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Arbaclofen placarbil in GERD: a randomized, double-blind, placebo-controlled study.
Nimish B Vakil1, F Jacob Huff, Amy Bian
1University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin 53066, USA. nvakil@wisc.edu
The American Journal of Gastroenterology
|April 27, 2011
Summary
Arbaclofen placarbil (AP) did not significantly reduce heartburn events in all gastroesophageal reflux disease (GERD) patients. However, AP showed promise in patients previously responsive to proton pump inhibitors (PPIs).
Area of Science:
- Gastroenterology
- Pharmacology
Background:
- Gastroesophageal reflux disease (GERD) is a common condition characterized by heartburn and regurgitation.
- Arbaclofen placarbil (AP) has demonstrated potential in inhibiting reflux.
- Evaluating AP's efficacy and safety in symptomatic GERD patients is crucial.
Purpose of the Study:
- To assess the 4-week efficacy and safety of arbaclofen placarbil (AP) in patients with symptomatic GERD.
- To investigate the impact of prior proton pump inhibitor (PPI) use on AP treatment response.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 156 subjects with GERD symptoms.
- Participants were stratified into PPI-naive (n=58) and PPI-responsive (n=98) subgroups.
- Subjects received AP (20, 40, 60 mg daily, or 30 mg twice daily) or placebo for 4 weeks after a 2-week washout period.
Main Results:
- The primary analysis showed no statistically significant difference in heartburn events between AP and placebo for the overall study group.
- A significant interaction was observed between prior PPI use and AP response.
- In PPI-responsive subjects, AP significantly reduced heartburn events compared to placebo, with notable complete resolution rates for the 30 mg twice daily dose.
Conclusions:
- Arbaclofen placarbil (AP) was not superior to placebo in the overall GERD population for reducing heartburn.
- Exploratory analyses suggest that patients previously responsive to PPIs may benefit from AP treatment.
- AP was generally well-tolerated with infrequent adverse event-related withdrawals.
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