PTDM | No PTDMa | Pre-existing diabetes | No pre-existing diabetes | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
(a) ZEUS | ||||||||||||
EVR (n = 14) | CsA (n = 8) | EVR (n = 128) | CsA (n = 125) | EVR (n = 13) | CsA (n = 12) | EVR (n = 142) | CsA (n = 133) | |||||
Everolimus C0 (ng/mL) | ||||||||||||
RDNb | – | – | – | – | – | – | – | – | ||||
M12 | 6.2 (1.4) | – | 6.5 (2.1) | – | 7.7 (2.8) | – | 6.5 (2.0) | – | ||||
CsA C0 (ng/mL), mean (SD) | ||||||||||||
At RDN (month 3) | 158 (25) | 142 (38) | 153 (51) | 147 (50) | 138 (63) | 159 (40) | 154 (49) | 147 (50) | ||||
M12 | – | 141 (85) | – | 118 (33) | – | 130 (40) | – | 120 (37) | ||||
EC-MPS dose (mg/day), mean (SD) | ||||||||||||
RDN (month 3) | 1234 (366) | 1035 (449) | 1317 (284) | 1294 (289) | 1246 (431) | 1110 (419) | 1309 (293) | 1278 (305) | ||||
M12 | 1108 (452) | 1080 (465) | 1193 (363) | 1234 (340) | 1135 (385) | 1211 (333) | 1186 (371) | 1226 (347) | ||||
Oral steroids(mg/day) | ||||||||||||
BL to RDN (month 3) | 21.3 (5.1) | 16.3 (4.2)c | 17.7 (5.7) | 17.9 (5.7) | 18.1 (6.2) | 15.4 (4.8) | 18.1 (5.7) | 17.8 (5.6) | ||||
RDN to M12 | 10.7 (7.9) | 10.2 (3.2) | 7.6 (2.8) | 7.2 (4.3)c | 10.3 (10.9) | 6.3 (3.1) | 7.9 (3.7) | 7.4 (4.3)c | ||||
I.V. steroids to treat rejection, n (%) | ||||||||||||
BL to RDN (month 3) | 4 (28.6) | 1 (12.5) | 13 (10.2) | 21 (16.8) | 2 (15.4) | 2 (16.7) | 17 (12.0) | 22 (16.5) | ||||
RDN to M12 | 3 (21.4) | 1 (12.5) | 12 (9.4) | 11 (8.8) | 1 (7.7) | 2 (16.7) | 15 (10.6) | 12 (9.0) | ||||
(b) HERAKLES | ||||||||||||
EVR (n = 10) | CsA (n = 11) | EVR/reduced CsA (n = 9) | EVR (n = 142) | CsA (n = 131) | EVR/reduced CsA (n = 134) | EVR (n = 19) | CsA (n = 23) | EVR/reduced CsA (n = 18) | EVR (n = 152) | CsA (n = 142) | EVR/reduced CsA (n = 143) | |
Everolimus C0 (ng/mL) | ||||||||||||
RDN (month 4.5) | 5.6 (3.0) | – | 4.5 (2.1) | 6.1 (3.2) | – | 7.0 (12.6) | 5.7 (2.1) | – | 6.1 (2.2) | 6.1 (3.1) | – | 6.8 (12.2) |
M12 | 7.2 (2.9) | – | 5.7 (2.4) | 6.6 (2.2) | – | 6.3 (2.7) | 7.2 (1.8) | – | 5.2 (2.2) | 6.6 (2.3) | – | 6.3 (2.7) |
CsA C0 (ng/mL) | ||||||||||||
RDN (month 4.5) | 155 (29) | 167 (48) | 157 (38) | 154 (46) | 164 (55) | 161 (72) | 169 (61) | 167 (50) | 157 (42) | 154 (45) | 164 (54) | 161 (70) |
M12 | – | 138 (56) | 126 (34) | – | 119 (29) | 80 (34) | – | 116 (36) | 59 (22) | – | 120 (32) | 83 (35) |
EC-MPS dose (mg/day) | ||||||||||||
RDN (month 4.5) | 1305 (268) | 1360 (240) | 1440 (0) | 1345 (246) | 1375 (214) | 1287 (314) | 1357 (216) | 1271 (288) | 1305 (413) | 1342 (246) | 1374 (215) | 1296 (307) |
M12 | 1183 (342) | 1280 (317) | – | 1171 (345) | 1266 (335) | – | 1260 (306) | 1239 (336) | – | 1172 (343) | 1267 (332) | – |
Oral steroids(mg/day) | ||||||||||||
BL to RDN (month 4.5) | 21.4 (4.4) | 19.7 (5.5)c | 20.9 (2.6) | 19.2 (5.6) | 19.2 (5.6) | 19.3 (5.3) | 16.6 (4.4) | 18.4 (5.4) | 18.8 (5.3) | 19.4 (5.0) | 19.3 (5.6) | 19.4 (5.2) |
RDN to M12 | 8.2 (3.4) | 7.4 (3.2) | 6.0 (2.7) | 7.4 (3.6) | 6.8 (3.7) | 6.9 (3.1) | 7.3 (4.0) | 7.1 (4.2) | 6.5 (1.7) | 7.4(3.6) | 6.9(3.6) | 6.9 (3.1) |
I.V. steroids to treat rejection, n (%) | ||||||||||||
BL to RDN (month 4.5) | 0 | 0 | 2 (22.2) | 12 (8.5) | 7 (5.3) | 11 (8.2) | 4 (21.1) | 1 (4.3) | 1 (5.6) | 12 (7.9) | 7 (4.9) | 13 (9.1) |
RDN to M12 | 1 (10.0) | 2 (18.2) | 1 (11.1) | 13 (9.2) | 10 (7.6) | 12 (9.0) | 4 (21.1) | 2 (8.7) | 1 (5.6) | 14 (9.2) | 12 (8.5) | 13 (9.1) |