Efficacy of 5-Day Levofloxacin -Containing Concomitant Therapy in Eradication of Helicobacter pylori Infection . Gastroenterology, Volume 143, Issue 1, July 2012, Pages 10-12 Alessandro Federico et al. Your Logo.
Efficacy of 5-Day Levofloxacin-Containing Concomitant Therapy in Eradication of Helicobacter pylori Infection
Gastroenterology, Volume 143, Issue 1, July 2012, Pages 10-12
Alessandro Federico et al
To assess whether the infection had been eradicated, H pylori status was reevaluated by 13C-UBT performed by nonmedical personnel unaware of the eradication regimen of each patient at 6 and 10 weeks after completion of therapy.
The test result was considered positive if the difference between the baseline sample and the 30-minute sample exceeded 5.0 parts/1000 of 13co2.
Patients who failed to eradicate the infection were re-treated with a quadruple therapy consisting of esomeprazole 40 mg twice daily plus MET 500 mg 3 times daily plus TET 500 mg 4 times a day plus bismuth subcitrate 240 mg twice daily and underwent a new 13C-UBT after 6 weeks.
The trial was designed as a noninferiority trial. The primary outcome was the ITT H pylori eradication rates for the 2 treatments.
Patients with unsuccessful first-line therapy were treated with bismuth-containing quadruple therapy, which led to eradication of the infection in the 3patients who had not been eradicated of the infection with 5d-QCT and in the 4 patients who had not been eradicated of the infection following 10d-ST.
Symptoms that caused discontinuation of therapy were skin rash and itching in 2 patients after 2 days of treatment and diarrhea, nausea, and vomiting after 3 days of treatment in 2 more patients in the 5d-QCT group; diarrhea and epigastric pain at the third day of the first period caused discontinuation of therapy in 2 patients in the 10d-ST group.
The cost of 5d-QCT, according to the Italian National Health System, was €33.5 ($43.50), whereas the cost of the 10d-ST was €40.2 ($52.30).
Our results are in agreement with a recent study by Wu et al showing that concomitant and sequential therapies were equally effective in the eradication of H pylori infection in patients naïve to treatment. However, unlike our study, both treatments lasted for 10 days, and therefore patients in the concomitant arm of treatment received twice as much of antimicrobials compared with those in the sequential arm.
We performed in vitro antimicrobial susceptibility testing, which confirmed the high prevalence of CLA-, MET-, and dual-resistant H pylori strains together with an approximately 8% prevalence of LEV resistance.
In a recent study by Molina–Infante et al, a 10-day LEV-containing sequential regimen, while showing higher efficacy compared with a 10-day CLA-containing sequential regimen, achieved ITT eradication rates of approximately 85%, which is lower than that reported in our study (ie, 93%).
A limitation to 100% efficiency of eradication regimens is compliance to treatment, mainly due to drug-related adverse events.
A limitation of the study is that only 55% of the participants underwent endoscopy and had assessment of H pylori status at entry by 2 tests on biopsy specimens