Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers – results from two phase 3, non‐inferiority randomised controlled trials

Miwa, Hiroto; Uedo, Noriya; Watari, Jiro; Mori, Yujiro; Sakurai, Yuuichi; Takanami, Yohei; Nishimura, Akira; Tatsumi, Tomohide; Sakaki, Nobuhiro

doi:10.1111/apt.13876

Cited by 91 publications

(91 citation statements)

References 17 publications

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“…The pharmaceutical advantages of P-CAB over PPIs include more rapid, stronger and longer-lasting inhibition of gastric acid secretion after administration [7,15,16]. For the treatment of peptic ulcers, Miwa et al reported that a 20 mg dose of vonoprazan had a similar tolerability profile as a 30 mg dose of lansoprazole, and was not inferior to lansoprazole with respect to gastric ulcer healing [17]. The relative effectiveness of vonoprazan compared to PPIs for the management of artificial ulcers after ESD remains controversial.…”

Section: Discussionmentioning

confidence: 99%

Risk Factors for Delayed Ulcer Healing after Endoscopic Submucosal Dissection of Gastric Neoplasms

Shimozato

Sasaki

Ogasawara

et al. 2017

JGLD

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Background & Aims: With improved technology, the size of artificial ulcers after endoscopic submucosal dissection (ESD) has increased. The aim of our study was to examine the risk factors for delayed gastric ulcer healing after ESD, including the possible benefit of potassium-competitive acid blocker (P-CAB) treatment.Methods: The primary outcome was the rate of healing of the artificial ulcers induced by ESD at 8 weeks post intervention. Design: retrospective case series. Setting: Aichi Medical University Hospital. Patients: patients who underwent ESD for gastric neoplasm, between April 2015 and March 2017. Intervention: ESD, with a follow-up endoscopic examination at 8 weeks post-ESD. Univariate and multivariate analyses were used to identify the independent risk factors for delayed healing.Results: Of the 73 gastric neoplasms included in the analysis, delayed ulcer healing was identified in 21.9%. Dyslipidemia (p=0.04), ESD procedure time (p=0.003) and artificial ulcer size (p<0.001) were identified as risk factors for delayed healing, with location in the lower third of the stomach [Odds ratio (OR) 6.76; p=0.016] and artificial ulcer size (OR, 1.18; p=0.024) retained as independent risk factors. A cut-off ulcer size of 854 mm2 was predictive of delayed healing, with a sensitivity of 29.8% and specificity of 87.5%. For large ulcers, the rate of healing of 70% with vonoprazan was higher than the rate of 47.6% with proton pump inhibitors (PPIs), although this difference was not significant.Conclusion: For artificial ulcers after ESD with a resection diameter >35 mm, it might be desirable to use PPIs for >8 weeks or P-CAB.Abbreviations: EGC: early gastric cancers; EMR: endoscopic mucosal resection; ESD: endoscopic submucosal dissection; H. pylori: Helicobacter pylori; H2RA: H2-receptor antagonist: PRP: platelet rich plasma; PGA: polyglycolic acid; P-CAB: potassium-competitive acid blocker; PPI: proton pump inhibitor.

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Section: Discussionmentioning

confidence: 99%

Risk Factors for Delayed Ulcer Healing after Endoscopic Submucosal Dissection of Gastric Neoplasms

Shimozato

Sasaki

Ogasawara

et al. 2017

JGLD

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“…But within the studies involved, treatment duration was different; two studies just observed the results at 2 weeks after ESD, and others were at 4 weeks at least. Treatment duration is known to be an extremely important factor for ulcer healing; longer treatment duration leads to more complete healing . Subgroup analysis in our study, after excluding the two studies with short treatment duration, showed that pooled MD of the remaining studies (with treatment durations of at least 4 weeks) was 0.26 ( P = 0.008).…”

Section: Discussionmentioning

confidence: 59%

“…A systematic review and meta‐analysis has shown that triple therapy with vonoprazan as the acid inhibitor had superior efficacy in terms of H. pylori eradication compared with the triple therapy including PPIs . Studies have also shown a better potential capacity of vonoprazan to heal benign ulcers such as peptic ulcers and nonsteroidal anti‐inflammatory drugs (NSAIDs)‐induced ulcers . Kagawa et al reported a better efficacy of vonoprazan in reducing the risk of post‐ESD bleeding compared with PPIs (1.3% vs 10%), at the same time vonoprazan had a higher ulcer shrinkage rate.…”

Section: Discussionmentioning

confidence: 99%

“…13 Studies have also shown a better potential capacity of vonoprazan to heal benign ulcers such as peptic ulcers and nonsteroidal anti-inflammatory drugs (NSAIDs)-induced ulcers. 43,44 Kagawa et al 15 reported a better efficacy of vonoprazan in reducing the risk of post-ESD bleeding compared with PPIs (1.3% vs 10%), at the same time vonoprazan had a higher ulcer shrinkage rate. However, other studies reported that vonoprazan had no advantage or was even inferior to PPIs in the management of post-ESD ulcers.…”

