PMID- 37113190 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230430 IS - 1756-283X (Print) IS - 1756-2848 (Electronic) IS - 1756-283X (Linking) VI - 16 DP - 2023 TI - Incidence and type of adverse events in patients taking vonoprazan: A systematic review and meta-analysis. PG - 17562848231167858 LID - 10.1177/17562848231167858 [doi] LID - 17562848231167858 AB - BACKGROUND: Vonoprazan, a novel acid-suppressive drug, is non-inferior to proton pump inhibitors (PPIs) for the management of gastric acid-related diseases. However, the safety of vonoprazan has not been systematically evaluated yet. OBJECTIVES: To elucidate the incidence and type of adverse events (AEs) in patients taking vonoprazan. DESIGN: Systematic review and meta-analysis. DATA SOURCES AND METHODS: PubMed, EMBASE, and Cochrane Library databases were searched for all studies reporting the safety of vonoprazan. The incidences of any AEs, drug-related AEs, serious AEs, AEs leading to drug discontinuation, and common AEs were pooled. Odds ratios (ORs) were calculated to compare the incidence of AEs between patients taking vonoprazan and PPIs. RESULTS: Seventy-seven studies were included. The pooled incidences of any AEs, drug-related AEs, serious AEs, and AEs leading to drug discontinuation were 20, 7, 1, and 1%, respectively. The incidences of any AEs (OR = 0.96, p = 0.66), drug-related AEs (OR = 1.10, p = 0.44), serious AEs (OR = 1.14, p = 0.36), and AEs leading to drug discontinuation (OR = 1.09, p = 0.55) were not significantly different between patients taking vonoprazan and PPIs. In subgroup analyses, patients with peptic ulcer disease (PUD) had higher incidences of any AEs, serious AEs, and AEs leading to drug discontinuation than those with gastroesophageal reflux disease (GERD), Helicobacter pylori (H. pylori) infection, and artificial ulcer after gastric endoscopic submucosal dissection (ESD), but patients with H. pylori infection had a higher incidence of drug-related AEs than those with PUD, GERD, and artificial ulcer after gastric ESD. The incidence of AEs was higher in patients taking long-term use of vonoprazan than those taking short-term use of vonoprazan. CONCLUSION: Vonoprazan is well tolerated and shows similar safety compared to PPIs. The safety of vonoprazan may be primarily influenced by its indications and duration. REGISTRATION: PROSPERO CRD42022314982. CI - (c) The Author(s), 2023. FAU - Xu, Wentao AU - Xu W AUID- ORCID: 0000-0002-0156-791X AD - Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China. AD - Department of Life Sciences and Biopharmaceutics, Shenyang Pharmaceutical University, Shenyang, China. FAU - Bai, Zhaohui AU - Bai Z AUID- ORCID: 0000-0001-6206-7153 AD - Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China. AD - Department of Life Sciences and Biopharmaceutics, Shenyang Pharmaceutical University, Shenyang, China. FAU - Shang, Yiyang AU - Shang Y AUID- ORCID: 0000-0003-3128-7991 AD - Department of Gastroenterology, General Hospital of Northern Theater Command, Shenyang, China. AD - Department of Life Sciences and Biopharmaceutics, Shenyang Pharmaceutical University, Shenyang, China. FAU - Wang, Jing AU - Wang J AD - Department of Gastroenterology, The 960th Hospital of the PLA, Jinan, China. FAU - Wong, Yujun AU - Wong Y AD - Department of Gastroenterology and Hepatology, Changi General Hospital, Singapore, Singapore. FAU - Qi, Xingshun AU - Qi X AUID- ORCID: 0000-0002-9448-6739 AD - Department of Gastroenterology, General Hospital of Northern Theater Command, No. 83 Wenhua Road, Shenyang, Liaoning 110840, China. LA - eng PT - Journal Article DEP - 20230420 PL - England TA - Therap Adv Gastroenterol JT - Therapeutic advances in gastroenterology JID - 101478893 PMC - PMC10126681 OTO - NOTNLM OT - adverse event OT - gastric acid OT - proton pump inhibitor OT - safety OT - vonoprazan COIS- The authors declare that there is no conflict of interest. EDAT- 2023/04/28 06:42 MHDA- 2023/04/28 06:43 PMCR- 2023/04/20 CRDT- 2023/04/28 02:24 PHST- 2022/11/15 00:00 [received] PHST- 2023/03/20 00:00 [accepted] PHST- 2023/04/28 06:43 [medline] PHST- 2023/04/28 06:42 [pubmed] PHST- 2023/04/28 02:24 [entrez] PHST- 2023/04/20 00:00 [pmc-release] AID - 10.1177_17562848231167858 [pii] AID - 10.1177/17562848231167858 [doi] PST - epublish SO - Therap Adv Gastroenterol. 2023 Apr 20;16:17562848231167858. doi: 10.1177/17562848231167858. eCollection 2023.