Lansoprazole in adolescents with gastroesophageal reflux disease: Pharmacokinetics, pharmacodynamics, symptom relief efficacy, and tolerability

Journal of Pediatric Gastroenterology and Nutrition

Volumn 35, Issue SUPPL. 4, 2002, Pages

  Gunasekaran, Thirumazhisai ^a   Gupta, Sandeep ^b   Gremse, David ^c   Karol, Michael ^d   Pan, Wei Jian ^d   Chiu, Yi Lin ^d   Keith, Roberta ^e   Fitzgerald, Joseph ^b  

^a Lutheran General Children's Hospital   (United States)

^b RILEY HOSPITAL FOR CHILDREN   (United States)

^c UNIVERSITY OF SOUTH ALABAMA   (United States)

^d ABBOTT LABORATORIES   (United States)

^e TAP PHARMACEUTICAL PRODUCTS INC   (United States)

Author keywords

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

Indexed keywords

ANTACID AGENT; ATTAPULGITE; LANSOPRAZOLE; PROTON PUMP INHIBITOR;

ADOLESCENT; ADULT; ALLERGIC REACTION; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE EXACERBATION; DISEASE SEVERITY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GASTROESOPHAGEAL REFLUX; HEADACHE; HEARTBURN; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PERIPHERAL EDEMA; PH MEASUREMENT; PHARMACODYNAMICS; PHARMACOKINETICS; PHARYNGITIS; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; STOMACH PH; SYMPTOMATOLOGY; TOOTH PAIN; URTICARIA; VERTIGO;

EID: 0036445857     PISSN: 02772116     EISSN: None     Source Type: Journal    
DOI: 10.1097/00005176-200211004-00005     Document Type: Article

References (43)

