Tetracycline-levofloxacin versus amoxicillin-levofloxacin quadruple therapies in the second-line treatment of Helicobacter pylori infection.
Amoxicillin
/ therapeutic use
Anti-Bacterial Agents
/ therapeutic use
Drug Therapy, Combination
Helicobacter Infections
/ drug therapy
Helicobacter pylori
Humans
Levofloxacin
/ therapeutic use
Metronidazole
/ therapeutic use
Proton Pump Inhibitors
/ therapeutic use
Tetracycline
/ therapeutic use
Treatment Outcome
Helicobacter pylori
antibiotic resistance
second-line treatment
tetracycline-levofloxacin quadruple therapy
Journal
Helicobacter
ISSN: 1523-5378
Titre abrégé: Helicobacter
Pays: England
ID NLM: 9605411
Informations de publication
Date de publication:
Oct 2021
Oct 2021
Historique:
revised:
05
06
2021
received:
30
04
2021
accepted:
27
06
2021
pubmed:
15
8
2021
medline:
16
10
2021
entrez:
14
8
2021
Statut:
ppublish
Résumé
The Maastricht V/Florence Consensus Report recommends amoxicillin-fluoroquinolone triple or quadruple therapy as a second-line treatment for Helicobacter pylori infection. An important caveat of amoxicillin-fluoroquinolone rescue therapy is poor eradication efficacy in the presence of fluoroquinolone resistance. The study aimed to investigate the efficacies of tetracycline-levofloxacin (TL) quadruple therapy and amoxicillin-levofloxacin (AL) quadruple therapy in the second-line treatment of H. pylori infection. Consecutive H. pylori-infected subjects after the failure of first-line therapies were randomly allocated to receive either TL quadruple therapy (tetracycline 500 mg QID, levofloxacin 500 mg QD, esomeprazole 40 mg BID, and tripotassium dicitrato bismuthate 300 mg QID) or AL quadruple therapy (amoxicillin 500 mg QID, levofloxacin 500 mg QD, esomeprazole 40 mg BID, and tripotassium dicitrato bismuthate 300 mg QID) for 10 days. Post-treatment H. pylori status was assessed 6 weeks after the end of therapy. The study was early terminated after an interim analysis. In the TL quadruple group, 50 out of 56 patients (89.3%) had successful eradication of H. pylori infection. Cure of H. pylori infection was achieved only in 39 of 52 patients (69.6%) receiving AL quadruple therapy. Intention-to-treat analysis showed that TL quadruple therapy achieved a markedly higher eradication rate than AL quadruple therapy (95% confidence interval: 4.8% to 34.6%; p = 0.010). Further analysis revealed that TL quadruple therapy had a high eradication rate for both levofloxacin-susceptible and resistant strains (100% and 88.9%). In contrast, AL quadruple therapy yielded a high eradication for levofloxacin-susceptible strains (90.9%) but a poor eradication efficacy for levofloxacin-resistant strains (50.0%). The two therapies exhibited comparable frequencies of adverse events (37.5% vs 21.4%) and drug adherence (98.2% vs 94.6%). Ten-day TL quadruple therapy is more effective than AL quadruple therapy in the second-line treatment of H. pylori infection in a population with high levofloxacin resistance.
Sections du résumé
BACKGROUND
BACKGROUND
The Maastricht V/Florence Consensus Report recommends amoxicillin-fluoroquinolone triple or quadruple therapy as a second-line treatment for Helicobacter pylori infection. An important caveat of amoxicillin-fluoroquinolone rescue therapy is poor eradication efficacy in the presence of fluoroquinolone resistance. The study aimed to investigate the efficacies of tetracycline-levofloxacin (TL) quadruple therapy and amoxicillin-levofloxacin (AL) quadruple therapy in the second-line treatment of H. pylori infection.
METHODS
METHODS
Consecutive H. pylori-infected subjects after the failure of first-line therapies were randomly allocated to receive either TL quadruple therapy (tetracycline 500 mg QID, levofloxacin 500 mg QD, esomeprazole 40 mg BID, and tripotassium dicitrato bismuthate 300 mg QID) or AL quadruple therapy (amoxicillin 500 mg QID, levofloxacin 500 mg QD, esomeprazole 40 mg BID, and tripotassium dicitrato bismuthate 300 mg QID) for 10 days. Post-treatment H. pylori status was assessed 6 weeks after the end of therapy.
