Efficacy and safety of histamine-2 receptor antagonists

JAMA Pediatrics

Volumn 168, Issue 10, 2014, Pages 947-954

  Van Der Pol, Rachel ^a   Langendam, Miranda ^b   Benninga, Marc ^a   Van Wijk, Michiel ^a   Tabbers, Merit ^a  

^a EMMA CHILDREN S HOSPITAL   (Netherlands)

^b ACADEMIC MEDICAL CENTER   (Netherlands)

Author keywords

[No Author keywords available]

Indexed keywords

ANTACID AGENT; HISTAMINE H2 RECEPTOR ANTAGONIST; PLACEBO; PROTON PUMP INHIBITOR;

ABDOMINAL PAIN; DIZZINESS; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; ESOPHAGITIS; FOOD REGURGITATION; GASTROESOPHAGEAL REFLUX; HEARTBURN; HUMAN; NAUSEA; QUALITY CONTROL; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; STOMACH PH; SYSTEMATIC REVIEW; TREATMENT DURATION; VOMITING; ADOLESCENT; CHILD; INFANT; NEWBORN; PATHOLOGY; PH; PRESCHOOL CHILD; TREATMENT OUTCOME;

ADOLESCENT; ANTACIDS; CHILD; CHILD, PRESCHOOL; GASTROESOPHAGEAL REFLUX; HISTAMINE H2 ANTAGONISTS; HUMANS; HYDROGEN-ION CONCENTRATION; INFANT; INFANT, NEWBORN; PROTON PUMP INHIBITORS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84908011827     PISSN: 21686203     EISSN: 21686211     Source Type: Journal    
DOI: 10.1001/jamapediatrics.2014.1273     Document Type: Review

References (55)

