| The clinical safety of long-term lansoprazole for the maintenance of healed erosive oesophagitis. | |
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MedLine Citation:
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PMID: 19416133 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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J W Freston; M Hisada; D A Peura; M M Haber; T O Kovacs; S Atkinson; B Hunt |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Date: 2009-03-17 |
Journal Detail:
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Title: Alimentary pharmacology & therapeutics Volume: 29 ISSN: 1365-2036 ISO Abbreviation: Aliment. Pharmacol. Ther. Publication Date: 2009 Jun |
Date Detail:
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Created Date: 2009-05-27 Completed Date: 2010-02-22 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8707234 Medline TA: Aliment Pharmacol Ther Country: England |
Other Details:
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Languages: eng Pagination: 1249-60 Citation Subset: IM |
Affiliation:
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Department of Medicine, University of Connecticut Health Center, Farmington, CT, USA. |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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2-Pyridinylmethylsulfinylbenzimidazoles
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adverse effects* Adult Aged Aged, 80 and over Anti-Ulcer Agents / adverse effects* Esophagitis / drug therapy* Female Follow-Up Studies Humans Male Middle Aged Recurrence Time Factors Treatment Outcome Young Adult |
| Chemical | |
Reg. No./Substance:
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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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