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Annals of the Rheumatic Diseases logoLink to Annals of the Rheumatic Diseases
. 1993 Dec;52(12):881–885. doi: 10.1136/ard.52.12.881

Double-blind comparison of efficacy and gastroduodenal safety of diclofenac/misoprostol, piroxicam, and naproxen in the treatment of osteoarthritis.

J A Melo Gomes 1, S H Roth 1, J Zeeh 1, G A Bruyn 1, E M Woods 1, G S Geis 1
PMCID: PMC1005220  PMID: 8311540

Abstract

OBJECTIVES--To compare the efficacy and gastroduodenal safety of a fixed-dose combination of diclofenac sodium 50 mg and misoprostol 200 micrograms twice daily with those of piroxicam 10 mg twice daily and naproxen 375 mg twice daily in patients with osteoarthritis. METHODS--A 4 week, randomised, double-blind, parallel-group, multicentre study was conducted in 643 patients with symptomatic osteoarthritis of the hip and/or knee, who required continuous non-steroidal anti-inflammatory drug therapy for 4 weeks and who were without significant upper gastrointestinal damage as confirmed by endoscopy. RESULTS--For patients who had pre- and post-treatment endoscopic examinations, gastroduodenal ulcers developed in 3 (1.5%) of 200 patients treated with diclofenac/misoprostol, 21 (10.3%) of 204 piroxicam-treated patients, and 17 (8.6%) of 198 patients receiving naproxen (Chi square = 13.771, p = 0.001). The improvement in the osteoarthritis severity index was greater in the diclofenac/misoprostol group than in the piroxicam group (p = 0.004). Changes in physician and patient global assessments showed no significant differences between treatment groups. The incidences of diarrhoea and abdominal pain were higher in the diclofenac/misoprostol group than in the piroxicam and naproxen groups. CONCLUSIONS--Diclofenac/misoprostol at twice daily dosing is associated with significantly fewer gastroduodenal ulcers than either piroxicam or naproxen. The efficacy of diclofenac/misoprostol in treating the signs and symptoms of osteoarthritis is at least comparable to that of piroxicam and naproxen.