1. Khoshoo V, Ross G, Brown S, Edell D. Smaller volume, thickened formulas in the management of gastroesophageal reflux in thriving infants. J Pediatr Gastroenterol Nutr. 2000;31(5):554-556.
2. Omari T. Gastroesophageal reflux in infants: can a simple left side positioning strategy help this diagnostic and therapeutic conundrum? Minerva Pediatr. 2008;60(2):193-200.
3. Anand G, Katz PO. Gastroesophageal reflux disease and obesity. Gastroenterol Clin North Am. 2010;39(1):39-46.
4. Lightdale JR, Gremse DA; Section on Gastroenterology, Hepatology, and Nutrition. Gastroesophageal reflux: management guidance for the pediatrician. Pediatrics. 2013;131(5):e1684-e1695.
5. van der Pol RJ, Smits MJ, van Wijk MP, Omari TI, Tabbers MM, BenningaMA. Efficacy of proton-pump inhibitors in children with gastroesophageal reflux disease: a systematic review. Pediatrics. 2011;127(5):925-935.
6. Tolia V, Johnston G, Stolle J, Lee C. Flavor and taste of lansoprazole strawberry-flavored delayed-release oral suspension preferred over ranitidine peppermint-flavored oral syrup: in children aged between 5-11 years. Paediatr Drugs. 2004;6(2):127-131.
7. Kothari S, Nelson SP,Wu EQ, Beaulieu N, McHale JM, Dabbous OH. Healthcare costs of GERD and acid-related conditions in pediatric patients, with comparison between histamine-2 receptor antagonists and proton pump inhibitors. Curr Med Res Opin. 2009;25(11):2703-2709.
8. Tighe MP, Afzal NA, Bevan A, Beattie RM. Current pharmacological management of gastro-esophageal reflux in children: an evidence-based systematic review. Paediatr Drugs. 2009;11(3):185-202.
9. van Pinxteren B, Sigterman KE, Bonis P, Lau J, Numans ME. Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease. Cochrane Database Syst Rev. 2010;10(11): CD002095.
10. Netzer P, Gaia C, SandozM, et al. Effect of repeated injection and continuous infusion of omeprazole and ranitidine on intragastric pH over 72 hours. Am J Gastroenterol. 1999;94(2):351-357.
11. Chiba N, De Gara CJ, Wilkinson JM, Hunt RH. Speed of healing and symptom relief in grade II to IV gastroesophageal reflux disease: ameta-analysis. Gastroenterology. 1997;112(6):1798-1810.
12. Barkun AN, Bardou M, Pham CQD, MartelM. Proton pump inhibitors vs. histamine 2 receptor antagonists for stress-related mucosal bleeding prophylaxis in critically ill patients: ameta-analysis. Am J Gastroenterol. 2012;107(4):507-520, quiz 521.
13. More K, Athalye-Jape G, Rao S, Patole S. Association of inhibitors of gastric acid secretion and higher incidence of necrotizing enterocolitis in preterm very low-birth-weight infants.AmJ Perinatol. 2013;30(10):849-856
14. Terrin G, Passariello A, De Curtis M, et al. Ranitidine is associated with infections, necrotizing enterocolitis, and fatal outcome in newborns. Pediatrics. 2012;129(1):e40-e45.
15. Canani RB, Terrin G. Gastric acidity inhibitors and the risk of intestinal infections. Curr Opin Gastroenterol. 2010;26(1):31-35.
16. Guillet R, Stoll BJ, Cotten CM, et al; National Institute of Child Health and Human Development Neonatal Research Network. Association of H2-blocker therapy and higher incidence of necrotizing enterocolitis in very low birth weight infants. Pediatrics. 2006;117(2):e137-e142.
17. Canani RB, Cirillo P, Roggero P, et al;Working Group on Intestinal Infections of the Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition (SIGENP). Therapy with gastric acidity inhibitors increases the risk of acute gastroenteritis and community-acquired pneumonia in children. Pediatrics. 2006;117(5):e817-e820.
18. Doorduyn Y, Van Den Brandhof WE, Van Duynhoven YTHP,WannetWJB, Van PeltW. Risk factors for salmonella enteritidis and typhimurium (DT104 and non-DT104) infections in the Netherlands: predominant roles for raw eggs in enteritidis and sandboxes in typhimurium infections. Epidemiol Infect. 2006;134(3): 617-626.
19. Vandenplas Y, Rudolph CD, Di Lorenzo C, et al; North American Society for Pediatric Gastroenterology Hepatology and Nutrition; European Society for Pediatric Gastroenterology Hepatology and Nutrition. Pediatric gastroesophageal 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(4):498-547.
20. MalcolmWF, Cotten CM. Metoclopramide, H2 blockers, and proton pump inhibitors: pharmacotherapy for gastroesophageal reflux in neonates. Clin Perinatol. 2012;39(1):99-109.
21. James LP, Kearns GL. Pharmacokinetics and pharmacodynamics of famotidine in paediatric patients. Clin Pharmacokinet. 1996;31(2):103-110.
22. Kumar Y, Sarvananthan R. GORD in children. Clin Evid (Online). 2008;310.
23. Higgins J, Altman D, Sterne J. Assessing risk of bias in included studies. In: Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. The Cochrane Collaboration; 2011:8.
24. Schnemann H, Oxman A, Vist G, et al. Interpreting results and drawing conclusions. In: Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. The Cochrane Collaboration; 2012:12.
