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Gastroenterology

Potassium-competitive acid blockers: rethinking acid suppression for gastroesophageal reflux disease and Helicobacter pylori

, , ORCID Icon, & ORCID Icon
Pages 131-140 | Received 18 Oct 2023, Accepted 13 Feb 2024, Published online: 06 Mar 2024

References

  • Katz PO, Dunbar KB, Schnoll-Sussman FH, et al. ACG clinical guideline for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol. 2022 Jan 1; 117(1):27–56. doi: 10.14309/ajg.0000000000001538
  • Chey WD, Leontiadis GI, Howden CW, et al. ACG clinical guideline: treatment of Helicobacter pylori infection. Am J Gastroenterol. 2017 Feb;112(2):212–239.
  • Locke GR 3rd, Talley NJ, Fett SL, et al. Prevalence and clinical spectrum of gastroesophageal reflux: a population-based study in Olmsted County, Minnesota. Gastroenterol. 1997 May;112(5):1448–1456. doi: 10.1016/S0016-5085(97)70025-8
  • Dent J, El-Serag HB, Wallander MA, et al. Epidemiology of gastro-oesophageal reflux disease: a systematic review. Gut. 2005 May;54(5):710–717.
  • Katzka DA, Pandolfino JE, Kahrilas PJ. Phenotypes of gastroesophageal reflux disease: where rome, lyon, and montreal meet. Clin Gastroenterol Hepatol. 2020 Apr;18(4):767–776.
  • Hooi JKY, Lai WY, Ng WK, et al. Global prevalence of Helicobacter pylori infection: systematic review and meta-analysis. Gastroenterology. 2017 Aug;153(2):420–429. doi: 10.1053/j.gastro.2017.04.022
  • Shah SC, Halvorson AE, Lee D, et al. Helicobacter pylori Burden in the United States according to individual demographics and geography: a nationwide analysis of the veterans healthcare system. Clin Gastroenterol Hepatol. 2024 Jan;22(1):42–50 e26. doi: 10.1016/j.cgh.2023.05.016
  • Kusters JG, van Vliet AH, Kuipers EJ. Pathogenesis of Helicobacter pylori infection. Clin Microbiol Rev. 2006 Jul;19(3):449–490.
  • Malfertheiner P, Camargo MC, El-Omar E et al. Helicobacter pylori infection. Nat Rev Dis Primers. 2023 Apr 20;9(1):19. doi: 10.1038/s41572-023-00431-8
  • Wroblewski LE, Peek RM Jr, Wilson KT. Helicobacter pylori and gastric cancer: factors that modulate disease risk. Clin Microbiol Rev. 2010 Oct;23(4):713–739.
  • Uemura N, Okamoto S, Yamamoto S, et al. Helicobacter pylori infection and the development of gastric cancer. N Engl J Med. 2001 Sep 13;345(11):784–789. doi: 10.1056/NEJMoa001999
  • Vonquenza (vonoprazan) [prescribing information]. Buffalo Grove (IL): Phathom Pharmaceuticals, Inc; 2022.
  • Shibli F, Kitayama Y, Fass R. Novel therapies for gastroesophageal reflux disease: beyond proton pump inhibitors.Curr Gastroenterol Rep. 2020 Mar 17;22(4):16. doi: 10.1007/s11894-020-0753-y
  • Shin JM, Munson K, Vagin O, et al. The gastric HK-ATPase: structure, function, and inhibition. Pflugers Arch. 2009 Jan;457(3):609–622.
  • Beil W, Hackbarth I, Sewing KF. Mechanism of gastric antisecretory effect of SCH 28080. Br J Pharmacol. 1986 May;88(1):19–23.
  • Shin JM, Kim N. Pharmacokinetics and pharmacodynamics of the proton pump inhibitors. J Neurogastroenterol Motil. 2013 Jan;19(1):25–35.
  • Engevik AC, Kaji I, Goldenring JR. The Physiology of the Gastric Parietal Cell.Physiol Rev. 2020 Apr 1;100(2):573–602. doi: 10.1152/physrev.00016.2019
  • Yao X, Forte JG. Cell biology of acid secretion by the parietal cell. Annu Rev Physiol. 2003;65(1):103–131.
  • Scott D, Weeks D, Melchers K, et al. The life and death of Helicobacter pylori. Gut. 1998 Jul;43(Suppl 1):S56–S60.
  • Marieb EN, Brady PM, Mallatt JB. Human anatomy. New Jersey: Pearson; 2019.
  • Sjostedt S, Sagar M, Lindberg G, et al. Prolonged and profound acid inhibition is crucial in Helicobacter pylori treatment with a proton pump inhibitor combined with amoxicillin. Scand J Gastroenterol. 1998 Jan;33(1):39–43. doi: 10.1080/00365529850166185
  • Schade C, Flemstrom G, Holm L. Hydrogen ion concentration in the mucus layer on top of acid-stimulated and -inhibited rat gastric mucosa. Gastroenterology. 1994 Jul;107(1):180–188.
