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Should patients stand for office BP readings?
a new study suggests.
Combining three standing and three seated BP measurements in the same visit may lead to a “quicker diagnosis and save people a trip back to the office,” Wanpen Vongpatanasin, MD, professor of internal medicine and director of the hypertension section, cardiology division, UT Southwestern Medical Center, Dallas, said in an interview.
The study was presented at the Hypertension Scientific Sessions, sponsored by the American Heart Association.
Practice changing?
Clinical guidelines recommend office BP be taken in a seated position for most patients.
However, research has suggested that the sensitivity of seated office BP in diagnosing hypertension is about 50%, with high specificity around 90% during a single visit, Dr. Vongpatanasin explained.
At the follow-up visit, however, the second office BP yielded higher sensitivity to 80% but specificity fell to 55%. Nevertheless, the accuracy of standing BP measurements for diagnosing hypertension has not been investigated.
In a cross-sectional study, Dr. Vongpatanasin and colleagues determined the accuracy of both seated and standing BP for diagnosing hypertension in a single visit in 125 healthy adults who had not had a previous diagnosis of hypertension and were not taking any BP medications. The cohort had a mean age of 49 years, 62% were women, and 24% were Black.
During each office visit, seated BP was measured three times, then standing BP was measured three times using an automated and validated device.
Average seated BP was 123/76 mm Hg and average standing BP was 126/80 mm Hg.
Of the 125 participants, 42 (34%) had hypertension, defined as 24-hour ambulatory systolic/diastolic BP (SBP/DBP) of ≥ 125/75 mm Hg.
The sensitivity and specificity of seated SBP for hypertension was 43% and 92%, respectively.
“Interestingly, with standing SBP, sensitivity was improved to 74% and specificity dropped to 65% – which is okay; you will have to confirm a positive test anyway and when screening for a common disease you’d rather have a high sensitivity rather than low sensitivity to pick it up in this case,” Dr. Vongpatanasin said.
The area under receiver operating characteristic curve (AUROC) of standing SBP was significantly higher than seated SBP (Bayes factor [BF] = 11.8) when hypertension was defined as 24-hour SBP ≥ 125 mm Hg.
Similarly, when hypertension was defined as 24-hour DBP ≥ 75 mm Hg or daytime DBP ≥ 80 mm Hg, the AUROC of standing DBP was higher than seated DBP (all BF > 3).
The addition of standing to seated BP improved detection of hypertension compared with seated BP alone based on 24-hour SBP/DBP ≥ 125/75 mm Hg or daytime SBP/DBP ≥ 130/80 mm Hg (all BF > 3).
“In our hypertension clinic, we always measure both seated and standing BP in all of our patients,” John Giacona, PA-C, a PhD candidate at UT Southwestern Medical Center and coauthor of the study, told this news organization,
Multiple readings most important
Reached for comment, Johanna Contreras, MD, a cardiologist at Mount Sinai Hospital in New York, noted that diagnosing hypertension is “difficult” and she agrees that multiple readings are important.
“I usually take at least two readings in two different visits before I tell the patient they have high blood pressure,” Dr. Contreras said in an interview.
Dr. Contreras said she takes blood pressure both seated and standing.
“I’m not sure standing versus seated makes a big difference. However, when the patient first comes into the office, it is really important to let them rest and calm down before taking the blood pressure,” she said.
The study had no commercial funding. The authors and Dr. Contreras have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
a new study suggests.
Combining three standing and three seated BP measurements in the same visit may lead to a “quicker diagnosis and save people a trip back to the office,” Wanpen Vongpatanasin, MD, professor of internal medicine and director of the hypertension section, cardiology division, UT Southwestern Medical Center, Dallas, said in an interview.
The study was presented at the Hypertension Scientific Sessions, sponsored by the American Heart Association.
Practice changing?
Clinical guidelines recommend office BP be taken in a seated position for most patients.
However, research has suggested that the sensitivity of seated office BP in diagnosing hypertension is about 50%, with high specificity around 90% during a single visit, Dr. Vongpatanasin explained.
At the follow-up visit, however, the second office BP yielded higher sensitivity to 80% but specificity fell to 55%. Nevertheless, the accuracy of standing BP measurements for diagnosing hypertension has not been investigated.
