- Efficacy and Safety of Peripherally Acting Mu-Opioid Receptor Antagonists for the Treatment of Opioid-Induced Constipation: A Bayesian Network Meta-analysis. [Journal Article]Pain Med. 2020 Jun 03 [Online ahead of print]PM
- CONCLUSIONS: We found that PAMORAs are effective and can be safely used for the treatment of OIC. In network meta-analysis, naldemedine and naloxone appear to be the most effective PAMORAs for the treatment of OIC.
- Alvimopan Is Associated With a Reduction in Length of Stay and Hospital Costs for Patients Undergoing Radical Cystectomy. [Journal Article]Urology. 2020 Jun; 140:115-121.U
- CONCLUSIONS: Our data show that alvimopan is associated with a substantial cost-saving in patients undergoing RC, and suggest that routine use of alvimopan may be a potential cost-effective strategy to reduce the overall financial burden of bladder cancer.
- Early recovery after surgery for radical cystectomy: comprehensive assessment and meta-analysis of existing protocols. [Journal Article]World J Urol. 2020 Mar 02 [Online ahead of print]WJ
- CONCLUSIONS: Current EPs focus on omitting oral BP, early mobilization, and optimized fluid management while they differ in methods preventing postoperative ileus. Our meta-analysis revealed a benefit in introducing these protocols into clinical practice.
- How the Beneficial Effects of Alvimopan Differ With Surgical Approach for Radical Cystectomy. [Journal Article]Urology. 2020 Jun; 140:107-114.U
- CONCLUSIONS: We observed a diminished beneficial effect of alvimopan among patients undergoing RARC and a statistically significant benefit of alvimopan among patients undergoing ORC. The implications of these findings may permit more selective medication use for patients who would benefit the most from this drug.
- Improving postoperative quality of care in germ cell tumor patients: Does scheduled alvimopan, acetaminophen, and gabapentin improve short-term clinical outcomes after retroperitoneal lymph node dissection? [Journal Article]Urol Oncol. 2020 Apr; 38(4):305-312.UO
- CONCLUSIONS: Multimodal pain management improves length of stay in men undergoing retroperitoneal lymph node dissection for testis cancer. The addition of alvimopan allows for quicker return of bowel movements and reduces overall narcotic requirements.
- Response to: "Alvimopan and outcome after colectomy?" [Letter]Surgery. 2020 03; 167(3):677.S
- The contribution of specific enhanced recovery after surgery (ERAS) protocol elements to reduced length of hospital stay after ventral hernia repair. [Journal Article]Surg Endosc. 2019 Nov 08 [Online ahead of print]SE
- CONCLUSIONS: Implementation of an ERAS protocol for VHR results in decreased hospital LOS. Evaluation of the impact of specific ERAS element compliance to LOS is unique to this study. Compliance with acceleration of intestinal recovery, early postoperative mobilization, and multimodal pain management standards provided the greatest LOS reduction.
- Alvimopan for the Prevention of Postoperative Ileus in Inflammatory Bowel Disease Patients. [Journal Article]Dig Dis Sci. 2020 Apr; 65(4):1164-1171.DD
- CONCLUSIONS: Alvimopan is effective in accelerating time to gastrointestinal recovery and reducing POI in IBD patients. While the benefits of alvimopan have been demonstrated previously, this is the first study of the efficacy of alvimopan in IBD patients.
- Alvimopan is associated with decreased length of stay for both open and laparoscopic segmental colectomy. [Journal Article]Surgery. 2019 10; 166(4):483-488.S
- CONCLUSIONS: Alvimopan use is associated with decreased length of stay for both open and laparoscopic colon resections, decreased cost in open procedures, and no cost difference for laparoscopic procedures.
- Systematic scoping review of enhanced recovery protocol recommendations targeting return of gastrointestinal function after colorectal surgery. [Review]ANZ J Surg. 2020 01; 90(1-2):41-47.AJ
- CONCLUSIONS: ERP recommendations specific to interventions targeting POI and return of GI function are varied. While laxatives are the most commonly recommended intervention, there is only weak evidence reported to support this practice.
