Title: Randomised clinical trial: 3-year interim analysis results of the VISION trial to
evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive
oesophagitis
Version: 1 Date: 24 Nov 2022
Reviewer's report:
The results of an interim analysis of the evaluation of the safety of vonoprazan are appropriately
reported. The association of vonoprazan with adverse effects, especially with the development
of epithelial and endocrine tumors, is of great interest.
1. The association of Hp infection with the development of epithelial tumors is important. In this
study, it seems that urea breath test was performed  depending on the presence of endoscopic
gastritis (n=2) (12p, line 244). However, endoscopic atrophy was observed in about 40% of
cases in the vestibular region at the beginning of treatment (Table 4), and it is possible that Hp
infection cases were included in this group. If possible, please describe the results of Hp-IgG
antibody and urea breath test in such cases.
2. If a urea breath test is performed after endoscopy (line 173 on page 9), a false negative result
may be possible. Please tell me if the test was performed on a different day.
3.  The number of cases excluded due to AEs in Fig 1 is high for vonoprazan (n=10), but
the details of the exclusion need to be described. If possible, the degree of AE should also be
described.
Title: Randomised clinical trial: 3-year interim analysis results of the VISION trial to
evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive
oesophagitis
Version: 1 Date: 24 Nov 2022
Reviewer's report:
The results of an interim analysis of the evaluation of the safety of vonoprazan are appropriately
reported. The association of vonoprazan with adverse effects, especially with the development
of epithelial and endocrine tumors, is of great interest.
1. The association of Hp infection with the development of epithelial tumors is important. In this
study, it seems that urea breath test was performed  depending on the presence of endoscopic
gastritis (n=2) (12p, line 244). However, endoscopic atrophy was observed in about 40% of
cases in the vestibular region at the beginning of treatment (Table 4), and it is possible that Hp
infection cases were included in this group. If possible, please describe the results of Hp-IgG
antibody and urea breath test in such cases.
2. If a urea breath test is performed after endoscopy (line 173 on page 9), a false negative result
may be possible. Please tell me if the test was performed on a different day.
3.  The number of cases excluded due to AEs in Fig 1 is high for vonoprazan (n=10), but
the details of the exclusion need to be described. If possible, the degree of AE should also be
described.
Please review this paper.
user
Title: Randomised clinical trial: 3-year interim analysis results of the VISION trial to
evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive
oesophagitis
Version: 1 Date: 24 Nov 2022
Reviewer's report:
The results of an interim analysis of the evaluation of the safety of vonoprazan are appropriately
reported. The association of vonoprazan with adverse effects, especially with the development
of epithelial and endocrine tumors, is of great interest.
1. The association of Hp infection with the development of epithelial tumors is important. In this
study, it seems that urea breath test was performed  depending on the presence of endoscopic
gastritis (n=2) (12p, line 244). However, endoscopic atrophy was observed in about 40% of
cases in the vestibular region at the beginning of treatment (Table 4), and it is possible that Hp
infection cases were included in this group. If possible, please describe the results of Hp-IgG
antibody and urea breath test in such cases.
2. If a urea breath test is performed after endoscopy (line 173 on page 9), a false negative result
may be possible. Please tell me if the test was performed on a different day.
3.  The number of cases excluded due to AEs in Fig 1 is high for vonoprazan (n=10), but
the details of the exclusion need to be described. If possible, the degree of AE should also be
described.
assistant