In a cross-sectional study, Dr. Vongpatanasin and colleagues determined the accuracy of both seated and standing BP for diagnosing hypertension in a single visit in 125 healthy adults who had not had a previous diagnosis of hypertension and were not taking any BP medications. The cohort had a mean age of 49 years, 62% were women, and 24% were Black.
During each office visit, seated BP was measured three times, then standing BP was measured three times using an automated and validated device.
Average seated BP was 123/76 mm Hg and average standing BP was 126/80 mm Hg.
Of the 125 participants, 42 (34%) had hypertension, defined as 24-hour ambulatory systolic/diastolic BP (SBP/DBP) of ≥ 125/75 mm Hg.
The sensitivity and specificity of seated SBP for hypertension was 43% and 92%, respectively.
“Interestingly, with standing SBP, sensitivity was improved to 74% and specificity dropped to 65% – which is okay; you will have to confirm a positive test anyway and when screening for a common disease you’d rather have a high sensitivity rather than low sensitivity to pick it up in this case,” Dr. Vongpatanasin said.
The area under receiver operating characteristic curve (AUROC) of standing SBP was significantly higher than seated SBP (Bayes factor [BF] = 11.8) when hypertension was defined as 24-hour SBP ≥ 125 mm Hg.
Similarly, when hypertension was defined as 24-hour DBP ≥ 75 mm Hg or daytime DBP ≥ 80 mm Hg, the AUROC of standing DBP was higher than seated DBP (all BF > 3).
The addition of standing to seated BP improved detection of hypertension compared with seated BP alone based on 24-hour SBP/DBP ≥ 125/75 mm Hg or daytime SBP/DBP ≥ 130/80 mm Hg (all BF > 3).
“In our hypertension clinic, we always measure both seated and standing BP in all of our patients,” John Giacona, PA-C, a PhD candidate at UT Southwestern Medical Center and coauthor of the study, told this news organization,
Multiple readings most important
Reached for comment, Johanna Contreras, MD, a cardiologist at Mount Sinai Hospital in New York, noted that diagnosing hypertension is “difficult” and she agrees that multiple readings are important.
“I usually take at least two readings in two different visits before I tell the patient they have high blood pressure,” Dr. Contreras said in an interview.
Dr. Contreras said she takes blood pressure both seated and standing.
“I’m not sure standing versus seated makes a big difference. However, when the patient first comes into the office, it is really important to let them rest and calm down before taking the blood pressure,” she said.
The study had no commercial funding. The authors and Dr. Contreras have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
a new study suggests.
Combining three standing and three seated BP measurements in the same visit may lead to a “quicker diagnosis and save people a trip back to the office,” Wanpen Vongpatanasin, MD, professor of internal medicine and director of the hypertension section, cardiology division, UT Southwestern Medical Center, Dallas, said in an interview.
The study was presented at the Hypertension Scientific Sessions, sponsored by the American Heart Association.
Practice changing?
Clinical guidelines recommend office BP be taken in a seated position for most patients.
However, research has suggested that the sensitivity of seated office BP in diagnosing hypertension is about 50%, with high specificity around 90% during a single visit, Dr. Vongpatanasin explained.
At the follow-up visit, however, the second office BP yielded higher sensitivity to 80% but specificity fell to 55%. Nevertheless, the accuracy of standing BP measurements for diagnosing hypertension has not been investigated.
In a cross-sectional study, Dr. Vongpatanasin and colleagues determined the accuracy of both seated and standing BP for diagnosing hypertension in a single visit in 125 healthy adults who had not had a previous diagnosis of hypertension and were not taking any BP medications. The cohort had a mean age of 49 years, 62% were women, and 24% were Black.
During each office visit, seated BP was measured three times, then standing BP was measured three times using an automated and validated device.
Average seated BP was 123/76 mm Hg and average standing BP was 126/80 mm Hg.
Of the 125 participants, 42 (34%) had hypertension, defined as 24-hour ambulatory systolic/diastolic BP (SBP/DBP) of ≥ 125/75 mm Hg.
The sensitivity and specificity of seated SBP for hypertension was 43% and 92%, respectively.
