Utilization and safety of proton-pump inhibitors and histamine-2 receptor antagonists in children and adolescents: an observational cohort study.

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 (H2 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 H2 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 H2 RAs cohort, 193 safety outcomes occurred, most commonly gastroenteritis (n = 62; 32.1%). The incidence of most safety outcomes was higher in the H2 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/H2 RAs. Overall, more safety outcomes occurred in the H2 RAs cohort than in the PPI cohorts.