Safety and Tolerability of Esomeprazole in Children With Gastroesophageal Reflux Disease

Gilger, Mark A.; Tolia, Vasundhara; Vandenplas, Yvan; Youssef, Nader N.; Traxler, Barry; Illueca, Marta

doi:10.1097/mpg.0b013e318176b2cb

Cited by 40 publications

(49 citation statements)

References 33 publications

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“…Even if a limited number of patients reported symptoms during 7 days preceding the registration visit, most patients who reported symptoms at baseline became asymptomatic during treatment. Almost all patients had no or only mild symptoms at the end of the study, which was generally consistent with previous studies in Caucasian children …”

Section: Discussionsupporting

confidence: 91%

“…The safety of 10 or 20 mg esomeprazole, given once daily as capsules or sachets for 8 weeks, was considered acceptable for all study groups and in line with the safety profile from previous studies in Caucasian children and in Japanese adults …”

Section: Discussionsupporting

confidence: 54%

“…Three patients with endoscopically verified DU or RE at baseline had complete resolution following treatment with esomeprazole. Even if limited, however, these clinical findings suggest that esomeprazole has a clinically beneficial effect in Japanese children, as has been demonstrated in adult Japanese and Western pediatric patients …”

Section: Discussionmentioning

confidence: 78%

“…The esomeprazole doses in this study were based on US/EU approved doses and on PK, safety and clinical data from previous pediatric studies in Caucasian subjects that demonstrated relevant exposure following 10 and 20 mg, but too low exposure following a dose of 5 mg . Bioequivalence has previously been demonstrated between esomeprazole given as sachets (granules for suspension) and capsules (Dr Helen Lunde, unpubl.…”

Section: Methodsmentioning

confidence: 99%

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Oral esomeprazole in Japanese pediatric patients with gastric acid‐related disease: Safety, efficacy, and pharmacokinetics

Shimizu

Nakayama

Ishii

et al. 2019

Pediatrics International

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Background Proton pump inhibitors (PPI) are widely used for the treatment of gastric acid‐related disease, but they are not approved for use in children in Japan. To assess the safety, pharmacokinetics, pharmacodynamics, and efficacy (gastrointestinal symptom improvement) of PPI in Japanese pediatric patients with gastric acid‐related disease, we conducted an 8 week, open‐label, parallel‐group, multicenter, phase I/III study of once‐daily oral esomeprazole use. Methods Japanese children, aged 1–14 years with gastric acid‐related disease, were stratified by weight and age into five groups (10 patients/group) to receive esomeprazole as granules for suspension (10 mg) or capsules (10 mg or 20 mg) once daily. Results Esomeprazole was absorbed and eliminated rapidly in all groups, with a median time to reach maximum plasma concentration of 1.47–1.75 h, an arithmetic mean terminal elimination half‐life of 0.80–1.37 h, and a weight‐correlated apparent total body clearance of 0.216–0.343 L/h/kg. Area under the plasma concentration–time curve during a dosage interval and maximum plasma drug concentration were generally higher in groups given a higher dose (20 mg) or with a lower age/weight, but also in patients identified as poor metabolizers on cytochrome P450 2C19 genotype. Most patients who had any upper gastrointestinal symptoms at baseline were asymptomatic at the end of the study. Thirty‐three patients (66%) reported ≥1 adverse events, including three patients who reported serious adverse events not judged to be causally related to esomeprazole. Conclusions Oral esomeprazole, at 10 mg or 20 mg once daily, had a similar safety, efficacy, and pharmacokinetic profile in Japanese pediatric patients to that previously seen in adults and Caucasian children.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 54%

Section: Discussionmentioning

confidence: 78%

Section: Methodsmentioning

confidence: 99%

See 2 more Smart Citations

Oral esomeprazole in Japanese pediatric patients with gastric acid‐related disease: Safety, efficacy, and pharmacokinetics

Shimizu

Nakayama

Ishii

et al. 2019

Pediatrics International

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“…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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Gastro-oesophageal reflux treatment for prolonged non-specific cough in children and adults

Chang

Lasserson

Gaffney

et al. 2011

Cochrane Database of Systematic Reviews

159

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PPI is not efficacious for cough associated with GORD symptoms in very young children (including infants) and should not be used for cough outcomes. There is insufficient data in older children to draw any valid conclusions. In adults, there is insufficient evidence to conclude definitely that GORD treatment with PPI is universally beneficial for cough associated with GORD. Clinicians should be cognisant of the period (natural resolution with time) and placebo effect in studies that utilise cough as an outcome measure. Future paediatric and adult studies should be double-blind, randomised controlled and parallel-design, using treatments for at least two months, with validated subjective and objective cough outcomes and include ascertainment of time to respond as well as assessment of acid and/or non-acid reflux.

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Safety and Tolerability of Esomeprazole in Children With Gastroesophageal Reflux Disease

Abstract: In children ages 1 to 11 years with endoscopically proven GERD, esomeprazole (at daily doses of 5, 10, or 20 mg) was generally well tolerated. The frequency and severity of GERD-related symptoms were significantly reduced during the active treatment period.

Cited by 40 publications

References 33 publications

Oral esomeprazole in Japanese pediatric patients with gastric acid‐related disease: Safety, efficacy, and pharmacokinetics

Oral esomeprazole in Japanese pediatric patients with gastric acid‐related disease: Safety, efficacy, and pharmacokinetics

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

Gastro-oesophageal reflux treatment for prolonged non-specific cough in children and adults

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