“Interestingly, with standing SBP, sensitivity was improved to 74% and specificity dropped to 65% – which is okay; you will have to confirm a positive test anyway and when screening for a common disease you’d rather have a high sensitivity rather than low sensitivity to pick it up in this case,” Dr. Vongpatanasin said.
The area under receiver operating characteristic curve (AUROC) of standing SBP was significantly higher than seated SBP (Bayes factor [BF] = 11.8) when hypertension was defined as 24-hour SBP ≥ 125 mm Hg.
Similarly, when hypertension was defined as 24-hour DBP ≥ 75 mm Hg or daytime DBP ≥ 80 mm Hg, the AUROC of standing DBP was higher than seated DBP (all BF > 3).
The addition of standing to seated BP improved detection of hypertension compared with seated BP alone based on 24-hour SBP/DBP ≥ 125/75 mm Hg or daytime SBP/DBP ≥ 130/80 mm Hg (all BF > 3).
“In our hypertension clinic, we always measure both seated and standing BP in all of our patients,” John Giacona, PA-C, a PhD candidate at UT Southwestern Medical Center and coauthor of the study, told this news organization,
Multiple readings most important
Reached for comment, Johanna Contreras, MD, a cardiologist at Mount Sinai Hospital in New York, noted that diagnosing hypertension is “difficult” and she agrees that multiple readings are important.
“I usually take at least two readings in two different visits before I tell the patient they have high blood pressure,” Dr. Contreras said in an interview.
Dr. Contreras said she takes blood pressure both seated and standing.
“I’m not sure standing versus seated makes a big difference. However, when the patient first comes into the office, it is really important to let them rest and calm down before taking the blood pressure,” she said.
The study had no commercial funding. The authors and Dr. Contreras have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM HYPERTENSION 2022
Schizophrenia and postmodernism: A philosophical exercise in treatment
Schizophrenia is defined as having episodes of psychosis: periods of time when one suffers from delusions, hallucinations, disorganized behaviors, disorganized speech, and negative symptoms. The concept of schizophrenia can be simplified as a detachment from reality. Patients who struggle with this illness frame their perceptions with a different set of rules and beliefs than the rest of society. These altered perceptions frequently become the basis of delusions, one of the most recognized symptoms of schizophrenia.
A patient with schizophrenia doesn’t have delusions, as much as having a belief system, which is not recognized by any other. It is not the mismatch between “objective reality” and the held belief, which qualifies the belief as delusional, so much as the mismatch with the beliefs of those around you. Heliocentrism denial, denying the knowledge that the earth rotates around the sun, is incorrect because it is not factual. However, heliocentrism denial is not a delusion because it is incorrect, but because society chooses it to be incorrect.
We’d like to invite the reader to a thought experiment. “Objective reality” can be referred to as “anything that exists as it is independent of any conscious awareness of it.”1 “Consciousness awareness” entails an observer. If we remove the concept of consciousness or observer from existence, how would we then define “objective reality,” as the very definition of “objective reality” points to the existence of an observer. One deduces that there is no way to define “objective reality” without invoking the notion of an observer or of consciousness.
It is our contention that the concept of an “objective reality” is tautological – it answers itself. This philosophical quandary helps explain why a person with schizophrenia may feel alienated by others who do not appreciate their perceived “objective reality.”
Schizophrenia and ‘objective reality’
A patient with schizophrenia enters a psychiatrist’s office and may realize that their belief is not shared by others and society. The schizophrenic patient may understand the concept of delusions as fixed and false beliefs. However, to them, it is everyone else who is delusional. They may attempt to convince you, as their provider, to switch to their side. They may provide you with evidence for their belief system. One could argue that believing them, in response, would be curative. If not only one’s psychiatrist, but society accepted the schizophrenic patient’s belief system, it would no longer be delusional, whether real or not. Objective reality requires the presence of an object, an observer, to grant its value of truth.
