Abstract
Gastro-oesophageal reflux afflicts up to 7% of all infants. Histamine-2 receptor antagonists are the most commonly prescribed medications for this disorder, but few controlled studies support this practice. To evaluate the safety and efficacy of famotidine for infant gastro-oesophageal reflux disease. Thirty-five infants, 1.3-10.5 months of age, entered an 8-week, multi-centre, randomized, placebo-controlled, two-phase trial: first 4 weeks, observer-blind comparison of famotidine 0.5 mg/kg and famotidine 1.0 mg/kg; second 4 weeks, double-blind withdrawal comparison (safety and efficacy) of each dose with placebo. No serious adverse events were reported. Eleven patients had 16 non-serious, possibly drug-related adverse experiences: 6 patients with agitation or irritability (manifested as head-rubbing in two), 3 patients with somnolence, 2 patients with anorexia, 2 with headache, 1 patient with vomiting, 1 patient with hiccups, and 1 patient with candidiasis. Of the 35 infants, 27 completed Part I. There were significant score improvements for famotidine 0.5 mg/kg in regurgitation frequency (P = 0.04), and for famotidine 1.0 mg/kg in crying time (P = 0.027) and regurgitation frequency (P = 0.004) and volume (P = 0.01). Eight infa...Continue Reading
References
Mar 1, 1992·The Journal of Pediatrics·J LambertR J Grand
Dec 1, 1991·Archives of Internal Medicine·S M SabesinS Zaidi
Sep 1, 1991·Clinical Pharmacokinetics·H Echizen, T Ishizaki
May 1, 1991·The Journal of Pediatrics·W R TreemJ S Hyams
Jan 1, 1990·Clinical Pharmacokinetics·G KrausU Klotz
Feb 1, 1989·Journal of Pediatric Gastroenterology and Nutrition·S CucchiaraS Guandalini
Nov 1, 1987·Biopharmaceutics & Drug Disposition·K C YehR L Williams
Jan 1, 1986·Annals of Internal Medicine·D A Lieberman, E B Keeffe
Oct 1, 1994·Journal of Pediatric Gastroenterology and Nutrition·D A Kelly
Oct 1, 1994·Therapeutic Drug Monitoring·A NagitaK Ashida
Apr 1, 1994·Gut·J M MarreroJ D Maxwell
Jan 1, 1996·Journal of Clinical Pharmacology·L P JamesG L Kearns
Dec 1, 1996·Clinical Pediatrics·S R OrensteinJ F Cohn
Mar 20, 1998·The Journal of Pediatrics·P AlliëtP Gillis
Feb 9, 2002·Archives of Pediatrics & Adolescent Medicine·Aaron E CarrollDimitri A Christakis
Jan 10, 2003·The Journal of Pediatrics·Theresa M Shalaby, Susan R Orenstein
Citations
Jul 16, 2008·Current Gastroenterology Reports·Eric Hassall
Sep 28, 2007·Current Treatment Options in Gastroenterology·Neelesh A Tipnis, Colin D Rudolph
Jun 1, 2005·Clinical Therapeutics·Susan R OrensteinKeith S Rotenberg
Jan 18, 2011·Journal of Pediatric Gastroenterology and Nutrition·Hayat M MousaSamuel Nurko
Feb 16, 2005·Biology of the Neonate·Eleanor J MolloyRichard J Martin
Jun 28, 2005·Paediatric Drugs·Mark D ScarupaBrendan J Canning
May 19, 2009·Paediatric Drugs·Mark P TigheR Mark Beattie
Mar 15, 2014·Archives of Disease in Childhood·Manigandan Chandrasekaran, Paul Fleming
Jul 29, 2006·Canadian Journal of Anaesthesia = Journal Canadien D'anesthésie·Klaus KjaerBarbara L Leighton
Sep 2, 2008·European Journal of Pediatrics·Karel PaulJaroslava Dittrichová
Feb 22, 2012·Clinics in Perinatology·William F Malcolm, C Michael Cotten
Jan 24, 2009·Clinics in Perinatology·Neelesh A Tipnis, Sajani M Tipnis
Dec 5, 2008·The Journal of Pediatrics·Susan R OrensteinMarsha Raanan
Jun 28, 2012·Journal for Specialists in Pediatric Nursing : JSPN·Madalynn NeuCassandra Marcheggiani-Howard
Jul 24, 2013·Gastroenterology Research and Practice·Luigi CorvagliaGiacomo Faldella
Jul 9, 2016·Early Human Development·Andrew RomaineUNKNOWN Best Pharmaceuticals for Children Act – Pediatric Trials Network
Jul 18, 2016·Italian Journal of Pediatrics·Silvia SalvatoreUNKNOWN SIPPS Working Group on FGIDs
Jan 1, 2014·Biological Research for Nursing·Madalynn NeuMark L Laudenslager
Oct 27, 2017·The Journal of Perinatal & Neonatal Nursing·Sara E Rostas
Nov 25, 2014·The Cochrane Database of Systematic Reviews·Mark TigheR Mark Beattie
Nov 15, 2017·Clinical Pediatrics·Brendan Ryan Harris, William E Bennett
Jan 3, 2012·Allergy, Asthma & Immunology Research·Woo Jin JungBok Yang Pyun
Oct 27, 2018·Expert Review of Clinical Pharmacology·Pamela D BrowneMerit M Tabbers
Nov 22, 2007·Journal of Pediatric Gastroenterology and Nutrition·Susan R Orenstein, Eric Hassall
Apr 20, 2010·Journal of Pediatric Gastroenterology and Nutrition·Harland WinterGail M Comer
Feb 14, 2018·Neonatal Network : NN·Sara E Rostas, Christopher McPherson
Oct 15, 2013·Journal of Pediatric Gastroenterology and Nutrition·Sunny HussainWilliam Treem
May 8, 2020·Pediatric Research·Sudarshan R JadcherlaCarlo Di Lorenzo
Sep 28, 2017·Arquivos De Gastroenterologia·Ângelo Zambam de MattosMarta Brenner Machado
Sep 16, 2004·Advances in Neonatal Care : Official Journal of the National Association of Neonatal Nurses·Shawna M Henry
Sep 11, 2018·Paediatric Drugs·Steven L Ciciora, Frederick W Woodley
Apr 1, 2020·Journal of the American Veterinary Medical Association·Renata S CostaLois A Wetmore
Sep 12, 2009·Journal of Pediatric Gastroenterology and Nutrition·Yvan Vandenplas European Society for Pediatric Gastroenterology Hepatology and Nutrition
Dec 3, 2020·Journal of Pediatric Gastroenterology and Nutrition·Daniel R DuncanRachel L Rosen
Feb 3, 2004·Pediatrics·Christian F Poets