Drug Utilization and Safety Events Among Children Using Esomeprazole, Other Proton Pump Inhibitors or H2-receptor Antagonists

AstraZeneca23,470 enrolled

Overview

The purpose of this study is 1. To describe patient characteristics and drug usage among children that are prescribed esomeprazole for the first time and to compare them with patients who are prescribed other proton pump inhibitors (PPIs) or H2-receptor antagonists for the first time. 2. To ascertain all incident hospitalized cases of angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia among new users in the three cohorts of esomeprazole, other PPIs and H2-receptor antagonists.

Time Perspective: Other = Retrospective analysis of prospectively collected data Number of Anticipated Subjects: All subjects dispensed esomeprazole, other PPIs or H2-receptor antagonists for the first time during the study period

Study Type

OBSERVATIONAL

Enrollment

23,470

Conditions

Hospitalized Cases of Angioneurotic Oedema Pneumonia Gastroenteritis Failure to Thrive Seizures Acute Interstitial Nephritis and Thrombocytopenia

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Age 0-18 years * Newly dispensed esomeprazole, other proton pump inhibitors or H2-receptor antagonists Exclusion Criteria: * Children with less than one year of history in PHARMO RLS before study cohort entry (if a child is \<1 year at cohort entry, history from birth is required) * Children using more than 1 acid suppressing drug concomitantly at cohort entry

Outcomes

Primary Outcomes

Drug utilization: Description of patient characteristics and drug usage

Time frame: Study period 3 years

Follow-up of safety outcomes: First occurrence of hospitalized angioneurotic oedema, pneumonia, gastroenteritis, failure to thrive, convulsions/seizures, acute interstitial nephritis and thrombocytopenia

Time frame: 18 months