Efficacy of vonoprazan for initial and maintenance therapy in reflux esophagitis, nonerosive esophagitis, and proton pump inhibitor-resistant gastroesophageal reflux disease

Gotoh, Yasuhiko; Ishibashi, Emiko; Honda, Shunichiro; Nakaya, Tomohisa; Noguchi, Chishio; Kagawa, Koichi; Murakami, Kazunari

doi:10.1097/md.0000000000019520

Cited by 12 publications

(18 citation statements)

References 39 publications

(44 reference statements)

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“…These included studies which were published between 2015 and 2022. Seventy-four studies were conducted in Asia, 10–15,19–22,24–28,30–53,55–…”

Section: Resultsmentioning

confidence: 99%

“…23,29,54 Thirty-four studies were RCTs, 10–14,19–23,32–35,38,42–44,46,52,54,55,57,60,61,63,72,74,77,80,83,85,86,89 24 cohort studies, 15,24,27,31,36,37,41,47,50,51,53,56,59,62,64–67,71,75,79,81,84,87 and 19 single-arm studies. 25,26,28–30,39,…”

Section: Resultsmentioning

confidence: 99%

“…These included studies which were published between 2015 and 2022. Seventy-four studies were conducted in Asia, [10][11][12][13][14][15][19][20][21][22][24][25][26][27][28] and three in non-Asian countries. 23,29,54 Thirty-four studies were RCTs, [10][11][12][13][14][19][20][21][22][23][32][33][34][35]38,[42][43][44]46,52,54,55,57,60,61,63,72,74,77,80,83,85,86,…”

Section: Study Selection and Characteristicsmentioning

confidence: 99%

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

Bai

Shang

et al. 2023

Therap Adv Gastroenterol

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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.

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“…These included studies which were published between 2015 and 2022. Seventy-four studies were conducted in Asia, 10–15,19–22,24–28,30–53,55–…”

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Study Selection and Characteristicsmentioning

confidence: 99%

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

Bai

Shang

et al. 2023

Therap Adv Gastroenterol

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“…A final list of 12 studies was included in this systematic review, and the reasons for full-text exclusion are detailed in Table S3. Of the included studies, eight were prospective, 5,[11][12][13][14][15][16][17] and four were retrospective (Table S4). 6,[18][19][20] All studies except for three had included only standard-dose PPI-resistant GERD patients; two studies 13,18 included both standard-dose or double-standard dose PPI-resistant GERD, and one study 20 included only double-standard dose PPI-resistant GERD.…”

Section: Resultsmentioning

confidence: 99%

A systematic review and meta‐analysis of the efficacy of vonoprazan for proton pump inhibitor‐resistant gastroesophageal reflux disease

Simadibrata,

Lesmana,

Fass

2024

J of Gastro and Hepatol

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Background and AimUp to 40% of gastroesophageal reflux disease (GERD) patients experience inadequate symptom relief with a proton pump inhibitor (PPI), termed PPI‐resistant or refractory GERD. Vonoprazan, a potassium‐competitive acid blocker, has better efficacy than PPI in suppressing gastric acid secretion. This meta‐analysis summarizes the efficacy and safety of vonoprazan for treating PPI‐resistant GERD (both erosive esophagitis [EE] and non‐erosive reflux disease [NERD]).MethodsFour electronic databases (Medline, Embase, SCOPUS, and CENTRAL) were searched for studies indexed until August 1, 2023. Both observational studies and clinical trials assessing the efficacy and safety of vonoprazan in PPI‐resistant GERD were included. Efficacy outcomes included healing and maintenance rates of EE and improvement of the Frequency Scale for Symptoms of GERD (FSSG) scores. Serious adverse events (SAEs) were considered a safety outcome. The modified Newcastle‐Ottawa Scale (NOS) was used to assess study quality.ResultsTwelve studies were included in this meta‐analysis. Healing rates of PPI‐resistant EE with vonoprazan 20 mg were 91.7% (95% CI 86.8–94.8%) and 88.5% (95% CI 69.7–96.2%) at weeks 4 and 8, respectively. For healed PPI‐resistant EE, the overall maintenance rates with vonoprazan 10 mg were 82.6% (95% 61.2–95.0%) at week 8, 86.0% (95% CI 72.1–94.7%) at week 24, and 93.8% (95% CI 69.8–99.8%) at week 48. FSSG scores were improved in 74.6% (95% CI 65.8–81.7%) and 51.9% (95% CI 37.8–65.7%) of patients at weeks 4 and 8. Overall, no SAE was reported.ConclusionVonoprazan demonstrated high efficacy in the healing and maintenance of PPI‐resistant EE and moderate efficacy for the improvement of FSSG score. Vonoprazan was well tolerated in PPI‐resistant GERD patients.

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“…Moreover, some patients remained symptom‐free for 4 weeks 159 . An open‐label, single‐center observational study showed that both initial and maintenance vonoprazan therapies significantly improved heartburn in patients with PPI‐resistant GERD 160 …”

Section: Introductionmentioning

confidence: 99%

Chinese expert consensus on gastroesophageal reflux disease in 2020

Xiao

Zhou

Hou

et al. 2021

J of Digest Diseases

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Efficacy of vonoprazan for initial and maintenance therapy in reflux esophagitis, nonerosive esophagitis, and proton pump inhibitor-resistant gastroesophageal reflux disease

Cited by 12 publications

References 39 publications

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

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

A systematic review and meta‐analysis of the efficacy of vonoprazan for proton pump inhibitor‐resistant gastroesophageal reflux disease

Chinese expert consensus on gastroesophageal reflux disease in 2020

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