title: A prospective trial to evaluate the safety and efficacy of pravastatin for the treatment of refractory chronic graft-versus-host disease.
abstract: This prospective study evaluates the safety and efficacy of pravastatin for the treatment of chronic graft-versus-host disease (GVHD). We included 18 patients with refractory chronic GVHD. Oral pravastatin was started at 10 mg/day, and the dose was increased up to 40 mg/day in 4 weeks. This maximum dose was administered over 8 weeks. There were no severe adverse events caused by pravastatin. A clinical response was observed in the skin score in two patients, mouth score in five patients, eye score in two patients, liver score in three patients, platelet count score in one patient, and weight loss in two patients. The overall response rate was 28%. Immunophenotypic analyses showed that T-helper (Th)1 cells were dominant in all but one patient before treatment and that the Th1/Th2 ratio tended to be lower in the responders than in the nonresponders. A randomized controlled trial is warranted to evaluate the efficacy of pravastatin against chronic GVHD.
authors.affiliation: Hematopoietic Stem Cell Transplant Unit, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Akiko
authors.initials: A
authors.lastname: Hori
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Kanda
authors.forename: Susumu
authors.initials: S
authors.lastname: Goyama
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Onishi
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Komeno
authors.forename: Kinuko
authors.initials: K
authors.lastname: Mitani
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Kishi
authors.forename: Seishi
authors.initials: S
authors.lastname: Ogawa
authors.forename: Osamu
authors.initials: O
authors.lastname: Imataki
authors.forename: Shigeru
authors.initials: S
authors.lastname: Chiba
authors.forename: Rie
authors.initials: R
authors.lastname: Kojima
authors.forename: Tamae
authors.initials: T
authors.lastname: Hamaki
authors.forename: Michiyo
authors.initials: M
authors.lastname: Sakiyama
authors.forename: Masahiro
authors.initials: M
authors.lastname: Kami
authors.forename: Atsushi
authors.initials: A
authors.lastname: Makimoto
authors.forename: Ryuji
authors.initials: R
authors.lastname: Tanosaki
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Takaue
authors.forename: Hisamaru
authors.initials: H
authors.lastname: Hirai
mesh_terms: D002908:Chronic Disease; D006086:Graft vs Host Disease / Q000188:drug therapy*; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D017035:Pravastatin / Q000009:adverse effects / Q000627:therapeutic use*; D018417:Th1 Cells / Q000187:drug effects / Q000276:immunology; D018418:Th2 Cells / Q000187:drug effects / Q000276:immunology
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D017035:Pravastatin