Short-course therapy with amoxycillin-clarithromycin triple therapy for 10 days (ACT-10) eradicates Helicobacter pylori and heals duodenal ulcer. ACT-10 Study Group.
BACKGROUND
Whilst the role of Helicobacter pylori eradication in managing duodenal ulcers has been established, consensus regarding the ideal regimen has not been achieved.


METHODS
Patients with H. pylori-positive active duodenal ulcer were randomly assigned to receive triple therapy with amoxycillin 1000 mg b.d. + clarithromycin 500 mg b.d. + omeprazole 20 mg daily for 10 days (ACT-10) or dual therapy with clarithromycin 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 13C-urea breath testing (13C-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 antral biopsies), and 13C-UBT. Ulcer healing by endoscopy and change in clinical symptoms were also assessed at 4-6 weeks.


RESULTS
Two hundred and sixty-seven (267) patients were randomized to ACT-10 (n = 137) or Dual therapy (n = 130). By per-protocol and intention-to-treat analyses, H. pylori eradication at 4-6 weeks follow-up was 91% (115/127) and 88% (120/136), respectively, for ACT-10 patients and 59% (68/115) and 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, 91% (104/114) and 85% (111/130), respectively. Pre-treatment resistance to clarithromycin was low (4%, 8/214) as compared to metronidazole resistance which was over 40%. Emergence of resistance to clarithromycin was observed in 2% of patients receiving ACT-10 and in 25% of those receiving Dual therapy. ACT-10 and Dual therapy patients experienced similar 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 prescribed medication.


CONCLUSIONS
In patients with active duodenal ulcer, a 10-day course of amoxycillin-clarithromycin-based triple therapy without additional acid suppression is highly effective in eradicating H. pylori and healing duodenal ulcer.
Wurzer
H
H
Department of Gastroenterology, Landeskrankenhaus-Universitaetskliniken, Graz, Austria.
Rodrigo
L
L
Stamler
D
D
Archambault
A
A
Rokkas
T
T
Skandalis
N
N
Fedorak
R
R
Bazzoli
F
F
Hentschel
E
E
Mora
P
P
Archimandritis
A
A
Megraud
F
F
D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002170:Canada; D017291:Clarithromycin / Q000627:therapeutic use*; D004311:Double-Blind Method; D004352:Drug Resistance, Microbial; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000473:pathology; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D005060:Europe; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000494:pharmacology; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010406:Penicillins / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors
D000900:Anti-Bacterial Agents; D004791:Enzyme Inhibitors; D010406:Penicillins; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole