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Published in: BMC Gastroenterology 1/2023

Open Access 01-12-2023 | Endoscopy | Research

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

Authors: Ken Haruma, Yoshikazu Kinoshita, Takashi Yao, Ryoji Kushima, Junichi Akiyama, Nobuo Aoyama, Tatsuhiro Kanoo, Kouji Miyata, Naomi Kusumoto, Naomi Uemura

Published in: BMC Gastroenterology | Issue 1/2023

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Abstract

Background

VISION is a randomised, phase 4, open-label, parallel-group, multicentre study conducted in 33 centres in Japan. The aim of this study was to assess the long-term safety of vonoprazan for maintenance treatment of healed erosive oesophagitis versus lansoprazole.

Methods

Patients with endoscopically diagnosed erosive oesophagitis were randomised 2:1 to once-daily vonoprazan 20 mg or lansoprazole 30 mg, for a 4- to 8-week healing phase. Patients with endoscopically confirmed healing entered a 260-week maintenance phase with a once-daily starting dose of vonoprazan 10 mg or lansoprazole 15 mg. Primary endpoint was change in gastric mucosal histopathology.

Results

Of 208 patients (vonoprazan, n = 139; lansoprazole, n = 69) entering the healing phase, 202 entered the maintenance phase (vonoprazan, n = 135; lansoprazole, n = 67). At 3 years, 109 vonoprazan-treated and 58 lansoprazole-treated patients remained on treatment. Histopathological evaluation of gastric mucosa showed that hyperplasia of parietal, foveolar and G cells was more common with vonoprazan than lansoprazole at week 156 of the maintenance phase. There was no marked increase in the occurrence of parietal, foveolar and G cell hyperplasia among patients in the vonoprazan group from week 48 to week 156. Histopathological evaluation of the gastric mucosa also showed no neoplastic changes in either group. No new safety issues were identified.

Conclusions

In this interim analysis of VISION, no new safety concerns were identified in Japanese patients with healed erosive oesophagitis receiving vonoprazan or lansoprazole as maintenance treatment for 3 years. (CT.gov identifier: NCT02679508; JapicCTI-163153; Japan Registry of Clinical Trials: jRCTs031180040).
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Literature
1.
go back to reference Hori Y, Imanishi A, Matsukawa J, Tsukimi Y, Nishida H, Arikawa Y, et al. 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438), a novel and potent potassium-competitive acid blocker for the treatment of acid-related diseases. J Pharmacol Exp Ther. 2010;335(1):231–8.PubMedCrossRef Hori Y, Imanishi A, Matsukawa J, Tsukimi Y, Nishida H, Arikawa Y, et al. 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438), a novel and potent potassium-competitive acid blocker for the treatment of acid-related diseases. J Pharmacol Exp Ther. 2010;335(1):231–8.PubMedCrossRef
2.
go back to reference Shin JM, Inatomi N, Munson K, Strugatsky D, Tokhtaeva E, Vagin O, et al. Characterization of a novel potassium-competitive acid blocker of the gastric H, K-ATPase, 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438). J Pharmacol Exp Ther. 2011;339(2):412–20.PubMedPubMedCentralCrossRef Shin JM, Inatomi N, Munson K, Strugatsky D, Tokhtaeva E, Vagin O, et al. Characterization of a novel potassium-competitive acid blocker of the gastric H, K-ATPase, 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438). J Pharmacol Exp Ther. 2011;339(2):412–20.PubMedPubMedCentralCrossRef
3.
go back to reference Sugano K. Vonoprazan fumarate, a novel potassium-competitive acid blocker, in the management of gastroesophageal reflux disease: safety and clinical evidence to date. Therap Adv Gastroenterol. 2018;11:1756283X17745776.PubMedPubMedCentralCrossRef Sugano K. Vonoprazan fumarate, a novel potassium-competitive acid blocker, in the management of gastroesophageal reflux disease: safety and clinical evidence to date. Therap Adv Gastroenterol. 2018;11:1756283X17745776.PubMedPubMedCentralCrossRef
4.
go back to reference Iwakiri K, Sakurai Y, Shiino M, Okamoto H, Kudou K, Nishimura A, et al. A randomized, double-blind study to evaluate the acid-inhibitory effect of vonoprazan (20 mg and 40 mg) in patients with proton-pump inhibitor-resistant erosive esophagitis. Therap Adv Gastroenterol. 2017;10(6):439–51.PubMedPubMedCentralCrossRef Iwakiri K, Sakurai Y, Shiino M, Okamoto H, Kudou K, Nishimura A, et al. A randomized, double-blind study to evaluate the acid-inhibitory effect of vonoprazan (20 mg and 40 mg) in patients with proton-pump inhibitor-resistant erosive esophagitis. Therap Adv Gastroenterol. 2017;10(6):439–51.PubMedPubMedCentralCrossRef
5.
