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Tacrolimus versus cyclosporine after lung transplantation: a prospective, open, randomized two-center trial comparing two different immunosuppressive protocols
Abstract
Background The need for better immunosuppressive protocols after lung transplantation led us to investigate tacrolimus (Tac) in combination with mycophenolate mofetil (MMF) and steroids or cyclosporine (CsA) in combination with MMF and steroids in a prospective, open, randomized trial after lung transplantation. Methods Between September 1997 and April 1999, 50 lung transplant recipients were randomized to receive either Tac (n = 26) or CsA (n = 24) in combination with MMF and steroids. All patients underwent induction therapy with rabbit antithymocyte globulin (ATG) for 3 days. Freedom from acute rejection (AR), patient survival, infection episodes, and side effects were monitored. Results There was no difference in patient demographics between the two groups. Six-month and 1-year survival was similar (84.6% and 73.1% in the Tac group vs 83.3% and 79.2% in the CsA group). Freedom from AR at 6 months and 1 year after lung transplantation was slightly higher in the Tac group (57.7% and 50% vs 45.8% and 33.3%, p = not significant [n.s.]), whereas the number of treated rejection episodes per 100 patient days in the Tac group was significantly lower (0.225 vs 0.426, p < .05). Four patients in the CsA group had to be switched to Tac. Two patients in the CsA group had to be retransplanted. Incidence of infections was similar in both groups with a trend toward more fungal infections in the Tac group (n = 7 vs n = 1, p = n.s.). Conclusions The combination of Tac and MMF seems to have slightly higher immunosuppressive potential compared with CsA and MMF. The effectiveness of Tac as a rescue agent is not paralleled with undue signs of overimmunosuppression.
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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 [19]
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Clinical Pharmacokinetics and Pharmacodynamics of Tacrolimus in Solid Organ Transplantation
Staatz, C. E., & Tett, S. E. (2004) · Clinical Pharmacokinetics · doi:10.2165/00003088-200443100-00001 · Cited by 920
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Chronic Lung Allograft Rejection: Mechanisms and Therapy
Belperio, J. A., WEIGT, S. S., Fishbein, M. C., & Lynch, J. P. (2009) · Proceedings of the American Thoracic Society · doi:10.1513/pats.200807-073go · Cited by 205
Acute Rejection and Humoral Sensitization in Lung Transplant Recipients
Martinu, T., Chen, D.-F., & Palmer, S. M. (2009) · Proceedings of the American Thoracic Society · doi:10.1513/pats.200808-080go · Cited by 174
Immunosuppression in lung transplantation.
Scheffert, J. L., & Raza, K. (2014) · PubMed Central · doi:10.3978/j.issn.2072-1439.2014.04.23 · Cited by 140
Metadata
- Authors
- Treede, H., Klepetko, W., Reichenspurner, H., Zuckermann, A., Meiser, B., Birsan, T., Wisser, W., & Reichert, B.
- Affiliations
- Ludwig-Maximilians-Universität München (DE)
- University of Vienna (AT)
- Corresponding author
- Reichenspurner, Hermann
- Venue
- The Journal of Heart and Lung Transplantation
- Publisher
- Elsevier BV
- Published
- 2001-05
- Volume
- 20
- Issue
- 5
- Pages
- 511-517
- ISSN
- 1053-2498 (ISSN-L)
- OpenAlex
- W1970749259
- Cited by
- 108
- References
- 21
- Citations by year
- 2026: 2 · 2025: 4 · 2024: 1 · 2023: 8 · 2022: 5 · 2021: 3 · 2020: 3 · 2019: 2 · 2018: 4 · 2017: 1 · 2016: 4 · 2015: 1 · 2014: 5 · 2013: 4 · 2012: 5
- FWCI
- 6.62
- 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, immunosuppressive therapy, mycophenolate mofetil, acute rejection, patient survival, infection incidence, fungal infection, induction therapy, antithymocyte globulin
- MeSH terms
- Acute Disease, Adult, Aged, Bronchiolitis Obliterans, Chronic Disease, Creatinine, Drug Combinations, Female, Follow-Up Studies, Graft Rejection, Humans, Immunosuppressive Agents, Infections, Male, Middle Aged, Mycophenolic Acid, Prospective Studies, Time Factors, Incidence, Survival Rate, Lung Transplantation, Tacrolimus, Cyclosporine, Treatment Outcome
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