Esomeprazole for the Treatment of GERD in Infants Ages 1–11 Months

Winter, Harland S.; Gunasekaran, Thirumazhisai S.; Tolia, Vasundhara; Gottrand, Frédéric; Barker, Peter; Illueca, Marta

doi:10.1097/mpg.0b013e3182496b35

Cited by 49 publications

(51 citation statements)

References 22 publications

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“…The review focused on 12 randomized, controlled and crossover studies in children ranging in age from 0–17 years. In addition to the systematic review, we included in our review a multicenter, randomized, double‐blind, placebo‐controlled trial published in 2012 that compared the efficacy and safety of esomeprazole in infants to provide more updated information . Table provides a summary of these trials …”

Section: Efficacy Of Proton Pump Inhibitors In Infants Children Andmentioning

confidence: 99%

Efficacy and Safety of Proton Pump Inhibitors in the Management of Pediatric Gastroesophageal Reflux Disease

Tjon

Soscia

et al. 2013

Pharmacotherapy

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Proton pump inhibitors (PPIs) are commonly prescribed to infants and children for managing gastroesophageal reflux disease (GERD). Recently published literature illustrates conflicting evidence on the efficacy of PPIs in infants and children. Randomized controlled trials and systematic reviews have demonstrated a lack of efficacy of PPIs, specifically in young infants. Furthermore, emerging evidence also suggests that PPIs are not as benign as once thought, with newer data implicating a potential association of PPIs with an increased risk of respiratory tract infections, gastrointestinal infections, bone fractures, hypomagnesemia, and the occurrence of rebound hyperacidity after discontinuation of PPI therapy. To summarize the emerging data in children, we reviewed the literature to assess the efficacy and safety of PPIs in managing pediatric GERD. Despite conflicting evidence on the efficacy of PPIs, most studies in children demonstrated some benefit when compared with placebo. With respect to the safety of PPIs in children, only a few small studies and case reports indicated a potential association of PPIs with an increased risk of respiratory tract or gastrointestinal infections, bone fractures, and hypomagnesemia; however, many of those studies had their own limitations. From the review, it is clear that further well-designed trials and observational studies are needed to shed more light on the efficacy and safety of PPIs in the pediatric population.

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Section: Efficacy Of Proton Pump Inhibitors In Infants Children Andmentioning

confidence: 99%

Efficacy and Safety of Proton Pump Inhibitors in the Management of Pediatric Gastroesophageal Reflux Disease

Tjon

Soscia

et al. 2013

Pharmacotherapy

View full text Add to dashboard Cite

show abstract

“…These observations suggest that pathological GER is an unlikely cause of infant irritability under the age of 3 months [40]. Several placebocontrolled prospective trials with PPIs in infants presenting with "excessive crying and reflux-like symptoms" have been performed and show negative results, with an increased incidence of adverse events in the PPI group sometimes as being the only difference in outcome [56][57][58].…”

Section: H²-receptor Antagonists and Proton Pump Inhibitorsmentioning

confidence: 90%

“…GERD may cause excessive crying in infants [40]. The concept that infant irritability and sleep disturbances are manifestations of GER is largely extrapolated from adult descriptions of heartburn and sleep disturbances that improve with antacid therapy OA [158] 1-11 month During double-blind treatment, there were no significant differences between pantoprazole and placebo in withdrawal rates due to lack of efficacy Winter (2012) OA [56] 1-11 month During double-blind treatment, there were no significant differences between esomeprazole and placebo in withdrawal rates due to lack of efficacy OA [159] 1-11 years Symptom improvement Gold (2007) OA [160] 12-17 years Symptom improvement Shashidhar (2013) Rev [161] 0-18 years PPIs are effective in healing reflux esophagitis in children of all ages but do not improve GER-related symptoms in infants The table is not exhaustive but lists the papers on Pubmed between 2007 and 2013 with "proton pump inhibitor infant" and "proton pump inhibitor pediatric" as search terms and illustrates the differences in outcome according to age of the patients PPI proton pump inhibitor, H²RA histamine receptor antagonists, RCTs randomized controlled trials, GERD gastroesophageal reflux disease [1]. However, there is no evidence for this hypothesis.…”

Section: H²-receptor Antagonists and Proton Pump Inhibitorsmentioning

confidence: 95%

Gastroesophageal Reflux

Vandenplas¹

2015

Textbook of Pediatric Gastroenterology, Hepatology and Nutrition

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“…Notably, Moore et al[24] enrolled infants with endoscopically confirmed GORD and found omeprazole significantly reduced the reflux index (percentage of total duration pH < 4) in these infants compared with placebo, but irritability improved regardless of treatment. In the most recent randomised controlled trial of PPI (Esomeprazole) for the treatment of symptomatic GORD, without endoscopy, all children were initially treated with PPI and then randomised to continuation of PPI or placebo[25]. It found no statistically significant difference in apparent treatment failure between the PPI or placebo group.…”

Section: Action and Efficacy Of Ppimentioning

confidence: 99%

Widespread use of gastric acid inhibitors in infants: Are they needed? Are they safe?

Safe¹,

Chan²,

Leach³

et al. 2016

WJGPT

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Gastroesophageal reflux is a common phenomenon in infants, but the differentiation between gastroesophageal reflux and gastroesophageal reflux disease can be difficult. Symptoms are non-specific and there is increasing evidence that the majority of symptoms may not be acid-related. Despite this, gastric acid inhibitors such as proton pump inhibitors are widely and increasingly used, often without objective evidence or investigations to guide treatment. Several studies have shown that these medications are ineffective at treating symptoms associated with reflux in the absence of endoscopically proven oesophagitis. With a lack of evidence for efficacy, attention is now being turned to the potential risks of gastric acid suppression. Previously assumed safety of these medications is being challenged with evidence of potential side effects including GI and respiratory infections, bacterial overgrowth, adverse bone health, food allergy and drug interactions.

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Esomeprazole for the Treatment of GERD in Infants Ages 1–11 Months

Abstract: The discontinuation rate owing to symptom worsening did not differ significantly between infants receiving esomeprazole versus those receiving placebo. Improved diagnostic criteria in this age group are needed to identify infants with GERD who may benefit from acid suppression therapy.

Cited by 49 publications

References 22 publications

Efficacy and Safety of Proton Pump Inhibitors in the Management of Pediatric Gastroesophageal Reflux Disease

Efficacy and Safety of Proton Pump Inhibitors in the Management of Pediatric Gastroesophageal Reflux Disease

Gastroesophageal Reflux

Widespread use of gastric acid inhibitors in infants: Are they needed? Are they safe?

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