title: Randomised, double-blind, placebo-controlled study of tacrolimus in myasthenia gravis.
abstract: OBJECTIVE
  To evaluate the ability of tacrolimus to reduce the corticosteroid dose in patients with myasthenia gravis (MG) and the drug's safety in a double-blind, placebo-controlled, parallel group study.
  
  
  METHODS
  Patients being treated with oral prednisolone at doses equivalent to 10-20 mg/day, and with stable symptoms, were randomised to tacrolimus or placebo in a 28-week double-blind study. The dose of corticosteroid was tapered with the procedures specified in the protocol. The primary efficacy endpoint was the mean daily prednisolone dose given in the last 12&emsp14;weeks of the study.
  
  
  RESULTS
  Eighty patients received the study drug (40 patients in each group) and were included in the full analysis set. In the full analysis set, there was no significant difference in the primary efficacy endpoint between the two groups (p = 0.078). However, some secondary analyses suggested the steroid-sparing effect of tacrolimus. Tacrolimus was well tolerated, and no safety concerns were noted.
  
  
  CONCLUSIONS
  This study suggests that tacrolimus has a potential advantage as a steroid-sparing agent in the treatment of MG patients.
  
  
  BACKGROUND
  NCT00309088. Name of the trial registry: FK506 Phase 3 STUDY: A STUDY for Steroid Non-Resistant MG Patients.
authors.affiliation: Health Service Center, Kanazawa University, Kakuma-machi, Kanazawa, Ishikawa 920-1192, Japan. hiroaki@kenroku.kanazawa-u.ac.jp
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Yoshikawa
authors.forename: Takahiro
authors.initials: T
authors.lastname: Kiuchi
authors.forename: Takahiko
authors.initials: T
authors.lastname: Saida
authors.forename: Masaharu
authors.initials: M
authors.lastname: Takamori
mesh_terms: D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D007376:Interleukin-2 / Q000097:blood; D008297:Male; D008875:Middle Aged; D009157:Myasthenia Gravis / Q000188:drug therapy*; D011239:Prednisolone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016559:Tacrolimus / Q000009:adverse effects / Q000627:therapeutic use*; D013934:Thymectomy; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D002800:Cholinesterase Inhibitors; D007166:Immunosuppressive Agents; D007376:Interleukin-2; D011239:Prednisolone; D016559:Tacrolimus