Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis

Citation
C. Faure et al., Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis, ALIM PHARM, 15(9), 2001, pp. 1397-1402
Citations number
18
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Pharmacology,"da verificare
Journal title
ALIMENTARY PHARMACOLOGY & THERAPEUTICS
ISSN journal
0269-2813 → ACNP
Volume
15
Issue
9
Year of publication
2001
Pages
1397 - 1402
Database
ISI
SICI code
0269-2813(200109)15:9<1397:LICPAE>2.0.ZU;2-I
Abstract
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.