ABSTRACT
OBJECTIVES: To evaluate the efficacy, safety and pharmacokinetics of fi-cyclodextrin-piroxicam in patients with osteoarthritis of knee. METHODS: Thirty patients with osteoarthritis(28 women, 2 men) were enrolled in the study. fi-cyclodextrin-piroxicam 20mg was administered orally, once daily for 8 weeks. The indices of efficacy(evaluation of the pain, joint swelling, tenderness and functional limitation) were evaluated at 0,2,4,8 weeks. Piroxicam plasma concentrations were determined by HPLC over 24 hours in 4 healthy volunteers, and were compared with those of reference formulation. RESULTS: There were statistically significant improvement in the indices of efficacy between entry and end of the study. The majority of side effects were related to the gastrointestinal tract, but the symptoms were mild except 1 drop-out case. According to pharmacokinetic study, the bioavailability and absorption rate of piroxicam were improved in fi-cyclodextrin-piroxicam group. Peak plasma piroxicam concentrations were higher in fi-cyclodextrin-piroxicam group than were in reference group. CONCLUSIONS: fi-cyclodextrin-piroxicam is efficacious and well tolerated in patients with osteoarthritis. Because of its rapid absorption, good bioavailability and fewer gastrointestinal disturbance, it seems to be a useful drug for long-term management of osteoarthritis.
