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Follow-up of cyclosporin A treatment in Type 1 (insulin-dependent) diabetes mellitus: lack of long-term effects
Authors:S. Martin  G. Schernthaner  J. Nerup  F. A. Gries  V. A. Koivisto  J. Dupré  E. Standl  P. Hamet  R. McArthur  M. H. Tan  K. Dawson  A. E. Mehta  S. Van Vliet  B. von Graffenried  C. Stiller  H. Kolb
Affiliation:(1) Diabetes Research Institute, University of Düsseldorf, Düsseldorf, FRG;(2) Krankenanstalt Rudolfstiftung, Vienna, Austria;(3) Steno Memorial Hospital, Gentofte, Denmark;(4) Second Department of Medicine, Helsinki University, Helsinki, Finland;(5) University Hospital, London, Ontario, Canada;(6) Städtisches Krankenhaus München-Schwabing, Munich, FRG;(7) Clinical Research Institute, Montreal, Quebec;(8) Alberta Children's Hospital, University of Calgary, Calgary, Alberta;(9) Camp Hill Medical Centre, Halifax, Nova Scotia;(10) University Hospital, Vancouver, British Columbia;(11) Health Science Centre, Winnipeg, Manitoba;(12) University of Saskatchewan, Saskatoon, Saskatchewan, Canada;(13) Sandoz, Basal, Switzerland
Abstract:Summary In the Canadian/European randomized controlled study on cyclosporin A (CsA) in recent onset Type 1 (insulin-dependent) diabetes, treatment with the immunosuppressive drug had increased and maintained Beta-cell function and clinical remission during the first 12 months. Following discontinuation of the study drug and double-blinding after a mean of 13.8 months former CsA patients doubled the daily insulin dose within 6 months reaching the level of former placebo patients. The difference in Beta-cell function between the two groups was also lost. Metabolic control (HbA1c) was transiently worse in the former CsA group. Adverse effects of cyclosporin A on systolic blood pressure, haemoglobin levels, serum potassium and creatinine levels also remitted during that time. We conclude that treatment with cyclosporin A for a mean of 13.8 months had no long-lasting effect on the course of Type 1 diabetes persisting beyond drug discontinuation.Prepared by the authors on behalf of The Canadian/European Randomized Control Trial Group (Please see acknowledgements for complete listing).
Keywords:Cyclosporin A  Type 1 (insulin-dependent) diabetes mellitus  immunotherapy  C-peptide  islet function  remission of Type 1 diabetes
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