1 Department of Colorectal Surgery, Digestive Disease and Surgery Institute, Cleveland Clinic, Cleveland, Ohio2 Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio3 Premier Research Solutions, Charlotte, North Carolina4 Merck & Co, Inc, Kenilworth, New Jersey
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BACKGROUND:Postoperative ileus is a significant complication after bowel resection surgeries. Alvimopan is the only US Food and Drug Administration–approved therapy for accelerating the return of bowel function after large- and small-bowel resection.OBJECTIVE:The purpose of this study was to estimate the healthcare use and in-hospital morbidities associated with on-label use of alvimopan in patients undergoing bowel resection surgeries.DESIGN:A retrospective observational propensity-matched cohort study was conducted using a large hospital administrative database.SETTING:The study included inpatient postsurgical patients.PATIENTS:Patients aged ≥18 years undergoing a primary large or small segmental bowel resection with discharge dates between January 2010 and December 2014 were included.INTERVENTIONS:Patients receiving 2 to 15 doses of alvimopan were defined as the treatment cohort, and those without any alvimopan use were included as control subjects.MAIN OUTCOME MEASURES:The primary outcome was postoperative length of stay. Secondary outcomes included postoperative in-hospital morbidities, inpatient mortality, intensive care unit length of stay, discharge disposition, and 30-day readmission.RESULTS:Each propensity-score matched cohort included 18,559 patients. The mean (±SD) postoperative length of stay was 4.62 ± 2.45 days in alvimopan-treated patients compared with 5.24 ± 3.35 days in control subjects (p < 0.001). Alvimopan-treated patients had lower rates of postoperative GI complication (12.15% vs 16.50%; p < 0.001). The rates of urinary tract infections; other postoperative infections; and cardiovascular, pulmonary, thromboembolic, and cerebrovascular events were also lower compared with the control subjects.LIMITATIONS:The study was limited by its inability to generalize to the US population, because the database included a convenience sample of hospital discharges. The identification of patients undergoing bowel resection and their clinical conditions relied on the accuracy and completeness of International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis and procedure coding. There may be a confounding effect by the use of enhanced recovery pathways associated with the use of alvimopan.CONCLUSIONS:The use of alvimopan was associated with a reduction of 0.62 days in postsurgery length of stay and lower rates of postoperative GI complications, infections, and other in-hospital morbidities. See Video Abstract at http://links.lww.com/DCR/A703.