Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis.
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.
Faure
C
C
Service de Gastro-entérologie Pédiatrique, Hôpital Robert Debré, Paris, France. christophe.faure@rdb.ap-hop-paris.fr
Michaud
L
L
Shaghaghi
E K
EK
Popon
M
M
Laurence
M
M
Mougenot
J F
JF
Hankard
R
R
Navarro
J
J
Jacoz-Aigrain
E
E
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
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D009853:Omeprazole