RESUMEN
BACKGROUND: Helicobacter pylori (H. pylori) is the most common chronic bacterial infection. Its management has to rely on local effectiveness, given the geographical variability of bacterial antibiotic resistance. We evaluated treatment effectiveness in naïve patients in Greece, as part of the European Registry on the management of H. pylori (Hp-EuReg). METHODS: Patients were registered in the AEG-REDCap Electronic Case Report Form from 2013-2020. All cases with a first-line treatment were included. Modified intention-to-treat (mITT) analysis was used. RESULTS: A total of 547 patients from 5 medical institutions were treated with the following regimens: concomitant with proton pump inhibitors (PPIs), clarithromycin, amoxicillin and metronidazole (concomitant-C+A+M) (38%); hybrid with PPI, clarithromycin, amoxicillin and metronidazole (hybrid-C+A+M) (20%); sequential with PPI, clarithromycin, amoxicillin and tinidazole (sequential-C+A+T) (12%); sequential with PPI, clarithromycin, amoxicillin and metronidazole (sequential-C+A+M) (12%); concomitant with PPI, clarithromycin, amoxicillin and tinidazole (concomitant-C+A+T) (8%); triple with PPI, clarithromycin and amoxicillin (triple-C+A) (7%); and other (3%). Overall compliance was 99%. Triple-C+A, sequential-C+A+T, sequential-C+A+M and concomitant-C+A+T were used from 2013-2015. The respective mITT cure rates (95% confidence interval) were 92% (78-98), 87% (76-94), 67% (54-78) and 91% (79-98). Since 2015, patients were also treated with concomitant-C+A+M and hybrid-C+A+M regimens, with respective mITT cure rates of 90% (85-94) and 88% (80.5-94). Adverse events were reported by 31% of the patients, dysgeusia being the most frequent (15%). CONCLUSIONS: "Optimized" H. pylori therapies should achieve cure rates over 90%. In Greece, at present, only non-bismuth quadruple concomitant regimens achieve this target and can be recommended as first-line treatment.
RESUMEN
BACKGROUND: Concomitant nonbismuth quadruple therapy is recommended as first-line treatment for Helicobacter pylori infection in high clarithromycin resistance areas, but the ideal duration of the regimen remains elusive. Aim of this study was to assess the efficacy and tolerability of 10- versus 14-day concomitant therapy for H. pylori eradication in an area of high clarithromycin and low dual clarithromycin/metronidazole resistance. METHODS: This was a prospective, open-label study including adult patients with H. pylori infection without previous treatment, from September 2014 to June 2017. Concomitant therapy consisting of pantoprazole 40 mg, amoxicillin 1g, clarithromycin 500 mg, and a nitroimidazole 500 mg was administered twice daily for 10 days in the first phase and for 14 days in the second phase of the study. Efficacy and side effects were compared between groups using chi-square and Fisher's exact tests. RESULTS: In per protocol analysis, rates of eradication for the 10- and 14-day regimen were 91.9% (114/124) and 90.9% (110/121), respectively (P = 0.77). In intention to treat analysis, rates of eradication were lower than 90%. Specifically, rates were 86.3% (114/132) for the 10-day regimen and 85.2% (110/129) for the 14-day regimen (P = 0.8). Side effects, present in 31.3% of treated patients, were significantly more common in the 14-day group (P = 0.015). Four patients discontinued treatment, all in the 14-day group. CONCLUSIONS: Ten day concomitant nonbismuth quadruple therapy for H. pylori is highly efficacious and better tolerated than the 14-day regimen. Thus, 10-day therapy may be preferred as first-line treatment in clinical practice.
