Vonoprazan versus lansoprazole in erosive esophagitis - A systematic review and meta-analysis of randomized controlled trials.
Erosive esophagitis
Lansoprazole
PPI
Vonoprazan
Journal
Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology
ISSN: 0975-0711
Titre abrégé: Indian J Gastroenterol
Pays: India
ID NLM: 8409436
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
received:
01
03
2023
accepted:
28
04
2023
medline:
27
7
2023
pubmed:
7
7
2023
entrez:
7
7
2023
Statut:
ppublish
Résumé
Proton-pump inhibitors (PPIs) are the mainstay of treatment in erosive esophagitis (EE). An alternative to PPIs in EE is Vonoprazan, a potassium competitive acid blocker. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing vonoprazan to lansoprazole. Multiple databases searched through November 2022. Meta-analysis was performed to assess endoscopic healing at two, four and eight weeks, including for patients with severe EE (Los Angeles C/D). Serious adverse events (SAE) leading to drug discontinuation were assessed. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. Four RCTs with 2208 patients were included in the final analysis. Vonoprazan 20 mg once-daily was compared to lansoprazole 30 mg once-daily dosing. Among all patients, at two and eight weeks post-treatment, vonoprazan resulted in significantly higher rates of endoscopic healing as compared to lansoprazole, risk ratios (RR) 1.1, p<0.001 and RR 1.04, p=0.03. The same effect was not observed at four weeks, RR 1.03 (CI 0.99-1.06, I Based on limited number of published non-inferiority RCTs, our analysis demonstrates that among patients with EE, vonoprazan 20 mg once-daily dosing achieves comparable and in those with severe EE, higher endoscopic healing rates as compared to lansoprazole 30 mg once-daily dosing. Both drugs have a comparable safety profile.
Sections du résumé
BACKGROUND
Proton-pump inhibitors (PPIs) are the mainstay of treatment in erosive esophagitis (EE). An alternative to PPIs in EE is Vonoprazan, a potassium competitive acid blocker. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing vonoprazan to lansoprazole.
METHODS
Multiple databases searched through November 2022. Meta-analysis was performed to assess endoscopic healing at two, four and eight weeks, including for patients with severe EE (Los Angeles C/D). Serious adverse events (SAE) leading to drug discontinuation were assessed. The quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology.
RESULTS
Four RCTs with 2208 patients were included in the final analysis. Vonoprazan 20 mg once-daily was compared to lansoprazole 30 mg once-daily dosing. Among all patients, at two and eight weeks post-treatment, vonoprazan resulted in significantly higher rates of endoscopic healing as compared to lansoprazole, risk ratios (RR) 1.1, p<0.001 and RR 1.04, p=0.03. The same effect was not observed at four weeks, RR 1.03 (CI 0.99-1.06, I
CONCLUSION
Based on limited number of published non-inferiority RCTs, our analysis demonstrates that among patients with EE, vonoprazan 20 mg once-daily dosing achieves comparable and in those with severe EE, higher endoscopic healing rates as compared to lansoprazole 30 mg once-daily dosing. Both drugs have a comparable safety profile.
Identifiants
pubmed: 37418052
doi: 10.1007/s12664-023-01384-2
pii: 10.1007/s12664-023-01384-2
doi:
Substances chimiques
Lansoprazole
0K5C5T2QPG
1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
0
Proton Pump Inhibitors
0
Pyrroles
0
Types de publication
Meta-Analysis
Systematic Review
Journal Article
Review
Comment
Langues
eng
Sous-ensembles de citation
IM
Pagination
475-484Commentaires et corrections
Type : CommentOn
Informations de copyright
© 2023. Indian Society of Gastroenterology.
