Skip to main content
Erschienen in: Journal of Gastroenterology 7/2021

19.04.2021 | Original Article—Alimentary Tract

Prevention of delayed bleeding with vonoprazan in upper gastrointestinal endoscopic treatment

verfasst von: Hiroko Abe, Waku Hatta, Yohei Ogata, Tomoyuki Koike, Masahiro Saito, Xiaoyi Jin, Kenichiro Nakagawa, Takeshi Kanno, Kaname Uno, Naoki Asano, Akira Imatani, Tomohiro Nakamura, Naoki Nakaya, Kunio Tarasawa, Kenji Fujimori, Kiyohide Fushimi, Atsushi Masamune

Erschienen in: Journal of Gastroenterology | Ausgabe 7/2021

Einloggen, um Zugang zu erhalten

Abstract

Background

Delayed bleeding is the major adverse event in upper gastrointestinal endoscopic treatment (UGET). We aimed to investigate the efficacy of vonoprazan, which is the novel strong antisecretory agent, to reduce the risk for delayed bleeding in comparison with proton pump inhibitors (PPIs) in UGET.

Methods

This retrospective population-based cohort study used the Diagnosis Procedure Combination database in Japan. We included patients on vonoprazan or PPI in UGET between 2014 and 2019. The primary outcome was delayed bleeding. We conducted propensity score matching to balance the comparison groups, and logistic regression analyses to compare the bleeding outcomes.

Results

We enrolled 124,422 patients, in which 34,822 and 89,600 were prescribed with vonoprazan and PPI, respectively. After propensity score matching, the risk for delayed bleeding was lower in vonoprazan than in PPI (odds ratio [OR], 0.75; 95% confidence interval [CI], 0.71–0.80), consistent with sensitivity analysis results. In the subgroup analyses of seven UGET procedures, vonoprazan was significantly advantageous in esophageal endoscopic submucosal dissection (E-ESD) (OR, 0.71; 95% CI, 0.54–0.94) and gastroduodenal endoscopic submucosal dissection (GD-ESD) (OR, 0.70; 95% CI, 0.65–0.75), although correction for multiple testing of the outcome data removed the significance in E-ESD. These results were also consistent with sensitivity analysis results. In the five other procedures, no significant advantage was found.

