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Cited by 130Transplantation: Methods and OutcomesRenal Transplantation Outcomes and TreatmentsOrgan and Tissue Transplantation Research

Tacrolimus and cyclosporine have differential effects on the risk of development of bronchiolitis obliterans syndrome: Results of a prospective, randomized international trial in lung transplantation

Treede, Hendrik, Glanville, Allan R., Klepetko, Walter, Aboyoun, Christina, Vettorazzi, Eik, Lama, Raffael, Bravo, Carlos, Knoop, Christiane +2 more·2012·The Journal of Heart and Lung Transplantation
DOI 10.1016/j.healun.2012.03.008
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Abstract

Background Chronic lung allograft dysfunction, which manifests as bronchiolitis obliterans syndrome (BOS), is recognized as the primary cause of morbidity and mortality after lung transplantation. In this study we assessed the efficacy and safety of two de novo immunosuppression protocols to prevent BOS. Methods Our study approach was a multicenter, prospective, randomized (1:1) open-label superiority investigation of de novo tacrolimus vs cyclosporine, with both study arms given mycophenolate mofetil and prednisolone after lung transplantation. Cytolytic induction therapy was not employed. Patients were stratified at entry for cystic fibrosis. Primary outcome was incidence of BOS 3 years after transplant (intention-to-treat analysis). Secondary outcomes were survival and incidence of acute rejection, infection and other adverse events. Results Group demographic data were well matched: 110 of 124 tacrolimus vs 74 of 125 cyclosporine patients were treated per protocol (p < 0.01 by chi-square test). Cumulative incidence of BOS Grade ≥1 at 3 years was 11.6% (tacrolimus) vs 21.3% (cyclosporine) (cumulative incidence curves, p = 0.037 by Gray's test, pooled over strata). Univariate proportional sub-distribution hazards regression confirmed cyclosporine as a risk for BOS (HR 1.97, 95% CI 1.04 to 3.77, p = 0.039). Three-year cumulative incidence of acute rejection was 67.4% (tacrolimus) vs 74.9% (cyclosporine) (p = 0.118 by Gray's test). One- and 3-year survival rates were 84.6% and 78.7% (tacrolimus) vs 88.6% and 82.8% (cyclosporine) (p = 0.382 by log-rank test). Cumulative infection rates were similar (p = 0.91), but there was a trend toward new-onset renal failure with tacrolimus (p = 0.09). Conclusions Compared with cyclosporine, de novo tacrolimus use was found to be associated with a significantly reduced risk for BOS Grade ≥1 at 3 years despite a similar rate of acute rejection. However, no survival advantage was detected.

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  • Cyclosporine-based immunosuppressive regimens have been shown to be inferior to tacrolimus-based therapy, with higher rates of acute cellular rejection and increased CLAD incidence.

    “This finding is plausible, as cyclosporine-based immunosuppressive regimens have been shown to be inferior to tacrolimus-based therapy, with higher rates of acute cellular rejection and increased CLAD incidence.16, 17, 18, 19, 20”

    From Lung retransplantation during the Lung Allocation Score era: Outcomes from a large single center (2026) · cites this paper as [17]

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Authors
Treede, H., Glanville, A. R., Klepetko, W., Aboyoun, C., Vettorazzi, E., Lama, R., Bravo, C., Knoop, C., Aubert, J.-D., & Reichenspurner, H.
Affiliations
Universität Hamburg (DE)
ORCID
Venue
The Journal of Heart and Lung Transplantation
Publisher
Elsevier BV
Published
2012-08
Volume
31
Issue
8
Pages
797-804
ISSN
1053-2498 (ISSN-L)
DOI
10.1016/j.healun.2012.03.008
OpenAlex
W2165001333
Cited by
130
References
28
Citations by year
2026: 7 · 2025: 6 · 2024: 8 · 2023: 17 · 2022: 13 · 2021: 12 · 2020: 6 · 2019: 6 · 2018: 14 · 2017: 5 · 2016: 7 · 2015: 6 · 2014: 13 · 2013: 8 · 2012: 2
FWCI
9.40
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • The Journal of Heart and Lung Transplantation (publishedVersion)
  • PubMed (publishedVersion)
  • Dépôt institutionnel de l'Université libre de Bruxelles (Université Libre de Bruxelles) (submittedVersion)
  • IRIS (submittedVersion)
  • SERVAL (Université de Lausanne) (submittedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Transplantation: Methods and Outcomes
  • Health Sciences › Medicine › Transplantation › Renal Transplantation Outcomes and Treatments
  • Health Sciences › Medicine › Transplantation › Organ and Tissue Transplantation Research
Keywords
bronchiolitis obliterans syndrome, lung transplantation, tacrolimus, cyclosporine, de novo immunosuppression, mycophenolate mofetil, prednisolone, chronic lung allograft dysfunction, acute rejection, graft survival, cystic fibrosis, infection risk
MeSH terms
Adult, Bronchiolitis Obliterans, Female, Follow-Up Studies, Graft Rejection, Humans, Immunosuppressive Agents, International Cooperation, Male, Middle Aged, Prospective Studies, Risk Factors, Syndrome, Incidence, Survival Rate, Lung Transplantation, Tacrolimus, Cyclosporine, Treatment Outcome, Outcome Assessment, Health Care

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