RESULTS
RESULTS
The study was early terminated after an interim analysis. In the TL quadruple group, 50 out of 56 patients (89.3%) had successful eradication of H. pylori infection. Cure of H. pylori infection was achieved only in 39 of 52 patients (69.6%) receiving AL quadruple therapy. Intention-to-treat analysis showed that TL quadruple therapy achieved a markedly higher eradication rate than AL quadruple therapy (95% confidence interval: 4.8% to 34.6%; p = 0.010). Further analysis revealed that TL quadruple therapy had a high eradication rate for both levofloxacin-susceptible and resistant strains (100% and 88.9%). In contrast, AL quadruple therapy yielded a high eradication for levofloxacin-susceptible strains (90.9%) but a poor eradication efficacy for levofloxacin-resistant strains (50.0%). The two therapies exhibited comparable frequencies of adverse events (37.5% vs 21.4%) and drug adherence (98.2% vs 94.6%).
CONCLUSIONS
CONCLUSIONS
Ten-day TL quadruple therapy is more effective than AL quadruple therapy in the second-line treatment of H. pylori infection in a population with high levofloxacin resistance.
Substances chimiques
Anti-Bacterial Agents
0
Proton Pump Inhibitors
0
Metronidazole
140QMO216E
Levofloxacin
6GNT3Y5LMF
Amoxicillin
804826J2HU
Tetracycline
F8VB5M810T
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
e12840Subventions
Organisme : Kaohsiung Veterans General Hospital
ID : VGHKS 108-105
Organisme : An Nan Hospital, China Medical University
ID : ANHRF 109-07,
Organisme : An Nan Hospital, China Medical University
ID : ANHRF 109-13 and ANHRF 110-18
Organisme : Ministry of Science and Technology, Executive Yuan, Taiwan, ROC
ID : MOST108-2314-B075B-006
Organisme : Ministry of Science and Technology, Executive Yuan, Taiwan, ROC
ID : MOST109-2314-B075B-007
Informations de copyright
© 2021 John Wiley & Sons Ltd.
Références
Suerbaum S, Michetti P. Helicobacter pylori infection. N Engl J Med. 2002;347:1175-1186.
Malfertheiner P, Chan FK, McColl KE. Peptic ulcer disease. Lancet. 2009;374:1449-1461.
Sung JJY, Chung SCS, Ling TKW, et al. Antibacterial treatment of gastric ulcer associated with Helicobacter pylori. N Eng J Med. 1995;332:139-142.
Ford AC, Forman D, Hunt RH, et al. Helicobacter pylori eradication therapy to prevent gastric cancer in healthy asymptomatic infected individuals: systematic review and meta-analysis of randomized controlled trials. BMJ. 2014;348: g3174.
Chuah YY, Wu CC, Chuah SK, et al. Real-world practice and Expectation of Asia-Pacific physicians and patients in Helicobacter pylori eradication (REAP-HP Survey). Helicobacter. 2017;22:1-9. https://doi.org/10.1111/hel.12380
Gumurdulu Y, Serin E, Ozer B, et al. Low eradication rate of Helicobacter pylori with triple 7-14 days and quadruple therapy in Turkey. World J Gastroenterol. 2004;10:668-671.
Bigard MA, Delchier JC, Riachi G, et al. One-week triple therapy using omeprazole, amoxycillin and clarithromycin for the eradication of Helicobacter pylori in patients with non-ulcer dyspepsia: influence of dosage of omeprazole and clarithromycin. Aliment Pharmacol Ther. 1998;12:383-388.
Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010;59:1143-1153.
Saleem N, Howden CW. Update on the management of Helicobacter pylori infection. Curr Treat Options Gastroenterol. 2020;7:1-12.
Hsu PI, Wu DC, Wu JY, et al. Modified sequential Helicobacter pylori therapy: proton pump inhibitor and amoxicillin for 14 days with clarithromycin and metronidazole added as a quadruple (hybrid) therapy for the final 7 days. Helicobacter. 2011;16:139-145.
Wu DC, Hsu PI, Wu JY, et al. Sequential and concomitant therapies with 4 drugs are equally effective for eradication of H pylori Infection. Clin Gastroenterol Hepatol. 2010;8:36-41.
Malfertheiner P, Megraud F, O’Morain CA, et al. Management of Helicobacter pylori infection - The Maastricht V/ Florence Consensus Report. Gut. 2017;66:6-30.
Chey WD, Leontiadis GI, Howden CW, et al. ACG clinical guideline: treatment of Helicobacter pylori infection. Am J Gastroenterol. 2017;112:212-238.
Fallone CA, Chiba N, van Zanten SV, et al. The Toronto consensus for the treatment of Helicobacter pylori infection in adults. Gastroenterology. 2016;151:61-69.
Di Caro S, Fini L, Daoud Y, et al. Levofloxacin/amoxicillin-based schemes vs quadruple therapy for Helicobacter pylori eradication in second-line. World J Gastroenterol. 2012;18:5669-5678.
Liang CM, Tai WC, Hsu PI, et al. Trend of changes in antibiotic resistance in Helicobacter pylori from 2013 to 2019: a multicentre report from Taiwan. Therap Adv Gastroenterol. 2020;13:1756284820976990.
