Background: Data on the proton pump inhibitor lansoprazole in paediatric pa
tients are limited.
Aim: To investigate the pharmacokinetics, optimal dosage and efficacy of la
nsoprazole in paediatric patients.
Methods: A 24-h gastric pH recording and a pharmacokinetic study were perfo
rmed after 7 days of lansoprazole, 17 mg/m(2) in 23 patients with reflux oe
sophagitis (median age, 3.5 years). Response was defined as pH > 3 for > 65
% of the recording. The dosage was doubled in non-responders. Patients with
no response on day 14 were excluded. Responders underwent endoscopy after
4 weeks on the response-inducing dosage; abnormal findings led to a repeat
endoscopy after four additional weeks.
Results: Nine patients responded to 17 mg/m(2) and six to 30.3 mg/m(2). On
day 7, time with pH > 3 was significantly correlated with the area under th
e plasma concentration-time curve (P = 0.003). The area under the plasma co
ncentration-time curve was significantly greater in the nine responders to
17 mg/m(2) than in the 14 other patients. Pharmacokinetic parameters were s
imilar in responders and non-responders to the higher dose. After 4 weeks,
oesophagitis was healed in 80% of responders. Adverse events occurred in th
ree patients and required treatment discontinuation in one.
Conclusions: Lansoprazole is effective and safe in children. The optimal st
arting dosage is 30 mg/m(2) or 1.4 mg/kg.