Korean J Gastroenterol.  2017 Oct;70(4):176-180. 10.4166/kjg.2017.70.4.176.

High and Frequent Dose of Dexlansoprazole and Amoxicillin Dual Therapy for Helicobacter pylori Infections: A Single Arm Prospective Study

• Park HY
• Kang EJ
• Kim DG
• Kim KJ
• Choi JW
• Nam SY
• Kwon YH
• Lee HS
• Jeon SW

• KMID: 2392913
• DOI: http://doi.org/10.4166/kjg.2017.70.4.176

Abstract

BACKGROUND/AIMS
Recently, the eradication rate of Helicobacter pylori (H. pylori) infection has decreased to less than 80% worldwide with the use of clarithromycin-based triple therapy owing to the increased resistance of H. pylori to antibiotics, especially clarithromycin and metronidazole. This prospective study aimed to determine eradication rate of H. pylori following high and frequent doses of extended-release dexlansoprazole and amoxicillin, as a dual therapy in a region with high clarithromycin resistance rate.
METHODS
A total of 50 treatment-naïve patients with active H. pylori infections, who were confirmed through via rapid urease test or histology and serology between November 2015 and February 2016 at our hospital, were included for analysis. All enrolled patients were treated with 750 mg amoxicillin and 30 mg dexlansoprazole, four times a day for a total duration of 14 days. Treatment success was determined using urea breath test four weeks after treatment completion.
RESULTS
Seven out of the 50 patients (29 men and 21 women; mean age, 57 years) dropped out during the study. The total eradication rate was 52% (26/50), and that for those with a compliance rate of over 90% was 68.4% (26/38). H. pylori infections were not successfully eradicated in patients with a compliance rate of less than 90%. Nine patients (18%) reported side effects, such as mild diarrhea and abdominal fullness. No significant factors, such as smoking and alcohol consumption, affected the infection the eradication rate.
CONCLUSIONS
High and frequent doses of proton pump inhibitor-amoxicillin dual therapy were not effective in eradicating H. pylori infection in a province with high clarithromycin resistance rate.

Keyword

Antibiotics; Resistance; Helicobacter pylori; Treatment

MeSH Terms

Alcohol Drinking
Amoxicillin*
Anti-Bacterial Agents
Arm*
Breath Tests
Clarithromycin
Compliance
Dexlansoprazole*
Diarrhea
Female
Helicobacter pylori*
Helicobacter*
Humans
Male
Metronidazole
Prospective Studies*
Proton Pumps
Smoke
Smoking
Urea
Urease
Amoxicillin
Anti-Bacterial Agents
Clarithromycin
Metronidazole
Proton Pumps
Smoke
Urea
Urease

Figure

• 

  Fig. 1. Flow chart of the study. H. pylori, Helicobacter pylori.

Reference

References

1. Maehata Y, Nakamura S, Fujisawa K, et al. Longterm effect of helicobacter pylori eradication on the development of metachronous gastric cancer after endoscopic resection of early gastric cancer. Gastrointest Endosc. 2012; 75:39–46.

2. Fukase K, Kato M, Kikuchi S, et al. Effect of eradication of helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial. Lancet. 2008; 372:392–397.

3. Heo J, Jeon SW. Changes in the eradication rate of conventional triple therapy for helicobacter pylori infection in Korea. Korean J Gastroenterol. 2014; 63:141–145.

4. Graham DY, Fischbach L. Helicobacter pylori treatment in the era of increasing antibiotic resistance. Gut. 2010; 59:1143–1153.

5. Kim KB, Kim YS. Recent trends of helicobacter pylori eradication therapy: focusing on first line treatment. Korean J Helicobacter Up Gastrointest Res. 2014; 14:237–241.

6. Kim JY, Kim N, Park HK, et al. Primary antibiotic resistance of helicobacter pylori strains and eradication rate according to gastroduodenal disease in Korea. Korean J Gastroenterol. 2011; 58:74–81.

7. Horiki N, Omata F, Uemura M, et al. Annual change of primary resistance to clarithromycin among helicobacter pylori isolates from 1996 through 2008 in Japan. Helicobacter. 2009; 14:86–90.

8. Heo J, Jeon SW, Jung JT, et al. A randomised clinical trial of 10-day concomitant therapy and standard triple therapy for helicobacter pylori eradication. Dig Liver Dis. 2014; 46:980–984.

