Pylera® plus ranitidine vs Pylera® plus esomeprazole in first-line treatment of Helicobacter pylori infection: Two pilot studies

Background: Several studies have shown that Pylera^® (three-in-one capsules containing 140 mg bismuth potassium subcitrate, 125 metronidazole, and Tetracycline 125 mg) in association with omeprazole or esomeprazole is a good option in the treatment of Helicobacter pylori Infection. In particular, the adjunction of a PPI to Pylera^® may be useful to overcome metronidazole resistance. However, omeprazole and its derivatives can promote greater bismuth absorption and enhance its toxicity. The H2 receptor antagonist (H2RA) ranitidine seems to induce less bismuth absorption and as a consequence less systemic toxicity.

Aim: To evaluate whether Pylera^® in combination with esomeprazole or with ranitidine is equally effective in the treatment of H. pylori Infection.

Material and methods: Two separate groups of patients were treated simultaneously. One group was treated with Pylera^® three capsules qid plus esomeprazole 40 mg bid for 10 days (group A), and the Other group was treated with Pylera^® three capsules qid plus ranitidine 300 mg bid for 10 days (group B). H. pylori eradication was defined as a negative result in ¹³ C urea breath test performed at least 8 weeks after the end of treatment with a delta-over-baseline value less than 5.

Results: Thirty-two patients were recruited for group A and thirty-three patients in group B. Eradication rates were 93.7% (30/32) and 90.9% (30/33), respectively, at intention-to-treat analysis, and 96.6% (29/30) and 93.3% (28/30), respectively, at per-protocol analysis. Adverse events occurred in 26 patients and led to the suspension of treatment in one patient in group A and in one patient in group B.

Conclusion: The results showed that Pylera® plus a PPI or ranitidine were equally effective in the population studied. The high cure rates of bismuth triple therapy (without an antisecretory drug) and the lack of susceptibility testing make it impossible to exclude the possibility that the results would have been similar if neither the PPI nor the ranitidine were given.