title: Lubiprostone for constipation in adults with cystic fibrosis: a pilot study.
abstract: BACKGROUND
  Constipation is prevalent in the cystic fibrosis (CF) population and yet there are few data demonstrating the effectiveness of currently used treatments. Lubiprostone is a laxative that works by activating the type 2 chloride channel in the gastrointestinal tract and thus has the potential to be especially effective for constipation associated with CF.
  
  
  OBJECTIVE
  To evaluate the effectiveness of lubiprostone for the treatment of constipation in adults with CF.
  
  
  METHODS
  In this pilot study, participants acted as their own controls and comparisons were made between run-in and treatment periods. During the 2-week run-in period, participants continued their usual treatment for constipation; during the 4-week treatment period, participants received lubiprostone 24 μg twice daily. Efficacy outcomes included spontaneous bowel movement frequency, Bristol Stool Scale scores, and Patient Assessment of Constipation Symptoms (PAC-SYM) survey scores. Outcomes were assessed during both the run-in and treatment periods (0, 2, and 4 weeks of treatment). Safety outcomes included spirometry, body weight, and serum chemistry.
  
  
  RESULTS
  Seven participants completed the study. Mean (SD) baseline forced expiratory volume in 1 second was 83.0% (9.4) of predicted and body mass index was 24.0 (2.8) kg/m², indicating an overall healthy, well-nourished group of adults with CF. Lubiprostone improved overall symptoms of constipation as measured by PAC-SYM survey scores (1.18 [0.56], 0.54 [0.27], and 0.44 [0.36] at 0, 2, and 4 weeks, respectively; p < 0.001). Spontaneous bowel movement frequency and Bristol Stool Scale scores were not statistically significantly different between periods. There were no differences in safety measures. Transient chest tightness and shortness of breath were reported by 2 separate participants, although neither participant withdrew due to these adverse effects.
  
  
  CONCLUSIONS
  Lubiprostone may be an effective option for the treatment of constipation in adults with CF.
authors.affiliation: Department of Pharmacy Practice, College of Pharmacy, University of Arkansas for Medical Sciences, Little Rock, AR, USA. obriencatherinee@uams.edu
authors.forename: Catherine E
authors.initials: CE
authors.lastname: O'Brien
authors.forename: Paula J
authors.initials: PJ
authors.lastname: Anderson
authors.forename: Cindy D
authors.initials: CD
authors.lastname: Stowe
mesh_terms: D000328:Adult; D000527:Alprostadil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000090007:CLC-2 Chloride Channels; D018118:Chloride Channels / Q000187:drug effects / Q000378:metabolism; D003248:Constipation / Q000188:drug therapy* / Q000209:etiology; D003550:Cystic Fibrosis / Q000150:complications*; D005260:Female; D006801:Humans; D000068238:Lubiprostone; D008297:Male; D010865:Pilot Projects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000090007:CLC-2 Chloride Channels; D018118:Chloride Channels; D000068238:Lubiprostone; D000527:Alprostadil