Diclofenac Sodium Topical Solution 1.5% w/w with Dimethyl Sulfoxide Compared with Placebo for the Treatment of Osteoarthritis: Pooled Safety Results

References

• . Centers for Disease Control and Prevention. Prevalence of doctor-diagnosed arthritis and arthritis-attributable activity limitation—United States, 2007–2009. MMWR Morb Mortal Wkly Rep. 2010; 59(39): 1261–1265
   PubMedGoogle Scholar
• . Lawrence RC, Felson DT, Helmick CG, ; National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States. Part II. Arthritis Rheum. 2008; 58(1):26–35
   PubMed Web of Science ®Google Scholar
• . Centers for Disease Control and Prevention. Osteoarthritis. http://www.cdc.gov/arthritis/basics/osteoarthritis.htm. Updated June 25, 2010. Accessed August 1, 2011
   Google Scholar
• . Felson DT, Zhang Y. An update on the epidemiology of knee and hip osteoarthritis with a view to prevention. Arthritis Rheum. 1998; 41(8):1343–1355
   PubMed Web of Science ®Google Scholar
• . Rossignol M, Leclerc A, Allaert FA, . Primary osteoarthritis of hip, knee, and hand in relation to occupational exposure. Occup Environ Med. 2005; 62(11):772–777
   PubMedGoogle Scholar
• . 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
   PubMed Web of Science ®Google Scholar
• . 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
   PubMed Web of Science ®Google Scholar
• . National Institute for Health and Clinical Excellence. Osteoarthritis: The Care and Management of Osteoarthritis in Adults. NICE clinical guideline no. 59. London, England: National Institute for Health and Clinical Excellence; 2008
   Google Scholar
• . 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
   PubMed Web of Science ®Google Scholar
• . Schjerning Olsen AM, Fosbøl EL, Lindhardsen J, . Duration of treatment with nonsteroidal anti-inflammatory drugs and impact on risk of death and recurrent myocardial infarction in patients with prior myocardial infarction: A nationwide cohort study. Circulation. 2011; 123(20):2226–2235
   PubMed Web of Science ®Google Scholar
• . American Geriatrics Society Panel on the Pharmacological Management of Persistent Pain in Older Persons. Pharmacological management of persistent pain in older persons. J Am Geriatr Soc. 2009; 57(8): 1331–1346
   PubMed Web of Science ®Google Scholar
• . Zhao SZ, Burke TA, Whelton A, von Allmen H, Henderson SC. Blood pressure destabilization and related healthcare utilization among hypertensive patients using nonspecific NSAIDs and COX-2-specific inhibitors. Am J Manag Care. 2002; 8( 15 suppl):S401–S413
   PubMed Web of Science ®Google Scholar
• . 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
   PubMed Web of Science ®Google Scholar
• . PENNSAID (diclofenac sodium topical solution) 1.5% w/w [prescribing information]. Hazelwood, MO: Mallinckrodt Inc; 2010
   Google Scholar
• . Simon LS, Grierson LM, Naseer Z, Bookman AA, Zev Shainhouse J. Efficacy and safety of topical diclofenac containing dimethyl sulfoxide (DMSO) compared with those of topical placebo, DMSO vehicle and oral diclofenac for knee osteoarthritis. Pain. 2009; 143(3):238–245
   PubMed Web of Science ®Google Scholar
• . 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
   PubMed Web of Science ®Google Scholar
• . Roth SH, Fuller P. Diclofenac topical solution compared with oral diclofenac: A pooled safety analysis. J Pain Res. 2011; 4:159–167
   PubMedGoogle Scholar
• . 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
   PubMedGoogle Scholar
