Summary
A multicentre, double-blind, randomised, parallel group study was undertaken to investigate the efficacy and safety of aceclofenac (123 patients, 100 mg twice daily) in comparison to piroxicam (117 patients, 20 mg once daily and placebo once daily) in patients with osteoarthritis of the knee. The treatment period of two months was preceded by a washout period of one week duration. On completion of the study, patients in both aceclofenac and piroxicam-treated groups exhibited significant improvement in pain intensity and functional capacity of the affected knee, as represented by the Osteoarthritis Severity Index (OSI) (p<0.0001 and p<0.001 respectively). This was further substantiated following the patient's assessment of pain intensity using the Visual Analogue Scale (VAS), in which significant improvements were demonstrated at all time points for each treatment group (p<0.001). Although both treatment groups showed a significant improvement in all investigator's clinical assessments (functional exploration of the knee, knee flexion and extension (EXT)), there were no significant differences between the groups. There was, however, a more rapid improvement in knee flexion in the aceclofenac group after 15 days of treatment. Both aceclofenac and piroxicam were well tolerated by patients, the most commonly reported adverse events being gastrointestinal, although their incidence was low. Only 24 patients on aceclofenac, as opposed to 33 on piroxicam complained of dyspepsia, epigastralgia and pyrosis. While 7 patients in each group were withdrawn because of adverse events, only one patient with piroxicam was withdrawn because of severe upper gastrointestinal bleeding. Twice as many reports of fecal blood loss were made in the piroxicam group in comparison to the aceclofenac group. In summary, this study confirms the therapeutic efficacy of aceclofenac and suggests that it is a well-tolerated alternative NSAID to piroxicam in the treatment of osteoarthritis.
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References
Felson DT. Osteoarthritis. Rheum Dis Clin North Am 1990; 16:499–512.
Dieppe P, Cushnaghan J. The natural course and prognosis of osteoarthritis. In: Moskowitz, R.W. et al. eds. Osteoarthritis: diagnosis and medical surgical management. Philadelphia: WB Saunders, 1992, 399–412.
Altman RD, Gray R. Inflammation in osteoarthritis. Clin Rheum Dis 1985; 11: 353–65.
Brooks PM, Potter SR, Buchanan WW. Non-steroidal anti-inflammatory drugs and OA: Help or hindrance? J Rheumatol 1982; 9:3–5.
Haslock I. Psychodynamics of treating chronic arthritis. In: Maddison, P. Ed. New developments in the management of chronic arthritis. UK: Colwood Medical Publications, 1991, 32–6.
Gabriel SE, Bombardier C. NSAID induced ulcers. An emerging epidemic? J Rheumatol 1990; 17:1–4.
Delmas PD. Nonsteroidal anti-inflammatory drugs and renal function. Br J Rheumatol 1995; 34: (suppl. 1) 25–8.
Hess EV, Herman JH. Cartilage metabolism and anti-inflammatory drugs in osteoarthritis. Am J Med 1986; 81 (suppl. 5B): 36–43.
Roth SH, Bennet RE. Nonsteroidal anti-inflammatory drug gastropathy. Arch Intern Med 1987; 147: 2093–2100.
Caldwell J. Diclofenac sodium in the treatment of rheumatoid arthritis and osteoarthritis. Semin Arthritis Rheum 1985; 15 (suppl 1): 73–9.
Dieppe P, Cushnaghan J, Jasani MK, McCrae F, Watts I. A two year, placcbo-controlled trial of nonsteroidal anti-inflammatory therapy in osteoarthritis of the knee joint. Br J Rheum 1993; 32: 595–600.
Grau M, Montero JL, Guasch J, Felipe A, Carrasco E, Julia S. The pharmacological profile of aceclofenac, a new non steroidal anti-inflammatory and analgesic drug. Agents Actions Supplements 1991; 32: 125–9.
O'Brien WM. Adverse reactions to nonsteroidal anti-inflammatory drugs. Diclofenac compared with other nonsteroidal anti-inflammatory drugs. Am J Med 1986; 80 (Suppl. 4B): 70–80.
Sainz Olalla F. Analgesic efficacy of aceclofenac. Double-blind study vs placebo in the treatment of odontalgia. Curr Ther Res 1989; 43: 900–2.
Movilia PG. Evaluation of the analgesic activity and tolerability of aceclofenac in the treatment of post-episiotomy pain. Drugs Exp Clin Res 1989; 15:47–51.
Giorgianni G, Ottaviani C, Soliano A, Campi N. Efficacy and tolerability of aceclofenac versus ketoprofen in the treatment of rheumatoid arthritis. Curr Ther Res 1992; 51: 175–84.
Diaz C, Rodriguez A, Geli C, Llobet JM, Tapounet R. Comparison of aceclofenac and diclofenac in osteoarthritic pain. Curr Ther Res 1988; 44: 252–6.
Birrell DH, Roma J, Bowdler JM. Evaluation of the efficacy and safety of aceclofenac in the treatment of osteoarthritis. Br J Clin Res 1995; 6: 45–55.
Ward DE, Veys EM, Bowdler JM, Roma J. Comparison of aceclofenac with diclofenac in the treatment of osteoarthritis. Clin Rheumatol, In Press.
Kellgren JH, Lawrence JS. Radiological assessment of osteoarthrosis. Ann Rheum Dis 1957; 16: 494–501.
Lequesne M. European guidelines for clinical trials of new antirheumatic drugs. EULAR Bull 1980; Suppl 6: 171–5.
Lequesne MG, 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 1987; Suppl 65: 85–9.
Kaufmann DW, Kelly JP, Sheehan JE, Laszlo A, Wiholm BE, Alfredsson L, Koff RS, Shapiro S. Nonsteroidal anti-inflammatory drug use in relation to major upper gastrointestinal bleeding. Clin Pharmacol Ther 1993; 53: 485–94.
Garcia Rodriguez LA, Jick H. Risk of upper gastrointestinal bleeding and perforation associated with individual non-steroidal anti-inflammatory drugs. Lancet 1994; 343: 769–72.
Langman MJS, Weil J, Wainwright P, Lawson DH, Rawlins MD, Logan RFA, Murphy M, Vessey MP, Colin-Jones DG. Risks of bleeding peptic ulcer associated with individual nonsteroidal anti-inflammatory drugs. Lancet 1994; 343:1075–78.
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Busquier, M.P., Calero, E., Rodriguez, M. et al. Comparison of aceclofenac with piroxicam in the treatment of osteoarthritis. Clin Rheumatol 16, 154–159 (1997). https://doi.org/10.1007/BF02247844
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DOI: https://doi.org/10.1007/BF02247844