Pharmacokinetics and safety of dexlansoprazole MR in adolescents with symptomatic GERD

Journal of Pediatric Gastroenterology and Nutrition

Volumn 54, Issue 1, 2012, Pages 41-47

  Kukulka, Michael ^a   Wu, Jingtao ^a   Perez, Maria Claudia ^a  

^a Takeda Global Research   (United States)

Author keywords

adolescents; pharmacokinetics; proton pump inhibitor; safety; TAK 390MR

Indexed keywords

LANSOPRAZOLE;

ABDOMINAL PAIN; ADOLESCENT; ADOLESCENT DISEASE; AREA UNDER THE CURVE; ARTICLE; CHILD; CLINICAL ARTICLE; DISEASE SEVERITY; DIZZINESS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG SAFETY; ELECTROCARDIOGRAM; FEMALE; GASTROESOPHAGEAL REFLUX; HEMATOLOGY; HUMAN; MALE; MAXIMUM PLASMA CONCENTRATION; MORNING DOSAGE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PHYSICAL EXAMINATION; PRESYNCOPE; PRIORITY JOURNAL; SCHOOL CHILD; SIDE EFFECT; TIME TO MAXIMUM PLASMA CONCENTRATION; URINALYSIS; VITAL SIGN; VOMITING;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; ADOLESCENT; AREA UNDER CURVE; CHILD; ESOPHAGITIS; FEMALE; GASTROESOPHAGEAL REFLUX; HUMANS; MALE; PROTON PUMP INHIBITORS;

EID: 84855355725     PISSN: 02772116     EISSN: 15364801     Source Type: Journal    
DOI: 10.1097/MPG.0b013e31822a323a     Document Type: Article

References (22)

1. Rudolph CD, Mazur LJ, Liptak GS, et al. Guidelines for evaluation and treatment of gastroesophageal reflux in infants and children: Recommendations of theNorthAmerican Society for Pediatric Gastroenterology and Nutrition. J Pediatr Gastroenterol Nutr 2001;32(suppl 2):S1-31. (Pubitemid 32606853)
2. Gold BD, Freston JW. Gastroesophageal reflux in children: Pathogenesis, prevalence, diagnosis, and role of proton pump inhibitors in treatment. Paediatr Drugs 2002;4:673-85. (Pubitemid 35168451)
3. Nelson SP, Chen EH, Syniar GM, et al. Prevalence of symptoms of gastroesophageal reflux during childhood: A pediatric practice-based survey. Pediatric Practice Research Group. Arch Pediatr Adolesc Med 2000;154:150-4. (Pubitemid 30075195)
4. Cezard JP. Managing gastro-oesophageal reflux disease in children. Digestion 2004;69(suppl 1):3-8. (Pubitemid 38316481)
5. Prevacid (lansoprazole) Delayed-Release Capsules, Delayed-Release Oral Suspension, and Delayed-Release Orally Disintegrating Tablets. Full Prescribing Information (R36). Takeda Pharmaceuticals America, Deerfield, IL, 2010.
6. Sontag SJ, Kogut DG, Fleischmann R, et al. 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. (Pubitemid 26307178)
7. Sontag SJ, Kogut DG, Fleischmann R, et al. Lansoprazole heals erosive reflux esophagitis resistant to histamine H2-receptor antagonist therapy. Am J Gastroenterol 1997;92:429-37.
8. Robinson M, Campbell DR, Sontag S, et al. Treatment of erosive reflux esophagitis resistant to H2-receptor antagonist therapy. Lansoprazole, a new proton pump inhibitor. Dig Dis Sci 1995;40:590-7.
9. Freston JW, Rose PA, Heller CA, et al. Safety profile of lansoprazole: The US clinical trial experience. Drug Saf 1999;20:195-205. (Pubitemid 29101282)
10. 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. (Pubitemid 35416903)
11. 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. (Pubitemid 35416902)
12. Vakily M, Zhang W, Wu J, et al. Pharmacokinetics and pharmacodynamics of a known active PPI with a novel dual delayed release technology, dexlansoprazole MR: A combined analysis of randomized controlled clinical trials. Curr Med Res Opin 2009;25:627-38.
13. Dexilant (dexlansoprazole) Delayed Release Capsules. Full Prescribing Information (R8). Takeda Pharmaceuticals America, Inc, Deerfield, IL, 2011.
14. Peura DA, Metz DC, Dabholkar AH, et al. Safety profile of dexlansoprazole MR, a proton pump inhibitor with a novel dual delayed release formulation: Global clinical trial experience. Aliment Pharmacol Ther 2009;30:1010-21.
15. Adachi K, Katsube T, Kawamura A, et al. CYP2C19 genotype status and intragastric pH during dosing with lansoprazole or rabeprazole. Aliment Pharmacol Ther 2000;14:1259-66.
16. Zhang W, Wu J, Atkinson S. Pharmacokinetic (PK), pharmacodynamic (PD), and safety evaluation of single and multiple 60 mg, 90 mg, and 120mg oral doses of modified release TAK-390 (TAK-390MR) and 30mg oral doses of lansoprazole (Lan) in healthy subjects (abstract). Gastroenterology 2007;132(4 suppl 2):A-487.
17. Lee RD, Mulford D,Wu J, et al. The effect of time-of-day dosing on the pharmacokinetics and pharmacodynamics of dexlansoprazole MR: Evidence for dosing flexibility with a dual delayed release proton pump inhibitor. Aliment Pharmacol Ther 2010;31:1001-11.
18. Zhang W, Wu J, Atkinson SN. Effects of dexlansoprazole MR, a novel dual delayed release formulation of a proton pump inhibitor, on plasma gastrin levels in healthy subjects. J Clin Pharmacol 2009; 49:444-54.
19. Prilosec (omeprazole) Delayed-Release Capsules and (omeprazole magnesium) Delayed-Release Oral Suspension. Full Prescribing Information. Wilmington, DE: AstraZeneca Pharmaceuticals LP, revised August 2010.
20. Nexium (esomeprazole magnesium) Delayed-Release Capsules, Delayed-Release Oral Suspension. Full Prescribing Information.Wilmington, DE: AstraZeneca Pharmaceuticals LP, revised August 2010.
21. Katsuki H, Yagi H, Arimori K, et al. Determination of R(+)-and S(-)-lansoprazole using chiral stationary-phase liquid chromatography and their enantioselective pharmacokinetics in humans. Pharm Res 1996;13:611-5. (Pubitemid 26119066)
22. 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.