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Recommendations to providers on taking into account risks for patients with hepatic encephalopathy in the prevention of relapses and rehospitalization.
Arun B. Jesudian, MD: Elliot, I know you've been working on defining protocols for hospitalization of patients with cirrhosis. And how do you and your team [at the] Michigan [Medicine Hepatology Clinic] take care of patients with hepatic encephalopathy and what recommendations could you have for providers who are not in a transplant center and do not have hepatologists [or] specialized care?
Elliot B. Tapper, MD: Yeah, I think the bottom line is that if you use a well-oiled machine, like Northwestern [Memorial] At the hospital, when you enter, you will have this four-pronged approach, and patients will very often have a chance of being served very well. And the typical experience that we see is that a person with pure hepatic encephalopathy has to wake up very quickly. So … a few years ago, I noticed that some nurses were independently asking for additional doses of lactulose in case of declared encephalopathy, and that their patients would wake up and go home sooner.
Anecdotally, we decided to protocol the treatment of hepatic encephalopathy. And what does it do, it helps you in a context [in which] you can not have a hepatologist on the staff, or the staff of the house [members] alternates and often resembles those modeled notes about what to do in a given situation. So we gave a lot of lactulose in advance, and we started the rifaximin early, not because we were expecting it [affect] changes to the hospital. But we [did] for 2 reasons. One is that often the pre-approval work has to be done before the patient leaves. And second, the episode of care for manifest hepatic encephalopathy does not end at the time of discharge. Because these patients have a risk of readmission that may exceed 30% [or] 40%. And you must do everything possible to take the data that Flamm and his colleagues have provided to reduce the risk of a new episode. And starting this therapy in hospitals is one of the best ways to make sure this is done on an outpatient basis.
Arun B. Jesudian, MD: Steve, how effective [are] lactulose and rifaximin to prevent these episodes, prevent readmissions?
Steven L. Flamm, MD: Another good question, Arun. You know this study, this pivotal study that was published in the New England Journal of Medicine in March 2010, was a very well done study, that's why it was published in the New England Journal of Medicine. And the first, the primary endpoint, in metric terms, was the recurrence of hepatic encephalopathy in these high-risk patients. Again, 90% of patients, lactulose and rifaximin, are compared to lactulose and placebo. The remaining 10% were rifaximin compared to placebo because they did not take lactulose.
And in this 6-month period, reducing the recurrence of encephalopathy in the rifaximin group, compared with [with] placebo, was 58%, and it was highly statistically significant. This is a fairly remarkable reduction in a relatively short time for a very bad thing, keeping in mind that the rifaximin really did not have any difference anymore [adverse]-effect-wise compared [with] placebo. It was therefore the main measure of result.
Now, the secondary endpoint, there were many, but the most important one I would submit was encephalopathy-related hospitalizations, not just encephalopathy, which was the primary endpoint. And the reduction of hospitalizations [for] encephalopathy was 50%. Again, highly statistically significant. Again, a remarkable result with rifaximin for prophylaxis in a high risk group. And as a result, this was adopted by the guidelines, which I mentioned earlier were published at the end of 2014 and really [are] now the standard of care around the world. In patients with encephalopathy, they should be kept on rifaximine, usually with lactulose, as most patients treated in this way have been treated this way, to prevent recurrence. Is it perfect? No, there were patients [who] always had recurrence and were still hospitalized. But there was a marked reduction, and that should be the norm.
And I want to mention one last thing. It does not happen often – I should not say much. That does not happen enough in the United States. Some data suggest that patients who should take rifaximin prophylaxis are not, for one reason or another. And we, in the health care field, who care for these patients – hospitalists, primary care physicians, gastroenterologists – need to optimize this care, treat these types of patients appropriately with standard care, and that would include rifaximin. Thoughts, Elliot?
Elliot B. Tapper, MD: Yeah. I totally agree with that. You know, after this pivotal randomized trial, there were two observational studies. One of my center as a result of our protocol, and another from England, which was a multicentre study before and after [that] used the rifaximin. And in both of these studies, you see an adjusted 40% reduction in the readmission rate.
You know, readmissions are one of the worst things that can happen to a patient and a hospital. But cirrhosis is almost unique in that there is a pill to reduce the risk of readmission. And that does not mean that everyone should be on rifaximin, right? But that means that people at risk of readmission must follow the optimal treatment for hepatic encephalopathy, which includes, in my opinion, education, proper dosage of their lactulose and rifaximin co-therapy.
David M. Salerno, PharmD: Another point I would like to add is something we did in New York, trying to increase the amount of medication that goes to the bedside before it goes out. Because, as you previously said, Elliot, it is very important to talk about care transitions to prevent these patients from returning to the hospital. So, if we could give the patient not only the education, but all the tools and everything he will need to stay home to prevent his readmission, such as bringing the medications to bed, showing the caregivers how to use [them], giving them a list of medications, getting [all of those prior authorizations and] s & # 39; ensure [those] things are settled before the patient leaves the hospital is one of the important points to ensure that rifaximin can do its job.
Arun B. Jesudian, MD: Absolutely. The secondary prophylaxis of these episodes is therefore of paramount importance. So, follow the right treatment and make sure the patient actually has the medicine and knows how to take it correctly.