In a simplistic way, those were the arguments of postmodernist philosophers. Reality is tainted by its observer, in a similar way that the Heisenberg uncertainty principle teaches that there is a limit to our simultaneous understanding of position and momentum of particles. This perspective may explain why Michel Foucault, PhD, the famous French postmodernist philosopher, was so interested in psychiatry and in particular schizophrenia. Dr. Foucault was deeply concerned with society imposing its beliefs and value system on patients, and positioning itself as the ultimate arbiter of reality. He went on to postulate that the bigger difference between schizophrenic patients and psychiatrists was not who was in the correct plane of reality but who was granted by society to arbitrate the answer. If reality is a subjective construct enforced by a ruling class, who has the power to rule becomes of the utmost importance.
Intersubjectivity theory in psychoanalysis has many of its sensibilities rooted in such thought. It argues against the myth of the isolated mind. Truth, in the context of psychoanalysis, is seen as an emergent product of dialogue between the therapist/patient dyad. It is in line with the ontological shift from a logical-positivist model to the more modern, constructivist framework. In terms of its view of psychosis, “delusional ideas were understood as a form of absolution – a radical decontextualization serving vital and restorative defensive functions.”2
It is an interesting proposition to advance this theory further in contending that it is not the independent consciousness of two entities that create the intersubjective space; but rather that it is the intersubjective space that literally creates the conscious entities. Could it not be said that the subjective relationship is more fundamental than consciousness itself? As Chris Jaenicke, Dipl.-Psych., wrote, “infant research has opened our eyes to the fact that there is no unilateral action.”3
Postmodernism and psychiatry
Postmodernism and its precursor skepticism have significant histories within the field of philosophy. This article will not summarize centuries of philosophical thought. In brief, skepticism is a powerful philosophical tool that can powerfully point out the limitations of human knowledge and certainty.
As a pedagogic jest to trainees, we will often point out that none of us “really knows” our date of birth with absolute certainty. None of us were conscious enough to remember our birth, conscious enough to understand the concept of date or time, and conscious enough to know who participated in it. At a fundamental level, we chose to believe our date of birth. Similarly, while the world could be a fictionalized simulation,4 we chose to believe that it is real because it behaves in a consistent way that permits scientific study. Postmodernism and skepticism are philosophical tools that permit one to question everything but are themselves limited by the real and empiric lives we live.
Psychiatrists are empiricists. We treat real people, who suffer in a very perceptible way, and live in a very tangible world. We frown on the postmodernist perspective and do not spend much or any time studying it as trainees. However, postmodernism, despite its philosophical and practical flaws, and adjacency to antipsychiatry,5 is an essential tool for the psychiatrist. In addition to the standard treatments for schizophrenia, the psychiatrist should attempt to create a bond with someone who is disconnected from the world. Postmodernism provides us with a way of doing so.
A psychiatrist who understands and appreciates postmodernism can show a patient why at some level we cannot refute all delusions. This psychiatrist can subsequently have empathy that some of the core beliefs of a patient may always be left unanswered. The psychiatrist can appreciate that to some degree the reason why the patient’s beliefs are not true is because society has chosen for them not to be true. Additionally, the psychiatrist can acknowledge to the patient that in some ways the correctness of a delusion is less relevant than the power of society to enforce its reality on the patient. This connection in itself is partially curative as it restores the patient’s attachment to society; we now have some plane of reality, the relationship, which is the same.
Psychiatry and philosophy
However, tempting it may be to be satisfied with this approach as an end in itself; this would be dangerous. While gratifying to the patient to be seen and heard, they will over time only become further entrenched in that compromise formation of delusional beliefs. The role of the psychiatrist, once deep and meaningful rapport has been established and solidified, is to point out to the patient the limitations of the delusions’ belief system.
“I empathize that not all your delusions can be disproved. An extension of that thought is that many beliefs can’t be disproved. Society chooses to believe that aliens do not live on earth but at the same time we can’t disprove with absolute certainty that they don’t. We live in a world where attachment to others enriches our lives. If you continue to believe that aliens affect all existence around you, you will disconnect yourself from all of us. I hope that our therapy has shown you the importance of human connection and the sacrifice of your belief system.”
In the modern day, psychiatry has chosen to believe that schizophrenia is a biological disorder that requires treatment with antipsychotics. We choose to believe that this is likely true, and we think that our empirical experience has been consistent with this belief. However, we also think that patients with this illness are salient beings that deserve to have their thoughts examined and addressed in a therapeutic framework that seeks to understand and acknowledge them as worthy and intelligent individuals. Philosophy provides psychiatry with tools on how to do so.
Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Khalafian practices full time as a general outpatient psychiatrist. He trained at the University of California, San Diego, for his psychiatric residency and currently works as a telepsychiatrist, serving an outpatient clinic population in northern California. Dr. Badre and Dr. Khalafian have no conflicts of interest.
References
1. https://iep.utm.edu/objectiv/.
2. Stolorow, RD. The phenomenology of trauma and the absolutisms of everyday life: A personal journey. Psychoanal Psychol. 1999;16(3):464-8. doi: 10.1037/0736-9735.16.3.464.
3. Jaenicke C. “The Risk of Relatedness: Intersubjectivity Theory in Clinical Practice” Lanham, Md.: Jason Aronson, 2007.
4. Cuthbertson A. “Elon Musk cites Pong as evidence that we are already living in a simulation” The Independent. 2021 Dec 1. https://www.independent.co.uk/space/elon-musk-simulation-pong-video-game-b1972369.html.
5. Foucault M (Howard R, translator). “Madness and Civilization: A History of Insanity in the Age of Reason” New York: Vintage, 1965.
Schizophrenia is defined as having episodes of psychosis: periods of time when one suffers from delusions, hallucinations, disorganized behaviors, disorganized speech, and negative symptoms. The concept of schizophrenia can be simplified as a detachment from reality. Patients who struggle with this illness frame their perceptions with a different set of rules and beliefs than the rest of society. These altered perceptions frequently become the basis of delusions, one of the most recognized symptoms of schizophrenia.
A patient with schizophrenia doesn’t have delusions, as much as having a belief system, which is not recognized by any other. It is not the mismatch between “objective reality” and the held belief, which qualifies the belief as delusional, so much as the mismatch with the beliefs of those around you. Heliocentrism denial, denying the knowledge that the earth rotates around the sun, is incorrect because it is not factual. However, heliocentrism denial is not a delusion because it is incorrect, but because society chooses it to be incorrect.
We’d like to invite the reader to a thought experiment. “Objective reality” can be referred to as “anything that exists as it is independent of any conscious awareness of it.”1 “Consciousness awareness” entails an observer. If we remove the concept of consciousness or observer from existence, how would we then define “objective reality,” as the very definition of “objective reality” points to the existence of an observer. One deduces that there is no way to define “objective reality” without invoking the notion of an observer or of consciousness.
It is our contention that the concept of an “objective reality” is tautological – it answers itself. This philosophical quandary helps explain why a person with schizophrenia may feel alienated by others who do not appreciate their perceived “objective reality.”
Schizophrenia and ‘objective reality’
A patient with schizophrenia enters a psychiatrist’s office and may realize that their belief is not shared by others and society. The schizophrenic patient may understand the concept of delusions as fixed and false beliefs. However, to them, it is everyone else who is delusional. They may attempt to convince you, as their provider, to switch to their side. They may provide you with evidence for their belief system. One could argue that believing them, in response, would be curative. If not only one’s psychiatrist, but society accepted the schizophrenic patient’s belief system, it would no longer be delusional, whether real or not. Objective reality requires the presence of an object, an observer, to grant its value of truth.
In a simplistic way, those were the arguments of postmodernist philosophers. Reality is tainted by its observer, in a similar way that the Heisenberg uncertainty principle teaches that there is a limit to our simultaneous understanding of position and momentum of particles. This perspective may explain why Michel Foucault, PhD, the famous French postmodernist philosopher, was so interested in psychiatry and in particular schizophrenia. Dr. Foucault was deeply concerned with society imposing its beliefs and value system on patients, and positioning itself as the ultimate arbiter of reality. He went on to postulate that the bigger difference between schizophrenic patients and psychiatrists was not who was in the correct plane of reality but who was granted by society to arbitrate the answer. If reality is a subjective construct enforced by a ruling class, who has the power to rule becomes of the utmost importance.
