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The clinical safety of long‐term lansoprazole for the maintenance of healed erosive oesophagitis
Author(s) -
FRESTON J. W.,
HISADA M.,
PEURA D. A.,
HABER M. M.,
KOVACS T. O.,
ATKINSON S.,
HUNT B.
Publication year - 2009
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2009.03998.x
Subject(s) - lansoprazole , medicine , adverse effect , gastroenterology , clinical trial , abdominal pain , surgery , omeprazole
Summary 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 ≥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.