Dexlansoprazole is used for short-term (up to 8 weeks) treatment of all grades of erosive esophagitis, as maintenance therapy (for up to 6 months) following healing of erosive esophagitis to reduce recurrence of the disease, and for short-term (up to 4 weeks) management of symptoms (e.g., heartburn) of gastroesophageal reflux disease (GERD) in patients without erosive esophagitis.
Suppression of gastric acid secretion is considered by the American College of Gastroenterology (ACG) to be the mainstay of treatment for GERD, and a proton-pump inhibitor or histamine H2-receptor antagonist is used to achieve acid suppression, control symptoms, and prevent complications of the disease. Because GERD is a chronic condition, the ACG states that continuous therapy to control symptoms and prevent complications is appropriate, and chronic, even lifelong, use of a proton-pump inhibitor is effective and appropriate as maintenance therapy in many patients with GERD. The ACG states that proton-pump inhibitors are more effective (i.e., provide more frequent and more rapid symptomatic relief and healing of esophagitis) than histamine H2-receptor antagonists in the treatment of GERD. Proton-pump inhibitors also provide greater control of acid reflux than do prokinetic agents (e.g., cisapride [no longer commercially available in the US], metoclopramide) without the risk of severe adverse effects associated with these agents.
Efficacy of dexlansoprazole in the treatment of endoscopically diagnosed erosive esophagitis was established in 2 controlled studies in patients receiving dexlansoprazole 60 or 90 mg daily or lansoprazole 30 mg daily for 8 weeks. Healing rates at 4 weeks were similar for dexlansoprazole 60 mg daily and lansoprazole 30 mg daily (66-70 and 65%, respectively). Findings of one study showed higher rates of healing (85 versus 79%) for dexlansoprazole 60 mg daily versus lansoprazole 30 mg daily at 8 weeks; however, in the other study, healing rates at 8 weeks for these 2 regimens did not differ significantly (87 versus 85%, respectively). No additional benefit of the 90-mg dosage over the 60-mg dosage of dexlansoprazole was reported.
Efficacy of dexlansoprazole as maintenance therapy following healing of erosive esophagitis was established in a controlled study in patients with endoscopically confirmed healing of erosive esophagitis who received dexlansoprazole 30 or 60 mg daily or placebo for 6 months. Healing was maintained in 66% of patients receiving dexlansoprazole 30 mg daily compared with 14% of patients receiving placebo. In addition, patients receiving dexlansoprazole 30 mg daily reported a higher percentage of heartburn-free 24-hour periods over 6 months of maintenance therapy than did patients receiving placebo. Most patients receiving placebo discontinued such treatment between months 2 and 6 because of recurrent erosive esophagitis. No additional clinical benefit of the 60-mg dosage over the 30-mg dosage was reported.
Efficacy in patients with symptomatic nonerosive GERD was established in a controlled study in patients with a 6-month or longer history of heartburn episodes, no endoscopic evidence of erosive esophagitis, and heartburn for at least 4 of the 7 days immediately prior to randomization; patients received dexlansoprazole 30 or 60 mg daily or placebo for 4 weeks. The median percentage of days (24-hour periods) without heartburn was 55 or 19% during 4 weeks of therapy with dexlansoprazole or placebo, respectively; no additional benefit of the 60-mg dosage over the 30-mg dosage was reported.
For further information on the treatment of GERD,
Crohn's Disease-associated Ulcers
Although evidence currently is limited, proton-pump inhibitors have been used for gastric acid-suppressive therapy as an adjunct in the symptomatic treatment of upper GI Crohn's disease, including esophageal, gastroduodenal, and jejunoileal disease. Most evidence of efficacy to date has been from case studies in patients with Crohn's-associated peptic ulcer disease unresponsive to other therapies (e.g., histamine H2-receptor antagonists, cytoprotective agents, antacids, and/or sucralfate).
For further information on the management of Crohn's disease,