Pooled safety analysis of diclofenac sodium topical solution 1.5% (w/w) in the treatment of osteoarthritis in patients aged 75 years or older

Clinical Interventions in Aging

Volumn 7, Issue , 2012, Pages 127-137

  Roth, Sanford H ^a   Fuller, Philip ^b  

^a Arizona Research and Education   (United States)

^b MALLINCKRODT PHARMACEUTICALS   (United States)

Author keywords

Adverse events; Analgesic; Arthritis; Gastrointestinal; Nonsteroidal anti inflammatory drugs; Tolerability

Indexed keywords

DICLOFENAC; PLACEBO; DIMETHYL SULFOXIDE; NONSTEROID ANTIINFLAMMATORY AGENT; SOLVENT;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; AGED; APPLICATION SITE ERYTHEMA; APPLICATION SITE PARESTHESIA; APPLICATION SITE REACTION; ARTHRALGIA; ARTICLE; ASTHENIA; BLOOD PRESSURE; BLOOD TRANSFUSION REACTION; BULLOUS DERMATITIS; BURNING SENSATION; CARDIOVASCULAR DISEASE; CEREBROVASCULAR ACCIDENT; CONSTIPATION; CONTACT DERMATITIS; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DRY SKIN; DYSPEPSIA; ERYTHEMA; GASTROINTESTINAL SYMPTOM; HAND OSTEOARTHRITIS; HUMAN; HYPERTENSION; HYPESTHESIA; KIDNEY DISEASE; KNEE OSTEOARTHRITIS; MACULOPAPULAR RASH; MALIGNANT NEOPLASTIC DISEASE; MULTICENTER STUDY (TOPIC); NAUSEA; PARESTHESIA; PHASE 3 CLINICAL TRIAL (TOPIC); POLLAKISURIA; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; SKIN DISEASE; SKIN EXFOLIATION; SKIN IRRITATION; SPIDER VEIN; SYSTOLIC BLOOD PRESSURE; UPPER ABDOMINAL PAIN; URINARY TRACT DISEASE; URINE ODOR; VASODILATATION; ANALYSIS OF VARIANCE; CANADA; DRUG EFFECT; DRUG TOXICITY; FEMALE; GASTROINTESTINAL TRACT; HAND JOINT; MALE; OSTEOARTHRITIS; PATHOLOGY; SKIN; TOPICAL DRUG ADMINISTRATION; UNITED STATES;

ADMINISTRATION, TOPICAL; AGED; AGED, 80 AND OVER; ANALYSIS OF VARIANCE; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; CANADA; CLINICAL TRIALS, PHASE III AS TOPIC; DICLOFENAC; DIMETHYL SULFOXIDE; DRUG TOXICITY; FEMALE; GASTROINTESTINAL TRACT; HAND JOINTS; HUMANS; MALE; MULTICENTER STUDIES AS TOPIC; OSTEOARTHRITIS; OSTEOARTHRITIS, KNEE; SKIN; SOLVENTS; UNITED STATES;

EID: 84871690340     PISSN: 11769092     EISSN: 11781998     Source Type: Journal    
DOI: 10.2147/CIA.S30884     Document Type: Article

References (49)

