Summary
To compare the efficacy and safety of aceclofenac (AC) and tenoxicam (TX) in the treatment of rheumatoid arthritis (RA), a multicentric parallel, randomized, double-blind trial of three months duration was performed in 292 patients: 145 were randomized to the AC treatment group and 147 to the TX treatment group. The trial was completed by 237 (81.1%) patients. Both treatment groups showed amelioration of clinical parameters monitored at 15 days, and this improvement continued until the end of the trial, no statistically significant differences being observed between AC and TX. Twenty-four patients (8.2%, 12 AC and 12 TX) did not complete the trial because of inefficacy, and 15 because of side effects (5.1%, 6 AC and 9 TX), in 7 of them due to gastrointestinal intolerance (2,4%, 1 AC, 6 TX, p=0.052). These data demonstrate that AC shows similar efficacy to TX in the treatment of rheumatoid arthritis and better safety profile than TX, mainly regarding gastrointestinal tolerability.
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American Rheumatism Association Cooperating Clinics Committee: Aspirin in rheumatoid arthritis: a seven-day double-blind trial preliminary report. Bull Rheum Dis 1965, 16, 338.
Grau, M., Guasch, J., Montero, L., Felipe, A., Garrasco, E., Julia, S. Pharmacology of the potent new monsteroidal antiinflammatory agent aceclofenac. Arzneim Forsch Drug Res 1991, 41, 1265–1276.
Grau, M., Montero, J.L., Guasch, J., Felipe, A., Carrasco, E., Julia, S. The pharmacological profile of aceclofenac, a new non-steroid antiinflammatory and analgesic drug. Agent Actions. Suppl 1991, 129.
Ballesteros, R., Ansoleaga, J.J., Tapounet, R. The efficacy and tolerance of aceclofenac in rheumatoid arthritis. Clin Trials J 1990, 27, 12–19.
Diaz, C., Rodriguez, A., Geli, C., Llobet, J.M., Tapounet, R. Comparison of aceclofenac and diclofenac in osteoarthritic pain. Curr Ther Res 1988, 44, 252–256.
Caughey, D., Waterworth, R.F. A study in the safety of tenoxicam in general practice: N Z Med J 1989, 102, 582–583.
Simpson, J., Golding, D.N., Freeman, A.M., Cooke, D., Hooper, P.A., Jamieson, V., Osborne, C. A large, multicentre, parallel group, double-blind study comparing tenoxicam and piroxicam in the treatment of osteoarthritis and rheumatoid arthritis. Br J Clin Pract 1989, 43, 328–333.
Atkinson, M., Kahna, V., Ménard, H., Russel, S., Tannenbaum, H. A comparison of tenoxicam and piroxicam in the treatment of rheumatoid arthritis. J Rheumatol 1991, 19, 538–42.
Carne, X., Moreno, V., Porta Serra, M. Velilla, E. Calculating the number of patients necessary for designing a clinical study. Med Clin (Barc) 1989, 72, 72–77.
Arnett, F.G., Edworthy, S.M., Bloch, D.A., McShane, D.J., Fries, J.F., et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988, 31, 315–324.
Ritchie, D.M., Boyle, J.A., McInnes, J.M., Jasani, M.K., Dalakos, T.G., Grieveson, P., Buchanan, W.W. Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritís. Q Med J 1968, 37, 393–406.
Sandoval, D.M., Alarcon, G.S., Morgan, S.L. Adverse events in methotrexate-treated rheumatoid arthritis patients. Br J Rheumatol 1995, 34 (suppl 2), 49–56.
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Perez-Ruiz, F., Alonso-Ruiz, A. & Ansoleaga, J.J. Comparative study of the efficacy and safety of Aceclofenac and Tenoxicam in rheumatoid arthritis. Clin Rheumatol 15, 473–477 (1996). https://doi.org/10.1007/BF02229644
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DOI: https://doi.org/10.1007/BF02229644