Background: Triple therapy including a proton pump inhibitor, clarithromycin, and amoxicillin (PPI-CA) is the first-choice treatment used for H. pylori eradication. The efficacy of this treatment is declining of late, and alternative therapies are currently under evaluation.
Objectives: To evaluate the efficacy, safety and compliance of a triple therapy with a PPI, amoxicillin and levofloxacin (PPI-LA)--replacing clarithromycin--for the eradication of H. pylori.
Methods: The study included 135 patients (65% women), mean age 53 years, with dyspeptic symptoms and H. pylori infection proven by a positive urease rapid test, histological analysis, or C13-urea breath test.
Diagnosis: non-investigated dyspepsia 48.9%, functional dyspepsia 36.3%, and ulcerative dyspepsia 14.8%. Treatment was indicated with a proton pump inhibitor at usual doses, amoxicillin 1 g, and levofloxacin 500 mg, administered jointly during breakfast and dinner for 10 days. We studied the performance of this triple therapy and its effects using a questionnaire, and effectiveness by the negativity of the C13-urea breath test after 6-8 weeks after treatment discontinuation. Per protocol, we compared the effectiveness of PPI-LA with a control group of 270 patients treated with PPI-CA for 10 days.
Results: 130 patients (96.2%) could complete the treatment and follow-up protocol. Effectiveness (intention to treat) was 71.8% (97/135) and 74.6% (per protocol) (97/130). Sixteen patients (11.8%) had well-tolerated adverse effects, except for 5 subjects (3.7%) who dropped out. PPI-CA was effective (per protocol) in 204 patients out of 270 (75.5%) in the control group.
Conclusions: Triple therapy with a PPI, amoxicillin and levofloxacin for 10 days is a well-tolerated treatment that is easy to comply with; however it has low efficiency - less than 80% - and is not recommended as a first-choice treatment for H. pylori eradication. Similar results were obtained with the classic triple therapy using a PPI, clarithromycin and amoxicillin.