Références
Eusebi LH, Ratnakumaran R, Yuan Y, et al. Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: a meta-analysis. Gut. 2018;67:430–40.
pubmed: 28232473
Delshad SD, Almario CV, Chey WD, Spiegel BMR. Prevalence of gastroesophageal reflux disease and proton pump inhibitor-refractory symptoms. Gastroenterology. 2020;158:1250–61.e2.
pubmed: 31866243
Thomson AB, Chiba N, Armstrong D, et al. The second Canadian gastroesophageal reflux disease consensus: moving forward to new concepts. Can J Gastroenterol. 1998;12:551–6.
pubmed: 9926265
Moole H, Patel J, Ahmed Z, et al. Progression from low-grade dysplasia to malignancy in patients with Barrett’s esophagus diagnosed by two or more pathologists. World J Gastroenterol. 2016;22:8831–43.
pubmed: 27818599
pmcid: 5075558
Tsoi EH, Williams RA, Christie M, et al. Not all low grade dysplasia in Barrett’s oesophagus is the same: using specific histological criteria in predicting progression to neoplasia. Pathology. 2021;53:700–4.
pubmed: 34420794
Yadlapati R, Hubscher E, Pelletier C, et al. Induction and maintenance of healing in erosive esophagitis in the United States. Expert Rev Gastroenterol Hepatol. 2022;16:967–80.
pubmed: 36254610
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;117:27–56.
pubmed: 34807007
pmcid: 8754510
Muthusamy VR, Lightdale JR, Acosta RD, et al. The role of endoscopy in the management of GERD. Gastrointest Endosc. 2015;81:1305–10.
pubmed: 25863867
Higuchi K, Joh T, Nakada K, Haruma K. Is proton pump inhibitor therapy for reflux esophagitis sufficient?: a large real-world survey of Japanese patients. Intern Med. 2013;52:1447–54.
pubmed: 23812190
Richter JE, Kahrilas PJ, Johanson J, et al. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomized controlled trial. Am J Gastroenterol. 2001;96:656–65.
pubmed: 11280530
Abdel-Aziz Y, Metz DC, Howden CW. Review article: potassium-competitive acid blockers for the treatment of acid-related disorders. Aliment Pharmacol Ther. 2021;53:794–809.
pubmed: 33592125
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;117:1158–61.
pubmed: 35294415
Benedetto Tiz D, Bagnoli L, Rosati O, et al. FDA-approved small molecules in 2022: clinical uses and their synthesis. Pharmaceutics. 2022;14:2538.
pubmed: 36432728
pmcid: 9695118
Miwa H, Igarashi A, Teng L, et al. Systematic review with network meta-analysis: indirect comparison of the efficacy of vonoprazan and proton-pump inhibitors for maintenance treatment of gastroesophageal reflux disease. J Gastroenterol. 2019;54:718–29.
pubmed: 30919071
pmcid: 6647489
Yang S, Deng W, Xie Z, Chen J. Efficacy and safety of proton pump inhibitors versus vonoprazan in treatment of erosive esophagitis: a PRISMA-compliant systematic review and network meta-analysis. Medicine (Baltimore). 2022;101:e31807.
pubmed: 36451489
pmcid: 9704910
Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.
pubmed: 33782057
pmcid: 8005924
Mohan BP, Chandan S, Siau K. Young GI angle: How to learn & conduct meta-analysis: Tips & tricks for the emerging researcher. United European. Gastroenterol J. 2022;10:1031.
Engels EA, Schmid CH, Terrin N, et al. Heterogeneity and statistical significance in meta-analysis: an empirical study of 125 meta-analyses. Stat Med. 2000;19:1707–28.
pubmed: 10861773
Atkins D, Eccles M, Flottorp S, et al. Systems for grading the quality of evidence and the strength of recommendations I: critical appraisal of existing approaches The GRADE Working Group. BMC Health Serv Res. 2004;4:38.
pubmed: 15615589
pmcid: 545647
DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177–88.
pubmed: 3802833
Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta-analyses. BMJ. 2003;327:557–60.
pubmed: 12958120
pmcid: 192859
Sutton AJ, Abrams KR, Jones DR, Sheldon TA, Song F. Methods for Meta-Analysis in Medical Research. New York: J. Wiley; 2000.
