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Updated: Jul 26, 2026

Functional Assessment of Intestinal Motility and Gut Wall Inflammation in Rodents: Analyses in a Standardized Model of Intestinal Manipulation
Published on: September 11, 2012
Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after
E R Viscusi1, S Goldstein, T Witkowski
1Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA 19107-5092, USA. eugene.viscusi@jefferson.edu
Background:
Alvimopan is a peripherally acting mu-opioid receptor (PAM-OR) antagonist for accelerating gastrointestinal recovery after surgery.
Methods:
Patients undergoing open laparotomy (bowel resection, n = 418; hysterectomy, n = 197) were randomized to receive alvimopan 6 or 12 mg or placebo orally > or = 2 h before surgery and then b.i.d. until hospital discharge (up to 7 days). The primary efficacy endpoint was time to gastrointestinal (GI) recovery (measured by toleration of solid food and passage of flatus/stool; GI-3). Secondary endpoints included time to GI-2 recovery (toleration of solid food and passage of stool) and hospital discharge order written (DCO).
Results:
Alvimopan did not significantly accelerate GI-3 compared with placebo [6 mg: hazard ratio (HR) = 1.20, p = 0.080; 12 mg: HR = 1.24, p = 0.038). However, after adjustment for significant covariates (sex/surgical duration), benefits were significant for both doses (6 mg: HR = 1.24, p = 0.037; 12 mg: HR = 1.26, p = 0.028). Alvimopan also significantly accelerated time to GI-2 (6 mg: HR = 1.37, p = 0.008; 12 mg: HR = 1.33, p = 0.018) and DCO (6 mg: HR = 1.31, p = 0.008; 12 mg: HR = 1.28, p = 0.015). Adverse events were similar between groups.
Conclusions:
Alvimopan (6 or 12 mg) accelerates GI recovery and is well tolerated in patients undergoing open laparotomy.
Insights
Alvimopan accelerates gastrointestinal recovery after surgery. This peripherally acting mu-opioid receptor antagonist was well-tolerated in patients undergoing open laparotomy.
Area of Science:
- Gastroenterology
- Pharmacology
- Surgical Recovery
Background:
- Alvimopan is a peripherally acting mu-opioid receptor antagonist.
- It is used to accelerate gastrointestinal recovery post-surgery.
Purpose of the Study:
- To evaluate the efficacy of alvimopan in accelerating gastrointestinal recovery.
- To assess safety and tolerability of alvimopan in surgical patients.
Main Methods:
- Randomized trial of patients undergoing open laparotomy (bowel resection or hysterectomy).
- Patients received alvimopan (6 or 12 mg) or placebo orally before surgery and twice daily until discharge.
- Primary endpoint: time to gastrointestinal (GI) recovery (GI-3). Secondary endpoints: GI-2 recovery and hospital discharge order written (DCO).
Main Results:
- Alvimopan did not significantly accelerate GI-3 recovery before covariate adjustment.
- After adjustment, both 6 mg and 12 mg doses significantly accelerated GI-3 recovery.
- Alvimopan significantly accelerated time to GI-2 recovery and DCO for both doses.
- Adverse events were similar across treatment groups.
Conclusions:
- Alvimopan (6 or 12 mg) effectively accelerates gastrointestinal recovery in patients undergoing open laparotomy.
- The drug demonstrated good tolerability in this patient population.
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