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Simultaneous Laryngopharyngeal and Conventional Esophageal pH Monitoring
Published on: December 14, 2020
Observational cohort study: safety outcomes in children using proton pump inhibitors or histamine-2 receptor
Eline Houben1, Saga Johansson2, Péter Nagy3
1a PHARMO Institute for Drug Outcomes Research , Utrecht , Netherlands.
Insights
This study compared safety outcomes in children using esomeprazole, other proton pump inhibitors (PPIs), or histamine-2 receptor antagonists (H2RAs). Hospitalization rates were low and similar, except for failure to thrive associated with esomeprazole.
Area of Science:
- Pediatric Gastroenterology
- Pharmacovigilance
- Drug Safety
Background:
- Acid suppression therapy, including proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs), is a common treatment for pediatric gastroesophageal reflux disease.
- Understanding the comparative safety profiles of different acid suppressants in children is crucial for clinical decision-making.
Purpose of the Study:
- To assess and compare safety outcomes in pediatric patients initiating esomeprazole, other PPIs, or H2RAs.
- To evaluate hospitalization rates for specific adverse events in young patients using these acid-suppressing medications.
Main Methods:
- A retrospective, observational postauthorization study utilizing data from the Dutch PHARMO Database Network.
- Inclusion of children (0-18 years) first dispensed esomeprazole, other PPIs, or H2RAs between September 2008 and August 2011.
- Evaluation of hospitalizations for seven predefined safety outcomes with a maximum follow-up of 18 months, using Poisson regression for adjusted rate ratios.
Main Results:
- Out of 23,470 children, 504 (2%) were hospitalized for predefined events, with gastroenteritis, convulsion/seizure, and pneumonia being most common.
- A significant difference was observed for failure to thrive, with higher adjusted rate ratios for esomeprazole compared to other PPIs and H2RAs.
- Hospitalization rates for most outcomes were low and comparable across the different acid suppressant cohorts.
Conclusions:
- Hospitalization rates for most assessed safety outcomes were low and similar among pediatric first-time users of PPIs and H2RAs.
- The study identified a potential increased risk of failure to thrive associated with esomeprazole use in children.
- Further investigation into specific safety concerns, like failure to thrive, may be warranted for pediatric acid suppression therapy.
Objective:
Acid suppression with histamine-2 receptor antagonists (H2RAs) or proton pump inhibitors (PPIs) is recommended for children with persistent gastroesophageal reflux disease symptoms. In this retrospective, observational postauthorization study, we aimed to assess and compare safety outcomes in pediatric first-time users of esomeprazole, other PPIs or H2RAs.
Methods:
Data on children (aged 0-18 years) first dispensed esomeprazole, other PPIs or H2RAs between September 2008 and August 2011 was obtained from the Dutch PHARMO Database Network. Hospitalizations for seven predefined safety outcomes were evaluated (maximum follow-up: 18 months). Rate ratios were calculated using Poisson regression adjusted for baseline imbalances. Discharge letters were reviewed for event occurrence confirmation.
Results:
Of 23,470 included children, 2820 (median age: 3 years) were prescribed esomeprazole, 13,818 (median age: 15 years) other PPIs and 6832 (median age: 5 years) H2RAs. In total, 504 (2%) children were hospitalized for 762 predefined events: gastroenteritis (246); convulsion/seizure (200); pneumonia (154); failure to thrive (119); acute interstitial nephritis (19); thrombocytopenia (23); and angioneurotic edema (1). Significant differences between cohorts were observed only for failure to thrive, with adjusted rate ratios (95% confidence interval) for esomeprazole of 6.1 (2.4-15.7) vs. other PPIs and 6.1 (2.9-12.8) vs. H2RAs among current users. Occurrence was confirmed for 74% of assessable events. Confirmation rates were highest for pneumonia (81%) and lowest for failure to thrive (40%).
Conclusions:
Hospitalization rates for predefined outcomes were low and mostly similar in pediatric first-time users of PPIs and of H2RAs.
Trial Registration:
NCT01338363.
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