Table 2.
Effect of treatment with tesamorelin vs. placebo on body composition, biochemical indices, and cIMT
| Baseline |
6 months |
12 months |
Change |
Effect size for tesamorelin vs. placebo |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Tesamorelin | Placebo | P value | Tesamorelin | Placebo | Tesamorelin | Placebo | Tesamorelin | Placebo | Effect size (95% CI) | P value | |
| Body composition | |||||||||||
| VAT (cm2) | 209 ± 13 | 193 ± 14 | 0.39 | 188 ± 14 | 205 ± 16 | 193 ± 15 | 212 ± 16 | −16 ± 9 | 19 ± 9 | −35 (−58, −12) | 0.003 |
| SAT (cm2) | 480 ± 26 | 535 ± 28 | 0.15 | 475 ± 26 | 547 ± 27 | 463 ± 25 | 538 ± 29 | −6 ± 6 | 3 ± 11 | −10 (−32, 13) | 0.40 |
| Weight (kg) | 115.7 ± 3.8 | 115.8 ± 3.3 | 0.99 | 116.0 ± 3.9 | 116.7 ± 3.5 | 116.5 ± 3.7 | 116.6 ± 3.4 | 0.1 ± 1.1 | 0.9 ± 1.1 | −0.8 (−3.2, 1.6) | 0.52 |
| BMI (kg/m2) | 38.2 ± 0.9 | 37.9 ± 0.7 | 0.81 | 38.4 ± 0.9 | 38.4 ± 0.7 | 38.2 ± 0.9 | 38.4 ± 0.8 | −0.1 ± 0.4 | 0.6 ± 0.4 | −0.6 (−1.4, 0.2) | 0.14 |
| WC (cm) | 121 ± 2 | 121 ± 2 | 0.94 | 120 ± 3 | 121 ± 2 | 120 ± 2 | 122 ± 2 | −2 ± 1 | 1 ± 1 | −3 (−5, −0.3) | 0.03 |
| Lean mass (kg) | 71.8 ± 2.5 | 70.7 ± 2.2 | 0.74 | 72.7 ± 2.6 | 70.6 ± 2.3 | 72.8 ± 2.6 | 70.3 ± 2.1 | 1.0 ± 0.5 | −0.4 ± 0.4 | 1.4 (0.2, 2.6) | 0.03 |
| Fat mass (kg) | 42.6 ± 1.9 | 44.0 ± 2.0 | 0.26 | 42.1 ± 2.0 | 44.8 ± 2.1 | 41.9 ± 2.0 | 45.0 ± 2.2 | −0.7 ± 0.7 | 1.0 ± 0.7 | −1.7 (−3.4, −0.1) | 0.04 |
| Trunk fat (kg) | 23.3 ± 1.3 | 23.3 ± 1.1 | 0.53 | 22.7 ± 1.3 | 23.8 ± 1.2 | 22.6 ± 1.3 | 24.0 ± 1.3 | −0.6 ± 0.4 | 0.7 ± 0.4 | −1.4 (−2.4, −0.3) | 0.01 |
| Biochemical | |||||||||||
| IGF-I (μg/liter) | 160 ± 43 | 142 ± 12 | 0.17 | 225 ± 42 | 134 ± 9 | 234 ± 41 | 139 ± 10 | 86 ± 21 | −6 ± 8 | 92 (52, 132) | <0.0001 |
| Total cholesterol (mg/dl) | 176 ± 5 | 168 ± 5 | 0.28 | 186 ± 5 | 175 ± 5 | 180 ± 6 | 174 ± 6 | 4 ± 4 | 7 ± 5 | −2 (−13, 9) | 0.69 |
| Triglycerides (mg/dl) | 196 ± 26 | 132 ± 11 | 0.03 | 166 ± 17 | 133 ± 10 | 170 ± 18 | 141 ± 13 | −26 ± 16 | 12 ± 8 | −37 (−67, −7) | 0.02 |
| HDL cholesterol (mg/dl) | 35 ± 1 | 36 ± 2 | 0.61 | 40 ± 2 | 40 ± 2 | 39 ± 2 | 39 ± 2 | 4 ± 1 | 3 ± 1 | 1 (−3, 5) | 0.66 |
| LDL cholesterol (mg/dl) | 114 ± 5 | 117 ± 6 | 0.72 | 125 ± 6 | 119 ± 6 | 118 ± 5 | 117 ± 6 | 4 ± 4 | 1 ± 4 | 3 (−8, 14) | 0.60 |
| Log CRPa | 0.51 ± 0.15 | 0.66 ± 0.09 | 0.89 | 0.42 ± 0.15 | 0.65 ± 0.08 | 0.35 ± 0.15 | 0.64 ± 0.08 | −0.17 ± 0.04 | −0.03 ± 0.05 | −0.15 (−0.30, −0.01) | 0.04 |
| cIMT (mm) | 0.68 ± 0.02 | 0.66 ± 0.04 | 0.18 | 0.68 ± 0.02 | 0.67 ± 0.04 | 0.66 ± 0.02 | 0.67 ± 0.04 | −0.03 ± 0.01 | 0.01 ± 0.01 | −0.04 (−0.07, −0.01) | 0.02 |
Results are presented as mean ± sem. P values from baseline data were obtained by Student's t test for normally distributed variables and Wilcoxon rank sum for nonnormally distributed samples. Effect size and P values were obtained by longitudinal linear mixed-effects modeling for each parameter over 12 months with last value carried forward. One patient in the tesamorelin group discontinued the study before obtaining baseline body composition and biochemical data.
For CRP, the final value in one patient was 5 sd above all other data points and over 100 points above all her previous data points. This patient had skin manifestations and swelling from multiple insect bites while camping immediately before the final visit. Therefore, this data point was excluded as an outlier. Instead, data were assessed from her 9-month safety visit, before the insect bites, and used in the analysis.