Rabeprazole is used for the short-term (4-8 weeks) treatment of erosive or ulcerative esophagitis in patients with gastroesophageal reflux disease (GERD). The drug also is used as maintenance therapy following healing of erosive or ulcerative esophagitis to reduce recurrence of the disease. In addition, rabeprazole is used for the treatment of symptoms (e.g., heartburn) of GERD in patients without erosive or ulcerative esophagitis. Potential benefits in gastroesophageal reflux and esophagitis are thought to result principally from reduced acidity of gastric contents induced by the drug and resultant reduced irritation of esophageal mucosa; the drug can effectively relieve symptoms of esophagitis (e.g., heartburn) and promote healing of ulcerative and erosive lesions.
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 considered to be a chronic disease, the ACG states that many patients with GERD require long-term, even lifelong, treatment. 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, and are effective and appropriate as maintenance therapy in many patients with the disease. 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 rabeprazole for treating acute GERD was established in 2 short-term (up to 8 weeks) controlled studies in adults; rabeprazole was more effective than placebo or ranitidine and at least as effective as omeprazole in healing lesions and providing symptomatic relief. Efficacy as maintenance therapy following healing of erosive or ulcerative esophagitis was established in two 52-week controlled studies in adults; maintenance of lesion healing and symptomatic relief were superior with rabeprazole versus placebo. Efficacy in patients with symptomatic GERD without erosive or ulcerative esophagitis was established in 2 short-term (4 weeks) controlled studies in patients with daytime and nocturnal heartburn, no endoscopic evidence of esophageal erosion, and 5 or more episodes of heartburn during the 7 days immediately prior to randomization. The percentage of daytime or nocturnal periods free of heartburn symptoms was greater, daily antacid consumption was substantially decreased, and other GERD-associated symptoms (regurgitation, belching, early satiety) were improved in patients receiving rabeprazole sodium 20 mg daily compared with those receiving placebo.
Antacids may be used concomitantly as needed for pain relief.
For further information on the treatment of GERD,
Rabeprazole is used for the short-term (up to 4 weeks) treatment of active duodenal ulcers. Efficacy for treating acute duodenal ulcers was established in two 4-week studies; rabeprazole was more effective than placebo and at least as effective as omeprazole in healing ulcers and providing symptomatic relief. Antacids may be used concomitantly as needed for pain relief.
Rabeprazole is used in combination with amoxicillin and clarithromycin (triple therapy) for the treatment of Helicobacter pylori infection and duodenal ulcer disease in individuals with active duodenal ulcer or a history of duodenal ulcer within the preceding 5 years. Efficacy of rabeprazole-based triple therapy for H. pylori eradication was established in a double-blind, parallel-group comparison study in patients with H. pylori infection; patients were stratified in a 1:1 ratio between those with peptic ulcer disease (active ulcer or a history of ulcer in the past 5 years) and symptomatic patients with no endoscopic evidence of peptic ulcer disease. Patients received 3, 7, or 10 days of therapy with rabeprazole (20 mg twice daily), amoxicillin (1 g twice daily), and clarithromycin (500 mg twice daily) or 10 days of therapy with omeprazole (20 mg twice daily), amoxicillin (1 g twice daily), and clarithromycin (500 mg twice daily).H. pylori eradication was defined as a negative C urea breath test 6 weeks or more after completion of the assigned regimen.H. pylori eradication rates achieved with the 7- and 10-day rabeprazole regimens (77.3 and 78.1%, respectively, by intent-to-treat analysis) were similar to those achieved with the 10-day omeprazole regimen (73.3%); eradication rates achieved with the 3-day rabeprazole regimen (27.3%) were inferior to those achieved with the other regimens. For a more complete discussion of H. pylori infection, including details about the efficacy of various regimens and rationale for drug selection,
Pathologic GI Hypersecretory Conditions
Rabeprazole is used in the long-term treatment of pathologic GI hypersecretory conditions (e.g., Zollinger-Ellison syndrome). Experience in the treatment of these conditions is limited, but rabeprazole has been used effectively for up to 12 months; the optimum duration of treatment has not been clearly established.
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., H2-receptor antagonists, cytoprotective agents, antacids, and/or sucralfate).
For further information on the management of Crohn's Disease,