19 January 2021: Original Paper
Sirolimus Adverse Event Profile in a Non-Clinical Trial Cohort of Heart Transplantation Patients
Karim Sallam 12DEFG , Geetha P. Bhumireddy 2B , Vishnu D. Evuri 2B , Joshua P. Abella 2BC , Francois Haddad 1D , Hannah A. Valantine 1AD , Patricia K. Nguyen 12CDE , Michael X. Pham 3ADEG*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 |
| Diagnosis | 0.73 | ||
| Ischemic cardiomyopathy | 29 (26.6%) | 34 (30%) | |
| Non-ischemic cardiomyopathy | 71 (65.1%) | 67 (60%) | |
| Congenital heart disease | 5 (4.6%) | 8 (7.1%) | |
| Re-transplant | 4 (3.8%) | 3 (2.7%) | |
| Prior sternotomy | 0.06 | ||
| 0 | 82 (75.2%) | 81 (7%) | |
| 1 | 14 (12.8%) | 25 (22%) | |
| ≥2 | 13 (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 | ||
| None | 2 (1.8%) | 5 (4.5%) | |
| OKT3 | 52 (47.7%) | 69 (62%) | |
| Thymoglobulin | 2 (1.8) | 0 (0%) | |
| Daclizumab | 53 (48.6%) | 38 (34%) | |
| Concurrent immunosuppression | |||
| Cyclosporine | 66 (60.6%) | 70 (63%) | 0.77 |
| Tacrolimus | 36 (33.0%) | 39 (35%) | 0.78 |
| Prednisone | 74 (67.9%) | 82 (73%) | 0.36 |
| Renal insufficiency* | 44 (40.3%) | 31 (28%) | 0.06 |
| Diabetes mellitus | 0.35 | ||
| Requiring oral medications | 19 (17.4%) | 27 (24%) | |
| Requiring insulin therapy | 19 (17.4%) | 14 (13%) | |
| Cardiac allograft vasculopathy | 41 (37.6%) | 28 (25%) | 0.04 |
| * Defined as a serum creatinine of >2.5. | |||