EFFICACY AND TOLERABILITY OF A TOPICAL NSAID PATCH (LOCAL-ACTION TRANSCUTANEOUS FLURBIPROFEN) AND ORAL DICLOFENAC IN THE TREATMENT OF SOFT-TISSUE RHEUMATISM

The efficacy and safety of local action transcutaneous flurbiprofen 40 mg [flurbiprofen LAT] patches and diclofenac sodium tablets, 50 mg b. d., were compared in an open, multicentre, randomized, parallel-group study in patients with soft-tissue rheumatism. Patches were replaced a t 12-hourly intervals. Clinical assessments were performed after 7 and 14 days of treatment. Fifty-six patients were treated with flurbiprof en LAT and 53 with diclofenac. Six withdrawals (three from each group) occurred during the treatment period. A statistically significant dif ference was observed in favour of flurbiprofen LAT for the principal m easure, namely the investigator's opinion of overall change in clinica l condition: 49/53 (92%) patients treated with flurbiprofen LAT had im proved by day 14 compared with 36/49 (73%) patients receiving diclofen ac sodium (p=0.03; eligible dataset). There were also statistically si gnificant differences in favour of flurbiprofen LAT for the investigat or's assessments of the overall severity of the clinical condition (p= 0.03; eligible dataset), for the severity of pain at the region treate d (p=0.04; intent-to-treat), and for the severity of tenderness (p <0. 001; intent-to-treat). Supplementary analgesia (paracetamol) was requi red by two patients in the flurbiprofen LAT group and by eight diclofe nac-treated patients. The difference in favour of flurbiprofen LAT in the average daily consumption of paracetamol was significant (p=0.04). The patients' assessment of severity of pain on movement also favoure d flurbiprofen LAT (p =0.049; eligible dataset), bat there were no sta tistically significant differences in day or night pain or quality of sleep. For the patients' opinion of treatment there was, however, a st atistically significant difference in favour of flurbiprofen LAT (p=0. 02). Of the patients receiving flurbiprofen LAT, 94% regarded it as a convenient form of treatment. With respect to tolerability 8/56 (14%) patients applying flurbiprofen patches reported a total of nine advers e effects (AEs) (mainly local, mild skin irritations), vs 9/52 (17%) p atients receiving diclofenac, who reported 12 AEs. Most AEs in the ent eric-coated diclofenac group were of a gastrointestinal nature (one of which was severe). In terms of the proportion of patients reporting A Es related to the digestive system, there was a statistically signific ant difference in favour of flurbiprofen LAT (p=0.011). In conclusion, local treatment of soft-tissue rheumatism with flurbiprofen LAT was d emonstrably superior to benchmark oral therapy with diclofenac sodium over a 2-week period in terms of both efficacy and gastrointestinal to lerability. Flurbiprofen LAT provided both an effective and convenient form of topical SAID treatment.