title: Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection.
abstract: OBJECTIVE
  To evaluate in-hospital clinical outcomes after open and laparoscopic bowel resection (BR) with or without alvimopan treatment.
  
  
  BACKGROUND
  Delayed return of gastrointestinal function after BR may be associated with greater postoperative morbidity and increased hospital length of stay (LOS). In clinical trials, alvimopan--a peripherally acting μ-opioid receptor antagonist--accelerated gastrointestinal recovery after open BR.
  
  
  METHODS
  A retrospective matched-cohort study (NCT01150760) was conducted using a national inpatient database. Each alvimopan patient was exact matched (surgical procedure, surgeon specialty) and propensity score matched (baseline characteristics) to a nonalvimopan BR patient. Outcomes included gastrointestinal and other morbidity (cardiovascular, pulmonary, infection, cerebrovascular, thromboembolic); mortality; readmission rate; and intensive care unit (ICU) stay (intent-to-treat [ITT] population). Postoperative LOS and estimated cost were also compared (modified ITT population).
  
  
  RESULTS
  Each cohort included 3525 ITT patients with similar baseline characteristics. Gastrointestinal (29.8% vs 35.7%) and other morbidity (cardiovascular [19.4% vs 24.0%], pulmonary [7.3% vs 10.5%], infectious [9.6% vs 11.8%], thromboembolic [1.2% vs 2.1%]), mortality (0.4% vs 1.0%), and mean ICU stay (0.3 vs 0.6 days) were lower in the alvimopan group (P ≤ 0.003 for each). Postoperative LOS and estimated direct cost were lower for all alvimopan patients and after laparoscopic and open BR (LOS: -1.1, -0.8, and -1.8 days respectively; cost: -$2345, -$1382, and -$3218, respectively; P ≤ 0.0008 for each).
  
  
  CONCLUSIONS
  On average, alvimopan-treated patients had a lower incidence of mortality and most incidents of morbidities. Length of stay, ICU use, and estimated cost were also lower with comparable readmissions. These results in patients outside the clinical trial setting include laparoscopic colectomy and demonstrate a potential association between acceleration of gastrointestinal recovery and improved early postoperative outcomes.
authors.affiliation: Department of Surgery, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH 44106, USA. Conor.Delaney@UHhospitals.org
authors.forename: Conor P
authors.initials: CP
authors.lastname: Delaney
authors.forename: Christopher
authors.initials: C
authors.lastname: Craver
authors.forename: Melinda M
authors.initials: MM
authors.lastname: Gibbons
authors.forename: Amy W
authors.initials: AW
authors.lastname: Rachfal
authors.forename: Christine J
authors.initials: CJ
authors.lastname: VandePol
authors.forename: Suzanne F
authors.initials: SF
authors.lastname: Cook
authors.forename: Sara A
authors.initials: SA
authors.lastname: Poston
authors.forename: Michael
authors.initials: M
authors.lastname: Calloway
authors.forename: Lee
authors.initials: L
authors.lastname: Techner
mesh_terms: D000328:Adult; D000368:Aged; D000714:Anastomosis, Surgical; D015331:Cohort Studies; D013505:Digestive System Surgical Procedures / Q000191:economics / Q000379:methods; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D017721:Hospital Costs; D006801:Humans; D007362:Intensive Care Units / Q000706:statistics & numerical data; D007422:Intestines / Q000601:surgery*; D010535:Laparoscopy / Q000191:economics / Q000401:mortality; D007902:Length of Stay / Q000706:statistics & numerical data; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D010359:Patient Readmission / Q000706:statistics & numerical data; D010880:Piperidines / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000191:economics / Q000453:epidemiology / Q000517:prevention & control*; D057216:Propensity Score; D020127:Recovery of Function; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D005765:Gastrointestinal Agents; D010880:Piperidines; C419502:alvimopan