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Clinical trial: maintenance intermittent therapy with rabeprazole 20 mg in patients with symptomatic gastro-oesophageal reflux disease - a double-blind, placebo-controlled, randomized study.

AbstractBACKGROUND:
Optimal long-term management of symptomatic gastro-oesophageal reflux disease (sGERD) patients has not been established.
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.
AuthorsR Fass, B Delemos, L Nazareno, R Kao, J Xiang, Y Lu
JournalAlimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 31 Issue 9 Pg. 950-60 (May 2010) ISSN: 1365-2036 [Electronic] England
PMID20132154 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents
  • Rabeprazole
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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