Á. Burgos, M. P. Busquier, J. G. Reino
Feb 1, 2001
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Influential Citations
8
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Quality indicators
Journal
Clinical Drug Investigation
Abstract
ObjectiveA local action transcutaneous (LAT) system has been developed for the topical application of the nonsteroidal anti-inflammatory drug flurbiprofen. The purpose of the present study was to compare the efficacy and tolerability as well as the patients’ acceptance of flurbiprofen LAT versus the cream formulation of piketoprofen in the treatment of patients with soft tissue rheumatism.Design and SettingThis was a multicentre, randomised, double-blind, double-dummy, parallel group study conducted at five hospitals in Spain.Patients129 patients with soft tissue rheumatism were randomised to receive either one 40mg flurbiprofen LAT patch twice daily or 4cm of 1.8% piketoprofen cream (equivalent to 36mg) three times daily for 14 days. As supplemental medication, the use of paracetamol, one or two 500mg tablets every 4 to 6 hours, was allowed if necessary (maximum eight tablets/day).MethodsAt the start of the study and on days 7 and 14, the investigator assessed the severity of the disease and the intensity of pain and tenderness, as well as the mobility of the joints involved. The patients made a daily assessment of the quality of sleep. At the end of the study the patients gave their general opinion about the treatment.Results74 of the 129 patients recruited were assigned to the flurbiprofen LAT group and 65 to the piketoprofen group. 126 patients had soft tissue rheumatism in the shoulder and three in the elbow. Patients showed a significant improvement in all clinical parameters assessed: severity of the disease (p < 0.0005), spontaneous pain (p < 0.0005), tenderness (p < 0.0005), and mobility of the involved joints (p < 0.0005), with no statistically significant differences between the two treatment groups. No differences were found between groups with regard to patient assessment of the quality of sleep 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 were well tolerated, adverse events being reported in six (9.7%) of the patients treated with flurbiprofen LAT and in six (9.8%) of those treated with piketoprofen.ConclusionsFlurbiprofen LAT is a topically applied nonsteroidal anti-inflammatory drug that is effective and well tolerated and thus provides an attractive treatment option for extra-articular rheumatism.