This work is licensed under a Table 3.
Patient demographics and baseline characteristics in a randomized clinical trial of Tesomet for hypopituitary patients with hypothalamic obesity. Data presented as mean ± s.d. or n (% of total) for each treatment group. No statistically significant differences using Student’s t-test for continuous variables or Fisher’s exact test for categorical variables were found.
| Tesomet (n =14) | Placebo (n =8) | |
|---|---|---|
| Age (years) | 45.4 ± 13.3 | 44.4 ± 18.3 |
| Sex, n (%) | ||
| Female | 11 (78.6%) | 6 (75%) |
| Male | 3 (21.4%) | 2 (25%) |
| White or Caucasian n (%) | 14 (100%) | 8 (100%) |
| Not Hispanic or Latino n (%) | 14 (100%) | 8 (100%) |
| Time from assumed hypothalamic injury (years) | 12.0 ± 8.3 | 20.3 ± 15.7 |
| Age at initial treatment (years) | 33.9 ± 16.9 | 24.6 ± 16.4 |
| Height (cm)a | 175.1 ± 7.6 | 171.3 ± 10.8 |
| Weight (kg)a | 114.3 ± 18.1 | 112.2 ± 27.0 |
| Waist circumference (cm)a | 117.5 ± 12.2 | 116.1 ± 17.9 |
| BMI (kg/m2)a | 37.3 ± 5.6 | 37.8 ± 5.8 |
| DXA | ||
| Fat mass (kg)a | 51.7 ± 15.0 | 48.6 ± 13.3 |
| Lean mass (kg)a | 58.7 ± 11.5 | 59.7 ± 19.2 |
| Tumour type, n (%)b | ||
| Craniopharyngioma | 6 (42.9%) | 4 (50%) |
| Adamantinomatous | 4 (28,6%) | 2 (25%) |
| Papillary | 2 (14,3%) | 0 |
| Unknownc | 0 | 2 (25%) |
| Pituitary Macroadenomad | 4 (28.6%) | 1 (12.5%) |
| Astrocytoma | 2 (14.3%) | 1 (12.5%) |
| Meningioma | 1 (7.1%) | 1 (12.5%) |
| Glioma | 0 | 1 (12.5%) |
| Germinoma | 1 (7.1%) | 0 |
| Tumour treatment, n (%) | ||
| Neurosurgery | 13 (92.9%) | 6 (75%) |
| Irradiation therapy | 9 (64.3%) | 3 (37.5%) |
| Chemotherapy | 2 (14.3%) | 1 (12.5%) |
| Endocrinopathy, n (%) | ||
| Central hypothyroidism | 14 (100%) | 8 (100%) |
| Central adrenal insufficiency | 13 (92.9%) | 6 (75%) |
| Hypogonadotropic hypogonadism | 11 (78.6%) | 6 (75%) |
| Diabetes insipidus | 7 (50.0%) | 4 (50%) |
| Growth hormone deficiency | 11 (78.6%) | 5 (62.5%) |
| Diabetes mellitus type 2 | 2 (14.3%) | 1 (12.5%) |
aData unavailable for one patient randomized to Tesomet. bDiagnosis confirmed by histological or radiological presentation. cHistological type could not be determined from medical history. dGiant macroadenomas; three of four patients (Tesomet) had undergone several pituitary surgeries + subsequent irradiation, whereas one patient (Placebo) had only undergone surgery. This patient developed an SAE (hyponatraemia) and withdrew from the trial.