Table 7.
Comparison of safety lab values.
|
rhGH, mean (sd) |
Placebo, mean (sd) |
p-value | |
|---|---|---|---|
| HDL CHOLESTEROL | |||
| Baseline | 39.9 (11.7) | 37.7 (10.2) | 0.84 |
| 1 Month | 49.3 (13) | 43.3 (10.5) | 0.13 |
| 3 Month | 48.3 (13.3) | 42.2 (9.5) | 0.20 |
| 6 Month | 47.3 (10.6) | 44.4 (8.6) | 0.45 |
| 12 Month | 48.9 (14.8) | 41.3 (13.9) | 0.23 |
| LDL CHOLESTEROL | |||
| Baseline | 108.1 (33.3) | 109.7 (29.6) | 0.54 |
| 1 Month | 109.9 (26.8) | 112.7 (33.7) | 0.66 |
| 3 Month | 110.2 (35.1) | 100.6 (31) | 0.35 |
| 6 Month | 108.9 (34.9) | 102.4 (40.2) | 0.46 |
| 12 Month | 108.9 (32.2) | 109.9 (35) | 0.93 |
| TOTAL CHOLESTEROL | |||
| Baseline | 172.9 (41) | 176.6 (40.2) | 0.76 |
| 1 Month | 183.8 (32.8) | 184.5 (39.1) | 0.88 |
| 3 Month | 188.2 (43.9) | 177.9 (36.9) | 0.35 |
| 6 Month | 182.5 (40.6) | 187.4 (42.5) | 0.97 |
| 12 Month | 186.6 (42.5) | 184.2 (32.5) | 0.74 |
| TRIGLYCERIDES | |||
| Baseline | 127.5 (64.1) | 147.3 (67.3) | 0.23 |
| 1 Month | 123 (48.4) | 141.9 (56) | 0.23 |
| 3 Month | 150.7 (100.9) | 175.6 (91.9) | 0.29 |
| 6 Month | 130.8 (72.2) | 192.5 (139.8) | 0.17 |
| 12 Month | 143.8 (82.5) | 164.9 (80.2) | 0.38 |
| GLUCOSE | |||
| Baseline | 84.4 (9.2) | 86 (8.3) | 0.42 |
| 1 Month | 69.7 (25.3) | 80 (16.2) | 0.27 |
| 3 Month | 83.6 (22.1) | 90.2 (20.5) | 0.41 |
| 6 Month | 88.7 (15.8) | 84.5 (10.3) | 0.25 |
| 12 Month | 88.3 (10.8) | 89.1 (12.1) | 0.90 |
| t4, FREE | |||
| Baseline | 1.6 (2.1) | 1.1 (0.3) | 0.89 |
| 1 Month | 1.4 (1.6) | 1.1 (0.3) | 0.99 |
| 3 Month | 1.7 (2.2) | 1.1 (0.2) | 0.33 |
| 6 Month | 1.9 (2.3) | 1.2 (0.2) | 0.90 |
| 12 Month | 1.2 (0.2) | 1.2 (0.2) | 0.86 |
| INSULIN | |||
| Baseline | 3.2 (3.1) | 7.1 (9.5) | 0.21 |
| 1 Month | 5.9 (9.9) | 5.4 (5.9) | 0.34 |
| 3 Month | 11.9 (20) | 11.1 (14.7) | 0.44 |
| 6 Month | 9.8 (15.1) | 8.4 (8.9) | 0.38 |
| 12 Month | 7.3 (12.9) | 16.9 (16.9) | 0.04 |
All laboratory diagnostics were performed via Quest Diagnostics. Normal lab value references: Cholesterol, total 125–200 mg/dL; HDL Cholesterol > or + 40 mg/dL; Triglycerides <150 mg/dL; LDL Cholesterol <130 mg/dL; Glucose 65–99 mg/dL; T4, free 0.8–1.8 ng/dL; Insulin <17 uIU/mL; Growth hormone: Using the GH stimulation test, the following results would rule out GH deficiency: Adults (> or + 20 years) – Arginine/GHRH > or = 5.1 ng/mL, Children (<20 years) – Arginine/GHRH > or = 10 ng/mL; IGF 1 50–303 ng/mL.
rhGH n = 20 at baseline, 3 and 6 months, n = 16 at 12 months; placebo n = 20 at baseline, 3 and 6 months, n = 18 at 12 months.