EFFICACY AND TOLERABILITY OF DICLOFENAC DISPERSIBLE IN PATIENTS WITH OSTEOARTHROSIS

A 12-week, multicenter, double-blind, randomized trial was conducted to evaluate the efficacy and tolerability of diclofenac dispersible, a new drinkable form of diclofenac, in patients with osteoarthrosis of the knee or hip. Adult patients of either sex complaining of moderate or severe pain at rest or during activity were treated with 50 mg of diclofenac dispersible or conventional enteric-coated diclofenac sodium tablets orally three times daily. In the 134 patients eligible for efficacy analyses (67 in each treatment group), both formulations of diclofenac led to comparable and clinically significant reductions in the intensities of pain at rest and during activity within 2 weeks of treatment. Approximately 80% of patients in both treatment groups had no or mild pain on full passive movement by the end of 12 weeks of diclofenac therapy, with the Lequesne Index showing a reduction of 50% from initial values. Overall assessments of efficacy by the patients and the investigators indicated a positive response rate for the two diclofenac formulations ranging from 86% to 94%. The proportion of patients reporting one or more side effects was slightly higher in the dispersible group than in the enteric-coated group (20.9% versus 16.4%), but the difference was not statistically significant. All but one of the observed side effects were related to the gastrointestinal system. The results of this controlled study show that both diclofenac dispersible and enteric-coated diclofenac sodium are effective therapeutic agents for the treatment of osteoarthrosis.