- Alvimopan for post-radical cystectomy ileus: what should we know? [Editorial]Transl Androl Urol. 2019 Mar; 8(Suppl 1):S96-S98.TA
- Postoperative Ileus. [Review]Clin Colon Rectal Surg. 2019 May; 32(3):166-170.CC
- Postoperative ileus (POI) is a common complication following colon and rectal surgery, with reported incidence ranging from 10 to 30%. It can lead to increased morbidity, cost, and length of stay. Although definitions vary considerably in the literature, in its pathologic form, it can be characterized by a temporary inhibition of gastrointestinal motility after surgical intervention due to nonmec…
Postoperative ileus (POI) is a common complication following colon and rectal surgery, with reported incidence ranging from 10 to 30%. It can lead to increased morbidity, cost, and length of stay. Although definitions vary considerably in the literature, in its pathologic form, it can be characterized by a temporary inhibition of gastrointestinal motility after surgical intervention due to nonmechanical causes that prevents sufficient oral intake. Various risk factors for development of POI have been identified including increasing age, American Society of Anesthesiologists scores 3 to 4, open approach, operative difficulty, operative duration more than 3 hours, bowel handling, drop in hematocrit or need for a transfusion, increasing crystalloid administration, and delayed mobilization. While treatment is expectant and supportive, significant investigations into strategies to mitigate development of POI or shorten its duration have been undertaken with mixed results. There is significant evidence to suggest that a minimally invasive approach and multimodal pain regimens reduce the development of POI. The beneficial effect of chewing gum, alvimopan, and enhanced recovery after surgery protocols may decrease development of POI in selected groups of patients who undergo elective colorectal surgery, and shorten time to return of bowel function, but overall, the data remain inconclusive.
- The Impact of Alvimopan on Return of Bowel Function After Major Spine Surgery - A Prospective, Randomized, Double-Blind Study. [Randomized Controlled Trial]Neurosurgery. 2019 08 01; 85(2):E233-E239.N
- CONCLUSIONS: This study shows that the perioperative use of alvimopan significantly reduced the time to return of bowel function with no increase in postoperative opioid use despite a slight increase in pain scores.
- Effect of alvimopan on gastrointestinal recovery and length of hospital stay after retroperitoneal lymph node dissection for testicular cancer. [Journal Article]J Clin Urol. 2019 Mar; 12(2):122-128.JC
- CONCLUSIONS: Alvimopan may facilitate gastrointestinal recovery after retroperitoneal lymph node dissection for testicular cancer. Whether this translates into reduced length of stay needs to be determined by randomized controlled trials using larger cohorts.
- Alvimopan Significantly Reduces Length of Stay and Costs Following Colorectal Resection and Ostomy Reversal Even Within an Enhanced Recovery Protocol. [Journal Article]Dis Colon Rectum. 2019 06; 62(6):755-761.DC
- CONCLUSIONS: The introduction of alvimopan to a postoperative protocol following elective colorectal resection or ostomy reversal significantly reduces length of stay and is associated with cost savings even within an enhanced recovery protocol. See Video Abstract at http://links.lww.com/DCR/A911.
- Identification and structural characterization of hydrolytic degradation products of alvimopan by LC/QTOF/MS/MS and NMR studies. [Journal Article]J Pharm Biomed Anal. 2019 Feb 20; 165:399-409.JP
- Alvimopan (ALV), a peripherally acting mu-opioid receptor (PAM-OR) antagonist used for the treatment of postoperative ileus, was examined for its degradation behaviour under different stress conditions. A total of five degradation products (DP1-DP5) were formed and identified using high-performance liquid chromatography (HPLC) method. Primarily, complete fragmentation pathways of the protonated d…
Alvimopan (ALV), a peripherally acting mu-opioid receptor (PAM-OR) antagonist used for the treatment of postoperative ileus, was examined for its degradation behaviour under different stress conditions. A total of five degradation products (DP1-DP5) were formed and identified using high-performance liquid chromatography (HPLC) method. Primarily, complete fragmentation pathways of the protonated drug and its degradation products (DP1-DP5) were elucidated by using liquid chromatography-mass spectrometry (LC/MS) and high-resolution mass spectrometry (HRMS) studies. Subsequently, three major degradation products (DP1-DP3) formed under acid hydrolytic stress conditions were isolated by preparative-high performance liquid chromatography (prep-HPLC) and subjected to nuclear magnetic resonance (NMR) experiments (1D and 2D NMR) for further confirmation of their structures. All the spectral data from LC/QTOF/MS/MS and NMR studies were used for the identification and structural characterization of degradation products (DP1-DP5).
