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A Randomized Controlled Trial of Tacrolimus Versus Cyclosporine After Lung Transplantation
Abstract
Background The optimal maintenance immunosuppressive regimen after lung transplantation is uncertain. Methods We conducted a randomized controlled trial of tacrolimus versus cyclosporine in combination with azathioprine and prednisone after lung transplantation. Ninety adults were randomized to tacrolimus (n = 44) or cyclosporine (n = 46). The primary end point was a composite of a cumulative acute rejection A score of 3 or higher, a cumulative lymphocytic bronchitis B score of 4 or higher, or the onset of bronchiolitis obliterans syndrome (BOS) stage 0-p. Results Recipients randomized to cyclosporine were significantly more likely to develop the primary end point than those randomized to tacrolimus. During the study period, the primary end point developed in 39 of 46 cyclosporine subjects compared with 24 of 44 tacrolimus subjects (p = 0.002); acute rejection or lymphocytic bronchitis end points developed in 29 of 46 cyclosporine subjects compared with 18 of 44 tacrolimus subjects (p = 0.036). Furthermore, BOS stage 0-p was more likely to develop in the cyclosporine group than in the tacrolimus group, but this was not statistically significant (log-rank p = 0.1). In addition, there was a trend to a higher incidence of diabetes among those in the tacrolimus group, but there was no significant difference in graft survival or the total number of infections, or in the incidence of hypertension, chronic kidney disease, or cancer between the 2 groups. Conclusions Tacrolimus is associated with a lower burden of acute rejection and lymphocytic bronchitis and a trend to a greater freedom from BOS stage 0-p than cyclosporine after lung transplantation.
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“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 [18]
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Metadata
- Authors
- Hachem, R. R., Yusen, R. D., Chakinala, M. M., Meyers, B. F., Lynch, J. P., Aloush, A. A., Patterson, G. A., & Trulock, E. P.
- Affiliations
- Washington University in St. Louis (US)
- ORCID
- Venue
- The Journal of Heart and Lung Transplantation
- Publisher
- Elsevier BV
- Published
- 2007-10
- Volume
- 26
- Issue
- 10
- Pages
- 1012-1018
- ISSN
- 1053-2498 (ISSN-L)
- OpenAlex
- W2082707670
- Cited by
- 160
- References
- 27
- Citations by year
- 2026: 8 · 2025: 7 · 2024: 8 · 2023: 18 · 2022: 8 · 2021: 9 · 2020: 8 · 2019: 3 · 2018: 12 · 2017: 6 · 2016: 6 · 2015: 2 · 2014: 9 · 2013: 7 · 2012: 6
- FWCI
- 10.63
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- The Journal of Heart and Lung Transplantation (publishedVersion)
- PubMed (publishedVersion)
- 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
- tacrolimus, cyclosporine, lung transplantation, maintenance immunosuppression, acute rejection, bronchiolitis obliterans syndrome, azathioprine, prednisone, diabetes mellitus, graft survival
- MeSH terms
- Adult, Azathioprine, Bronchiolitis Obliterans, Bronchitis, Diabetes Mellitus, Drug Therapy, Combination, Female, Graft Rejection, Graft Survival, Humans, Immunosuppressive Agents, Male, Middle Aged, Postoperative Care, Lung Transplantation, Tacrolimus, Cyclosporine
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