User login
WASHINGTON – The nonopioid pain reliever alvimopan significantly decreased the incidence of postoperative ileus and shortened hospital stay among bowel surgery patients who took the drug as part of an existing accelerated recovery program.
Compared with patients who took placebo, those who took alvimopan left the hospital about 1 day sooner. In addition to the decrease in ileus, patients experienced a quicker return to normal bowel function, including time to first flatus and first bowel movement, Dr. Robert Moesinger said at the annual clinical congress of the American College of Surgeons.
"Alvimopan augmented the already improved outcomes we had seen with our validated recovery pathway, in both laparoscopic- and open-surgery patients," said Dr. Moesinger of Intermountain Healthcare, Salt Lake City. "Given the very diverse nature of our health care system, with multiple types of hospitals and surgeons, we feel these data are widely applicable and we are very comfortable recommending its routine use for patients having elective bowel surgery."
Dr. Moesinger and his colleagues conducted a randomized, placebo-controlled trial of alvimopan in 248 such patients. Those taking the study drug received 12 mg before surgery; after surgery, they received 12 mg twice a day until discharge.
The primary endpoint was postoperative length of stay. Secondary endpoints included the incidence of postoperative ileus, time to first flatus and first bowel movement, tolerance of solid food, total hospital and pharmacy costs, nasogastric tube reinsertion, 30-day readmission rates, and anastomotic leak.
The patients’ mean age was 61 years. There were no significant differences in any of their baseline demographics or clinical characteristics. Because of a statistical fluke, the placebo group did contain significantly more open-surgery patients than the alvimopan group (34% vs. 20%). The rest of the patients had laparoscopic surgery. Patients had an average of nine doses of the study drug.
The mean length of stay was 4 days in the alvimopan group and 5 in the placebo group – a significant difference.
There was significantly less postoperative ileus in the alvimopan group (2% vs. 10%). Significantly fewer of those taking the study drug needed a nasogastric tube reinserted (2% vs. 9%). The rates of 30-day readmission, reoperation, and anastomotic leak were similar in both groups. The mean time to first bowel movement was about 1 day sooner in the alvimopan group.
The median hospital cost was $10,832 for the alvimopan group and $11,924 for the placebo group – a significant difference. The median total pharmacy cost was $476 vs. $501; this difference was not significant.
Because Cubist Pharmaceuticals, which makes alvimopan, provided the study drug at no cost, the overall cost analysis cannot be considered complete, Dr. Moesinger noted. However, the pharmacy cost for a similar course of the drug would be $84. Figuring that cost into the total saved for each admission ($1,686) still yielded a net financial benefit of $930 per patient, he said.
Dr. Moesinger had no financial disclosures.
Alvimopan (Entereg, Cubist Pharmaceuticals) is an orally administered, peripherally acting mu-opioid receptor antagonist that does not cross the blood-brain barrier. It is designed to reverse opioid-induced changes in the gastrointestinal tract without adversely affecting opioid-induced analgesia.
 |
| Dr. Brian E. Lacy |
Alvimopan, the first FDA-approved medication for the treatment of postoperative ileus (POI), was approved in May 2008 with a Risk Evaluation and Mitigation Strategy in place, due to concerns over an increased number of myocardial infarctions in one research study.
Postoperative ileus is the impairment of gastrointestinal motility after abdominal or pelvic surgery, and is an expected complication of major abdominal surgery. It can affect all segments of the gastrointestinal tract and may lead to symptoms of nausea, vomiting, bloating, distention, constipation, and inability to evacuate flatus. Several studies have demonstrated that POI delays hospital discharges, increases the rate of hospital readmission after abdominal surgery, and increases the risk of postoperative complications. As such, POI imposes a significant economic impact on the health care system.
The current study confirms earlier studies involving over 2,000 patients that led to the approval of alvimopan. The current study was a single-center, randomized, double-blind study comparing placebo to alvimopan. Patients randomized to alvimopan (12 mg preoperatively; 12 mg twice daily until discharge) were discharged from the hospital 1 day earlier, were less likely to have a nasogastric tube reinserted, and had a bowel movement 1 day earlier, compared with those patients receiving placebo. The authors reported a significant cost savings per patient.*
These findings are important given the absence of other FDA-approved medications for the treatment of POI and the lack of other effective treatments. Alvimopan is available only to patients who are in hospitals that are registered to use this medication under the EASE (Entereg Access Support and Education) program. This recent study should prompt nonparticipating hospitals to consider routine use of alvimopan in all patients undergoing elective and emergent surgeries at risk for development of POI.
Dr. Brian E. Lacy is a professor of medicine at the Geisel School of Medicine at Dartmouth, Hanover, N.H., and chief of the section of gastroenterology and hepatology at Dartmouth-Hitchcock Medical Center. He has no relevant conflicts of interest.
*CORRECTION 11/21/13: The original version of this story misstated the cost savings per patient.
