title: A double-blind, randomized, placebo-controlled phase III study of the safety of alvimopan in patients who undergo simple total abdominal hysterectomy.
abstract: OBJECTIVE
  The purpose of this study was to investigate the safety and efficacy of alvimopan, a novel peripherally acting mu-opioid receptor antagonist, in patients who undergo simple total abdominal hysterectomy.
  
  
  METHODS
  Women (n = 519) were randomized (4:1) to receive alvimopan 12 mg (n = 413) or placebo (n = 106) > or = 2 hours before the operation then twice daily for 7 days (hospital and home). Adverse events were monitored up to 30 days after the last dose of study drug was administered. Efficacy was assessed for 7 postoperative days.
  
  
  RESULTS
  Overall, the most common adverse events were nausea, vomiting, and constipation; < 5% of patients discontinued use because of adverse events. Alvimopan significantly accelerated the time to first bowel movement (hazard ratio, 2.33; P <.001). Average time to first bowel movement was reduced by 22 hours, with more frequent bowel movement and better bowel movement quality found in the treatment cohort.
  
  
  CONCLUSIONS
  Alvimopan has a safety profile that is similar to that of placebo and provides significantly improved lower gastrointestinal recovery in women who undergo simple total abdominal hysterectomy.
authors.affiliation: Columbia University, New York, NY 10032, USA. th2135@columbia.edu
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Herzog
authors.forename: Robert L
authors.initials: RL
authors.lastname: Coleman
authors.forename: James P
authors.initials: JP
authors.lastname: Guerrieri
authors.forename: Kathie
authors.initials: K
authors.lastname: Gabriel
authors.forename: Wei
authors.initials: W
authors.lastname: Du
authors.forename: Lee
authors.initials: L
authors.lastname: Techner
authors.forename: John G
authors.initials: JG
authors.lastname: Fort
authors.forename: Bruce
authors.initials: B
authors.lastname: Wallin
mesh_terms: D000328:Adult; D000701:Analgesics, Opioid; D003672:Defecation / Q000187:drug effects*; D004311:Double-Blind Method; D005260:Female; D005769:Gastrointestinal Motility / Q000187:drug effects; D006801:Humans; D007044:Hysterectomy; D007889:Leiomyoma / Q000601:surgery; D008875:Middle Aged; D010147:Pain Measurement; D010880:Piperidines / Q000009:adverse effects / Q000494:pharmacology*; D020250:Postoperative Nausea and Vomiting / Q000139:chemically induced / Q000453:epidemiology; D011184:Postoperative Period; D020127:Recovery of Function; D014594:Uterine Neoplasms / Q000601:surgery
chemical_list: D000701:Analgesics, Opioid; D010880:Piperidines; C419502:alvimopan