go back to reference Mizuno H, Yamada K, Minouchi K, Kamiyamamoto S, Hinoue Y. Efficacy of vonoprazan for 24-week maintenance therapy of patients with healed reflux esophagitis refractory to proton pump inhibitors. Biomed Rep. 2018;8(2):148–55.PubMed Mizuno H, Yamada K, Minouchi K, Kamiyamamoto S, Hinoue Y. Efficacy of vonoprazan for 24-week maintenance therapy of patients with healed reflux esophagitis refractory to proton pump inhibitors. Biomed Rep. 2018;8(2):148–55.PubMed
6.
go back to reference Tanabe T, Hoshino S, Kawami N, Hoshikawa Y, Hanada Y, Takenouchi N, et al. Efficacy of long-term maintenance therapy with 10-mg vonoprazan for proton pump inhibitor-resistant reflux esophagitis. Esophagus. 2019;16(4):377–81.PubMedCrossRef Tanabe T, Hoshino S, Kawami N, Hoshikawa Y, Hanada Y, Takenouchi N, et al. Efficacy of long-term maintenance therapy with 10-mg vonoprazan for proton pump inhibitor-resistant reflux esophagitis. Esophagus. 2019;16(4):377–81.PubMedCrossRef
7.
go back to reference Ashida K, Sakurai Y, Nishimura A, Kudou K, Hiramatsu N, Umegaki E, et al. Randomised clinical trial: a dose-ranging study of vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis. Aliment Pharmacol Ther. 2015;42(6):685–95.PubMedPubMedCentralCrossRef Ashida K, Sakurai Y, Nishimura A, Kudou K, Hiramatsu N, Umegaki E, et al. Randomised clinical trial: a dose-ranging study of vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis. Aliment Pharmacol Ther. 2015;42(6):685–95.PubMedPubMedCentralCrossRef
8.
go back to reference Ashida K, Sakurai Y, Hori T, Kudou K, Nishimura A, Hiramatsu N, et al. Randomised clinical trial: vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the healing of erosive oesophagitis. Aliment Pharmacol Ther. 2016;43(2):240–51.PubMedCrossRef Ashida K, Sakurai Y, Hori T, Kudou K, Nishimura A, Hiramatsu N, et al. Randomised clinical trial: vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the healing of erosive oesophagitis. Aliment Pharmacol Ther. 2016;43(2):240–51.PubMedCrossRef
9.
go back to reference Ashida K, Iwakiri K, Hiramatsu N, Sakurai Y, Hori T, Kudou K, et al. Maintenance for healed erosive esophagitis: phase III comparison of vonoprazan with lansoprazole. World J Gastroenterol. 2018;24(14):1550–61.PubMedPubMedCentralCrossRef Ashida K, Iwakiri K, Hiramatsu N, Sakurai Y, Hori T, Kudou K, et al. Maintenance for healed erosive esophagitis: phase III comparison of vonoprazan with lansoprazole. World J Gastroenterol. 2018;24(14):1550–61.PubMedPubMedCentralCrossRef
10.
go back to reference Xiao Y, Zhang S, Dai N, Fei G, Goh KL, Chun HJ, et al. Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis. Gut. 2020;69(2):224–30.PubMedCrossRef Xiao Y, Zhang S, Dai N, Fei G, Goh KL, Chun HJ, et al. Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis. Gut. 2020;69(2):224–30.PubMedCrossRef
11.
go back to reference Iwakiri K, Kinoshita Y, Habu Y, Oshima T, Manabe N, Fujiwara Y, et al. Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2015. J Gastroenterol. 2016;51(8):751–67.PubMedCrossRef Iwakiri K, Kinoshita Y, Habu Y, Oshima T, Manabe N, Fujiwara Y, et al. Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2015. J Gastroenterol. 2016;51(8):751–67.PubMedCrossRef
12.
go back to reference Matsukawa J, Hori Y, Nishida H, Kajino M, Inatomi N. A comparative study on the modes of action of TAK-438, a novel potassium-competitive acid blocker, and lansoprazole in primary cultured rabbit gastric glands. Biochem Pharmacol. 2011;81(9):1145–51.PubMedCrossRef Matsukawa J, Hori Y, Nishida H, Kajino M, Inatomi N. A comparative study on the modes of action of TAK-438, a novel potassium-competitive acid blocker, and lansoprazole in primary cultured rabbit gastric glands. Biochem Pharmacol. 2011;81(9):1145–51.PubMedCrossRef
16.
go back to reference Mastracci L, Rindi G, Grillo F, Solcia E, Campora M, Fassan M, et al. Neuroendocrine neoplasms of the esophagus and stomach. Pathologica. 2021;113(1):5–11.PubMedPubMedCentralCrossRef Mastracci L, Rindi G, Grillo F, Solcia E, Campora M, Fassan M, et al. Neuroendocrine neoplasms of the esophagus and stomach. Pathologica. 2021;113(1):5–11.PubMedPubMedCentralCrossRef
17.