Alvimopan (Entereg, Cubist Pharmaceuticals) is an orally administered, peripherally acting mu-opioid receptor antagonist that does not cross the blood-brain barrier. It is designed to reverse opioid-induced changes in the gastrointestinal tract without adversely affecting opioid-induced analgesia.
|
| Dr. Brian E. Lacy |
Alvimopan, the first FDA-approved medication for the treatment of postoperative ileus (POI), was approved in May 2008 with a Risk Evaluation and Mitigation Strategy in place, due to concerns over an increased number of myocardial infarctions in one research study.
Postoperative ileus is the impairment of gastrointestinal motility after abdominal or pelvic surgery, and is an expected complication of major abdominal surgery. It can affect all segments of the gastrointestinal tract and may lead to symptoms of nausea, vomiting, bloating, distention, constipation, and inability to evacuate flatus. Several studies have demonstrated that POI delays hospital discharges, increases the rate of hospital readmission after abdominal surgery, and increases the risk of postoperative complications. As such, POI imposes a significant economic impact on the health care system.
The current study confirms earlier studies involving over 2,000 patients that led to the approval of alvimopan. The current study was a single-center, randomized, double-blind study comparing placebo to alvimopan. Patients randomized to alvimopan (12 mg preoperatively; 12 mg twice daily until discharge) were discharged from the hospital 1 day earlier, were less likely to have a nasogastric tube reinserted, and had a bowel movement 1 day earlier, compared with those patients receiving placebo. The authors reported a significant cost savings per patient.*
These findings are important given the absence of other FDA-approved medications for the treatment of POI and the lack of other effective treatments. Alvimopan is available only to patients who are in hospitals that are registered to use this medication under the EASE (Entereg Access Support and Education) program. This recent study should prompt nonparticipating hospitals to consider routine use of alvimopan in all patients undergoing elective and emergent surgeries at risk for development of POI.
Dr. Brian E. Lacy is a professor of medicine at the Geisel School of Medicine at Dartmouth, Hanover, N.H., and chief of the section of gastroenterology and hepatology at Dartmouth-Hitchcock Medical Center. He has no relevant conflicts of interest.
*CORRECTION 11/21/13: The original version of this story misstated the cost savings per patient.
Alvimopan (Entereg, Cubist Pharmaceuticals) is an orally administered, peripherally acting mu-opioid receptor antagonist that does not cross the blood-brain barrier. It is designed to reverse opioid-induced changes in the gastrointestinal tract without adversely affecting opioid-induced analgesia.
|
| Dr. Brian E. Lacy |
Alvimopan, the first FDA-approved medication for the treatment of postoperative ileus (POI), was approved in May 2008 with a Risk Evaluation and Mitigation Strategy in place, due to concerns over an increased number of myocardial infarctions in one research study.
Postoperative ileus is the impairment of gastrointestinal motility after abdominal or pelvic surgery, and is an expected complication of major abdominal surgery. It can affect all segments of the gastrointestinal tract and may lead to symptoms of nausea, vomiting, bloating, distention, constipation, and inability to evacuate flatus. Several studies have demonstrated that POI delays hospital discharges, increases the rate of hospital readmission after abdominal surgery, and increases the risk of postoperative complications. As such, POI imposes a significant economic impact on the health care system.
The current study confirms earlier studies involving over 2,000 patients that led to the approval of alvimopan. The current study was a single-center, randomized, double-blind study comparing placebo to alvimopan. Patients randomized to alvimopan (12 mg preoperatively; 12 mg twice daily until discharge) were discharged from the hospital 1 day earlier, were less likely to have a nasogastric tube reinserted, and had a bowel movement 1 day earlier, compared with those patients receiving placebo. The authors reported a significant cost savings per patient.*
These findings are important given the absence of other FDA-approved medications for the treatment of POI and the lack of other effective treatments. Alvimopan is available only to patients who are in hospitals that are registered to use this medication under the EASE (Entereg Access Support and Education) program. This recent study should prompt nonparticipating hospitals to consider routine use of alvimopan in all patients undergoing elective and emergent surgeries at risk for development of POI.
Dr. Brian E. Lacy is a professor of medicine at the Geisel School of Medicine at Dartmouth, Hanover, N.H., and chief of the section of gastroenterology and hepatology at Dartmouth-Hitchcock Medical Center. He has no relevant conflicts of interest.
*CORRECTION 11/21/13: The original version of this story misstated the cost savings per patient.
WASHINGTON – The nonopioid pain reliever alvimopan significantly decreased the incidence of postoperative ileus and shortened hospital stay among bowel surgery patients who took the drug as part of an existing accelerated recovery program.
Compared with patients who took placebo, those who took alvimopan left the hospital about 1 day sooner. In addition to the decrease in ileus, patients experienced a quicker return to normal bowel function, including time to first flatus and first bowel movement, Dr. Robert Moesinger said at the annual clinical congress of the American College of Surgeons.
"Alvimopan augmented the already improved outcomes we had seen with our validated recovery pathway, in both laparoscopic- and open-surgery patients," said Dr. Moesinger of Intermountain Healthcare, Salt Lake City. "Given the very diverse nature of our health care system, with multiple types of hospitals and surgeons, we feel these data are widely applicable and we are very comfortable recommending its routine use for patients having elective bowel surgery."
