Alvimopan
Regulatory sources consulted
Approved indications
- Accelerate gastrointestinal recovery after surgeries including partial bowel resection with primary anastomosis.
Contraindications
Absolute
- Therapeutic opioid doses for more than 7 consecutive days immediately before starting alvimopan.
- Known or suspected complete gastrointestinal obstruction.
Clinical warnings
- Boxed warning · Long-term studies showed a signal for increased myocardial infarction; use is therefore restricted to short-term hospital treatment. — FDA label
- Major warning · The indication is limited to gastrointestinal recovery after partial bowel resection with primary anastomosis. It has not been studied in surgery with pancreatic or gastric anastomosis. — FDA label
Adverse events
Rare but serious
Myocardial infarction with long-term exposure
Recent literature (PubMed)
Postoperative ileus (POI) is a prevalent surgical complication, which results in prolonged hospitalization, patient distress, and substantial economic burden. The literature aims to present a brief outline of interventions for preventing and treating POI post-surgery. Data from 2014 to 2023 were gathered from reputable sources like PubMed, PubMed Central, Google Scholar, Research Gate, and Science Direct. Inclusion criteria focused on studies exploring innovative treatments and prevention strategies for POI, using keywords such as novel POI treatments, non-pharmacological prevention, POI incidence rates, POI management, and risk factors. The findings revealed that integration of preventive measures such as coffee consumption, chewing gum, probiotics, and use of dikenchuto within enhanced recovery programs has significantly reduced both the frequency and duration of POI, without any adverse effects, with minimally invasive surgical approaches showing promise as an additional preventive strategy. While treatment options such as alvimopan, NSAIDs, and acupuncture have demonstrated efficacy, the use of lidocaine has raised concerns due to associated adverse effects. The ongoing exploration of novel therapeutic strategies such as targeting the mast cells, vagal nerve stimulation and tight junction protein, and prokinetic-mediated instigation of the cholinergic anti-inflammatory trail not only holds promise for enhanced treatment but also deepens the understanding of intricate cellular and molecular pathways underlying POI. POI presents a complex challenge in various surgical specialties, necessitating a multifaceted management approach. The integration of preventive and treatment measures within enhanced recovery programs has significantly reduced POI frequency and duration.
Postoperative paralytic ileus (POI) is a significant concern following gastrointestinal tumor surgery. Effective preventive and therapeutic strategies are crucial but remain elusive. Current evidence from randomized-controlled trials on pharmacological interventions for prevention or treatment of POI are systematically reviewed to guide clinical practice and future research. Literature was systematically searched for prospective randomized-controlled trials testing pharmacological interventions for prevention or treatment of POI after gastrointestinal tumor surgery. Meta-analysis was performed using a random effects model to determine risk ratios and mean differences with 95% CI. Risk of bias and evidence quality were assessed. Results from 55 studies, involving 5078 patients who received experimental interventions, indicate that approaches of opioid-sparing analgesia, peripheral opioid antagonism, reduction of sympathetic hyperreactivity, and early use of laxatives effectively prevent POI. Perioperative oral Alvimopan or intravenous administration of Lidocaine or Dexmedetomidine, while safe regarding cardio-pulmonary complications, demonstrated effectiveness concerning various aspects of postoperative bowel recovery [Lidocaine: -5.97 (-7.20 to -4.74)h, P <0.0001; Dexmedetomidine: -13.00 (-24.87 to -1.14)h, P =0.03 for time to first defecation; Alvimopan: -15.33 (-21.22 to -9.44)h, P <0.0001 for time to GI-2 ] and length of hospitalization [Lidocaine: -0.67 (-1.24 to -0.09)d, P =0.02; Dexmedetomidine: -1.28 (-1.96 to -0.60)d, P =0.0002; Alvimopan: -0.58 (-0.84 to -0.32)d, P <0.0001] across wide ranges of evidence quality. Perioperative nonopioid analgesic use showed efficacy concerning bowel recovery as well as length of hospitalization [-1.29 (-1.95 to -0.62)d, P =0.0001]. Laxatives showed efficacy regarding bowel movements, but not food tolerance and hospitalization. Evidence supporting pharmacological treatment for clinically evident POI is limited. Results from
Postoperative ileus is a severe condition occurring especially in high-risk patients following acute and prolonged surgical procedures. Multiple factors are described as important in etiology, such as inflammation as well as neurological, hormonal and pharmacological influences. In prevention and treatment, we try to apply non-pharmaceutical procedures, to influence reversible etiological factors and, in post-operative period, to implement and use ERAS procedures. Drugs are the other pos-sibility how to influence this pathology. Short-term impairment of intestinal motility following the most of the intraabdominal surgeries must be also taken in count in the differential diagnosis and treatment. We try to describe all possibilities of pharmacological treatment and prevention of the postoperative ileus. Effectiveness of drugs used in present praxis, especially group of so-called prokinetics is analyzed. Postoperative ileus is still recognized as severe complication. Pharmacological treatment options are limited, only a few substances have evident positive impact (neostigmin for treatment and alvimopan - not registered in the Czech Republic for prevention). More evidence is necessary for positive effect of 5-hydroxytryptamine 4 (5HT4) agonists, and the effect of selective COX-2 inhibitors is still controversial.
Enhanced Recovery after Surgery (ERAS) is a multimodal pathway that provides evidence-based guidance for improving perioperative care and outcomes in patients undergoing surgery. In 2013, the ERAS society released its original guidelines for radical cystectomy (RC) for bladder cancer (BC), adopting much of its supporting data from colorectal literature. In the last decade, growing interest in ERAS has increased RC-specific ERAS research, including prospective randomized controlled trials (RCTs). Collective data suggest ERAS contributes to improved complication rates, decreased hospital length-of-stay, and/or time to bowel recovery. Various institutions have adopted modified versions of the ERAS pathway, yet there remains a lack of consensus on the efficacy of specific ERAS items and standardization of the protocol. In this review, we summarize updated evidence and practice patterns of ERAS pathways for RC since the introduction of the original 2013 guidelines. Novel target interventions, including use of immunonutrition, prehabilitation, alvimopan, and methods of local analgesia are reviewed. Finally, we discuss barriers to implementing and future steps in advancing the ERAS movement.
Postoperative ileus (POI) has long been a challenging clinical problem for both patients and healthcare physicians alike. Although a standardized definition does not exist, it generally includes symptoms of intolerance to diet, lack of passing stool, abdominal distension, or flatus. Not only does prolonged POI increase patient discomfort and morbidity, but it is possibly the single most important factor that results in prolongation of the length of hospital stay with a significant deleterious effect on healthcare costs in surgical patients. Determining the exact pathogenesis of POI is difficult to achieve; however, it can be conceptually divided into patient-related and operative factors, which can further be broadly classified as neurogenic, inflammatory, hormonal, and pharmacological mechanisms. Different strategies have been introduced aimed at improving the quality of perioperative care by reducing perioperative morbidity and length of stay, which include Enhanced Recovery After Surgery (ERAS) protocols, minimally invasive surgical approaches, and the use of specific pharmaceutical therapies. Recent studies have shown that the ERAS pathway and laparoscopic approach are generally effective in reducing patient morbidity with early return of gut function. Out of many studies on pharmacological agents over the recent years, alvimopan has shown the most promising results. However, due to its potential complications and cost, its clinical use is limited. Therefore, this article aimed to review the pathophysiology of POI and explore recent advances in treatment modalities and prevention of postoperative ileus.