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Alvimopan accelerates gastrointestinal recovery after radical cystectomy: a multicenter randomized placebo-controlled trial.
Eur Urol 2014; 66(2):265-72EU

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.

Authors+Show Affiliations

University of Michigan, Ann Arbor, MI, USA. Electronic address: ctlee@med.umich.edu.Vanderbilt University Medical Center, Nashville, TN, USA.The University of Texas MD Anderson Cancer Center, Houston, TX, USA.Baylor University, Baylor College of Medicine, Houston, TX, USA.Bend Memorial Clinic, Bend, OR, USA.Cleveland Clinic Foundation, Cleveland, OH, USA.Mayo Clinic, Rochester, MN, USA.Cleveland Clinic Foundation, Cleveland, OH, USA.Cleveland Clinic Foundation, Cleveland, OH, USA.H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, USA.The University of Oklahoma College of Medicine, Oklahoma City, OK, USA.The University of Texas Health Science Center San Antonio, San Antonio, TX, USA.University of Colorado Health Science Center, Aurora, CO, USA.Cubist Pharmaceuticals, Inc., Lexington, MA, USA.Indiana University Medical Center, Indianapolis, IN, USA.University of Chicago Medical Center, Chicago, IL, USA.Indiana University Medical Center, Indianapolis, IN, USA.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24630419

Citation

Lee, Cheryl T., et al. "Alvimopan Accelerates Gastrointestinal Recovery After Radical Cystectomy: a Multicenter Randomized Placebo-controlled Trial." European Urology, vol. 66, no. 2, 2014, pp. 265-72.
Lee CT, Chang SS, Kamat AM, et al. Alvimopan accelerates gastrointestinal recovery after radical cystectomy: a multicenter randomized placebo-controlled trial. Eur Urol. 2014;66(2):265-72.
Lee, C. T., Chang, S. S., Kamat, A. M., Amiel, G., Beard, T. L., Fergany, A., ... Koch, M. (2014). Alvimopan accelerates gastrointestinal recovery after radical cystectomy: a multicenter randomized placebo-controlled trial. European Urology, 66(2), pp. 265-72. doi:10.1016/j.eururo.2014.02.036.
Lee CT, et al. Alvimopan Accelerates Gastrointestinal Recovery After Radical Cystectomy: a Multicenter Randomized Placebo-controlled Trial. Eur Urol. 2014;66(2):265-72. PubMed PMID: 24630419.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Alvimopan accelerates gastrointestinal recovery after radical cystectomy: 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, Y1 - 2014/02/26/ PY - 2013/10/25/received PY - 2014/02/13/accepted PY - 2014/3/18/entrez PY - 2014/3/19/pubmed PY - 2015/7/8/medline KW - Alvimopan KW - Enhanced recovery pathway KW - Gastrointestinal recovery KW - Postoperative ileus KW - Radical cystectomy SP - 265 EP - 72 JF - European urology JO - Eur. Urol. VL - 66 IS - 2 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. SN - 1873-7560 UR - https://www.unboundmedicine.com/medline/citation/24630419/Alvimopan_accelerates_gastrointestinal_recovery_after_radical_cystectomy:_a_multicenter_randomized_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(14)00165-1 DB - PRIME DP - Unbound Medicine ER -