go back to reference Sumiyoshi H, Yasui W, Ochiai A, Tahara E. Effects of gastrin on tumor growth and cyclic nucleotide metabolism in xenotransplantable human gastric and colonic carcinomas in nude mice. Cancer Res. 1984;44(10):4276–80.PubMed Sumiyoshi H, Yasui W, Ochiai A, Tahara E. Effects of gastrin on tumor growth and cyclic nucleotide metabolism in xenotransplantable human gastric and colonic carcinomas in nude mice. Cancer Res. 1984;44(10):4276–80.PubMed
18.
go back to reference Takhar AS, Eremin O, Watson SA. The role of gastrin in colorectal carcinogenesis. Surgeon. 2004;2(5):251–7.PubMedCrossRef Takhar AS, Eremin O, Watson SA. The role of gastrin in colorectal carcinogenesis. Surgeon. 2004;2(5):251–7.PubMedCrossRef
19.
go back to reference Walsh JH. Role of gastrin as a trophic hormone. Digestion. 1990;47(Suppl 1):11–6; discussion 49-52.PubMedCrossRef Walsh JH. Role of gastrin as a trophic hormone. Digestion. 1990;47(Suppl 1):11–6; discussion 49-52.PubMedCrossRef
20.
go back to reference Koh TJ, Chen D. Gastrin as a growth factor in the gastrointestinal tract. Regul Pept. 2000;93(1–3):37–44.PubMedCrossRef Koh TJ, Chen D. Gastrin as a growth factor in the gastrointestinal tract. Regul Pept. 2000;93(1–3):37–44.PubMedCrossRef
21.
go back to reference Baldwin GS. The role of gastrin and cholecystokinin in normal and neoplastic gastrointestinal growth. J Gastroenterol Hepatol. 1995;10(2):215–32.PubMedCrossRef Baldwin GS. The role of gastrin and cholecystokinin in normal and neoplastic gastrointestinal growth. J Gastroenterol Hepatol. 1995;10(2):215–32.PubMedCrossRef
22.
go back to reference Chen WC, Warner RRP, Harpaz N, Zhu H, Roayaie S, Kim MK. Gastric neuroendocrine tumor and duodenal gastrinoma with chronic autoimmune atrophic gastritis. Pancreas. 2019;48(1):131–4.PubMedCrossRef Chen WC, Warner RRP, Harpaz N, Zhu H, Roayaie S, Kim MK. Gastric neuroendocrine tumor and duodenal gastrinoma with chronic autoimmune atrophic gastritis. Pancreas. 2019;48(1):131–4.PubMedCrossRef
23.
go back to reference Ito M, Tanaka S, Maeda M, Takamura A, Tatsugami M, Wada Y, et al. Role of the gastrin-gastrin receptor system in the expansive growth of human gastric neoplasms. Digestion. 2008;78(2–3):163–70.PubMedCrossRef Ito M, Tanaka S, Maeda M, Takamura A, Tatsugami M, Wada Y, et al. Role of the gastrin-gastrin receptor system in the expansive growth of human gastric neoplasms. Digestion. 2008;78(2–3):163–70.PubMedCrossRef
24.
go back to reference Kinoshita Y, Ishihara S. Mechanism of gastric mucosal proliferation induced by gastrin. J Gastroenterol Hepatol. 2000;15(Suppl):D7-11.PubMedCrossRef Kinoshita Y, Ishihara S. Mechanism of gastric mucosal proliferation induced by gastrin. J Gastroenterol Hepatol. 2000;15(Suppl):D7-11.PubMedCrossRef
25.
go back to reference García Rodríguez LA, Lagergren J, Lindblad M. Gastric acid suppression and risk of oesophageal and gastric adenocarcinoma: a nested case control study in the UK. Gut. 2006;55(11):1538–44.PubMedCrossRef García Rodríguez LA, Lagergren J, Lindblad M. Gastric acid suppression and risk of oesophageal and gastric adenocarcinoma: a nested case control study in the UK. Gut. 2006;55(11):1538–44.PubMedCrossRef
26.
go back to reference Tamim H, Duranceau A, Chen LQ, Lelorier J. Association between use of acid-suppressive drugs and risk of gastric cancer. A nested case-control study. Drug Saf. 2008;31(8):675–84.PubMedCrossRef Tamim H, Duranceau A, Chen LQ, Lelorier J. Association between use of acid-suppressive drugs and risk of gastric cancer. A nested case-control study. Drug Saf. 2008;31(8):675–84.PubMedCrossRef
27.
go back to reference Poulsen AH, Christensen S, McLaughlin JK, Thomsen RW, Sørensen HT, Olsen JH, et al. Proton pump inhibitors and risk of gastric cancer: a population-based cohort study. Br J Cancer. 2009;100(9):1503–7.PubMedPubMedCentralCrossRef Poulsen AH, Christensen S, McLaughlin JK, Thomsen RW, Sørensen HT, Olsen JH, et al. Proton pump inhibitors and risk of gastric cancer: a population-based cohort study. Br J Cancer. 2009;100(9):1503–7.PubMedPubMedCentralCrossRef
28.
