Efficacy of 5-Day Levofloxacin-Containing Concomitant Therapy in Eradication of Helicobacter pylori Infection

Background & Aims Helicobacter pylori have become resistant to antimicrobial agents, reducing eradication rates. A 10-day sequential regimen that contains levofloxacin was efficient, safe, and cost saving in eradicating H pylori infection in an area with high prevalence of clarithromycin resista...

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Published in:	Gastroenterology (New York, N.Y. 1943) Vol. 143; no. 1; pp. 55 - 61.e1
Main Authors:	Federico, Alessandro, Nardone, Gerardo, Gravina, Antonietta G, Iovene, Maria Rosaria, Miranda, Agnese, Compare, Debora, Pilloni, Paola A, Rocco, Alba, Ricciardiello, Luigi, Marmo, Riccardo, Loguercio, Carmelina, Romano, Marco
Format:	Journal Article
Language:	English
Published:	United States Elsevier Inc 01-07-2012
Subjects:	Adult Aged Amoxicillin - administration & dosage Anti-Bacterial Agents - administration & dosage Anti-Ulcer Agents - administration & dosage Antibiotic Clinical Trial Bacterial Infection Drug Administration Schedule Drug Therapy, Combination Esomeprazole - administration & dosage Female Fluoroquinolone Gastroenterology and Hepatology Helicobacter Infections - drug therapy Helicobacter pylori Humans Levofloxacin Male Middle Aged Ofloxacin - administration & dosage Prospective Studies Tinidazole - administration & dosage Treatment Outcome Young Adult PP amoxicillin TET 5d-QCT Bacterial Infection ITT PPI intention-to-treat 10-day sequential therapy proton pump inhibitor 5-day quadruple concomitant therapy levofloxacin Fluoroquinolone ST AMO CI tinidazole UBT clarithromycin sequential therapy per-protocol TIN CLA 10d-ST Antibiotic Clinical Trial confidence interval metronidazole tetracycline urea breath test LEV MET
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Summary:	Background & Aims Helicobacter pylori have become resistant to antimicrobial agents, reducing eradication rates. A 10-day sequential regimen that contains levofloxacin was efficient, safe, and cost saving in eradicating H pylori infection in an area with high prevalence of clarithromycin resistance. We performed a noninferiority randomized trial to determine whether a 5-day levofloxacin-containing quadruple concomitant regimen was as safe and effective as the 10-day sequential regimen in eradicating H pylori in previously untreated patients. Methods We randomly assigned patients with H pylori infection to groups that were given 5 days of concomitant therapy (esomeprazole 40 mg twice daily, amoxicillin 1 g twice daily, levofloxacin 500 mg twice daily, and tinidazole 500 mg twice daily; n = 90) or 10 days of sequential therapy (esomeprazole 40 mg twice daily, amoxicillin 1g twice daily for 5 days followed by esomeprazole 40 mg twice daily, levofloxacin 500 mg twice daily, and tinidazole 500 mg twice daily for 5 more days; n = 90). Antimicrobial resistance was assessed by the E-test. Efficacy, adverse events, and costs were determined. Results Intention-to-treat analysis showed similar eradication rates for concomitant (92.2%; 95% confidence interval [CI], 84.0%–95.8%) and sequential therapies (93.3%; 95% CI, 86.9%–97.3%). Per-protocol eradication results were 96.5% (95% CI, 91%–99%) for concomitant therapy and 95.5% for sequential therapy (95% CI, 89.6%–98.5%). The differences between sequential and concomitant treatments were 1.1% in the intention-to-treat study (95% CI; −7.6% to 9.8%) and −1.0% in the per-protocol analysis (95% CI; −8.0% to 5.9%). The prevalence of antimicrobial resistance and incidence of adverse events were comparable between groups. Concomitant therapy cost $9 less than sequential therapy. Conclusions Five days of levofloxacin-containing quadruple concomitant therapy is as effective and safe, and less expensive, in eradicating H pylori infection than 10 days of levofloxacin-containing sequential therapy.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23
ISSN:	0016-5085 1528-0012
DOI:	10.1053/j.gastro.2012.03.043