Recommendations to providers on taking into account risks for patients with hepatic encephalopathy in the prevention of relapses and rehospitalization.
Arun B. Jesudian, MD: Elliot, I know you've been working on defining protocols for hospitalization of patients with cirrhosis. And how do you and your team [at the] Michigan [Medicine Hepatology Clinic] take care of patients with hepatic encephalopathy and what recommendations could you have for providers who are not in a transplant center and do not have hepatologists [or] specialized care?
Elliot B. Tapper, MD: Yeah, I think the bottom line is that if you use a well-oiled machine, like Northwestern [Memorial] At the hospital, when you enter, you will have this four-pronged approach, and patients will very often have a chance of being served very well. And the typical experience that we see is that a person with pure hepatic encephalopathy has to wake up very quickly. So … a few years ago, I noticed that some nurses were independently asking for additional doses of lactulose in case of declared encephalopathy, and that their patients would wake up and go home sooner.
Anecdotally, we decided to protocol the treatment of hepatic encephalopathy. And what does it do, it helps you in a context [in which] you can not have a hepatologist on the staff, or the staff of the house [members] alternates and often resembles those modeled notes about what to do in a given situation. So we gave a lot of lactulose in advance, and we started the rifaximin early, not because we were expecting it [affect] changes to the hospital. But we [did] for 2 reasons. One is that often the pre-approval work has to be done before the patient leaves. And second, the episode of care for manifest hepatic encephalopathy does not end at the time of discharge. Because these patients have a risk of readmission that may exceed 30% [or] 40%. And you must do everything possible to take the data that Flamm and his colleagues have provided to reduce the risk of a new episode. And starting this therapy in hospitals is one of the best ways to make sure this is done on an outpatient basis.
Arun B. Jesudian, MD: Steve, how effective [are] lactulose and rifaximin to prevent these episodes, prevent readmissions?
Steven L. Flamm, MD: Another good question, Arun. You know this study, this pivotal study that was published in the New England Journal of Medicine in March 2010, was a very well done study, that's why it was published in the New England Journal of Medicine. And the first, the primary endpoint, in metric terms, was the recurrence of hepatic encephalopathy in these high-risk patients. Again, 90% of patients, lactulose and rifaximin, are compared to lactulose and placebo. The remaining 10% were rifaximin compared to placebo because they did not take lactulose.
And in this 6-month period, reducing the recurrence of encephalopathy in the rifaximin group, compared with [with] placebo, was 58%, and it was highly statistically significant. This is a fairly remarkable reduction in a relatively short time for a very bad thing, keeping in mind that the rifaximin really did not have any difference anymore [adverse]-effect-wise compared [with] placebo. It was therefore the main measure of result.
Now, the secondary endpoint, there were many, but the most important one I would submit was encephalopathy-related hospitalizations, not just encephalopathy, which was the primary endpoint. And the reduction of hospitalizations [for] encephalopathy was 50%. Again, highly statistically significant. Again, a remarkable result with rifaximin for prophylaxis in a high risk group. And as a result, this was adopted by the guidelines, which I mentioned earlier were published at the end of 2014 and really [are] now the standard of care around the world. In patients with encephalopathy, they should be kept on rifaximine, usually with lactulose, as most patients treated in this way have been treated this way, to prevent recurrence. Is it perfect? No, there were patients [who] always had recurrence and were still hospitalized. But there was a marked reduction, and that should be the norm.
And I want to mention one last thing. It does not happen often – I should not say much. That does not happen enough in the United States. Some data suggest that patients who should take rifaximin prophylaxis are not, for one reason or another. And we, in the health care field, who care for these patients – hospitalists, primary care physicians, gastroenterologists – need to optimize this care, treat these types of patients appropriately with standard care, and that would include rifaximin. Thoughts, Elliot?
Elliot B. Tapper, MD: Yeah. I totally agree with that. You know, after this pivotal randomized trial, there were two observational studies. One of my center as a result of our protocol, and another from England, which was a multicentre study before and after [that] used the rifaximin. And in both of these studies, you see an adjusted 40% reduction in the readmission rate.
You know, readmissions are one of the worst things that can happen to a patient and a hospital. But cirrhosis is almost unique in that there is a pill to reduce the risk of readmission. And that does not mean that everyone should be on rifaximin, right? But that means that people at risk of readmission must follow the optimal treatment for hepatic encephalopathy, which includes, in my opinion, education, proper dosage of their lactulose and rifaximin co-therapy.
David M. Salerno, PharmD: Another point I would like to add is something we did in New York, trying to increase the amount of medication that goes to the bedside before it goes out. Because, as you previously said, Elliot, it is very important to talk about care transitions to prevent these patients from returning to the hospital. So, if we could give the patient not only the education, but all the tools and everything he will need to stay home to prevent his readmission, such as bringing the medications to bed, showing the caregivers how to use [them], giving them a list of medications, getting [all of those prior authorizations and] s & # 39; ensure [those] things are settled before the patient leaves the hospital is one of the important points to ensure that rifaximin can do its job.
Arun B. Jesudian, MD: Absolutely. The secondary prophylaxis of these episodes is therefore of paramount importance. So, follow the right treatment and make sure the patient actually has the medicine and knows how to take it correctly.
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