Kathleen Louden

October 19, 2015

CHICAGO — Patients who underwent colorectal surgery fared better when they received the opioid receptor antagonist alvimopan (Entereg, Cubist Pharmaceuticals) than when they did not, according to a retrospective cohort study.

"Many surgeons in Washington State were using alvimopan, and we were pretty sure it improved outcomes, including length of stay, but we were concerned it was costing a lot of money," said investigator Anne Pugel Ehlers, MD, a research fellow at the University of Washington in Seattle.

The patients went home nearly a day sooner and their hospital costs were about $1000 lower, Dr Ehlers told Medscape Medical News here at the American College of Surgeons (ACS) Clinical Congress 2015.

Alvimopan was approved by the US Food and Drug Administration in 2008 to speed upper and lower gastrointestinal recovery after partial bowel resection with primary anastomosis. It neutralizes the gastrointestinal effects of opioid narcotics by binding to the mu-opioid receptor.

At the University of Washington, the cost per 12 mg capsule is slightly more than $100, Dr Ehlers reported. The drug is taken once before surgery and twice a day afterward, for a maximum of 15 pills, until bowel function returns.

The research was conducted as part of the Surgical Care Outcomes and Assessment Program (SCOAP)–Comparative Effectiveness Research Translation Network Collaborative (CERTAIN). CERTAIN is a research network of some 50 hospitals in Washington, which includes the University of Washington and community-based and urban hospitals.

Using the data from 46 hospitals linked to a claims database, the investigators identified 8102 patients (56% women) who underwent elective colorectal from 2009 to 2011. Alvimopan was administered at least once in 17 of the participating hospitals, and 729 patients (9%) received the drug.

The risk for postoperative complication was significantly lower in patients who received alvimopan than in those who did not. Alvimopan-treated patients were more likely to be insured and to be treated with a less invasive surgical approach.

Table. Patients Who Underwent Elective Colorectal Surgery

Patient Characteristic Alvimopan, % (n = 729) No Alvimopan, % (n = 7373) P Value
At least 1 comorbid condition 70 76 .003
Commercial insurance 77 71 .001
Underwent laparoscopy 57 37 .001


Length of hospital stay — a surrogate for return of bowel function — was 18 hours shorter in the alvimopan-treated patients than in the untreated patients (95% confidence interval [CI], −11 to −26 hours), after adjustment for patient characteristics, procedures, and care processes.

In addition, total hospital costs were $1050 lower in the alvimopan-treated patients than in the untreated patients (CI, −$646 to −$1455).

"We don't know how alvimopan lowered costs, but it was associated with lower costs," Dr Ehlers said. "Looking backward, we cannot infer causality."

She added that the team did not examine whether surgeons used enhanced recovery programs.

"Some physicians feed their patients solid food on postoperative day 1 and encourage early ambulation," she explained. "We know these practices can help patients get better faster."

Effect on Cost Questioned

"Surgeons who use this medication tend to utilize enhanced recovery pathways," said session moderator Neil Hyman, MD, chief of colorectal surgery at the University of Chicago, who is chair of the ACS advisory council for colon and rectal surgery.

Dr Ehlers said she agrees, and explained that the surgeons in the study were using alvimopan in the first few years after the drug was approved, and were considered early adopters.

If we were able to control for the surgeon, I expect the effect on length of stay and cost savings would be diminished.

"If we were able to control for the surgeon, I expect the effect on length of stay and cost savings would be diminished, but we don't know that for sure," she told Medscape Medical News. "They are motivated to accelerate the recovery process and reduce length of stay, so these lower costs may be attributed to these surgeons and not the drug."

The University of Washington is now using alvimopan in an enhanced recovery pathway, she reported.

However, a randomized controlled trial to prove better outcomes with alvimopan is unlikely. "The added value we would gain from a randomized trial wouldn't be worth the expense, given the modest savings in length of stay and cost we saw in our study," Dr Ehlers said.

Alvimopan is contraindicated for patients who have received therapeutic doses of opioids for more than 7 consecutive days before consideration of treatment, according to the manufacturer.

SCOAP is administered by the Foundation for Health Care Quality, and was developed in partnership with and supported by the leadership of the American College of Surgeons, Washington State chapter. The Agency for Healthcare Research and Quality funds CERTAIN. Dr Ehlers and Dr Hyman have disclosed no relevant financial relationships. Coauthor David Flum, MD, from the University of Washington, reports receiving a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.

American College of Surgeons (ACS) Clinical Congress 2015. Presented October 8, 2015.


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