Document Detail

C2 therapeutic drug monitoring of cyclosporine is a safe and feasible method in de novo heart transplant patients.
MedLine Citation:
PMID:  18089381     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The narrow therapeutic window of cyclosporine (CsA) requires close therapeutic drug monitoring (TDM). While C2-TDM has been established after renal and liver transplantations, clinical experience is limited for patients after de novo heart transplantation (HTX). PATIENTS AND METHODS: In a retrospective study, we investigated 40 patients undergoing HTX; 34 patients received induction therapy using antithymocyte globulin (ATG Mérieux). Immunosuppression was administered with CsA (Sandimmun-Optoral), with dosages adjusted according to C2 levels (800-1100 ng/mL during the first 6 months and reduced to 400-600 ng/mL from the beginning of the first year). At different times TI (months 1-3). TII (months 12-14) TIII (months 24-26), and TIV (months 34-36), we obtained measures of acute cellular rejections (ARs), cytomegalovirus (CMV) infections, creatinine, and safety laboratory parameters. RESULTS: The cumulative survival was 95% after 1 year, and 88% after 3.8 years. Eight ARs were diagnosed at a mean of 7.6 months after HTX in 7 patients. Twenty-four CMV infections/reactivations were verified. In 10 cases, treatment was started because of clinical symptoms. The mean creatinine values significantly rose in the early postoperative phase (TI: 1.23+/-0.47 mg/dL, TII: 1.49+/-0.41 mg/dL; P<.0001). Thereafter the creatinine values declined; however, this was not statistically significant (TIII: 1.38+/-0.57 mg/dL, TIV: 1.15+/-0.30 mg/dL). All other safety parameters showed no significant changes. CONCLUSIONS: C2 allows individualization of immunosuppression with reduced CsA toxicity, but without loss in safety among de novo patients after HTX. We obtained freedom from severe AR, a low number of CMV infections, and excellent patient survival.
T Puehler; L Goepel; M v Tschirschnitz; U Struckmeyer; M Ernst; S Ladenburger; C Schmid; J Cremer; S W Hirt
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Transplantation proceedings     Volume:  39     ISSN:  0041-1345     ISO Abbreviation:  Transplant. Proc.     Publication Date:  2007 Dec 
Date Detail:
Created Date:  2007-12-19     Completed Date:  2008-02-20     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0243532     Medline TA:  Transplant Proc     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3329-33     Citation Subset:  IM    
Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein Campus Kiel, Kiel, Germany.
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MeSH Terms
Alanine Transaminase / blood
Aspartate Aminotransferases / blood
Cholesterol / blood
Creatine Kinase / blood
Creatinine / blood
Cyclosporine / pharmacokinetics*,  therapeutic use
Drug Monitoring / methods,  standards
Heart Transplantation / immunology*,  mortality
Immunosuppressive Agents / pharmacokinetics,  therapeutic use
Lipoproteins / blood
Retrospective Studies
Survival Analysis
Time Factors
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Lipoproteins; 57-88-5/Cholesterol; 59865-13-3/Cyclosporine; 60-27-5/Creatinine; EC Aminotransferases; EC Transaminase; EC Kinase

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