title: Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis.
abstract: BACKGROUND
  Data on the proton pump inhibitor lansoprazole in paediatric patients are limited.
  
  
  OBJECTIVE
  To investigate the pharmacokinetics, optimal dosage and efficacy of lansoprazole in paediatric patients.
  
  
  METHODS
  A 24-h gastric pH recording and a pharmacokinetic study were performed after 7 days of lansoprazole, 17 mg/m2, in 23 patients with reflux oesophagitis (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/m2 and six to 30.3 mg/m2. On day 7, time with pH > 3 was significantly correlated with the area under the plasma concentration-time curve (P=0.003). The area under the plasma concentration-time curve was significantly greater in the nine responders to 17 mg/m2 than in the 14 other patients. Pharmacokinetic parameters were similar in responders and non-responders to the higher dose. After 4 weeks, oesophagitis was healed in 80% of responders. Adverse events occurred in three patients and required treatment discontinuation in one.
  
  
  CONCLUSIONS
  Lansoprazole is effective and safe in children. The optimal starting dosage is 30 mg/m2 or 1.4 mg/kg.
authors.affiliation: Service de Gastro-entérologie Pédiatrique, Hôpital Robert Debré, Paris, France. christophe.faure@rdb.ap-hop-paris.fr
authors.forename: C
authors.initials: C
authors.lastname: Faure
authors.forename: L
authors.initials: L
authors.lastname: Michaud
authors.forename: E K
authors.initials: EK
authors.lastname: Shaghaghi
authors.forename: M
authors.initials: M
authors.lastname: Popon
authors.forename: M
authors.initials: M
authors.lastname: Laurence
authors.forename: J F
authors.initials: JF
authors.lastname: Mougenot
authors.forename: R
authors.initials: R
authors.lastname: Hankard
authors.forename: J
authors.initials: J
authors.lastname: Navarro
authors.forename: E
authors.initials: E
authors.lastname: Jacoz-Aigrain
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000293:Adolescent; D000897:Anti-Ulcer Agents / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D019540:Area Under Curve; D002648:Child; D002675:Child, Preschool; D002851:Chromatography, High Pressure Liquid; D004305:Dose-Response Relationship, Drug; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000378:metabolism; D006207:Half-Life; D006801:Humans; D006863:Hydrogen-Ion Concentration / Q000187:drug effects; D007223:Infant; D064747:Lansoprazole; D008297:Male; D008657:Metabolic Clearance Rate; D009853:Omeprazole / Q000031:analogs & derivatives / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*; D054328:Proton Pump Inhibitors; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D009853:Omeprazole