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Safety and Tolerability of Esomeprazole in Children With Gastroesophageal Reflux Disease
Mark A Gilger1, Vasundhara Tolia, Yvan Vandenplas
1*Baylor College of Medicine, Houston, TX †Wayne State University, Detroit, MI ‡Vrije Universiteit Brussels, Brussels, Belgium §Goryeb Children's Hospital at Atlantic Health, Morristown, NJ ||AstraZeneca LP, Wilmington, DE.
Insights
Once-daily esomeprazole effectively and safely reduced gastroesophageal reflux disease (GERD) symptoms in children aged 1-11 years. The medication was well-tolerated, with significant improvements in symptom severity observed during the study.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Clinical Trials
Background:
- Gastroesophageal reflux disease (GERD) is a common condition in children.
- Effective and safe treatment options are crucial for managing pediatric GERD.
- Proton pump inhibitors like esomeprazole are widely used for GERD treatment.
Purpose of the Study:
- To assess the safety and tolerability of once-daily esomeprazole in pediatric patients with GERD.
- To evaluate the efficacy of esomeprazole in improving GERD-related symptoms.
- To determine optimal dosing based on patient weight.
Main Methods:
- An 8-week, multicenter, randomized, double-blind study involving children aged 1-11 years with endoscopically confirmed GERD.
- Patients received weight-stratified doses of esomeprazole (5, 10, or 20 mg once daily).
- Safety was monitored via adverse events and clinical assessments; symptom severity was evaluated using Physician's Global Assessment and patient-reported outcomes.
Main Results:
- Esomeprazole was generally well-tolerated across all tested doses.
- Most adverse events were not treatment-related; common ones included diarrhea and headache.
- Significant improvements in Physician's Global Assessment scores (P < 0.001) and patient-reported GERD symptoms (P < 0.01) were observed.
Conclusions:
- Once-daily esomeprazole is a safe and effective treatment for children aged 1-11 years with GERD.
- The medication leads to significant reductions in the frequency and severity of GERD symptoms.
- Weight-based dosing of esomeprazole is appropriate for this pediatric population.
Objectives:
To evaluate safety, tolerability, and symptom improvement with once-daily esomeprazole in children with endoscopically proven gastroesophageal reflux disease (GERD).
Patients And Methods:
In this 8-week, multicenter, randomized, uncontrolled, double-blind study, children ages 1 to 11 years were stratified by weight to receive esomeprazole 5 or 10 mg (children < 20 kg) or 10 or 20 mg (children ≥ 20 kg) once daily. Safety and tolerability was assessed by evaluating adverse events (AEs; both treatment- and non-treatment-related AEs) and changes from baseline in medical history, physical examinations, and clinical laboratory tests. Investigators scored symptom severity every 2 weeks using the Physician's Global Assessment (PGA). Patients' parents rated GERD symptoms of heartburn, acid regurgitation, and epigastric pain (none to severe, 0-3) at baseline (based on past 72 hours) and daily (from past 24 hours).
Results:
Of 109 patients randomized, 108 had safety data. AEs were experienced by 68.0% and 65.2% of children <20 kg receiving esomeprazole 5 and 10 mg, respectively, and 83.9% and 82.8% of children ≥ 20 kg receiving esomeprazole 10 and 20 mg, respectively, regardless of causality. Overall, only 9.3% of patients reported 13 treatment-related AEs; the most common were diarrhea (2.8% [3/108]), headache (1.9% [2/108]), and somnolence (1.9% [2/108]). Vomiting, a serious AE in 2 patients, was not judged by the investigator to be related to treatment. At the final visit, PGA scores improved significantly from baseline (P < 0.001). Of 58 patients with moderate to severe baseline PGA symptom scores, 91.4% had lower scores by the final visit. GERD symptom scores were significantly improved from baseline to the final week of the study in all of the treatment groups (P < 0.01) CONCLUSIONS:: In children ages 1 to 11 years with endoscopically proven GERD, esomeprazole (at daily doses of 5, 10, or 20 mg) was generally well tolerated. The frequency and severity of GERD-related symptoms were significantly reduced during the active treatment period.
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