BACKGROUND AND AIM: Gastroesophageal reflux occurs in the majority of infants, with severity ranging from asymptomatic to severe esophagitis and failure to thrive. Omeprazole is recognized as a safe and effective treatment of gastroesophageal reflux in older children, at an initial dosage of 0.7 mg x kg(-1) x day(-1). To our knowledge, no dose-finding studies have been carried out in children under 2 years of age. The aim of the present study was to prospectively determine the dosage of omeprazole required to treat symptomatic gastroesophageal reflux in children younger than 2 years. PATIENTS AND METHODS: Children under 2 years with clinical suspicion of gastroesophageal reflux underwent 24-hour dual-channel intraesophageal/gastric pH monitoring. A reflux index above 10% in children under 1 year and above 6% in children older than 1 year was deemed significant. Treatment with omeprazole at an initial dosage of 0.7 mg x kg(-1) x day(-1) (in 2 divided doses) was followed by dual-channel pH study after 14 days. The dosage was increased in increments of 0.7 mg x kg(-1) x day(-1), and pH studies were repeated until the gastroesophageal reflux was controlled. RESULTS: Ten children (5 male, 5 female), mean age 7.75 months (range, 1.25-20 months), were investigated. The initial median reflux index was 18.5% (range, 6.5%-56.3%). Follow-up median reflux index was improved at 1.6% (0.1%-8.1%) (P < 0.05). The median dosage required was 1.05 mg x kg(-1) x day(-1). Four children required 1.4 mg x kg(-1) x day(-1), and 1 required 2.8 mg x kg(-1) x day(-1). Corrected reflux index improved from 34.8% (16.8%-90.8%) to 20.1% (0.4%-100%) but did not achieve statistical significance. There were no serious complications or side effects. CONCLUSIONS: Omeprazole is an effective treatment for gastroesophageal reflux in children younger than 2 years. The majority respond to a dosage of 0.7 mg x kg(-1) x day(-1), but increased dosages up to 2.8 mg x kg(-1) x day(-1) may be required.
BACKGROUND AND AIM: Gastroesophageal reflux occurs in the majority of infants, with severity ranging from asymptomatic to severe esophagitis and failure to thrive. Omeprazole is recognized as a safe and effective treatment of gastroesophageal reflux in older children, at an initial dosage of 0.7 mg x kg(-1) x day(-1). To our knowledge, no dose-finding studies have been carried out in children under 2 years of age. The aim of the present study was to prospectively determine the dosage of omeprazole required to treat symptomatic gastroesophageal reflux in children younger than 2 years. PATIENTS AND METHODS: Children under 2 years with clinical suspicion of gastroesophageal reflux underwent 24-hour dual-channel intraesophageal/gastric pH monitoring. A reflux index above 10% in children under 1 year and above 6% in children older than 1 year was deemed significant. Treatment with omeprazole at an initial dosage of 0.7 mg x kg(-1) x day(-1) (in 2 divided doses) was followed by dual-channel pH study after 14 days. The dosage was increased in increments of 0.7 mg x kg(-1) x day(-1), and pH studies were repeated until the gastroesophageal reflux was controlled. RESULTS: Ten children (5 male, 5 female), mean age 7.75 months (range, 1.25-20 months), were investigated. The initial median reflux index was 18.5% (range, 6.5%-56.3%). Follow-up median reflux index was improved at 1.6% (0.1%-8.1%) (P < 0.05). The median dosage required was 1.05 mg x kg(-1) x day(-1). Four children required 1.4 mg x kg(-1) x day(-1), and 1 required 2.8 mg x kg(-1) x day(-1). Corrected reflux index improved from 34.8% (16.8%-90.8%) to 20.1% (0.4%-100%) but did not achieve statistical significance. There were no serious complications or side effects. CONCLUSIONS:Omeprazole is an effective treatment for gastroesophageal reflux in children younger than 2 years. The majority respond to a dosage of 0.7 mg x kg(-1) x day(-1), but increased dosages up to 2.8 mg x kg(-1) x day(-1) may be required.
Authors: Jaroslaw Kierkus; Wanda Furmaga-Jablonska; Janice E Sullivan; Elmer S David; Dan L Stewart; Natalie Rath; Caifeng Fu; Wenjin Wang; Mary K Maguire; Gail M Comer Journal: Dig Dis Sci Date: 2010-07-07 Impact factor: 3.199
Authors: Petra Bestebreurtje; Barbara A E de Koning; Nel Roeleveld; Catherijne A J Knibbe; Dick Tibboel; Bianca van Groen; Cees P van de Ven; Frans B Plötz; Saskia N de Wildt Journal: Eur J Drug Metab Pharmacokinet Date: 2020-10 Impact factor: 2.441
Authors: Petra Bestebreurtje; Nel Roeleveld; Catherijne A J Knibbe; Adriaan A van Sorge; Frans B Plötz; Saskia N de Wildt Journal: Eur J Drug Metab Pharmacokinet Date: 2020-10 Impact factor: 2.441
Authors: Giovanni Tafuri; Francesco Trotta; Hubert G M Leufkens; Nello Martini; Luciano Sagliocca; Giuseppe Traversa Journal: Eur J Clin Pharmacol Date: 2008-09-17 Impact factor: 2.953