go back to reference Brusselaers N, Wahlin K, Engstrand L, Lagergren J. Maintenance therapy with proton pump inhibitors and risk of gastric cancer: a nationwide population-based cohort study in Sweden. BMJ Open. 2017;7(10):e017739.PubMedPubMedCentralCrossRef Brusselaers N, Wahlin K, Engstrand L, Lagergren J. Maintenance therapy with proton pump inhibitors and risk of gastric cancer: a nationwide population-based cohort study in Sweden. BMJ Open. 2017;7(10):e017739.PubMedPubMedCentralCrossRef
29.
go back to reference Cheung KS, Chan EW, Wong AYS, Chen L, Wong ICK, Leung WK. Long-term proton pump inhibitors and risk of gastric cancer development after treatment for Helicobacter pylori: a population-based study. Gut. 2018;67(1):28–35.PubMedCrossRef Cheung KS, Chan EW, Wong AYS, Chen L, Wong ICK, Leung WK. Long-term proton pump inhibitors and risk of gastric cancer development after treatment for Helicobacter pylori: a population-based study. Gut. 2018;67(1):28–35.PubMedCrossRef
30.
go back to reference Niikura R, Hayakawa Y, Hirata Y, Yamada A, Fujishiro M, Koike K. Long-term proton pump inhibitor use is a risk factor of gastric cancer after treatment for Helicobacter pylori: a retrospective cohort analysis. Gut. 2018;67(10):1908–10.PubMedCrossRef Niikura R, Hayakawa Y, Hirata Y, Yamada A, Fujishiro M, Koike K. Long-term proton pump inhibitor use is a risk factor of gastric cancer after treatment for Helicobacter pylori: a retrospective cohort analysis. Gut. 2018;67(10):1908–10.PubMedCrossRef
31.
go back to reference Lai SW, Lai HC, Lin CL, Liao KF. Proton pump inhibitors and risk of gastric cancer in a case-control study. Gut. 2019;68(4):765–7.PubMedCrossRef Lai SW, Lai HC, Lin CL, Liao KF. Proton pump inhibitors and risk of gastric cancer in a case-control study. Gut. 2019;68(4):765–7.PubMedCrossRef
32.
go back to reference Peng YC, Huang LR, Lin CL, Hsu WY, Chang CS, Yeh HZ, et al. Association between proton pump inhibitors use and risk of gastric cancer in patients with GERD. Gut. 2019;68(2):374–6.PubMedCrossRef Peng YC, Huang LR, Lin CL, Hsu WY, Chang CS, Yeh HZ, et al. Association between proton pump inhibitors use and risk of gastric cancer in patients with GERD. Gut. 2019;68(2):374–6.PubMedCrossRef
33.
go back to reference Cheung KS, Leung WK. Long-term use of proton-pump inhibitors and risk of gastric cancer: a review of the current evidence. Therap Adv Gastroenterol. 2019;12:1756284819834511.PubMedPubMedCentralCrossRef Cheung KS, Leung WK. Long-term use of proton-pump inhibitors and risk of gastric cancer: a review of the current evidence. Therap Adv Gastroenterol. 2019;12:1756284819834511.PubMedPubMedCentralCrossRef
34.
go back to reference Haruma K, Yoshihara M, Sumii K, Tari A, Watanabe C, Kodoi A, et al. Gastric acid secretion, serum pepsinogen I, and serum gastrin in Japanese with gastric hyperplastic polyps or polypoid-type early gastric carcinoma. Scand J Gastroenterol. 1993;28(7):633–7.PubMedCrossRef Haruma K, Yoshihara M, Sumii K, Tari A, Watanabe C, Kodoi A, et al. Gastric acid secretion, serum pepsinogen I, and serum gastrin in Japanese with gastric hyperplastic polyps or polypoid-type early gastric carcinoma. Scand J Gastroenterol. 1993;28(7):633–7.PubMedCrossRef
35.
go back to reference Martin FC, Chenevix-Trench G, Yeomans ND. Systematic review with meta-analysis: fundic gland polyps and proton pump inhibitors. Aliment Pharmacol Ther. 2016;44(9):915–25.PubMedCrossRef Martin FC, Chenevix-Trench G, Yeomans ND. Systematic review with meta-analysis: fundic gland polyps and proton pump inhibitors. Aliment Pharmacol Ther. 2016;44(9):915–25.PubMedCrossRef
36.
go back to reference Hongo M, Fujimoto K. Incidence and risk factor of fundic gland polyp and hyperplastic polyp in long-term proton pump inhibitor therapy: a prospective study in Japan. J Gastroenterol. 2010;45(6):618–24.PubMedCrossRef Hongo M, Fujimoto K. Incidence and risk factor of fundic gland polyp and hyperplastic polyp in long-term proton pump inhibitor therapy: a prospective study in Japan. J Gastroenterol. 2010;45(6):618–24.PubMedCrossRef
37.
