Postoperative ileus presents significant clinical challenges that potentially prolong hospital stay, contribute to readmission, and increase morbidity.
There is no approved treatment for postoperative ileus.
|Alvimopan 12 mg reduces the incidence of nausea and vomiting by 53%|
|Diseases of the Colon & Rectum|
Alvimopan is a novel, peripherally acting, mu opioid receptor antagonist currently in development for the management of postoperative ileus.
Dr Conor Delaney and colleagues conducted a randomized placebo controlled trial on the effects of alvimopan in gastrointestinal function.
The team included patients undergoing partial colectomy or simple or radical hysterectomy into 3 groups.
The researchers randomized 152 patients to receive 6 mg alvimopan, and 146 to receive 12 mg alvimopan.
Treatment was given orally 2 hours before surgery and twice daily until discharge or for up to 7 days.
The team also randomized 153 patients to a placebo group.
The primary efficacy end point, time to return of gastrointestinal function, was a composite measure of passage of flatus or stool and tolerating solid food.
The researchers included time to the hospital discharge order written as secondary endpoints.
The research team monitored adverse events throughout the study.
The researchers found that mean time to gastrointestinal recovery was significantly reduced in patients treated with 6 mg alvimopan versus placebo.
A smaller reduction in mean time to gastrointestinal recovery was seen with alvimopan 12 mg.
The team noted that mean time to the hospital discharge order written was significantly accelerated in patients treated with alvimopan 6 mg.
The most common treatment-emergent adverse events across all treatment groups observed by the team were nausea, vomiting, and hypotension.
The researchers found a 53% reduction in the incidence of nausea and vomiting in the alvimopan 12 mg group.
Dr Delaney's team concluded, “In patients undergoing major abdominal surgery, alvimopan accelerated gastrointestinal recovery and time to the hospital discharge order written compared with placebo, and was well tolerated.”