Esomeprazole magnesium

(Nexium®)

Nexium®

Drug updated on 9/4/2024

Dosage FormCapsules (oral; 20 mg, 40 mg); Suspension (oral; 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg)
Drug ClassProton pump inhibitors (PPI)
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age.
  • NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the maintenance of healing of EE in adults.
  • NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age.
  • NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers.
  • NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin.
  • NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults.
  • NEXIUM for delayed-release oral suspension is indicated for the short-term treatment in the healing of EE in pediatric patients 1 year to 11 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age.
  • NEXIUM for delayed-release oral suspension is indicated for the short-term treatment of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age.

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Summary
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  • Nexium (esomeprazole magnesium) is indicated for the short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age; the maintenance of healing of EE in adults; the short-term treatment of heartburn and other symptoms associated with GERD in adults and pediatric patients 12 years to 17 years of age; the risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers; the Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin; the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults; the short-term treatment in the healing of EE in pediatric patients 1 year to 11 years of age, and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age; and the short-term treatment of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age.
  • This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
  • H. pylori Eradication: High and standard doses of esomeprazole and rabeprazole showed similar eradication rates of H. pylori (85.3% vs. 84.2%). R40bid had the highest cure rate at 83.8%.
  • Gastroesophageal Reflux Disease (GERD): Esomeprazole was highly effective in relieving GERD symptoms, ranking second and third in complete symptom relief for ENRD and second in mucosal healing for erosive esophagitis.
  • Laryngopharyngeal Reflux Disease (LPRD): Esomeprazole's effectiveness varied widely (18%-87%) depending on the treatment setting.
  • Eosinophilic Esophagitis (EoE): While esomeprazole was included in evaluated therapies, budesonide and fluticasone were more effective in adults and pediatric patients, respectively.
  • Adverse events in H. pylori treatment were highest with E40qd (91.1%) and varied among other dosages, with R40bid showing the lowest rate (20.4%). High doses induced more adverse events, but the difference was not significant compared to standard doses.
  • In GERD and related conditions, including ENRD and EE, esomeprazole was well-tolerated with no specific safety concerns. Serious adverse events were less likely with esomeprazole compared to placebo in GERD treatment.
  • Safety profiles for esomeprazole were comparable to other PPIs and vonoprazan across various conditions, with no significant differences in adverse event rates based on ethnicity or clarithromycin-resistance status.
  • There is no population types or subgroups information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Nexium (esomeprazole magnesium) Prescribing Information.2021AstraZeneca Pharmaceuticals LP Wilmington, DE

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Network meta-analysis of different dosages of esomeprazole and rabeprazole for the treatment of Helicobacter pylori.2023Helicobacter
Pharmacological treatment of gastro-oesophageal reflux in children.2023The Cochrane Database of Systematic Reviews
Comparison of acid-lowering drugs for endoscopy negative reflux disease: Systematic review and network meta-analysis.2022Neurogastroenterology & Motility
Efficacy and safety of proton pump inhibitors versus vonoprazan in treatment of erosive esophagitis: A PRISMA-compliant systematic review and network meta-analysis. 2022Medicine
Different dose of new generation proton pump inhibitors for the treatment of Helicobacter pylori infection: A meta-analysis.2021International Journal of Immunopathology and Pharmacology
A network meta-analysis of randomized controlled trials on the treatment of eosinophilic esophagitis in adults and children.2021Journal of Clinical Gastroenterology
Efficacy and safety of esomeprazole for the treatment of reflux symptoms in patients with gastroesophageal reflux disease: A systematic review and meta-analysis2020Iranian Journal of Public Health
Treatment of laryngopharyngeal reflux disease: A systematic review.2019World Journal of Clinical Cases
Vonoprazan versus proton-pump inhibitors for healing gastroesophageal reflux disease: A systematic review.2019Journal of Gastroenterology and Hepatology
Systematic review with network meta-analysis: Indirect comparison of the efficacy of vonoprazan and proton-pump inhibitors for maintenance treatment of gastroesophageal reflux disease.2019Journal of Gastroenterology
Standard triple therapy in Helicobacter pylori eradication in Turkey: Systematic evaluation and meta-analysis of 10-year studies. 2019The Turkish Journal of Gastroenterology

Clinical Practice Guidelines