Intersubjectivity theory in psychoanalysis has many of its sensibilities rooted in such thought. It argues against the myth of the isolated mind. Truth, in the context of psychoanalysis, is seen as an emergent product of dialogue between the therapist/patient dyad. It is in line with the ontological shift from a logical-positivist model to the more modern, constructivist framework. In terms of its view of psychosis, “delusional ideas were understood as a form of absolution – a radical decontextualization serving vital and restorative defensive functions.”2
It is an interesting proposition to advance this theory further in contending that it is not the independent consciousness of two entities that create the intersubjective space; but rather that it is the intersubjective space that literally creates the conscious entities. Could it not be said that the subjective relationship is more fundamental than consciousness itself? As Chris Jaenicke, Dipl.-Psych., wrote, “infant research has opened our eyes to the fact that there is no unilateral action.”3
Postmodernism and psychiatry
Postmodernism and its precursor skepticism have significant histories within the field of philosophy. This article will not summarize centuries of philosophical thought. In brief, skepticism is a powerful philosophical tool that can powerfully point out the limitations of human knowledge and certainty.
As a pedagogic jest to trainees, we will often point out that none of us “really knows” our date of birth with absolute certainty. None of us were conscious enough to remember our birth, conscious enough to understand the concept of date or time, and conscious enough to know who participated in it. At a fundamental level, we chose to believe our date of birth. Similarly, while the world could be a fictionalized simulation,4 we chose to believe that it is real because it behaves in a consistent way that permits scientific study. Postmodernism and skepticism are philosophical tools that permit one to question everything but are themselves limited by the real and empiric lives we live.
Psychiatrists are empiricists. We treat real people, who suffer in a very perceptible way, and live in a very tangible world. We frown on the postmodernist perspective and do not spend much or any time studying it as trainees. However, postmodernism, despite its philosophical and practical flaws, and adjacency to antipsychiatry,5 is an essential tool for the psychiatrist. In addition to the standard treatments for schizophrenia, the psychiatrist should attempt to create a bond with someone who is disconnected from the world. Postmodernism provides us with a way of doing so.
A psychiatrist who understands and appreciates postmodernism can show a patient why at some level we cannot refute all delusions. This psychiatrist can subsequently have empathy that some of the core beliefs of a patient may always be left unanswered. The psychiatrist can appreciate that to some degree the reason why the patient’s beliefs are not true is because society has chosen for them not to be true. Additionally, the psychiatrist can acknowledge to the patient that in some ways the correctness of a delusion is less relevant than the power of society to enforce its reality on the patient. This connection in itself is partially curative as it restores the patient’s attachment to society; we now have some plane of reality, the relationship, which is the same.
Psychiatry and philosophy
However, tempting it may be to be satisfied with this approach as an end in itself; this would be dangerous. While gratifying to the patient to be seen and heard, they will over time only become further entrenched in that compromise formation of delusional beliefs. The role of the psychiatrist, once deep and meaningful rapport has been established and solidified, is to point out to the patient the limitations of the delusions’ belief system.
“I empathize that not all your delusions can be disproved. An extension of that thought is that many beliefs can’t be disproved. Society chooses to believe that aliens do not live on earth but at the same time we can’t disprove with absolute certainty that they don’t. We live in a world where attachment to others enriches our lives. If you continue to believe that aliens affect all existence around you, you will disconnect yourself from all of us. I hope that our therapy has shown you the importance of human connection and the sacrifice of your belief system.”
In the modern day, psychiatry has chosen to believe that schizophrenia is a biological disorder that requires treatment with antipsychotics. We choose to believe that this is likely true, and we think that our empirical experience has been consistent with this belief. However, we also think that patients with this illness are salient beings that deserve to have their thoughts examined and addressed in a therapeutic framework that seeks to understand and acknowledge them as worthy and intelligent individuals. Philosophy provides psychiatry with tools on how to do so.
Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Khalafian practices full time as a general outpatient psychiatrist. He trained at the University of California, San Diego, for his psychiatric residency and currently works as a telepsychiatrist, serving an outpatient clinic population in northern California. Dr. Badre and Dr. Khalafian have no conflicts of interest.
References
1. https://iep.utm.edu/objectiv/.
2. Stolorow, RD. The phenomenology of trauma and the absolutisms of everyday life: A personal journey. Psychoanal Psychol. 1999;16(3):464-8. doi: 10.1037/0736-9735.16.3.464.
