Document Detail


Continuous maintenance with low-dose lansoprazole versus Helicobacter pylori eradication in the prevention of duodenal ulcer recurrence.
MedLine Citation:
PMID:  9755995     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND/AIMS: Reduction of gastric acid secretion by maintenance treatment with antisecretory agents and eradication of H. pylori by antibiotics constitute the most effective therapeutic options in preventing duodenal ulcer relapse. The aim of this study was to compare the effect of a 12-month low-dose lansoprazole maintenance treatment with H. pylori eradication on the rate of ulcer relapse in H. pylori-positive duodenal ulcer patients. METHODOLOGY: After a healing phase with lansoprazole 30 mg/die or lansoprazole 30-60 mg/die plus antibiotics (amoxycillin, tinidazole and colloidal bismuth subcitrate), 84 patients with healed duodenal ulcer entered the follow-up phase. Thirty-eight patients with persistent H. pylori infection received lansoprazole 15 mg at bedtime, whereas 46 in whom H. pylori was eradicated during the acute phase received no active therapy during the 12-month follow-up. The two groups were well balanced concerning all demographic characteristics. Clinical controls were performed every 3 months or sooner in the event of symptomatic relapse. RESULTS: In terms of per protocol analysis, the overall rate of ulcer relapse at 6 months was 5.5% (2/36) in the maintenance group and 0 (0/42) in the antibiotic group. The corresponding figures at 12 months were 20.5% (7/34) and 5.7% (2/35), respectively (p:ns, 95% CI for the difference -0.30+0.02). On intent to treat analysis, the rate of ulcer relapse at 6 months was 5.2% (2/38) in the first group and 0% (0/46) in the second group: at 12 months the corresponding figures were 19.4% (7/36) and 4.3% (2/46), respectively (p=0.06; CI 95%: +0.016+0.28). No significant side effects were observed during long-term maintenance with lansoprazole. CONCLUSIONS: Continuous maintenance with low-dose lansoprazole may constitute a valuable alternative to H. pylori eradication for the prevention of relapse and complications in duodenal ulcer patients not suitable for, or who have failed, H. pylori eradication.
Authors:
F Parente; S Bargiggia; S Bollani; E Colombo; G Bianchi Porro
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Hepato-gastroenterology     Volume:  45     ISSN:  0172-6390     ISO Abbreviation:  Hepatogastroenterology     Publication Date:    1998 Jul-Aug
Date Detail:
Created Date:  1998-12-09     Completed Date:  1998-12-09     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  8007849     Medline TA:  Hepatogastroenterology     Country:  GREECE    
Other Details:
Languages:  eng     Pagination:  990-3     Citation Subset:  IM    
Affiliation:
Department of Gastroenterology, L.Sacco University Hospital, Milan, Italy.
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MeSH Terms
Descriptor/Qualifier:
2-Pyridinylmethylsulfinylbenzimidazoles
Adult
Anti-Ulcer Agents / therapeutic use*
Drug Administration Schedule
Duodenal Ulcer / drug therapy,  prevention & control*
Female
Follow-Up Studies
Helicobacter Infections / drug therapy*,  prevention & control
Helicobacter pylori*
Humans
Male
Middle Aged
Omeprazole / analogs & derivatives*,  therapeutic use
Recurrence / prevention & control
Treatment Outcome
Chemical
Reg. No./Substance:
0/2-Pyridinylmethylsulfinylbenzimidazoles; 0/Anti-Ulcer Agents; 103577-45-3/lansoprazole; 73590-58-6/Omeprazole

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