Alvimopan accelerates gastrointestinal recovery after radical cystectomy: A multicenter randomized placebo-controlled trial

Cheryl T. Lee, Sam S. Chang, Ashish M. Kamat, Gilad Amiel, Timothy L. Beard, Amr Fergany, R. Jeffrey Karnes, Andrea Kurz, Venu Menon, Wade J. Sexton, Joel W. Slaton, Robert S. Svatek, Shandra S. Wilson, Lee Techner, Richard Bihrle, Gary D. Steinberg, Michael Koch

Research output: Contribution to journalArticle

103 Citations (Scopus)

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

Original languageEnglish
Pages (from-to)265-272
Number of pages8
JournalEuropean Urology
Volume66
Issue number2
DOIs
StatePublished - 2014

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alvimopan
Cystectomy
Randomized Controlled Trials
Placebos
Length of Stay
Ileus
Opioid Analgesics
Urinary Bladder Neoplasms
Morbidity
Safety
Epidural Analgesia

Keywords

  • Alvimopan
  • Enhanced recovery pathway
  • Gastrointestinal recovery
  • Postoperative ileus
  • Radical cystectomy

ASJC Scopus subject areas

  • Urology
  • Medicine(all)

Cite this

Alvimopan accelerates gastrointestinal recovery after radical cystectomy : A multicenter randomized placebo-controlled trial. / Lee, Cheryl T.; Chang, Sam S.; Kamat, Ashish M.; Amiel, Gilad; Beard, Timothy L.; Fergany, Amr; Karnes, R. Jeffrey; Kurz, Andrea; Menon, Venu; Sexton, Wade J.; Slaton, Joel W.; Svatek, Robert S.; Wilson, Shandra S.; Techner, Lee; Bihrle, Richard; Steinberg, Gary D.; Koch, Michael.

In: European Urology, Vol. 66, No. 2, 2014, p. 265-272.

Research output: Contribution to journalArticle

Lee, CT, Chang, SS, Kamat, AM, Amiel, G, Beard, TL, Fergany, A, Karnes, RJ, Kurz, A, Menon, V, Sexton, WJ, Slaton, JW, Svatek, RS, Wilson, SS, Techner, L, Bihrle, R, Steinberg, GD & Koch, M 2014, 'Alvimopan accelerates gastrointestinal recovery after radical cystectomy: A multicenter randomized placebo-controlled trial', European Urology, vol. 66, no. 2, pp. 265-272. https://doi.org/10.1016/j.eururo.2014.02.036
Lee, Cheryl T. ; Chang, Sam S. ; Kamat, Ashish M. ; Amiel, Gilad ; Beard, Timothy L. ; Fergany, Amr ; Karnes, R. Jeffrey ; Kurz, Andrea ; Menon, Venu ; Sexton, Wade J. ; Slaton, Joel W. ; Svatek, Robert S. ; Wilson, Shandra S. ; Techner, Lee ; Bihrle, Richard ; Steinberg, Gary D. ; Koch, Michael. / Alvimopan accelerates gastrointestinal recovery after radical cystectomy : A multicenter randomized placebo-controlled trial. In: European Urology. 2014 ; Vol. 66, No. 2. pp. 265-272.
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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",
year = "2014",
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T1 - Alvimopan accelerates gastrointestinal recovery after radical cystectomy

T2 - A multicenter randomized placebo-controlled trial

AU - Lee, Cheryl T.

AU - Chang, Sam S.

AU - Kamat, Ashish M.

AU - Amiel, Gilad

AU - Beard, Timothy L.

AU - Fergany, Amr

AU - Karnes, R. Jeffrey

AU - Kurz, Andrea

AU - Menon, Venu

AU - Sexton, Wade J.

AU - Slaton, Joel W.

AU - Svatek, Robert S.

AU - Wilson, Shandra S.

AU - Techner, Lee

AU - Bihrle, Richard

AU - Steinberg, Gary D.

AU - Koch, Michael

PY - 2014

Y1 - 2014

N2 - 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

AB - 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

KW - Alvimopan

KW - Enhanced recovery pathway

KW - Gastrointestinal recovery

KW - Postoperative ileus

KW - Radical cystectomy

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