  • Lambrecht NW, Yakubov I, Scott D, et al. Identification of the K efflux channel coupled to the gastric H-K-ATPase during acid secretion.Physiol Genomics. 2005 Mar 21;21(1):81–91. doi: 10.1152/physiolgenomics.00212.2004
  • Gedda K, Scott D, Besancon M, et al. Turnover of the gastric H+,K(+)-adenosine triphosphatase alpha subunit and its effect on inhibition of rat gastric acid secretion. Gastroenterology. 1995 Oct;109(4):1134–1141. doi: 10.1016/0016-5085(95)90571-5
  • Shin JM, Sachs G. Pharmacology of proton pump inhibitors. Curr Gastroenterol Rep. 2008 Dec;10(6):528–534.
  • ClinicalTrials.gov. A study to evaluate the efficacy and safety of BLI5100 in patients with non-erosive reflux disease. [cited 2023 Sept 3]. Available from: https://classic.clinicaltrials.gov/study/NCT05587322.2023
  • ClinicalTrials.gov. A study to evaluate the efficacy and safety of BLI5100 in patients with erosive esophagitis. [cited 2023 Sept 1]. Available from: https://classic.clinicaltrials.gov/study/NCT05587309. 2023.
  • Abdel-Aziz Y, Metz DC, Howden CW. Review article: potassium-competitive acid blockers for the treatment of acid-related disorders. Aliment Pharmacol Ther. 2021 Apr;53(7):794–809.
  • Sachs G, Shin JM, Howden CW. Review article: the clinical pharmacology of proton pump inhibitors. Aliment Pharmacol Ther. 2006 Jun;23 Suppl 2(s2):2–8.
  • Wiesner A, Zwolinska-Wcislo M, Pasko P. Effect of food and dosing regimen on safety and efficacy of proton pump inhibitors therapy-a literature review.Int J Environ Res Public Health. 2021 Mar 29;18(7):3527. doi: 10.3390/ijerph18073527
  • Srebro J, Brniak W, Mendyk A. Formulation of dosage forms with proton pump inhibitors: state of the art, challenges and future perspectives.Pharmaceutics. 2022 Sep 25 14(10):2043. doi: 10.3390/pharmaceutics14102043
  • El Rouby N, Lima JJ, Johnson JA. Proton pump inhibitors: from CYP2C19 pharmacogenetics to precision medicine. Expert Opin Drug Metab Toxicol. 2018 Apr;14(4):447–460.
  • Furuta T, Shirai N, Sugimoto M, et al. Influence of CYP2C19 pharmacogenetic polymorphism on proton pump inhibitor-based therapies. Drug Metab Pharmacokinet. 2005 Jun;20(3):153–167. doi: 10.2133/dmpk.20.153
  • Bundhun PK, Teeluck AR, Bhurtu A et al. Is the concomitant use of clopidogrel and proton pump inhibitors still associated with increased adverse cardiovascular outcomes following coronary angioplasty?: a systematic review and meta-analysis of recently published studies (2012 - 2016).BMC Cardiovasc Disord. 2017 Jan 5;17(1):3. doi: 10.1186/s12872-016-0453-6
  • 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 Apr;41(7):636–648. doi: 10.1111/apt.13121
  • Echizen H. the first-in-class potassium-competitive acid blocker, vonoprazan fumarate: pharmacokinetic and pharmacodynamic considerations. Clin Pharmacokinet. 2016 Apr;55(4):409–418.
  • Laine L, DeVault K, Katz P, et al. Vonoprazan versus lansoprazole for healing and maintenance of healing of erosive esophagitis: a randomized trial. Gastroenterology. 2023 Jan;164(1):61–71. doi: 10.1053/j.gastro.2022.09.041
  • Scott DR, Munson KB, Marcus EA, et al. The binding selectivity of vonoprazan (TAK-438) to the gastric H+K+-ATPase. Aliment Pharmacol Ther. 2015 Dec;42(11–12):1315–1326. doi: 10.1111/apt.13414
  • Hori Y, Imanishi A, Matsukawa J, et al. 1-[5-(2-Fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine monofumarate (TAK-438), a novel and potent potassium-competitive acid blocker for the treatment of acid-related diseases. J Pharmacol Exp Ther. 2010 Oct;335(1):231–238. doi: 10.1124/jpet.110.170274
  • 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 Jul 1;117(7):1158–1161. doi: 10.14309/ajg.0000000000001735
  • 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 Sep;42(6):719–730. doi: 10.1111/apt.13325
  • 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 Mar;51(5):534–543. doi: 10.1111/apt.15641
  • Sakurai Y, Nishimura A, Kennedy G, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising TAK-438 (Vonoprazan) doses in healthy male Japanese/non-Japanese Subjects. Clin Transl Gastroenterol. 2015 Jun 25;6(6):e94. doi: 10.1038/ctg.2015.18
  • Bansal A, Kahrilas PJ. Treatment of GERD complications (Barrett’s, peptic stricture) and extra-oesophageal syndromes. Best Pract Res Clin Gastroenterol. 2010 Dec;24(6):961–968.
  • Savarino E, Zentilin P, Savarino V. NERD: an umbrella term including heterogeneous subpopulations. Nat Rev Gastroenterol Hepatol. 2013 Jun;10(6):371–380.
