PMID- 19054529
OWN - NLM
STAT- MEDLINE
DCOM- 20090414
LR  - 20220318
IS  - 1097-6833 (Electronic)
IS  - 0022-3476 (Linking)
VI  - 154
IP  - 4
DP  - 2009 Apr
TI  - Multicenter, double-blind, randomized, placebo-controlled trial assessing the 
      efficacy and safety of proton pump inhibitor lansoprazole in infants with 
      symptoms of gastroesophageal reflux disease.
PG  - 514-520.e4
LID - 10.1016/j.jpeds.2008.09.054 [doi]
AB  - OBJECTIVE: To assess the efficacy and safety of lansoprazole in treating infants 
      with symptoms attributed to gastroesophageal reflux disease (GERD) that have 
      persisted despite a >or= 1-week course of nonpharmacologic management. STUDY 
      DESIGN: This multicenter, double-blind, parallel-group study randomized infants 
      with persisting symptoms attributed to GERD to treatment with lansoprazole or 
      placebo for 4 weeks. Symptoms were tracked through daily diaries and weekly 
      visits. Efficacy was defined primarily by a >or= 50% reduction in measures of 
      feeding-related crying and secondarily by changes in other symptoms and global 
      assessments. Safety was assessed based on the occurrence of adverse events (AEs) 
      and clinical/laboratory data. RESULTS: Of the 216 infants screened, 162 met the 
      inclusion/exclusion criteria and were randomized. Of those, 44/81 infants (54%) 
      in each group were responders--identical for lansoprazole and placebo. No 
      significant lansoprazole-placebo differences were detected in any secondary 
      measures or analyses of efficacy. During double-blind treatment, 62% of 
      lansoprazole-treated subjects experienced 1 or more treatment-emergent AEs, 
      versus 46% of placebo recipients (P= .058). Serious AEs (SAEs), particularly 
      lower respiratory tract infections, occurred in 12 infants, significantly more 
      frequently in the lansoprazole group compared with the placebo group (10 vs 2; P= 
      .032). CONCLUSIONS: This study detected no difference in efficacy between 
      lansoprazole and placebo for symptoms attributed to GERD in infants age 1 to 12 
      months. SAEs, particularly lower respiratory tract infections, occurred more 
      frequently with lansoprazole than with placebo.
FAU - Orenstein, Susan R
AU  - Orenstein SR
AD  - University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. 
      sro.pitt.edu@verizon.net
FAU - Hassall, Eric
AU  - Hassall E
FAU - Furmaga-Jablonska, Wanda
AU  - Furmaga-Jablonska W
FAU - Atkinson, Stuart
AU  - Atkinson S
FAU - Raanan, Marsha
AU  - Raanan M
LA  - eng
SI  - ClinicalTrials.gov/NCT00324974
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20081203
PL  - United States
TA  - J Pediatr
JT  - The Journal of pediatrics
JID - 0375410
RN  - 0 (2-Pyridinylmethylsulfinylbenzimidazoles)
RN  - 0 (Proton Pump Inhibitors)
RN  - 0K5C5T2QPG (Lansoprazole)
SB  - IM
CIN - J Pediatr. 2009 Apr;154(4):475-6. PMID: 19324214
CIN - J Pediatr. 2009 Oct;155(4):601; author reply 601-2. PMID: 19773015
MH  - 2-Pyridinylmethylsulfinylbenzimidazoles/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Female
MH  - Gastroesophageal Reflux/*drug therapy
MH  - Humans
MH  - Infant
MH  - Lansoprazole
MH  - Male
MH  - Proton Pump Inhibitors/adverse effects/*therapeutic use
EDAT- 2008/12/05 09:00
MHDA- 2009/04/15 09:00
CRDT- 2008/12/05 09:00
PHST- 2008/06/02 00:00 [received]
PHST- 2008/07/28 00:00 [revised]
PHST- 2008/09/30 00:00 [accepted]
PHST- 2008/12/05 09:00 [pubmed]
PHST- 2009/04/15 09:00 [medline]
PHST- 2008/12/05 09:00 [entrez]
AID - S0022-3476(08)00864-0 [pii]
AID - 10.1016/j.jpeds.2008.09.054 [doi]
PST - ppublish
SO  - J Pediatr. 2009 Apr;154(4):514-520.e4. doi: 10.1016/j.jpeds.2008.09.054. Epub 
      2008 Dec 3.