Cyclosporin increases the rate and length of remissions in insulin-dependent diabetes of recent onset. Results of a multicentre double-blind trial.
In a double-blind trial 122 patients aged 15-40 years with insulin-dependent diabetes of recent onset were randomly assigned to cyclosporin 7.5 mg/kg per day or placebo. At the sixth month 25.4% of the cyclosporin group and 18.6% of the placebo group were in complete remission (not a significant difference). Treatment was continued in those patients with complete or partial remission (insulin requirement less than 0.25 U/kg per day) and 106 patients were followed to nine months, at which stage 24.1% of the original cyclosporin group and 5.8% of the original placebo group were in complete remission (p less than 0.01). For those patients whose whole-blood trough cyclosporin levels in the first three months averaged 300 ng/ml or more, the rates of complete remission at six and nine months were 37.5% and 37%. The rates of partial remission were also higher in the cyclosporin group and at six months the rate of complete or partial remission was 46% in the whole cyclosporin group and 65.6% in those with an average blood level exceeding 300 ng/ml in the first three months, versus 28.8% in the placebo group. The principal side-effect of cyclosporin was a modest and reversible increase in plasma creatinine. These results indicate that cyclosporin promotes the remission of type I diabetes and suggest the need for new controlled protocols aimed at evaluating the length of the effect and selecting the best drug regimen.
Feutren
G
G
Papoz
L
L
Assan
R
R
Vialettes
B
B
Karsenty
G
G
Vexiau
P
P
Du Rostu
H
H
Rodier
M
M
Sirmai
J
J
Lallemand
A
A
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D001424:Bacterial Infections / Q000139:chemically induced; D002986:Clinical Trials as Topic; D003524:Cyclosporins / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D006983:Hypertrichosis / Q000139:chemically induced; D007328:Insulin / Q000008:administration & dosage / Q000627:therapeutic use; D007677:Kidney Function Tests; D008297:Male; D011897:Random Allocation
D003524:Cyclosporins; D007328:Insulin