Table 1.
Demographic and baseline clinical characteristics of the patients enrolled in the study stratified by treatment group
| Tesamorelin (n = 31) | Placebo (n = 29) | P value | |
|---|---|---|---|
| Demographics | |||
| Age (yr) | 42.5 ± 1.3 | 39.9 ± 1.8 | 0.25 |
| Gender [male/female (% male)] | 20/11 (65.5) | 19/10 (64.5) | 0.94 |
| Race [n (% Caucasian)] | 16 (51.6) | 19 (65.5) | 0.28 |
| Current or past tobacco use [n (%)] | 18 (58) | 13 (45) | 0.31 |
| Medication usea [n (%)] | |||
| HMG CoA reductase inhibitor | 3 (10) | 1 (3) | 0.33 |
| Lipid-lowering therapyb | 8 (26) | 12 (41) | 0.20 |
| Antihypertensive | 10 (32) | 5 (17) | 0.18 |
| Body composition | |||
| Weight (kg) | 115.7 ± 3.8 | 115.8 ± 3.3 | 0.99 |
| BMI (kg/m2) | 37.5 (34, 41.4) | 38.3 (34.4, 40.5) | 0.81 |
| WC (cm) | 121 ± 2 | 121 ± 2 | 0.94 |
| VAT (cm2) | 209 ± 13 | 193 ± 14 | 0.39 |
| GH parameters | |||
| Peak stimulated GH on GHRH-arginine stimulation test (μg/liter) | 4.22 ± 0.46 | 5.19 ± 0.47 | 0.15 |
| IGF-I (μg/liter) | 101 (79, 145) | 131 (107, 172) | 0.17 |
Results are presented as the mean ± sem for normally distributed data and analyzed by Student's t test. For data that is not normally distributed, results are presented as median with interquartile range (25, 75%) and analyzed using the Wilcoxon rank sum test. Noncontinuous variables are compared using χ2 test. One patient in the tesamorelin group discontinued the study before obtaining baseline body composition data. VAT was measured via abdominal computed tomography scan. HMG CoA, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase.
Medication use includes baseline data as well as initiation of new medications during the course of the study.
Lipid-lowering medication use includes subjects using HMG CoA reductase inhibitors, niacin, and fish oil.