Efficacy and safety of concentration-controlled everolimus with reduced-dose cyclosporine in Japanese de novo renal transplant patients: 12-month results

Table 6 Vital signs, hematological and biochemical abnormalities over 12 months of treatment (safety population)

	Everolimus 1.5 mg (n= 61)	MMF 2 g (n= 61)
SBP (mmHg)
≤90 mmHg or <75 mmHg^a	1 (1.6)	0 (0.0)
≥180 mmHg or >200 mmHg^b	9 (14.8)	6 (9.8)
DBP (mmHg)
≤50 mmHg or <40 mmHg	4 (6.6)	0 (0.0)
≥105 mmHg or >115 mmHg	14 (23.0)	16 (26.2)
Hematology
Platelets, low: <50 k/mm³	0 (0.0)	1 (1.6)
Eosinophils, high: ≥12%	1 (1.6)	1 (1.6)
Hemoglobin, low: <7 g/dl	5 (8.2)	5 (8.2)
Lymphocytes, low: ≤1,000/mm³	48 (78.7)	56 (91.8)
Leukocytes
Low: ≤2.0 k/mm³	0 (0.0)	1/61(1.6)
High: ≥16 k/mm³	32 (52.5)	20 (32.8)
Neutrophils, low: ≤1,000/mm³	0 (0.0)	2 (3.3)
Lipids
Total cholesterol, high: ≥350 mg/dl	2 (3.3)	1 (1.6)
Triglycerides, high: ≥750 mg/dl	1 (1.6)	0 (0.0)
Cholesterol (total)/HDL ratio
High: ≥5 and ≤7	24 (39.3)	17 (27.9)
Very high: >7	5 (8.2)	3 (4.9)
Lipid modifying agents	42 (68.9)	24 (39.3)
Number of patients with normalized cholesterol values after statin treatment (n/month)	16/18 (88.9)	6/7 (85.7)
Number of patients with normalized triglyceride values after statin treatment	9/12 (75)	3/4 (75)

Data presented as n (%). ^aDecrease from baseline ≥30 mmHg. ^bIncrease from baseline ≥30 mmHg. DBP, diastolic blood pressure; HDL, high-density lipoprotein; SBP, systolic blood pressure.

ISSN: 2047-1440