go back to reference Takahari K, Haruma K, Ohtani H, Kiyoto S, Watanabe A, Kamada T, et al. Proton pump inhibitor induction of gastric cobblestone-like lesions in the stomach. Intern Med. 2017;56(20):2699–703.PubMedPubMedCentralCrossRef Takahari K, Haruma K, Ohtani H, Kiyoto S, Watanabe A, Kamada T, et al. Proton pump inhibitor induction of gastric cobblestone-like lesions in the stomach. Intern Med. 2017;56(20):2699–703.PubMedPubMedCentralCrossRef
38.
go back to reference Hasegawa R, Yao K, Ihara S, Miyaoka M, Kanemitsu T, Chuman K, et al. Magnified endoscopic findings of multiple white flat lesions: a new subtype of gastric hyperplastic polyps in the stomach. Clin Endosc. 2018;51(6):558–62.PubMedPubMedCentralCrossRef Hasegawa R, Yao K, Ihara S, Miyaoka M, Kanemitsu T, Chuman K, et al. Magnified endoscopic findings of multiple white flat lesions: a new subtype of gastric hyperplastic polyps in the stomach. Clin Endosc. 2018;51(6):558–62.PubMedPubMedCentralCrossRef
39.
go back to reference Hatano Y, Haruma K, Ayaki M, Kamada T, Ohtani H, Murao T, et al. Black spot, a novel gastric finding potentially induced by proton pump inhibitors. Intern Med. 2016;55(21):3079–84.PubMedPubMedCentralCrossRef Hatano Y, Haruma K, Ayaki M, Kamada T, Ohtani H, Murao T, et al. Black spot, a novel gastric finding potentially induced by proton pump inhibitors. Intern Med. 2016;55(21):3079–84.PubMedPubMedCentralCrossRef
40.
go back to reference Uemura N, Kinoshita Y, Haruma K, Yao T, Kushima R, Kanoo T. Rationale and design of the VISION study: a randomized, open-label study to evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive esophagitis. Clin Exp Gastroenterol. 2018;11:51–6.PubMedPubMedCentralCrossRef Uemura N, Kinoshita Y, Haruma K, Yao T, Kushima R, Kanoo T. Rationale and design of the VISION study: a randomized, open-label study to evaluate the long-term safety of vonoprazan as maintenance treatment in patients with erosive esophagitis. Clin Exp Gastroenterol. 2018;11:51–6.PubMedPubMedCentralCrossRef
41.
go back to reference Iwai K, Yao T, Nakamura S, Matsumoto T, Nishiyama K, Iida M, et al. Multiple gastric carcinoids and endocrine cell micronests in type A gastritis: nuclear morphometric and immunohistochemical analysis. Oncol Rep. 2005;13(3):397–404.PubMed Iwai K, Yao T, Nakamura S, Matsumoto T, Nishiyama K, Iida M, et al. Multiple gastric carcinoids and endocrine cell micronests in type A gastritis: nuclear morphometric and immunohistochemical analysis. Oncol Rep. 2005;13(3):397–404.PubMed
42.
go back to reference Mizokami Y, Oda K, Funao N, Nishimura A, Soen S, Kawai T, et al. Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study. Gut. 2018;67(6):1042–51.PubMedCrossRef Mizokami Y, Oda K, Funao N, Nishimura A, Soen S, Kawai T, et al. Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study. Gut. 2018;67(6):1042–51.PubMedCrossRef
43.
go back to reference Kawai T, Oda K, Funao N, Nishimura A, Matsumoto Y, Mizokami Y, et al. Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study. Gut. 2018;67(6):1033–41.PubMedCrossRef Kawai T, Oda K, Funao N, Nishimura A, Matsumoto Y, Mizokami Y, et al. Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study. Gut. 2018;67(6):1033–41.PubMedCrossRef
44.
go back to reference Vanoli A, La Rosa S, Luinetti O, Klersy C, Manca R, Alvisi C, et al. Histologic changes in type A chronic atrophic gastritis indicating increased risk of neuroendocrine tumor development: the predictive role of dysplastic and severely hyperplastic enterochromaffin-like cell lesions. Hum Pathol. 2013;44(9):1827–37.PubMedCrossRef Vanoli A, La Rosa S, Luinetti O, Klersy C, Manca R, Alvisi C, et al. Histologic changes in type A chronic atrophic gastritis indicating increased risk of neuroendocrine tumor development: the predictive role of dysplastic and severely hyperplastic enterochromaffin-like cell lesions. Hum Pathol. 2013;44(9):1827–37.PubMedCrossRef
45.
go back to reference Haruma K, Kato M, Inoue K, Murakami K, Kamada T. Kyoto classification of gastritis. 1st ed. Tokyo: Nihon Medical Center; 2017. Haruma K, Kato M, Inoue K, Murakami K, Kamada T. Kyoto classification of gastritis. 1st ed. Tokyo: Nihon Medical Center; 2017.
