title: The effect of dexlansoprazole MR on nocturnal heartburn and GERD-related sleep disturbances in patients with symptomatic GERD.
abstract: OBJECTIVE
  Nocturnal heartburn and related sleep disturbances are common among patients with gastroesophageal reflux disease (GERD). This study evaluated the efficacy 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/final 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 significantly 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 significantly 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 significantly more efficacious 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.
authors.affiliation: Southern Arizona VA Health Care System, Section of Gastroenterology (111G-1), Tucson, Arizona 85723, USA. ronnie.fass@med.va.gov
authors.forename: Ronnie
authors.initials: R
authors.lastname: Fass
authors.forename: David A
authors.initials: DA
authors.lastname: Johnson
authors.forename: William C
authors.initials: WC
authors.lastname: Orr
authors.forename: Cong
authors.initials: C
authors.lastname: Han
authors.forename: Reema
authors.initials: R
authors.lastname: Mody
authors.forename: Kathleen N
authors.initials: KN
authors.lastname: Stern
authors.forename: Betsy L
authors.initials: BL
authors.lastname: Pilmer
authors.forename: M Claudia
authors.initials: MC
authors.lastname: Perez
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D064748:Dexlansoprazole; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004526:Efficiency; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000188:drug therapy*; D006304:Health Status; D006356:Heartburn / Q000150:complications* / Q000209:etiology*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D011788:Quality of Life; D012307:Risk Factors; D012720:Severity of Illness Index; D012893:Sleep Wake Disorders / Q000209:etiology*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D064748:Dexlansoprazole