Tolerability of sirolimus

A decade of experience at a single cardiac transplant center

Jennifer T. Thibodeau, Joseph D. Mishkin, Parag C. Patel, Patricia A. Kaiser, Colby R. Ayers, Pradeep P A Mammen, David W. Markham, William Steves Ring, Matthias Peltz, Mark H. Drazner

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Sirolimus is used in cardiac transplant recipients to prevent rejection, progression of cardiac allograft vasculopathy, and renal dysfunction. However, sirolimus has many potential side effects and its tolerability when used outside of clinical trials is not well established. We describe a decade of experience with sirolimus in cardiac transplant recipients at our institution. We retrospectively reviewed records of all adult cardiac transplant recipients living between September 1999 and February 2010 (n = 329) and identified 67 patients (20%) who received sirolimus. The indications for sirolimus were cardiac allograft vasculopathy (67%), renal dysfunction (25%), rejection (4%), and intolerability of tacrolimus (3%). One-third of patients discontinued sirolimus at a median (25th, 75th percentiles) of 0.9 (0.2, 1.6) yr of duration. Over 70% of subjects experienced an adverse event attributed to sirolimus. Adverse events were associated with higher average sirolimus levels (9.1 ng/mL vs. 7.1 ng/mL, p = 0.004). We conclude that sirolimus is frequently used in cardiac transplant recipients (20%) and commonly causes side effects, often necessitating discontinuation. Higher average sirolimus levels were associated with adverse events, suggesting that tolerability may improve if levels are maintained within the lower end of the current therapeutic range; however, the improvement in tolerability would need to be balanced with the potential for decreased efficacy.

Original languageEnglish (US)
Pages (from-to)945-952
Number of pages8
JournalClinical Transplantation
Volume27
Issue number6
DOIs
StatePublished - Nov 2013

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Sirolimus
Transplants
Allografts
Kidney
Tacrolimus
Clinical Trials
Transplant Recipients

Keywords

  • Adverse events
  • Cardiac transplantation
  • Immunosuppression
  • Sirolimus
  • Tolerability

ASJC Scopus subject areas

  • Transplantation

Cite this

Tolerability of sirolimus : A decade of experience at a single cardiac transplant center. / Thibodeau, Jennifer T.; Mishkin, Joseph D.; Patel, Parag C.; Kaiser, Patricia A.; Ayers, Colby R.; Mammen, Pradeep P A; Markham, David W.; Ring, William Steves; Peltz, Matthias; Drazner, Mark H.

In: Clinical Transplantation, Vol. 27, No. 6, 11.2013, p. 945-952.

Research output: Contribution to journalArticle

Thibodeau, Jennifer T. ; Mishkin, Joseph D. ; Patel, Parag C. ; Kaiser, Patricia A. ; Ayers, Colby R. ; Mammen, Pradeep P A ; Markham, David W. ; Ring, William Steves ; Peltz, Matthias ; Drazner, Mark H. / Tolerability of sirolimus : A decade of experience at a single cardiac transplant center. In: Clinical Transplantation. 2013 ; Vol. 27, No. 6. pp. 945-952.
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