Abstract
Aiming at investigating the dose-response of UHAC62 (Generic Name: Meloxicam), a novel non-steroidal anti-inflammatory drug of the oxycam group, in the treatment of 75 patients with rheumatoid arthritis, a double-blind group comparative study was conducted at 20 medical centers disseminated nationwide.
Regarding the method of the study, the protocol which was far stricter than usual study protocols on the NSAIDs that were employed. This involved selecting only those patients who had shown a high rheumatic activities and who had never received any DMARDs or immunomodulators; further, any NSAIDs which had been administered were completely washed-out before the study. The doses administered were 1 mg/day (Group L) and 10 mg/day (Group H) ; and, the treatments were carried out principally for 4 weeks.
1) The rate of the patients who showed better than “Moderate Improvement” in the Final Global Improvement Rating was 41.4 % and 7.7 % in GroupH and Group L, respectively; and there was a significant difference between the groups.
2) The overall safety ratings of both groups were not significantly different from each other. Neither was there any significant difference in the incidence of adverse drug reactions between both groups, which was 10.8 % and 2.9 % in Group H and Group L, respectively.
3) The ratio of the patients on whom the usefulness ratings were made better than “Useful” was 36.4 % and 6.9 % in Group H and Group L, respectively; and thus the rating in Group H was significantly higher than that of Group L.
According to these results, it was clarified that the high dose of UHAC62, 10 mg/day, showed a significantly higher clinical effect than that of the low dose, 1 mg/day; and the efficacy of UHAC62 in the treatment of rheumatoid arthritis was clearly verified.