Section: Discussionmentioning

confidence: 99%

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The efficacy of vonoprazan for management of post‐endoscopic submucosal dissection ulcers compared with proton pump inhibitors: A meta‐analysis

Liu

Feng

Zhang

et al. 2019

J of Digest Diseases

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Objective Artificial ulcers after endoscopic submucosal dissection (ESD) are usually treated by proton pump inhibitors (PPIs) in clinical setting. Vonoprazan, a newly developed potassium‐competitive acid blocker, has recently been used to treat post‐ESD ulcers. We aimed to evaluate the efficacy and safety of vonoprazan on the healing of post‐ESD artificial ulcers compared with those of proton pump inhibitors (PPIs) using a meta‐analysis. Methods EMBASE, MEDLINE, Scopus and Cochrane Library databases were searched for all studies comparing the efficacy and safety of vonoprazan with those of PPIs in the treatment of post‐ESD ulcers. Results Fourteen articles with 1328 patients were included in this meta‐analysis. When comparing ulcer shrinkage rate, vonoprazan showed a better efficacy than PPIs (mean difference 0.56, 95% confidence interval [CI] 0.18‐0.93). Vonoprazan also led to a higher scar formation rate (odds ratio [OR] 1.58, 95% CI 1.00‐2.47) and showed a potential superiority on reducing the risk of post‐ESD bleeding compared with PPIs, with a pooled OR of 0.69, although there was no statistically significant difference. Conclusions Compared with PPIs, vonoprazan showed a better efficacy in ulcer shrinkage rate and achieved more complete healing in the treatment of post‐ESD ulcers. Vonoprazan did not induce any incremental risk of post‐ESD bleeding as well. It may be an appropriate choice in the management of artificial ulcers after ESD.

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“…In addition, the intragastric pH following VPZ treatment (pH 5.2) has been identified to be significantly higher than that following esomeprazole treatment (pH 3.0) on day 1 of therapy (18). The superior efficacy of VPZ compared with PPIs has been reported in various gastrointestinal diseases (19)(20)(21)(22).…”

Section: Eradication Rate % (N) -------------------------------------mentioning

confidence: 99%

Second‑line triple therapy in failures with vonoprazan‑based triple therapy for eradication of Helicobacter pylori

et al. 2018

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Abstract. Gastric acid inhibition during treatment is important for the eradication of Helicobacter pylori (H. pylori) infection. A novel potassium-competitive acid blocker, vonoprazan (VPZ), has been demonstrated to achieve high eradication rates; however, the efficacy of second-line treatment in failures of VPZ-based triple therapy has not been well studied.The aim of the current study was to determine the efficacy of VPZ in a first-line regimen for H. pylori eradication, and the efficacy of a second-line regimen using metronidazole (MTZ) in failures with the first-line regimen. Of 580 subjects enrolled in the study, 524 patients completed first-line treatment (275 patients who received VPZ and 249 patients who received LPZ). First-line regimens consisted of a combination of clarithromycin (CAM) 200 or 400 mg twice a day, amoxicillin (AMPC) 750 mg twice a day, and either LPZ 30 mg or VPZ 20 mg twice a day, administered orally for 7 days. CAM and VPZ/LPZ were replaced with metronidazole (MTZ) 250 mg and rabeprazole 10 mg in the second-line regimens. The eradication of H. pylori was assessed by the H. pylori stool antigen test. The overall first-line eradication rate with VPZ was significantly higher than that with LPZ [91.0% (250/275) vs. 84.7% (211/249), respectively, P=0.030]. The dose of CAM (400 vs. 800 mg) did not affect the eradication rate in either the VPZ or LPZ regimens. The overall eradication rates of the second-line regimens with MTZ did not differ significantly between the VPZ-failure and LPZ-failure groups [87.0% (20/23) vs. 87.9% (29/33), respectively, P= 0.700]. Therefore, VPZ was significantly more effective than LPZ for first-line treatment. In patients with failure of first-line eradication therapy, successful results of second-line eradication therapy did not differ between the VPZ-and LPZ-failure groups. In conclusion, VPZ-based triple therapy should be recommended for eradication of H. pylori.

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Randomised clinical trial: efficacy and safety of vonoprazan vs. lansoprazole in patients with gastric or duodenal ulcers – results from two phase 3, non‐inferiority randomised controlled trials

Cited by 91 publications

References 17 publications

Risk Factors for Delayed Ulcer Healing after Endoscopic Submucosal Dissection of Gastric Neoplasms

Risk Factors for Delayed Ulcer Healing after Endoscopic Submucosal Dissection of Gastric Neoplasms

The efficacy of vonoprazan for management of post‐endoscopic submucosal dissection ulcers compared with proton pump inhibitors: A meta‐analysis

Second‑line triple therapy in failures with vonoprazan‑based triple therapy for eradication of Helicobacter pylori

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