Postoperative ileus-related morbidity profile in patients treated with alvimopan after bowel resection.
BACKGROUND
Postoperative ileus (POI), an interruption of coordinated bowel motility after operation, is exacerbated by opioids used to manage pain. Alvimopan, a peripherally acting mu-opioid receptor antagonist, accelerated gastrointestinal (GI) recovery after bowel resection in randomized, double-blind, placebo-controlled, multicenter phase III POI trials. The effect of alvimopan on POI-related morbidity for patients who underwent bowel resection was evaluated in a post-hoc analysis.


METHODS
Incidence of POI-related postoperative morbidity (postoperative nasogastric tube insertion or POI-related prolonged hospital stay or readmission) was analyzed in four North American trials for placebo or alvimopan 12 mg administered 30 minutes or more preoperatively and twice daily postoperatively until hospital discharge (7 or fewer postoperative days). GI-related adverse events and opioid consumption were summarized for each treatment. Estimations of odds ratios of alvimopan to placebo and number needed to treat (NNT) to prevent one patient from experiencing an event of POI-related morbidity were derived from the analysis.


RESULTS
Patients receiving alvimopan 12 mg were less likely to experience POI-related morbidity than patients receiving placebo (odds ratio = 0.44, p < 0.001). Fewer patients receiving alvimopan (alvimopan, 7.6%; placebo, 15.8%; NNT = 12) experienced POI-related morbidity. There was a lower incidence of postoperative nasogastric tube insertion, and other GI-related adverse events on postoperative days 3 to 6 in the alvimopan group than the placebo group. Opioid consumption was comparable between groups.


CONCLUSIONS
Alvimopan 12 mg was associated with reduced POI-related morbidity compared with placebo, without compromising opioid-based analgesia in patients undergoing bowel resection. Relatively low NNTs are clinically meaningful and reinforce the potential benefits of alvimopan for the patient and health care system.
Wolff
Bruce G
BG
Division of Colon and Rectal Surgery, Mayo Clinic College of Medicine, Rochester, MN 55905, USA. wolff.bruce@mayo.edu
Weese
James L
JL
Ludwig
Kirk A
KA
Delaney
Conor P
CP
Stamos
Michael J
MJ
Michelassi
Fabrizio
F
Du
Wei
W
Techner
Lee
L
D013505:Digestive System Surgical Procedures / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005765:Gastrointestinal Agents / Q000627:therapeutic use*; D006801:Humans; D045823:Ileus / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000517:prevention & control; D017450:Receptors, Opioid, mu / Q000037:antagonists & inhibitors*
D005765:Gastrointestinal Agents; D010880:Piperidines; D017450:Receptors, Opioid, mu; C419502:alvimopan