Drug updated on 11/4/2024
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
- This summary is based on the review of 11 systematic review(s)/meta-analysis(es). [1-11]
- In H. pylori eradication, concomitant therapy (CT) was more effective than sequential therapy (ST), with CT achieving higher eradication rates, particularly in Asian populations and with PPIs like lansoprazole, pantoprazole, and esomeprazole (RR (relative risk)=0.96, P<0.001 for per-protocol analysis; RR=0.94, P=0.005 for modified intent-to-treat analysis). Additionally, higher doses of esomeprazole and rabeprazole (40 mg twice daily) showed superior eradication rates, with rabeprazole reaching an 83.8% cure rate.
- H. pylori treatment effectiveness was influenced by CYP2C19 polymorphisms, with poor and intermediate metabolizers achieving higher cure rates using omeprazole and lansoprazole compared to extensive metabolizers, though such differences were not observed with esomeprazole, rabeprazole, or pantoprazole.
- For GERD (gastroesophageal reflux disease) and erosive esophagitis (EE), esomeprazole improved clinical symptoms and reduced relapse, ranking second in mucosal healing effectiveness for EE after ilaprazole and providing notable symptom relief in endoscopy-negative reflux disease. In Barrett's esophagus (BE), esomeprazole was beneficial for chemoprophylaxis when combined with acetylsalicylic acid.
- Concomitant therapy (CT) for H. pylori eradication was associated with a higher incidence of adverse events such as diarrhea, vomiting, dysgeusia, and dizziness compared to sequential therapy (ST). Higher doses of esomeprazole (E40qd) also had an elevated adverse event rate (91.1%) compared to lower doses of esomeprazole and rabeprazole.
- In GERD and erosive esophagitis (EE) treatment, no significant differences in adverse event rates were observed among PPIs, vonoprazan, and placebo, indicating that esomeprazole and similar treatments were generally well-tolerated. However, esomeprazole was associated with fewer serious adverse events compared to placebo in GERD (RR = 1.406, P = 0.032).
- There is a potential cardiovascular risk linked to chronic esomeprazole use due to its inhibition of the enzyme DDAH1, which may increase the likelihood of cardiovascular events in long-term users, warranting monitoring for adverse cardiovascular outcomes.
- There are clinically relevant differences in H. pylori eradication and PPI effectiveness based on patient population characteristics: Asian populations responded better to concomitant therapy (CT) compared to sequential therapy (ST) for H. pylori eradication, with improved outcomes in conjunction with PPIs like lansoprazole, pantoprazole, and esomeprazole. In addition, CYP2C19 polymorphisms affected eradication success, with higher cure rates in poor and intermediate metabolizers using omeprazole and lansoprazole, but not with esomeprazole, rabeprazole, or pantoprazole.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Nexium (esomeprazole magnesium) Prescribing Information. | 2023 | AstraZeneca, 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 |