1. Nelson SP, Chen EH, Syniar GM, Christoffel KK, for the Pediatric Practice Research Group. Prevalence of symptoms of gastroesophageal reflux during childhood. Arch Pediatr Adolesc Med 2000;154:150-4.
2. Werlin SL, Dodds WJ, Hogan WJ, Arndorfer RC. Mechanisms of gastroesophageal reflux in children. J Pediatr 1980;97:244-9.
3. Ramesh P, Braden D, Dey S, Gunasekaran T. Prevalence of gastroesophageal reflux disease (GERD) symptoms in a Caucasian predominant adolescent population [abstract]. Gastroenterology 2002;122:4:A-213.
4. Ramesh P, Santiago M, Schmidt K, Gunasekaran TS. Prevalence of gastroesophageal reflux disease symptoms in an African American predominant adolescent high school population [abstract]. J Pediatr Gastroenterol Nutr 2001;33:A194.
5. Treem WR, Davis PM, Hyams JS. Gastroesophageal reflux in the older child: Presentation, response to treatment and long-term follow-up. Clin Pediatr 1991;30:435-40.
6. Ashorn M, Ruuska T, Karikoski R, Laippala P. The natural course of gastroesophageal reflux disease in children. Scand J Gastroenterol 2002;37:638-41.
7. Orenstein SR. Gastroesophageal reflux. Curr Prob Pediatr 1991;May/June: 193-241.
8. Lagergren J, Bergstrom R, Lindgrena A, Nyren O. Symptomatic gastroesophageal reflux as a risk factor for esophageal adenocarcinoma. N Engl J Med 1999;340:825-31.
9. Robinson M, Earnest D, Rodriquez-Stanley S, et al. Heartburn requiring frequent antacid use may indicate significant illness. Arch Intern Med 1998;158:2373.
10. Euler AR, Ament ME. Value of esophageal manometric studies in the gastroesophageal reflux of infancy. Pediatrics 1977;59:58-61.
11. Herbst JJ, Book LS, Bray PF. Gastroesophageal reflux in the "near miss" sudden infant death syndrome. J Pediatr 1978;92:73-5.
12. Blum RA, Shi H, Karol MD. The comparative effects of lansoprazole, omeprazole, and ranitidine in suppressing gastric acid secretion. Clin Ther 1997;19:1013-23.
13. Jones RH, Baxter G. Lansoprazole 30 mg daily versus ranitidine 150 mg b.d. in the treatment of acid-related dyspepsia in general practice. Aliment Pharmacol Ther 1997;11:541-6.
14. Chiba N, De Gara CJ, Wilkinson JM, Hunt RH. Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: A meta-analysis. Gastroenterology 1997;112:1798-810.
15. Huang J-Q, Hunt RH. Meta-analysis of comparative trials for healing erosive esophagitis (EE) with proton pump inhibitors (PPIs) and H2-receptor antagonists (H2RAs) [abstract]. Gastroenterology 1998;114:A154.
16. Sontag SJ, Kugut DG, Fleischmann R, et al. Lansoprazole heals erosive reflux esophagitis resistant to histamine H2-receptor antagonist therapy. Am J Gastroenterol 1997;92:429-37.
17. Sontag SJ, Kogut DG, Fleischmann R, Campbell DR, Richter J, Haber M. Lansoprazole prevents recurrence of erosive reflux esophagitis previously resistant to H2-RA therapy. The lansoprazole maintenance study group. Am J Gastroenterol 1996;91:1758-65.
18. Robinson M, Campbell DR, Sontag S, Sabesin SM. Treatment of erosive reflux esophagitis resistant to H2-receptor antagonist therapy. Lansoprazole, a new proton pump inhibitor. Dig Dis Sci 1995;40:590-7.
19. Scott Levin & Associates. IMS America Prescription Audit. Scott Levin Audit 2000.
20. Riddell RH. The biopsy diagnosis of gastroesophageal reflux disease, "carditis," and Barrett's esophagus, and sequelae of therapy. Am J Surg Pathol 1996;20(suppl 1):S31-50.
21. Ismail-Beigi F, Horton PF, Pope CE. Histological consequences of gastroesophageal reflux in man. Gastroenterology 1970;58:163-74.
22. Behar J, Sheahan DC. Histologic abnormalities in reflux esophagitis. Arch Pathol 1975;99:387-91.
23. Winter HS, Madara JL, Stafford RJ, Grand RJ, Quinlan J, Goldman H. Intraepithelial eosinophils: A new diagnostic criterion for reflux esophagitis. Gastroenterology 1982;83:818-23.
24. Black DD, Haggitt RC, Orenstein SR, Whitington PF. Esophagitis in infants. Morphometric histological diagnosis and correlation with measures of gastroesophageal reflux. Gastroenterology 1990; 98:1408-14.
25. Cucchiara S, Franco MT, Terrin G, Spadaro R, di Nardo G, Iula V. Role of drug therapy in the treatment of gastro-oesophageal reflux disorder in children. Paediatr Drugs 2000;2:263-72.
26. Vandenplas Y. Gastroesophageal reflux in children. Scand J Gastroenterol 1995;30(suppl 213):31-8.
27. Grill BB, Hillemeier AC, Semeraro AL, et al. Effects of domperidone therapy on symptoms and upper gastrointestinal motility in infants with gastroesophageal reflux. J Pediatr 1985;106:311-16.
28. Orenstein SR, Lofton SW, Orenstein DM, et al. Bethanechol for pediatric gastroesophageal reflux: A prospective blind controlled study. J Pediatr Gastroenterol Nutr 1986;5:549-55.
29. Hassall E. Wrap session: Is the Nissen slipping? Can medical treatment replace surgery for severe gastroesophageal reflux disease in children? Am J Gastroenterol 1995;90:1212-20.
30. Hassall E. Antireflux surgery in children: Time for a harder look. Pediatrics 1998;101:467-8.
31. Israel DM, Hassall E. Omeprazole and other proton pump inhibitors: Pharmacology, efficacy and safety with special reference to use in children. J Pediatr Gastroenterol Nutr 1998;27:566-79.
32. Abdullah B, Gupta SK, Fitzgerald JF, Chong SKF, Croffie J. Long term management of moderate/severe peptic esophagitis in children/adolescents. H2 blocker vs. proton pump inhibitor (PPI) [Abstract]. Gastroenterology 1998;114:A51.
33. Hassall E, Israel D, Shepherd R, et al. Omeprazole for treatment of chronic erosive esophagitis in children: A multicenter study of efficacy, safety, tolerability and dose requirements. International Pediatric Omeprazole Study Group. J Pediatr 2000;137:800-7.
34. Gunasekaran TS, Hassall EG. Efficacy and safety of omeprazole for severe gastroesophageal reflux in children. J Pediatr 1993;123: 148-54.
35. Karjoo M, Kane R. Omeprazole treatment of children with peptic esophagitis refractory to ranitidine therapy. Arch Pediatr Adolesc Med 1995;149:267-71.
36. Franco MT, Salvia G, Terrin G, et al. Lansoprazole in the treatment of gastroesophageal reflux disease in childhood. Dig Liver Dis 2000;32:660-6.
37. Faure C, Michaud L, Shaghaghi ED, et al. Lansoprazole in children: Pharmacokinetics and efficacy in reflux oesophagitis. Aliment Pharmacol Ther 2001;15:1397-402.
38. Cucchiara S, Borrelli O, Gaudiello G, Boccia G, Fecarotta S, Spadaro R, Terrin G. Lansoprazole in children with severe gastroesophageal reflux disease: Effect on gastric acidity, esophagitis, and clinical outcome [abstract]. Gastroenterology 1999;116:A142.
39. Tran A, Rey E, Pons G, Pariente-Khayat A, D'Athis P, Sallerin V, Dupont C. Pharmacokinetic-pharmacodynamic study of oral lansoprazole in children. Clin Pharmacol Ther 2002;71:359-67.
40. Karol MD. Abbott-65006 Drug Metabolism Report No. 32. Overview and Summary of the Human Pharmacokinetics and Biopharmaceutics of Lansoprazole. Abbott Laboratories Division 46 Report No. R & D/92/393, October 1992.
41. Oderda G, Chiorboli E, Rapa A, Haitink O, Bona G. Inhibition of gastric acidity in children by lansoprazole in granules [abstract]. Gastroenterology 1998;114:A24.
42. Freston JW, Rose PA, Heller CA, Haber M, Jennings D. Safety profile of lansoprazole: The US clinical trial experience. Drug Safety 1999;20:195-205.
43. Leufkens H, Claessens A, Heerdink E, van Eijk J, Lamers CB. A prospective follow-up study of 5669 users of lansoprazole in daily practice. Aliment Pharmacol Ther 1997;11:887-97.