  • Armstrong D. Review article: gastric pH – the most relevant predictor of benefit in reflux disease? Aliment Pharmacol Ther. 2004 Oct;20(Suppl 5):19–26. discussion 38-9
  • Joelsson B, Johnsson F. Heartburn–the acid test. Gut. 1989 Nov;30(11):1523–1525.
  • Johnson DA, Katz PO, Levine D, et al. Prevention of relapse of healed reflux esophagitis is related to the duration of intragastric pH > 4. J Clin Gastroenterol. 2010 Aug;44(7):475–478. doi: 10.1097/MCG.0b013e3181dd9c5b
  • Carlsson R, Galmiche JP, Dent J, et al. Prognostic factors influencing relapse of oesophagitis during maintenance therapy with antisecretory drugs: a meta-analysis of long-term omeprazole trials. Aliment Pharmacol Ther. 1997 Jun;11(3):473–482. doi: 10.1046/j.1365-2036.1997.00167.x
  • Bell NJV, Burger D, Howden CW. Appropriate acid suppression for the management of gastro-oesophageal reflux disease. Digestion. 1992;51(1):59–67.
  • 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 Jan;49(2):140–146. doi: 10.1111/apt.15062
  • Fass R, Vaezi M, Sharma P, et al. Randomised clinical trial: efficacy and safety of on-demand vonoprazan versus placebo for non-erosive reflux disease. Aliment Pharmacol Ther. 2023 Sep 26;58(10):1016–1027. doi: 10.1111/apt.17728
  • Scott DR, Marcus EA, Wen Y, et al. Gene expression in vivo shows that Helicobacter pylori colonizes an acidic niche on the gastric surface. Proc Natl Acad Sci USA. 2007 Apr 24;104(17):7235–7240. doi: 10.1073/pnas.0702300104
  • Scott DR, Sachs G, Marcus EA. The role of acid inhibition in Helicobacter pylori eradication. F1000Res. 2016;5:1747.
  • Sipponen P, Varis K, Fraki O, et al. Cumulative 10-year risk of symptomatic duodenal and gastric ulcer in patients with or without chronic gastritis. A clinical follow-up study of 454 outpatients. Scand J Gastroenterol. 1990 Oct;25(10):966–973. doi: 10.3109/00365529008997621
  • Yamagata H, Kiyohara Y, Aoyagi K, et al. Impact of Helicobacter pylori infection on gastric cancer incidence in a general Japanese population: the Hisayama study. Arch Intern Med. 2000 Jul 10;160(13):1962–1968. doi: 10.1001/archinte.160.13.1962
  • Parsonnet J, Friedman GD, Vandersteen DP, et al. Helicobacter pylori infection and the risk of gastric carcinoma. N Engl J Med. 1991 Oct 17;325(16):1127–1131. doi: 10.1056/NEJM199110173251603
  • Wong F, Rayner-Hartley E, Byrne MF. Extraintestinal manifestations of Helicobacter pylori: a concise review.World J Gastroenterol. 2014 Sep 14;20(34):11950–11961. doi: 10.3748/wjg.v20.i34.11950
  • Sugimoto M, Furuta T, Shirai N, et al. Evidence that the degree and duration of acid suppression are related to Helicobacter pylori eradication by triple therapy. Helicobacter. 2007 Aug;12(4):317–323. doi: 10.1111/j.1523-5378.2007.00508.x
  • Ke H, Li J, Lu B, et al. The appropriate cutoff gastric pH value for Helicobacter pylori eradication with bismuth-based quadruple therapy. Helicobacter. 2021 Feb;26(1):e12768. doi: 10.1111/hel.12768
  • Moss SF, Chey WD, Daniele P, et al. Brief communication: global temporal trends in the efficacy of clarithromycin-based regimens for the treatment of Helicobacter pylori infection. Therap Adv Gastroenterol. 2023;16:17562848231167284.
  • Lind T, Megraud F, Unge P, et al. The MACH2 study: role of omeprazole in eradication of Helicobacter pylori with 1-week triple therapies. Gastroenterology. 1999 Feb;116(2):248–253. doi: 10.1016/S0016-5085(99)70119-8
  • Chey WD, Megraud F, Laine L, et al. Vonoprazan triple and dual therapy for Helicobacter pylori infection in the United States and Europe: randomized clinical trial. Gastroenterology. 2022 Sep;163(3):608–619. doi: 10.1053/j.gastro.2022.05.055
  • Malfertheiner P, Moss SF, Daniele P, et al. Potassium-Competitive Acid Blocker and Proton Pump Inhibitor–Based Regimens for First-Line Helicobacter pylori Eradication: a Network Meta-Analysis. Gastro Hep Advances. 2022;1(5):824–834.
  • Shinozaki S, Kobayashi Y, Osawa H, et al. Effectiveness and safety of vonoprazan versus proton pump inhibitors for second-line helicobacter pylori eradication therapy: systematic review and meta-analysis. Digestion. 2021;102(3):319–325. doi: 10.1159/000504939