262
Views
39
CrossRef citations to date
0
Altmetric
Clinical Focus: Orthopedic and Ligament Injuries

Safety and Efficacy of Topical Diclofenac Sodium 1% Gel in Knee Osteoarthritis: A Randomized Controlled Trial

, MD, , ScD, , MD & , MD
Pages 19-28 | Published online: 13 Mar 2015

References

  • . Cicuttini FM, Forbes A, Yuanyuan W, Rush G, Stuckey SL. Rate of knee cartilage loss after partial meniscectomy. J Rheumatol. 2002;29(9):1954–1956
  • . Englund M, Guermazi A, Roemer FW, . Meniscal tear in knees without surgery and the development of radiographic osteoarthritis among middle-aged and elderly persons; The Multicenter Osteoarthritis Study. Arthritis Rheum. 2009;60(3):831–839
  • . Englund M, Lohmander LS. Risk factors for symptomatic knee osteoarthritis fifteen to twenty-two years after meniscectomy. Arthritis Rheum. 2004;50(9):2811–2819
  • . Holm I, Oiestad BE, Risberg MA, Aune AK. No difference in knee function or prevalence of osteoarthritis after reconstruction of the anterior cruciate ligament with 4-strand hamstring autograft versus patellar tendon-bone autograft: a randomized study with 10-year follow-up. Am J Sports Med. 2010;38(3):448–454
  • . Vairo GL, McBrier NM, Miller SJ, Buckley WE. Premature knee osteoarthritis after anterior cruciate ligament reconstruction dependent on autograft. J Sport Rehabil. 2010;19(1):86–97
  • . Consumer Health Sciences. The Osteoarthritis Market: US Core Therapeutic Report. Princeton, NJ: Consumer Health Sciences; 2008
  • . Matthews P, Derry S, Moore RA, McQuay HJ. Topical rubefacients for acute and chronic pain in adults. Cochrane Database Syst Rev. 2009(3):CD007403
  • . Zhang W, Nuki G, Moskowitz RW, . OARSI recommendations for the management of hip and knee osteoarthritis: part III: changes in evidence following systematic cumulative update of research published through January 2009. Osteoarthritis Cartilage. 2010;18(4):476–499
  • . Chun LJ, Tong MJ, Busuttil RW, Hiatt JR. Acetaminophen hepatotoxicity and acute liver failure. J Clin Gastroenterol. 2009;43(4):342–349
  • . Towheed TE, Maxwell L, Judd MG, Catton M, Hochberg MC, Wells G. Acetaminophen for osteoarthritis. Cochrane Database Syst Rev. 2006(1):CD004257
  • . Zhang W, Moskowitz RW, Nuki G, . OARSI recommendations for the management of hip and knee osteoarthritis, part II: OARSI evidence-based, expert consensus guidelines. Osteoarthritis Cartilage. 2008;16(2):137–162
  • . Jordan KM, Arden NK, Doherty M, ; Standing Committee for International Clinical Studies Including Therapeutic Trials ESCISIT. EULAR Recommendations 2003: an evidence based approach to the management of knee osteoarthritis: Report of a Task Force of the Standing Committee for International Clinical Studies Including Therapeutic Trials (ESCISIT). Ann Rheum Dis. 2003;62(12):1145–1155
  • . Recommendations for the medical management of osteoarthritis of the hip and knee: 2000 update. American College of Rheumatology Subcommittee on Osteoarthritis Guidelines. Arthritis Rheum. 2000;43(9):1905–1915
  • . American Academy of Orthopaedic Surgeons. Treatment of Osteoarthritis of the Knee (Non-Arthroplasty). Rosemont, IL: December 6, 2008
  • . Bjordal JM, Ljunggren AE, Klovning A, Slørdal L. Non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 inhibitors, in osteoarthritic knee pain: meta-analysis of randomised placebo controlled trials. BMJ. 2004;329(7478):1317–1322
  • . Grifka JK, Zacher J, Brown JP, . Efficacy and tolerability of lumiracoxib versus placebo in patients with osteoarthritis of the hand. Clin Exp Rheumatol. 2004;22(5):589–596
  • . Antman EM, Bennett JS, Daugherty A, Furberg C, Roberts H, Taubert KA; American Heart Association. Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation. 2007;115(12):1634–1642
  • . Evans JM, McGregor E, McMahon AD, . Non-steroidal anti-inflammatory drugs and hospitalization for acute renal failure. QJM. 1995;88(8):551–557
  • . Evans JM, McMahon AD, McGilchrist MM, . Topical non-steroidal anti-inflammatory drugs and admission to hospital for upper gastrointestinal bleeding and perforation: a record linkage case-control study. BMJ. 1995;311(6996):22–26
  • . Motsko SP, Rascati KL, Busti AJ, . Temporal relationship between use of NSAIDs, including selective COX-2 inhibitors, and cardiovascular risk. Drug Saf. 2006;29(7):621–632
