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Table 2 Immunosuppression in (a) the ZEUS study and (b) the HERAKLES study

From: Onset and progression of diabetes in kidney transplant patients receiving everolimus or cyclosporine therapy: an analysis of two randomized, multicenter trials

 

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)

  1. aAnd no pre-existing diabetes
  2. bNot recorded at RDN
  3. cp < 0.05 for everolimus vs CsA (two-sample Wilcoxon rank-sum test of the F-test)
  4. Continuous variables are shown as mean (SD)
  5. Last observation carried forward (LOCF) method applied to month 12 values. All differences versus the standard CsA groups were not significant unless stated otherwise
  6. BL baseline, C0 trough concentration, CsA cyclosporine, EC-MPS enteric-coated mycophenolate sodium, EVR everolimus, I.V. intravenous, M12 month 12, M6 month 6, PTDM posttransplant diabetes mellitus, RDN randomization, SD standard deviation