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 2 Drug related adverse events.
Adverse event | Sirolimus (N=109) | MMF (N=112) | P-value |
---|---|---|---|
Any adverse event | 77 (70.6%) | 45 (40.2%) | |
Elevated TG (>300 mg/dL) | 32 (29.3%) | 8 (7.1%) | |
Lower extremity edema | 22 (20.1%) | 10 (8.9%) | 0.02 |
Wound healing complications | 14 (12.8%) | 6 (5.4%) | |
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 | 14 (12.8%) | 19 (17.0%) | 0.39 |
Anemia (Hematocrit | 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 | 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. |