Alvimopan for the management of postoperative ileus after bowel resection: characterization of clinical benefit by pooled responder analysis

Kirk Ludwig, Eugene R Viscusi, Bruce G Wolff, Conor P Delaney, Anthony Senagore, Lee Techner, Kirk Ludwig, Eugene R Viscusi, Bruce G Wolff, Conor P Delaney, Anthony Senagore, Lee Techner

Abstract

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.

Methods: Adult patients who underwent laparotomy for bowel resection scheduled for opioid-based intravenous patient-controlled analgesia received oral alvimopan or placebo preoperatively and twice daily postoperatively until hospital discharge or for 7 postoperative days. The proportion of responders and numbers needed to treat (NNT) were examined on postoperative days (POD) 3-8 for GI-2 recovery (first bowel movement, toleration of solid food) and hospital discharge order (DCO) written.

Results: Alvimopan significantly increased the proportion of patients with GI-2 recovery and DCO written by each POD (P < 0.001 for all). More patients who received alvimopan achieved GI-2 recovery on or before POD 5 (alvimopan, 80%; placebo, 66%) and DCO written before POD 7 (alvimopan, 87%; placebo, 72%), with corresponding NNTs equal to 7.

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.

Trial registration: ClinicalTrials.gov NCT00205842 NCT00388258 NCT00388401 NCT00388479.

Figures

Fig. 1
Fig. 1
Proportion of patients achieving GI-2 recovery by calendar day (a) and the number needed to treat to prevent delayed GI-2 recovery by postsurgery day (b) (modified intent-to-treat population). GI-2 time to first toleration of solid food and first bowel movement
Fig. 2
Fig. 2
Proportion of patients receiving discharge order written by calendar day (a) and the number needed to treat to prevent delayed discharge order written by postsurgery day (b) (modified intent-to-treat population)

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Source: PubMed

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