Optimized Concomitant Therapy for the First-line Eradication of Helicobacter pylori Infection / 中国药学杂志

OBJECTIVE: To investigate the efficacy, safety and compliance of optimized concomitant therapy for the first-line eradication of Helicobacter pylori infection through a prospective, single-center and open-label cohort study. METHODS: From January 2014 to October 2018, 200 nafive patients with Helicobacter pylori infection and dyspepsia received 14 d concomitant therapy (esomeprazole 40 mg, amoxicillin 1 000 mg, clarithromycin 500 mg and tinidazole 500 mg, twice daily orally). Safety and compliance were assessed 1-3 days after eradication. The therapeutic outcome was determined by 13C-urea breath test 4-8 weeks after eradication. Some patients underwent strain culture, antibiotic sensitivity testing and CYP2C19 polymorphism assay. RESULTS: The eradication rates of optimized concomitant therapy: intention-to-treat analysis 88.0% (95% confidence interval 83.0%-92.0%), modified intention-to-treat analysis 91.2% (87.0%-94.8%) and per-protocol analysis 93.0% (89.2%-96.2%). 43.1% of patients had adverse reactions, the majority were mild to moderate, and only 3.0% of patients discontinued medication because of intolerance to adverse reactions. Patients with good compliance accounted for 94.4%. Variate analyses showed that poor compliance and clarithromycin resistance were the independent risk factors for eradication failure. CONCLUSION: Optimized concomitant therapy (14 d duration and double dose of esomeprazole) achieved good efficacy, safety and compliance for the first-line eradication of Helicobacter pylori infection.

Ten-Day Concomitant, 10-Day Sequential, and 7-Day Triple Therapy as First-Line Treatment for Helicobacter pylori Infection: A Nationwide Randomized Trial in Korea

BACKGROUND/AIMS: This nationwide, multicenter prospective randomized controlled trial aimed to compare the efficacy and safety of 10-day concomitant therapy (CT) and 10-day sequential therapy (ST) with 7-day clarithromycin-containing triple therapy (TT) as first-line treatment for Helicobacter pylori infection in the Korean population. METHODS: Patients with H. pylori infection were assigned randomly to 7d-TT (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 7 days), 10d-ST (lansoprazole 30 mg and amoxicillin 1 g twice daily for the first 5 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg twice daily for the remaining 5 days), or 10d-CT (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 10 days). The primary endpoint was eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. RESULTS: A total of 1,141 patients were included. The 10d-CT protocol achieved a markedly higher eradication rate than the 7d-TT protocol in both the ITT (81.2% vs 63.9%) and PP analyses (90.6% vs 71.4%). The eradication rate of the 10d-ST protocol was superior to that of the 7d-TT protocol (76.3% vs 63.9%, ITT analysis; 85.0% vs 71.4%, PP analysis). No significant differences in adherence or serious side effects were found among the three treatment arms. CONCLUSIONS: The 10d-CT and 10d-ST regimens were superior to the 7d-TT regimen as standard first-line treatment in Korea.

Concomitant or Sequential Therapy as the First-line Therapy for Eradication of Helicobacter pylori Infection in Korea: A Systematic Review and Meta-analysis / 대한소화기학회지

BACKGROUND/AIMS: In Korea, increasing clarithromycin resistance has led to the need for an alternative first-line therapy for the eradication of Helicobacter pylori (H. pylori) infection. Concomitant therapy (CT) and sequential therapy (ST) have been proposed as alternative regimens. The aim of this study was to compare the eradication rate from using CT and ST in Korea. METHODS: A literature review was performed on studies comparing the efficacy of CT and ST in Korea. Data were pooled to obtain the odds ratio (OR) of the eradication rate with 95% confidence intervals (CIs). The eradication rates were considered both on an intention-to-treat (ITT) and a per-protocol (PP) bases. RESULTS: Six studies provided data on 1,897 Korean adult patients. The pooled OR was 1.382 (95% CI: 1.031-1.853, p=0.031) for ITT analysis and 2.114 (95% CI: 1.502-2.974, p < 0.001) for PP analysis. There was no difference in the rate of adverse events and compliances between the two regimens. CONCLUSIONS: The efficacy of CT was superior to ST in both ITT and PP analyses. Therefore, CT could be an excellent alternative regimen for the eradication of H. pylori as a first-line therapy in Korea.

First-line Helicobacter pylori Eradication with Standard Triple Therapy and Concomitant Therapy: A Retrospective Study

BACKGROUND/AIMS: The eradication rate of Helicobacter pylori with standard triple therapy as a first-line treatment has decreased to 70~85%. Recently, concomitant therapy has been reported to overcome this decrease in eradication rate to some degree. The aim of this retrospective study was to compare the efficacy of 7-day concomitant therapy with that of 7-day standard triple therapy as a first-line treatment. MATERIALS AND METHODS: Between March 2013 and February 2017, the medical records of 261 patients who received 7-day standard triple therapy or 7-day concomitant therapy as a first-line H. pylori eradication therapy were retrospectively evaluated. Successful eradication was confirmed using the 13C-urea breath test 6 to 8 weeks after the end of the eradication therapy. RESULTS: This study included 261 patients, 140 patients in the standard triple therapy group and 121 in the concomitant therapy group. The H. pylori eradication rate by intention-to-treat analysis was 60.0% in the standard triple therapy group and 81.0% in the concomitant therapy group (P<0.001). In the per-protocol analysis, the H. pylori eradication rates in the standard triple therapy and concomitant therapy groups were 69.4% and 88.3%, respectively (P<0.001). CONCLUSIONS: Concomitant therapy was more effective as a first-line H. pylori eradication therapy than the standard triple therapy.