Introduction

Gastroesophageal reflux disease (GERD) frequently occurs in children 3 to 17 years of age. It may lead to erosive esophagitis which may further worsen to complications like ulceration or hemorrhage in children. Proton pump inhibitors are widely used for healing erosive esophagitis and reducing symptoms.

Aim

To evaluate the efficacy of lansoprazole for the relief of symptoms due to GERD in children 1 to 11 years of age

Patient Profile

• 66 children (age 1 to 12 years old) with symptomatic GERD with confirmed erosive esophagitis (> grade 2), and/or intra-esophageal pH < 4 for greater than 4.2% of the time based on 24-hour pH testing or Barett’s esophagus

  Method

  Study Design

• Phase I/II, open-label, multicenter study
• Depending on their bodyweight, patients were assigned to lansoprazole 15 mg (< 30 kg) or 30 mg (> 30 kg) once daily for 8 to 12 weeks; dosage was increased up to 60 mg daily in children who continued to be symptomatic after 2 weeks of treatment

Endpoints

• Primary efficacy analyses: percentage of children with esophagitis healing (after 8 and, if applicable, 12 weeks of treatment)
• Gastrointestinal symptom analyses by:
  • Investigator interview: change in each symptom severity from baseline to the final visit (rated as none, mild, moderate or severe); relief of overall GERD symptoms (better, no change or worse); percentage of children who experienced resolution or improvement of each symptom
  • Daily diary recorded by parents/caregivers: changes in percentage of days with GERD symptoms; average GERD symptom severity (graded as none, mild, moderate, severe or very severe); percentage of days that antacid was used; average number of antacids taken per day
• Symptom relief analyses in the subgroup of children with erosive and non-erosive esophagitis

Results

Efficacy

• Lansoprazole treatment achieved esophagitis healing in 78% of children with erosive esophagitis (at baseline) by week 8 and in 100% patients by week 12 of follow up (Figure 1)
• As per investigator interview, 70% of children experienced resolution or improvement in their overall symptoms of GERD with lansoprazole treatment by week 12
• Lansoprazole was effective in significantly reducing the severity of each symptom from baseline (regurgitation, cough, irritability with meals, anorexia, epigastric pain, heart burn, dysphagia, painful swallowing, belching, hoarseness, abdominal pain, all p < 0.05) and overall symptoms, except wheezing, hematemesis, and melena
• It achieved resolution or improvement of each symptom in 57% to 100% of children with erosive esophagitis (except diarrhoea) and 62% to 100% of children with nonerosive esophagitis (except wheezing)
• As per the daily diary data, lansoprazole improved overall GERD symptoms in significantly higher percentage of all children than in those in whom symptoms were recorded as no change or worse (76% vs. 16% or 8%, resp., p < 0.001)
• Lansoprazole significantly (P < 0.05) reduced the percentage of days the children had GERD symptoms, average daily severity of GERD symptoms, the percentage of days antacid was used, and the average number of antacid tablets/teaspoons taken per day during each of the 2-week treatment intervals of the study period from baseline, in both erosive and nonerosive esophagitis
• It achieved better overall GERD symptoms during the last week of treatment versus no change or worsening of symptoms in significantly higher percentage of erosive (82%) and nonerosive esophagitis (71%) patients
• The majority of children (92%) were >90% compliant with lansoprazole treatment regimen; remaining showed at least 70% compliance

Figure 1: Healing effect of lansoprazole in children with erosive esophagitis

Conclusion

Lansoprazole 15 mg or 30 mg once daily effectively achieved healing of erosive esophagitis and relief in GERD-related symptoms in children 1 to 11 years of age.

J Pediatr Gastroenterol Nutr.  2002; 35 Suppl 4: S308-18