Vonoprazan - a new drug for inhibiting gastric acid secretion
DOI:
https://doi.org/10.12775/JEHS.2022.12.08.068Keywords
Vonoprazan, Potassium-competitive acid blocker, Proton Pump Inhibitors, Acid-related diseasesAbstract
Introduction and purpose
Vonoprazan is a potassium-competent acid blocker (P-CAB). It has the potential to be an alternative to proton pump inhibitors (PPIs) as it inhibits hydrochloric acid secretion. The mechanism of action is different than PPIs - vonoprazan reversibly inhibits gastric H+, K+-ATPase, while PPIs irreversibly. Vonoprazan is approved for use in Japan and the US. The aim of the study was to review articles on the use of vonoprazan instead of PPIs in the treatment of acid-related gastrological diseases and to present the results obtained.
A brief description of the state of knowledge
Vonoprazan is used in the treatment of acid-related gastrological diseases. The 20 mg dose is suitable for most diseases, such as treatment of ulcers during low-dose aspirin treatment, post-endoscopic submucosal dissection (post-ESD) ulcers, erosive esophagitis (EE) in gastroesophageal reflux disease (GERD), and Helicobacter pylori eradication.
Summary
Researches suggest that the drug is an alternative for PPIs and can be used instead of them. The main advantage of this drug over PPIs is that it works faster, more potent and long-lasting. Studies suggest that vonoprazan can be use to treatment of the acid-related diseases and may be a better choice than PPIs. Vonoprazan may have a particular use in the treatment of PPI-refractory GERD. In post-ESD ulcers, a significant benefit in treatment effects of vonoprazan over PPIs cannot be clearly concluded.
References
Saleem N, Howden CW. Update on the Management of Helicobacter pylori Infection. Curr Treat Options Gastroenterol. 2020;18(3):476-487. doi:10.1007/s11938-020-00300-3
Sachs G, Shin JM, Hunt R. Novel approaches to inhibition of gastric acid secretion [published correction appears in Curr Gastroenterol Rep. 2011 Feb;13(1):110]. Curr Gastroenterol Rep. 2010;12(6):437-447. doi:10.1007/s11894-010-0149-5
Shin JM, Inatomi N, Munson K, et al. Characterization of a novel potassium-competitive acid blocker of the gastric H,K-ATPase, 1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438). J Pharmacol Exp Ther. 2011;339(2):412-420. doi:10.1124/jpet.111.185314
Jenkins H, Sakurai Y, Nishimura A, et al. Randomised clinical trial: safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of TAK-438 (vonoprazan), a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2015;41(7):636-648. doi:10.1111/apt.13121
Sachs G, Shin JM, Vagin O, Lambrecht N, Yakubov I, Munson K. The gastric H,K ATPase as a drug target: past, present, and future. J Clin Gastroenterol. 2007;41 Suppl 2(Suppl 2):S226-S242. doi:10.1097/MCG.0b013e31803233b7
Garnock-Jones KP. Vonoprazan: first global approval. Drugs. 2015;75(4):439-443. doi:10.1007/s40265-015-0368-z
Phathom Pharmaceuticals Announces FDA Approval of VOQUEZNA™ TRIPLE PAK™ (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA™ DUAL PAK™ (vonoprazan, amoxicillin) for the Treatment of H. pylori Infection in Adults. https://investors.phathompharma.com/node/8091/pdf (access 2022.08.01)
Jenkins H, Sakurai Y, Nishimura A, et al. Randomised clinical trial: safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of TAK-438 (vonoprazan), a novel potassium-competitive acid blocker, in healthy male subjects. Aliment Pharmacol Ther. 2015;41(7):636-648. doi:10.1111/apt.13121
Mulford DJ, Leifke E, Hibberd M, Howden CW. The Effect of Food on the Pharmacokinetics of the Potassium-Competitive Acid Blocker Vonoprazan. Clin Pharmacol Drug Dev. 2022;11(2):278-284. doi:10.1002/cpdd.1009
