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Editorial: non‐erosive reflux disease is often not GERD—time to change the definition or abandon the term?

P. Katz

Alimentary Pharmacology and Therapeutics, 2021

2 citations

Abstract

Potassiumcompetitive acid blockers (PCABs) have a more rapid onset and superior pH control at steady state than proton pump inhibitors (PPIs).1 This holds promise of superior outcomes in patients with gastrooesophageal reflux disease (GERD) whose symptoms are, for the most part, generated by exposure of oesophageal mucosa to acid. It would thus surprise most that a PCAB would offer no greater improvement compared to placebo in patients with nonerosive reflux disease (NERD) as a PPI. Yet this is what was demonstrated in the study by Kim et al2 assessing complete relief of heartburn and regurgitation comparing tegoprazan (50 or 100 mg a day) to placebo for 4 weeks in patients with NERD. In total, 42.5%, 48.5% and 24.2% of patients showed complete resolution of major symptoms after 4 weeks of 50 or 100 mg tegoprazan or placebo (P < 0.01 for both doses). The study design, historically sanctioned by the Food and Drug Administration in the United States to obtain an approved ‘indication’ for symptomatic GERD, defined NERD as frequent heartburn and/or regurgitation with a ‘normal’ endoscopy. Whether this historic definition of NERD is clinically useful today is open to question. The improvement over placebo, while statistically significant, appears to offer no clinically important advantage over placebo compared to what is available with PPIs,3 although this drug was not compared with a PPI. The studies in the literature with vonoprazan, another PCAB, appear to offer similar…

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