Conclusions

This nationwide study found that, compared with PPI, vonoprazan can reduce delayed bleeding with approximately 30% in GD-ESD. Vonoprazan has the possibility to become a new treatment method for preventing delayed bleeding in this procedure.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
1.
Zurück zum Zitat Urabe Y, Hiyama T, Tanaka S, et al. Advantages of endoscopic submucosal dissection versus endoscopic oblique aspiration mucosectomy for superficial esophageal tumors. J Gastroenterol Hepatol. 2011;26:275–80.CrossRef Urabe Y, Hiyama T, Tanaka S, et al. Advantages of endoscopic submucosal dissection versus endoscopic oblique aspiration mucosectomy for superficial esophageal tumors. J Gastroenterol Hepatol. 2011;26:275–80.CrossRef
2.
Zurück zum Zitat Kanzaki H, Ishihara R, Ohta T, et al. Randomized study of two endo-knives for endoscopic submucosal dissection of esophageal cancer. Am J Gastroenterol. 2013;108:1293–8.CrossRef Kanzaki H, Ishihara R, Ohta T, et al. Randomized study of two endo-knives for endoscopic submucosal dissection of esophageal cancer. Am J Gastroenterol. 2013;108:1293–8.CrossRef
3.
Zurück zum Zitat Kagemoto K, Oka S, Tanaka S, et al. Clinical outcomes of endoscopic submucosal dissection for superficial Barrett’s adenocarcinoma. Gastrointest Endosc. 2014;80:239–45.CrossRef Kagemoto K, Oka S, Tanaka S, et al. Clinical outcomes of endoscopic submucosal dissection for superficial Barrett’s adenocarcinoma. Gastrointest Endosc. 2014;80:239–45.CrossRef
4.
Zurück zum Zitat Tsujii Y, Nishida T, Nishiyama O, et al. Clinical outcomes of endoscopic submucosal dissection for superficial esophageal neoplasms: a multicenter retrospective cohort study. Endoscopy. 2015;47:775–83.CrossRef Tsujii Y, Nishida T, Nishiyama O, et al. Clinical outcomes of endoscopic submucosal dissection for superficial esophageal neoplasms: a multicenter retrospective cohort study. Endoscopy. 2015;47:775–83.CrossRef
5.
Zurück zum Zitat Hirasawa K, Kokawa A, Oka H, et al. Superficial adenocarcinoma of the esophagogastric junction: long-term results of endoscopic submucosal dissection. Gastrointest Endosc. 2010;72:960–6.CrossRef Hirasawa K, Kokawa A, Oka H, et al. Superficial adenocarcinoma of the esophagogastric junction: long-term results of endoscopic submucosal dissection. Gastrointest Endosc. 2010;72:960–6.CrossRef
6.
Zurück zum Zitat Park JS, Youn YH, Park JJ, et al. Clinical Outcomes of Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Neoplasms. Clin Endosc. 2016;49:168–75.CrossRef Park JS, Youn YH, Park JJ, et al. Clinical Outcomes of Endoscopic Submucosal Dissection for Superficial Esophageal Squamous Neoplasms. Clin Endosc. 2016;49:168–75.CrossRef
7.
Zurück zum Zitat Yang D, Coman RM, Kahaleh M, et al. Endoscopic submucosal dissection for Barrett’s early neoplasia: a multicenter study in the United States. Gastrointest Endosc. 2017;86:600–7.CrossRef Yang D, Coman RM, Kahaleh M, et al. Endoscopic submucosal dissection for Barrett’s early neoplasia: a multicenter study in the United States. Gastrointest Endosc. 2017;86:600–7.CrossRef
8.
Zurück zum Zitat Chung IK, Lee JH, Lee SH, et al. Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study. Gastrointest Endosc. 2009;69:1228–35.CrossRef Chung IK, Lee JH, Lee SH, et al. Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study. Gastrointest Endosc. 2009;69:1228–35.CrossRef
9.
Zurück zum Zitat Yano T, Tanabe S, Ishido K, et al. Different clinical characteristics associated with acute bleeding and delayed bleeding after endoscopic submucosal dissection in patients with early gastric cancer. Surg Endosc. 2017;31:4542–50.CrossRef Yano T, Tanabe S, Ishido K, et al. Different clinical characteristics associated with acute bleeding and delayed bleeding after endoscopic submucosal dissection in patients with early gastric cancer. Surg Endosc. 2017;31:4542–50.CrossRef
10.
Zurück zum Zitat Hatta W, Tsuji Y, Yoshio T, et al. Prediction model of bleeding after endoscopic submucosal dissection for early gastric cancer: BEST-J score. Gut. 2021;70:476–84.CrossRef Hatta W, Tsuji Y, Yoshio T, et al. Prediction model of bleeding after endoscopic submucosal dissection for early gastric cancer: BEST-J score. Gut. 2021;70:476–84.CrossRef
11.
