PMID- 28699796 OWN - NLM STAT- MEDLINE DCOM- 20180501 LR - 20181202 IS - 1473-4877 (Electronic) IS - 0300-7995 (Linking) VI - 33 IP - 12 DP - 2017 Dec TI - Utilization and safety of proton-pump inhibitors and histamine-2 receptor antagonists in children and adolescents: an observational cohort study. PG - 2201-2209 LID - 10.1080/03007995.2017.1354830 [doi] AB - BACKGROUND: Little is known about the use of acid-suppressing treatments and related safety events in children. OBJECTIVE: This study compared patient characteristics and safety outcomes among children prescribed acid-suppressing drugs for the first time. METHODS: The Health Improvement Network was used to determine the characteristics of children prescribed a proton pump inhibitor (PPI; esomeprazole or another PPI) or a histamine-2 receptor antagonist (H(2)RA) by UK primary care physicians between October 2009 and September 2012. Pre-defined safety outcomes were compared among the treatment groups in up to 18 months of follow-up. RESULTS: The cohorts comprised 8,172 patients on PPIs (including 24 patients on esomeprazole) and 7,905 on H(2)RAs. The baseline characteristics were similar between cohorts, although the children in the PPI cohorts tended to be older. No safety outcomes occurred in the esomeprazole cohort. In the other-PPIs cohort, 92 safety outcomes occurred, most commonly gastroenteritis (n = 36; 39.1%). In the H(2)RAs cohort, 193 safety outcomes occurred, most commonly gastroenteritis (n = 62; 32.1%). The incidence of most safety outcomes was higher in the H(2)RAs cohort than in the other-PPIs cohort, including failure to thrive (3.11 [95% confidence interval (CI) = 2.25-4.28] vs 0.49 per 1,000 person-years [95% CI = 0.22-1.07]) and gastroenteritis (5.27 [95% CI = 4.11-6.75] vs 3.04 per 1,000 person-years [95% CI = 2.20-4.20]). CONCLUSION: Esomeprazole is rarely prescribed to children when they first require acid-suppressing medication, compared with other PPIs/H(2)RAs. Overall, more safety outcomes occurred in the H(2)RAs cohort than in the PPI cohorts. FAU - Ruigomez, A AU - Ruigomez A AD - a Spanish Centre for Pharmacoepidemiologic Research (CEIFE) , Madrid , Spain. FAU - Johansson, S AU - Johansson S AD - b AstraZeneca Gothenburg , Molndal , Sweden. FAU - Nagy, P AU - Nagy P AD - c Former employee of AstraZeneca Gothenburg , Molndal , Sweden. FAU - Garcia Rodriguez, L A AU - Garcia Rodriguez LA AD - a Spanish Centre for Pharmacoepidemiologic Research (CEIFE) , Madrid , Spain. LA - eng PT - Journal Article PT - Observational Study DEP - 20170721 PL - England TA - Curr Med Res Opin JT - Current medical research and opinion JID - 0351014 RN - 0 (Histamine H2 Antagonists) RN - 0 (Proton Pump Inhibitors) RN - N3PA6559FT (Esomeprazole) SB - IM MH - Adolescent MH - Child MH - Child, Preschool MH - Cohort Studies MH - Esomeprazole/*therapeutic use MH - Female MH - Histamine H2 Antagonists/*therapeutic use MH - Humans MH - Incidence MH - Infant MH - Male MH - Proton Pump Inhibitors/*therapeutic use OTO - NOTNLM OT - Acid-suppressing drugs OT - The Health Improvement Network (THIN) OT - children OT - drug safety OT - gastroesophageal reflux disease OT - pharmacoepidemiology EDAT- 2017/07/13 06:00 MHDA- 2018/05/02 06:00 CRDT- 2017/07/13 06:00 PHST- 2017/07/13 06:00 [pubmed] PHST- 2018/05/02 06:00 [medline] PHST- 2017/07/13 06:00 [entrez] AID - 10.1080/03007995.2017.1354830 [doi] PST - ppublish SO - Curr Med Res Opin. 2017 Dec;33(12):2201-2209. doi: 10.1080/03007995.2017.1354830. Epub 2017 Jul 21.