Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naïve patients with gastroesophageal reflux disease: a post hoc analysis of two study populations

Nimish Vakil, Anna Niklasson, Hans Denison, Anna Rydén, Nimish Vakil, Anna Niklasson, Hans Denison, Anna Rydén

Abstract

Background: Partial response to proton pump inhibitor (PPI) therapy poses a healthcare challenge. This study aimed to compare symptom profiles in partial PPI responders and treatment-naïve patients with gastroesophageal reflux disease (GERD).

Methods: A post hoc analysis of data from two studies was performed. Partial PPI responders with GERD (n = 580; NCT00703534) had frequent (≥ 3 days/week) heartburn and/or regurgitation despite PPI therapy; patients with no improvement were excluded. Treatment-naïve patients with GERD (diagnosed by endoscopy and pH-metry; n = 203; NCT00291746) had frequent (≥ 3 days/week) upper gastrointestinal symptoms. The Gastrointestinal Symptom Rating Scale (GSRS) was completed by all patients at study entry and by treatment-naïve patients after PPI therapy.

Results: The highest (mean [95% confidence interval]) discomfort scores were reported in the Reflux (heartburn, regurgitation), Indigestion, and Abdominal pain domains of the GSRS, both in partial PPI responders (4.3 [4.2-4.4], 3.7 [3.6-3.8], and 3.4 [3.3-3.5], respectively) and in treatment-naïve patients (3.5 [3.3-3.7], 3.6 [3.4-3.7], and 3.1 [3.0-3.3], respectively). Partial PPI responders reported more discomfort than treatment-naïve patients in the Reflux, Abdominal pain, and Constipation domains (4.3 [4.2-4.4] vs. 3.5 [3.3-3.7], 3.4 [3.3-3.5] vs. 3.1 [3.0-3.3], and 2.5 [2.4-2.6] vs. 2.1 [1.9-2.2], respectively). All GSRS domain scores improved in treatment-naïve patients following PPI therapy.

Conclusions: Symptom patterns in partial PPI responders were similar to those in treatment-naïve patients with GERD, but partial PPI responders experienced more severe reflux, abdominal pain, and constipation than did treatment-naïve patients.

Figures

Figure 1
Figure 1
GSRS discomfort scores in partial PPI responders and in treatment-naïve patients with GERD before and after 2 weeks of PPI therapy. PPI treatment comprised esomeprazole 40 mg once daily for 2 weeks. The degree of discomfort was rated on a 7-point Likert scale (1, no discomfort at all; 7, very severe discomfort). Mean (95% CI) values are shown. aGSRS data were unavailable for 3 patients in the partial PPI responders group. *Lack of 95% CI overlap vs. partial PPI responders.

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Pre-publication history
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