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Table 3 Estimated GFR (Nankivell formula [32]) (mL/min/1.73m2) in (a) the ZEUS study (b) the HERAKLES study. Values are shown as mean (SD)

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

(a) ZEUS study

PTDM

No PTDMa

Pre-existing diabetes

No pre-existing diabetes

 

EVR (n = 14)

CsA (n = 8)

EVR (n = 128)

CsA (n = 125)

EVR (n = 13)

CsA (n = 12)

EVR (n = 142)

CsA (n = 133)

RDN (month 3)

64.8 (13.8)

54.3 (23.0)

63.3 (17.6)

63.0 (14.7)

67.6 (22.4)

64.4 (19.7)

63.4 (17.2)

62.5 (15.2)

P value vs CsAb

0.31

–

0.92

–

0.50

–

0.85

–

M12

78.5 (17.9)

49.2 (16.3)

70.4 (18.7)

61.6 (16.1)

73.1 (22.1)

65.7 (22.2)

71.1 (18.7)

61.0 (16.2)

P value vs CsAb

0.008

–

< 0.001

 

0.22

< 0.001

–

Change from RDN to M12

14.0 (11.4)

−9.2 (15.9)

7.5 (10.5)

−1.5 (9.6)

5.5 (5.9)

0.7 (10.0)

8.2 (10.8)

−1.8 (10.0)

P value vs CsAc

Not availabled

–

< 0.001

–

0.87

–

< 0.001

–

(b) HERAKLES study

PTDM

No PTDMa

Pre-existing diabetes

No pre-existing diabetes

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)

RND (month 4.5)

70.6 (22.1)

62.4 (16.7)

59.4 (23.4)

64.9 (14.6)

61.2 (15.1)

62.8 (14.1)

71.3 (17.9)

65.1 (13.6)

67.6 (15.2)

65.3 (15.2)

61.3 (15.2)

62.6 (14.8)

P value vs CsAb

0.34

–

0.81

0.05

–

0.39

0.41

–

0.59

0.03

–

0.43

M12

75.5 (29.9)

60.5 (26.3)

56.4 (28.1)

70.8 (18.3)

62.2 (16.1)

63.1 (18.9)

76.5 (20.8)

65.5 (16.8)

70.5 (19.8)

71.1 (19.2)

62.1 (17.0)

62.7 (19.5)

P value vs CsAb

0.19

–

1.0

< 0.001

–

0.61

0.11

–

0.50

< 0.001

–

0.63

Change from RDN to M12

4.9 (16.7)

−1.9 (15.8)

−3.0 (10.1)

5.9 (13.9)

1.0 (11.1)

0.4 (12.8)

5.3 (12.9)

2.8 (11.8)

0.1 (11.7)

5.8 (14.0)

0.7 (11.5)

0.1 (12.7)

P value vs CsAc

0.11

–

0.86

< 0.001

–

< 0.001

0.17

–

0.78

< 0.001

–

< 0.001

  1. aAnd no pre-existing diabetes
  2. bP values based on the two-sample Wilcoxon rank-sum test of the F-test
  3. cP values based on ANCOVA model with treatment, center, donor type as factors and estimated GFR value at randomization as covariate
  4. dNumbers too low to permit a meaningful ANCOVA analysis
  5. Last observation carried forward (LOCF) method applied to month 12 values
  6. CsA cyclosporine, EVR everolimus, GFR glomerular filtration rate, M12 month 12, PTDM posttransplant diabetes mellitus, RDN randomization
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BMC Nephrology

ISSN: 1471-2369

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