Objective: Acid suppression with histamine-2 receptor antagonists (HRAs) 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 HRAs.
Methods: Data on children (aged 0-18 years) first dispensed esomeprazole, other PPIs or HRAs 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) HRAs. 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. HRAs 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 HRAs.
Trial Registration: NCT01338363.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1080/03007995.2017.1407302 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Comparative safety of transvenous and leadless pacemakers in patients with cardiovascular diseases: A meta-analysis study.
Heliyon
January 2025
Faculty of Medicine and Medical Sciences, University of Balamand, Kalhat, Lebanon.
Background: Transvenous pacemakers (TVP) and leadless pacemakers (LP) are two reliable permanent modalities for the treatment of heart rhythm disorders. Several observational studies explored the safety and efficacy of the two devices. The aim of this meta-analysis study is to present a comparative analysis of the safety of leadless versus transvenous pacemakers.
View Article and Find Full Text PDFProtocol for the MERINO study: A randomized placebo-controlled trial assessing the efficacy, safety, and cost-effectiveness of methotrexate in people with erosive hand osteoarthritis.
Osteoarthr Cartil Open
March 2025
Center for Treatment of Rheumatic and Musculoskeletal Diseases (REMEDY), Diakonhjemmet Hospital, Oslo, Norway.
Objective: Previous studies on the efficacy of methotrexate in people with hand osteoarthritis (OA) have shown conflicting results. The MERINO trial aims to investigate the efficacy and safety of methotrexate in people with painful inflammatory erosive hand OA.
Design: In total 163 participants with erosive hand OA, synovitis by ultrasound, and finger joint pain of 40-80 mm on a visual analogue scale (VAS) will be recruited from a rheumatology outpatient clinic.
Phase 1b/2a safety study of lemborexant as an adjunctive treatment for insomnia to buprenorphine-naloxone for opioid use disorder: A randomized controlled trial.
Drug Alcohol Depend Rep
March 2025
Institute for Drug and Alcohol Studies, Virginia Commonwealth University, 203 East Cary Street, Richmond, VA 23219, USA.
Background: Evidence supports the common incidence of sleep disturbance in opioid use disorder (OUD) as a potential marker of disrupted orexin system functioning. This study evaluated the initial safety and tolerability of a challenge dose of lemborexant, a dual orexin antagonist, as an adjunct to buprenorphine/naloxone.
Methods: Patients (18-65 years old) with OUD receiving sublingual buprenorphine/naloxone, with a Pittsburgh Sleep Quality Index total score of 6 or higher, were recruited from outpatient clinics.
Comparison of Jinzhen oral liquid and ambroxol hydrochloride and clenbuterol hydrochloride oral solution in the treatment of acute bronchitis in children: A multicenter, non-inferiority, prospective, randomized controlled trial.
Acta Pharm Sin B
December 2024
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.
The comparison between traditional Chinese medicine Jinzhen oral liquid (JZOL) and Western medicine in treating children with acute bronchitis (AB) showed encouraging outcomes. This trial evaluated the efficacy and safety of the JZOL for improving cough and expectoration in children with AB. 480 children were randomly assigned to take JZOL or ambroxol hydrochloride and clenbuterol hydrochloride oral solution for 7 days.
View Article and Find Full Text PDFOutcomes following resective and disconnective strategies in the treatment of epileptic spasms: a systematic review of the literature and individual patient data meta-analysis.
Front Neurol
December 2024
Brain and Development Research Axis, Azrieli CHU Ste-Justine Research Center, Montreal, QC, Canada.
Epileptic spasms (ES) are a unique seizure type typically presenting in the form of infantile epileptic spasms syndrome (IESS) with characteristic hypsarrhythmia on scalp EEG and a preponderance with developmental delay or regression. While pharmacotherapy is the mainstay of treatment, surgical options, including disconnective or resective procedures, are increasingly recognized as viable therapeutic options for recurrent or persistent ES. However, limited data on safety, effectiveness, and prognostic factors hinder informed decision-making regarding surgery indications, timing, and intervention type.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!