TENIDAP IN PATIENTS WITH RHEUMATOID-ARTHRITIS - A 4-WEEK, PLACEBO-CONTROLLED STUDY

The present double-blind, placebo-controlled study was conducted to Co mpare the safely and efficacy of tenidap in patients with rheumatoid a rthritis (RA). Patients with dare of active RA following NSAID withdra wal were randomized to receive either placebo (n=67) or tenidap (n=131 ; 40-200 mg/day). The mean changes from baseline in efficacy and bioch emical variables were compared between treatment groups at endpoint (4 weeks). The improvements in four of the five primary efficacy variabl es were significantly greater in the tenidap group compared with the p lacebo group (p<0.01). Tenidap was also associated with an 18% reducti on in erythrocyte sedimentation rate (ESR) and a marked, 51%, reductio n in serum C-reactive protein (CRP) lever, both of which were signific antly greater than the changes in the placebo group (p<0.05). The perc entage of patients who discontinued because of side effects was the sa me in both groups (3%). In conclusion, tenidap 40-200 mg/day was effec tive and well tolerated in the treatment of patients with RA for 4 wee ks.