Dr Benjamin Gold and colleagues assessed the safety of esomeprazole 20 or 40 mg once daily in adolescents with clinically diagnosed gastroesophageal reflux disease (GERD).
The investigators' secondary aim was to assess changes in GERD symptoms after esomeprazole therapy.
|15% experienced adverse events related to treatment|
|Journal of Pediatric Gastroenterology & Nutrition
The team conducted a multicenter, randomized, double-blind study of 148 adolescents aged 12 to 17 years.
The patients received esomeprazole 20 or 40 mg once daily for 8 weeks.
Adverse events and changes in clinical parameters were evaluated to assess safety.
Patients or their parents or guardians scored symptom severity daily.
The investigators scored overall GERD symptom severity every 2 weeks using a 4-point scale.
The investigative team found that safety data, treatment-related and non-treatment-related adverse events were reported by 75% and 78% of patients in the esomeprazole 20- and 40-mg groups, respectively.
The team observed that 15% experienced adverse events that were considered related to treatment.
The most common adverse events were headache, abdominal pain, nausea, and diarrhea.
No serious adverse events or clinically important findings in other safety assessments were observed.
At baseline, the team noted that 68% had heartburn, 63% had epigastric pain, 57% had acid regurgitation, and 15% had vomiting symptoms.
Symptom scores decreased significantly in both the esomeprazole 20-mg and 40-mg groups by the final study week.
The investigators rated 63% of the patients as having moderate or severe symptoms at baseline.
At the final visit, this percentage decreased significantly to 9%.
Dr Gold‘s team concluded, "In adolescent patients with GERD, esomeprazole 20 or 40 mg daily for 8 weeks was well tolerated."
"GERD-related symptoms were significantly reduced from baseline values in both groups."