FDDF (fast dissolving dosage form) piroxicam for sublingual administration in the treatment of rheumatoid arthritis

Open non-comparative study for the evaluation of the efficacy and tolerance of piroxicam FDDF for sublingual administration in the treatment of rheumatoid arthritis. Thirty patients (6 males and 24 females) suffering from rheumatoid arthritis in the active phase have been treated. All the patients had to fulfil the criteria for the rheumatoid arthritis classification proposed by the American Rheumatism Association (ARA). The efficacy of therapy has been evaluated, after 2, 4 and 6 week of treatment, through the changes in: the number of painful or tender joints on motion, the number of swollen joints, grip strength, ESR. Also day pain, night pain, duration of morning stiffness and functional index have been evaluated. As regards the functional index, activities as dressing, arising, eating, walking, taking care of hygiene, bending, standing and sitting have been considered. The study sample was composed by 30 patients, with a mean age of 59.73 years, suffering from rheumatoid arthritis from 4.76 years. As regards efficacy parameters, day pain, which is recorded on a 21 compartment visual analogue scale, was initially of 8.13 (+/- 3.73), and after 2 weeks of therapy decreased of about 1 point and after 4 weeks was of 6.57 (+/- 3.73). This improvement was already statistically significant at the first control (p = 0.01). At the first control also morning stiffness resulted improved in a statistically significant way (p < 0.0001). As regards functional index a statistically significant improvement was observed in the disability of walking and of picking up objects after 2 weeks; after 4 weeks a significant improvement was observed in the disability of arising and of bending. These changes in functional ability probably depend upon the kind of joint involved and the duration of these lesions. Also the grip strength resulted statistically improved at the 2 control. As regards objective values, there was a statistically significant improvement in tender and swollen joints after only 2 weeks. As regards ESR, which is an index of disease activity, was initially of 40.73 (+/- 16.75) in mean; at the end of the 6th week it was of 34.72 (+/- 15.13): this reduction was statistically significant. No improvement was observed in night pain, normally the pain form which is more difficult to cure. As regards toleration, only 2 patients reported side-effects: the first reported epigastralgia and the second oral burning Both side-effects lasted 1 day and, according to the physician, their relation with the study drug is not sure.