The clinical relevance of
piroxicam-beta-cyclodextrin (PBC) in the long-term treatment of
osteoarthritis and
rheumatoid arthritis is reviewed. Two hundred and twenty-five patients--one hundred with
rheumatoid arthritis and one hundred and twenty five with
osteoarthritis--were enrolled in a double-blind, randomised, controlled study versus
piroxicam. Drugs were administered once-daily, for twelve weeks. The indices of efficacy (
pain intensity, severity of
inflammation, functional impairment evaluated at 0,2,4,8 and 12 weeks showed the good
analgesic effect of
piroxicam without significant differences between its two formulations. Tolerance appeared to be better in the group of patients treated with PBC than in the one treated with
piroxicam. Both the incidence and severity of side effects were lower for patients treated with PBC. The majority of side effects were related to the gastrointestinal tract. The study suggests that PBC, used in the long term treatment of
rheumatic diseases, improves the safety of
piroxicam without affecting its efficacy. In another study, thirty patients with chronic
osteoarthritis were randomly assigned to receive PBC or
tenoxicam daily for eight weeks. Both drugs effectively reduced
pain,
inflammation, and functional limitation of the affected joints. Endoscopy revealed minor post-treatment mucosal lesions; these tended to be less severe with PBC than with
tenoxicam. The clinical experience in the long-term treatment of rheumatic conditions indicates that the microencapsulation of
piroxicam as
piroxicam-beta-cyclodextrin has provided a new
drug with a superior tolerability compared to the parent compound without affecting its high efficacy on the symptoms of the primary disease.