Lansoprazole in adolescents with gastroesophageal reflux disease

Pharmacokinetics, pharmacodynamics, symptom relief efficacy, and tolerability

Thirumazhisai Gunasekaran, Sandeep Gupta, David Gremse, Michael Karol, Wei Jian Pan, Yi Lin Chiu, Roberta Keith, Joseph Fitzgerald

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Objectives: 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, Tmax 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 Cmax and AUC were observed in the treatment groups. Age, weight, and gender had no significant effect on Tmax, Cmax, or AUC. Lansoprazole produced significant increases (P ≤ 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 heart-burn, 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. Conclusion: 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.

Original languageEnglish
JournalJournal of Pediatric Gastroenterology and Nutrition
Volume35
Issue numberSUPPL. 4
StatePublished - 2002

Fingerprint

Lansoprazole
gastroesophageal reflux
pharmacology
Gastroesophageal Reflux
pharmacokinetics
signs and symptoms (animals and humans)
Pharmacokinetics
antacids
Antacids
lansoprazole
hypersensitivity
Area Under Curve
Hypersensitivity
Toothache
Heartburn
headache
Pharyngitis
Dizziness
Therapeutics
dosage

Keywords

  • Adolescents
  • Gastroesophageal reflux disease
  • Lansoprazole
  • Pharmacodynamics
  • Pharmacokinetics
  • Prevacid
  • Proton pump inhibitors
  • Safety
  • Symptom relief

ASJC Scopus subject areas

  • Gastroenterology
  • Histology
  • Medicine (miscellaneous)
  • Food Science
  • Pediatrics, Perinatology, and Child Health

Cite this

Lansoprazole in adolescents with gastroesophageal reflux disease : Pharmacokinetics, pharmacodynamics, symptom relief efficacy, and tolerability. / Gunasekaran, Thirumazhisai; Gupta, Sandeep; Gremse, David; Karol, Michael; Pan, Wei Jian; Chiu, Yi Lin; Keith, Roberta; Fitzgerald, Joseph.

In: Journal of Pediatric Gastroenterology and Nutrition, Vol. 35, No. SUPPL. 4, 2002.

Research output: Contribution to journalArticle

Gunasekaran, Thirumazhisai ; Gupta, Sandeep ; Gremse, David ; Karol, Michael ; Pan, Wei Jian ; Chiu, Yi Lin ; Keith, Roberta ; Fitzgerald, Joseph. / Lansoprazole in adolescents with gastroesophageal reflux disease : Pharmacokinetics, pharmacodynamics, symptom relief efficacy, and tolerability. In: Journal of Pediatric Gastroenterology and Nutrition. 2002 ; Vol. 35, No. SUPPL. 4.
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abstract = "Objectives: 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, Tmax 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 Cmax and AUC were observed in the treatment groups. Age, weight, and gender had no significant effect on Tmax, Cmax, or AUC. Lansoprazole produced significant increases (P ≤ 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 heart-burn, 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. Conclusion: 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.",
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T2 - Pharmacokinetics, pharmacodynamics, symptom relief efficacy, and tolerability

AU - Gunasekaran, Thirumazhisai

AU - Gupta, Sandeep

AU - Gremse, David

AU - Karol, Michael

AU - Pan, Wei Jian

AU - Chiu, Yi Lin

AU - Keith, Roberta

AU - Fitzgerald, Joseph

PY - 2002

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N2 - Objectives: 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, Tmax 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 Cmax and AUC were observed in the treatment groups. Age, weight, and gender had no significant effect on Tmax, Cmax, or AUC. Lansoprazole produced significant increases (P ≤ 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 heart-burn, 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. Conclusion: 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.

AB - Objectives: 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, Tmax 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 Cmax and AUC were observed in the treatment groups. Age, weight, and gender had no significant effect on Tmax, Cmax, or AUC. Lansoprazole produced significant increases (P ≤ 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 heart-burn, 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. Conclusion: 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.

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KW - Pharmacodynamics

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KW - Prevacid

KW - Proton pump inhibitors

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