Evaluation of a four-drug, three-antibiotic, nonbismuth-containing "concomitant" therapy as first-line Helicobacter pylori eradication regimen in Greece.
BACKGROUND
The eradication rates of Helicobacter pylori (H. pylori) with standard treatments are decreasing worldwide as in Greece. Studies with new antibiotic combinations are needed to find better methods of eradication. Therefore, the aim of this study was to evaluate efficacy and tolerability of a 10-day, four-drug, three-antibiotic, nonbismuth-containing concomitant regimen.


METHODS
This is a prospective, open-label, multicenter study that included 131 patients infected with H. pylori. All patients were diagnosed with peptic ulcer disease or nonulcer dyspepsia by endoscopy. H. pylori infection was established by at least two positive tests among rapid urease test, gastric histology, and (13) C-urea breath test. For 10 days, all patients received esomeprazole 40mg, amoxycillin 1000mg, clarithromycin 500mg, and metronidazole 500mg, all b.d. eradication was assessed with (13) C urea breath test 8weeks after the start of treatment. Intention-to-treat and per-protocol eradication rates were determined.


RESULTS
One hundred and twenty-seven of the 131 patients completed the study. At intention-to-treat analysis, the eradication rate was 91.6% (95% confidence interval (CI), 85.5-95.7%). For the per-protocol analysis, the eradication rate was 94.5% (95% CI, 89-97.8%). Adverse events were noted in 42 of 131 (32.1%); drug compliance was excellent with 96.9% of the patients taking more than 90% of the prescribed medication.


CONCLUSIONS
A 10-day concomitant regimen appears to be an effective, safe, and well-tolerated treatment option for first-line H. pylori eradication in Greece.
Gastroenterology Department, Athens Medical, P. Falliron Hospital, Athens, Greece.
Sotirios
S
Georgopoulos
Vasilios
V
Papastergiou
Elias
E
Xirouchakis
Fotini
F
Laudi
Nikitas
N
Papantoniou
Phillipos
P
Lisgos
Chariklia
C
Spiliadi
Paraskevi
P
Fragou
Lamprini
L
Skorda
Stylianos
S
Karatapanis
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000494:pharmacology / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000494:pharmacology / Q000627:therapeutic use; D017291:Clarithromycin / Q000494:pharmacology / Q000627:therapeutic use; D060740:Disease Eradication; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D006115:Greece / Q000453:epidemiology; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010437:Peptic Ulcer / Q000188:drug therapy; D011446:Prospective Studies
D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D000658:Amoxicillin; D017291:Clarithromycin; D064098:Esomeprazole