Kasai T, Suzuki S, Kusano C, et al. High Body Mass Index Is Correlated with the Success of Vonoprazan-Based Second-Line Therapy for Helicobacter Pylori Infection. Tohoku J Exp Med. 2021;253(2):85-94. doi:10.1620/tjem.253.85
Takeuchi T, Furuta T, Fujiwara Y, et al. Randomised trial of acid inhibition by vonoprazan 10/20 mg once daily vs rabeprazole 10/20 mg twice daily in healthy Japanese volunteers (SAMURAI pH study). Aliment Pharmacol Ther. 2020;51(5):534-543. doi:10.1111/apt.15641
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(6):719-730. doi:10.1111/apt.13325
Laine L, Sharma P, Mulford DJ, et al. Pharmacodynamics and Pharmacokinetics of the Potassium-Competitive Acid Blocker Vonoprazan and the Proton Pump Inhibitor Lansoprazole in US Subjects. Am J Gastroenterol. 2022;117(7):1158-1161. doi:10.14309/ajg.0000000000001735
Ohkuma K, Iida H, Inoh Y, et al. Comparison of the early effects of vonoprazan, lansoprazole and famotidine on intragastric pH: a three-way crossover study [published correction appears in J Clin Biochem Nutr. 2019 Jan;64(1):96]. J Clin Biochem Nutr. 2018;63(1):80-83. doi:10.3164/jcbn.17-128
Suzuki T, Kagami T, Uotani T, et al. Comparison of effect of an increased dosage of vonoprazan versus vonoprazan plus lafutidine on gastric acid inhibition and serum gastrin. Eur J Clin Pharmacol. 2018;74(1):45-52. doi:10.1007/s00228-017-2324-1
Suzuki T, Higuchi T, Kagami T, et al. Effects of pirenzepine on vonoprazan-induced gastric acid inhibition and hypergastrinemia. Eur J Clin Pharmacol. 2021;77(7):971-978. doi:10.1007/s00228-021-03162-5
Kawai T, Oda K, Funao N, et al. Vonoprazan prevents low-dose aspirin-associated ulcer recurrence: randomised phase 3 study. Gut. 2018;67(6):1033-1041. doi:10.1136/gutjnl-2017-314852
Sakurai Y, Shiino M, Horii S, et al. Pharmacokinetic Drug-Drug Interactions Between Vonoprazan and Low-Dose Aspirin or Nonsteroidal Anti-inflammatory Drugs: A Phase 2, Open-Label, Study in Healthy Japanese Men. Clin Drug Investig. 2017;37(1):39-49. doi:10.1007/s40261-016-0455-2
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(6):1042-1051. doi:10.1136/gutjnl-2017-314010
Tsujimoto H, Hirata Y, Ueda Y, et al. Effect of a proton-pump inhibitor on intestinal microbiota in patients taking low-dose aspirin. Eur J Clin Pharmacol. 2021;77(11):1639-1648. doi:10.1007/s00228-021-03167-0
Kagawa T, Iwamuro M, Ishikawa S, et al. Vonoprazan prevents bleeding from endoscopic submucosal dissection-induced gastric ulcers. Aliment Pharmacol Ther. 2016;44(6):583-591. doi:10.1111/apt.13747
Hidaka Y, Imai T, Inaba T, et al. Efficacy of vonoprazan against bleeding from endoscopic submucosal dissection-induced gastric ulcers under antithrombotic medication: A cross-design synthesis of randomized and observational studies. PLoS One. 2021;16(12):e0261703. doi:10.1371/journal.pone.0261703
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(2):122-130. doi:10.1007/s00535-018-1487-6
Ishida T, Dohi O, Yamada S, et al. Clinical Outcomes of Vonoprazan-Treated Patients after Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Multicenter Observation Study. Digestion. 2021;102(3):386-396. doi:10.1159/000507807
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(5):576-583. doi:10.1111/den.12857
Ichida T, Ueyama S, Eto T, et al. Randomized Controlled Trial Comparing the Effects of Vonoprazan Plus Rebamipide and Esomeprazole Plus Rebamipide on Gastric Ulcer Healing Induced by Endoscopic Submucosal Dissection. Intern Med. 2019;58(2):159-166. doi:10.2169/internalmedicine.1146-18
Hirai A, Takeuchi T, Takahashi Y, et al. Comparison of the Effects of Vonoprazan and Lansoprazole for Treating Endoscopic Submucosal Dissection-Induced Artificial Ulcers. Dig Dis Sci. 2018;63(4):974-981. doi:10.1007/s10620-018-4948-0
