Cyclosporin

StudyPopulationInterventionOutcomesResultsCommentsDesignEL
Dupre et al, 198848188 patients with type 1 diabetes within 6 weeks of initiation of insulin therapy
Aged 9–35 years
Europe and Canada
Cyclosporin 110 mg/kg daily
versus
placebo
Trial length: 1 year
Insulin-free remission6 months: 38.7 vs. 19.1, p < 0.001
12 months: 24.2 vs. 9.8, p < 0.002
Loss to follow-up numbers do not add upRCTIb
Martin et al, 199149188 patients with type 1 diabetes within 6 weeks of initiation of insulin therapy
Aged 9–35 years
Europe and Canada
Follow-up from above trial using statistical twin pairs
Cyclosporin or placebo discontinued on average at 13.8 ±7.4 months
HbA1c6 months after discontinuation of intervention: p < 0.05
15 months after discontinuation of intervention: no significant difference
Numbers not given – only presented as a graphFollow-up from RCT reported above 48IIa
Levy-Marchal et al, 19865128 children with diabetes
Aged 2–15 years
France
Cyclosporine A soon after start of insulin therapy given 3 times a day for 6 months
Target trough plasma levels of 100 ng/ml, dosage 9.8 ± 3.4 mg/kg/day (n = 14)
versus
target trough plasma levels of 200 ng/ml, dosage 17 ± 4 mg/kg/day (n = 14)
versus
control group children referred to unit in the year before this study (n = ?)
  1. Remission period
  2. Adverse effects
  1. No difference among treatment groups and control.
  2. At 6 months no remission: 3/14 vs. 0/14 vs. all controls n = ?
    At 6 months partial remission: 11/14 vs. 3/6 vs. 0/?
    At 6 months total remission: 5/14 vs. 3/6 vs. 0/?
  3. Cyclosporine A: in low-dose group alkaline phosphatases were evaluated. In high-dose groups, evaluated blood pressure in 6/14 cases and elevated plasma creatinine in 2 cases; all adverse effects were reversible after cyclosporine A was discontinued
Short articleNon-randomised intervention studyIIa
De Filippo et al, 199652130 children diagnosed with diabetes before 1988
Cyclosporin-treated children with diabetes mean age 10.0 ± 3.2 years, control children with diabetes mean age 11.1 ± 2.6 years
France
83 cyclosporin-treated children (treatment given at initial dosage of 7.2 ± 0.1 mg/kg/day, decreased stepwise then interrupted after 6–62 months depending on response to therapy)
versus
47 children with diabetes not treated with cyclosporin
Follow-up 4 years
  1. Average frequency of severe hypoglycaemia
  1. During first 4 years of follow-up HbA1c level was lower by approximately 1–1.5% in cyclosporin-treated children compared with controls (displayed in graph – numbers not given)
  2. 0.03 ± 0.03 per patient per year vs. 0.23 ± 0.09 per patient per year, p < 0.05
Children from previous studyCohortIIa
Feutren et al, 198650122 patients aged 15–40 with type 1 diabetes
Mean age 25.7 ± 0.6 (SEM) years
France
Cyclosporin 7.5 mg/kg/day
versus
placebo
Followed up weekly for first month and then monthly
RemissionAt 6 months complete remission: 25.4% (16/57) vs. 18.6% (11/53) (not significantly different)
At 9 months complete remission: 24.1% vs. 5.8%, p < 0.01
At 6 months partial remission: 46% (13/57) vs. 28.8% (6/53)
Adverse effects: Hypertrichosis, gingival hyperplasia, parasthesias, hypertension, abdominal discomfort, lymphadenopathy, adenofibroma of the breast
Randomisation based on sequence of entry to the studyRCTIb

From: Evidence tables

Cover of Type 1 Diabetes
Type 1 Diabetes: Diagnosis and Management of Type 1 Diabetes in Children and Young People.
NICE Clinical Guidelines, No. 15.2.
National Collaborating Centre for Women's and Children's Health (UK).
London: RCOG Press; 2004 Sep.
Copyright © 2004, National Collaborating Centre for Women’s and Children’s Health.

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