1. Roth SH. Coming to terms with nonsteroidal anti-inflammatory drug gastropathy. Drugs. 2012;72(7):873-879.
2. United States Bone and Joint Decade. The Burden of Musculoskeletal Diseases in the United States. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2008.
3. Busija L, Bridgett L, Williams SRM, etal. Osteoarthritis. Best Pract Res Clin Rheumatol. 2010;24(6):757-768.
4. Bijlsma JW, Berenbaum F, Lafeber FP. Osteoarthritis: an update with relevance for clinical practice. Lancet. 2011;377(9783):2115-2126.
5. Lawrence RC, Felson DT, Helmick CG, etal; for the 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.
6. Zhang Y, Niu J, Kelly-Hayes M, Chaisson CE, Allabadi P, Felson DT. Prevalence of symptomatic hand osteoarthritis and its impact on functional status among the elderly: the Framingham Study. Am J Epidemiol. 2002;156(11):1021-1027.
7. Oliveria SA, Felson DT, Reed JI, Cirillo PA, Walker AM. Incidence of symptomatic hand, hip, and knee osteroarthritis among patients in a health maintenance organization. Arthritis Rheum. 1995;38(8): 1134-1141.
8. Huskisson EC. Modern management of mild-to-moderate joint pain due to osteoarthritis: a holistic approach. J Int Med Res. 2010;38(4):1175-1212.
9. Seed SM, Dunican KC, Lynch AM. Treatment options for osteoarthritis: considerations for older adults. Hosp Pract (Minneap). 2011;39(1):62-73.
10. 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.
11. Barkin RL, Beckerman M, Blum SL, Clark FM, Koh EK, Wu DS. Should nonsteroidal anti-inflammatory drugs (NSAIDs) be prescribed to the older adult? Drugs Aging. 2010;27(10):775-789.
12. Makris UE, Kohler MJ, Fraenkel L. Adverse effects of topical nonsteroidal antiinflammatory drugs in older adults with osteoarthritis: a systematic literature review. J Rheumatol. 2010;37(6):1236-1243.
13. Schjerning Olsen AM, Fosbøl EL, Lindhardsen J, etal. 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.
14. Laine L. Approaches to nonsteroidal anti-inflammatory drug use in the high-risk patient. Gastroenterology. 2001;120(3):594-606.
15. Lazzaroni M, Porro GB. Management of NSAID-induced gastrointestinal toxicity: focus on proton pump inhibitors. Drugs. 2009;69(1):51-69.
16. Scarpignato C, Hunt RH. Nonsteroidal antiinflammatory drug-related injury to the gastrointestinal tract: clinical picture, pathogenesis, and prevention. Gastroenterol Clin North Am. 2010;39(3):433-464.
17. Farkouh ME, Greenberg BP. An evidence-based review of the cardiovascular risks of nonsteroidal anti-inflammatory drugs. Am J Cardiol. 2009;103(9):1227-1237.
18. Trelle S, Reichenbach S, Wandel S, etal. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ. 2011;342:c7086.
19. Harirforoosh S, Jamali F. Renal adverse effects of nonsteroidal anti-inflammatory drugs. Expert Opin Drug Saf. 2009;8(6):669-681.
20. John R, Herzenberg AM. Renal toxicity of therapeutic drugs. J Clin Pathol. 2009;62(6):505-515.
21. Agency for Healthcare Research and Quality, US Department of Health and Human Services. Choosing nonopioid analgesics for osteoarthritis: clinician summary guide. J Pain Palliat Care Pharmacother. 2009;23(1):433-457.
22. Sun DC, Roth SH, Mitchell CS, Englund DW. Upper gastrointestinal disease in rheumatoid arthritis. Am J Dig Dis. 1974;19(5):405-410.
23. Roth SH, Bennett RE. Nonsteroidal anti-inflammatory drug gastropathy. Recognition and response. Arch Intern Med. 1987;147(12):2093-2100.
24. Roth SH. Nonsteroidal anti-inflammatory drugs: gastropathy, deaths, and medical practice. Ann Intern Med. 1988;109(5):353-354.
25. 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.
26. 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.
27. Aithal GP, Day CP. Nonsteroidal anti-inflammatory drug-induced hepatotoxicity. Clin Liver Dis. 2007;11(3):563-575.
28. 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.
29. Jordan KM, Arden NK, Doherty M, etal. 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):1145-1455.
30. National Institute for Health and Clinical Excellence. Osteoarthritis: the care and management of osteoarthritis in adults. London, UK: National Institutes for Health and Clinical Excellence; 2008. NICE clinical guideline 59.
31. Zhang W, Moskowitz RW, Nuki G, etal. 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.
32. Hochberg MC, Altman RD, April KT, etal. 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. 2012;64(4):465-474.
33. Pennsaid® [package insert]. Hazelwood, MO: Mallinckrodt Brand Pharmaceuticals, Inc.; 2010.
34. Santos NC, Figueira-Coelho J, Martins-Silva J, Saldanha C. Multidisciplinary utilization of dimethyl sulfoxide: pharmacological, cellular, and molecular aspects. Biochem Pharmacol. 2003;65(7): 1035-1041.
35. 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.
36. US Food and Drug Administration. COSTART: Coding Symbols for Thesaurus of Adverse Reaction Terms, 4th ed. Springfield, VA: National Technical Information Service, US Department of Commerce; 1995.
37. Spilker B. Collecting adverse event and adverse reaction data in clinical trials. In: Guide to Clinical Trials. Philadelphia, PA: Lippincott Williams & Wilkins; 1991.
38. Jones R. Nonsteroidal anti-inflammatory drug prescribing: past, present, and future. Am J Med. 2001;110(1A):4S-7S.
39. Bookman AAM, Williams KSA, Shainhouse JZ. Effect of a topical diclofenac solution for relieving symptoms of primary osteoarthritis of the knee: a randomized controlled trial. CMAJ. 2004;171(4):333-338.
40. 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.
41. 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.
42. 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.
43. Bhatt DL, Scheiman J, Abraham NS, etal. ACCF/ACG/AHA 2008 expert consensus document on reducing the gastrointestinal risks of antiplatelet therapy and NSAID use. Am J Gastroenterol. 2008;103(11): 2890-2907.
44. Roth SH, Fuller P. Diclofenac topical solution compared with oral diclofenac: a pooled safety analysis. J Pain Res. 2011;4:159-167.
45. Lévesque LE, Brophy JM, Zhang B. The risk for myocardial infarction with cyclooxygenase-2inhibitors: a population study of elderly adults. Ann Intern Med. 2005;142(7):481-489.
46. Taber SS, Pasko DA. The epidemiology of drug-induced disorders: the kidney. Expert Opin Drug Saf. 2008;7(6):679-690.
47. de Abajo FJ, Montero D, Madurga M, García Rodriguez LA. Acute and clinically relevant drug-induced liver injury: a population based case-control study. Br J Clin Pharmacol. 2004;58(1):71-80.
48. 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.
49. Baraf HSB, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011;28(1):27-40.