PMID- 21989146 OWN - NLM STAT- MEDLINE DCOM- 20120103 LR - 20220410 IS - 1572-0241 (Electronic) IS - 0002-9270 (Print) IS - 0002-9270 (Linking) VI - 106 IP - 11 DP - 2011 Nov TI - A randomized study comparing levofloxacin, omeprazole, nitazoxanide, and doxycycline versus triple therapy for the eradication of Helicobacter pylori. PG - 1970-5 LID - 10.1038/ajg.2011.306 [doi] AB - OBJECTIVES: Resistance to standard Helicobacter pylori (HP) treatment regimens has led to unsatisfactory cure rates in HP-infected patients. This study was designed to evaluate a novel four-drug regimen (three antibiotics and a proton pump inhibitor (PPI)) for eradication of HP infection in treatment-naive patients. METHODS: Patients with a diagnosis of HP gastritis or peptic ulcer disease confirmed using endoscopy and stool antigen testing were eligible for inclusion in this study. All patients underwent a washout period of 6 weeks from any prior antibiotic or PPI usage. Patients were then randomized to either levofloxacin, omeprazole, nitazoxanide, and doxycycline (LOAD) therapy for 7 days (LOAD-7) or 10 days (LOAD-10), including levofloxacin 250 mg with breakfast, omeprazole 40 mg before breakfast, nitazoxanide (Alina) 500 mg twice daily with meals and doxycycline 100 mg at dinner, or lansoprozole, amoxicillin, and clarithromycin (LAC) therapy for 10 days, which included lansoprozole 30 mg, amoxicillin 1 g with breakfast and dinner, and clarithromycin 500 mg with breakfast and dinner. HP eradication was confirmed by stool antigen testing at least 4 weeks after cessation of therapy. RESULTS: Intention-to-treat analysis revealed significant differences (P<0.05) in the respective eradication rates of the LOAD therapies (88.9% (80/90) LOAD-10, 90% (81/90) LOAD-7, 89.4% (161/180) for combined LOAD) compared with those receiving LAC, 73.3% (66/90). There were no differences in adverse effects between the groups. CONCLUSIONS: This open-label, prospective trial demonstrates that LOAD is a highly active regimen for the treatment of HP in treatment-naive patients. A large randomized controlled trial is warranted to further evaluate the efficacy of this regimen. FAU - Basu, P Patrick AU - Basu PP AD - Department of Gastroenterology, Hepatology and Liver Transplant, Columbia University, College of Physicians and Surgeons, New York, New York, USA. basu.patrick@gmail.com FAU - Rayapudi, Krishna AU - Rayapudi K FAU - Pacana, Tommy AU - Pacana T FAU - Shah, Niraj James AU - Shah NJ FAU - Krishnaswamy, Nithya AU - Krishnaswamy N FAU - Flynn, Molly AU - Flynn M LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial DEP - 20111011 PL - United States TA - Am J Gastroenterol JT - The American journal of gastroenterology JID - 0421030 RN - 0 (2-Pyridinylmethylsulfinylbenzimidazoles) RN - 0 (Anti-Bacterial Agents) RN - 0 (Anti-Ulcer Agents) RN - 0 (Nitro Compounds) RN - 0 (Proton Pump Inhibitors) RN - 0 (Thiazoles) RN - 0K5C5T2QPG (Lansoprazole) RN - 6GNT3Y5LMF (Levofloxacin) RN - 804826J2HU (Amoxicillin) RN - A4P49JAZ9H (Ofloxacin) RN - H1250JIK0A (Clarithromycin) RN - KG60484QX9 (Omeprazole) RN - N12000U13O (Doxycycline) RN - SOA12P041N (nitazoxanide) SB - IM CIN - Am J Gastroenterol. 2011 Nov;106(11):1976-7. PMID: 22056576 CIN - Am J Gastroenterol. 2012 Jul;107(7):1106-7; author reply 1107. PMID: 22764031 MH - 2-Pyridinylmethylsulfinylbenzimidazoles/therapeutic use MH - Adult MH - Amoxicillin/therapeutic use MH - Anti-Bacterial Agents/administration & dosage/*therapeutic use MH - Anti-Ulcer Agents/administration & dosage/*therapeutic use MH - Clarithromycin/therapeutic use MH - Doxycycline/administration & dosage/therapeutic use MH - Drug Therapy, Combination MH - Female MH - Helicobacter Infections/complications/*drug therapy MH - *Helicobacter pylori MH - Humans MH - Intention to Treat Analysis MH - Lansoprazole MH - Levofloxacin MH - Male MH - Middle Aged MH - Nitro Compounds MH - Ofloxacin/administration & dosage/therapeutic use MH - Omeprazole/administration & dosage/therapeutic use MH - Prospective Studies MH - Proton Pump Inhibitors/administration & dosage/*therapeutic use MH - Recurrence MH - Thiazoles/administration & dosage/therapeutic use MH - Young Adult PMC - PMC3209586 EDAT- 2011/10/13 06:00 MHDA- 2012/01/04 06:00 CRDT- 2011/10/13 06:00 PHST- 2011/10/13 06:00 [entrez] PHST- 2011/10/13 06:00 [pubmed] PHST- 2012/01/04 06:00 [medline] AID - ajg2011306 [pii] AID - 10.1038/ajg.2011.306 [doi] PST - ppublish SO - Am J Gastroenterol. 2011 Nov;106(11):1970-5. doi: 10.1038/ajg.2011.306. Epub 2011 Oct 11.