Drug updated on 9/4/2024
Dosage Form | Capsules (oral; 20 mg, 40 mg); Suspension (oral; 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg) |
Drug Class | Proton 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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Nexium (esomeprazole magnesium) Prescribing Information. | 2021 | AstraZeneca Pharmaceuticals LP Wilmington, DE |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
ACG clinical guideline for the diagnosis and management of gastroesophageal reflux disease. | 2022 | The American Journal of Gastroenterology |
Evidence-based clinical practice guidelines for gastroesophageal reflux disease 2021. | 2021 | Journal of Gastroenterology |