-ADLR presented three abstracts on Entereg (alvimopan) - full text details below the jump
Adolor $ADLR will present the following abstracts:
EVALUATION OF ALVIMOPAN IN CLINICAL PRACTICE: A NATIONAL MATCHED-COHORT STUDY OF 30-DAY POSTOPERATIVE IN-HOSPITAL MORBIDITY AND MORTALITY IN PATIENTS UNDERGOING BOWEL RESECTION. (P267)
C. Delaney, C. Christopher Craver, M. Maggard Gibbons, A. Rachfal, C. VandePol, S. Cook, S. Poston, M. Calloway, L. Techner Cleveland, OH; Charlotte, NC; Los Angeles, CA; Exton,
PA; Chester Springs, PA; Research Triangle Park, NC
Purpose: To evaluate early in-hospital morbidity, mortality, and length of stay (LOS) in bowel resection (BR)- patients (colon and rectal resection, small bowel resection, and ostomy reversal or diversion) with or without exposure to alvimopan, a peripherally acting mu-opioidreceptor antagonist.
Methods: A retrospective matched-cohort study was conducted using 2009 data from a national inpatient database. Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity scorematched (baseline characteristics) to a non-alvimopan BR
patient. Outcomes collected in the intent-to-treat population (≥ 1 dose of alvimopan) included gastrointestinal,cardiovascular, pulmonary, infection, cerebrovascular, and thromboembolic morbidity; mortality; and readmission rate. Postoperative LOS and estimated hospital cost were
also collected in a modified intent-to-treat population (≥ 3 and ≤ 15 doses of alvimopan and parenteral opioids on ≥ 1 postoperative day).
Results: Baseline characteristics were similar in each cohort. The mean age was 62 years and the majority of patients were white (74.0%). The most frequently reported procedure type was laparoscopic colon and rectal resection (40.5%). The mean number of alvimopan doses was
7.7 in the intent-to-treat and 8.5 in the modified intent to- treat population. Gastrointestinal and other in-hospital morbidities and mortality were lower in the alvimopan cohort compared with the matched control cohort (Table). Mean postoperative LOS, and estimated hospital cost were lower in the alvimopan cohort compared with matched controls.
Conclusions: Alvimopan-treated patients had a lower incidence of mortality and several morbidities. Mean LOS, and estimated cost were lower with comparable readmission rates. These results, generated from data outside the clinical trial setting, include laparoscopic colectomy and demonstrate a potential association between acceleration of GI recovery and improved early postoperativeoutcomes with alvimopan use.
ALVIMOPAN REDUCES LENGTH OF STAY FOR PATIENTS UNDERGOING LAPAROSCOPIC BOWEL SURGERY. (P268)
A. Kandel, N. Pokharel, S. Anantha Sathyanarayana, M. Lafonte, M. GreenwaldManhasset, NY; Brooklyn, NY
Purpose: Postoperative (postop) ileus is a major contributor to prolonged hospital stay. It is well known that opioids reduce intestinal motility by binding to peripheral mu-opioid receptors in the GI tract. Alvimopan(Entereg), a peripherally acting mu receptor antagonist, has been
shown to enhance recovery of bowel function in open laparotomies. In addition, evidence has shown that laparoscopic colectomy results in earlier bowel recovery and shorter length of stay when compared to the open approach. The aim of this study was to determine if Alvimopan reduces length of stay (LOS) in patients undergoing laparoscopic bowel surgery.
Methods: A retrospective review of 164 consecutive patients undergoing laparoscopic bowel surgery by the same colorectal surgeon before and after the initiation of Alvimopan was performed. All patients had the same preop and postop protocols for bowel surgery, including
bowel preparation. Out of 164 patients, 104 were not given Entereg, while 60 were given the drug. Entereg was administered to patients 30 minutes prior to taking them to the operating room and the second dose administered within 12 hours of surgery. Entereg was then continued until discharge or regain of bowel function.
Results: The mean postop length of hospital stay in the Entereg group was 4.6 days and the median stay was 4 days. Postop morbidity included diarrhea due to c.diff(8.6%), atrial fibrillation(1.7%), and intra-abdominal hematoma(1.7%). The mean postop length of hospital
stay in the Non Entereg group was 6.3 days and the median stay was 5 days. Postop morbidity included fever due to atelectasis(0.9%), pneumonia(0.9%), diarrhea due to c.diff(8%), lower GI bleed(1.9%), MI(0.9%), ileus(3.8), atrial fibrillation(0.9%), urinary retention(1.9%), and return to OR due to small bowel obstruction(0.9%).
Conclusions: The use of Alvimopan in patients undergoinglaparoscopic bowel surgery in this retrospective review reduced the mean postop length of hospital stay by almost two days and the median postop length of stay by one day. This 20% reduction in length of stay has the potential to impact a hospital’s budget and further investigation is indicated.
ALVIMOPAN DECREASES POSTOPERATIVE HOSPITAL STAY FOLLOWING LAPAROSCOPIC COLON AND RECTAL RESECTION. (P269)
H. Al-azzawi, F. Lane, O. Johansen, B. Melbert, B. Sanders, D. Maun, B. Tsai; Indianapolis, IN
Purpose: Length of hospital stay following colectomy is largely dependent upon return of bowel function. Alvimopan, a selective mu-opiod receptor antagonist, has been shown to decrease the time to return of bowel function following bowel resection. Initial studies on alvimopan
were performed in open intestinal resection, and there is little data on its use in laparoscopic colon and rectal resection. The purpose of this study was to compare hospital stay with and without the use of alvimopan in laparoscopic colon and rectal resection.
Methods: A retrospective database review was performed on all patients undergoing laparoscopic colon and rectal resection at a single colorectal surgical practice between January 2008 through January 2010. Patients were grouped according to alvimopan use and stratified by
resection location (right, left, rectal) and laparoscopic technique (hand assistance or standard laparoscopic surgery). The primary endpoint was hospital stay and secondary endpoint was hospital readmission rate. Data were compared using student’s t-test or one-way ANOVA withpost-hoc Tukey multiple comparison test.
Results: Alvimopan use (n=115) decreased length of stay in laparoscopic colon and rectal resection compared to no alvimopan use (n=81) (4.4 ± 0.2 vs. 5.8 ± 0.3 days, p<0.0001). Stratified by anatomic site, alvimopan significantly decreased hospital stay in left colectomy and proctectomy, but not right colectomy. There was no difference in hospital stay between hand-assisted laparoscopic colectomy compared to standard laparoscopic colectomy. Alvimopan decreased the incidence of extended hospital stay (> 7 days) compared to no alvimopan use. All readmissions and readmissions for ileus were not significantly
different with or without alvimopan.
Conclusions: Alvimopan decreased length of postoperative hospitalization following laparoscopic left colectomy and proctectomy. The greatest effect was in decreased rate
of extended hospital stay with alvimopan use. Hospital stay was not affected by technique of laparoscopic surgery. These results support alvimopan administration in laparoscopic
colon and rectal resection.