TABLE 2.

Comparative risk of laboratory-defined hepatic events (TEGO vs. ESOME) in the matched cohort.

Analysis	Baseline definition	Covariates in the cox model	HR (95% CI)	p-value
Primary analysis	​	​	​	​
All patients	365-day, maximum	Drug use period	0.733 (0.564, 0.952)	0.020
Subgroup analyses	​	​	​	​
Baseline ALT, normal	365-day, maximum	Drug use period	0.699 (0.526, 0.929)	0.013
Baseline ALT, abnormal	365-day, maximum	Drug use period, dementia, COPD	0.938 (0.479, 1.839)	0.853
P For interaction	​	​	—	0.496
Sensitivity analyses	​	​	​	​
No covariate adjustment beyond matching	365-day, maximum	None (matched)	0.774 (0.597, 1.002)	0.052
Drug use period retained in the propensity score model	365-day, maximum	None (matched)	0.723 (0.558, 0.937)	0.014
Median baseline value	365-day, median	Drug use period	0.747 (0.588, 0.950)	0.017
Median baseline value, no adjustment	365-day, median	None (matched)	0.798 (0.629, 1.012)	0.063

All estimates are from Cox proportional hazards models fitted in the propensity score-matched cohort (4,634 ESOME, and 2,970 TEGO, users). Drug use period was not included in the propensity score model; because it remained imbalanced after matching (ASMD, 0.256) and was associated with the outcome, it was entered as a covariate in the primary Cox model. Estimates without this adjustment are shown among the sensitivity analyses. Additional model specifications, including adjustment for all matching variables and analyses using a 90-day baseline window, are presented in Supplementary Table S2. The proportional hazards assumption was assessed using Schoenfeld residuals and was not violated overall (global p = 0.789) or for the treatment variable (p = 0.241). Abbreviations: TEGO, tegoprazan; ESOME, esomeprazole; HR, hazard ratio; CI, confidence interval; ALT, alanine aminotransferase; COPD, chronic obstructive pulmonary disease.