Dexlansoprazole MR for Treatment for Nocturnal Heartburn in Patients with Symptomatic Nonerosive GERD: 29
Abstract
Purpose: Nocturnal heartburn (HB) and sleep disturbances commonly occur in patients with GERD. These symptoms are important to treat since nighttime reflux creates a high risk for esophagitis and impacts quality of life. This study evaluated the effects of dexlansoprazole MR (DEX), a PPI with a Dual Delayed ReleaseTM formulation designed to extend the duration of acid suppression, in patients with nighttime symptoms. Methods: A multicenter, randomized, double-blind, placebo controlled, parallel group trial in patients aged 18-66 with symptomatic GERD, with no esophageal erosions based on endoscopy. The patients enrolled in the study had moderate to very severe nocturnal HB and GERD-related sleep disturbances on at least 3 of 7 nights based on twice daily diary entries, recorded upon waking and before bedtime. Night time was defined as the time at which the patient laid down to fall asleep to the time when the patient woke up and began daily activities. Patients received DEX 30 mg or placebo (PBO) orally, every morning for 4 weeks. In addition to the diary, patients completed questionnaires on sleep quality and work productivity at baseline and week 4. The primary endpoint was the % of nights without heartburn over 4 weeks. Secondary endpoints were % of patients with relief of nocturnal HB and % of patients with relief of GERD-associated sleep disturbances over the last 7 days of treatment. Relief was rigorously defined as 6 of 7 days without nighttime HB and at most 1 night…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 305 participants or records.
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