Abstract
Background Sirolimus (rapamycin) is a potent anti-proliferative agent with immunosuppressive properties that is increasingly being used in solid-organ and hematopoietic stem cell transplantation. In addition, this drug is being investigated for treatment of a broad range of disorders, including cardiovascular disease, malignancies, tuberous sclerosis, and lymphangeioleiomyomatosis. In this study, we found an increased risk of venous thromboembolism (VTE) in lung transplant recipients treated with a sirolimus (SIR)-based immunosuppressive regimen. Methods One hundred eighty-one lung transplant recipients were enrolled in a prospective, multicenter, randomized, open-label trial comparing a tacrolimus (TAC)/SIR/prednisone immunosuppression regimen with a TAC/azathioprine (AZA)/prednisone immunosuppressive regimen. The differences in rates of VTE were examined. Results There was a significantly higher occurrence of VTE in the SIR cohort [15 of 87 (17.2%)] compared with the AZA cohort [3 of 94 (3.2%)] (stratified log-rank statistic = 7.44, p < 0.01). When adjusted for pre-transplant diagnosis and stratified by transplant center, this difference remained essentially unchanged (hazard ratio for SIR vs AZA = 5.2, 95% confidence interval 1.4 to 19.5, p = 0.01). Conclusion Clinicians prescribing SIR should maintain a high level of vigilance for VTE, particularly among patients with other risk factors for this complication.
Original language | English (US) |
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Pages (from-to) | 175-181 |
Number of pages | 7 |
Journal | Journal of Heart and Lung Transplantation |
Volume | 30 |
Issue number | 2 |
DOIs | |
State | Published - Feb 2011 |
Funding
Financial support was provided by Astellas, Pharma, Inc . None of the authors has personal or financial conflicts of interest related to the topics discussed in this manuscript. This study, however, was an investigator-initiated industry sponsored study.
Keywords
- drug toxicity
- immunosuppression
- lung transplantation
- mTOR (mammalian target of rapamycin) inhibitors
- sirolimus
- venous thromboembolism
ASJC Scopus subject areas
- Surgery
- Pulmonary and Respiratory Medicine
- Cardiology and Cardiovascular Medicine
- Transplantation