- A Retrospective Study of Patients Undergoing Radical Cystectomy and Receiving Peri-Operative Naloxegol or Alvimopan: Comparison of Length of Stay. [Journal Article]J Surg (N Y N Y). 2018 Oct; 6(5):129-134.JS
- Alvimopan is a μ-opioid receptor antagonist used in the post-operative period to decrease rates of post-operative ileus (POI) following radical cystectomy (RC) and thereby shorten length of stay (LOS). Naloxegol is a much less expensive drug of the same class that has yet to be studied for prevention of POI in the peri-operative period. The purpose of the current study is to evaluate the differen…
Alvimopan is a μ-opioid receptor antagonist used in the post-operative period to decrease rates of post-operative ileus (POI) following radical cystectomy (RC) and thereby shorten length of stay (LOS). Naloxegol is a much less expensive drug of the same class that has yet to be studied for prevention of POI in the peri-operative period. The purpose of the current study is to evaluate the differences in LOS and development of POI in patients post-RC who take alvimopan versus those who take naloxegol, with the hope that drug efficacy can be evaluated against the significant difference in cost burden between the two drugs. The study population included all adult patients between 18-89 years of age with bladder cancer undergoing radical cystectomy with urostomy at University of Colorado Hospital. Those patients who received usual post-operative care as well as either alvimopan or naloxegol between September 2011 and December 2017 were selected for analysis. Patients who did not take either medication or were switched from one drug to the other were excluded from the study. A zero-truncated binomial regression analysis was used to analyze differences in length of stay in patients who received alvimopan versus those who received naloxegol. Additionally, the incidence of post-operative ileus was compared between treatment groups. 130 patients who underwent RC and received either alvimopan or naloxegol were included in the study: 75 (58%) received alvimopan and 55 (42%) received naloxegol. Baseline characteristics were similar between treatment groups. There was no significant difference in the length of stay between patients who received alvimopan and patients who received naloxegol after adjusting for age, sex, BMI, length of surgical time, or stage of disease (p = 0.41). There was no significant between the two drugs for development of POI (p = 0.85). Development of POI was significantly associated with a longer LOS (p = 0.007). The analysis showed that naloxegol was comparable to alvimopan when it came to length of hospital stay following RC. Therefore, naloxegol may be offered as a less expensive, effective alternative to alvimopan.
- Evaluation of Healthcare Use and Clinical Outcomes of Alvimopan in Patients Undergoing Bowel Resection: A Propensity Score-Matched Analysis. [Journal Article]Dis Colon Rectum. 2018 12; 61(12):1418-1425.DC
- CONCLUSIONS: The use of alvimopan was associated with a reduction of 0.62 days in postsurgery length of stay and lower rates of postoperative GI complications, infections, and other in-hospital morbidities. See Video Abstract at http://links.lww.com/DCR/A703.
- New developments in the treatment of opioid-induced gastrointestinal symptoms. [Review]United European Gastroenterol J. 2018 Oct; 6(8):1126-1135.UE
- Chronic pain affects a large part of the global population, leading to an increase of opioid use. Opioid-induced constipation (OIC), a highly prevalent adverse effect of opioid use, has a major impact on patients' quality of life. Thanks to the introduction of new drugs for chronic constipation, which can also be used in OIC, and the development of peripherally acting mu-opioid receptor blockers,…
Chronic pain affects a large part of the global population, leading to an increase of opioid use. Opioid-induced constipation (OIC), a highly prevalent adverse effect of opioid use, has a major impact on patients' quality of life. Thanks to the introduction of new drugs for chronic constipation, which can also be used in OIC, and the development of peripherally acting mu-opioid receptor blockers, specifically for use in OIC, therapeutic options have seen major development. This review summarises current and emerging treatment options for OIC based on an extensive bibliographical search. Efficacy data for laxatives, lubiprostone, prucalopride, linaclotide, oxycodone/naloxone combinations, methylnaltrexone, alvimopan, naloxegol, naldemedine, axelopran, and bevenopran in OIC are summarised.
- Alvimopan usage increasing following radical cystectomy. [Journal Article]World J Urol. 2019 Jun; 37(6):1151-1155.WJ
- CONCLUSIONS: This study, the largest to examine the real-world utilization of alvimopan since FDA approval for RC, shows that alvimopan utilization has increased substantially and is associated with reduced perioperative morbidity in patients undergoing cystectomy.
- Alvimopan, Regardless of Ileus Risk, Significantly Impacts Ileus, Length of Stay, and Readmission After Intestinal Surgery. [Journal Article]J Gastrointest Surg. 2018 12; 22(12):2104-2116.JG
- CONCLUSIONS: Alvimopan, regardless of ileus risk, improves ileus, hospital stay, and ileus-related readmission after intestinal resection and these effects are sustained over the long term. Since fewer than a third of patients currently receive alvimopan, its routine adoption with small and large intestinal resection will significantly impact patients and health systems.
