Table 1.
Demographic and clinical characteristics TUDCA-treated and non-TUDCA-treated patients with ALS after matching.
| Clinical features | Patients not treated with TUDCA (n = 172) n (%) m [SD] | Patients treated with TUDCA (n = 86) n (%) m [SD] | p-value |
|---|---|---|---|
| Sex, n (%) | 0.77 | ||
| Male | 125 (72.7) | 64 (74.4) | |
| Female | 47 (27.3) | 22 (25.6) | |
| Months from onset to diagnosis, mean [SD] | 11.6 [8.2] | 11.9 [10.2] | 0.78 |
| Age at onset, mean [SD] | 58.1 [10.8] | 58.2 [9.3] | 0.97 |
| Site of onset, n (%) | 0.95 | ||
| Bulbar | 38 (22.1) | 19 (22.1) | |
| Upper limbs | 72 (41.9) | 35 (40.7) | |
| Lower limbs | 59 (34.3) | 31 (36.0) | |
| Respiratory | 3 (1.7) | 1 (1.2) | |
| Phenotype | 0.94 | ||
| Bulbar | 38 (22.1) | 18 (20.9) | |
| Classic | 99 (57.6) | 52 (60.5) | |
| Flail arm and flail leg | 28 (16.3) | 12 (14.0) | |
| UMN-p | 4 (2.3) | 3 (3.49) | |
| Respiratory | 3 (1.7) | 1 (1.16) | |
| Familial ALS, n (%) | 15 (8.7) | 10 (11.6) | 0.46 |
| BMI at diagnosis, mean [SD] | 24.4 [4.0] | 24.7 [3.7] | 0.59 |
| ALSFRS-r at diagnosis, mean [SD] | 41.7 [4.8] | 41.8 [5.1] | 0.86 |
| Disease progression rate at diagnosis, mean [SD] | 0.648 [0.589] | 0.626 [0.650] | 0.79 |
| FVC at diagnosis, mean [SD] | 93.5 [22.0] | 92.9 [23.9] | 0.89 |
| FTD at diagnosis, n (%) | 11 (6.4) | 6 (7.0) | 0.86 |
| Riluzole, n (%) | 152 (88.4) | 82 (95.4) | 0.069 |
| MiToS stage at TUDCA beginning [SD] | – | 0.58 [0.89] | – |
| King's stage at TUDCA beginning [SD] | – | 2.26 [0.96] | – |
| Months from onset to TUDCA intake, mean [SD] | – | 22.8 [16.4] | – |
| Months from diagnosis to TUDCA intake, mean [SD] | – | 11.0 [10.7] | – |
| Absolute duration of TUDCA treatment in days, mean [SD] | – | 449 [392] | – |
SD: Standard Deviation; UMN-p: Upper Motor Neuron predominant; BMI: Body Mass Index; ALSFRS-R: ALS Functional Rating Scale—Revised; FVC: Forced Vital Capacity; FTD: Frontotemporal Dementia. Based on the nature of the clinical variable under investigation, homogeneity between cases and controls was assessed by the Student's T test or chi-square test.
The resulting p-values are representative of good homogeneity of clinical features among tested groups.