3. Jaenicke C. “The Risk of Relatedness: Intersubjectivity Theory in Clinical Practice” Lanham, Md.: Jason Aronson, 2007.
4. Cuthbertson A. “Elon Musk cites Pong as evidence that we are already living in a simulation” The Independent. 2021 Dec 1. https://www.independent.co.uk/space/elon-musk-simulation-pong-video-game-b1972369.html.
5. Foucault M (Howard R, translator). “Madness and Civilization: A History of Insanity in the Age of Reason” New York: Vintage, 1965.
Schizophrenia is defined as having episodes of psychosis: periods of time when one suffers from delusions, hallucinations, disorganized behaviors, disorganized speech, and negative symptoms. The concept of schizophrenia can be simplified as a detachment from reality. Patients who struggle with this illness frame their perceptions with a different set of rules and beliefs than the rest of society. These altered perceptions frequently become the basis of delusions, one of the most recognized symptoms of schizophrenia.
A patient with schizophrenia doesn’t have delusions, as much as having a belief system, which is not recognized by any other. It is not the mismatch between “objective reality” and the held belief, which qualifies the belief as delusional, so much as the mismatch with the beliefs of those around you. Heliocentrism denial, denying the knowledge that the earth rotates around the sun, is incorrect because it is not factual. However, heliocentrism denial is not a delusion because it is incorrect, but because society chooses it to be incorrect.
We’d like to invite the reader to a thought experiment. “Objective reality” can be referred to as “anything that exists as it is independent of any conscious awareness of it.”1 “Consciousness awareness” entails an observer. If we remove the concept of consciousness or observer from existence, how would we then define “objective reality,” as the very definition of “objective reality” points to the existence of an observer. One deduces that there is no way to define “objective reality” without invoking the notion of an observer or of consciousness.
It is our contention that the concept of an “objective reality” is tautological – it answers itself. This philosophical quandary helps explain why a person with schizophrenia may feel alienated by others who do not appreciate their perceived “objective reality.”
Schizophrenia and ‘objective reality’
A patient with schizophrenia enters a psychiatrist’s office and may realize that their belief is not shared by others and society. The schizophrenic patient may understand the concept of delusions as fixed and false beliefs. However, to them, it is everyone else who is delusional. They may attempt to convince you, as their provider, to switch to their side. They may provide you with evidence for their belief system. One could argue that believing them, in response, would be curative. If not only one’s psychiatrist, but society accepted the schizophrenic patient’s belief system, it would no longer be delusional, whether real or not. Objective reality requires the presence of an object, an observer, to grant its value of truth.
In a simplistic way, those were the arguments of postmodernist philosophers. Reality is tainted by its observer, in a similar way that the Heisenberg uncertainty principle teaches that there is a limit to our simultaneous understanding of position and momentum of particles. This perspective may explain why Michel Foucault, PhD, the famous French postmodernist philosopher, was so interested in psychiatry and in particular schizophrenia. Dr. Foucault was deeply concerned with society imposing its beliefs and value system on patients, and positioning itself as the ultimate arbiter of reality. He went on to postulate that the bigger difference between schizophrenic patients and psychiatrists was not who was in the correct plane of reality but who was granted by society to arbitrate the answer. If reality is a subjective construct enforced by a ruling class, who has the power to rule becomes of the utmost importance.
Intersubjectivity theory in psychoanalysis has many of its sensibilities rooted in such thought. It argues against the myth of the isolated mind. Truth, in the context of psychoanalysis, is seen as an emergent product of dialogue between the therapist/patient dyad. It is in line with the ontological shift from a logical-positivist model to the more modern, constructivist framework. In terms of its view of psychosis, “delusional ideas were understood as a form of absolution – a radical decontextualization serving vital and restorative defensive functions.”2
It is an interesting proposition to advance this theory further in contending that it is not the independent consciousness of two entities that create the intersubjective space; but rather that it is the intersubjective space that literally creates the conscious entities. Could it not be said that the subjective relationship is more fundamental than consciousness itself? As Chris Jaenicke, Dipl.-Psych., wrote, “infant research has opened our eyes to the fact that there is no unilateral action.”3
Postmodernism and psychiatry
Postmodernism and its precursor skepticism have significant histories within the field of philosophy. This article will not summarize centuries of philosophical thought. In brief, skepticism is a powerful philosophical tool that can powerfully point out the limitations of human knowledge and certainty.
