Favorable outcome of low-dose cyclosporine afteir pulse methylprednisolone in Japanese adult minimal-change nephrotic syndrome

Objective There have been few studies on cyclosporine (CsA) monotherapy in adult minimal change nephrotic syndrome (MCNS). To delineate CsA therapy as new treatment options for MCNS, we conducted a prospective single-center study. Methods We assessed the efficacy of 3 different regimens in 36 patients, consisting of 26 first attacks or 10 relapses, of adult-onset MCNS. In 12 patients, CsA alone was given orally at a dose of 2-3 mg/kg/d, and in 12 patients, CsA after intravenous pulse methylprednisolone therapy (CsA/PMT) was given at the same dose. CsA was given for 12 months, tapered slowly, then stopped. The other 12 patients were treated with oral prednisolone (PSL, 40-60 mg/d) alone for 4 to 6 weeks, followed by daily PSL, with slowly tapering doses. Results Complete remission (CR) was obtained in 75% with CsA alone, 100% with CsA/PMT and 92% with PSL alone (p=0.0379). The days required for CR were shortest in the CsA/PMT group (40.9 +/- 35.5 days with CsA alone vs. 11.0 +/- 5.6 with CsA/PMT vs. 21.5 +/- 15.8 with PSL alone). The cumulative rates of CR were significantly different among the 3 groups (p<0.0001). The real numbers of the relapse were smallest in the CsA/PMT group, however, the cumulative rates of sustained remission among the 3 treatment arms were not statistically different. Renal function was well preserved with each treatment period. CsA-associated adverse effects were minimal but one patient developed new-onset hypertension and gingival hyperplasia. However, the adverse effects of PSL alone were serious in 3 cases: bleeding from gastric ulcer, diabetes mellitus, and aseptic necrosis. Many patients with PSL but few with CsA experienced cosmetic problems. Conclusions CsA/PMT may be the most advantageous when the clinical efficacy of each treatment for MCNS is integrated.