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Evaluation of Clinical Outcomes With Alvimopan in Clinical Practice: A National Matched-Cohort Study in Patients Undergoing Bowel Resection

Delaney, Conor P. MD, PhD*; Craver, Christopher MA; Gibbons, Melinda M. MD; Rachfal, Amy W. PhD§; VandePol, Christine J. MD; Cook, Suzanne F. PhD; Poston, Sara A. PharmD#; Calloway, Michael PhD#; Techner, Lee DPM§

doi: 10.1097/SLA.0b013e31824a36cc
Original Articles
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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.

Using a large, national inpatient administrative claims database, comparison of 2 matched cohorts revealed patients treated with alvimopan experienced a significantly lower incidence of the majority of morbidities studied and mortality and a shorter length of hospital stay after open and laparoscopic bowel resection than matched controls.

*Department of Surgery, University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH

Premier Research Services, Premier Inc, Charlotte, NC

Department of Surgery, Olive View-UCLA Medical Center, Sylmar, CA

§Formerly Medical Affairs, Adolor Corporation, Exton, PA

EnPharma Consulting, Inc, Chester Springs, PA

Epidemiology, GlaxoSmithKline, Research Triangle Park, NC

#US Health Outcomes, GlaxoSmithKline, Research Triangle Park, NC.

Reprints: Conor P. Delaney, MD, PhD, University Hospitals Case Medical Center, Case Western Reserve University, 11100 Euclid Ave, Cleveland, OH 44106. E-mail: Conor.Delaney@UHhospitals.org.

Disclosure: This study was funded by Adolor Corporation and GlaxoSmithKline. Premier Inc received funding for the conduct of this study. Dr Delaney has been a paid speaker and is a consultant for Adolor GlaxoSmithKline. Dr Gibbons was a paid consultant for this study. Drs Rachfal and Techner are employees of Adolor and have stock options. Dr VandePol was a paid consultant for this study. Drs Poston, Calloway, and Cook are employees of GlaxoSmithKline.

© 2012 Lippincott Williams & Wilkins, Inc.