| Figures/TablesFigures/Tables
Purpose
Patients (pts) enrolled from NA in study A2310 had a different pattern of induction therapy use; no induction therapy (~50 % vs 15 % ex-NA); thymoglobulin (17 % vs 46 % ex-NA). Since this may impact complications post-transplant, we report safety results for NA pts.
Methods and Materials
A 24-month (M), randomized, open-label study of EVR 1.5 or 3mg/d (C0: 3-8 or 6-12ng/mL)+reduced-dose cyclosporine (CsA) vs MMF 3g/d+standard-dose CsA in de novo HTx recipients. All pts received steroids ¡À induction. The EVR 3mg arm was prematurely terminated due to higher mortality.
Results
Compared to the overall population, mortality rates in NA for both EVR (7.7 % vs 10.6 % ) & MMF (7.6 % vs 9.2 % ) were low. The incidence of AEs for NA (EVR/MMF) vs overall was also low: neutropenia (5.3 % /8.3 % vs 17.9 % /40.3 % ); hyperlipidemia (11.8 % /5.8 % vs 37.3 % /26.9 % ); peripheral edema (48.7 % /47.4 % vs 57.7 % /57.1 % ) & CMV infection (5.3 % /16.0 % vs 7.2 % /21.6 % ). For NA, AE rates were similar at 12 & 24M in EVR & MMF groups ().
Conclusions
EVR 1.5mg or MMF was better tolerated in NA pts vs the overall population, perhaps due to differences in induction therapy use.
| Relevant AEs in NA pts |
|---|
| AE, n ( % ) at month 12/month 24 | EVR 1.5mg (n=152) | MMF (n=156) |
|---|
| Thrombocytopenia | 15 (9.9)/15 (9.9) | 18 (11.5)/19 (12.2) |
| Leukopenia | 18 (11.8)/21 (13.8) | 38 (24.4)/43 (27.6) |
| Neutropenia | 8 (5.3)/8 (5.3) | 12 (7.7)/13 (8.3) |
| Hyperlipidemia | 11 (7.2)/18 (11.8) | 10 (6.4)/9 (5.8) |
| Diabetes mellitus | 17 (11.2)/17 (11.2) | 13 (8.3)/15 (9.6) |
| Any wound event | 58 (38.2)/65 (42.8) | 44 (28.2)/47 (30.1) |
| Pericardial effusion | 67 (44.1)/71 (46.7) | 40 (25.6)/43 (27.6) |
| Pleural effusion | 50 (32.9)/52 (34.2) | 36 (23.1)/39 (25.0) |
| Peripheral edema | 68 (44.7)/74 (48.7) | 59 (37.8)/74 (47.4) |
| Proteinuria | 6 (3.9)/6 (3.9) | 2 (1.3)/2 (1.3) |
| Any infection | 98 (64.5)/107 (70.4) | 96 (61.5)/103 (66.0) |
| Viral infection | 14 (9.2)/17 (11.2) | 34 (21.8)/41 (26.3) |
| CMV infection | 8 (5.3)/8 (5.3) | 21 (13.5)/25 (16.0) |
