Logo Annals of Transplantation Logo Annals of Transplantation Logo Annals of Transplantation

19 January 2021 : Original article  

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

Karim Sallam12DEFG, Geetha P. Bhumireddy2B, Vishnu D. Evuri2B, Joshua P. Abella2BC, Francois Haddad3D, Hannah A. Valentine3AD, Patricia K. Nguyen32CDE, Michael X. Pham4ADEG*

DOI: 10.12659/AOT.923536

Ann Transplant 2021; 26:e923536

Table 1 Clinical demographics.

Sirolimus (n=109)MMF (n=112)P-value
Recipient age (years)54.0 (42.8–60.0)53.5 (41.0–62.0)0.92
Weight (kg)82.5 (74.3–96.0)82.0 (73.0–94.5)0.55
Body mass index (kg/m)27.7 (24.0–31.7)27.17 (24.6–30.3)0.48
Time from transplant to initiation of Sirolimus or MMF (days)420 (1–2928)40 (0–658)0.0003
Diagnosis0.73
 Ischemic cardiomyopathy29 (26.6%)34 (30%)
 Non-ischemic cardiomyopathy71 (65.1%)67 (60%)
 Congenital heart disease5 (4.6%)8 (7.1%)
 Re-transplant4 (3.8%)3 (2.7%)
Prior sternotomy0.06
 082 (75.2%)81 (7%)
 114 (12.8%)25 (22%)
 ≥213 (11.9%)6 (5.4%)
CMV donor positivity (%)70 (64.2%)69 (62%)0.69
CMV recipient positivity (%)71 (65.1%)62 (55%)0.14
Induction therapy (%)0.04
 None2 (1.8%)5 (4.5%)
 OKT352 (47.7%)69 (62%)
 Thymoglobulin2 (1.8)0 (0%)
 Daclizumab53 (48.6%)38 (34%)
Concurrent immunosuppression
 Cyclosporine66 (60.6%)70 (63%)0.77
 Tacrolimus36 (33.0%)39 (35%)0.78
 Prednisone74 (67.9%)82 (73%)0.36
Renal insufficiency* 44 (40.3%)31 (28%)0.06
Diabetes mellitus0.35
 Requiring oral medications19 (17.4%)27 (24%)
 Requiring insulin therapy19 (17.4%)14 (13%)
 Cardiac allograft vasculopathy41 (37.6%)28 (25%)0.04
* Defined as a serum creatinine of >2.5.

Your Privacy

We use cookies to ensure the functionality of our website, to personalize content and advertising, to provide social media features, and to analyze our traffic. If you allow us to do so, we also inform our social media, advertising and analysis partners about your use of our website, You can decise for yourself which categories you you want to deny or allow. Please note that based on your settings not all functionalities of the site are available. View our privacy policy.

Annals of Transplantation eISSN: 2329-0358
Annals of Transplantation eISSN: 2329-0358