title: Lansoprazole in adolescents with gastroesophageal reflux disease: pharmacokinetics, pharmacodynamics, symptom relief efficacy, and tolerability.
abstract: OBJECTIVE
  To evaluate the pharmacokinetics, pharmacodynamics, symptom relief efficacy, and tolerability of lansoprazole in adolescents between 12 and 17 years of age with gastroesophageal reflux disease (GERD).
  
  
  METHODS
  Adolescents with symptomatic, endoscopically and/or histologically proven GERD were enrolled in this multicenter, double-blind trial and randomized to lansoprazole 15 mg or 30 mg once daily for 5 days.
  
  
  RESULTS
  Sixty-three adolescents were enrolled in the study. After lansoprazole administration, T(max) occurred at 1.6 hours in those treated with lansoprazole 15 mg and at 1.7 hours in those treated with lansoprazole 30 mg. Dose-proportional increases in lansoprazole C(max) and AUC were observed in the treatment groups. Age, weight, and gender had no significant effect on T(max), C(max), or AUC. Lansoprazole produced significant increases (P < or = 0.05) in mean 24-hour intragastric pH and the percentages of time intragastric pH was above 3 and 4. The majority of adolescents treated with lansoprazole 15 mg (69%, 22/32) or lansoprazole 30 mg (74%, 23/31) demonstrated improvement in their reflux symptoms after 5 days of treatment. Adolescents in both dosage groups exhibited reductions from baseline in the percentage of days and nights with heartburn (or other predominant symptom of GERD), the severity of heartburn, the percentage of days antacids were used, and the number of antacid tablets used per day. Pharyngitis and headache were the most commonly reported side effects among adolescents treated with lansoprazole 15 mg and 30 mg, respectively. Five patients experienced adverse events considered to be possibly treatment-related. One patient with a history of environmental allergies experienced a mild allergic reaction after 3 days of treatment with lansoprazole 15 mg. Among those treated with lansoprazole 30 mg, 4 patients each reported one occurrence of pain (toothache), diarrhea, dizziness, and rash.
  
  
  CONCLUSIONS
  The pharmacokinetic parameters of lansoprazole observed in this study of adolescents are similar to those observed in studies of healthy adults. Lansoprazole 15 mg or 30 mg once daily for 5 days produces significant increases in intragastric pH, effectively relieves symptoms of reflux disease, and is well tolerated in adolescents with GERD.
authors.affiliation: Center for Children's Digestive Health, Lutheran General Children's Hospital, Park Ridge, Illinois 60068, USA.
authors.forename: Thirumazhisai
authors.initials: T
authors.lastname: Gunasekaran
authors.forename: Sandeep
authors.initials: S
authors.lastname: Gupta
authors.forename: David
authors.initials: D
authors.lastname: Gremse
authors.forename: Michael
authors.initials: M
authors.lastname: Karol
authors.forename: Wei-Jian
authors.initials: WJ
authors.lastname: Pan
authors.forename: Yi-Lin
authors.initials: YL
authors.lastname: Chiu
authors.forename: Roberta
authors.initials: R
authors.lastname: Keith
authors.forename: Joseph
authors.initials: J
authors.lastname: Fitzgerald
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000293:Adolescent; D000897:Anti-Ulcer Agents / Q000009:adverse effects / Q000493:pharmacokinetics* / Q000494:pharmacology*; D019540:Area Under Curve; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000378:metabolism; D006801:Humans; D006863:Hydrogen-Ion Concentration; D064747:Lansoprazole; D008297:Male; D009853:Omeprazole / Q000009:adverse effects / Q000031:analogs & derivatives / Q000493:pharmacokinetics* / Q000494:pharmacology*; D012449:Safety; D013270:Stomach / Q000737:chemistry; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D064747:Lansoprazole; D009853:Omeprazole