Kawai D, Takenaka R, Ishiguro M, et al. Vonoprazan versus lansoprazole in the treatment of artificial gastric ulcers after endoscopic submucossal dissection: a randomized, open-label trial. BMC Gastroenterol. 2021;21(1):236. doi:10.1186/s12876-021-01822-5
Komori H, Ueyama H, Nagahara A, et al. A prospective randomized trial of a potassium competitive acid blocker vs proton pump inhibitors on the effect of ulcer healing after endoscopic submucosal dissection of gastric neoplasia. J Int Med Res. 2019;47(4):1441-1452. doi:10.1177/0300060519828514
Ashida K, Honda Y, Sanada K, Takemura Y, Sakamoto S. The safety and effectiveness of vonoprazan-based Helicobacter pylori eradication therapy; a prospective post-marketing surveillance. Expert Opin Drug Saf. 2019;18(12):1255-1261. doi:10.1080/14740338.2019.1676722
Sue S, Kuwashima H, Iwata Y, et al. The Superiority of Vonoprazan-based First-line Triple Therapy with Clarithromycin: A Prospective Multi-center Cohort Study on Helicobacter pylori Eradication. Intern Med. 2017;56(11):1277-1285. doi:10.2169/internalmedicine.56.7833
Huh KY, Chung H, Kim YK, et al. Evaluation of safety and pharmacokinetics of bismuth-containing quadruple therapy with either vonoprazan or lansoprazole for Helicobacter pylori eradication. Br J Clin Pharmacol. 2022;88(1):138-144. doi:10.1111/bcp.14934
Kusano C, Gotoda T, Suzuki S, Ikehara H, Moriyama M. Safety of first-line triple therapy with a potassium-competitive acid blocker for Helicobacter pylori eradication in children. J Gastroenterol. 2018;53(6):718-724. doi:10.1007/s00535-017-1406-2
Bunchorntavakul C, Buranathawornsom A. Randomized clinical trial: 7-day vonoprazan-based versus 14-day omeprazole-based triple therapy for Helicobacter pylori. J Gastroenterol Hepatol. 2021;36(12):3308-3313. doi:10.1111/jgh.15700
Ang D, Koo SH, Chan YH, et al. Clinical trial: seven-day vonoprazan- versus 14-day proton pump inhibitor-based triple therapy for first-line Helicobacter pylori eradication. Aliment Pharmacol Ther. 2022;56(3):436-449. doi:10.1111/apt.17070
Furuta T, Yamade M, Kagami T, et al. Dual Therapy with Vonoprazan and Amoxicillin Is as Effective as Triple Therapy with Vonoprazan, Amoxicillin and Clarithromycin for Eradication of Helicobacter pylori. Digestion. 2020;101(6):743-751. doi:10.1159/000502287
Ozaki H, Harada S, Takeuchi T, et al. Vonoprazan, a Novel Potassium-Competitive Acid Blocker, Should Be Used for the Helicobacter pylori Eradication Therapy as First Choice: A Large Sample Study of Vonoprazan in Real World Compared with Our Randomized Control Trial Using Second-Generation Proton Pump Inhibitors for Helicobacter pylori Eradication Therapy. Digestion. 2018;97(3):212-218. doi:10.1159/000485097
Maruyama M, Tanaka N, Kubota D, et al. Vonoprazan-Based Regimen Is More Useful than PPI-Based One as a First-Line Helicobacter pylori Eradication: A Randomized Controlled Trial. Can J Gastroenterol Hepatol. 2017;2017:4385161. doi:10.1155/2017/4385161
Chey WD, Mégraud F, Laine L, López LJ, Hunt BJ, Howden CW. Vonoprazan Triple and Dual Therapy for Helicobacter pylori Infection in the United States and Europe: Randomized Clinical Trial. Gastroenterology. 2022;S0016-5085(22)00609-6. doi:10.1053/j.gastro.2022.05.055
Zuberi BF, Ali FS, Rasheed T, Bader N, Hussain SM, Saleem A. Comparison of Vonoprazan and Amoxicillin Dual Therapy with Standard Triple Therapy with Proton Pump Inhibitor for Helicobacter Pylori eradication: A Randomized Control Trial. Pak J Med Sci. 2022;38(4Part-II):965-969. doi:10.12669/pjms.38.4.5436
