Maintenance for healed erosive esophagitis: Phase III comparison of vonoprazan with lansoprazole

Table 3 Recurrence rate of erosive esophagitis within 24 wk: sub-group analysis according to baseline characteristics

	LPZ 15 mg		VPZ 10 mg			VPZ 20 mg
	Estimate (%)1	Estimate (%)1	Difference2 and 95%CI (%)	Fisher exact test, P value3	Estimate (%)1	Difference2 and 95%CI (%)	Fisher exact test, P value3
Age (yr)
< 65	14.4 (19/132)	4.3 (6/139)	-10.1 [-16.95, -3.20]	0.0056	0.0 (0/136)	-14.4 [-20.38, -8.41]	< 0.0001
≥ 65 to < 75	21.7 (10/46)	7.0 (3/43)	-14.8 [-28.91, -0.62]	0.0711	7.0 (3/43)	-14.8 [-28.91, -0.62]	0.0711
≥ 75	22.2 (4/18)	6.7 (1/15)	-15.6 [-38.54, 7.43]	0.3457	4.5 (1/22)	-17.7 [-38.76, 3.41]	0.1554
Sex
Male	13.9 (19/137)	6.3 (10/159)	-7.6 [-14.49, -0.67]	0.0321	1.3 (2/159)	-12.6 [-18.65, -6.57]	< 0.0001
Female	23.7 (14/59)	0.0 (0/38)	-23.7 [-34.58, -12.87]	0.0007	4.8 (2/42)	-19.0 [-31.59, -6.35]	0.0120
Smoking classification
Never smoked	22.4 (17/76)	1.9 (1/54)	-20.5 [-30.55, -10.48]	0.0006	5.0 (3/60)	-17.4 [-28.24, -6.50]	0.0062
Current smoker	20.0 (8/40)	6.6 (4/61)	-13.4 [-27.31, 0.42]	0.0588	0.0 (0/57)	-20.0 [-32.40, -7.60]	0.0005
Ex-smoker	10.0 (8/80)	6.1 (5/82)	-3.9 [-12.27, 4.47]	0.3998	1.2 (1/84)	-8.8 [-15.78, -1.84]	0.0160
Erosive esophagitis grade4
LA Grade A/B	11.0 (17/155)	3.1 (5/159)	-7.8 [-13.44, -2.21]	0.0075	1.3 (2/158)	-9.7 [-14.92, -4.48]	0.0002
LA Grade C/D	39.0 (16/41)	13.2 (5/38)	-25.9 [-44.26, -7.47]	0.0114	4.7 (2/43)	-34.4 [-50.58, -18.17]	0.0001
CYP2C19 genotype
Extensive metabolizers	19.6 (31/158)	5.4 (9/166)	-14.2 [-21.28, -7.11]	0.0001	1.8 (3/168)	-17.8 [-24.34, -11.33]	< 0.0001
Poor metabolizers	5.3 (2/38)	3.2 (1/31)	-2.0 [-11.48, 7.40]	1.0000	3.0 (1/33)	-2.2 [-11.43, 6.97]	1.0000
H. pylori infection status
Positive	3.7 (1/27)	2.7 (1/37)	-1.0 [-9.84, 7.83]	1.0000	0.0 (0/27)	-3.7 [-10.83, 3.42]	1.0000
Negative	18.9 (32/169)	5.6 (9/160)	-13.3 [-20.21, -6.41]	0.0003	2.2 (4/179)	-16.7 [-22.99. -10.41]	< 0.0001

¹Data expressed as percentages with number of subjects in parentheses;

²Calculated for difference between VPZ group and LPZ 15 mg group;

³Post hoc analysis;

⁴LA Classification Grade of erosive esophagitis by principal investigator at baseline. CI: Confidence interval; LA: Los Angeles; LPZ: Lansoprazole; VPZ: Vonoprazan.