Table 2.
Clinical characteristics of patients with ALS stratified according to exposure to different dosages of TUDCA.
| Clinical features | Patients treated with TUDCA <1000 mg/day (n = 20) n (%), m [SD] | Patients treated with TUDCA ≥1000 mg/day (n = 66) n (%), m [SD] | p-value |
|---|---|---|---|
| Sex, n (%) | 0.60 | ||
| Male | 14 (70.0) | 50 (75.8) | |
| Female | 6 (30.0) | 16 (24.2) | |
| Months from onset to diagnosis, mean [SD] | 11.5 [7.9] | 12.1 [10.9] | 0.82 |
| Age at onset, mean [SD] | 61.7 [10] | 57.1 [8.9] | 0.055 |
| Site of onset, n (%) | 0.054 | ||
| Bulbar | 7 (35) | 12 (18.2) | |
| Upper limbs | 3 (15) | 32 (48.5) | |
| Lower limbs | 10 (50) | 21 (31.3) | |
| Respiratory | – | 1 (1.5) | |
| Phenotype | 0.28 | ||
| Bulbar | 7 (35) | 11 (16.7) | |
| Classic | 10 (50) | 42 (63.6) | |
| Flail arm and flail leg | 3 (15) | 9 (13.6) | |
| UMN-p | – | 3 (4.6) | |
| Respiratory | – | 1 (1.5) | |
| BMI at diagnosis, mean [SD] | 25.3 [4.8] | 24.5 [3.4] | 0.54 |
| ALSFRS-r at diagnosis, mean [SD] | 40.3 [5.5] | 42.3 [4.9] | 0.12 |
| Disease progression rate at diagnosis, mean [SD] | 0.82 [0.7] | 0.57 [0.6] | 0.12 |
| FVC at diagnosis, mean [SD] | 87 [22.6] | 95.1 [24.3] | 0.35 |
| FTD presence at diagnosis, n (%) | 2 (10) | 4 (6.1) | 0.54 |
| Riluzole, n (%) | 20 (100) | 62 (93.9) | 0.26 |
| MiToS stage at TUDCA beginning [SD] | 0.80 [1] | 0.51 [0.84] | 0.21 |
| King's stage at TUDCA beginning [SD] | 2.50 [1.05] | 2.18 [0.93] | 0.20 |
| Months from onset to TUDCA intake, mean [SD] | 19.8 [14.4] | 23.7 [17] | 0.36 |
| Absolute duration of TUDCA treatment in days, mean [SD] | 365 [376] | 474 [396] | 0.28 |
| Drug titration, n (%) | 9 (45) | 47 (71.2) | 0.034 |
| Drug discontinuation, n (%) | 5 (25) | 11 (16.7) | 0.40 |
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, the homogeneity between cases and controls was assessed by ANOVA or chi-square test.
The resulting p-values are representative of good homogeneity of clinical features among tested groups.
p-values inferior to 0.05 are reported in bold character.