Zurück zum Zitat Zhu J, Qi X, Yu H, et al. Acid suppression in patients treated with endoscopic therapy for the management of gastroesophageal varices: a systematic review and meta-analysis. Expert Rev Gastroenterol Hepatol. 2018;12:617–24.CrossRef Zhu J, Qi X, Yu H, et al. Acid suppression in patients treated with endoscopic therapy for the management of gastroesophageal varices: a systematic review and meta-analysis. Expert Rev Gastroenterol Hepatol. 2018;12:617–24.CrossRef
12.
Zurück zum Zitat Boo GB, Oh JC, Lee BJ, et al. The effect of proton pump ininhibitor.on healing of post-esophageal variceal ligation ulcers. Korean J Gastroenterol. 2008;41:232–40. Boo GB, Oh JC, Lee BJ, et al. The effect of proton pump ininhibitor.on healing of post-esophageal variceal ligation ulcers. Korean J Gastroenterol. 2008;41:232–40.
13.
Zurück zum Zitat Repici A, Hassan C, Carlino A, et al. Endoscopic submucosal dissection in patients with early esophageal squamous cell carcinoma: results from a prospective Western series. Gastrointest Endosc. 2010;71:715–21.CrossRef Repici A, Hassan C, Carlino A, et al. Endoscopic submucosal dissection in patients with early esophageal squamous cell carcinoma: results from a prospective Western series. Gastrointest Endosc. 2010;71:715–21.CrossRef
14.
Zurück zum Zitat Yamamoto Y, Kikuchi D, Nagami Y, et al. Management of adverse events related to endoscopic resection of upper gastrointestinal neoplasms: Review of the literature and recommendations from experts. Dig Endosc. 2019;31(Suppl 1):4–20.CrossRef Yamamoto Y, Kikuchi D, Nagami Y, et al. Management of adverse events related to endoscopic resection of upper gastrointestinal neoplasms: Review of the literature and recommendations from experts. Dig Endosc. 2019;31(Suppl 1):4–20.CrossRef
15.
Zurück zum Zitat Uedo N, Takeuchi Y, Yamada T, et al. Effect of a proton pump inhibitor or an H2-receptor antagonist on prevention of bleeding from ulcer after endoscopic submucosal dissection of early gastric cancer: a prospective randomized controlled trial. Am J Gastroenterol. 2007;102:1610–6.CrossRef Uedo N, Takeuchi Y, Yamada T, et al. Effect of a proton pump inhibitor or an H2-receptor antagonist on prevention of bleeding from ulcer after endoscopic submucosal dissection of early gastric cancer: a prospective randomized controlled trial. Am J Gastroenterol. 2007;102:1610–6.CrossRef
16.
Zurück zum Zitat Yang Z, Wu Q, Liu Z, et al. Proton pump inhibitors versus histamine-2-receptor antagonists for the management of iatrogenic gastric ulcer after endoscopic mucosal resection or endoscopic submucosal dissection: a meta-analysis of randomized trials. Digestion. 2011;84:315–20.CrossRef Yang Z, Wu Q, Liu Z, et al. Proton pump inhibitors versus histamine-2-receptor antagonists for the management of iatrogenic gastric ulcer after endoscopic mucosal resection or endoscopic submucosal dissection: a meta-analysis of randomized trials. Digestion. 2011;84:315–20.CrossRef
17.
Zurück zum Zitat Sakurai Y, Mori Y, Okamoto H, et al. Acid-inhibitory effects of vonoprazan 20 mg compared with esomeprazole 20 mg or rabeprazole 10 mg in healthy adult male subjects–a randomised open-label cross-over study. Aliment Pharmacol Ther. 2015;42:719–30.CrossRef Sakurai Y, Mori Y, Okamoto H, et al. Acid-inhibitory effects of vonoprazan 20 mg compared with esomeprazole 20 mg or rabeprazole 10 mg in healthy adult male subjects–a randomised open-label cross-over study. Aliment Pharmacol Ther. 2015;42:719–30.CrossRef
18.
Zurück zum Zitat Suzuki S, Gotoda T, Kusano C, et al. The efficacy and tolerability of a triple therapy containing a potassium-competitive acid blocker compared with a 7-Day ppi-based low-dose clarithromycin triple therapy. Am J Gastroenterol. 2016;111:949–56.CrossRef Suzuki S, Gotoda T, Kusano C, et al. The efficacy and tolerability of a triple therapy containing a potassium-competitive acid blocker compared with a 7-Day ppi-based low-dose clarithromycin triple therapy. Am J Gastroenterol. 2016;111:949–56.CrossRef
19.
Zurück zum Zitat Murakami K, Sakurai Y, Shiino M, et al. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016;65:1439–46.CrossRef Murakami K, Sakurai Y, Shiino M, et al. Vonoprazan, a novel potassium-competitive acid blocker, as a component of first-line and second-line triple therapy for Helicobacter pylori eradication: a phase III, randomised, double-blind study. Gut. 2016;65:1439–46.CrossRef
20.
