Long-term therapy with the new glucocorticosteroid deflazacort in rheumatoid arthritis. Double-blind controlled randomized 12-months study against prednisone.
The long-term anti-inflammatory and immunosuppressive properties and the safety of deflazacort (Calcort, CAS 14484-47-0) were assessed investigating the effect on clinical symptoms and safety parameters in patients with rheumatoid arthritis compared to prednisone as standard therapy in a randomized double-blind controlled clinical trial. Monitoring was performed according to GCP-guidelines closely in order to have a maximum of the patients entered completed at the end of the 12-month therapy with high data quality. 76 patients, meeting the criteria for classical or definite rheumatoid arthritis and requiring corticosteroid therapy, were randomly allocated to a 12-months treatment with either deflazacort (6 mg/tablet) or the corticoid standard prednisone (5 mg/tablet). Steady state dosage between 1/2 and 3 tablets per day was individually adjusted according to the severity of the clinical symptoms. Due to the close monitoring of the trial in the 6 study centres, 25 patients completed 12 months of deflazacort and 28 patients 12 months of prednisone treatment, being controlled 7 times during the trial. Five efficacy parameters were assessed at each visit: Ritchie Index, duration of morning stiffness, grip strength, effective dosage of study medication and global assessment of disease status. Following safety and tolerance parameters were controlled during the trial: vital signs, weight, Cushing's symptoms and adverse events at each visit; 32 laboratory parameters at 6 visits; ECG at 3 visits; and the global tolerance was assessed at the end of the study.(ABSTRACT TRUNCATED AT 250 WORDS)
Eberhardt
R
R
Pharmacolog Institut for Clinical Research, Munich, Fed. Rep. of Germany.
Krüger
K
K
Reiter
W
W
Gross
W
W
Zwingers
T
T
D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D001835:Body Weight / Q000187:drug effects; D003480:Cushing Syndrome / Q000503:physiopathology; D004311:Double-Blind Method; D004562:Electrocardiography / Q000187:drug effects; D005260:Female; D006728:Hormones / Q000097:blood; D006801:Humans; D007136:Immunoglobulins / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage / Q000627:therapeutic use*; D011282:Pregnenediones / Q000008:administration & dosage / Q000627:therapeutic use*
D000893:Anti-Inflammatory Agents; D006728:Hormones; D007136:Immunoglobulins; D011282:Pregnenediones; C021988:deflazacort; D011241:Prednisone