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eISSN: 2329-0358

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Annals of Transplantation is one of the fast-developing journals open to all scientists and fields of transplant medicine and related research. The journal is published quarterly and provides extensive coverage of the most important advances in transplantation.
Using an electronic on-line submission and peer review tracking system, Annals of Transplantation is committed to rapid review and publication. The average time... read more

Published: 2021-01-19


Sirolimus Adverse Event Profile in a Non-Clinical Trial Cohort of Heart Transplantation Patients

Karim Sallam, Geetha P. Bhumireddy, Vishnu D. Evuri, Joshua P. Abella, Francois Haddad, Hannah A. Valentine, Patricia K. Nguyen, Michael X. Pham

Division of Cardiovascular Medicine and Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA, USA

Ann Transplant 2021; 26:e923536

DOI: 10.12659/AOT.923536

BACKGROUND: Sirolimus has been used increasingly in heart transplantation for its ability to reduce acute rejection, prevent the progression of cardiac allograft vasculopathy (CAV), and preserve renal function. We sought to assess the adverse reactions associated with the use of sirolimus compared to mycophenolate mofetil (MMF).
MATERIAL AND METHODS: We retrospectively reviewed the charts of 221 adult heart transplant patients who received either sirolimus or MMF as part of their immunosuppression from June 1, 2001 to April 1, 2005. Patients were assigned to 2 groups based upon immunosuppression use. The prevalence and types of complications were recorded in each group.
RESULTS: Sirolimus was received by 109 patients and 112 patients received MMF during the study period. Seventy-seven patients (71%) in the sirolimus group experienced adverse reactions compared to 45 patients (40%) in the MMF group (P<0.01). Compared to MMF, the use of sirolimus was associated with a higher prevalence of elevated triglyceride levels, lower-extremity edema, and oral ulcerations. Sirolimus was discontinued due to adverse reactions in 22% of patients, whereas no patients in the MMF group experienced adverse effects requiring drug discontinuation.
CONCLUSIONS: Compared to MMF, sirolimus use is associated with a higher prevalence of adverse reactions requiring drug discontinuation, but most patients were able to stay on therapy despite adverse effects.

Keywords: Drug-Related Side Effects and Adverse Reactions, Heart Transplantation, Immunosuppression, Sirolimus

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DOI: 10.12659/AOT.926476