Mohan BP, Adler DG. Heterogeneity in systematic review and meta-analysis: how to read between the numbers. Gastrointest Endosc. 2019;89:902–3.
pubmed: 30902218
Duval S, Tweedie R. Trim and fill: a simple funnel-plot–based method of testing and adjusting for publication bias in meta-analysis. Biometrics. 2000;56:455–63.
pubmed: 10877304
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;42:685–95.
pubmed: 26201312
pmcid: 5014135
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;43:240–51.
pubmed: 26559637
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.
pubmed: 31409606
Laine L, DeVault K, Katz P, et al. Vonoprazan versus lansoprazole for healing and maintenance of healing of erosive esophagitis: a randomized trial. Gastroenterology. 2022;164:61–71.
pubmed: 36228734
Gralnek IM, Stanley AJ, Morris AJ, et al. Endoscopic diagnosis and management of nonvariceal upper gastrointestinal hemorrhage (NVUGIH): European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2021. Endoscopy. 2021;53:300–32.
pubmed: 33567467
Shaheen NJ, Falk GW, Iyer PG, et al. Guideline to practice: diagnosis and management of Barrett’s esophagus: an updated ACG guideline. Am J Gastroenterol. 2022;117:1177–80.
pubmed: 35467555
pmcid: 10201350
Lightdale CJ, Schmitt C, Hwang C, Hamelin B. A multicenter, randomized, double-blind, 8-week comparative trial of low-dose esomeprazole (20 mg) and standard-dose omeprazole (20 mg) in patients with erosive esophagitis. Dig Dis Sci. 2006;51:852–7.
pubmed: 16773434
Besancon M, Simon A, Sachs G, Shin JM. Sites of reaction of the gastric H,K-ATPase with extracytoplasmic thiol reagents. J Biol Chem. 1997;272:22438–46.
pubmed: 9278394
Sugano K. Vonoprazan fumarate, a novel potassium-competitive acid blocker, in the management of gastroesophageal reflux disease: safety and clinical evidence to date. Therap Adv Gastroenterol. 2018;11:1756283X17745776.
pubmed: 29383028
pmcid: 5784563
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;335:231–8.
pubmed: 20624992
Hori Y, Matsukawa J, Takeuchi T, et al. A study comparing the antisecretory effect of TAK-438, a novel potassium-competitive acid blocker, with lansoprazole in animals. J Pharmacol Exp Ther. 2011;337:797–804.
pubmed: 21411494
Wang Z, Sun R, Sheng Y, et al. Cost-effectiveness analysis of vonoprazan versus proton pump inhibitors in the treatment of reflux esophagitis in China. Ann Transl Med. 2022;10:480.
pubmed: 35571388
pmcid: 9096411
Habu Y. Vonoprazan versus lansoprazole for the initial treatment of reflux esophagitis: a cost-effectiveness analysis in Japan. Intern Med. 2019;58:2427–33.
pubmed: 31178490
pmcid: 6761357
Habu Y, Hamasaki R, Maruo M, et al. Treatment strategies for reflux esophagitis including a potassium-competitive acid blocker: a cost-effectiveness analysis in Japan. J Gen Fam Med. 2021;22:237–45.
pubmed: 34484992
pmcid: 8411401
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;49:140–6.
pubmed: 30589965
Oshima T, Igarashi A, Nakano H, et al. Network meta-analysis comparing vonoprazan and proton pump inhibitors for heartburn symptoms in erosive esophagitis. J Clin Gastroenterol. 2022;56:493–504.
pubmed: 35470298
Cheng Y, Liu J, Tan X, et al. Direct comparison of the efficacy and safety of vonoprazan versus proton-pump inhibitors for gastroesophageal reflux disease: a systematic review and meta-analysis. Dig Dis Sci. 2021;66:19–28.
pubmed: 32095968
Simadibrata DM, Syam AF, Lee YY. A comparison of efficacy and safety of potassium-competitive acid blocker and proton pump inhibitor in gastric acid-related diseases: a systematic review and meta-analysis. J Gastroenterol Hepatol. 2022;37:2217–28.
pubmed: 36181401
pmcid: 10092067
Miyazaki H, Igarashi A, Takeuchi T, et al. Vonoprazan versus proton-pump inhibitors for healing gastroesophageal reflux disease: a systematic review. J Gastroenterol Hepatol. 2019;34:1316–28.
pubmed: 30883868
Tsui M, Rehal S, Jairath V, Kahan BC. Most noninferiority trials were not designed to preserve active comparator treatment effects. J Clin Epidemiol. 2019;110:82–9.
pubmed: 30858020
Verdú EF, Armstrong D, Fraser R, et al. Effect of Helicobacter pylori status on intragastric pH during treatment with omeprazole. Gut. 1995;36:539–43.
pubmed: 7737560
pmcid: 1382493