Approximately 14 -20 % of US adults experience gastroesophageal refl ux disease (GERD) weekly ( 1,2 ), which translates to more than 60 million adults ( 3 ). Among those reporting GERD symptoms, up to 89 % report nocturnal symptoms ( 1,4 -6 ), resulting in impairment in health-related quality of life (HRQoL) and signifi cantly worse sleep quality ( 7,8 ). Because continued sleep disruption leads to increased daytime sleepiness ( 9 ), nocturnal heartburn can reduce productivity while patients are present at work, as well as reduce function when performing normal daily activities ( 7,8,10,11 ). Th e continued presence of nocturnal heartburn despite routine medical treatment is strongly associated with decreases in HRQoL ( 12 ). In addition, the majority of GERD patients participating in a Gallup survey were not completely satisfi ed with their over-the-counter or prescription medication due to persistent nocturnal symptoms ( 6 ).Th e aims of this study were to assess, in patients with symptomatic GERD, the effi cacy and safety of dexlansoprazole MR 30 mg Nocturnal heartburn and related sleep disturbances are common among patients with gastroesophageal refl ux disease (GERD). This study evaluated the effi cacy of dexlansoprazole MR 30 mg in relieving nocturnal heartburn and GERD-related sleep disturbances, improving work productivity, and decreasing nocturnal symptom severity in patients with symptomatic GERD.
METHODS:Patients ( N = 305) with frequent, moderate-to-very severe nocturnal heartburn and associated sleep disturbances were randomized 1:1 in a double-blind fashion to receive dexlansoprazole MR or placebo once daily for 4 weeks. The primary end point was the percentage of nights without heartburn. Secondary end points were the percentage of patients with relief of nocturnal heartburn and of GERD-related sleep disturbances over the last 7 days of treatment. At baseline and week 4 / fi nal visit, patients completed questionnaires that assessed sleep quality, work productivity, and the severity and impact of nocturnal GERD symptoms.
RESULTS:Dexlansoprazole MR 30 mg ( n = 152) was superior to placebo ( n = 153) in median percentage of nights without heartburn (73.1 vs. 35.7 % , respectively; P < 0.001). Dexlansoprazole MR was signifi cantly better than placebo in percentage of patients with relief of nocturnal heartburn and GERD-related sleep disturbances (47.5 vs. 19.6 % , 69.7 vs. 47.9 % , respectively; P < 0.001), and led to signifi cantly greater improvements in sleep quality and work productivity and decreased nocturnal symptom severity. Adverse events were similar across treatment groups.CONCLUSIONS: In patients with symptomatic GERD, dexlansoprazole MR 30 mg is signifi cantly more effi cacious than placebo in providing relief from nocturnal heartburn, in reducing GERD-related sleep disturbances and the consequent impairments in work productivity, and in improving sleep quality / quality of life.SUPPLEMENTARY MATERIAL is linked to the online version of the paper at