46.
go back to reference Saito M, Koike T, Abe Y, Nakagawa K, Kanno T, Jin X, et al. The development of foveolar-type gastric adenocarcinoma during maintenance therapy of vonoprazan for reflux esophagitis. Intern Med. 2021;60(3):391–6.PubMedCrossRef Saito M, Koike T, Abe Y, Nakagawa K, Kanno T, Jin X, et al. The development of foveolar-type gastric adenocarcinoma during maintenance therapy of vonoprazan for reflux esophagitis. Intern Med. 2021;60(3):391–6.PubMedCrossRef
47.
go back to reference Campana D, Nori F, Piscitelli L, Morselli-Labate AM, Pezzilli R, Corinaldesi R, et al. Chromogranin A: is it a useful marker of neuroendocrine tumors? J Clin Oncol. 2007;25(15):1967–73.PubMedCrossRef Campana D, Nori F, Piscitelli L, Morselli-Labate AM, Pezzilli R, Corinaldesi R, et al. Chromogranin A: is it a useful marker of neuroendocrine tumors? J Clin Oncol. 2007;25(15):1967–73.PubMedCrossRef
48.
go back to reference Nielsen HO, Jensen KB, Christiansen LA. The antral gastrin-producing cells in duodenal ulcer patients. A density study before and during treatment with cimetidine. Acta Pathol Microbiol Scand A. 1980;88(6):383–6.PubMed Nielsen HO, Jensen KB, Christiansen LA. The antral gastrin-producing cells in duodenal ulcer patients. A density study before and during treatment with cimetidine. Acta Pathol Microbiol Scand A. 1980;88(6):383–6.PubMed
49.
go back to reference Pashankar DS, Israel DM, Jevon GP, Buchan AM. Effect of long-term omeprazole treatment on antral G and D cells in children. J Pediatr Gastroenterol Nutr. 2001;33(5):537–42.PubMedCrossRef Pashankar DS, Israel DM, Jevon GP, Buchan AM. Effect of long-term omeprazole treatment on antral G and D cells in children. J Pediatr Gastroenterol Nutr. 2001;33(5):537–42.PubMedCrossRef
50.
go back to reference Sano J, Miki K, Ichinose M, Kimura M, Kurokawa K, Aida T, et al. In situ localization of pepsinogens I and II mRNA in human gastric mucosa. Acta Pathol Jpn. 1989;39(12):765–71.PubMed Sano J, Miki K, Ichinose M, Kimura M, Kurokawa K, Aida T, et al. In situ localization of pepsinogens I and II mRNA in human gastric mucosa. Acta Pathol Jpn. 1989;39(12):765–71.PubMed
51.
go back to reference Qian JM, Rowley WH, Jensen RT. Gastrin and CCK activate phospholipase C and stimulate pepsinogen release by interacting with two distinct receptors. Am J Physiol. 1993;264(4 Pt 1):G718–27.PubMed Qian JM, Rowley WH, Jensen RT. Gastrin and CCK activate phospholipase C and stimulate pepsinogen release by interacting with two distinct receptors. Am J Physiol. 1993;264(4 Pt 1):G718–27.PubMed
52.
go back to reference Cherner JA, Sutliff VE, Grybowski DM, Jensen RT, Gardner JD. Functionally distinct receptors for cholecystokinin and gastrin on dispersed chief cells from guinea pig stomach. Am J Physiol. 1988;254(2 Pt 1):G151–5.PubMed Cherner JA, Sutliff VE, Grybowski DM, Jensen RT, Gardner JD. Functionally distinct receptors for cholecystokinin and gastrin on dispersed chief cells from guinea pig stomach. Am J Physiol. 1988;254(2 Pt 1):G151–5.PubMed
53.
go back to reference Nishino K, Kawanaka M, Suehiro M, Yoshioka N, Nakamura J, Urata N, et al. Gastric hyperplastic polyps after argon plasma coagulation for gastric antral vascular ectasia in patients with liver cirrhosis: a case suggesting the “gastrin link theory.” Intern Med. 2021;60(7):1019–25.PubMedCrossRef Nishino K, Kawanaka M, Suehiro M, Yoshioka N, Nakamura J, Urata N, et al. Gastric hyperplastic polyps after argon plasma coagulation for gastric antral vascular ectasia in patients with liver cirrhosis: a case suggesting the “gastrin link theory.” Intern Med. 2021;60(7):1019–25.PubMedCrossRef
54.
go back to reference Kuipers EJ, Lee A, Klinkenberg-Knol EC, Meuwissen SG. Review article: the development of atrophic gastritis—Helicobacter pylori and the effects of acid suppressive therapy. Aliment Pharmacol Ther. 1995;9(4):331–40.PubMedCrossRef Kuipers EJ, Lee A, Klinkenberg-Knol EC, Meuwissen SG. Review article: the development of atrophic gastritis—Helicobacter pylori and the effects of acid suppressive therapy. Aliment Pharmacol Ther. 1995;9(4):331–40.PubMedCrossRef
55.
