Safety and pharmacodynamics of lansoprazole in patients with gastroesophageal reflux disease aged <1 year

Pediatric Drugs

Volumn 10, Issue 4, 2008, Pages 255-263

  Springer, Margaret ^a   Atkinson, Stuart ^b   North, Janine ^b   Raanan, Marsha ^b  

^a LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER   (United States)

^b TAP PHARMACEUTICAL PRODUCTS INC   (United States)

Author keywords

Children; Gastro oesophageal reflux, treatment; Infants; Lansoprazole, adverse reactions; Lansoprazole, pharmacodynamics; Neonates

Indexed keywords

LANSOPRAZOLE;

ANEMIA; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; CLINICAL ARTICLE; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE SEVERITY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FLUSHING; FOLLOW UP; GASTRIC PH MONITORING; GASTROESOPHAGEAL REFLUX; HUMAN; INFANT; MALE; MULTICENTER STUDY; NEONATAL RESPIRATORY DISTRESS SYNDROME; NEWBORN; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REPEATED DRUG DOSE; SIDE EFFECT; TREATMENT OUTCOME; VIRUS PNEUMONIA;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; ANTI-ULCER AGENTS; DOSE-RESPONSE RELATIONSHIP, DRUG; ESOPHAGEAL PH MONITORING; FEMALE; GASTROESOPHAGEAL REFLUX; HUMANS; HYDROGEN-ION CONCENTRATION; INFANT; INFANT, NEWBORN; MALE; PROTON PUMP INHIBITORS;

EID: 46349094132     PISSN: 11745878     EISSN: None     Source Type: Journal    
DOI: 10.2165/00148581-200810040-00004     Document Type: Article

References (23)

1. Rudolph CD, Mazur LJ, Liptak GS, et al. Guidelines for evaluation and treatment of gastroesophageal reflux in infants and children: recommendations of the North American Society for Pediatric Gastroenterology and Nutrition. J Pediatr Gastroenterol Nutr 2001; 32 Suppl. 2: 1-31S
2. Vandenplas Y, Salvatore S, Hauser B. The diagnosis and management of gastrooesophageal reflux in infants. Early Hum Dev 2005 Dec; 81: 1011-24
3. Cezard JP. Managing gastro-oesophageal reflux disease in children. Digestion 2004; 69 Suppl. 1: 3-8
4. 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 Jun; 151 (6): 569-72
5. Nelson SP, Chen EH, Syniar GM, et al. One-year follow-up of symptoms of gastroesophageal reflux during infancy. Pediatric Practice Research Group. Pediatrics 1998 Dec; 106 (6): E67
6. Martin AJ, Pratt N, Kennedy JD, et al. Natural history and familial relationships of infant spilling to 9 years of age. Pediatrics 2002 Jun; 109 (6): 1061-7
7. Gremse DA. GERD in the pediatric patient: management considerations. MedGenMed 2004 May; 6 (2): 13
8. Chiba N, De Gara CJ, Wilkinson JM, et al. Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: a meta-analysis. Gastroenterology 1997 Jun; 112: 1798-810
9. Cucchiara S, Minella R, Iervolino C, et al. Omeprazole and high dose ranitidine in the treatment of refractory reflux oesophagitis. Arch Dis Child 1993; 69: 655-9
10. Reilly JP. Safety profile of proton pump inhibitors. Am J Health Syst Pharm 1999 Dec; 56 Suppl. 4: 11S-7S
11. Barron JJ, Hiangkiat T, Spalding J, et al. Proton pump inhibitor utilization patterns in infants. J Pediatr Gastroenterol Nutr 2007 Oct; 45 (4): 421-7
12. Jadcherla SR. Gastroesophageal reflux in the neonate. Clin Perinatol 2002 Mar; 29 (1): 135-58
13. Zhang W, Kukulka M, Witt G, et al. Age-dependent pharmacokinetics of lansoprazole in neonates and infants. Pediatr Drugs 2008; 10 (4): 265-74
14. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Adopted by the 18th World Medical Assembly, Helsinki, 1964 and amended by the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 [online]. Available from URL: http://www.wma.net/e/policy/b3.htm [Accessed 2008 Jun 3]
15. Strobel CT, Byrne WJ, Ament ME, et al. Correlation of esophageal lengths in children with height: application to the Tuttle test without prior esophageal manometry. J Pediatr 1979 Jan; 94 (1): 81-4
16. Fiedorek S, Tolia V, Gold BD, et al. Efficacy and safety of lansoprazole in adolescents with symptomatic erosive and non-erosive gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr 2005 Mar; 40 (3): 319-27
17. Croom KF, Scott LJ. Lansoprazole: in the treatment of gastro-oesophageal reflux disease in children and adolescents. Drugs 2005; 65 (15): 2129-35
18. Gunasekaran T, Gupta S, Gremse D, et al. Lansoprazole in adolescents with gastroesophageal reflux disease: pharmacokinetics, pharmacodynamics, symptom relief efficacy, and tolerability. J Pediatr Gastroenterol Nutr 2002; 35 Suppl. 4: S327-35
19. Gremse D, Winter H, Tolia V, et al. Pharmacokinetics and pharmacodynamics of lansoprazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr 2002; 35 Suppl. 4: S319-26
20. Faure C, Michaud L, Shaghaghi EK, et al. Lansoprazole in children: pharmacokinetics and efficacy in reflux oesophagitis. Aliment Pharmacol Ther 2001 Sep; 15 (9): 1397-402
21. Tran A, Rey E, Pons G, et al. Pharmacokinetic-pharmacodynamic study of oral lansoprazole in children. Clin Pharmacol Ther 2002 May; 71 (5): 359-67
22. Franco MT, Salvia G, Terrin G, et al. Lansoprazole in the treatment of gastroesophageal reflux disease in childhood. Dig Liver Dis 2000 Nov; 32 (8): 660-6
23. Cucchiara S, Borreli O, Gaudiello G, et al. Lansoprazole in children with severe gastroesophageal reflux disease: effect on gastric acidity, esophagitis and clinic outcome [abstract]. Gastroenterology 1999; 116 (4): A142