PMID- 21118280
OWN - NLM
STAT- MEDLINE
DCOM- 20110603
LR  - 20131121
IS  - 1365-2036 (Electronic)
IS  - 0269-2813 (Linking)
VI  - 33
IP  - 3
DP  - 2011 Feb
TI  - The 12-month safety profile of dexlansoprazole, a proton pump inhibitor with a 
      dual delayed release formulation, in patients with gastro-oesophageal reflux 
      disease.
PG  - 366-77
LID - 10.1111/j.1365-2036.2010.04519.x [doi]
AB  - BACKGROUND: Dexlansoprazole MR is a Dual Delayed Release formulation of 
      dexlansoprazole, an enantiomer of lansoprazole, designed to extend the duration 
      of acid suppression. AIM: To assess the 12-month safety of dexlansoprazole MR in 
      patients with symptomatic gastro-oesophageal reflux disease (GERD). METHODS: In 
      this randomised open-label study, patients received dexlansoprazole MR 60 or 90 
      mg once-daily for 12 months. Safety was evaluated at months 1, 3, 6, 9 and 
      12/final visit through physical examinations, laboratory evaluations, 
      endoscopies, gastric biopsies, fasting serum gastrin values and adverse events 
      (AEs). RESULTS: Of 591 patients receiving dexlansoprazole MR 60 and 90 mg, 71% 
      and 65%, respectively, experienced >/=1 treatment-emergent AE; the most frequent AE 
      was upper respiratory infection (14% and 13% in the 60- and 90-mg groups). Thirty 
      patients experienced >/=1 serious AE; a majority of serious AEs were unrelated to 
      study drug. No clinically meaningful change in any clinical laboratory parameters 
      was noted. As expected, serum gastrin values rose with dexlansoprazole therapy; 
      increases were not dose related. No clinically concerning trends were identified 
      in gastric pathology results; no endocrine cell hyperplasia, adenocarcinoma, or 
      lymphoma were observed. CONCLUSIONS: Twelve-month treatment with dexlansoprazole 
      MR 60 and 90 mg was well tolerated by GERD patients in this study 
      (Clinicaltrials.gov identifier NCT00255190).
CI  - (c) 2010 Blackwell Publishing Ltd.
FAU - Dabholkar, A H
AU  - Dabholkar AH
AD  - Takeda Global Research & Development Center, Inc., Deerfield, IL 60015, USA. 
      aruna.dabholkar@tgrd.com
FAU - Han, C
AU  - Han C
FAU - Paris, M M
AU  - Paris MM
FAU - Perez, M C
AU  - Perez MC
FAU - Atkinson, S N
AU  - Atkinson SN
FAU - Peura, D A
AU  - Peura DA
LA  - eng
SI  - ClinicalTrials.gov/NCT00255190
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20101130
PL  - England
TA  - Aliment Pharmacol Ther
JT  - Alimentary pharmacology & therapeutics
JID - 8707234
RN  - 0 (2-Pyridinylmethylsulfinylbenzimidazoles)
RN  - 0 (Delayed-Action Preparations)
RN  - 0 (Proton Pump Inhibitors)
RN  - 0K5C5T2QPG (Lansoprazole)
RN  - UYE4T5I70X (Dexlansoprazole)
SB  - IM
MH  - 2-Pyridinylmethylsulfinylbenzimidazoles/*adverse effects
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Delayed-Action Preparations/administration & dosage
MH  - Dexlansoprazole
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Gastroesophageal Reflux/*drug therapy
MH  - Humans
MH  - Lansoprazole
MH  - Male
MH  - Middle Aged
MH  - Proton Pump Inhibitors/*adverse effects
MH  - Statistics as Topic
MH  - Time Factors
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2010/12/02 06:00
MHDA- 2011/06/04 06:00
CRDT- 2010/12/02 06:00
PHST- 2010/12/02 06:00 [entrez]
PHST- 2010/12/02 06:00 [pubmed]
PHST- 2011/06/04 06:00 [medline]
AID - 10.1111/j.1365-2036.2010.04519.x [doi]
PST - ppublish
SO  - Aliment Pharmacol Ther. 2011 Feb;33(3):366-77. doi: 
      10.1111/j.1365-2036.2010.04519.x. Epub 2010 Nov 30.