go back to reference Klinkenberg-Knol EC, Nelis F, Dent J, Snel P, Mitchell B, Prichard P, et al. Long-term omeprazole treatment in resistant gastroesophageal reflux disease: efficacy, safety, and influence on gastric mucosa. Gastroenterology. 2000;118(4):661–9.PubMedCrossRef Klinkenberg-Knol EC, Nelis F, Dent J, Snel P, Mitchell B, Prichard P, et al. Long-term omeprazole treatment in resistant gastroesophageal reflux disease: efficacy, safety, and influence on gastric mucosa. Gastroenterology. 2000;118(4):661–9.PubMedCrossRef
56.
go back to reference Nasser SC, Slim M, Nassif JG, Nasser SM. Influence of proton pump inhibitors on gastritis diagnosis and pathologic gastric changes. World J Gastroenterol. 2015;21(15):4599–606.PubMedPubMedCentralCrossRef Nasser SC, Slim M, Nassif JG, Nasser SM. Influence of proton pump inhibitors on gastritis diagnosis and pathologic gastric changes. World J Gastroenterol. 2015;21(15):4599–606.PubMedPubMedCentralCrossRef
57.
go back to reference Marusic M, Babic Z, Nesanovic M, Lucijanic-Mlinac M, Stajcar V. Influence of various proton pump inhibitors on intestinal metaplasia in noneradicated Helicobacter pylori patients. World J Gastroenterol. 2005;11(15):2334–6.PubMedPubMedCentralCrossRef Marusic M, Babic Z, Nesanovic M, Lucijanic-Mlinac M, Stajcar V. Influence of various proton pump inhibitors on intestinal metaplasia in noneradicated Helicobacter pylori patients. World J Gastroenterol. 2005;11(15):2334–6.PubMedPubMedCentralCrossRef
58.
go back to reference Kuipers EJ, Lundell L, Klinkenberg-Knol EC, Havu N, Festen HP, Liedman B, et al. Atrophic gastritis and Helicobacter pylori infection in patients with reflux esophagitis treated with omeprazole or fundoplication. N Engl J Med. 1996;334(16):1018–22.PubMedCrossRef Kuipers EJ, Lundell L, Klinkenberg-Knol EC, Havu N, Festen HP, Liedman B, et al. Atrophic gastritis and Helicobacter pylori infection in patients with reflux esophagitis treated with omeprazole or fundoplication. N Engl J Med. 1996;334(16):1018–22.PubMedCrossRef
59.
go back to reference Kuipers EJ, Uyterlinde AM, Peña AS, Hazenberg HJ, Bloemena E, Lindeman J, et al. Increase of Helicobacter pylori-associated corpus gastritis during acid suppressive therapy: implications for long-term safety. Am J Gastroenterol. 1995;90(9):1401–6.PubMed Kuipers EJ, Uyterlinde AM, Peña AS, Hazenberg HJ, Bloemena E, Lindeman J, et al. Increase of Helicobacter pylori-associated corpus gastritis during acid suppressive therapy: implications for long-term safety. Am J Gastroenterol. 1995;90(9):1401–6.PubMed
60.
go back to reference Lundell L, Miettinen P, Myrvold HE, Pedersen SA, Thor K, Andersson A, et al. Lack of effect of acid suppression therapy on gastric atrophy. Nordic GERD Study Group. Gastroenterology. 1999;117(2):319–26.PubMedCrossRef Lundell L, Miettinen P, Myrvold HE, Pedersen SA, Thor K, Andersson A, et al. Lack of effect of acid suppression therapy on gastric atrophy. Nordic GERD Study Group. Gastroenterology. 1999;117(2):319–26.PubMedCrossRef
61.
go back to reference Song H, Zhu J, Lu D. Long-term proton pump inhibitor (PPI) use and the development of gastric pre-malignant lesions. Cochrane Database Syst Rev. 2014;12:Cd010623. Song H, Zhu J, Lu D. Long-term proton pump inhibitor (PPI) use and the development of gastric pre-malignant lesions. Cochrane Database Syst Rev. 2014;12:Cd010623.
62.
go back to reference Sumi N, Haruma K, Kamada T, Suehiro M, Manabe N, Akiyama T, et al. Inflammatory cell numbers in the stomach of Japanese subjects with endoscopically normal mucosa without Helicobacter pylori infection. Dig Dis. 2021;39(6):598–605.PubMedCrossRef Sumi N, Haruma K, Kamada T, Suehiro M, Manabe N, Akiyama T, et al. Inflammatory cell numbers in the stomach of Japanese subjects with endoscopically normal mucosa without Helicobacter pylori infection. Dig Dis. 2021;39(6):598–605.PubMedCrossRef
63.
