Pharmacokinetics and tolerability of rabeprazole in children 1 to 11 years old with gastroesophageal reflux disease

Journal of Pediatric Gastroenterology and Nutrition

Volumn 52, Issue 6, 2011, Pages 691-701

  Zannikos, Peter N ^a   Doose, Dennis R ^a   Leitz, Gerhard J ^a   Rusch, Sarah ^b   Gonzalez, Martha D ^a   Solanki, Bhavna ^a   Haddad, Ibrahim ^b   Mulberg, Andrew E ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

^b NONE

Author keywords

Gastroesophageal reflux; pediatric; pharmacokinetics; rabeprazole

Indexed keywords

RABEPRAZOLE; SULFIDE;

ABDOMINAL PAIN; AREA UNDER THE CURVE; ARTICLE; ASTHMA; BODY WEIGHT; CHILD; CHILL; CLINICAL ARTICLE; CLINICAL ASSESSMENT; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE SEVERITY; DIZZINESS; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; FEVER; GASTRIN BLOOD LEVEL; GASTRITIS; GASTROESOPHAGEAL REFLUX; GROUPS BY AGE; HEADACHE; HEART MURMUR; HEPATITIS; HUMAN; HYPERGASTRINEMIA; INTESTINE VOLVULUS; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY; NAUSEA; PALATABILITY; PANCREATITIS; PATIENT COMPLIANCE; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; SIDE EFFECT; STREPTOCOCCAL PHARYNGITIS; TIME TO MAXIMUM PLASMA CONCENTRATION; TOOTH PAIN; UPPER RESPIRATORY TRACT INFECTION; URIC ACID BLOOD LEVEL; VIRAL GASTRITIS; VOMITING;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; AGE FACTORS; AREA UNDER CURVE; BODY WEIGHT; CHILD; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; GASTROESOPHAGEAL REFLUX; HUMANS; INFANT; MALE; PATIENT ACCEPTANCE OF HEALTH CARE; SULFIDES;

EID: 79959205508     PISSN: 02772116     EISSN: 15364801     Source Type: Journal    
DOI: 10.1097/MPG.0b013e318207834d     Document Type: Article

References (43)

