Pharmacodynamics and Systemic Exposure of Esomeprazole in Preterm Infants and Term Neonates with Gastroesophageal Reflux Disease

Journal of Pediatrics

Volumn 155, Issue 2, 2009, Pages 222-228

  Omari, Taher ^a   Lundborg, Per ^b   Sandström, Marie ^b   Bondarov, Patrik ^b   Fjellman, Mia ^b   Haslam, Ross ^a   Davidson, Geoffrey ^a  

^a UNIVERSITY OF ADELAIDE   (Australia)

^b ASTRAZENECA R AND D   (Sweden)

Author keywords

[No Author keywords available]

Indexed keywords

ESOMEPRAZOLE;

APNEA; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; COUGHING; CRYING; DRUG BLOOD LEVEL; DRUG SAFETY; GASTROESOPHAGEAL REFLUX; GASTROINTESTINAL SYMPTOM; HUMAN; INFANT; PREMATURITY; PRIORITY JOURNAL; SIDE EFFECT; STOMACH PH; VOMITING; WEIGHT; WHEEZING;

ADMINISTRATION, ORAL; ANTI-ULCER AGENTS; CRYING; ELECTRIC IMPEDANCE; ESOPHAGEAL PH MONITORING; FEMALE; FOOD; GAGGING; GASTROESOPHAGEAL REFLUX; HUMANS; INFANT, NEWBORN; INFANT, PREMATURE; IRRITABLE MOOD; MALE; OMEPRAZOLE; VOMITING;

EID: 67749130919     PISSN: 00223476     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpeds.2009.02.025     Document Type: Article

References (28)

