title: Increased adherence after switch from twice daily calcineurin inhibitor based treatment to once daily modified released tacrolimus in heart transplantation: a pre-experimental study.
abstract: BACKGROUND
  Modified release tacrolimus (TAC) is a new, once-daily oral formulation of the established immunosuppressive agent TAC. Simplification of regimen has been associated with better adherence. This study evaluated patient adherence, as well as safety and efficacy among chronic stable heart transplantation (HT) patients switched from a conventional twice daily calcineurin inhibitor-based regimen (TAC or cyclosporine A [CsA]) to (once daily) modified release TAC.
  
  
  METHODS
  We switched 54 chronic stable patients (41 males and 13 females) from twice daily dosing with conventional TAC or CsA to once daily dosing with modified release TAC. Self-reported adherence was assessed at baseline and at 4 months after the switch using the Basel Assessment of Adherence with Immunosuppressive Medication Scale [BAASIS]), a 4-item validated questionnaire including also a Visual Analogue Scale (VAS). Nonadherence was defined as any self-reported nonadherence on any item.
  
  
  RESULTS
  Modified release TAC was discontinued in 4 patients because of diarrhea (n = 1) or gastrointestinal discomfort (n = 3) leaving 50 evaluable patients. Overall nonadherence at baseline for any of the 4 items was 74% versus 38% after 4 months (P = .0001). Thereafter, adherence improved in 28 patients (56.0%), was unchanged in 18 (36.0%), and decreased in 4 subjects (8.0%). The VAS score improved from 82.3% ± 2.6% to 97.5% ± 4.8% (P < .0001). No significant changes were observed after 4 months regarding hematologic, renal, or liver function parameters (all P = NS).
  
  
  CONCLUSIONS
  Therapeutic regimens for transplant recipients are often complex, contributing to a high incidence of medication nonadherence. This study in chronic, stable, heart transplantation patients demonstrated a significant improvement in patient adherence after a switch to modified release TAC, which was generally well tolerated.
authors.affiliation: Department of Cardiology, University of Heidelberg, Heidelberg, Germany. Andreas.Doesch@med.uni-heidelberg.de
authors.forename: A O
authors.initials: AO
authors.lastname: Doesch
authors.forename: S
authors.initials: S
authors.lastname: Mueller
authors.forename: M
authors.initials: M
authors.lastname: Konstandin
authors.forename: S
authors.initials: S
authors.lastname: Celik
authors.forename: C
authors.initials: C
authors.lastname: Erbel
authors.forename: A
authors.initials: A
authors.lastname: Kristen
authors.forename: L
authors.initials: L
authors.lastname: Frankenstein
authors.forename: A
authors.initials: A
authors.lastname: Koch
authors.forename: T J
authors.initials: TJ
authors.lastname: Dengler
authors.forename: P
authors.initials: P
authors.lastname: Ehlermann
authors.forename: C
authors.initials: C
authors.lastname: Zugck
authors.forename: S
authors.initials: S
authors.lastname: De Geest
authors.forename: H A
authors.initials: HA
authors.lastname: Katus
mesh_terms: D000328:Adult; D065095:Calcineurin Inhibitors; D016572:Cyclosporine / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology; D004334:Drug Administration Schedule; D005260:Female; D016027:Heart Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D016559:Tacrolimus / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D065095:Calcineurin Inhibitors; D007166:Immunosuppressive Agents; D016572:Cyclosporine; D016559:Tacrolimus