This work is licensed under a Table 6.
Twenty-four-week change in outcomes in the modified intention-to-treat population of a randomized clinical trial of Tesomet for hypopituitary patients with hypothalamic obesity. Data presented as least squares mean (95% CI) change from baseline to week 24 in the mITT population. Last observation carried forward imputation was used for missing data. Pair-wise comparisons were performed using a baseline adjusted ANCOVA model with treatment as factor and change from baseline as dependent variable.
| Tesomet (n = 13) | Placebo (n = 8) | Est. difference: Tesomet vs placebo | P | |
|---|---|---|---|---|
| Body weight (kg) | −7.4 (−10.8; −3.9) | −0.4 (−4.9; 4.0) | −6.9 (−12.6; −1.3) | 0.02 |
| Body weight (%) | −6.6 (−9.7; −3.5) | −0.3 (−4.3; 3.6) | −6.3 (−11.3; −1.3) | 0.02 |
| Waist circumference (cm) | −6.5 (−10.1; −3.0) | −0.9 (−5.4; 3.7) | −5.7 (−11.5; 0.1) | 0.054 |
| Waist circumference (%) | −5.7 (−8.8; −2.5) | −0.6 (−4.6; 3.4) | −5.0 (−10.1; 0.0) | 0.052 |
| BMI (kg/m2) | −2.4 (−3.6; −1.2) | −0.1 (−1.7; 1.4) | −2.3 (−4.2; -0.3) | 0.03 |
| DXAa | ||||
| Fat mass (kg) | −5.3 (−8.2; -2.3) | −1.1 (−5.3; 3.1) | −4.2 (−9.3; 1.0) | 0.10 |
| Lean mass (kg) | −2.8 (−3.8; −1.7) | 0.4 (−1.2; 1.9) | −3.1 (−5.0; −1.2) | 0.003 |
| Bone mineral content (g) | −5.0 (−38.8; 28.8) | −14.7 (−63.6; 34.2) | 9.7 (−51.4; 70.9) | 0.74 |
| Bone mineral density (g/cm2) | 0.0 (−0.0; 0.0) | 0.0 (−0.0; 0.0) | 0.0 (−0.02; 0.02) | 0.99 |
| Vital signs variables | ||||
| Systolic blood pressure (mmHg) | 2.2 (−4.6; 9.0) | −3.7 (−12.5; 5.2) | 5.9 (−5.8; 17.5) | 0.30 |
| Diastolic blood pressure (mmHg) | 0.1 (−5.4; 5.6) | −1.1 (−8.1; 6.0) | 1.2 (−7.9; 10.2) | 0.79 |
| Heart rate (bpm) | −2.9 (−8.7; 2.8) | −5.6 (−13.0; 1.7) | 2.7 (−6.7; 12.1) | 0.56 |
| Corrected QT-interval (ms)a | −4.2 (−12.9; 4.4) | −3.2 (−15.4; 9.0) | −1.1 (−16; 13.9) | 0.88 |
| Cholesterola | ||||
| Total (mmol/L) | −0.2 (−0.5; 0.1) | −0.1 (−0.6; 0.3) | −0.05 (−0.59; 0.50) | 0.86 |
| LDL (mmol/L) | −0.2 (−0.5; 0.0) | −0.2 (−0.6; 0.2) | −0.06 (−0.53; 0.42) | 0.81 |
| HDL (mmol/L) | 0.0 (−0.1; 0.2) | 0.0 (−0.2; 0.2) | 0.03 (−0.25; 0.30) | 0.83 |
| Triglycerides (mmol/L) | −0.1 (−0.6; 0.4) | −0.3 (−1.0; 0.4) | 0.23 (−0.62; 1.07) | 0.58 |
| FPG (mg/dL)b | −6.7 (−10.6; −2.8) | −5.8 (−11.2; −0.5) | −0.85 (−7.58; 5.88) | 0.79 |
| FPG (mmol/L)b | −0.4 (−0.6; −0.2) | −0.3 (−0.6; 0) | −0.05 (−0.42; 0.33) | 0.79 |
| HbA1c (%)a | −0.5 (−0.6; −0.3) | −0.2 (−0.4; 0.1) | −0.28 (−0.58; 0.03) | 0.07 |
| HbA1c (mmol/mol)a | −5.1 (−7.0; −3.2) | −2.0 (−4.7; 0.7) | −3.02 (−6.34; 0.30) | 0.07 |
aData available for 12 patients in Tesomet; 6 in Placebo. bData unavailable for 1 patient randomized to placebo.
ANCOVA, analysis of covariance; FPG, fasting plasma glucose; HbA1c, haemoglobin A1c; HDL, high-density lipoprotein; LDL, low-density lipoprotein; mITT, modified intention-to-treat.