WARNING: FOR SHORT-TERM HOSPITAL USE ONLY
ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have registered in and met all of the requirements for the ENTEREG Access Support and Education (E.A.S.E.) program may use ENTEREG. [see Warnings and Precautions
(5.1 and 5.2) ]
ENTEREG Capsules contain alvimopan, a peripherally-acting µ-opioid receptor (PAM-OR) antagonist.
ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.
Published Studies Related to Entereg (Alvimopan)
A randomized, placebo-controlled phase 3 trial (Study SB-767905/012) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. [2011.02]
Gastrointestinal (GI) side effects are common with opioid medication, and constipation affects approximately 40% of patients...
A randomized, placebo-controlled phase 3 trial (study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. [2011.02]
The balance between the pain relief provided by opioid analgesics and the side effects caused by such agents is of particular significance to patients who take opioids for the long-term relief of non-cancer pain. The spectrum of signs and symptoms affecting the gastrointestinal (GI) tract associated with opioid use is known as opioid-induced bowel dysfunction...
Alvimopan for the management of postoperative ileus after bowel resection: characterization of clinical benefit by pooled responder analysis. [2010.09]
BACKGROUND: A pooled post hoc responder analysis was performed to assess the clinical benefit of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, for the management of postoperative ileus after bowel resection... CONCLUSIONS: On each POD analyzed, alvimopan significantly increased the proportion of patients who achieved GI-2 recovery and DCO written versus placebo and was associated with relatively low NNTs. The results of these analyses provide additional characterization and support for the overall clinical benefit of alvimopan in patients undergoing bowel resection.
Gastrointestinal tract recovery in patients undergoing bowel resection: results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway. [2008.11]
CONCLUSIONS: Alvimopan, 12 mg, administered 30 to 90 minutes before and twice daily after bowel resection is well tolerated, accelerates GI tract recovery, and reduces postoperative ileus-related morbidity without compromising opioid analgesia.
Clinical trial: alvimopan for the management of post-operative ileus after abdominal surgery: results of an international randomized, double-blind, multicentre, placebo-controlled clinical study. [2008.08.01]
BACKGROUND: Post-operative ileus (POI) affects most patients undergoing abdominal surgery. AIM: To evaluate the effect of alvimopan, a peripherally acting mu-opioid receptor antagonist, on POI by negating the impact of opioids on gastrointestinal (GI) motility without affecting analgesia in patients outside North America... CONCLUSION: Although the significant clinical effect of alvimopan on reducing POI observed in previous trials was not reproduced, this trial suggests potential benefit in bowel resection patients who received PCA.
Clinical Trials Related to Entereg (Alvimopan)
Entereg Laparoscopic Colon Resection Study [Recruiting]
Entereg (Alvimopan) is a peripherally acting mu-opioid receptor antagonist that has been
shown to increase postoperative bowel function in patients after open bowel resection
surgery. It has been proven safe and effective for short-term in-house treatment. At the
present there are several Drug Use Utilization Evaluation studies reporting results
involving the use of alvimopan (ENTEREG) in laparoscopic bowel resection patients. However,
this study will be the first randomized, prospective, double-blind, placebo-controlled trial
looking at this population. We propose that Entereg will decrease the length of stay by one
day in the laparoscopic colon resection patient. We wish to perform a voluntary,
double-blinded, placebo controlled study. We plan an enrollment population of 250 patients.
Twelve milligrams of Entereg will be administered 30 minutes to 5 hours pre-op followed by
12 mg BID, up to 7 days or 15 total doses. The primary endpoint of the study will be length
of stay. The time of GI-2 recovery (toleration of solid food and first bowel movement) and
time to GI-3 recovery (toleration of solid food, and flatus or bowel movement) will be
Estimated Enrollment = 250, Study Start Date: November 2010, Estimated Study Completion
Date: May 2012, Estimated Primary Completion Date: Nov 2011.
A Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy [Recruiting]
This study is being conducted to determine whether alvimopan can accelerate recovery of
gastrointestinal function following radical cystectomy when compared with a placebo.
Secondary objectives of the study are:
- to evaluate the effect of alvimopan on hospital length of stay;
- to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related
- to evaluate the overall and cardiovascular safety of alvimopan
Intermountain Healthcare's Enhanced Recovery Protocol for Colon Surgery With and Without Alvimopan Use [Recruiting]
The purpose of this study is to determine if the addition of alvimopan to our care process
model for colon resection patients will decrease length of stay. The care process model is a
combination of optimal IV fluid management, early feeding, early ambulation, patient
education, and pain management.
Accelerating Gastrointestinal Recovery [Recruiting]
This study is designed to determine whether an oral perioperative medication (alvimopan--a
selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian
Reports of Suspected Entereg (Alvimopan) Side Effects
Myocardial Infarction (4),
Respiratory Failure (3),
Metabolic Acidosis (2),
Ventricular Fibrillation (2),
Electrocardiogram QT Prolonged (1),
Acute Myocardial Infarction (1),
Intestinal Ischaemia (1),
Colon Cancer (1), more >>
Page last updated: 2011-12-09