Skip to main content
. 2023 Oct 5;65:102256. doi: 10.1016/j.eclinm.2023.102256

Table 3.

Median survival and hazard ratio on different dosages and durations of TUDCA treatment.

Group Survival (months)
 Hazard ratio
Median (CI) Log-Rank HR 95% CI p-value
Survival Analyses (from onset to death/tracheotomy) performed on PSM cohort
Level I: Survival: from onset to death/tracheotomy (treatment impact)
Patients not treated with TUDCA (n = 172) 36.2 (32.7–41.6) – – – –
Patients treated with TUDCA (n = 86) 49.6 (41.7–93.5) 0.0062 0.57 0.38–0.83 0.0042
Level II: Survival: from onset to death/tracheotomy (duration impact)
Patients not treated with TUDCA (n = 172) 36.2 (32.7–41.6) – – – –
Patients treated with TUDCA:
  • •

    With TUDCA <12 months (n = 40)

 44.5 (26.3-NAa) 0.23 0.73 0.44–1.22 0.23
  • •

    With TUDCA >12 months (n = 44)

 56.2 (43–96.2) 0.0022 0.67 0.52–0.87 0.0024
Level III: Survival: from onset to death/tracheotomy (dosage impact)
Patients not treated with TUDCA (n = 172) 36.2 (32.7–41.6) – – – –
Patients treated:
  • •

    With TUDCA <1000 mg/day (n = 20)

 29.7 (19.6–49.6) 0.16 1.10 0.64–1.92 0.72
  • •

    With TUDCA ≥1000 mg/day (n = 66)

 56.5 (43.0-NAa) <0.0001 0.42 0.26–0.68 <0.0001
Analyses performed on sub PSM cohort (excluding TUDCA < 1000 mg/day and their matched controls)
Survival: from onset to death/tracheotomy (treatment impact)
Patients not treated with TUDCA (n = 132) 39.0 (33.1–48.8)
Patients treated with ≥1000 mg/day (n = 66) 56.5 (43.0-NAa) 0.0019 0.45 0.28–0.73 0.0011

NA: not available. CI: confidence interval. HR: Hazard Ratio. FVC: forced vital capacity.

Median survival times from Kaplan–Meier analyses and Hazard Ratio descriptors from multiple Cox regression analyses were reported, respectively. For the latter ones, the following covariates were included in the model: riluzole treatment; delay of TUDCA initiation from onset; delay of TUDCA initiation from diagnosis; and FVC value at the baseline. Supplementary Table S3 reported p-values to estimate the impact of such covariates in terms of confounding factors.

p-values inferior to 0.05 are reported in bold character.

a

The CI cannot be estimated because a low observations' size or a higher number of censored observations.