Zurück zum Zitat Mizokami Y, Oda K, Funao N, et al. Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study. Gut. 2018;67:1042–51.CrossRef Mizokami Y, Oda K, Funao N, et al. Vonoprazan prevents ulcer recurrence during long-term NSAID therapy: randomised, lansoprazole-controlled non-inferiority and single-blind extension study. Gut. 2018;67:1042–51.CrossRef
21.
Zurück zum Zitat Kawai T, Oda K, Funao N, et al. Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study. Gut. 2018;67:1033–41.CrossRef Kawai T, Oda K, Funao N, et al. Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study. Gut. 2018;67:1033–41.CrossRef
22.
Zurück zum Zitat Xiao Y, Zhang S, Dai N, et al. Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis. Gut. 2020;69:224–30.CrossRef Xiao Y, Zhang S, Dai N, et al. Phase III, randomised, double-blind, multicentre study to evaluate the efficacy and safety of vonoprazan compared with lansoprazole in Asian patients with erosive oesophagitis. Gut. 2020;69:224–30.CrossRef
23.
Zurück zum Zitat Tsuchiya I, Kato Y, Tanida E, et al. Effect of vonoprazan on the treatment of artificial gastric ulcers after endoscopic submucosal dissection: Prospective randomized controlled trial. Dig Endosc. 2017;29:576–83.CrossRef Tsuchiya I, Kato Y, Tanida E, et al. Effect of vonoprazan on the treatment of artificial gastric ulcers after endoscopic submucosal dissection: Prospective randomized controlled trial. Dig Endosc. 2017;29:576–83.CrossRef
24.
Zurück zum Zitat Hamada K, Uedo N, Tonai Y, et al. Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers: a prospective randomized phase II study. J Gastroenterol. 2019;54:122–30.CrossRef Hamada K, Uedo N, Tonai Y, et al. Efficacy of vonoprazan in prevention of bleeding from endoscopic submucosal dissection-induced gastric ulcers: a prospective randomized phase II study. J Gastroenterol. 2019;54:122–30.CrossRef
25.
Zurück zum Zitat Martin, Zhou Y, Meng CX, et al. Vonoprazan vs proton pump inhibitors in treating post-endoscopic submucosal dissection ulcers and preventing bleeding: A meta-analysis of randomized controlled trials and observational studies. Medicine (Baltimore). 2020;99:e19357. Martin, Zhou Y, Meng CX, et al. Vonoprazan vs proton pump inhibitors in treating post-endoscopic submucosal dissection ulcers and preventing bleeding: A meta-analysis of randomized controlled trials and observational studies. Medicine (Baltimore). 2020;99:e19357.
26.
Zurück zum Zitat Bramer GR. International statistical classification of diseases and related health problems Tenth revision. World Health Stat Q. 1988;41:32–6.PubMed Bramer GR. International statistical classification of diseases and related health problems Tenth revision. World Health Stat Q. 1988;41:32–6.PubMed
28.
Zurück zum Zitat Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ. 2018;363:k3532.CrossRef Langan SM, Schmidt SA, Wing K, et al. The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE). BMJ. 2018;363:k3532.CrossRef
29.
Zurück zum Zitat Miwa H, Uedo N, Watari J, et al. 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. Aliment Pharmacol Ther. 2017;45:240–52. Miwa H, Uedo N, Watari J, et al. 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. Aliment Pharmacol Ther. 2017;45:240–52.
30.
Zurück zum Zitat Sahara S, Sugimoto M, Uotani T, et al. Twice-daily dosing of esomeprazole effectively inhibits acid secretion in CYP2C19 rapid metabolisers compared with twice-daily omeprazole, rabeprazole or lansoprazole. Aliment Pharmacol Ther. 2013;38:1129–37.CrossRef Sahara S, Sugimoto M, Uotani T, et al. Twice-daily dosing of esomeprazole effectively inhibits acid secretion in CYP2C19 rapid metabolisers compared with twice-daily omeprazole, rabeprazole or lansoprazole. Aliment Pharmacol Ther. 2013;38:1129–37.CrossRef
31.
Zurück zum Zitat Yamana H, Moriwaki M, Horiguchi H, et al. Validity of diagnoses, procedures, and laboratory data in Japanese administrative data. J Epidemiol. 2017;27:476–82.CrossRef Yamana H, Moriwaki M, Horiguchi H, et al. Validity of diagnoses, procedures, and laboratory data in Japanese administrative data. J Epidemiol. 2017;27:476–82.CrossRef
32.
Zurück zum Zitat Charlson ME, Pompei P, Ales KL, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373–83.CrossRef Charlson ME, Pompei P, Ales KL, et al. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373–83.CrossRef
33.