• . A double-blinded, placebo controlled, four-way parallel, clinical trial to evaluate the safety and efficacy of PENNSAID treatment of the osteoarthritic hand. Phase III Trial Clinical Study Report. Dimethaid Health Care, Inc. Report date May 2000
   Google Scholar
• . A double-blind, placebo controlled, three-way, parallel study of the safety and efficacy of Dimethaid-D (PENNSAID) topical lotion in the treatment of osteoarthritis. Phase III Trial Clinical Study Report. Dimethaid Health Care, Inc. Report date October 2000
   Google Scholar
• . Bookman AA, Williams KS, Shainhouse JZ. Effect of topical diclofenac solution for relieving symptoms of primary osteoarthritis of the knee: A randomized controlled trial. CMAJ. 2004; 171(4):333–338
   PubMed Web of Science ®Google Scholar
• . Baer PA, Thomas LM, Shainhouse Z. Treatment of osteoarthritis of the knee with a topical diclofenac solution: A randomised controlled, 6-week trial [ISRC TN53366886]. BMC Musculoskelet Disord. 2005; 6:44
   PubMed Web of Science ®Google Scholar
• . Roth SH. Nonsteroidal anti-inflammatory drugs: Gastropathy, deaths, and medical practice. Ann Intern Med. 1988; 109(5):353–354
   PubMed Web of Science ®Google Scholar
• . Roth SH, Bennett RE. Nonsteroidal anti-inflammatory drug gastropathy. Recognition and response. Arch Intern Med. 1987; 147(12): 2093–2100
   PubMedGoogle Scholar
• . Roth SH. Nonsteroidal antiinflammatory drug gastropathy: We started it, why don't we stop it? J Rheumatol. 2005; 32(7):1189–1191
   PubMedGoogle Scholar
• . Bombardier C, Laine L, Reicin A, ; VIGOR Study Group. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 2000; 343(21): 1520–1528
   PubMed Web of Science ®Google Scholar
• . Bresalier RS, Sandler RS, Quan H, ; 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(11):1092–1102
   PubMed Web of Science ®Google Scholar
• . Lévesque LE, Brophy JM, Zhang B. The risk for myocardial infarction with cyclooxygenase-2 inhibitors: A population study of elderly adults. Ann Intern Med. 2005; 142(7):481–489
   PubMed Web of Science ®Google Scholar
• . Solomon SD, McMurray JJ, Pfeffer MA, ; 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(11):1071–1080
   PubMed Web of Science ®Google Scholar
• . Becker MC, Thomas TH, Wisniewski L, ; PRECISION Investigators. Rationale, design, and governance of Prospective Randomized Evaluation of Celecoxib Integrated Safety versus Ibuprofen Or Naproxen (PRECISION), a cardiovascular end point trial of nonsteroidal antiinflammatory agents in patients with arthritis. Am Heart J. 2009; 157(4):606–612
   PubMed Web of Science ®Google Scholar
• . Turajane T, Wongbunnak R, Patcharatrakul T, Ratansumawong K, Poigampetch Y, Songpatanasilp T. Gastrointestinal and cardiovascular risk of non-selective NSAIDs and COX-2 inhibitors in elderly patients with knee osteoarthritis. J Med Assoc Thai. 2009; 92( suppl 6): S19–S26
   PubMedGoogle Scholar
• . Hinz B, Dormann H, Brune K. More pronounced inhibition of cyclooxygenase 2, increase in blood pressure, and reduction of heart rate by treatment with diclofenac compared with celecoxib and rofecoxib. Arthritis Rheum. 2006; 54(1):282–291
   PubMedGoogle Scholar
• . Hui X, Hewitt PG, Poblete N, Maibach HI, Shainhouse JZ, Wester RC. In vivo bioavailability and metabolism of topical diclofenac lotion in human volunteers. Pharm Res. 1998; 15(10):1589–1595
   PubMedGoogle Scholar
• . Keinzler 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
   PubMedGoogle Scholar
• . Chan FK. Primer: Managing NSAID-induced ulcer complications—balancing gastrointestinal and cardiovascular risks. Nat Clin Pract Gastroenterol Hepatol. 2006; 3(10):563–567
   PubMedGoogle Scholar
