Combining cytochrome P-450 3A4 modulators and cyclosporine or everolimus in transplantation is successful

Table 1 Characteristics of kidney donors and recipients

	Everolimus (n = 59)	Azathioprine/MMF (n = 114)	P value
Donor
Age (yr)	38.4 ± 13.7	44.1 ± 13.0	< 0.01
Male gender	30 (51%)	65 (57%)	0.44
Living	15 (25%)	14 (12%)	0.03
Non-living	44 (75%)	100 (88%)	0.03
Extended criteria donor	5 (9%)	20 (18%)	0.11
Stroke as donor's cause of death	10 (23%)	28 (28%)	0.51
Hypertension	3 (5%)	22 (19%)	0.01
Type 2 diabetes	0 (0%)	4 (4%)	0.15
Serum creatinine (mg/dL)	0.83 ± 0.26	0.90 ± 0.36	0.19
Cold ischemia time (h)	18.9 ± 5.4	20.1 ± 7.1	0.33
Warm ischemia time (min)	37.3 ± 9.25	41.3 ± 11.2	0.02
Recipient
Age (yr)	43.1 ± 12.5	45.0 ± 12.1	0.35
Male gender	32 (54%)	79 (69%)	0.05
List waiting time (mo)	27.9 ± 22.7	30.4 ± 28.3	0.57
Previous kidney transplant	0 (0%)	0 (0%)
Total time in dialysis (mo)	49.0 ± 26.5	58.4 ± 33.6	0.57
PRA (%)	3.0 ± 4.3	3.8 ± 5.2	0.35
HLA-mismatch	2.9 ± 1.4	2.8 ± 1.2	0.68
Double kidney transplant	1 (2%)	5 (4%)	0.36
Hypertension	42 (71%)	79 (69%)	0.80
Type 2 diabetes	0 (0%)	7 (6%)	0.10
Coronary artery disease	1 (2%)	1 (1%)	0.63
IgG CMV (+)	56 (97%)	98 (88%)	0.06
Immunosuppressive treatment
Induction	0 (0%)	1 (1%)	0.47
Cyclosporine	59 (100%)	114 (100%)
Azathioprine	59 (100%)	111 (97%)	0.21
Mycophenolate mofetyl	0 (0%)	3 (3%)	0.21
Delayed graft function	3 (5%)	65 (57%)	< 0.01

MMF: Mycophenolate mofetyl; PRA: Panel reactive antibodies; CMV: Cytomegalovirus.

Table 2 Follow up clinical findings and complications n (%)

	Everolimus (n = 59)	Azathioprine/MMF (n = 114)	P value
Surgical complication	11 (19)	25 (22)	0.61
Vascular complication	2 (3)	10 (9)	0.22
First year acute rejection episode	6 (10)	25 (22)	0.06
Acute rejection episode during entire follow up period	12 (20)	41 (36)	0.04
Cyclosporine toxicity	8 (14)	22 (19)	0.35
New onset diabetes after transplant	3 (5)	8 (7)	0.75
CMV disease	0 (0)	6 (5.3)	0.10
BK virus nephropathy	1 (2)	5 (4)	0.67
New onset neoplasia	2 (3)	6 (5)	0.72
Post-transplant Lymphoproliferative disease	1 (2)	2 (2)	0.98
Hospitalizations/yr	0.50 ± 0.72	0.62 ± 0.78	0.32
Leucopenia	12 (20)	58 (51)	< 0.01
Thrombocytopenia	29 (49)	73 (64)	0.06
Pneumonia	6 (10)	25 (22)	0.06
Urinary tract infection	27 (46)	46 (40)	0.49

MMF: Mycophenolate mofetyl; CMV: Cytomegalovirus.

Table 3 Graft survival uncensored by recipient death with a functioning graft at different periods after kidney transplant

Time	Everolimus (n = 59)	Azathioprine/MMF (n = 114)
Year 1	98%	97%
Year 2	98%	94%
Year 3	96%	93%
Year 4	94%	88%
Year 5	94%	86%
Year 6	91%	83%

MMF: Mycophenolate mofetyl.

Table 4 Graft survival censored by recipient death with a functioning graft at different periods after kidney transplant

Time	Everolimus (n = 59)	Azathioprine/MMF (n = 114)
Year 1	100%	97%
Year 2	100%	94%
Year 3	98%	93%
Year 4	96%	88%
Year 5	96%	88%
Year 6	93%	83%

MMF: Mycophenolate mofetyl.