SPIRAMYCIN IN TRIPLE THERAPY OF HELICOBACTER-PYLORI-ASSOCIATED PEPTIC-ULCER DISEASE - AN OPEN PILOT-STUDY WITH 12-MONTH FOLLOW-UP

Background: Spiramycin (Rovamycin) is a well-established macrolide ant ibiotic with good anti-Helicobacter pylori activity in vitro. It is ac id-stable and found in high concentration in various body fluids and c ells after oral administration. Its anti-H. pylori activity in vivo ha s not yet been tested. Methods: Twenty-five consecutive patients with endoscopically verified peptic ulcer and a positive biopsy urease test were given spiramycin tables 1.5 MIU instead of oxytetracycline 500 m g q.d.s. in our triple therapy regimen with bismuth subnitrate suspens ion 10 mL (150 mg bismuth subnitrate) q.d.s. and metronidazole 400 mg t.d.s. for 10 days. Bismuth was taken between meals and spiramycin and metronidazole with meals. Re-endoscopy and C-14-urea breath test were performed 4 weeks after completion of therapy. Those who were H. pylo ri negative according to the breath test returned for 1-year follow-up . Results: Per protocol analysis at 4 weeks showed that 21 out of 23 p atients were H. pylori negative and had healed ulcers. These 21 patien ts were persistingly H. pylori negative and had no ulcers at 1-year fo llowup. H. pylori eradication and ulcer healing rates were thus 91.3%; 95% confidence interval from 72.0% to 98.9%. Side-effects limiting da ily activity were significantly less frequent than we have experienced previously using oxytetracycline in triple therapy. Conclusions: Spir amycin appears to be an alternative to tetracycline in the triple ther apy of H. pylori infection. Further studies to position spiramycin as an anti-H. pylori drug are warranted.