title: Low-dose cyclosporin versus placebo in patients with rheumatoid arthritis.
abstract: 144 patients with severe rheumatoid arthritis from six centres were randomised to receive oral cyclosporin or placebo for 6 months. The initial daily dose of cyclosporin was 2.5 mg/kg, which was increased cautiously with monitoring of serum cyclosporin levels and creatinine; the mean stabilisation dose was 3.8 mg/kg. There were significant improvements in the cyclosporin-treated patients compared with the controls in the major outcomes of reduction of active joints (23% improvement), pain (24%), and functional status (16%); global improvement was 27%. In the cyclosporin group serum creatinine increased by a mean of 15.6 mumols/l and mean arterial blood pressure by 6.27 mmHg; these increases were controlled in all but 2 patients by dose adjustment without withdrawal from the study.
authors.affiliation: Division of Rheumatology, Chedoke-McMaster Hospital, Hamilton, Ontario, Canada.
authors.forename: P
authors.initials: P
authors.lastname: Tugwell
authors.forename: C
authors.initials: C
authors.lastname: Bombardier
authors.forename: M
authors.initials: M
authors.lastname: Gent
authors.forename: K J
authors.initials: KJ
authors.lastname: Bennett
authors.forename: W G
authors.initials: WG
authors.lastname: Bensen
authors.forename: S
authors.initials: S
authors.lastname: Carette
authors.forename: A
authors.initials: A
authors.lastname: Chalmers
authors.forename: J M
authors.initials: JM
authors.lastname: Esdaile
authors.forename: A V
authors.initials: AV
authors.lastname: Klinkhoff
authors.forename: G R
authors.initials: GR
authors.lastname: Kraag
mesh_terms: D000203:Activities of Daily Living; D000284:Administration, Oral; D001172:Arthritis, Rheumatoid / Q000097:blood / Q000188:drug therapy* / Q000652:urine; D001794:Blood Pressure / Q000187:drug effects; D003404:Creatinine / Q000097:blood / Q000652:urine; D003524:Cyclosporins / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index
chemical_list: D003524:Cyclosporins; D010919:Placebos; D003404:Creatinine