  • . Chou R, Helfand M, Peterson K, Dana T, Roberts C. Comparative effectiveness and safety of analgesics for osteoarthritis. In: Agency for Healthcare Research and Quality, ed. Comparative Effectiveness Review. Vol 4. Rockville, MD: US Department of Health and Human Services; 2006:1–116
  • . Kienzler JL, Gold M, Nollevaux F. Systemic bioavailability of topical diclofenac sodium gel 1% versus oral diclofenac sodium in healthy volunteers. J Clin Pharmacol. 2010;50(1):50–61
  • . Voltaren® Gel 1% [package insert]. Parsippany, NJ: Novartis Consumer Health, Inc; 2007
  • . Barthel HR, Haselwood D, Longley S 3rd, Gold MS, Altman RD. Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis. Semin Arthritis Rheum. 2009;39(3):203–212
  • . Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16(4):494–502
  • . Bellamy N, Buchanan WW, Goldsmith CH, Campbell J. Validation study of WOMAC: a health status instrument for measuring clinically-important patient-relevant outcomes following total hip or knee arthroplasty in osteoarthritis. J Orthop Rheumatol. 1988;1:95–108
  • . Pham T, Van Der Heijde D, Lassere M, ; OMERACT-OARSI. Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria. J Rheumatol. 2003;30(7):1648–1654
  • . Brühlmann P, de Vathaire F, Dreiser RL, Michel BA. Short-term treatment with topical diclofenac epolamine plaster in patients with symptomatic knee osteoarthritis: pooled analysis of two randomised clinical studies. Curr Med Res Opin. 2006;22(12):2429–2438
  • . Grace D, Rogers J, Skeith K, Anderson K. Topical diclofenac versus placebo: a double blind, randomized clinical trial in patients with osteoarthritis of the knee. J Rheumatol. 1999;26(12):2659–2663
  • . Niethard FU, Gold MS, Solomon GS, . Efficacy of topical diclofenac diethylamine gel in osteoarthritis of the knee. J Rheumatol. 2005;32(12):2384–2392
  • . Roth SH, Shainhouse JZ. Efficacy and safety of a topical diclofenac solution (pennsaid) in the treatment of primary osteoarthritis of the knee: a randomized, double-blind, vehicle-controlled clinical trial. Arch Intern Med. 2004;164(18):2017–2023
  • . Tugwell PS, Wells GA, Shainhouse JZ. Equivalence study of a topical diclofenac solution (pennsaid) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee: a randomized controlled trial. J Rheumatol. 2004;31(10):2002–2012
  • . Lin J, Zhang W, Jones A, Doherty M. Efficacy of topical non-steroidal anti-inflammatory drugs in the treatment of osteoarthritis: meta-analysis of randomised controlled trials. BMJ. 2004;329(7461):324
  • . Mason L, Moore RA, Edwards JE, Derry S, McQuay HJ. Topical NSAIDs for chronic musculoskeletal pain: systematic review and meta-analysis. BMC Musculoskelet Disord. 2004;5:28
  • . Tubach F, Ravaud P, Baron G, . Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005;64(1):29–33
  • . Figueras A, Capellá D, Castel JM, Laorte JR. Spontaneous reporting of adverse drug reactions to non-steroidal anti-inflammatory drugs. A report from the Spanish System of Pharmacovigilance, including an early analysis of topical and enteric-coated formulations. Eur J Clin Pharmacol. 1994;47(4):297–303
  • . Baer PA, Thomas LM, Shainhouse Z. Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]. BMC Musculoskelet Disord. 2005;6:44
  • . Singh G, Fort JG, Goldstein JL, ; SUCCESS-I Investigators. Celecoxib versus naproxen and diclofenac in osteoarthritis patients: SUCCESS-I Study. Am J Med. 2006;119(3):255–266
  • . Stricker K, Yu S, Krammer G. A 6-week, multicentre, randomised, double-blind, double-dummy, active-controlled, clinical safety study of lumiracoxib and rofecoxib in osteoarthritis patients. BMC Musculoskelet Disord. 2008;9:118
  • . Boers M, Tangelder MJ, van Ingen H, Fort JG, Goldstein JL. The rate of NSAID-induced endoscopic ulcers increases linearly but not exponentially with age: a pooled analysis of 12 randomised trials. Ann Rheum Dis. 2007;66(3):417–418
  • . Hippisley-Cox J, Coupland C. Risk of myocardial infarction in patients taking cyclo-oxygenase-2 inhibitors or conventional non-steroidal anti-inflammatory drugs: population based nested case-control analysis. BMJ. 2005;330(7504):1366
  • . Barkin RL, Buvanendran A. Focus on the COX-1 and COX-2 agents: renal events of nonsteroidal and anti-inflammatory drugs-NSAIDs. Am J Ther. 2004;11(2):124–129
  • . Puenpatom RA, Victor TW. Increased prevalence of metabolic syndrome in individuals with osteoarthritis: an analysis of NHANES III data. Postgrad Med. 2009;121(6):9–20

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.