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Nonbismuth Quadruple "Concomitant" Therapy Versus Standard Triple Therapy, Both of the Duration of 10 Days, for First-Line H. Pylori Eradication: A Randomized Trial.
MedLine Citation:
PMID:  22858517     Owner:  NLM     Status:  Publisher    
GOALS:: To compare the efficacy, compliance, and tolerability of a quadruple, nonbismuth-containing concomitant therapy with standard triple therapy, both of the duration of 10 days, for Helicobacter pylori eradication. BACKGROUND:: Eradication rates obtained with standard therapies are declining as antibiotic resistance becomes more prevalent worldwide. New first-line treatment strategies are needed. STUDY:: Two hundred fifty-seven patients with H. pylori infection were included in the study. Patients were randomized to receive 10-day concomitant therapy comprising esomeprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, and metronidazole 500 mg, all bid, or 10-day standard triple therapy comprising of esomeprazole 40 mg, amoxicillin 1000 mg, and clarithromycin 500 mg, all bid. Cure rates were defined as a negative C urea breath test 8 weeks after the start of treatment. RESULTS:: Two hundred forty-six patients completed the study. The intention-to-treat cure rates were 90.5% [95% confidence interval (CI): 84.1%-95%] and 73.8% (95%CI, 65.6%-80.7%), whereas the per protocol cure rates were 93.3% (95%CI, 87.2% -97.1%) and 78.5% (95%CI, 70.3%-84.9%), respectively. The eradication rate was significantly higher in the concomitant group compared with the triple therapy group in both the intention-to-treat (P=0.0006) and per protocol (P=0.0014) populations. Adverse events were generally of mild/moderate intensity and did not interfere significantly with compliance, which was excellent for both treatment groups (96.6% and 98.5%, respectively, P=0.44). CONCLUSIONS:: Performance of a 10-day conventional triple regimen is suboptimal. A 10-day concomitant regimen achieved a significantly higher eradication rate and seems to be an effective, safe, and well-tolerated treatment option for H. pylori eradication.
Sotirios Georgopoulos; Vasilios Papastergiou; Elias Xirouchakis; Foteini Laoudi; Philipos Lisgos; Charikleia Spiliadi; Nikitas Papantoniou; Stylianos Karatapanis
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-7-31
Journal Detail:
Title:  Journal of clinical gastroenterology     Volume:  -     ISSN:  1539-2031     ISO Abbreviation:  J. Clin. Gastroenterol.     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-8-3     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7910017     Medline TA:  J Clin Gastroenterol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
*Gastroenterology Department, Athens Medical, P. Faliron Hospital, Athens †First Department of Internal Medicine, General Hospital of Rhodes ‡Gastroenterology Department, Euromedica General Clinic, Rhodes, Greece.
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