Considerations in Administration of Alvimopan

Raoul Concepcion, MD: Again, I think it’s important to differentiate that you’re giving a dose preoperatively, and then maintaining it, orally, postoperatively.

Declan Fleming, MD: Absolutely.

Traci Hedrick, MD, MS, FACS, FACRS: Yes.

Raoul Concepcion, MD: And, again, I think, for our viewing audience who may not have familiarity with the drug, it’s used to mitigate postoperative ileus, which we’ll talk more and more about. If you haven’t started it, it should not be used in a patient? Or, can it be used in a patient who already has a postoperative ileus that you didn’t start the drug and now you want to give it?

Declan Fleming, MD: That’s not the setting in which we’ve chosen to use it.

Traci Hedrick, MD, MS, FACS, FACRS: No. In fact, it’s contraindicated in people who have been on opioids for longer than 7 days. Unfortunately, you can’t use it in the chronic opioid users.

Declan Fleming, MD: Right.

Raoul Concepcion, MD: That brings up an interesting point. You’re saying that for patients who are getting whatever type of surgery, if they have a history of chronic opioid use as an outpatient, that is an absolute contraindication?

Traci Hedrick, MD, MS, FACS, FACRS: It’s on the package insert. We don’t give it to those patients, if they’re on opioids for longer than 7 days.

Sanjay Patel, MD: And, if you look at the studies, I think that some of the preliminary data show that they are more sensitive to the drug if they were on opioids before. They have worsening diarrhea symptoms, gastrointestinal issues, abdominal pain, nausea, vomiting, and things like that. That’s one of the reasons why some of the earlier studies show that. And then, the other thing that I’d like to mention is that when they were giving it chronically—they did a study where they looked at giving it to patients for about a year—they found that there’s an increased rate of having cardiac events. But in a short dose, the 7-day dose that we give perioperatively, there has really been no study across multiple studies that show that there’s an increased rate of cardiac events. It’s a concern for the chronic use. And really, it was found in the trial where they kept them on it for a year. So, I think for our purposes, it’s really a safe drug, from a cardiac standpoint.

Raoul Concepcion, MD: It’s important to recognize that this is one of the things that receives pushback, primarily from your chief financial officer (CFO) at your institution. “It’s an expensive agent. Why are we using this?” And, again, I think it’s important to remember that it’s not about what you pay for it, but what it’s going to give you in the long-term. If you can reduce postoperative ileus, you can reduce hospital stays. That’s very impactful. John, any additions from an anesthetic standpoint?

John Dalton, MD: I can give you a private practice perspective. Most CFOs are going to ask you about the cost. If you put an ERAS (enhanced recovery after surgery) protocol in place that’s dependent on the use of alvimopan, you won’t succeed on cost or on outcomes. As I said earlier, if you’ve seen one, you’ve seen one. If you put together, at each of your locations, a program that touches all the bases, all of the inexpensive things, multimodal analgesia, you get narcotics out, chewing gum actually works fairly well maybe metoclopramide, maybe not, it may lead you to have better outcomes with postoperative ileus. And then, if you’re not where you need to be, you can then go to the C-suite and say, “If we have this drug, we’re going to reduce length-of-stay even more.”

To Traci’s point, you’ve got to be metric driven. If you’re not getting the length-of-stay that you want, or can’t compare with Declan—“They’re doing better than we are”—I can go to my CFO and say, “This is the missing piece. We need to add it.” But it is an adjunct. It’s not the answer to the question.

Declan Fleming, MD: But it is effective.

John Dalton, MD: It is effective, absolutely. You just can’t start with it in private practice.

Declan Fleming, MD: No.

Traci Hedrick, MD, MS, FACS, FACRS: In isolation.

Declan Fleming, MD: Right.

John Dalton, MD: Because it won’t work there. You have people giving narcotics. You’ve got to have everybody on the same page.

Declan Fleming, MD: Yes.

Sanjay Patel, MD: Yes, there’s no magic bullet. Each little piece adds up, and I think really contributes to the overall outcome. You can’t really rely, just like you’re saying, on 1 thing. It’s not the end all, be all.

John Dalton, MD: It is a good bullet, and I think it’s an exciting one.

Sanjay Patel, MD: Sure, yes.

John Dalton, MD: But it can’t be your only one.

Raoul Concepcion, MD: Is there any dosing adjustment for people that have hepatic insufficiency or renal insufficiency?

Sanjay Patel, MD: There is. I think if you have severe hepatic insufficiency, you have to dose it a certain way. Also, you have to dose reduce it in patients that have end-stage renal disease, certainly. We have some of those patients because we do cystectomies. They often have hydronephrosis and renal insufficiency, and they receive platinum-based chemotherapy. Overall, their renal function is poor. Occasionally, we’ll have to tweak it a little bit. But, it’s really in the severe hepatic insufficiency cases and more severe renal cases that you have to do that in.

Raoul Concepcion, MD: What is the side effect profile?

Traci Hedrick, MD, MS, FACS, FACRS: The side effect profile is minimal. When I have a patient that starts having diarrhea postoperatively, I reduce it. I personally haven’t seen many side effects, if any, attributable to it, other than the warning for cardiac issues, which I have not personally seen.

Declan Fleming, MD: Every once in a while, we’ll see some people that are taking narcotics chronically that don’t really reveal that beforehand. It’s so common for people with back or arthritic pain to self-medicate with narcotics. It’s one of the realities of our modern society. I have found that it’s almost like a person goes into gut narcotic withdrawal, and that can cause some cramping and diarrhea. It’s more severe than one would expect.

Transcript edited for clarity.