Randomized controlled trial to evaluate the efficacy and safety of fexuprazan compared with esomeprazole in erosive esophagitis

Table 2 Change in reflux disease questionnaires symptom scores from baseline at weeks 4 and 8 (per protocol set)

		Fexuprazan 40 mg			Esomeprazole 40 mg
		Baseline (n = 107)	Week 4 (n = 103)	Week 8 (n = 107)	Baseline (n = 111)	Week 4 (n = 104)	Week 8 (n = 111)
Frequency
Heartburn
	mean ± SD	1.92 ± 1.23	0.91 ± 1.37	0.86 ± 1.33	2.12 ± 1.42	0.80 ± 1.29	0.70 ± 1.28
	Change from baseline (mean ± SD)	-	-0.96 ± 1.50	-1.06 ± 1.49	-	-1.33 ± 1.69	-1.42 ± 1.64
	P value1	-	< 0.001w	< 0.001w	-	< 0.001w	< 0.001w
	LS mean difference from esomeprazole	-	0.19	0.22	-	-	-
	P value2	-	0.280	0.184	-	-	-
Reflux
	mean ± SD	2.14 ± 1.29	0.93 ± 1.48	0.92 ± 1.49	1.95 ± 1.29	0.61 ± 1.07	0.59 ± 1.12
	Change from baseline (mean ± SD)	-	-1.19 ± 1.58	-1.22 ± 1.53	-	-1.32 ± 1.44	-1.36 ± 1.40
	P value1	-	< 0.001w	< 0.001w	-	< 0.001w	< 0.001w
	LS mean difference from esomeprazole	-	0.28	0.28	-	-	-
	P value2	-	0.112	0.101	-	-	-
Severity
Heartburn
	mean ± SD	1.81 ± 1.18	0.57 ± 0.78	0.53 ± 0.77	2.10 ± 1.24	0.45 ± 0.75	0.42 ± 0.79
	Change from baseline (mean ± SD)	-	-1.23 ± 1.26	-1.28 ± 1.26	-	-1.63 ± 1.29	-1.68 ± 1.27
	P value1	-	< 0.001w	< 0.001w	-	< 0.001w	< 0.001w
	LS mean difference from esomeprazole	-	0.16	0.16	-	-	-
	P value2	-	0.116	0.121	-	-	-
Reflux
	mean ± SD	2.06 ± 1.22	0.61 ± 0.92	0.58 ± 0.90	1.97 ± 1.21	0.40 ± 0.69	0.39 ± 0.73
	Change from baseline (mean ± SD)	-	-1.43 ± 1.23	-1.48 ± 1.20	-	-1.55 ± 1.23	-1.58 ± 1.19
	P value1	-	< 0.001w	< 0.001w	-	< 0.001w	< 0.001w
	LS mean difference from esomeprazole	-	0.20	0.18	-	-	-
	P value2	-	0.066	0.089	-	-	-

¹Testing for change within-treatment groups [paired t-test (t) or Wilcoxon signed rank test (w)].

²Testing for difference between treatment groups (ANCOVA model with treatment group as a factor, baseline score and stratification factor (baseline LA classification) as covariates).

Note: If subjects did not have any RDQ assessment data by week 4, were treated as missing at week 4. RDQ: Reflux disease questionnaires; LS mean: Least square mean.