Dexilant (Dexlansoprazole) Uses
Dexilant (dexlansoprazole) is a proton pump inhibitor (PPI) primarily indicated for the treatment of gastroesophageal reflux disease (GERD), including healing of erosive esophagitis, maintenance of healed erosive esophagitis, and treatment of symptomatic non-erosive GERD in patients 12 years of age and older. 1
FDA-Approved Indications
- Healing of all grades of erosive esophagitis (EE) in patients 12 years and older 1
- Maintenance of healed erosive esophagitis and relief of heartburn in patients 12 years and older 1
- Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD) in patients 12 years and older 1
Mechanism of Action
Dexlansoprazole is the R-enantiomer of lansoprazole and functions as a proton pump inhibitor that reduces acid production in the stomach by:
- Blocking the hydrogen-potassium adenosine triphosphatase enzyme system (the "proton pump") 2
- Utilizing a modified release (MR) formulation that provides dual release of the active ingredient in both the duodenum and small intestine 2
- Achieving two peak plasma concentrations at different times (2 hours and 5 hours after administration) 2
- Providing the longest maintenance of drug concentration in plasma of all known PPIs 2
Clinical Efficacy
For Erosive Esophagitis
- Complete healing in ≥92% of patients with all grades of erosive esophagitis after 8 weeks of treatment with dexlansoprazole MR 60 mg once daily 3
- Non-inferior to lansoprazole 30 mg once daily for healing erosive esophagitis 3
For Maintenance of Healed Erosive Esophagitis
- Significantly more effective than placebo in maintaining healing following 6 months of treatment with dexlansoprazole MR 30 mg once daily 3
For Non-Erosive GERD
- Significantly greater proportion of 24-hour heartburn-free days compared to placebo after 4 weeks of treatment with dexlansoprazole MR 30 mg once daily 3
- Effective in improving both heartburn and regurgitation symptoms 4
For Asian Patients with GERD
- In a phase 4 study of Asian patients, dexlansoprazole demonstrated efficacy for both NERD (30 mg daily) and erosive esophagitis (60 mg daily) 5
- Median percentage of days without 24-hour heartburn or acid regurgitation was 26.9% in NERD and 65.5% in EE groups 5
Advantages Over Other PPIs
- Flexible dosing - Can be taken without regard to food intake or time of day 6
- Once-daily dosing may replace twice-daily dosing of other agents 6
- Dual release formulation provides prolonged acid suppression 2
- Effective for nighttime GERD symptoms - Particularly beneficial for patients with night-time heartburn and sleep disorders resulting from GERD 2
Treatment Approach for GERD
According to clinical guidelines, the approach to GERD treatment is:
- Initial therapy: Standard-dose PPI once daily for 4-8 weeks 7
- Assessment of response at 4-8 weeks 7
- If symptoms resolve: Wean to lowest effective dose, consider on-demand therapy 7
- If partial or no response: Assess compliance, increase to twice-daily PPI or switch to a more effective acid suppressive agent 7
Safety Profile
- Generally well tolerated in clinical trials of up to 12 months' duration 3
- Common side effects include headaches, diarrhea, constipation, and nausea (up to 14% of patients) 7
- Potential risks associated with long-term PPI use include:
Important Considerations
- Dexlansoprazole 60 mg contains FD&C Yellow #5 (tartrazine) which may cause allergic reactions in susceptible persons, particularly those with aspirin hypersensitivity 1
- Should not be taken by patients who are taking rilpivirine (used to treat HIV-1) 1
- Should be used at the lowest effective dose for the shortest time needed 7
- Regular review of ongoing indications for PPI use is recommended 7
Conclusion
Dexlansoprazole (Dexilant) is an effective proton pump inhibitor for treating GERD-related conditions with a unique dual-release formulation that provides prolonged acid suppression and flexible dosing options. Its efficacy has been demonstrated for healing erosive esophagitis, maintaining healing, and treating symptomatic non-erosive GERD.