Economic Analysis of Alvimopan—A Clarification and Commentary

Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/98345/1/phar1193.pd

Alvimopan for the Management of Postoperative Ileus After Bowel Resection: Characterization of Clinical Benefit by Pooled Responder Analysis

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 \u3c 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

Comment: update on the management of constipation in the elderly: new treatment options

Lee TechnerAdolor Corporation, Exton, PA, USATo the editor,I read with great interest the recent article by Rao and Go regarding new treatment options for the management of constipation in the elderly.1 In this article, alvimopan was described as having been “recently…introduced for the treatment of opioid-induced constipation”. Furthermore, alvimopan was included in a treatment algorithm for management of opioid-induced chronic constipation in the elderly (see Figure 1 in Rao and Go).1 Additionally, other “potential uses” for peripherally acting mu-opioid receptor antagonists (including alvimopan) were identified by the authors and included treatment of “opioid-related nausea and vomiting, urinary retention, pruritus or post-operative ileus”. This characterization of alvimopan requires further clarification

Development and Validation of the Post-Operative Recovery Index for Measuring Quality of Recovery after Surgery

Purpose: Current methods used to quantify aspects of recovery after surgery and anesthesia tend to be narrowly focused, not patient-rated, or have not been appropriately validated. We set out to develop a quality of recovery score system that is self-report and multi-dimensional, with applicability across various surgeries and surgical settings, from immediately post-surgery through discharge and covering the first 30 days of recovery. Methods: A Post-operative Recovery Index (PoRI) was validated on 225 patients (Nvalidation=96; NCross Validation=129) who had undergone a surgical procedure within the last 30 days. Domain level internal consistency on the validation and cross validation samples yielded coefficients ranging from α=0.813 to α=0.932, while test-retest reliability yielded stability coefficients ranging from r=0.660 to r=0.881. Confirmatory factor analyses demonstrated validity of the factorial structure of the 37-item PoRI on the validation patient sample and confirmed on the cross validation patient sample. Exploratory psychometric analyses provided evidence of an overarching (second-order) “Recovery” factor. Results: We developed, tested, validated, and cross validated the Post-operative Recovery Index (PoRI) consisting of 37 items assessing symptomatology a patient may experience after surgery. Conclusion: The PoRI is offered as a valid, multidimensional measure of recovery after surgery and anesthesia with broad applicability in post-surgical settings