Bioequivalence Of Deflazacort And Prednisone In The Treatment Of Idiopathic Nephrotic Syndrome - A Pilot-Study

To establish the bioequivalence of deflazacort and prednisone in the treatment of idiopathic nephrotic syndrome, we compared the effects of the two drugs on both glomerular and tubular functions in 10 adult patients with proteinuria >3.5 gm/day (range, 3.6 to 14 gm/day). A crossover, randomized clinical trial was conducted over a 3-month period (1-week induction with three 500-mg IV methylprednisolone bolus doses, followed by 5 weeks of treatment with 30 mg/day of deflazacort and 5 weeks with 25 mg/day of prednisone). The treatment sequence, deflazacort-prednisone or prednisone-deflazacort, was randomly assigned. After the crossover period, alt patients were treated with 30 mg/day of deflazacort for 3 to 6 months, eventually tapering (30 mg every other day for 2 weeks, then 15 mg every other day for 2 weeks) after remission of proteinuria. At the end of the crossover period, a significantly higher rate (80% vs 20%) of partial remission of nephrotic syndrome (ie, proteinuria <2 gm/day) was observed in the group of patients beginning the trial with deflazacort. Moreover, partial or complete remission (proteinuria <0.2 gm/day), once achieved with deflazacort or prednisone, was stable in the follow-up period. Finally, considering the additional patients achieving remission with deflazacort after the crossover period, an equal proportion of remission was observed in both groups. Other glomerular and tubular functions did not significantly differ between the groups entering the trial with deflazacort or prednisone. Therefore, results support at least bioequivalence of deflazacort and prednisone on the nephrotic kidney, while the apparent superiority of deflazacort on repairing the glomerular barrier requires further investigation on larger samples.