Drugs

, Volume 46, Supplement 1, pp 270–274 | Cite as

Long Term Tolerability Profile of Nimesulide in the Treatment of Osteoarthritis

  • R. L. Dreiser
  • D. Concas Benevelli
Article

Summary

As a primary objective, the safety profile of nimesulide was assessed in a nonblinded study that recruited 134 patients (aged 41 to 82 years) with osteoarthritis requiring long term treatment (⩾ 1 year). Nimesulide (100mg orally twice daily) was well tolerated. No statistically significant differences were found between the number of patients of varying ages reporting adverse events. Moreover, most adverse experiences were found to be mild to moderate in intensity, with a prevalence of gastrointestinal disorders.

The number of adverse episodes reported steadily decreased over the duration of the trial and no pathological changes in haematology and blood chemistry tests were found. Evaluation of efficacy revealed a progressive reduction in pain intensity with time.

Keywords

Osteoarthritis Nimesulide Adverse Experience Check List Nonblinded Study 

Preview

Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.

References

  1. Al Arfag A, Davis P. Osteoarthritis 1991: Current drug treatment regimens. University of Alberta, Edmonton, Alberta, Canada. Drugs 41: 193–201, 1991PubMedCrossRefGoogle Scholar
  2. Clinch D, Banerjee AK, Ostick G, Levy DW. Non-steroidal anti-inflammatory drugs and gastrointestinal adverse effects. Journal of the Royal College of Physicians of London, Vol. 17, No. 4, Oct, 1983Google Scholar
  3. Huskisson EC, Wojtulewski JA. Measurement of side effects of drugs. British Medical Journal 2: 698–699, 1974PubMedCrossRefGoogle Scholar
  4. Johnson AG, Day RO. The problems and pitfalls of NSAID therapy in the elderly (part 1). Drugs & Aging 1: 130–143, 1991CrossRefGoogle Scholar
  5. Kelley WN, Harris ED, Ruddy S, Sledge CB. Textbook of rheumatology, Vol. II, 3rd ed., pp. 1469–1511, WB Saunders and Company, Philadelphia, 1991Google Scholar
  6. Mankin HJ. Clinical features of osteoarthritis. In Kelley et al. (Eds) Textbook of Rheumatology, Vol. 1, Ch 81, pp. 1480–1492, WB Saunders and Company, Philadelphia, 1989Google Scholar
  7. Pochobradsky G, Mele G, Beretta A, Montagnani G. Post-marketing survey of nimesulide in the short-term treatment of osteoarthritis. Drugs Under Experimental and Clinical Research 17: 197–204, 1991PubMedGoogle Scholar
  8. Pocock SJ. Clinical trials: a practical approach. John Wiley & Sons Ltd, Chichester, 1983Google Scholar
  9. Rainsford KD. The comparative gastric ulcerogenic activities of non-steroid anti-inflammatory drugs. Agents and Actions 7: 5–6, 1977Google Scholar
  10. Spilker B. Guide to clincial studies and developing protocols. Raven Press, New York, 1984Google Scholar
  11. Woodbury DM, Fingle E. Analgesic-antipyretics, anti-inflammatory agents, and drugs employed in the therapy of gout. The pharmacological basis of therapeutics, 4th ed., pp. 325, MacMillan, New York, 1975Google Scholar

Copyright information

© ADIS International Limited 1993

Authors and Affiliations

  • R. L. Dreiser
    • 1
  • D. Concas Benevelli
    • 2
  1. 1.Rue ClapeyronParisFrance
  2. 2.Department of Products DevelopmentHelsinn Healthcare SAChiassoSwitzerland

Personalised recommendations