A comparison between dexlansoprazole modified release–based and lansoprazole-based nonbismuth quadruple (concomitant) therapy for first-line Helicobacter pylori eradication: a prospective randomized trial

Wei-Chen Tai,1 Chih-Ming Liang,1 Kuo-Wei Bi,2 Chung-Mou Kuo,1 Lung-Sheng Lu,1 Cheng-Kun Wu,1 Shih-Cheng Yang,1 Yuan-Hung Kuo,1 Chen-Hsiang Lee,3 Chih-Fang Huang,4 Chien-Ning Hsu,5 Pin-I Hsu,6 Deng-Chyang Wu,7 Tsung-Hui Hu,1,8 Keng-Liang Wu,1,8 Seng-Kee Chuah1,8 1Division of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; 2Division of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; 3Division of Infectious Diseases, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; 4Division of Family Physician, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; 5Department of Pharmacy, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; 6Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Veterans General Hospital, National Yang-Ming University, Kaohsiung, Taiwan; 7Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital and Kaohsiung Medical University, Kaohsiung, Taiwan; 8Chang Gung University College of Medicine, Taoyuan City, TaiwanCorrespondence: Seng-Kee Chuah; Chung-Mou KuoDivision of Hepatogastroenterology, Kaohsiung Chang Gung Memorial Hospital, 123, Ta-Pei Road, Niao-Sung Hsiang, Kaohsiung 833, TaiwanTel +886 7 731 7123 ext. 8301Fax +886 7 732 2402Email chuahsk@seed.net.tw; kuo51116@gmail.comPurpose: Steadily maintaining high intra-gastric PH is the major factor for successful Helicobacter pylori (H.pylori) eradication. It is important to search for a stronger PPI. Dexlansoprazole MR is a dual delayed release formulation PPI taken once daily which is capable of maintaining longer duration of high intra-gastric PH. It is very effective in treating gastroesophageal disease but reports on H, pylori eradication is very rare. This study sought to compare dexlansoprazole MR-based concomitant treatment and lansoprazole-based concomitant treatment in H. pylori infection and to investigate the factors that affect the eradication rates.Methods: Two hundred two participants with H. pylori infection were included and randomly assigned to seven days of dexlansoprazole MR-based concomitant therapy (dexlansoprazole MR 60 mg once daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily; DACM group) or a seven days of lansoprazole-based concomitant therapy (lansoprazole 30 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily, and metronidazole 500 mg twice daily; LACM group). The participants were asked to perform urea breath tests eight weeks later.Results: The eradication rates in the DACM group were 86.1% [95% confidence interval (CI): 77.8%–92.2%] in the ITT analysis and 90.6% (95% CI: 82.9%–95.6%) in the PP analysis, respectively, as compared with 90.1% (95% CI: 82.6%–95.2%) and 92.6% (95% CI: 85.5%–96.9%) (p=0.384 and p=0.572, respectively) in the LACM group for the same analyses. The adverse event rates were 11.5% in the DACM group and 10.2% in the LACM group (p=0.779).Conclusion: As a first-line H. pylori treatment regimen, dexlansoprazole MR-based concomitant therapy attained a successful eradication rate of 90%, which was non inferior to that of lansoprazole-based concomitant treatment.ClinicalTrials.gov identifier: NCT03829150.Keywords: Helicobacter pylori eradication, strong proton-pump inhibitor, dexlansoprazole MR-based concomitant therapy, lansoprazole-based concomitant therapy, antibiotic resistance