{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T23:04:49Z","timestamp":1793228689663,"version":"4.5.0"},"reference-count":56,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2024,12,25]],"date-time":"2024-12-25T00:00:00Z","timestamp":1735084800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,12,25]],"date-time":"2024-12-25T00:00:00Z","timestamp":1735084800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Patients with erosive oesophagitis, and those with persistent symptomatic non\u2010erosive gastro\u2010oesophageal reflux disease, require long\u2010term maintenance treatment with acid\u2010suppressing agents.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the safety of vonoprazan, a potassium\u2010competitive acid blocker, in an integrated analysis of data from clinical trials in adults.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We included 14 clinical trials of vonoprazan conducted in multiple countries. Mean duration of exposure in person\u2010years to vonoprazan (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20095318) was 2068, to comparators lansoprazole (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20091925) or esomeprazole (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200986) was 751, and to placebo (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009779) was 59. We report adverse events, serum gastrin, and liver enzyme levels as the main outcomes. Post\u2010marketing safety data from December 26, 2014 (date of commercialisation in Japan) to December 25, 2023, are also provided.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Nasopharyngitis was the only adverse event reported by at least 5.0% of patients (6.94% vonoprazan, 5.07% proton pump inhibitor (PPI), 4.49% placebo). Incidence rates per 100 person\u2010years for serious adverse events were 10.39 for vonoprazan, 10.65 for PPIs, and 1.69 for placebo. One patient each on vonoprazan and lansoprazole was diagnosed with gastric cancer. Mean serum gastrin levels were higher on vonoprazan than lansoprazole but normalised by 4\u2009weeks after discontinuation. Elevated liver enzyme levels were infrequent and of low magnitude with no differences between vonoprazan and PPIs. There were four deaths; none was considered related to study drug.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Vonoprazan was well tolerated. Its safety profile from both clinical trial and post\u2010marketing data were consistent and comparable to that of its PPI comparators with respect to treatment\u2010emergent adverse events.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.18458","type":"journal-article","created":{"date-parts":[[2024,12,25]],"date-time":"2024-12-25T06:59:28Z","timestamp":1735109968000},"page":"835-851","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":17,"title":["Integrated Analysis of Vonoprazan Safety for Symptomatic Gastro\u2010Oesophageal Reflux Disease or Erosive Oesophagitis"],"prefix":"10.1111","volume":"61","author":[{"given":"Colin W.","family":"Howden","sequence":"first","affiliation":[{"name":"University of Tennessee College of Medicine  Memphis Tennessee USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8021-0651","authenticated-orcid":false,"given":"Philip","family":"Katz","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology &amp; Hepatology Weill Cornell Medicine  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenneth R.","family":"DeVault","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology Mayo Clinic  Jacksonville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David C.","family":"Metz","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology University of Pennsylvania Perelman School of Medicine  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Tamene","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceuticals International Co.  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