Original article—alimentary tract
Regurgitation Is Less Responsive to Acid Suppression Than Heartburn in Patients With Gastroesophageal Reflux Disease

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Background & Aims

Although most patients with gastroesophageal reflux disease (GERD) achieve substantial symptom relief with acid suppression, many have some residual symptoms. We evaluated the responsiveness of regurgitation, characterized by the reflux disease questionnaire (RDQ) to potent acid suppression.

Methods

We analyzed data from 2 randomized controlled trials of AZD0865 (a potassium-competitive acid blocker) 25–75 mg/day vs esomeprazole 20–40 mg/day for the treatment of nonerosive reflux disease (NERD, n = 1460) or reflux esophagitis (RE, n = 1514). Inclusion criteria for both studies were high-severity substernal burning (≥4 days per week of at least moderate intensity) during the week before enrollment. Pooled data from all treatment arms were used to ascertain the response of the reflux disease questionnaire regurgitation items to potent acid suppression during the fourth week of treatment.

Results

When the study began, 93% of patients with NERD or RE had either “acid taste in the mouth” (regurgitation-taste) or “unpleasant movement of material upwards from the stomach” (regurgitation-movement). Either or both symptoms were present and severe in 53% of NERD (n = 717) and 54% of RE patients (n = 751) for the main study outcome. During week 4 of therapy, patients with severe “regurgitation-taste” and “regurgitation-movement” responded significantly less well than patients with NERD and high severity “substernal burning” (34% and 26% vs 49%) or those with RE (44% and 33% vs 55%). There were no differences in symptom response between patients with healed and nonhealed RE.

Conclusions

Regurgitation was less responsive to acid suppression than heartburn in patients with gastroesophageal reflux disease, indicating that persistent regurgitation is a common cause of incomplete treatment response.

Section snippets

Methods

We retrospectively reviewed data from the 2 parallel-group, double-blind, randomized trials introduced above: (1) AZD0865 25, 50, or 75 mg/day vs esomeprazole 20 mg/day for NERD,4 clinicaltrials.gov identifier: NCT00206284; and (2) AZD0865 25, 50, or 75 mg/day vs esomeprazole 40 mg/day for RE,3 clinicaltrials.gov identifier: NCT00206245. There were no placebo controls in these trials.

At the screening visit to assess eligibility, baseline symptoms were recorded using 7-day patient recall of the

Baseline Symptoms

Figure 1 illustrates the baseline symptom profile for the RDQ heartburn and regurgitation domains in both trials. There were no substantive differences in the baseline symptom profile between patients with RE and those with NERD. Overall, regurgitation was reported by approximately 93% of patients both in the NERD and RE trials. In 53% of patients with NERD (n = 717) and 54% of patients with RE (n = 751), either or both regurgitation item was of high severity at entry.

Patient Population Included in the Symptom Response Analysis

The proportion of patients

Discussion

The objectives of GERD treatment are to eliminate esophageal mucosal damage and reflux-induced symptoms. Much has been written regarding the utility of acid-suppressive medications, particularly PPIs, in resolving mucosal injury.2 This study aimed to quantify the effectiveness of potent acid suppression in relieving the cardinal symptoms of GERD: heartburn and regurgitation. Data from 2 clinical trials that used a well-validated questionnaire, both to screen patients for study enrollment and to

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Conflicts of interest The authors disclose the following: Peter Kahrilas has acted as a consultant for AstraZeneca, Eisai, EndoGastric Solutions, Ironwood, Novartis, and XenoPort. Colin Howden has acted as a consultant for Boehringer Ingelheim, Novartis Consumer Health, Novartis Oncology, Otsuka, Takeda, and XenoPort, and as a speaker for Novartis, Otsuka, Takeda and GlaxoSmithKline. Andreas Jonsson, Hans Denison, and Börje Wernersson are employees of AstraZeneca R&D, Mölndal, Sweden. Nesta Hughes is an employee of Oxford PharmaGenesis Ltd, Oxford, United Kingdom, and was funded by AstraZeneca R&D, Mölndal, Sweden.

Funding This study was supported by AstraZeneca R&D, Mölndal, Sweden.

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