title: Observational study with everolimus (Certican) in combination with low-dose cyclosporine in de novo heart transplant recipients.
abstract: METHODS
  This observational study reports on immunosuppression with cyclosporine (CsA) in 38 de novo heart transplant recipients receiving everolimus compared with 14 patients receiving mycophenolate mofetil (MMF).
  
  
  RESULTS
  Mean (+/- SD) everolimus C0 blood levels remained stable within 5 to 7 ng/ml. Mean CsA C0 blood levels were reduced by 47%, from 240 +/- 57 ng/ml at 2 weeks post-transplant to 128 +/- 38 ng/ml at Month 6 and by 58% to 101 +/- 26 ng/ml at Month 12 in the everolimus group, compared to 18% from 246 +/- 54 ng/ml at 2 weeks post-transplant to 201 +/- 48 ng/ml at Month 6 and by 35% to 160 +/- 41 ng/ml in MMF patients. Efficacy was high with a rejection rate of 23.6% (everolimus) vs 28.5% (MMF) by Month 12. Mean pre-transplant serum creatinine levels of 1.67 +/- 0.59 mg/dl decreased to 1.53 +/- 0.57 mg/dl under everolimus and increased from 1.22 +/- 0.36 to 1.99 +/- 0.75 mg/dl in the MMF group by Month 12 post-transplant. However, calculated GFR declined in both groups by Month 12 (everolimus: from 71 +/- 29 to 57 +/- 27 ml/min/1.73 m2; MMF: from 73 +/- 22 to 44 +/- 24 ml/min/1.73 m2), with stabilization after 3 to 6 months in everolimus-treated patients and after 6 to 9 months in MMF-treated patients.
  
  
  CONCLUSIONS
  Everolimus allows marked reduction of CsA exposure without significant loss of efficacy and also provides early protection of renal function.
authors.affiliation: Department of Cardiothoracic and Vascular Surgery, Deutsches Herzzentrum Berlin, Berlin, Germany. lehmkuhl@dhzb.de
authors.forename: Hans B
authors.initials: HB
authors.lastname: Lehmkuhl
authors.forename: Daniel
authors.initials: D
authors.lastname: Mai
authors.forename: Michael
authors.initials: M
authors.lastname: Dandel
authors.forename: Christoph
authors.initials: C
authors.lastname: Knosalla
authors.forename: Nicola E
authors.initials: NE
authors.lastname: Hiemann
authors.forename: Onnen
authors.initials: O
authors.lastname: Grauhan
authors.forename: Michael
authors.initials: M
authors.lastname: Huebler
authors.forename: Miralem
authors.initials: M
authors.lastname: Pasic
authors.forename: Yuguo
authors.initials: Y
authors.lastname: Weng
authors.forename: Rudolph
authors.initials: R
authors.lastname: Meyer
authors.forename: Markus
authors.initials: M
authors.lastname: Rothenburger
authors.forename: Manfred
authors.initials: M
authors.lastname: Hummel
authors.forename: Roland
authors.initials: R
authors.lastname: Hetzer
mesh_terms: D000328:Adult; D002784:Cholesterol / Q000097:blood; D003404:Creatinine / Q000097:blood; D016572:Cyclosporine / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D000068338:Everolimus; D005260:Female; D016027:Heart Transplantation / Q000379:methods*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007668:Kidney / Q000187:drug effects / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives / Q000627:therapeutic use; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D007166:Immunosuppressive Agents; D016572:Cyclosporine; D002784:Cholesterol; D000068338:Everolimus; D003404:Creatinine; D009173:Mycophenolic Acid; D020123:Sirolimus