Dr. Moesinger and his colleagues conducted a randomized, placebo-controlled trial of alvimopan in 248 such patients. Those taking the study drug received 12 mg before surgery; after surgery, they received 12 mg twice a day until discharge.
The primary endpoint was postoperative length of stay. Secondary endpoints included the incidence of postoperative ileus, time to first flatus and first bowel movement, tolerance of solid food, total hospital and pharmacy costs, nasogastric tube reinsertion, 30-day readmission rates, and anastomotic leak.
The patients’ mean age was 61 years. There were no significant differences in any of their baseline demographics or clinical characteristics. Because of a statistical fluke, the placebo group did contain significantly more open-surgery patients than the alvimopan group (34% vs. 20%). The rest of the patients had laparoscopic surgery. Patients had an average of nine doses of the study drug.
The mean length of stay was 4 days in the alvimopan group and 5 in the placebo group – a significant difference.
There was significantly less postoperative ileus in the alvimopan group (2% vs. 10%). Significantly fewer of those taking the study drug needed a nasogastric tube reinserted (2% vs. 9%). The rates of 30-day readmission, reoperation, and anastomotic leak were similar in both groups. The mean time to first bowel movement was about 1 day sooner in the alvimopan group.
The median hospital cost was $10,832 for the alvimopan group and $11,924 for the placebo group – a significant difference. The median total pharmacy cost was $476 vs. $501; this difference was not significant.
Because Cubist Pharmaceuticals, which makes alvimopan, provided the study drug at no cost, the overall cost analysis cannot be considered complete, Dr. Moesinger noted. However, the pharmacy cost for a similar course of the drug would be $84. Figuring that cost into the total saved for each admission ($1,686) still yielded a net financial benefit of $930 per patient, he said.
Dr. Moesinger had no financial disclosures.
WASHINGTON – The nonopioid pain reliever alvimopan significantly decreased the incidence of postoperative ileus and shortened hospital stay among bowel surgery patients who took the drug as part of an existing accelerated recovery program.
Compared with patients who took placebo, those who took alvimopan left the hospital about 1 day sooner. In addition to the decrease in ileus, patients experienced a quicker return to normal bowel function, including time to first flatus and first bowel movement, Dr. Robert Moesinger said at the annual clinical congress of the American College of Surgeons.
"Alvimopan augmented the already improved outcomes we had seen with our validated recovery pathway, in both laparoscopic- and open-surgery patients," said Dr. Moesinger of Intermountain Healthcare, Salt Lake City. "Given the very diverse nature of our health care system, with multiple types of hospitals and surgeons, we feel these data are widely applicable and we are very comfortable recommending its routine use for patients having elective bowel surgery."
Dr. Moesinger and his colleagues conducted a randomized, placebo-controlled trial of alvimopan in 248 such patients. Those taking the study drug received 12 mg before surgery; after surgery, they received 12 mg twice a day until discharge.
The primary endpoint was postoperative length of stay. Secondary endpoints included the incidence of postoperative ileus, time to first flatus and first bowel movement, tolerance of solid food, total hospital and pharmacy costs, nasogastric tube reinsertion, 30-day readmission rates, and anastomotic leak.
The patients’ mean age was 61 years. There were no significant differences in any of their baseline demographics or clinical characteristics. Because of a statistical fluke, the placebo group did contain significantly more open-surgery patients than the alvimopan group (34% vs. 20%). The rest of the patients had laparoscopic surgery. Patients had an average of nine doses of the study drug.
The mean length of stay was 4 days in the alvimopan group and 5 in the placebo group – a significant difference.
There was significantly less postoperative ileus in the alvimopan group (2% vs. 10%). Significantly fewer of those taking the study drug needed a nasogastric tube reinserted (2% vs. 9%). The rates of 30-day readmission, reoperation, and anastomotic leak were similar in both groups. The mean time to first bowel movement was about 1 day sooner in the alvimopan group.
The median hospital cost was $10,832 for the alvimopan group and $11,924 for the placebo group – a significant difference. The median total pharmacy cost was $476 vs. $501; this difference was not significant.
Because Cubist Pharmaceuticals, which makes alvimopan, provided the study drug at no cost, the overall cost analysis cannot be considered complete, Dr. Moesinger noted. However, the pharmacy cost for a similar course of the drug would be $84. Figuring that cost into the total saved for each admission ($1,686) still yielded a net financial benefit of $930 per patient, he said.
Dr. Moesinger had no financial disclosures.
AT THE ACS CLINICAL CONGRESS
Major finding: Compared with placebo, alvimopan given before and after elective bowel surgery reduced the length of stay by 1 day and significantly decreased the incidence of postoperative ileus (2% vs. 10%).
Data source: The randomized placebo-controlled trial comprised 248 patients.
Disclosures: Dr. Moesinger had no financial disclosures.
