Document Detail

The clinical safety of long-term lansoprazole for the maintenance of healed erosive oesophagitis.
MedLine Citation:
PMID:  19416133     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: The clinical safety of long-term lansoprazole therapy for the maintenance of healed erosive oesophagitis has not been extensively studied in clinical trials. AIM: To assess the long-term clinical safety of dose-titrated lansoprazole as maintenance therapy for up to 82 months in subjects with healed erosive oesophagitis. METHODS: Clinical safety was assessed by monitoring adverse events (AEs), laboratory data including serum gastrin levels, and endoscopy. RESULTS: Mean duration (+/- s.d.) of lansoprazole treatment during the titrated open-label period was 56 +/- 24 months (range <1-82 months). Overall, 189 of 195 (97%) subjects experienced a total of 2825 treatment-emergent AEs. Most AEs occurred during the first year of treatment, were mild-to-moderate in severity and resolved while on treatment. Of 155 serious AEs (in 74 subjects), only two (colitis and rectal haemorrhage in one subject) were considered treatment-related. Sixty-nine of 195 subjects (35%) experienced 187 treatment-related AEs, with diarrhoea (10%), headache (8%) and abdominal pain (6%) being the most common. Gastrin levels > or = 400 pg/mL were seen in 9% of subjects; hypergastrinemia was not associated with gastro-intestinal AEs or nodules/polyps. CONCLUSIONS: Lansoprazole maintenance therapy for up to 6 years is safe and well tolerated in subjects with healed erosive oesophagitis.
J W Freston; M Hisada; D A Peura; M M Haber; T O Kovacs; S Atkinson; B Hunt
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2009-03-17
Journal Detail:
Title:  Alimentary pharmacology & therapeutics     Volume:  29     ISSN:  1365-2036     ISO Abbreviation:  Aliment. Pharmacol. Ther.     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-05-27     Completed Date:  2010-02-22     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8707234     Medline TA:  Aliment Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  1249-60     Citation Subset:  IM    
Department of Medicine, University of Connecticut Health Center, Farmington, CT, USA.
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MeSH Terms
2-Pyridinylmethylsulfinylbenzimidazoles / adverse effects*
Aged, 80 and over
Anti-Ulcer Agents / adverse effects*
Esophagitis / drug therapy*
Follow-Up Studies
Middle Aged
Time Factors
Treatment Outcome
Young Adult
Reg. No./Substance:
0/2-Pyridinylmethylsulfinylbenzimidazoles; 0/Anti-Ulcer Agents; 103577-45-3/lansoprazole

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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