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

Table 4 Summary of treatment-emergent adverse events during maintenance treatment n (%)

	LPZ 15 mg (n = 201)		VPZ 10 mg (n = 202)		VPZ 20 mg (n = 204)
	Events	Patients	Events	Patients	Events	Patients
Any TEAE	166	103 (51.2)	220	109 (54.0)	212	120 (58.8)
Drug-related TEAE	30	23 (11.4)	26	21 (10.4)	23	21 (10.3)
TEAE leading to study discontinuation	10	8 (4.0)	5	5 (2.5)	8	8 (3.9)
Any serious TEAE	4	4 (2.0)	5	5 (2.5)	4	4 (2.0)
Death	0	0 (0.0)	0	0 (0.0)	0	0 (0.0)
TEAEs reported in ≥ 2% of patients in any group, irrespective of causal relationship to study medication, during maintenance treatment.
TEAE (preferred term)	LPZ 15 mg		VPZ 10 mg		VPZ 20 mg
Nasopharyngitis	28 (13.9)		34 (16.8)		27 (13.2)
Diarrhea	11 (5.5)		6 (3.0)		5 (2.5)
Upper respiratory tract inflammation	3 (1.5)		8 (4.0)		4 (2.0)
Elevated blood creatinine phosphokinase	2 (1.0)		4 (2.0)		6 (2.9)
Elevated blood triglycerides	6 (3.0)		1 (0.5)		5 (2.5)
Fall	1 (0.5)		8 (4.0)		2 (1.0)
Gastroenteritis	1 (0.5)		5 (2.5)		5 (2.5)
Back pain	1 (0.5)		3 (1.5)		5 (2.5)
Constipation	4 (2.0)		2 (1.0)		3 (1.5)
Elevated ALT1	1 (0.5)		3 (1.5)		4 (2.0)
Contusion	1 (0.5)		5 (2.5)		2 (1.0)
Seasonal allergy	2 (1.0)		4 (2.0)		2 (1.0)
Bronchitis	2 (1.0)		5 (2.5)		0 (0.0)
Dizziness	1 (0.5)		4 (2.0)		2 (1.0)
Abnormal liver function test2	1 (0.5)		2 (1.0)		4 (2.0)
Abnormal hepatic function2	1 (0.5)		0 (0.0)		4 (2.0)
Periodontitis	0 (0.0)		4 (2.0)		1 (0.5)

¹Recorded as a special-interest adverse event (SIAE) if ALT > 3 × the upper limit of normal (ULN);

²Recorded as a SIAE if total bilirubin > 2 × ULN in two consecutive measurements. ALT: Alanine aminotransferase; LPZ: Lansoprazole; TEAE: Treatment-emergent adverse event; VPZ: Vonoprazan.