Economic analysis of alvimopan in North American Phase III efficacy trials
ABSTRACT The economic effect of the use of alvimopan in four randomized, double-blind, placebo-controlled, Phase III, North American efficacy trials was analyzed.
Patients were eligible for the study if they were 18 years or older, were undergoing laparotomy for partial small or large bowel resection with primary anastomosis, and were scheduled for postoperative pain management with opioid-based i.v. patient-controlled analgesia. Patients analyzed in the North American Phase III trials received placebo or alvimopan 12 mg orally before surgery. Doses were administered twice daily beginning the day after surgery until hospital discharge or for a maximum of 15 doses.
Compared with placebo, alvimopan was associated with a significantly shorter mean time to gastrointestinal (GI) recovery and a significantly shorter mean time to a written discharge order. Alvimopan was also associated with a mean hospital length of stay (LOS) of one full day less than placebo. The mean cost of alvimopan based on a mean of 8.9 12-mg doses was $558.00; the alvimopan cost at the upper limit of allowed dosing was $937.50. Combining the alvimopan and hospital costs for each patient, total costs for the alvimopan group were estimated to be lower than for the placebo group.
In a post hoc analysis, alvimopan was associated with significantly faster upper and lower GI recovery after bowel resection and a mean LOS reduction of one day compared with placebo. The mean estimated hospital cost was $879-$977 less for patients who received alvimopan compared with placebo. The base-case and sensitivity analyses suggest that, on average, the use of alvimopan compared with placebo may have a cost-saving effect in the hospital setting.
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ABSTRACT: Postoperative ileus (POI) after open abdominal surgery and bowel resection can lead to significant patient discomfort, morbidity, and prolonged length of stay in the hospital. Several factors have been implicated in the pathophysiology of POI, including surgical manipulation of the bowel, inflammation, inhibitory neural reflexes, and endogenous and exogenous opioids. Alvimopan (Entereg), approved by the FDA to accelerate upper and lower gastrointestinal (GI) recovery following partial large-bowel or small- bowel resection with primary anastomosis, represents a potential advance in the care of these patients. In five randomized, double-blind, placebo-controlled, phase 3 clinical trials, alvimopan, compared with placebo, accelerated the time to GI recovery and hospital discharge status after bowel resection. In this article, we review the formulary details of alvimopan for in-hospital management of POI following this procedure.P&T 01/2010; 35(1):44-9. · 1.07 Impact Factor
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ABSTRACT: Almost all patients develop postoperative ileus (POI) after abdominal surgery. POI represents the single largest factor influencing length of stay (LOS) after bowel resection, and has great implications for patients and resource utilization in health care. New methods to treat and decrease the length of POI are therefore of great importance. During the past decade, a substantial amount of research has been performed evaluating POI, and great progress has been made in our understanding and treatment of POI. Laparoscopic procedures, enhanced recovery pathways and pharmacologic treatment have been introduced. Each factor has substantially contributed to decreasing the length of POI and thus LOS after bowel resection. This editorial outlines resource utilization of POI, normal physiology of gut motility and pathogenesis of POI. Pharmacological treatment, fast track protocols and laparoscopic surgery can each have significant impact on pathways causing POI. The optimal integration of these treatment options continues to be assessed in prospective studies.World Journal of Gastroenterology 05/2010; 16(17):2067-74. · 2.43 Impact Factor
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ABSTRACT: Chronic constipation is a common digestive problem in North America, with significant psychosocioeconomic implications. Dietary and lifestyle measures and low-cost traditional over-the-counter laxatives are usually the first line of therapy but help only half of the patients. Several newer agents that act by increasing colonic peristalsis, altering colonic secretion, and/or antagonizing enteric opioid receptors have been developed that are effective in treating constipation and its related symptoms as well as improving quality of life. This article focuses on the pharmacology of traditional and newer agents for the treatment of constipation.Gastroenterology clinics of North America 09/2010; 39(3):509-27. DOI:10.1016/j.gtc.2010.08.001 · 1.92 Impact Factor