Abstract | OBJECTIVES: Clinical results to date suggest that antisecretory therapy may be less effective in providing symptom relief for patients with nonerosive gastroesophageal reflux disease ( GERD) than for patients with erosive disease. This study was carried out to assess the efficacy and rapidity of once-daily rabeprazole (10 mg or 20 mg) in relieving symptoms in endoscopically negative patients with moderately severe GERD symptoms and to evaluate the safety of these doses over 4 wk. METHODS: This placebo-controlled, double blind study enrolled 203 men and women with moderately severe symptoms of GERD. After a 2-wk, single-blind placebo run-in phase, patients were randomized to receive 10 mg or 20 mg of rabeprazole or placebo once daily for 4 wk. RESULTS:
Rabeprazole rapidly and effectively relieved heartburn, with significant improvements on day 1 of dosing. It also improved most other GERD-related symptoms, including regurgitation, belching, bloating, early satiety, and nausea. Both rabeprazole doses were significantly superior to the placebo with respect to time to the first 24-h heartburn-free interval (2.5 and 4.5 days for 10 mg and 20 mg of rabeprazole, respectively, vs 21.5 days for the placebo) and first daytime or nighttime heartburn-free interval (1.5-3 days for rabeprazole groups vs 12.5-15 days for the placebo), as well as to percentage of time patients were heartburn-free and free of antacid use. Both rabeprazole doses were well tolerated. CONCLUSIONS: Based on these findings and prior studies, rabeprazole reliably relieves GI symptoms equally well in both nonerosive GERD and erosive GERD.
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Authors | Philip Miner Jr, William Orr, Joseph Filippone, Leonard Jokubaitis, Sheldon Sloan |
Journal | The American journal of gastroenterology
(Am J Gastroenterol)
Vol. 97
Issue 6
Pg. 1332-9
(Jun 2002)
ISSN: 0002-9270 [Print] United States |
PMID | 12094846
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Benzimidazoles
- Enzyme Inhibitors
- Rabeprazole
- Omeprazole
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Topics |
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Adult
- Benzimidazoles
(administration & dosage, adverse effects, therapeutic use)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Enzyme Inhibitors
(administration & dosage, adverse effects, therapeutic use)
- Female
- Gastroesophageal Reflux
(drug therapy)
- Humans
- Male
- Middle Aged
- Omeprazole
(analogs & derivatives)
- Rabeprazole
- Safety
- Single-Blind Method
- Treatment Outcome
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