Evidence map›Paper›PMID 15383800›Full record

SynthesisAnnals of surgery2004

Alvimopan, a novel, peripherally acting mu opioid antagonist: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial of major abdominal surgery and postoperative ileus.

Bruce G Wolff, Fabrizio Michelassi, Todd M Gerkin, Lee Techner, Kathie Gabriel, Wei Du, Bruce A Wallin, Alvimopan Postoperative Ileus Study Group

5 registry-linked trialsOpen access · greenAbstract readClinical TrialClinical Trial, Phase IIIComparative Study
In one paragraph

Synthesis in Annals of surgery, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 80 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 8 pooled it
21.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00388401 phase3completednot on this map

A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus

TypeinterventionalSponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Ran2002 to 2003Enrolled510ConditionsIleusArmsAlvimopan
NCT02218190 nacompletednot on this mapstarted 2014, after this paper: background citation

A Randomized Trial of Alvimopan for the Reduction of Ileus After Long Posterior Spinal Fusion

TypeinterventionalSponsorWashington University School of MedicineRan2014 to 2019Enrolled31ConditionsIleus, Spinal FusionArmsAlvimopan, Placebo
NCT02379858 naterminatednot on this mapstarted 2015, after this paper: background citation

Gastrointestinal Tract Recovery in Patients Undergoing Open Ventral Hernia Repair: A Multi-Center, Randomized, Double-Blind, Trial of Alvimopan and Placebo

TypeinterventionalSponsorMedical College of WisconsinRan2015 to 2018Enrolled10ConditionsVentral HerniaArmsAlvimopan, Placebo
NCT02789111 phase4completednot on this mapstarted 2016, after this paper: background citation

Randomized, Double-Blind, Placebo-Controlled Trial of Alvimopan in Major Spine Surgery

TypeinterventionalSponsorUniversity of VirginiaRan2016 to 2018Enrolled49ConditionsConstipationArmsAlvimopan, Placebo
NCT03068975 phase4terminatednot on this mapstarted 2017, after this paper: background citation

A Double Blind, Randomized, Parallel Design Study to Evaluate the Effectiveness of Post-operative Dose of Alvimopan(Entereg) in Preventing Post-operative Ileus in Poly-traumatized Patients

TypeinterventionalSponsorUniversity of Puerto RicoRan2017 to 2019Enrolled3ConditionsPost Operative IleusArmsAlvimopan, Placebo
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 8 syntheses or guidelines pooled it, 300 citations in OpenAlex.

  1. Pooled it
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  4. Selective Opioid Antagonists Following Bowel Resection for Prevention of Postoperative Ileus: a Systematic Review and Meta-analysis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2021
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pharmacological management to prevent ileus in major abdominal surgery: a systematic review and meta-analysis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2016
    Pooled it
  8. Defining postoperative ileus: results of a systematic review and global survey.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2013
    Pooled it
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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 1 country.

Bruce G WolffMayo Clinic, Rochester, MN, USA. wolff.bruce@mayo.edu
Fabrizio Michelassi
Todd M Gerkin
Lee Techner
Kathie Gabriel
Wei Du
Bruce A Wallin
Alvimopan Postoperative Ileus Study Group
Cubist Pharmaceuticals (United States) · USMayo Clinic · USUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo demonstrate that alvimopan (6 or 12 mg) accelerates recovery of gastrointestinal (GI) function in patients undergoing laparotomy for bowel resection or radical hysterectomy. SUMMARY BACKGROUND DATA: Postoperative ileus (POI) following laparotomy may increase morbidity and extend hospitalization. Opioids can contribute to the duration of POI. Alvimopan is a novel opioid receptor antagonist in development for the management of POI.

methodsA total of 510 patients scheduled for bowel resection or radical hysterectomy were randomized (1:1:1) to receive alvimopan 6 mg, alvimopan 12 mg, or placebo orally > or =2 hours before surgery, then twice a day (b.i.d.) until hospital discharge or for up to 7 days. The primary efficacy end point was a composite of time to recovery of upper and lower GI function. An associated secondary end point was time to hospital discharge order written.

resultsThe modified intent-to-treat population included 469 patients (451 bowel resection and 18 radical hysterectomy patients). Time to recovery of GI function was accelerated for the alvimopan 6 mg (hazard ratio [HR] = 1.28; P < 0.05) and 12 mg (HR = 1.54; P < 0.001) groups with a mean difference of 15 and 22 hours, respectively, compared with placebo. The time to hospital discharge order written was also accelerated in the alvimopan 12 mg group (HR = 1.42; P = 0.003) with a mean difference of 20 hours compared with placebo. The incidence of adverse events was similar among treatment groups.

conclusionsAlvimopan accelerated GI recovery and time to hospital discharge order written compared with placebo in patients undergoing laparotomy and was well tolerated.

Indexed as

LaparotomyAdultAgedAged, 80 and overDefecationDouble-Blind MethodFemaleGastrointestinal AgentsHumansHysterectomyIleusIntestine, LargeIntestine, SmallMaleMiddle AgedPatient DischargealvimopanGastrointestinal AgentsPiperidinesPlacebosReceptors, Opioid, mu

Identifiers

PMID15383800
PMCPMC1356474
OpenAlexW2095368589

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.