@article{4217c5a392584818be3dc2154e076274,
title = "Alvimopan accelerates gastrointestinal recovery after radical cystectomy: A multicenter randomized placebo-controlled trial",
abstract = "Background Radical cystectomy (RC) for bladder cancer is frequently associated with delayed gastrointestinal (GI) recovery that prolongs hospital length of stay (LOS). Objective To assess the efficacy of alvimopan to accelerate GI recovery after RC. Design, setting, and participants We conducted a randomized double-blind placebo-controlled trial in patients undergoing RC and receiving postoperative intravenous patient-controlled opioid analgesics. Intervention Oral alvimopan 12 mg (maximum: 15 inpatient doses) versus placebo. Outcome measurements and statistical analysis The two-component primary end point was time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2). Time to discharge order written, postoperative LOS, postoperative ileus (POI)-related morbidity, opioid consumption, and adverse events (AEs) were evaluated. An independent adjudication of cardiovascular AEs was performed. Results and limitations Patients were randomized to alvimopan (n = 143) or placebo (n = 137); 277 patients were included in the modified intention-to-treat population. The alvimopan cohort experienced quicker GI-2 recovery (5.5 vs 6.8 d; hazard ratio: 1.8; p < 0.0001), shorter mean LOS (7.4 vs 10.1 d; p = 0.0051), and fewer episodes of POI-related morbidity (8.4% vs 29.1%; p < 0.001). The incidence of opioid consumption and AEs or serious AEs (SAEs) was comparable except for POI, which was lower in the alvimopan group (AEs: 7% vs 26%; SAEs: 5% vs 20%, respectively). Cardiovascular AEs occurred in 8.4% (alvimopan) and 15.3% (placebo) of patients (p = 0.09). Generalizability may be limited due to the exclusion of epidural analgesia and the inclusion of mostly high-volume centers utilizing open laparotomy. Conclusions Alvimopan is a useful addition to a standardized care pathway in patients undergoing RC by accelerating GI recovery and shortening LOS, with a safety profile similar to placebo. Patient summary This study examined the effects of alvimopan on bowel recovery in patients undergoing radical cystectomy for bladder cancer. Patients receiving alvimopan experienced quicker bowel recovery and had a shorter hospital stay compared with those who received placebo, with comparable safety. Trial registration ClinicalTrials.gov identifier NCT00708201",
keywords = "Alvimopan, Enhanced recovery pathway, Gastrointestinal recovery, Postoperative ileus, Radical cystectomy",
author = "Lee, {Cheryl T.} and Chang, {Sam S.} and Kamat, {Ashish M.} and Gilad Amiel and Beard, {Timothy L.} and Amr Fergany and Karnes, {R. Jeffrey} and Andrea Kurz and Venu Menon and Sexton, {Wade J.} and Slaton, {Joel W.} and Svatek, {Robert S.} and Wilson, {Shandra S.} and Lee Techner and Richard Bihrle and Steinberg, {Gary D.} and Michael Koch",
note = "Funding Information: Financial disclosures: Cheryl T. Lee certifies that all conflicts of interest, including specific financial interests and relationships and affiliations relevant to the subject matter or materials discussed in the manuscript (eg, employment/affiliation, grants or funding, consultancies, honoraria, stock ownership or options, expert testimony, royalties, or patents filed, received, or pending), are the following: Cheryl T. Lee receives grants to institution and travel support from Cubist Pharmaceuticals. Ashish M. Kamat receives consultancy remuneration from Archimedes; grants to institution, and travel support from Cubist Pharmaceuticals; grants/grants pending to institution from FKD; and other remuneration from Photocure, Endo Pharmaceutical, Sanofi, Taris, Cubist Pharmaceuticals, and Allergan. Gilad Amiel receives travel support and provision of writing assistance, medicines, equipment, or administrative support from Cubist Pharmaceuticals. Timothy L. Beard receives speakers{\textquoteright} bureau remuneration from Cubist Pharmaceuticals. Venu Menon receives remuneration for CEC adjudication of blinded events to Cleveland Clinic. Wade J. Sexton receives consultancy remuneration from Endo Pharmaceuticals and Archimedes, payment for lectures including service on speakers{\textquoteright} bureaus from Endo Pharmaceuticals, and payment for development of educational presentations from Oakstone Medical Publishing. Joel W. Slaton receives travel support to institution from Cubist Pharmaceuticals. Robert S. Svatek receives consulting fees or honorariums and travel support from Adolor. Shandra S. Wilson receives remuneration to institution for employment and expert testimony not related to current submission one or two times per year. Lee Techner receives employment and stock/stock options from Cubist Pharmaceuticals. Gary D. Steinberg receives consultancy remuneration from Endo Pharmaceuticals, Photocure, Taris Biomedical, Predictive Biosciences, Abbott Molecular, and DuPont, and payment for lectures including service on speakers{\textquoteright} bureaus from Endo Pharmaceuticals and Photocure. Michael Koch receives travel support (expenses only, no honorarium) from Adolor. The remaining authors have nothing to disclose. ",
year = "2014",
month = aug,
doi = "10.1016/j.eururo.2014.02.036",
language = "English (US)",
volume = "66",
pages = "265--272",
journal = "European urology",
issn = "0302-2838",
publisher = "Elsevier",
number = "2",
}