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 2 Drug related adverse events.
| Adverse event | Sirolimus (N=109) | MMF (N=112) | P-value |
|---|---|---|---|
| Any adverse event | 77 (70.6%) | 45 (40.2%) | <0.00001 |
| Elevated TG (>300 mg/dL) | 32 (29.3%) | 8 (7.1%) | <0.0001 |
| Lower extremity edema | 22 (20.1%) | 10 (8.9%) | 0.02 |
| Wound healing complications | 14 (12.8%) | 6 (5.4%) | <0.05 |
| Superficial sternal wound healing | 3 | 1 | |
| Deep sternal wound healing | 6 | 1 | |
| Superficial sternal wound infection | 1 | 0 | |
| Deep sternal wound infection | 0 | 4 | |
| Non-sternal wound healing | |||
| Abdominal wound | 1 | 0 | |
| Thoracic wound | 1 | 0 | |
| Leukopenia (WBC <3 K/μL) | 14 (12.8%) | 19 (17.0%) | 0.39 |
| Anemia (Hematocrit <25%) | 14 (12.8%) | 7 (6.3%) | 0.09 |
| Elevated LDL (>160 mg/dL) | 8 (7.3%) | 5 (4.5%) | 0.36 |
| Pneumonitis | 0 | 0 | – |
| Alveolar hemorrhage | 0 | 0 | – |
| Thrombocytopenia (Platelet count <50 K/μL) | 7 (6.4%) | 1 (0.9%) | 0.03 |
| Oral ulcerations | 6 (5.5%) | 0 | 0.01 |
| Pleural effusion requiring drainage | 5 (4.6%) | 4 (3.6%) | 0.96 |
| Retrosternal fluid collection (sterile) | 4 (4.0%) | 1 (0.9%) | 0.17 |
| Recurrent pericardial effusion* | 3 (2.8%) | 3 (2.7%) | 1.0 |
| Joint pain | 2 (1.9%) | 0 | – |
| Gastrointestinal intolerance | 2 (1.9%) | 12 (11%) | 0.01 |
| Thrombosis | 1 (0.9%) | 0 | 0.3 |
| Dermatitis | 1 (0.9%) | 1 (0.9%) | 0.98 |
| * Requiring ≥2 therapeutic pericardiocenteses or creation of a pericardial window. | |||