14 Day sequential therapy versus 10 day bismuth quadruple therapy containing high-dose esomeprazole in the first-line and second-line treatment of Helicobacter pylori: A multicentre, non-inferiority, randomized trial
Journal
Journal of Antimicrobial Chemotherapy
Journal Volume
73
Journal Issue
9
Pages
2510-2518
Date Issued
2018
Author(s)
Chen P.-Y.
Chang C.-Y.
Chou C.-K.
Tseng C.-H.
Lee J.-Y.
Yang T.-H.
Chiu M.-C.
Yu J.-J.
Kuo C.-C.
Luo J.-C.
Tsai M.-H.
Lin J.-T.
Twu G.
Bair M.-J.
Taiwan Gastrointestinal Disease and Helicobacter Consortium
Helicobacter Consortium
Abstract
Background: Whether extending the treatment length and the use of high-dose esomeprazole may optimize the efficacy of Helicobacter pylori eradication remains unknown. Objectives: To compare the efficacy and tolerability of optimized 14 day sequential therapy and 10 day bismuth quadruple therapy containing high-dose esomeprazole in first-line therapy. Methods: We recruited 620 adult patients (?20 years of age) with H. pylori infection naive to treatment in this multicentre, open-label, randomized trial. Patients were randomly assigned to receive 14 day sequential therapy or 10 day bismuth quadruple therapy, both containing esomeprazole 40mg twice daily. Those who failed after 14 day sequential therapy received rescue therapy with 10 day bismuth quadruple therapy and vice versa. Our primary outcome was the eradication rate in the first-line therapy. Antibiotic susceptibility was determined. ClinicalTrials.gov: NCT03156855. Results: The eradication rates of 14 day sequential therapy and 10 day bismuth quadruple therapy were 91.3% (283 of 310, 95% CI 87.4%-94.1%) and 91.6%(284 of 310, 95% CI 87.8%-94.3%) in the ITT analysis, respectively (difference -0.3%, 95% CI -4.7% to 4.4%, P=0.886). However, the frequencies of adverse effects were significantly higher in patients treated with 10 day bismuth quadruple therapy than those treated with 14 day sequential therapy (74.4% versus 36.7%P,0.0001). The eradication rate of 14 day sequential therapy in strains with and without 23S ribosomal RNA mutation was 80% (24 of 30) and 99% (193 of 195), respectively (P < 0.0001). Conclusions: Optimized 14 day sequential therapy was non-inferior to, but better tolerated than 10 day bismuth quadruple therapy and both may be used in first-line treatment in populations with low to intermediate clarithromycin resistance. ? The Author(s) 2018.
SDGs
Other Subjects
amoxicillin; bismuth citrate; clarithromycin; esomeprazole; levofloxacin; metronidazole; RNA 23S; tetracycline; antacid agent; antiinfective agent; antiulcer agent; bismuth; esomeprazole; abdominal pain; abnormal feces; adult; antibiotic resistance; antibiotic sensitivity; antibiotic therapy; Article; bacterial strain; bloating; comparative effectiveness; constipation; controlled study; diarrhea; disease eradication; dizziness; double blind procedure; drug eruption; drug induced headache; drug megadose; drug safety; drug tolerability; eradication therapy; female; gene mutation; Helicobacter infection; Helicobacter pylori; human; intention to treat analysis; major clinical study; male; middle aged; multicenter study; nausea; non-inferiority trial; open study; outcome assessment; patient compliance; randomized controlled trial; taste disorder; tongue disease; treatment duration; vomiting; adverse drug reaction; adverse event; aged; clinical trial; combination drug therapy; comparative study; Helicobacter infection; Helicobacter pylori; isolation and purification; procedures; treatment outcome; very elderly; young adult; Adult; Aged; Aged, 80 and over; Antacids; Anti-Bacterial Agents; Anti-Ulcer Agents; Bismuth; Drug Therapy, Combination; Drug-Related Side Effects and Adverse Reactions; Esomeprazole; Helicobacter Infections; Helicobacter pylori; Humans; Middle Aged; Treatment Outcome; Young Adult
Type
journal article