PMID- 19416133
OWN - NLM
STAT- MEDLINE
DCOM- 20100222
LR  - 20131121
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 29
IP  - 12
DP  - 2009 Jun 15
TI  - The clinical safety of long-term lansoprazole for the maintenance of healed 
      erosive oesophagitis.
PG  - 1249-60
LID - 10.1111/j.1365-2036.2009.03998.x [doi]
AB  - 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.
FAU - Freston, J W
AU  - Freston JW
AD  - Department of Medicine, University of Connecticut Health Center, Farmington, CT, 
      USA.
FAU - Hisada, M
AU  - Hisada M
FAU - Peura, D A
AU  - Peura DA
FAU - Haber, M M
AU  - Haber MM
FAU - Kovacs, T O
AU  - Kovacs TO
FAU - Atkinson, S
AU  - Atkinson S
FAU - Hunt, B
AU  - Hunt B
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20090317
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (2-Pyridinylmethylsulfinylbenzimidazoles)
RN  - 0 (Anti-Ulcer Agents)
RN  - 0K5C5T2QPG (Lansoprazole)
SB  - IM
MH  - 2-Pyridinylmethylsulfinylbenzimidazoles/*adverse effects
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anti-Ulcer Agents/*adverse effects
MH  - Esophagitis/*drug therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Lansoprazole
MH  - Male
MH  - Middle Aged
MH  - Recurrence
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2009/05/07 09:00
MHDA- 2010/02/23 06:00
CRDT- 2009/05/07 09:00
PHST- 2009/05/07 09:00 [entrez]
PHST- 2009/05/07 09:00 [pubmed]
PHST- 2010/02/23 06:00 [medline]
AID - APT3998 [pii]
AID - 10.1111/j.1365-2036.2009.03998.x [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2009 Jun 15;29(12):1249-60. doi: 
      10.1111/j.1365-2036.2009.03998.x. Epub 2009 Mar 17.