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.
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.