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Selected References

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  1. Agrawal N. M., Roth S., Graham D. Y., White R. H., Germain B., Brown J. A., Stromatt S. C. Misoprostol compared with sucralfate in the prevention of nonsteroidal anti-inflammatory drug-induced gastric ulcer. A randomized, controlled trial. Ann Intern Med. 1991 Aug 1;115(3):195–200. doi: 10.7326/0003-4819-115-3-195. [DOI] [PubMed] [Google Scholar]
  2. Armstrong C. P., Blower A. L. Non-steroidal anti-inflammatory drugs and life threatening complications of peptic ulceration. Gut. 1987 May;28(5):527–532. doi: 10.1136/gut.28.5.527. [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. Bolten W., Gomes J. A., Stead H., Geis G. S. The gastroduodenal safety and efficacy of the fixed combination of diclofenac and misoprostol in the treatment of osteoarthritis. Br J Rheumatol. 1992 Nov;31(11):753–758. doi: 10.1093/rheumatology/31.11.753. [DOI] [PubMed] [Google Scholar]
  4. Collins A. J., Du Toit J. A. Upper gastrointestinal findings and faecal occult blood in patients with rheumatic diseases taking nonsteroidal anti-inflammatory drugs. Br J Rheumatol. 1987 Aug;26(4):295–298. doi: 10.1093/rheumatology/26.4.295. [DOI] [PubMed] [Google Scholar]
  5. Ehsanullah R. S., Page M. C., Tildesley G., Wood J. R. Prevention of gastroduodenal damage induced by non-steroidal anti-inflammatory drugs: controlled trial of ranitidine. BMJ. 1988 Oct 22;297(6655):1017–1021. doi: 10.1136/bmj.297.6655.1017. [DOI] [PMC free article] [PubMed] [Google Scholar]
  6. Farah D., Sturrock R. D., Russell R. I. Peptic ulcer in rheumatoid arthritis. Ann Rheum Dis. 1988 Jun;47(6):478–480. doi: 10.1136/ard.47.6.478. [DOI] [PMC free article] [PubMed] [Google Scholar]
  7. Fromm D. Mechanisms involved in gastric mucosal resistance to injury. Annu Rev Med. 1987;38:119–128. doi: 10.1146/annurev.me.38.020187.001003. [DOI] [PubMed] [Google Scholar]
  8. Graham D. Y., Agrawal N. M., Roth S. H. Prevention of NSAID-induced gastric ulcer with misoprostol: multicentre, double-blind, placebo-controlled trial. Lancet. 1988 Dec 3;2(8623):1277–1280. doi: 10.1016/s0140-6736(88)92892-9. [DOI] [PubMed] [Google Scholar]
  9. Jaszewski R. Frequency of gastroduodenal lesions in asymptomatic patients on chronic aspirin or nonsteroidal antiinflammatory drug therapy. J Clin Gastroenterol. 1990 Feb;12(1):10–13. doi: 10.1097/00004836-199002000-00004. [DOI] [PubMed] [Google Scholar]
  10. Jorde R., Burhol P. G. Asymptomatic peptic ulcer disease. Scand J Gastroenterol. 1987 Mar;22(2):129–134. doi: 10.3109/00365528708991869. [DOI] [PubMed] [Google Scholar]
  11. Larkai E. N., Smith J. L., Lidsky M. D., Graham D. Y. Gastroduodenal mucosa and dyspeptic symptoms in arthritic patients during chronic nonsteroidal anti-inflammatory drug use. Am J Gastroenterol. 1987 Nov;82(11):1153–1158. [PubMed] [Google Scholar]
  12. Lequesne M. G., Mery C., Samson M., Gerard P. Indexes of severity for osteoarthritis of the hip and knee. Validation--value in comparison with other assessment tests. Scand J Rheumatol Suppl. 1987;65:85–89. doi: 10.3109/03009748709102182. [DOI] [PubMed] [Google Scholar]
  13. Robinson M. G., Griffin J. W., Jr, Bowers J., Kogan F. J., Kogut D. G., Lanza F. L., Warner C. W. Effect of ranitidine on gastroduodenal mucosal damage induced by nonsteroidal antiinflammatory drugs. Dig Dis Sci. 1989 Mar;34(3):424–428. doi: 10.1007/BF01536266. [DOI] [PubMed] [Google Scholar]
  14. Roth S. H., Bennett R. E. Nonsteroidal anti-inflammatory drug gastropathy. Recognition and response. Arch Intern Med. 1987 Dec;147(12):2093–2100. [PubMed] [Google Scholar]
  15. Skander M. P., Ryan F. P. Non-steroidal anti-inflammatory drugs and pain free peptic ulceration in the elderly. BMJ. 1988 Oct 1;297(6652):833–834. doi: 10.1136/bmj.297.6652.833. [DOI] [PMC free article] [PubMed] [Google Scholar]
  16. Stern A. I., Ward F., Sievert W. Lack of gastric mucosal protection by sucralfate during long-term aspirin ingestion in humans. Am J Med. 1989 Jun 9;86(6A):66–69. doi: 10.1016/0002-9343(89)90160-5. [DOI] [PubMed] [Google Scholar]
  17. Vane J. R. Inhibition of prostaglandin synthesis as a mechanism of action for aspirin-like drugs. Nat New Biol. 1971 Jun 23;231(25):232–235. doi: 10.1038/newbio231232a0. [DOI] [PubMed] [Google Scholar]
  18. Verdickt W., Moran C., Hantzschel H., Fraga A. M., Stead H., Geis G. S. A double-blind comparison of the gastroduodenal safety and efficacy of diclofenac and a fixed dose combination of diclofenac and misoprostol in the treatment of rheumatoid arthritis. Scand J Rheumatol. 1992;21(2):85–91. doi: 10.3109/03009749209095074. [DOI] [PubMed] [Google Scholar]
  19. Ward J. R., Williams H. J., Egger M. J., Reading J. C., Boyce E., Altz-Smith M., Samuelson C. O., Jr, Willkens R. F., Solsky M. A., Hayes S. P. Comparison of auranofin, gold sodium thiomalate, and placebo in the treatment of rheumatoid arthritis. A controlled clinical trial. Arthritis Rheum. 1983 Nov;26(11):1303–1315. doi: 10.1002/art.1780261102. [DOI] [PubMed] [Google Scholar]
  20. Whittle B. J., Vane J. R. A biochemical basis for the gastrointestinal toxicity of non-steroid antirheumatoid drugs. Arch Toxicol Suppl. 1984;7:315–322. doi: 10.1007/978-3-642-69132-4_54. [DOI] [PubMed] [Google Scholar]

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