Abstract | BACKGROUND: AIM: To determine the clinical value of maintenance intermittent treatment with rabeprazole 20 mg vs. placebo in patients with sGERD. METHODS: This multicentre, US study enrolled patients with sGERD (>or=3-month history of GERD symptoms and >or=4 days/week of heartburn during a 2-week placebo run-in) without oesophageal erosions. Patients with complete heartburn control after 4 weeks of open-label rabeprazole 20 mg daily treatment were randomized to 6-month, double-blind, maintenance intermittent treatment (7- to 14-day courses when heartburn recurred) with rabeprazole 20 mg or placebo. RESULTS: The primary efficacy end point, mean percentage of heartburn-free days, was significantly greater with rabeprazole vs. placebo: 82.58% and 62.17% (ITT; P < 0.0001) [per protocol 86.74% rabeprazole vs. 74.93% placebo (P < 0.0254)]. Compared with placebo group, the rabeprazole group also experienced a significantly higher percentage of heartburn-free daytime (84.06% vs. 63.39%; P < 0.0001) and nighttime (95.41% vs. 90.25%; P = 0.0021) periods, had significantly fewer discontinuations because of insufficient heartburn control (6.3% vs. 36.3%; P < 0.0001) and took fewer antacid tablets daily (0.58 vs. 1.16; P = 0.0021). CONCLUSION: Intermittent use of rabeprazole may be an effective maintenance treatment strategy for patients with sGERD and warrants further investigation. This trial was registered with http://clinicaltrials.gov under the number NCT00165841.
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Authors | R Fass, B Delemos, L Nazareno, R Kao, J Xiang, Y Lu |
Journal | Alimentary pharmacology & therapeutics
(Aliment Pharmacol Ther)
Vol. 31
Issue 9
Pg. 950-60
(May 2010)
ISSN: 1365-2036 [Electronic] England |
PMID | 20132154
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- 2-Pyridinylmethylsulfinylbenzimidazoles
- Anti-Ulcer Agents
- Rabeprazole
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Topics |
- 2-Pyridinylmethylsulfinylbenzimidazoles
(administration & dosage)
- Adolescent
- Adult
- Aged
- Anti-Ulcer Agents
(therapeutic use)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Female
- Gastroesophageal Reflux
(drug therapy)
- Heartburn
(drug therapy)
- Humans
- Male
- Middle Aged
- Rabeprazole
- Treatment Outcome
- Young Adult
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