Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis

Abstract

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.

Lansoprazole for recurrent abdominal pain in adolescents

“…24,25 one study reported lansoprazole to be effective and safe in children with reflux oesophagitis, with an optimal starting dosage of 30 mg/m 2 or 1.4 mg/kg. 26 However, the use of lansoprazole for rAP treatment has not been previously reported.…”

Managing Gastro-Oesophageal Reflux Disease in Children

“…In those aged 1–10 years, a higher daily dosage is often necessary (2–2.5 mg/kg/day for omeprazole and 1.4 mg/kg/day for lansoprazole). Interindividual variability is observed as in adults [22, 23]. Clinical and biological tolerance is good, with side effects being mostly mild (e.g.…”

“…Clinical and biological tolerance is good, with side effects being mostly mild (e.g. 10–20% experience headache, constipation, diarrhoea or rash) [20, 21, 22, 23]. The safety of PPIs taken long term (mean 6.5 years) has been reported in adults but not in children [20, 21].…”

Clinical Management of Infants and Children with Gastroesophageal Reflux Disease

“…68 Lansoprazole has also been shown to improve symptoms and promote healing of esophagitis in children 4 months to 15 years of age with GERD refractory to H 2 RAs. [69][70][71] One study demonstrated that higher doses (1.3-1.5 mg/kg/day) had higher healing rates compared to lower doses (0.8-1 mg/kg/day). 69 Another study that measured the 24-hour intragastric pH in children ages 18 days to 14 years with GERD found that multiple daily doses provided greater acid suppression than did single daily doses.…”

“…69 Another study that measured the 24-hour intragastric pH in children ages 18 days to 14 years with GERD found that multiple daily doses provided greater acid suppression than did single daily doses. 71 All agents in this class are believed to have similar effectiveness, but comparative studies and studies of newer agents like pantoprazole and rabeprazole in infants and children are not yet available.…”