SHORT-COURSE THERAPY WITH AMOXICILLIN-CLARITHROMYCIN TRIPLE THERAPY FOR 10 DAYS (ACT-10) ERADICATES HELICOBACTER-PYLORI AND HEALS DUODENAL-ULCER

Background: Whilst the role of Helicobacter pylori eradication in mana ging duodenal ulcers has been established, consensus regarding the ide al regimen has not been achieved, Methods: Patients with H. pylori-pos itive active duodenal ulcer were randomly assigned to receive triple t herapy with amoxycillin 1000 mg b.d. + clarithromycin 500 mg b.d. + om eprazole 20 mg daily for 10 days (ACT-10) or dual therapy with clarith romycin 500 mg t.d.s. + omeprazole 40 mg daily for 14 days (Dual), No additional acid suppression was provided following eradication therapy , Endoscopy, with biopsy for culture and histology, as well as C-13-ur ea breath testing (C-13-UBT) were performed pre-treatment to assess H. pylori infection. H. pylori eradication was established at 4-6 weeks follow-up with culture (2 antral, 1 corpus biopsies), histology (2 ant ral biopsies), and C-13-UBT. Ulcer healing by endoscopy and change in clinical symptoms were also assessed at 4-6 weeks, Results: Two hundre d and sixty-seven (267) patients were randomized to ACT-10 (n = 137) o r Dual therapy (n = 130). By per-protocol and intention-to-treat analy ses, H. pylori eradication at 4-6 weeks follow-up was 91% (115/127) an d 88% (120/136), respectively, for ACT-10 patients and 59% (68/115) an d 55% (72/130), respectively, for Dual therapy patients (P < 0.001 for both analyses), Ulcer healing was high in both treatment groups: ACT- 10, 93% (118/127) and 90% (122/136), respectively; and Dual therapy, 9 1% (104/114) and 85% (111/130), respectively, Pretreatment resistance to clarithromycin was low (4%, 8/214) as compared to metronidazole res istance which was over 40%. Emergence of resistance to clarithromycin was observed in 2% of patients receiving ACT-10 and in 25% of those re ceiving Dual therapy, ACT-10 and Dual therapy patients experienced sim ilar rates of drug-related adverse events (33% vs. 32%, respectively) and discontinuation from therapy due to an adverse event (1.5% vs. 5%, respectively). More than 90% of patients were compliant with each pre scribed medication, Conclusion: In patients with active duodenal ulcer , a 10-day course of amoxycillin-clarithromycin-based triple therapy w ithout additional acid suppression is highly effective in eradicating H. pylori and healing duodenal ulcer.