Zurück zum Zitat Takeuchi T, Ota K, Harada S, et al. The postoperative bleeding rate and its risk factors in patients on antithrombotic therapy who undergo gastric endoscopic submucosal dissection. BMC Gastroenterol. 2013;13:136.CrossRef Takeuchi T, Ota K, Harada S, et al. The postoperative bleeding rate and its risk factors in patients on antithrombotic therapy who undergo gastric endoscopic submucosal dissection. BMC Gastroenterol. 2013;13:136.CrossRef
34.
Zurück zum Zitat Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med. 2009;28:3083–107.CrossRef Austin PC. Balance diagnostics for comparing the distribution of baseline covariates between treatment groups in propensity-score matched samples. Stat Med. 2009;28:3083–107.CrossRef
35.
Zurück zum Zitat Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015;34:3661–79.CrossRef Austin PC, Stuart EA. Moving towards best practice when using inverse probability of treatment weighting (IPTW) using the propensity score to estimate causal treatment effects in observational studies. Stat Med. 2015;34:3661–79.CrossRef
36.
Zurück zum Zitat Prasad V, Jena AB. Prespecified falsification end points: can they validate true observational associations? JAMA. 2013;309:241–2.CrossRef Prasad V, Jena AB. Prespecified falsification end points: can they validate true observational associations? JAMA. 2013;309:241–2.CrossRef
37.
Zurück zum Zitat VanderWeele TJ, Ding P. Sensitivity analysis in observational research: introducing the E-value. Ann Intern Med. 2017;167:268–74.CrossRef VanderWeele TJ, Ding P. Sensitivity analysis in observational research: introducing the E-value. Ann Intern Med. 2017;167:268–74.CrossRef
38.
Zurück zum Zitat Haneuse S, VanderWeele TJ, Arterburn D. Using the E-value to assess the potential effect of unmeasured confounding in observational studies. JAMA. 2019;321:602–3.CrossRef Haneuse S, VanderWeele TJ, Arterburn D. Using the E-value to assess the potential effect of unmeasured confounding in observational studies. JAMA. 2019;321:602–3.CrossRef
39.
Zurück zum Zitat Takahashi K, Sato Y, Takeuchi M, et al. Changes in esophageal motility after endoscopic submucosal dissection for superficial esophageal cancer: a high-resolution manometry study. Dis Esophagus. 2017;30:1–8.CrossRef Takahashi K, Sato Y, Takeuchi M, et al. Changes in esophageal motility after endoscopic submucosal dissection for superficial esophageal cancer: a high-resolution manometry study. Dis Esophagus. 2017;30:1–8.CrossRef
40.
Zurück zum Zitat Brunner G, Luna P, Thiesemann C. Drugs for pH control in upper gastrointestinal bleeding. Aliment Pharmacol Ther. 1995;9(Suppl 1):47–50.PubMed Brunner G, Luna P, Thiesemann C. Drugs for pH control in upper gastrointestinal bleeding. Aliment Pharmacol Ther. 1995;9(Suppl 1):47–50.PubMed
41.
Zurück zum Zitat Liu C, Feng BC, Zhang Y, et al. The efficacy of vonoprazan for management of post-endoscopic submucosal dissection ulcers compared with proton pump inhibitors: A meta-analysis. J Dig Dis. 2019;20:503–11.CrossRef Liu C, Feng BC, Zhang Y, et al. The efficacy of vonoprazan for management of post-endoscopic submucosal dissection ulcers compared with proton pump inhibitors: A meta-analysis. J Dig Dis. 2019;20:503–11.CrossRef
42.
Zurück zum Zitat Kataoka Y, Tsuji Y, Hirasawa K, et al. Endoscopic tissue shielding to prevent bleeding after endoscopic submucosal dissection: a prospective multicenter randomized controlled trial. Endoscopy. 2019;51:619–27.CrossRef Kataoka Y, Tsuji Y, Hirasawa K, et al. Endoscopic tissue shielding to prevent bleeding after endoscopic submucosal dissection: a prospective multicenter randomized controlled trial. Endoscopy. 2019;51:619–27.CrossRef
Metadaten
Titel
Prevention of delayed bleeding with vonoprazan in upper gastrointestinal endoscopic treatment
verfasst von
Hiroko Abe
Waku Hatta
Yohei Ogata
Tomoyuki Koike
Masahiro Saito
Xiaoyi Jin
Kenichiro Nakagawa
Takeshi Kanno
Kaname Uno
Naoki Asano
Akira Imatani
Tomohiro Nakamura
Naoki Nakaya
Kunio Tarasawa
Kenji Fujimori
Kiyohide Fushimi
Atsushi Masamune
Publikationsdatum
19.04.2021
Verlag
Springer Singapore
Erschienen in
Journal of Gastroenterology / Ausgabe 7/2021
Print ISSN: 0944-1174
Elektronische ISSN: 1435-5922
DOI
https://doi.org/10.1007/s00535-021-01781-4

Weitere Artikel der Ausgabe 7/2021

Journal of Gastroenterology 7/2021 Zur Ausgabe

Leitlinien kompakt für die Innere Medizin

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Update Innere Medizin

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.