title: Preprandial microemulsion cyclosporine administration is effective for patients with refractory nephrotic syndrome.
abstract: OBJECTIVE
  The present study evaluated the clinical efficacy and pharmacokinetics of microemulsion cyclosporine A (ME-CyA) with modification from postprandial to preprandial administration in adult patients with refractory nephrotic syndrome.
  
  
  METHODS
  We investigated 19 patients with refractory nephrotic syndrome who had been switched from the postprandial administration of ME-CyA to preprandial administration. The pharmacokinetics of ME-CyA were also evaluated before and 6 months after switching from postprandial to preprandial administration by serial measurement of the blood CyA concentration in 10 patients.
  
  
  RESULTS
  This study showed that 16 of 19 patients (84%) displayed an improvement in their clinical condition or continued to maintain remission after switching from post- to preprandial administration. In particular among 14 patients with minimal change nephrotic syndrome (MCNS) in this study, 13 patients maintained or achieved remission under preprandial ME-CyA administration. Only three of 10 patients with postprandial administration showed a peak concentration> 500 ng/ml within 1-2 h after administration, while with preprandial administration, nine of 10 patients showed this good absorption profiles. This effectiveness of preprandial administration seems to be dependent on the improved pharmacokinetics with the increase of area under the curve from 0-4 h (AUC(0-4)) and peak concentration. There were no statistical differences in the mean daily doses of ME-CyA between both administration periods. No ME-CyA-induced nephrotoxicity or other harmful events were encountered throughout the study.
  
  
  CONCLUSIONS
  The preprandial administration of ME-CyA results in a good pharmacokinetic profile and is useful for management of refractory nephrotic syndrome in adults, particularly in patients with MCNS.
authors.affiliation: Division of Nephrology and Hypertension, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan. sirababu@marianna-u.ac.jp.
authors.forename: Sayuri
authors.initials: S
authors.lastname: Shirai
authors.affiliation: Division of Nephrology and Hypertension, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Yasuda
authors.affiliation: Division of Nephrology and Hypertension, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Tsuchida
authors.affiliation: Division of Nephrology and Hypertension, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Kuboshima
authors.affiliation: Division of Nephrology and Hypertension, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Konno
authors.affiliation: Division of Nephrology and Hypertension, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Shima
authors.affiliation: Division of Nephrology and Hypertension, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
authors.forename: Takeo
authors.initials: T
authors.lastname: Sato
authors.affiliation: Department of Pharmacy, St. Marianna University School of Medicine, Kawasaki, Japan.
authors.forename: Shigeo
authors.initials: S
authors.lastname: Hatta
authors.affiliation: Department of Pharmacy, St. Marianna University School of Medicine, Kawasaki, Japan.
authors.forename: Keisou
authors.initials: K
authors.lastname: Masuhara
authors.affiliation: Division of Nephrology and Hypertension, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
authors.forename: Kenjirou
authors.initials: K
authors.lastname: Kimura
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D016572:Cyclosporine / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D004655:Emulsions; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000097:blood / Q000493:pharmacokinetics*; D007408:Intestinal Absorption; D008875:Middle Aged; D009402:Nephrosis, Lipoid / Q000188:drug therapy*; D019518:Postprandial Period; D055815:Young Adult
chemical_list: D004655:Emulsions; D007166:Immunosuppressive Agents; D016572:Cyclosporine