• . Ofman JJ, MacLean CH, Straus WL, . A meta-analysis of severe upper gastrointestinal complications of nonsteroidal antiinflammatory drugs. J Rheumatol. 2002; 29(4):804–812
   PubMed Web of Science ®Google Scholar
• . Boers M, Tangelder MJ, van Ingen H, . 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
   PubMedGoogle Scholar
• . Bardou M, Barkun AN. Preventing the gastrointestinal adverse effects of nonsteroidal anti-inflammatory drugs: From risk factor identification to risk factor intervention. Joint Bone Spine. 2010; 77(1):6–12
   PubMedGoogle Scholar
• . Barthel HR, Axford-Gatley RA. Topical nonsteroidal anti-inflammatory drugs for osteoarthritis. Postgrad Med. 2010; 122(6):98–106
   PubMed Web of Science ®Google Scholar
• . Rahme E, Barkun AN, Toubouti Y, . Do proton-pump inhibitors confer additional gastrointestinal protection in patients given celecoxib? Arthritis Rheum. 2007; 57(5):748–755
   PubMedGoogle Scholar
• . Eom CS, Park SM, Myung SK, . Use of acid-suppressive drugs and risk of fracture: A meta-analysis of observational studies. Ann Fam Med. 2011; 9(3):257–267
   PubMed Web of Science ®Google Scholar
• . Cundy T, Dissanayake A. Severe hypomagnesaemia in long-term users of proton-pump inhibitors. Clin Endocrinol (Oxf). 2008; 69(2):338–341
   PubMedGoogle Scholar
• . Juhász M, Herszényi L, Tulassay Z. Current standings of the proton pump inhibitor and clopidogrel co-therapy: Review on an evolving field with the eyes of the gastroenterologist. Digestion. 2010; 81(1):10–15
   PubMedGoogle Scholar
• . Makris UE, Kohler MJ, Fraenkel L. Adverse effects of topical non-steroidal antiinflammatory drugs in older adults with osteoarthritis: A systematic literature review. J Rheumatol. 2010; 37(6):1236–1243
   PubMedGoogle Scholar
• . Scott PA, Kingsley GH, Smith CM, Choy EH, Scott DL. Non-steroidal anti-inflammatory drugs and myocardial infarctions: Comparative systematic review of evidence from observational studies and randomised controlled trials. Ann Rheum Dis. 2007; 66(10):1296–1304
   PubMed Web of Science ®Google Scholar
• . Kearney PM, Baigent C, Godwin J, Halls H, Emberson JR, Patrono C. 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(7553):1302–1308
   PubMed Web of Science ®Google Scholar
• . Johnson AG, Nguyen TV, Day RO. Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis. Ann Intern Med. 1994; 121(4):289–300
   PubMed Web of Science ®Google Scholar
• . Brater DC, Anderson S, Baird B, . Effects of ibuprofen, naproxen, and sulindac on prostaglandins in men. Kidney Int. 1985; 27(1):66–73
   PubMedGoogle Scholar
• . O'Connor N, Dargan PI, Jones AL. Hepatocellular damage from non-steroidal anti-inflammatory drugs. QJM. 2003; 96(11):787–791
   PubMed Web of Science ®Google Scholar
• . Aithal GP, Day CP. Nonsteroidal anti-inflammatory drug-induced hepatotoxicity. Clin Liver Dis. 2007; 11(3):563–575
   PubMedGoogle Scholar
• . Banks AT, Zimmerman HJ, Ishak KG, Harter JG. Diclofenac-associated hepatotoxicity: Analysis of 180 cases reported to the Food and Drug Administration as adverse reactions. Hepatology. 1995; 22(3):820–827
   PubMed Web of Science ®Google Scholar
• . Barthel HR, Haselwood D, Longley S 3rd, . Randomized controlled trial of diclofenac sodium gel in knee osteoarthritis. Semin Arthritis Rheum. 2009; 39(3):203–212
   PubMed Web of Science ®Google Scholar
• . Shainhouse JZ, Grierson LM, Naseer Z. A long-term, open-label study to confirm the safety of topical diclofenac solution containing dimethyl sulfoxide in the treatment of the osteoarthritic knee. Am J Ther. 2010; 17(6):566–576
   PubMedGoogle Scholar