A clinical evaluation of flurbiprofen LAT and piroxicam gel: A multicentre study in general practice
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A prospective, randomized, multicentre, open, crossover study of the comparative efficacy, tolerability and acceptability of two topical nonsteroidal anti-inflammatory drug (NSAID) therapies, flurbiprofen local-action transcutaneous (LAT) patch (40 mg b.d.) and piroxicam gel (3 cm, 0.5% q.d.s), was conducted in general practice in the UK in 137 men and women with soft-tissue rheumatism of the shoulder or elbow (e.g. epicondylitis, tendinitis, bursitis and adhesive capsulitis). Patients received one therapy for 4 days before crossing over to the other NSAID for a further 4 days, followed by 6 days of their preferred therapy. Clinical assessment of severity of pain, tenderness and overall clinical condition was carried out at baseline and after 4, 8 and 14 days. Patients self-assessed the severity of pain during the day and at night, and also the quality of their sleep during each treatment phase.
More patients showed a greater improvement in all of the clinical assessments of efficacy following treatment with flurbiprofen LAT during the crossover phase. There was a statistically significant reduction in the severity of pain, the principal measure of efficacy, in favour of flurbiprofen LAT: 42% of patients showed greater improvement with flurbiprofen LAT compared with 26% who showed a greater improvement with piroxicam gel (p=0.012; n=131, intent-to-treat). Eligible dataset (n=126) analysis revealed statistically significant differences in favour of flurbiprofen LAT in the severity of lesion tenderness (p=0.03) and the overall change in clinical condition (p=0.04) compared with baseline status. Superior efficacy for flurbiprofen LAT was also indicated in the patients' assessment at the end of the crossover phase (day 8), at which 69% chose to continue treatment with flurbiprofen LAT compared with only 31% of patients who chose piroxicam gel (n=126; p<0.001). There were, in addition, statistically significant differences in favour of flurbiprofen LAT in assessments for night pain (p<0.001), quality of sleep (p=0.004) and the patients' overall opinion of treatment (p<0.001). Both treatments were well tolerated with a low incidence of mainly local adverse events. These results showed that flurbiprofen LAT had a greater efficacy than piroxicam gel, and was also preferred by patients in the treatment of painful soft-tissue rheumatism of the shoulder and elbow.
Key wordsTransdermal Nonsteroidal Anti-Inflammatory Drugs Flurbiprofen Piroxicam Gel Soft Tissue Rheumatism
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- 4.Bouchier-Hayes, T.A., Rotman, H., Darekar, B.S. Comparison of the efficacy and tolerability of diclofenac gel (Voltarol Emulgel) and felbinac gel (Traxam) in the treatment of soft tissue injuries. Br J Clin Pract 1990, 44, 19–20.Google Scholar
- 5.Atra, E., Metz, C.A., Brown, B.L., Teoh, K. Flurbiprofen versus diclofenac for the treatment of osteoarthritis of the knee. Ann Pharmacother 1990, 24, 920–923.Google Scholar
- 6.Stubbs, D.F., Freeman, B.E., Jonson, J.H. Efficacy of flurbiprofen for non-arthritic pain. Curr Ther Res 1989, 46, 1179–1195.Google Scholar
- 7.Grant, M., Walter, J., Wojtulewski, J.A. A double-blind parallel group comparison of flurbiprofen and indomethacin in the long term treatment of osteoarthrosis of the knee. Br J Clin Pract 1980, 37, suppl 9, 92–94.Google Scholar
- 10.Sugawara, S. A study of the concentration in the synovial fluid and tissues of patients treated with the transdermal topical application of flurbiprofen (FP-A). Therap Res 1987, 6, 289–294.Google Scholar
- 12.Memeo, A., Garofoli, F., Peretti, G. Evaluation of the efficacy and tolerability of a new topical formulation of flurbiprofen in acute soft tissue injuries. Drug Invest 1992, 4, 441–449.Google Scholar
- 13.Aoki, T., Sugawara, S., Fujimaki, Y. et al. Clinical evaluation of topical application of flurbiprofen (FP-A) as a treatment for periarthritis scapulohumeralis-collaborative double-blind test compared with the control. Jap J Inflamm 1989, 9, 335–344.Google Scholar
- 16.Hollander, M., Wolfe, D.A. Nonparametric Statistical Methods. New York: Wiley, 1973, 67–75.Google Scholar
- 17.Armitage, P., Berry, G. Statistical Methods in Medical Research, 2nd ed. Oxford: Blackwell, 1987, 106–108.Google Scholar
- 18.Shapiro, S.S., Wilk, M.B. An analysis of variance test for normality (complete samples). Biometrika 1965, 52, 591–611.Google Scholar
- 19.Brown, M.B., Forsyth, A.B. Robust tests for the equality of variances. J Am Stat Assoc 1974, 69, 364–367.Google Scholar
- 20.Armitage, P., Berry, G. Statistical Methods in Medical Research, 2nd ed. Oxford: Blackwell, 1987, 120–123.Google Scholar
- 21.Kay, E., Petty, D. Topical NSAIDs. Curr Pract Pharm Ther, 1991, 3(8), 5–7.Google Scholar