© 1995 British Society for Rheumatology
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A COMPARATIVE STUDY OF TENIDAP, A CYTOKINE-MODULATING ANTI-RHEUMATIC DRUG, AND DICLOFENAC IN RHEUMATOID ARTHRITIS: A 24-WEEK ANALYSIS OF A 1-YEAR CLINICAL TRIAL
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*Central Research Division, Pfizer Ltd Sandwich, Kent
Département de Rhumatologie, Höpital Erasme-ULB Brussels, Belgium
Rhewnaklinik II Wiesbaden Germany
University Hospital, Department of Rheumatology Leiden, The Netherlands
¶Department of Pharmacology and Therapeutics, St James' Hospital Dublin, Eire
||Département de Rhumatologie CHU Rouen Rouen, France
**Rheumatology Unit, Malmö General Hospital, Lund University Malmö, Sweden
Istituto di Reumatologia, Universita di Siena Siena, Italy
Centre for Rheumatic Diseases, Krankenhaus der Stadt Wien-Lainz Vienna, Austria
Correspondence to:
Correspondec to: M. R. G. Leeming, Clinical Team Leader, Central Research Division. Pfizer Ltd, Ramsgate Road. Sandwich, Kent CT13 9NJ.
Tenidap is a novel anti-rheumatic drug that combines cytokine modulation with cyclo-oxygenase inhibition. This 24-week, multicentre, double-blind, randomized study compared the clinical efficacy, biochemical effects and safety of tenidap 120 mg/day (once daily) with diclofenac 150 mg/day (50 mg t.i.d.) in the treatment of 384 patients with active rheumatoid arthritis. After 24 weeks, improvement with tenidap was significantly greater than with diclofenac for all five primary efficacy parameters, two of the four secondary efficacy parameters and 11 of the 13 Arthritis Impact Measurement Scales assessments. The superior efficacy of tenidap was apparent after 4 weeks of treatment with further improvements observed by 24 weeks. The probability of discontinuation due to lack of efficacy was significantly greater in the diclofenac group. Tenidap but not diclofenac was associated with significant, rapid and sustained reductions in C-reactive protein and serum amyloid A levels and with a significant reduction in plasma interleukin-6. The nature and frequency of side-effects were similar in the two groups as was the discontinuation rate for treatment-related safety reasons. Tenidap was associated with an equal incidence of elevated transaminases, but a higher incidence of mild ( 
500 mg/24 h < 1500 mg/24 h) non-progressive, proteinuria of proximal tubular origin compared with diclofenac.
KEY WORDS: Tenidap, Rheumatoid arthritis, Acute phase protiens, C-reactive protein, Serum amyloid A, Cytokines, Interleukin-6
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