1. Vandenplas Y, Rudolph CD, Di Lorenzo C, et al. Pediatric gastroeso-phageal reflux clinical practice guidelines: joint recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN). J Pediatr Gastroenterol Nutr 2009;49:498-557.
2. Nelson SP, Chen EH, Syniar GM, et al. Prevalence of symptoms of gastroesophageal reflux during infancy. A pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med 1997;151:569-72. (Pubitemid 27262280)
3. Nelson SP, Chen EH, Syniar GM, et al. Prevalence of symptoms of gastro-oesophageal reflux during childhood. Arch Pediatr Adolesc Med 2000;154:150-4. (Pubitemid 30075195)
4. Orenstein SR, Shalaby TM, Cohn JF. Reflux symptoms in 100 normal infants: diagnostic validity of the infant gastro-oesophageal reflux questionnaire. ClinPediatr(Phila) 1996;35:607-14. (Pubitemid 27014639)
5. Salvatore S, Vandenplas Y. Gastro-oesophageal reflux disease and motility disorders. Best Pract Res Clin Gastroenterol 2003;17:163-79.
6. Martin AJ, Pratt N, Kennedy JD, et al. Natural history and familial relationships of infant spilling to 9 years of age. Pediatrics 2002;109: 1061-7. (Pubitemid 34587431)
7. Nelson SP, Kothari S, Wu EQ, et al. Pediatric gastroesophageal reflux disease and acid-related conditions: trends in incidence of diagnosis and acid suppression therapy. J Med Econ 2009;12:348-55.
8. Hassall E. Decisions in diagnosing and managing chronic gastroeso-phageal reflux disease in children. J Pediatr 2005;146:S3-12.
9. Waring JP, Feiler MJ, Hunter JG, et al. Childhood gastroesophageal reflux symptoms in adult patients. J Pediatr Gastroenterol Nutr 2002; 35:334-8.
10. El-Serag HB, Gilger M, Carter J, et al. Childhood GERD is a risk factor for GERD in adolescents and young adults. Am J Gastroenterol 2004; 99:806-12. (Pubitemid 39090204)
11. Kahrilas PJ. Gastroesophageal reflux disease. N Engl JMed 2008;359: 1700-7.
12. Sachs G, Shin JM, Briving C, et al. The pharmacology of the gastric acid pump: the H+, K+ ATPase. Annu Rev Pharmacol Toxicol 1995;35: 277-305.
13. Fiedorek S, Tolia V, Gold BD, et al. Efficacy and safety of lansoprazole in adolescents with symptomatic erosive and non-erosive gastroesopha-geal reflux disease. J Pediatr Gastroenterol Nutr 2005;40:319-27. (Pubitemid 40344098)
14. Gunasekaran T, Gupta S, Gremse D, et al. Lansoprazole in adolescents with gastroesophageal reflux disease: pharmacokinetics, pharmacody-namics, symptom relief, efficacy, and tolerability. J Pediatric Gastro-enterol Nutr 2002;35(Suppl 4):S327-35. (Pubitemid 35416903)
15. Hassall E, for the International Pediatric Omeprazole Study Group. Omeprazole for the maintenance therapy of erosive esophagitis in children. Gastroenterology 2000;118A658.
16. Hassell E, Israel DM, Shepherd R, et al. Omeprazole for the treatment of chronic erosive esophagitis in children: a multicenter study of efficacy, safety, tolerability, and dose requirements. J Pediatr 2000;137:800-7.
17. Israel DM, Hassell E. Omeprazole and other proton pump inhibitors: pharmacology, efficacy, and safety, with special reference to use in children. J Pediatr Gastroenterol Nutr 1998;27:568-79. (Pubitemid 28492258)
18. Tolia V Ferry G, Gunasekaran T, et al. Efficacy of lansoprazole in the treatment of gastroesophageal reflux disease in children. J Pediatr Gastroenterol Nutr 2002;35(Suppl 4):S308-18. (Pubitemid 35416901)
19. Tolia V Bishop PR, Tsou M, et al. Multicenter, randomized, double-blind study comparing 10, 20, and 40mg pantoprazole in children (5-11 years) with symptomatic gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr 2006;42:384-91.
20. AcipHex (rabeprazole sodium) [package insert]. Tokyo: JapanEisai Co; 2009.
21. Protonix (pantoprazole sodium) [package insert]. Sellersville, PA: Teva Pharmaceuticals; 2008.
22. Williams MP, Sercombe J, Hamilton MI, et al. A placebo-controlled trial to assess the effects of 8 days dosing with rabeprazole versus omepra-zole on 24-h intragastric acidity and plasma gastrin concentrations in young healthy male subjects. Aliment Pharmacol Ther 1998;12: 1079-89. (Pubitemid 28508721)
