Double-blind, double-dummy comparative study of local action transcutaneous flurbiprofen (flurbiprofen LAT) versus piketoprofen cream in the treatment of extra-articular rheumatism

Objective: A local action transcutaneous (LAT) system has been developed fo r the topical application of the nonsteroidal anti-inflammatory drug flurbi profen. The purpose of the present study was to compare the efficacy and to lerability as well as the patients' acceptance of flurbiprofen LAT versus t he cream formulation of piketoprofen in the treatment of patients with soft tissue rheumatism. Design and Setting: This was a multicentre, randomised, double-blind, doubl e-dummy, parallel group study conducted at five hospitals in Spain. Patients: 129 patients with soft tissue rheumatism were randomised to recei ve either one 40mg flurbiprofen LAT patch twice daily or 4cm of 1.8% piketo profen cream (equivalent to 36mg) three times daily for 14 days. As supplem ental medication, the use of paracetamol, one or two 500mg tablets every 4 to 6 hours, was allowed if necessary (maximum eight tablets/day). Methods: At the start of the study and on days 7 and 14, the investigator a ssessed the severity of the disease and the intensity of pain and tendernes s, as well as the mobility of the joints involved. The patients made a dail y assessment of the quality of sleep. At the end of the study the patients gave their general opinion about the treatment. Results: 74 of the 129 patients recruited were assigned to the flurbiprofen LAT group and 65 to the piketoprofen group. 126 patients had soft tissue r heumatism in the shoulder and three in the elbow. Patients showed a signifi cant improvement in all clinical parameters assessed: severity of the disea se (p < 0.0005), spontaneous pain (p < 0.0005), tenderness (p < 0.0005), an d mobility of the involved joints (p < 0.0005), with no statistically signi ficant differences between the two treatment groups. No differences were fo und between groups with regard to patient assessment of the quality of slee p and the use of supplemental medication. About two-thirds of the patients participating in the study found their treatment adequate and easy to use ( both groups used patches as part of the double-dummy design). Both drugs we re well tolerated, adverse events being reported in six (9.7%) of the patie nts treated with flurbiprofen LAT and in six (9.8%) of those treated with p iketoprofen. Conclusions: Flurbiprofen LAT is a topically applied nonsteroidal anti-infl ammatory drug that is effective and well tolerated and thus provides an att ractive treatment option for extra-articular rheumatism.