25. Guyatt GH, Oxman AD, Vist GE, et al; GRADE Working Group. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008;336(7650):924-926.
26. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.
27. Cucchiara S, Gobio-Casali L, Balli F, et al. Cimetidine treatment of reflux esophagitis in children: an Italian multicentric study. J Pediatr Gastroenterol Nutr. 1989;8(2):150-156.
28. Orenstein SR, Blumer JL, Faessel HM, et al. Ranitidine, 75mg, over-the-counter dose: pharmacokinetic and pharmacodynamic effects in children with symptoms of gastro-oesophageal reflux. Aliment Pharmacol Ther. 2002;16(5): 899-907.
29. Orenstein SR, Shalaby TM, Devandry SN, et al. Famotidine for infant gastro-oesophageal reflux: a multi-centre, randomized, placebo-controlled, withdrawal trial. Aliment Pharmacol Ther. 2003;17 (9):1097-1107.
30. Simeone D, Caria MC, Miele E, Staiano A. Treatment of childhood peptic esophagitis: a double-blind placebo-controlled trial of nizatidine. J Pediatr Gastroenterol Nutr. 1997;25(1): 51-55.
31. Cucchiara S, Staiano A, Romaniello G, Capobianco S, Auricchio S. Antacids and cimetidine treatment for gastro-oesophageal reflux and peptic oesophagitis. Arch Dis Child. 1984;59(9): 842-847.
32. Oderda G, Dell'Olio D, ForniM, Farina L, Tavassoli K, Ansaldi N. Treatment of childhood peptic oesophagitis with famotidine or alginate-antacid. Ital J Gastroenterol. 1990;22(6): 346-349.
33. 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(6):655-659.
34. Ummarino D,Miele E, Masi P, Tramontano A, Staiano A, Vandenplas Y. Impact of antisecretory treatment on respiratory symptoms of gastroesophageal reflux disease in children. Dis Esophagus. 2012;25(8):671-677.
35. von Baeyer CL, Spagrud LJ. Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain. 2007;127(1-2):140-150.
36. Sigterman KE, van Pinxteren B, Bonis PA, Lau J, Numans ME. Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease. Cochrane Database Syst Rev. 2013;5:CD002095.
37. Sherman PM, Hassall E, Fagundes-Neto U, et al. A global, evidence-based consensus on the definition of gastroesophageal reflux disease in the pediatric population. Am J Gastroenterol. 2009;104(5):1278-1295, 1296.
38. (EMEA) EMA. Guideline on the Evaluation of Drugs for the Treatment of Gastro-oesophageal Reflux Disease. London, England: European Medical Agency; 2011.
39. Henschel AD, Rothenberger LG, Boos J. Randomized clinical trials in children: ethical and methodological issues. Curr Pharm Des. 2010;16 (22):2407-2415.
40. Spriggs M, Caldwell PHY. The ethics of paediatric research. J Paediatr Child Health. 2011;47 (9):664-667.
41. Caldwell PHY, Butow PN, Craig JC. Pediatricians' attitudes toward randomized controlled trials involving children. J Pediatr. 2002; 141(6):798-803.
42. Kelly DA. Do H2 receptor antagonists have a therapeutic role in childhood? J Pediatr Gastroenterol Nutr. 1994;19(3):270-276.
43. García Rodríguez LA, Jick H. Risk of gynaecomastia associated with cimetidine, omeprazole, and other antiulcer drugs. BMJ. 1994; 308(6927):503-506.
44. García Rodríguez LA,Wallander MA, Stricker BH. The risk of acute liver injury associated with cimetidine and other acid-suppressing anti-ulcer drugs. Br J Clin Pharmacol. 1997;43(2):183-188.
45. Galbraith RA,Michnovicz JJ. The effects of cimetidine on the oxidativemetabolism of estradiol. N Engl J Med. 1989;321(5):269-274.
46. Ribeiro JM, Lucas M, Baptista A, Victorino RM. Fatal hepatitis associated with ranitidine. Am J Gastroenterol. 2000;95(2):559-560.
47. Williams C, McColl KE. Review article: proton pump inhibitors and bacterial overgrowth. Aliment Pharmacol Ther. 2006;23(1):3-10.
48. Moharana AK, Bhattacharya SK, Mediratta PK, Sharma KK. Possible role of histamine receptors in the central regulation of immune responses. Indian J Physiol Pharmacol. 2000;44(2):153-160.
49. van der Pouw Kraan TC, Snijders A, Boeije LC, et al. Histamine inhibits the production of interleukin-12 through interaction with H2 receptors. J Clin Invest. 1998;102(10): 1866-1873.
50. St Peter SD, Sharp SW, Ostlie DJ. Influence of histamine receptor antagonists on the outcome of perforated appendicitis: analysis from a prospective trial. Arch Surg. 2010;145(2):143-146.
51. Hyman PE, Garvey TQ III, Abrams CE. Tolerance to intravenous ranitidine. J Pediatr. 1987; 110(5):794-796.
52. Nwokolo CU, Smith JT, Gavey C, Sawyerr A, Pounder RE. Tolerance during 29 days of conventional dosing with cimetidine, nizatidine, famotidine or ranitidine. Aliment Pharmacol Ther. 1990;4(1)(suppl 1):29-45.
53. Wilder-Smith CH, Ernst T, Gennoni M, Zeyen B, Halter F, Merki HS. Tolerance to oral H2-receptor antagonists. Dig Dis Sci. 1990;35(8):976-983.
54. Wheatley E, Kennedy KA. Cross-over trial of treatment for bradycardia attributed to gastroesophageal reflux in preterm infants. J Pediatr. 2009;155(4):516-521.
55. Chen I-L, Gao W-Y, Johnson AP, et al. Proton pump inhibitor use in infants: FDA reviewer experience. J Pediatr Gastroenterol Nutr. 2012;54 (1):8-14.