23. Tolman KG, Taubel J, Warrington S, et al. Comparison of the effects of single and repeated oral doses of lansoprazole and rabeprazole on ambulatory 24-hour intragastric pH in healthy volunteers. Clin Drug Invest 2006;26:21-8. (Pubitemid 43098405)
24. Pantoflickova D, Dorta G, Ravic M, et al. Acid inhibition on the first day of dosing: comparison of four proton pump inhibitors. Aliment Phar-macol Ther 2003;17:1507-14. (Pubitemid 36831441)
25. Warrington S, Baisley K, Boyce M, et al. Effect of rabeprazole, 20mg, or esomeprazole, 20mg on 24-h intragastric pH and serum gastrin in healthy subjects. Aliment Pharmacol Ther 2002;16:1301-7.
26. Kirchheiner J, Glatt S, Fuhr U, et al. Relative potency of proton-pump inhibitors\comparison of effects on intragastric pH. Eur J Clin Phar-macol 2009;65:19-31.
27. Thjodleifsson B. Review of rabeprazole in the treatment of gastro-oesophageal reflux disease. Expert Opin Pharmacother 2000;5:137-49.
28. Swan SK, Hoyumpa AM, Merritt GJ. Review article: the pharmacoki-netics of rabeprazole in health and disease. Aliment Pharmacol Ther 1999;13(Suppl 3):11-7. (Pubitemid 29389407)
29. Yasuda S, Ohnishi A, Ogawa T, et al. Pharmacokinetic properties of E3810, a new proton pump inhibitor, in healthy male volunteers. Int J Clin Pharmacol Ther 1994;32:466-73. (Pubitemid 24277056)
30. James L, Walson P, Lomax K, et al. Pharmacokinetics and tolerability of rabeprazole sodium in subjects aged 12 to 16 years with gastroesopha-geal reflux disease: an open-label, single-and multiple-dose study. Clin Ther 2007;29:2082-92. (Pubitemid 350212802)
31. Ishizaki T, Horai Y Review article: cytochrome P450 and the metabo-lism of proton punp inhibitors-emphasis on rabeprazole. Aliment Phar-macol Ther 1999;13(Suppl 3):27-36. (Pubitemid 29389409)
32. Shi S, Klotz U. Proton pump inhibitors: an update of their clinical use and pharmacokinetics. Eur J Clin Pharmacol 2008;64:935-51.
33. Tolman KG, Chandramouli J, Fang JC Proton pump inhibitors in the treatment of gastro-esophageal reflux disease. Exp Opin Pharmacother 2000;16:1171-94.
34. Miura M. Enantioselective disposition of lansoprazole and rabeprazole in human plasma. Yakugaku Zasshi 2006;12:395-402. (Pubitemid 44651288)
35. VandenBranden M, Ring BJ, Binkley SN, et al. Interaction of human liver cytochromes P450 in vitro with LY307640, a gastric proton pump inhibitor. Pharmacogenetics 1996;6:81-91. (Pubitemid 26097628)
36. Kearns GL, Abdel-Rhaman SM, Alander SW, et al. Developmental pharmacology\drug disposition, action, and therapy in infants and children. N Engl J Med 2003;349:1157-67. (Pubitemid 37122329)
37. Hoyumpa AM, Trevino-Alanis H, Grimes I, et al. Rabeprazole: phar-macokinetics in patients with stable, compensated cirrhosis. Clin Ther 1999;21:691-701. (Pubitemid 29252091)
38. Keane WF, Swan SK, Grimes I, et al. Rabeprazole: pharmacokinetics and tolerability in patients with stable, end-stage renal failure. J Clin Pharmacol 1999;39:927-33. (Pubitemid 30644028)
39. Gremse D, Winter H, Tolia V, et al. Pharmacokinetics and pharmaco-dynamics of lansoprazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr 2002;35(Suppl 4):S319-26. (Pubitemid 35416902)
40. Kearns GL, Andersson T, James LP, et al. Omeprazole disposition in children following single-dose administration. J Clin Pharmacol 2003; 43:840-8. (Pubitemid 36886104)
41. Kearns GL, Blumer J, Schexnayder S, et al. Single-dose pharmacoki-netics of oral and intravenous pantoprazole in children and adolescents. J Clin Pharmacol 2008;48:1356-65.
42. Zhao J, Li J, Hamer-Maansson JE, et al. Pharmacokinetic properties of esomeprazole in children aged 1 to 11 years with symptoms of gastro-esophageal reflux disease: a randomized, open-label study. Clin Ther 2006;28:1868-76. (Pubitemid 46043511)
43. Uno T, Norio Yasui-Furukori N, Shimizu M, et al. Determination of rabeprazole and its active metabolite, rabeprazole thioether in human plasma by column-switching high-performance liquid chromatography and its application to pharmacokinetic study. J Chromatogr B 2005; 824:238-43. (Pubitemid 41215603)