Incidence and type of adverse events in patients taking vonoprazan: A systematic review and meta-analysis

Abstract

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.

Comparative efficiency and safety of potassium competitive acid blockers versus Lansoprazole in peptic ulcer: a systematic review and meta-analysis

“…Serious adverse events unrelated to the study drugs including acute pancreatitis, subcutaneous abscess, and muscular weakness, among others. This result was consistent with the previously meta-analysis about adverse events of vonoprazan ( Xu et al, 2023 ). Further investigation is needed to determine whether these events are indeed related to the use of P-CABs.…”

Comparative Efficacy and Safety of Potassium-Competitive Acid Blockers vs. Proton Pump Inhibitors for Peptic Ulcer with or without Helicobacter pylori Infection: A Systematic Review and Network Meta-Analysis

“…Additionally, a meta-analysis on acid-related diseases also found that the incidence of adverse events in patients with duodenal ulcers treated with vonoprazan was significantly higher than that with PPIs [ 90 ]. Another study evaluated the safety of vonoprazan in various indications, and the results showed that patients with peptic ulcers had a higher rate of adverse events than other acid-related diseases such as gastroesophageal reflux and H. pylori infection [ 91 ]. This may be due to the fact that peptic ulcers are more complex and require longer treatment than other diseases.…”

“…This may be due to the fact that peptic ulcers are more complex and require longer treatment than other diseases. The most common adverse events associated with vonoprazan include increased serum gastrin levels, followed by increased pepsinogen I levels, nasopharyngitis, bloating, loose stools, and so on [ 91 , 92 ]. In addition, studies have reported that vonoprazan can affect human gut microbiota [ 93 ].…”