Alvimopan, a Peripherally Acting μ-Opioid Receptor Antagonist, is Associated with Reduced Costs after Radical Cystectomy: Economic Analysis of a Phase 4 Randomized, Controlled Trial
Abstract:In patients treated with radical cystectomy alvimopan decreased hospitalization cost by reducing the health care services associated with postoperative ileus and decreasing the hospital stay.
“…Median time to first BM with alvimopan was 5 days, similar to the 4.9 days reported by the RCT, and it was 6 days without alvimopan, comparable to the 6.1 days in the placebo arm. Postoperative LOS was similar to that reported in the RCT (6 vs. 7 days in alvimopan group, 8 vs. 8 days in non-alvimopan group), and use of TPN was comparable based on the reported phase IV data (3.7 vs. 10% in alvimopan group, 22.4 vs. 25% in non-alvimopan group) [7]. Additionally, our patient population was similar to that of the RCT, being predominately white males who were current or former smokers, and the distribution of surgical approaches for RC (i.e.…”
OBJECTIVE:To evaluate the clinical utilization patterns and outcomes of alvimopan, a peripherally-acting µ-opioid receptor antagonist, after radical cystectomy (RC) and urinary diversion at a high-volume cancer center.
PATIENTS AND METHODS:We retrospectively identified 130 consecutive patients who underwent RC and urinary diversion for bladder cancer at our institution from October 2013 to September 2014. Demographic, clinical, and postoperative outcomes were compared between patients who did and did not receive alvimopan using the Kruskal-Wallis test for medians and the chi-square test for proportions. Predictors of 30-day complications and prolonged length of stay (LOS) were analyzed using multivariate logistic regression analysis.
RESULTS:Perioperative alvimopan was given to 81 patients (62.3%) during the study period although in 17 patients (13.1%) it was indicated but not given. The most common absolute or relative contraindication for alvimopan usage was prior consumption of opioids for more than 7 consecutive days (n = 18; 13.8%). Patients who received alvimopan had a better performance status (P = 0.06), less comorbidities (P = 0.08), and were more likely to have minimally-invasive surgery (P = 0.07) although these differences did not reach statistical significance. Alvimopan usage was independently associated with less postoperative 30-day complications (odds ratio [OR]: 0.35, 95% confidence interval [CI]: 0.15-0.82; P = 0.015), less high-grade complications (OR: 0.12, 95% CI: 0.044-0.34; P < 0.01), and less prolonged hospitalization > 10 days (OR: 0.28, 95% CI: 0.11-0.72; P = 0.008).
CONCLUSIONS:Despite its clinical benefits, alvimopan was under-utilized in RC patients, especially in those with worse baseline health. We recommend its incorporation into standardized protocols to optimize perioperative care.
“…Median time to first BM with alvimopan was 5 days, similar to the 4.9 days reported by the RCT, and it was 6 days without alvimopan, comparable to the 6.1 days in the placebo arm. Postoperative LOS was similar to that reported in the RCT (6 vs. 7 days in alvimopan group, 8 vs. 8 days in non-alvimopan group), and use of TPN was comparable based on the reported phase IV data (3.7 vs. 10% in alvimopan group, 22.4 vs. 25% in non-alvimopan group) [7]. Additionally, our patient population was similar to that of the RCT, being predominately white males who were current or former smokers, and the distribution of surgical approaches for RC (i.e.…”
OBJECTIVE:To evaluate the clinical utilization patterns and outcomes of alvimopan, a peripherally-acting µ-opioid receptor antagonist, after radical cystectomy (RC) and urinary diversion at a high-volume cancer center.
PATIENTS AND METHODS:We retrospectively identified 130 consecutive patients who underwent RC and urinary diversion for bladder cancer at our institution from October 2013 to September 2014. Demographic, clinical, and postoperative outcomes were compared between patients who did and did not receive alvimopan using the Kruskal-Wallis test for medians and the chi-square test for proportions. Predictors of 30-day complications and prolonged length of stay (LOS) were analyzed using multivariate logistic regression analysis.
RESULTS:Perioperative alvimopan was given to 81 patients (62.3%) during the study period although in 17 patients (13.1%) it was indicated but not given. The most common absolute or relative contraindication for alvimopan usage was prior consumption of opioids for more than 7 consecutive days (n = 18; 13.8%). Patients who received alvimopan had a better performance status (P = 0.06), less comorbidities (P = 0.08), and were more likely to have minimally-invasive surgery (P = 0.07) although these differences did not reach statistical significance. Alvimopan usage was independently associated with less postoperative 30-day complications (odds ratio [OR]: 0.35, 95% confidence interval [CI]: 0.15-0.82; P = 0.015), less high-grade complications (OR: 0.12, 95% CI: 0.044-0.34; P < 0.01), and less prolonged hospitalization > 10 days (OR: 0.28, 95% CI: 0.11-0.72; P = 0.008).
CONCLUSIONS:Despite its clinical benefits, alvimopan was under-utilized in RC patients, especially in those with worse baseline health. We recommend its incorporation into standardized protocols to optimize perioperative care.
“…Numerous attempts have been made to reduce the incidence of gastrointestinal complications after RC, including gum chewing, medications targeting the peripheral m-opioid receptor, and fast track regimens. [25][26][27] However, these efforts are a series of conservative measures and should serve as adjunctive therapies, because the surgery itself has a much greater affect on the occurrence and development of POI. Kulkarni et al 12 first described extraperitoneal radical cystectomy using a retrograde technique in 1999.…”
“…[10][11][12] Bell and colleagues 10 performed an economic evaluation of the 4 pooled alvimopan North American bowel resection trials and demonstrated a costs savings of $977 per patient when implementing alvimopan. Touchette and colleagues 12 based their economic analysis on a published meta-analysis of 3 US phase 3 bowel resection clinical trials and used a sensitivity analysis based on the international phase 3 clinical trial data.…”
Section: Discussionmentioning
confidence: 99%
“…However, such a potential offset in nonalvimopan pharmacy costs was not observed in the radical cystectomy trial reported by Kauf and colleagues. 11 In addition, the duration of alvimopan dosing in the model was estimated based on dosing observed in the trials (ie, given up to discharge). However, realworld studies report mean durations of alvimopan therapy that reflect fewer doses than would be incurred if given up until discharge.…”
Section: Discussionmentioning
confidence: 99%
“…2 Alvimopan is a mu-opioid antagonist that mitigates the adverse GI effects of opioid use without diminishing the analgesic effect. 4,5 Studies have shown that alvimopan improves time to GI recovery in patients undergoing certain abdominal operations, [6][7][8][9] and several published economic models and other economic [10][11][12][13] Disclosure Information: This study was funded by Cubist Pharmaceuticals. Dr Earnshaw, Dr Reese, and Ms McDade are employees of RTI Health Solutions, an independent contract research organization that has received research funding for this study from Cubist Pharmaceuticals (now Merck and Co, Inc.).…”
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