Drug updated on 4/17/2024
| 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.
Summary
- Esomeprazole magnesium (Nexium) is indicated for the treatment and maintenance of erosive esophagitis, heartburn, and other symptoms associated with GERD in adults and pediatric patients aged 12 to 17 years. It is also used for reducing the risk of NSAID-associated gastric ulcers in at-risk adults, eradicating Helicobacter pylori to reduce duodenal ulcer recurrence when combined with amoxicillin and clarithromycin, treating pathological hypersecretory conditions like Zollinger-Ellison syndrome, and healing EE due to acid-mediated GERD in infants from one month old.
- The information was derived from a review of 11 systematic reviews/meta-analyses focusing on efficacy, safety, subgroup considerations including population types based on age-specific diseases.
- In terms of H. pylori eradication compared with Rabeprazole, high doses showed higher cure rates but fewer adverse events were reported using esomeprazole at certain dosages. There was no significant difference between high-dose versus standard dose across different populations regardless of clarithromycin resistance.
- For Gastroesophageal Reflux Disease (GERD) or GOR symptoms in infants, there are no clear benefits over placebo or ranitidine according to very low-certainty evidence, while similar robust data for older children suffering from GORD are lacking.
- Esomeprazole ranked highly, achieving symptom relief against endoscopy-negative reflux disease, suggesting its superiority over other treatments such as H2-receptor antagonists/alginates. It favorably improved mucosal healing compared to placebo among PPIs when treating EE/GERD alongside vonoprazan, which might have higher efficacy especially in severe erosive esophagitis cases during long-term maintenance therapy.
- Subgroup considerations reveal uncertain benefits regarding younger populations experiencing GOR/GORD symptoms where specific interventions like orodispersible budesonide are preferred for eosinophilic esophagitis in children with limited data directly relating to esomeprazole.
- The safety profile of Esomeprazole is consistent with the class effect of PPIs, showing no significant increase in adverse events at higher doses compared to standard doses for H. pylori eradication. Across all indications/dosages, its associated adverse events were comparable or fewer than those reported for other PPIs/treatment modalities.
- In conclusion, while demonstrating efficacy in managing GERD/EE/H. pylori infection with comparable/slightly improved outcomes versus other PPIs, robust evidence supporting use within pediatric populations suffering from GOR/GORD symptoms remains lacking, despite a favorable safety profile not significantly differing across dosages when compared against other treatments.
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 |