Deguchi H, Yamazaki H, Kamitani T, Yamamoto Y, Fukuhara S. Impact of Vonoprazan Triple-Drug Blister Packs on H. pylori Eradication Rates in Japan: Interrupted Time Series Analysis. Adv Ther. 2021;38(7):3937-3947. doi:10.1007/s12325-021-01784-w
Hou X, Meng F, Wang J, et al. Vonoprazan non-inferior to lansoprazole in treating duodenal ulcer and eradicating Helicobacter pylori in Asian patients. J Gastroenterol Hepatol. 2022;37(7):1275-1283. doi:10.1111/jgh.15837
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(2):240-252. doi:10.1111/apt.13876
Ashida K, Sakurai Y, Nishimura A, et al. Randomised clinical trial: a dose-ranging study of vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the treatment of erosive oesophagitis. Aliment Pharmacol Ther. 2015;42(6):685-695. doi:10.1111/apt.13331
Vonoprazan 20 mg jest skuteczny w leczeniu ciężkiej EO
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(2):224-230. doi:10.1136/gutjnl-2019-318365
Ashida K, Sakurai Y, Hori T, et al. Randomised clinical trial: vonoprazan, a novel potassium-competitive acid blocker, vs. lansoprazole for the healing of erosive oesophagitis. Aliment Pharmacol Ther. 2016;43(2):240-251. doi:10.1111/apt.13461
Umezawa M, Kawami N, Hoshino S, et al. Efficacy of On-Demand Therapy Using 20-mg Vonoprazan for Mild Reflux Esophagitis. Digestion. 2018;97(4):309-315. doi:10.1159/000485795
Okanobu H, Kohno T, Mouri R, et al. Efficacy of vonoprazan 10 mg compared with 20 mg for the initial treatment in patients with erosive esophagitis: a randomized pilot study. Esophagus. 2021;18(3):669-675. doi:10.1007/s10388-020-00798-7
Matsuda S, Kato M, Sakakibara Y, et al. A study for every second day administration of vonoprazan for maintenance treatment of erosive GERD (ESD von GERD): a multicenter randomized cross-over study. J Gastroenterol. 2022;57(3):133-143. doi:10.1007/s00535-022-01850-2
Okuyama M, Nakahara K, Iwakura N, et al. Factors Associated with Potassium-Competitive Acid Blocker Non-Response in Patients with Proton Pump Inhibitor-Refractory Gastroesophageal Reflux Disease. Digestion. 2017;95(4):281-287. doi:10.1159/000475658
Hoshino S, Kawami N, Takenouchi N, et al. Efficacy of Vonoprazan for Proton Pump Inhibitor-Resistant Reflux Esophagitis. Digestion. 2017;95(2):156-161. doi:10.1159/000456072
Iwakiri K, Sakurai Y, Shiino M, et al. A randomized, double-blind study to evaluate the acid-inhibitory effect of vonoprazan (20 mg and 40 mg) in patients with proton-pump inhibitor-resistant erosive esophagitis. Therap Adv Gastroenterol. 2017;10(6):439-451. doi:10.1177/1756283X17705329
Mizuno H, Nishino M, Yamada K, Kamiyamamoto S, Hinoue Y. Efficacy of Vonoprazan for 48-Week Maintenance Therapy of Patients with Healed Reflux Esophagitis. Digestion. 2020;101(4):411-421. doi:10.1159/000500399
Ashida K, Iwakiri K, Hiramatsu N, et al. Maintenance for healed erosive esophagitis: Phase III comparison of vonoprazan with lansoprazole. World J Gastroenterol. 2018;24(14):1550-1561. doi:10.3748/wjg.v24.i14.1550
Kinoshita Y, Sakurai Y, Takabayashi N, et al. Efficacy and Safety of Vonoprazan in Patients With Nonerosive Gastroesophageal Reflux Disease: A Randomized, Placebo-Controlled, Phase 3 Study. Clin Transl Gastroenterol. 2019;10(11):e00101. doi:10.14309/ctg.0000000000000101
Oshima T, Arai E, Taki M, et al. Randomised clinical trial: vonoprazan versus lansoprazole for the initial relief of heartburn in patients with erosive oesophagitis. Aliment Pharmacol Ther. 2019;49(2):140-146. doi:10.1111/apt.15062
Shinozaki S, Osawa H, Hayashi Y, et al. Vonoprazan treatment improves gastrointestinal symptoms in patients with gastroesophageal reflux disease. Kaohsiung J Med Sci. 2017;33(12):616-622. doi:10.1016/j.kjms.2017.07.004
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