Wu IT, Chuah SK, Lee CH, et al. Five-year sequential changes in secondary antibiotic resistance of Helicobacter pylori in Taiwan. World J Gastroenterol. 2015;21:10669-10674.
Wu DC, Hsu PI, Chen A, et al. Randomized comparison of two rescue therapies for Helicobacter pylori infection. Eur J Clin Invest. 2006;36:803-809.
Liou JM, Bair MJ, Chen CC, et al. Levofloxacin sequential therapy vs levofloxacin triple therapy in the second-line treatment of Helicobacter pylori: a randomized trial. Am J Gastroenterol. 2016;111:381-387.
Lin TF, Hsu PI. Second-line rescue treatment of Helicobacter pylori infection: Where are we now? World J Gastroenterol. 2018;24:4548-4553.
Hsu PI, Chen WC, Tsay FW, et al. Ten-day quadruple therapy comprising proton-pump inhibitor, bismuth, tetracycline, levofloxacin achieves a high eradication rate for Helicobacter pylori infection after failure of sequential therapy. Helicobacter. 2014;19:74-79.
Hsu PI, Tsai FW, Kao SS, et al. Ten-day quadruple therapy comprising proton pump inhibitor, bismuth, tetracycline, and levofloxacin is more effective than standard evofloxacin triple therapy in the second-line treatment of Helicobacter pylori infection: a randomized controlled trial. Am J Gastroenterol. 2017;112:1374-1381.
Hsu PI, Wu DC, Wu JY, et al. Is there a benefit to extending the duration of Helicobacter pylori sequential therapy to 14 days? Helicobacter. 2011;16:146-152.
Hsu PI, Wu DC, Chen WC, et al. Comparison of 7-day triple, 10-day sequential and 7-day concomitant therapies for Helicobacter pylori infection - a randomized controlled trial. Antimicrob Agents Chemother. 2014;214:5936-5942.
Hsu PI, Tsay FW, Kao JY, et al. Equivalent efficacies of reverse hybrid and concomitant therapies in first-line treatment of Helicobacter pylori infection. J Gastroenterol Hepatol. 2020;35:1731-1737.
Kita T, Sakaeda T, Aoyama N, et al. Optimal dose of omeprazole for CYP2C19 extensive metabolizers in anti-Helicobacter pylori therapy: pharmacokinetic considerations. Biol Pharm Bull. 2002;25:923-927.
Wu DC, Kuo CH, Tsay FW, et al. A pilot randomized controlled study of dexlansoprazole MR-based triple therapy for Helicobacter pylori infection. Medicine (Baltimore). 2016;95:e2698.
Gao X-Z, Qiao X-L, Song W-C, et al. Standard triple, bismuth pectin quadruple and sequential therapies for Helicobacter pylori eradication. World J Gastroenterol. 2010;16:4357-4362.
Kuo CH, Hu HM, Kuo FC, et al. Efficacy of levofloxacin-based rescue therapy for Helicobacter pylori infection after standard triple therapy: a randomized controlled trial. J Antimicrob Chemother. 2009;63:1017-1024.
Marin AC, McNicholl AG, Gisbert JP. A review of rescue regimens after clarithromycin-containing triple therapy failure for Helicobacter pylori eradication. Expert Opin Pharmacother. 2013;14:843-861.
Gisbert JP, Molina-Infante J, Marin AC, et al. Second-line rescue triple therapy with levofloxacin after failure of non-bismuth quadruple ‘sequential’ or ‘concomitant’ treatment to eradicate H. pylori infection. Gastroenterology. 2014;146:S394.
Liao J, Zheng Q, Liang X, et al. Effect of fluoroquinolone resistance on 14-day levofloxacin triple and triple plus bismuth quadruple therapy. Helicobacter. 2013;18:373-377.
Graham DY, Lee SY. How to effectively use bismuth quadruple therapy: the good, the bad, and the ugly. Gastroenterol Clin N Am. 2015;44:537-563.
Weel I, Chin B, Syn N, et al. The association between fluoroquinolones and aortic dissection and aortic aneurysms: a systematic review and meta-analysis. Sci Rep. 2021;11:11073.
Gatti M, Bianchin M, Raschi E, et al. Assessing the association between fluoroquinolones and emerging adverse drug reactions raised by regulatory agencies: an umbrella review. Eur J Intern Med. 2020;75:60-70.
Thung I, Aramin H, Vavinskaya V, et al. The global emergence of Helicobacter pylori antibiotic resistance. Aliment Pharmacol Ther. 2016;43:514-533.
Savoldi A, Carrara E, Graham DY, et al. Prevalence of antibiotic resistance in Helicobacter pylori: a systematic review and meta-analysis in World Health Organization regions. Gastroenterology. 2018;155:1372-1382.