Introduction

The efficacy and safety of lansoprazole, a proton pump inhibitor, is well established in reflux oesophagitis. This study involved paediatric patients with reflux oesophagitis.      

Aim

To evaluate the pharmacokinetics, optimal dosage for controlling gastric acid secretion and efficacy of lansoprazole in to heal lesions in paediatric reflux oesophagitis

Patient Profile

• 23 children with reflux oesophagitis (median age, 3.5 years)

Method

Study Design

• Lansoprazole 17 mg/m² was administered for 7 days
• The dosage was doubled in non-responders
• Patients whose oesophagitis lesions were not healed received additional four weeks of lansoprazole at the same dosage, and then underwent repeat endoscopy

Endpoints

• Response: an intragastric pH >3 during at least 65% of the 24-h recording
• Pharmacokinetic analysis: area under the plasma concentration-time curve (AUC; ng.h/mL) from zero to infinity and apparent oral clearance (CL/F, L/h)

Results

Efficacy

• Lansoprazole 17 mg/m² dose achieved response in nine patients and further, the higher dose of lansoprazole 30.3 mg/m² achieved response in six additional patients (out of the remaining 14 patients)
• The time spent with pH >3 significantly correlated with the AUC (P=0.003) on day 7
• AUC was significantly greater in the nine responders to 17 mg/m² as compared to 14 other patients (2034 vs. 626 ng.h/mL, P=0.0075) and further to the six patients who responded to 30.3 mg/m² (2035 vs. 478 ng.h/mL, P=0.01)
• The oral clearance was significantly lower in the nine responders to 17 mg/m² as compared to the six patients who responded to 30.3 mg/m² (0.76 vs. 2.94 L.kg/h; P=0.04)
• No significant differences were found in pharmacokinetic parameters between the six patients who did and the eight patients who did not respond to the higher lansoprazole dosage
• After 4 weeks of treatment, lansoprazole achieved an oesophagitis lesion healing rate of 80% in the responders

Safety 

• Lansoprazole was well tolerated by most patients; two patients experienced diarrhoea with lansoprazole 5 and 10 mg/day
• One child discontinued lansoprazole 20 mg due to adverse events (abdominal pain and vomiting) and comorbidity

Conclusion

• Lansoprazole was effective and safe in children with reflux oesophagitis at a starting dosage of 30 mg/m² (1.44 mg/kg)
• The study suggested that 1.44 mg/kg should be an optimal starting dosage for lansoprazole treatment

Aliment Pharmacol Ther 2001; 15: 1397-1402