Original article—alimentary tractRegurgitation Is Less Responsive to Acid Suppression Than Heartburn in Patients With Gastroesophageal Reflux Disease
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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Cited by (0)
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.