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Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis
C Faure1, L Michaud, E K Shaghaghi
1Service de Gastro-entérologie Pédiatrique, Hôpital Robert Debré, Paris, France. christophe.faure@rdb.ap-hop-paris.fr
Insights
Lansoprazole effectively treats reflux oesophagitis in children. Optimal starting doses are 30 mg/m2 or 1.4 mg/kg, with good safety and efficacy demonstrated in paediatric patients.
Area of Science:
- Pediatric Gastroenterology
- Pharmacology
- Clinical Therapeutics
Background:
- Limited data exists on lansoprazole use in pediatric populations.
- Proton pump inhibitors (PPIs) are crucial for managing acid-related disorders.
Purpose of the Study:
- To evaluate the pharmacokinetics, optimal dosage, and efficacy of lansoprazole in children.
- To establish safe and effective lansoprazole dosing for pediatric reflux oesophagitis.
Main Methods:
- 24-hour gastric pH monitoring and pharmacokinetic studies were conducted.
- Lansoprazole (17 mg/m2) was administered for 7 days to 23 patients with reflux oesophagitis.
- Dosage was adjusted based on response, with non-responders excluded.
Main Results:
- Lansoprazole demonstrated efficacy, with 80% of responders achieving healed oesophagitis after 4 weeks.
- A significant correlation was found between time with pH > 3 and plasma concentration-time curve (P=0.003).
- Adverse events were infrequent, with only one patient discontinuing treatment.
Conclusions:
- Lansoprazole is an effective and safe treatment option for paediatric patients with reflux oesophagitis.
- The recommended starting dosage for children is 30 mg/m2 or 1.4 mg/kg.
- Further research can build upon these findings to optimize pediatric PPI therapy.
Background:
Data on the proton pump inhibitor lansoprazole in paediatric patients are limited.
Aim:
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.