In findings from a phase 3 clinical study, alvimopan capsules (Entereg™, Adolor/GlaxoSmithKline) accelerated gastrointestinal (GI) recovery in patients undergoing laparotomy for bowel resection or radical hysterectomy. Patients taking 12 mg of the drug were discharged from the hospital about one day earlier than patients taking placebo.
Alvimopan is a peripherally acting mu-opioid receptor antagonist designed to block the negative effects of opioids (e.g., morphine) on the GI system without interfering with the analgesic effects on the central nervous system. It is the first in this new class with a New Drug Application accepted by the FDA for review.
Postoperative ileus is a transient impairment of GI motility and function that often affects patients undergoing abdominal surgery. It contributes to prolonged hospital stays and represents a substantial burden on health care resources. Despite its negative impact, there have been few advances in the treatment of postoperative ileus since the introduction of nasogastric decompression more than 100 years ago. This technique has limited effectiveness and is uncomfortable for patients. Currently, no drugs have been approved for the management of postoperative ileus.
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In one study, patients who were scheduled for bowel resection or radical total abdominal hysterectomy received 6 mg or 12 mg of alvimopan or placebo two or more hours before surgery, then twice daily until hospital discharge or for up to seven days. The medication did not interfere with opioid analgesia, and it appeared to result in decreased hospital readmission rates.
The incidence of nasogastric tube reinsertion after surgery was reported to be lower for the treated patients than for patients in the placebo group. This difference was statistically significant (P = .004) for the 12-mg group only.