title: Analysis of Clinical Predictors of Resolution of Sleep Disturbance Related to Frequent Nighttime Heartburn and Acid Regurgitation Symptoms in Individuals Taking Esomeprazole 20 mg or Placebo.
abstract: OBJECTIVE
  Sleep disturbances related to reflux symptoms have a significant impact on the daily lives of affected individuals. These analyses identified clinical factors related to resolution of reflux-related sleep disturbance in subjects treated with esomeprazole 20 mg for 14 days.
  
  
  METHODS
  Data from the first 14 days of 2 similar randomized, double-blind studies were pooled for subjects experiencing frequent heartburn and related sleep disturbances receiving esomeprazole 20 mg (n = 357) or placebo (n = 346). A stepwise logistic regression analysis was performed with pooled and individual study data to evaluate relationships between clinical factors [treatment (esomeprazole vs. placebo), run-in sleep disturbance frequency, occurrence (yes/no) of 24-h, daytime, and nighttime heartburn (yes: ≥1 episode in 14-day treatment period)] and complete sleep disturbance resolution (no disturbances for 7 consecutive days).
  
  
  RESULTS
  Absence of daytime (p = 0.0018) or nighttime (p < 0.0001) heartburn during treatment was a significant predictor of complete sleep disturbance resolution at 14 days for the total population, while higher run-in sleep disturbance frequency (p < 0.0001) was associated with a lower likelihood of resolution. Esomeprazole treatment was an independent significant predictor of improvement across all endpoints (p < 0.0001). A significant treatment by run-in sleep disturbance interaction was observed for complete resolution (p = 0.0231), indicating greater therapeutic benefit with esomeprazole in subgroups with higher run-in symptom frequency.
  
  
  CONCLUSIONS
  Lower run-in sleep disturbance frequency, no occurrence of daytime or nighttime heartburn during therapy, and esomeprazole treatment predicted complete reflux-related sleep disturbance resolution. The magnitude of therapeutic benefit for esomeprazole 20 mg over placebo increased with increasing baseline sleep disturbance.
authors.affiliation: Eastern Virginia Medical School, 885 Kempsville Road, Suite 114, Norfolk, VA, 23502, USA. dajevms@aol.com.
authors.forename: David A
authors.initials: DA
authors.lastname: Johnson
authors.affiliation: Pfizer Consumer Healthcare, Madison, NJ, USA.
authors.forename: Anne
authors.initials: A
authors.lastname: Le Moigne
authors.affiliation: Pfizer Consumer Healthcare, Madison, NJ, USA.
authors.forename: Jing
authors.initials: J
authors.lastname: Li
authors.affiliation: Pfizer Consumer Healthcare, Madison, NJ, USA.
authors.forename: Charles
authors.initials: C
authors.lastname: Pollack
authors.affiliation: AstraZeneca R&D, Mölndal, Sweden.
authors.forename: Peter
authors.initials: P
authors.lastname: Nagy
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D023381:Endpoint Determination; D064098:Esomeprazole / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000188:drug therapy*; D006356:Heartburn / Q000150:complications* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D054328:Proton Pump Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D012893:Sleep Wake Disorders / Q000209:etiology* / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D054328:Proton Pump Inhibitors; D064098:Esomeprazole