon A Beaulieu Z Paster D Dutta S Yu VS Sloan, Clin Ther 2005 27 64 77 10.1016/j.clinthera.2005.01.002 15763607
Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a 13 week, randomised, double blind study versus placebo and celecoxib. H Tannenbaum F Berenbaum JY Reginster J Zacher J Robinson G Poor H Bliddal D Uebelhart S Adami F Navarro A Lee A Moore A Gimona, Ann Rheum Dis 2004 63 1419 1426 15020310 10.1136/ard.2003.015974
An evaluation of the efficacy of lumiracoxib 400 mg, celecoxib 400 mg or placebo for treating pain following dental surgery. J Fricke N Davis V Yu, Reg Anesth Pain Med 2006 30 A-12
Lumiracoxib 400 mg once daily is comparable to naproxen 500 mg twice daily for treatment of acute muscular pain following soft tissue injury. C Kyle J Zachariah M Kasangra C Andrews G Ellis H Kinch, Ann Rheum Dis 2006 Suppl II 241 (Abstract THU0415)
Lumiracoxib 200 mg od is an effective and well-tolerated treatment for primary dysmenorrhoea. X Gitton W Zhou S Jayawardene S Daniels S Barton P Matchaba, British Pain Society (BPS) Abstract Book 2006, 24-27 April, Harrogate, UK (Abstract 7)
Lumiracoxib 400 mg once daily is comparable to indomethacin 50 mg three times daily for the treatment of acute flares of gout. RE Willburger E Mysler J Derbot T Jung H Thurston A Kreiss S Litschig G Krammer GA Tate, Rheumatology 2007 46 1126 1134 10.1093/rheumatology/kem090 17478464
Nonsteroidal antiinflammatory drug discontinuation in patients with osteoarthritis. D Scholes A Stergachis PM Penna EH Normand PD Hansten, J Rheumatol 1995 22 708 712 7791168
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. Antiplatelet Trialists' Collaboration (APTC), BMJ 1994 308 81 106 Erratum in: BMJ 1994, 308: 1540 8298418
Longer use of COX-2-specific inhibitors compared to nonspecific nonsteroidal antiinflammatory drugs: a longitudinal study of 3639 patients in community practice. F Wolfe K Michaud TA Burke SZ Zhao, J Rheumatol 2004 31 355 358 14760808
Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial. ME Farkouh H Kirshner RA Harrington S Ruland FW Verheugt TJ Schnitzer GR Burmester E Mysler MC Hochberg M Doherty E Ehrsam X Gitton G Krammer B Mellein A Gimona P Matchaba CJ Hawkey JH Chesebro TARGET Study Group, Lancet 2004 364 675 684 10.1016/S0140-6736(04)16894-3 15325832
Cardiovascular safety of lumiracoxib: a meta-analysis of all randomized controlled trials ≥1 week and up to 1 year in duration of patients with osteoarthritis and rheumatoid arthritis. P Matchaba X Gitton G Krammer E Ehrsam VS Sloan M Olson B Mellein G Hoexter J Orloff J-J Garaud, Clin Ther 2005 27 1196 1214 10.1016/j.clinthera.2005.07.019 16199245
Do selective COX-2 inhibitors and traditional NSAIDs increase the risk of atherothrombosis? Meta-analysis of randomised trials. PM Kearney C Baigent J Godwin H Halls JR Emberson C Patrono, BMJ 2006 332 1302 1308 16740558 10.1136/bmj.332.7553.1302
Cardiovascular risk and inhibition of cyclooxygenase: a systematic review of the observational studies of selective and nonselective inhibitors of cyclooxygenase 2. P McGettigan D Henry, JAMA 2006 296 1633 1644 10.1001/jama.296.13.jrv60011 16968831
Blood pressure profile of lumiracoxib is similar to placebo in arthritis patients. A Whitehead M Simmonds B Mellein T Friede X Gitton P Sallstig, Osteoarthritis Cartilage 2006 Suppl 2 S168 S169 (Abstract P309) 10.1016/S1063-4584(07)60757-2
Lumiracoxib provides superior blood pressure profile compared to NSAIDs after 4 weeks of treatment. ME Farkouh FWA Verheugt H Kirshner S Ruland P Sallstig K Stricker G Krammer B Mellein X Gitton P Matchaba JH Chesebro, Arthritis Rheum 2006 Suppl 1 S678 (Abstract 1692)
Cohort study of hepatotoxicity associated with nimesulide and other non-steroidal anti-inflammatory drugs. G Traversa C Bianchi R Da Cas I Abraha F Menniti-Ippolito M Venegoni, BMJ 2003 327 18 22 12842950 10.1136/bmj.327.7405.18
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. FE Silverstein G Faich JL Goldstein LS Simon T Pincus A Whelton R Makuch G Eisen NM Agrawal WF Stenson AM Burr WW Zhao JD Kent JB Lefkowith KM Verburg GS Geis, JAMA 2000 284 1247 1255 10.1001/jama.284.10.1247 10979111
Nonsteroidal anti-inflammatory drugs and hepatic toxicity: a systematic review of randomized controlled trials in arthritis patients. A Rostom L Goldkind L Laine, Clin Gastroenterol Hepatol 2005 3 489 498 10.1016/S1542- 3565(04)00777-3 15880319
Lumiracoxib is effective and well tolerated in the long-term treatment of knee osteoarthritis. K Pavelka O Zamani R Alten S Yu S Litschig VS Sloan, Ann Rheum Dis 2005 Suppl 3 353 (Abstract FRI0319)