9. Park HG, Jung MK, Jung JT, et al. Randomised clinical trial: a comparative study of 10-day sequential therapy with 7-day standard triple therapy for helicobacter pylori infection in naïve patients. Aliment Pharmacol Ther. 2012; 35:56–65.

10. Kawakami Y, Oana K, Hayama M, et al. In vitro bactericidal activities of Japanese rice-fluid against helicobacter pylori strains. Int J Med Sci. 2006; 3:112–116.

11. Lee JW, Kim N, Kim JM, et al. Prevalence of primary and secondary antimicrobial resistance of helicobacter pylori in Korea from 2003 through 2012. Helicobacter. 2013; 18:206–214.

12. Bayerdorffer E, Mannes GA, Sommer A, et al. High dose omeprazole treatment combined with amoxicillin eradicates helicobacter pylori. Eur J Gastroenterol Hepatol. 1992; 4:697–702.

13. Miehlke S, Mannes G, Lehn N, Hele C, Stolte M, Bayerdörffer E. An increasing dose of omeprazole combined with amoxycillin cures helicobacter pylori infection more effectively. Aliment Pharmacol Ther. 1997; 11:323–329.

14. Yang JC, Lu CW, Lin CJ. Treatment of helicobacter pylori infection: current status and future concepts. World J Gastroenterol. 2014; 20:5283–5293.

15. Yang JC, Lin CJ, Wang HL, et al. High-dose dual therapy is superior to standard first-line or rescue therapy for helicobacter pylori infection. Clin Gastroenterol Hepatol. 2015; 13:895–905.e5.

16. Emerson CR, Marzella N. Dexlansoprazole: a proton pump inhibitor with a dual delayed-release system. Clin Ther. 2010; 32:1578–1596.

17. Metz DC, Vakily M, Dixit T, Mulford D. Review article: dual delayed release formulation of dexlansoprazole MR, a novel approach to overcome the limitations of conventional single release proton pump inhibitor therapy. Aliment Pharmacol Ther. 2009; 29:928–937.

18. Graham DY. Efficient identification and evaluation of effective helicobacter pylori therapies. Clin Gastroenterol Hepatol. 2009; 7:145–148.

19. Graham DY, Javed SU, Keihanian S, Abudayyeh S, Opekun AR. Dual proton pump inhibitor plus amoxicillin as an empiric anti-H. pylori therapy: studies from the United States. J Gastroenterol. 2010; 45:816–820.

20. Attumi TA, Graham DY. High-dose extended-release lansoprazole (dexlansoprazole) and amoxicillin dual therapy for helicobacter pylori infections. Helicobacter. 2014; 19:319–322.

21. Liou JM, Chen CC, Chang CY, et al. Efficacy of genotypic resistance-guided sequential therapy in the third-line treatment of refractory helicobacter pylori infection: a multicentre clinical trial. J Antimicrob Chemother. 2013; 68:450–456.

22. Bayerdörffer E, Miehlke S, Mannes GA, et al. Double-blind trial of omeprazole and amoxicillin to cure helicobacter pylori infection in patients with duodenal ulcers. Gastroenterology. 1995; 108:1412–1417.

23. Murakami K, Furuta T, Ando T, et al. Multi-center randomized controlled study to establish the standard third-line regimen for helicobacter pylori eradication in Japan. J Gastroenterol. 2013; 48:1128–1135.

24. Kim SY, Jung SW, Kim JH, et al. Effectiveness of three times daily lansoprazole/amoxicillin dual therapy for helicobacter pylori infection in Korea. Br J Clin Pharmacol. 2012; 73:140–143.

25. Kim JH. Recent update on third-line helicobacter pylori eradication. Korean J Helicobacter Up Gastrointest Res. 2015; 15:89–94.

26. Francesco VD, Zullo A, Hassan C, Giorgio F, Rosania R, Ierardi E. Mechanisms of helicobacter pylori antibiotic resistance: an updated appraisal. World J Gastrointest Pathophysiol. 2011; 2:35–41.

27. Heo J, Jeon SW. Optimal treatment strategy for helicobacter pylori: era of antibiotic resistance. World J Gastroenterol. 2014; 20:5654–5659.