Increased adherence eight months after switch from twice daily calcineurin inhibitor based treatment to once daily modified released tacrolimus in heart transplantation
Authors Doesch AO, Mueller S, Akyol C, Erbel C, Frankenstein L, Ruhparwar A, Ehlermann P, Dengler TJ, Katus HA
Received 11 August 2013
Accepted for publication 10 September 2013
Published 21 October 2013 Volume 2013:7 Pages 1253—1258
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 3
Andreas O Doesch,1 Susanne Mueller,1 Ceylan Akyol,1 Christian Erbel,1 Lutz Frankenstein,1 Arjang Ruhparwar,2 Philipp Ehlermann,1 Thomas J Dengler,3 Hugo A Katus1
1Department of Cardiology, University of Heidelberg, Heidelberg, Germany; 2Department of Cardiovascular Surgery, University of Heidelberg, Heidelberg, Germany; 3Department of Cardiology, SLK-Kliniken Heilbronn, Bad Friedrichshall, Germany
Background: Modified-release tacrolimus (TAC) is a new, once-daily oral formulation of the established immunosuppressive agent TAC. This study evaluated long-term patient adherence, as well as safety and efficacy, in stable patients after heart transplantation (HTx) who switched from a conventional twice daily calcineurin inhibitor-based regimen (TAC or cyclosporine A [CsA]) to a once-daily modified-release TAC regimen.
Methods: Stable patients were switched from conventional TAC or CsA (twice-daily dosing) to modified-release TAC (once-daily dosing) according to manufacturer's recommendations using a pre-experimental design. Self-reported adherence was assessed at baseline and 8 months after the switch with the Basel Assessment of Adherence with Immunosuppressive Medication Scale (BAASIS). Additionally, routine laboratory values were analyzed 8 months after switch.
Results: Of 76 patients (58 male, 18 female) initially included, 72 were available for statistical analysis, as modified-release TAC was discontinued due to diarrhea in one patient and gastrointestinal discomfort in three patients. Overall nonadherence at baseline for any of the four BAASIS items was 75.0% versus 40.3% after 8 months (P<0.0001). After 8 months, adherence was improved in 41 patients (56.9%), unchanged in 27 (37.5%), and reduced in four patients (5.6%). The BAASIS visual analog scale score improved significantly from 87.0% ± 13.5% to 97.5% ± 5.7% (P<0.0001). No significant changes were observed for hematological, renal, or liver function parameters after 8 months (all P=not significant).
Conclusion: To our knowledge, this is the first study in stable patients after HTx to demonstrate a significant improvement in long-term (ie, 8-month) patient adherence after the switch to modified-release TAC. Modified-release TAC was generally well tolerated. Further studies are currently underway to investigate long-term safety after HTx of various calcineurin inhibitors for prevention of rejection and occurrence of side effects.
Keywords: heart transplant, immunosuppression, modified-release tacrolimus, long-term adherence
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