go back to reference Matsuhisa T, Arakawa T, Watanabe T, Tokutomi T, Sakurai K, Okamura S, et al. Relation between bile acid reflux into the stomach and the risk of atrophic gastritis and intestinal metaplasia: a multicenter study of 2283 cases. Dig Endosc. 2013;25(5):519–25.PubMedCrossRef Matsuhisa T, Arakawa T, Watanabe T, Tokutomi T, Sakurai K, Okamura S, et al. Relation between bile acid reflux into the stomach and the risk of atrophic gastritis and intestinal metaplasia: a multicenter study of 2283 cases. Dig Endosc. 2013;25(5):519–25.PubMedCrossRef
64.
go back to reference Nakamura M, Haruma K, Kamada T, Mihara M, Yoshihara M, Sumioka M, et al. Cigarette smoking promotes atrophic gastritis in Helicobacter pylori-positive subjects. Dig Dis Sci. 2002;47(3):675–81.PubMedCrossRef Nakamura M, Haruma K, Kamada T, Mihara M, Yoshihara M, Sumioka M, et al. Cigarette smoking promotes atrophic gastritis in Helicobacter pylori-positive subjects. Dig Dis Sci. 2002;47(3):675–81.PubMedCrossRef
65.
go back to reference Haber MM, Hunt B, Freston JW, Peura DA, Kovacs TO, Atkinson S, et al. Changes of gastric histology in patients with erosive oesophagitis receiving long-term lansoprazole maintenance therapy. Aliment Pharmacol Ther. 2010;32(1):83–96.PubMedCrossRef Haber MM, Hunt B, Freston JW, Peura DA, Kovacs TO, Atkinson S, et al. Changes of gastric histology in patients with erosive oesophagitis receiving long-term lansoprazole maintenance therapy. Aliment Pharmacol Ther. 2010;32(1):83–96.PubMedCrossRef
66.
go back to reference Tanigawa T, Watanabe T, Higuchi K, Machida H, Okazaki H, Yamagami H, et al. Lansoprazole, a proton pump inhibitor, suppresses production of tumor necrosis factor-alpha and interleukin-1beta induced by lipopolysaccharide and Helicobacter pylori bacterial components in human monocytic cells via inhibition of activation of nuclear factor-kappaB and extracellular signal-regulated kinase. J Clin Biochem Nutr. 2009;45(1):86–92.PubMedPubMedCentralCrossRef Tanigawa T, Watanabe T, Higuchi K, Machida H, Okazaki H, Yamagami H, et al. Lansoprazole, a proton pump inhibitor, suppresses production of tumor necrosis factor-alpha and interleukin-1beta induced by lipopolysaccharide and Helicobacter pylori bacterial components in human monocytic cells via inhibition of activation of nuclear factor-kappaB and extracellular signal-regulated kinase. J Clin Biochem Nutr. 2009;45(1):86–92.PubMedPubMedCentralCrossRef
67.
go back to reference Haruma K, Hamada H, Mihara M, Kamada T, Yoshihara M, Sumii K, et al. Negative association between Helicobacter pylori infection and reflux esophagitis in older patients: case-control study in Japan. Helicobacter. 2000;5(1):24–9.PubMedCrossRef Haruma K, Hamada H, Mihara M, Kamada T, Yoshihara M, Sumii K, et al. Negative association between Helicobacter pylori infection and reflux esophagitis in older patients: case-control study in Japan. Helicobacter. 2000;5(1):24–9.PubMedCrossRef
68.
go back to reference Shibagaki K, Fukuyama C, Mikami H, Izumi D, Yamashita N, Mishiro T, et al. Gastric foveolar-type adenomas endoscopically showing a raspberry-like appearance in the Helicobacter pylori-uninfected stomach. Endosc Int Open. 2019;7(6):E784–91.PubMedPubMedCentralCrossRef Shibagaki K, Fukuyama C, Mikami H, Izumi D, Yamashita N, Mishiro T, et al. Gastric foveolar-type adenomas endoscopically showing a raspberry-like appearance in the Helicobacter pylori-uninfected stomach. Endosc Int Open. 2019;7(6):E784–91.PubMedPubMedCentralCrossRef
69.
go back to reference Shibagaki K, Mishiro T, Fukuyama C, Takahashi Y, Itawaki A, Nonomura S, et al. Sporadic foveolar-type gastric adenoma with a raspberry-like appearance in Helicobacter pylori-naïve patients. Virchows Arch. 2021;479(4):687–95.PubMedCrossRef Shibagaki K, Mishiro T, Fukuyama C, Takahashi Y, Itawaki A, Nonomura S, et al. Sporadic foveolar-type gastric adenoma with a raspberry-like appearance in Helicobacter pylori-naïve patients. Virchows Arch. 2021;479(4):687–95.PubMedCrossRef
Metadata
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
Authors
Ken Haruma
Yoshikazu Kinoshita
Takashi Yao
Ryoji Kushima
Junichi Akiyama
Nobuo Aoyama
Tatsuhiro Kanoo
Kouji Miyata
Naomi Kusumoto
Naomi Uemura
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Gastroenterology / Issue 1/2023
Electronic ISSN: 1471-230X
DOI
https://doi.org/10.1186/s12876-023-02772-w

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