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Comparison of Sirolimus to Azathioprine in a Tacrolimus Based Immunosuppressive Regimen in Lung Transplantation.

Author(s): Bhorade S, Ahya VN, Baz MA, Valentine VG, Arcasoy SM, Love RB, Seethamraju H, Alex CG, Bag R, Deoliveira NC, Husain A, Vigneswaran WT, Charbeneau J, Krishnan JA, Durazo-Arvizu R, Norwick L, Garrity E

Affiliation(s): University of Chicago Medical Center, Chicago, Illinois, United States.

Publication date & source: 2010-09-10, Am J Respir Crit Care Med., [Epub ahead of print]

Abstract: BACKGROUND: Lung transplantation has evolved into a life-saving therapy for select patients with end stage lung diseases. However, long term survival remains limited due to chronic rejection. Sirolimus, a mTOR inhibitor with both anti-inflammatory and anti-proliferative properties is beneficial in preventing cardiac allograft vasculopathy and may decrease rejection after lung transplanataion. METHODS: We conducted a multicenter randomized, open label controlled trial comparing sirolimus (SIR) to azathioprine (AZA) in a tacrolimus- based immunosuppressive regimen in lung transplantation. The primary endpoint is the incidence of acute rejection at one year post transplantation between the two study groups. RESULTS: One hundred and eighty one patients were randomized to be included in this study. At one-year post transplantation, there was no significant difference in the incidence of Grade A acute rejection between the two study groups. Similarly, the incidence of chronic rejection and graft survival was no different between the two study groups. Cytomegalovirus infection was decreased in the SIR arm compared to the AZA arm (RR=0.67 (0.55, 0.82) (p < 0.01)). There was a higher rate of adverse events leading to early discontinuation of SIR (64%) compared to AZA (49%) during the course of this study. CONCLUSION: Sirolimus, a mTOR inhibitor, did not decrease the incidence of acute rejection at one year compared to azathioprine in lung transplantation. These results differ from previous results in cardiac and renal transplantation and emphasize the need for multicenter randomized controlled trials in lung transplantation. www.clinicaltrials.gov- NCT00321906.

Page last updated: 2010-10-05

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