1. Barr R.G. Colic and crying syndromes in infants. Pediatrics 102 (1998) 1282-1286
2. Hill D.J., Heine R.G., Cameron D.J., Catto-Smith A.G., Chow C.W., Francis D.E., et al. Role of food protein intolerance in infants with persistent distress attributed to reflux esophagitis. J Pediatr 136 (2000) 641-647
3. Hiscock H., and Jordan B. Problem crying in infancy. Med J Aust 181 (2004) 507-512
4. Iacono G., Cavataio F., Montalto G., Florena A., Tumminello M., Soresi M., et al. Intolerance of cow's milk and chronic constipation in children. N Engl J Med 339 (1998) 1100-1104
5. Orenstein S.R., and McGowan J.D. Efficacy of conservative therapy as taught in the primary care setting for symptoms suggesting infant gastroesophageal reflux. J Pediatr 152 (2008) 310-314
6. Cucchiara S., Minella R., Iervolino C., Franco M.T., Campanozzi A., Franceschi M., et al. Omeprazole and high dose ranitidine in the treatment of refractory reflux oesophagitis. Arch Dis Child 69 (1993) 655-659
7. De Giacomo C., Bawa P., Franceschi M., Luinetti O., and Fiocca R. Omeprazole for severe reflux esophagitis in children. J Pediatr Gastroenterol Nutr 24 (1997) 528-532
8. Hassall E., Israel D., Shepherd R., Radke M., Dalvag A., Skold B., 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 137 (2000) 800-807
9. Kato S., Ebina K., Fujii K., Chiba H., and Nakagawa H. Effect of omeprazole in the treatment of refractory acid-related diseases in childhood: endoscopic healing and twenty-four-hour intragastric acidity. J Pediatr 128 (1996) 415-421
10. Rudolph C.D., Mazur L.J., Liptak G.S., Baker R.D., Boyle J.T., Colletti R.B., 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 32 Suppl. 2 (2001) S1-31
11. Strauss R.S., Calenda K.A., Dayal Y., and Mobassaleh M. Histological esophagitis: clinical and histological response to omeprazole in children. Dig Dis Sci 44 (1999) 134-139
12. Tolia V., Ferry G., Gunasekaran T., Huang B., Keith R., and Book L. Efficacy of lansoprazole in the treatment of gastroesophageal reflux disease in children. J Pediatr Gastroenterol Nutr 35 Suppl 4 (2002) S308-S318
13. Omari T.I., Barnett C.P., Benninga M.A., Lontis R., Goodchild L., Haslam R.R., et al. Mechanisms of gastro-oesophageal reflux in preterm and term infants with reflux disease. Gut 51 (2002) 475-479
14. Omari T.I., Haslam R.R., Lundborg P., and Davidson G.P. Effect of omeprazole on acid gastroesophageal reflux and gastric acidity in preterm infants with pathological acid reflux. J Pediatr Gastroenterol Nutr 44 (2007) 41-44
15. Barron J.J., Tan H., Spalding J., Bakst A.W., and Singer J. Proton pump inhibitor utilization patterns in infants. J Pediatr Gastroenterol Nutr 45 (2007) 421-427
16. de Wildt S.N., Kearns G.L., Leeder J.S., and van den Anker J.N. Cytochrome P450 3A: ontogeny and drug disposition. Clin Pharmacokinet 37 (1999) 485-505
17. Treluyer J.M., Gueret G., Cheron G., Sonnier M., and Cresteil T. Developmental expression of CYP2C and CYP2C-dependent activities in the human liver: in-vivo/in-vitro correlation and inducibility. Pharmacogenetics 7 (1997) 441-452
18. Orenstein S.R., Hassall E., Furmaga-Jablonska W., Atkinson S., and Raanan M. Multicenter, double-blind, randomized, placebo-controlled trial assessing the efficacy and safety of proton pump inhibitor lansoprazole in infants with symptoms of gastroesophageal reflux disease. J Pediatr (2008) Epub ahead of print
19. Lopez-Alonso M., Moya M.J., Cabo J.A., Ribas J., del Carmen Macias M., Silny J., et al. Twenty-four-hour esophageal impedance-pH monitoring in healthy preterm neonates: rate and characteristics of acid, weakly acidic, and weakly alkaline gastroesophageal reflux. Pediatrics 118 (2006) e299-e308
20. Omari T.I., Benninga M.A., Haslam R.R., Barnett C.P., Davidson G.P., and Dent J. Lower esophageal sphincter position in premature infants cannot be correctly estimated with current formulas. J Pediatr 135 (1999) 522-525
21. Omari T.I., Rommel N., Staunton E., Lontis R., Goodchild L., Haslam R.R., et al. Paradoxical impact of body positioning on gastroesophageal reflux and gastric emptying in the premature neonate. J Pediatr 145 (2004) 194-200
22. Barnett C.P., Omari T., Davidson G.P., Goodchild L., Lontis R., Dent J., et al. Effect of cisapride on gastric emptying in premature infants with feed intolerance. J Paediatr Child Health 37 (2001) 559-563
23. Zhao J., Li J., Hamer-Maansson J.E., Andersson T., Fulmer R., Illueca M., et al. Pharmacokinetic properties of esomeprazole in children aged 1 to 11 years with symptoms of gastroesophageal reflux disease: a randomized, open-label study. Clin Ther 28 (2006) 1868-1876
24. Vandenplas Y., and Sacre-Smits L. Continuous 24-hour esophageal pH monitoring in 285 asymptomatic infants 0-15 months old. J Pediatr Gastroenterol Nutr 6 (1987) 220-224
25. Tamhankar A.P., Peters J.H., Portale G., Hsieh C.C., Hagen J.A., Bremner C.G., et al. Omeprazole does not reduce gastroesophageal reflux: new insights using multichannel intraluminal impedance technology. J Gastrointest Surg 8 (2004) 890-897
26. Vela M.F., Camacho-Lobato L., Srinivasan R., Tutuian R., Katz P.O., and Castell D.O. Simultaneous intraesophageal impedance and pH measurement of acid and nonacid gastroesophageal reflux: effect of omeprazole. Gastroenterology 120 (2001) 1599-1606
27. Omari T., Davidson G., Bondarov P., Naucler E., Nilsson C., and Lundborg P. Pharmacokinetics and acid-suppressive effects of esomeprazole in infants 1-24 months old with symptoms of gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr 45 (2007) 530-537
28. Loots C.M., Benninga M.A., Davidson G.P., and Omari T.I. Addition of pH-impedance monitoring to standard pH monitoring increases the yield of symptom association analysis in infants and children with gastroesophageal reflux. J Pediatr (2008) Epub ahead of print