- Assessing the efficacy of peripherally acting mu-opioid receptor antagonists (PAMORAs) in the treatment of opioid-induced constipation. [Letter]Gut. 2019 06; 68(6):1133-1134.Gut
- Mu-opioid antagonists for opioid-induced bowel dysfunction in people with cancer and people receiving palliative care. [Review]Cochrane Database Syst Rev. 2018 06 05; 6:CD006332.CD
- CONCLUSIONS: In this update, the conclusions for naldemedine are new. There is moderate-quality evidence to suggest that, taken orally, naldemedine improves bowel function over two weeks in people with cancer and OIBD but increases the risk of adverse events. The conclusions on naloxone and methylnaltrexone have not changed. The trials on naloxone did not assess laxation at 24 hours or over two weeks. There is moderate-quality evidence that methylnaltrexone improves bowel function in people receiving palliative care in the short term and over two weeks, and low-quality evidence that it does not increase adverse events. There is a need for more trials including more evaluation of adverse events. None of the current trials evaluated effects in children.
- Stereoselective HPLC separation of alvimopan on cellulose-based immobilized polysaccharide as a chiral stationary phase. [Journal Article]Chirality. 2018 May 21 [Online ahead of print]C
- Chiral separation by normal phase high performance liquid chromatography is one of the most powerful technique to quantify the chiral purity of the compounds. In this study, a novel, simple, and specific analytical method was proposed to ascertain the chiral purity of alvimopan (ALV). The normal phase HPLC method was developed based on cellulose tris (3,5-dichlorophenylcarbamate) stationary phase…
Chiral separation by normal phase high performance liquid chromatography is one of the most powerful technique to quantify the chiral purity of the compounds. In this study, a novel, simple, and specific analytical method was proposed to ascertain the chiral purity of alvimopan (ALV). The normal phase HPLC method was developed based on cellulose tris (3,5-dichlorophenylcarbamate) stationary phase. The separation of ALV isomers achieved by using column CHIRALPAK IC (250 × 4.6 mm, 5 μm), mobile phase n-hexane: isopropyl alcohol: ethanol: diethylamine (650:200:150:5 v/v), column oven temperature 30°C, flow rate 1.0 mL min-1 , injection volume was 10 μL, chromatographic response monitored at 273 nm. The developed method was validated as per the ICH guidelines and found precise, accurate, and linear. The advantage of the method is a good separation of ALV isomers within 35 minutes of the analysis time. Therefore, this method is suitable for routine determination of chiral purity of ALV active pharmaceutical ingredient.
- Efficacy of pharmacological therapies for the treatment of opioid-induced constipation: systematic review and network meta-analysis. [Journal Article]Gut. 2019 Mar; 68(3):434-444.Gut
- CONCLUSIONS: In network meta-analysis, naloxone and naldemedine appear to be the most efficacious treatments for OIC. Naloxone was the safest of these agents.
- Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Colorectal Surgery. [Review]Anesth Analg. 2019 05; 128(5):879-889.A&A
- The Agency for Healthcare Research and Quality, in partnership with the American College of Surgeons and the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, has developed the Safety Program for Improving Surgical Care and Recovery (ISCR), which is a national effort to disseminate best practices in perioperative care to more than 750 hospitals across multiple procedures …
The Agency for Healthcare Research and Quality, in partnership with the American College of Surgeons and the Johns Hopkins Medicine Armstrong Institute for Patient Safety and Quality, has developed the Safety Program for Improving Surgical Care and Recovery (ISCR), which is a national effort to disseminate best practices in perioperative care to more than 750 hospitals across multiple procedures in the next 5 years. The program will integrate evidence-based processes central to enhanced recovery and prevention of surgical site infection, venous thromboembolic events, catheter-associated urinary tract infections with socioadaptive interventions to improve surgical outcomes, patient experience, and perioperative safety culture. The objectives of this review are to evaluate the evidence supporting anesthesiology components of colorectal (CR) pathways and to develop an evidence-based CR protocol for implementation. Anesthesiology protocol components were identified through review of existing CR enhanced recovery pathways from several professional associations/societies and expert feedback. These guidelines/recommendations were supplemented by evidence made further literature searches. Anesthesiology protocol components were identified spanning the immediate preoperative, intraoperative, and postoperative phases of care. Components included carbohydrate loading, reduced fasting, multimodal preanesthesia medication, antibiotic prophylaxis, blood transfusion, intraoperative fluid management/goal-directed fluid therapy, normothermia, a standardized intraoperative anesthesia pathway, and standard postoperative multimodal analgesic regimens.
- Re: Alvimopan for Recovery of Bowel Function after Radical Cystectomy. [Comment]J Urol. 2018 04; 199(4):869.JU
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- Management of Opioid-Induced Constipation in Patients with Malignancy. [Review]Am J Med. 2018 09; 131(9):1041-1051.e3.AJ