STEROID-SPARING ACTIVITY OF TENIDAP IN PATIENTS WITH POLYMYALGIA-RHEUMATICA - A MULTICENTER DOUBLE-BLIND RANDOMIZED PLACEBO-CONTROLLED STUDY

Objective. To determine whether tenidap treatment would allow reductio n or replacement of systemic corticosteroid treatment in patients with polymyalgia rheumatica (PMR). Methods. A 15-week double blind, random ized, multicenter, placebo-controlled study of tenidap sodium (120 mg/ day) in patients with symptomatically controlled PMR receiving 10 mg/d ay prednisone was conducted. After receiving study drug for 3 weeks, p rednisone dose was reduced by 2.5 mg/day every 3 weeks. The lowest cli nically effective dose of prednisone was recorded as 10, 7.5, 5, 2.5 o r 0 mg/day. Results. Thirty-two patients were randomized to tenidap or placebo. As prednisone was reduced more placebo patients experienced an exacerbation of PMR symptoms, elevation of erythrocyte sedimentatio n rate and increased serum C-reactive protein. Twice as many placebo p atients (10 of 16) as tenidap patients (5 of 16) discontinued due to l ack of efficacy. The lowest effective dose of prednisone could be dete rmined in 27 of the 32 patients, 11 receiving tenidap and 16 placebo. A significantly (p = 0.027) greater proportion of patients receiving t enidap (5 of 11) than placebo (1 of 16) were able to discontinue predn isone without experiencing a symptomatic flare. Conclusion. As prednis one was reduced, symptoms of PMR were controlled better by tenidap tha n by placebo. Forty-five percent of evaluable patients receiving tenid ap were able to discontinue prednisone without a disease flare compare d to 6% for placebo.