Table 4.
Clinical and laboratory parameters at randomization and the end of the 1-year treatment period according to randomization to sirolimus added on to conventional therapy (sirolimus) or conventional therapy only (conventional)
| Sirolimus | Conventional | |||
|---|---|---|---|---|
| Patients Parameters | Baseline, n=16 | 1 yr, n=16 | Baseline, n=17 | 1 yr, n=17 |
| Weight, kg | 73.5 (15.2) | 72.0 (13.9) | 74.2 (17.2) | 75.4 (19.0)a |
| SBP, mmHg | 138.3 (9.5) | 132.8 (12.7) | 134.1 (13.3) | 127.9 (11.6)b |
| DBP, mmHg | 87.1 (8.3) | 84.8 (7.3) | 85.9 (7.2) | 81.9 (6.4)b |
| MAP, mmHg | 102.8 (7.8) | 100.8 (8.8) | 101.6 (9.8) | 97.2 (7.1)b |
| AST, U/L | 19.1 (3.1) | 17.6 (2.8) | 19.6 (5.5) | 17.4 (4.6)c |
| ALT, U/L | 17.8 (4.4) | 17.3 (3.6) | 16.6 (5.2) | 15.1 (6.0) |
| GGT, U/L | 27.4 (14.4) | 24.6 (12.9) | 23.7 (9.8) | 21.5 (9.7) |
| Alkaline phosphatase, U/L | 67.0 (14.4) | 63.9 (11.3) | 61.4 (18.3) | 57.6 (17.7) |
| Calcium, mg/dl | 9.4 (0.3) | 8.9 (0.5)b | 9.2 (0.5) | 9.2 (0.5)d |
| Phosphorus, mg/dl | 3.9 (0.5) | 4.0 (0.8) | 3.7 (0.4) | 4.0 (0.6)b |
| Sodium, mEq/L | 140.3 (1.6) | 139.5 (1.1) | 140.0 (1.5) | 139.5 (2.0) |
| Potassium, mEq/L | 4.3 (0.4) | 4.2 (0.5) | 4.1 (0.7) | 4.3 (0.6) |
| Blood glucose, mg/dl | 90.1 (12.3) | 88.4 (8.7) | 89.4 (11.7) | 88.6 (8.9) |
| Uric acid, mg/dl | 6.4 (1.4) | 6.3 (1.0) | 7.3 (1.4) | 6.3 (1.0)c |
| Total cholesterol, mg/dl | 198.4 (23.2) | 189.9 (24.0) | 201.6 (26.8) | 188.7 (34.8) |
| LDL cholesterol, mg/dl | 123.6 (18.1) | 121.6 (22.6) | 124.4 (31.8) | 116.1 (28.5) |
| HDL cholesterol, mg/dl | 46.7 (10.4) | 42.9 (8.8)c | 51.3 (14.0) | 46.6 (13.5)c |
| Triglycerides, mg/dl | 116.3 (39.9) | 114.4 (25.3) | 108.1 (46.7) | 103.9 (43.9) |
| Leukocytes, ×103/μl | 5.3 (1.5) | 5.2 (1.3) | 5.1 (0.8) | 5.0 (1.0) |
| Hemoglobin, g/dl | 12.7 (1.5) | 12.0 (1.3)c | 12.4 (1.3) | 11.6 (1.3)b |
| Hematocrit, % | 38.5 (4.6) | 36.4 (3.5)c | 37.6 (3.7) | 34.6 (3.6)b |
| Platelets, ×103/μl | 188.1 (56.8) | 176.5 (53.2) | 182.8 (38.0) | 184.2 (37.7) |
Data are means (SDs). SBP, systolic BP; DBP, diastolic BP; MAP, mean arterial pressure; AST, aspartate aminotransferase; ALT, alanine aminotransferase; GGT, γ-glutamyl-transpeptidase.
a
P<0.05 versus sirolimus adjusted for baseline value (analysis of covariance).
b
P<0.01 versus baseline (paired t test).
c
P<0.05 versus baseline (paired t test).
d
P<0.01 versus sirolimus adjusted for baseline value (analysis of covariance).