As a pedagogic jest to trainees, we will often point out that none of us “really knows” our date of birth with absolute certainty. None of us were conscious enough to remember our birth, conscious enough to understand the concept of date or time, and conscious enough to know who participated in it. At a fundamental level, we chose to believe our date of birth. Similarly, while the world could be a fictionalized simulation,4 we chose to believe that it is real because it behaves in a consistent way that permits scientific study. Postmodernism and skepticism are philosophical tools that permit one to question everything but are themselves limited by the real and empiric lives we live.
Psychiatrists are empiricists. We treat real people, who suffer in a very perceptible way, and live in a very tangible world. We frown on the postmodernist perspective and do not spend much or any time studying it as trainees. However, postmodernism, despite its philosophical and practical flaws, and adjacency to antipsychiatry,5 is an essential tool for the psychiatrist. In addition to the standard treatments for schizophrenia, the psychiatrist should attempt to create a bond with someone who is disconnected from the world. Postmodernism provides us with a way of doing so.
A psychiatrist who understands and appreciates postmodernism can show a patient why at some level we cannot refute all delusions. This psychiatrist can subsequently have empathy that some of the core beliefs of a patient may always be left unanswered. The psychiatrist can appreciate that to some degree the reason why the patient’s beliefs are not true is because society has chosen for them not to be true. Additionally, the psychiatrist can acknowledge to the patient that in some ways the correctness of a delusion is less relevant than the power of society to enforce its reality on the patient. This connection in itself is partially curative as it restores the patient’s attachment to society; we now have some plane of reality, the relationship, which is the same.
Psychiatry and philosophy
However, tempting it may be to be satisfied with this approach as an end in itself; this would be dangerous. While gratifying to the patient to be seen and heard, they will over time only become further entrenched in that compromise formation of delusional beliefs. The role of the psychiatrist, once deep and meaningful rapport has been established and solidified, is to point out to the patient the limitations of the delusions’ belief system.
“I empathize that not all your delusions can be disproved. An extension of that thought is that many beliefs can’t be disproved. Society chooses to believe that aliens do not live on earth but at the same time we can’t disprove with absolute certainty that they don’t. We live in a world where attachment to others enriches our lives. If you continue to believe that aliens affect all existence around you, you will disconnect yourself from all of us. I hope that our therapy has shown you the importance of human connection and the sacrifice of your belief system.”
In the modern day, psychiatry has chosen to believe that schizophrenia is a biological disorder that requires treatment with antipsychotics. We choose to believe that this is likely true, and we think that our empirical experience has been consistent with this belief. However, we also think that patients with this illness are salient beings that deserve to have their thoughts examined and addressed in a therapeutic framework that seeks to understand and acknowledge them as worthy and intelligent individuals. Philosophy provides psychiatry with tools on how to do so.
Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Khalafian practices full time as a general outpatient psychiatrist. He trained at the University of California, San Diego, for his psychiatric residency and currently works as a telepsychiatrist, serving an outpatient clinic population in northern California. Dr. Badre and Dr. Khalafian have no conflicts of interest.
References
1. https://iep.utm.edu/objectiv/.
2. Stolorow, RD. The phenomenology of trauma and the absolutisms of everyday life: A personal journey. Psychoanal Psychol. 1999;16(3):464-8. doi: 10.1037/0736-9735.16.3.464.
3. Jaenicke C. “The Risk of Relatedness: Intersubjectivity Theory in Clinical Practice” Lanham, Md.: Jason Aronson, 2007.
4. Cuthbertson A. “Elon Musk cites Pong as evidence that we are already living in a simulation” The Independent. 2021 Dec 1. https://www.independent.co.uk/space/elon-musk-simulation-pong-video-game-b1972369.html.
5. Foucault M (Howard R, translator). “Madness and Civilization: A History of Insanity in the Age of Reason” New York: Vintage, 1965.
Hidradenitis Suppurativa Overview
Opioids after lung cancer surgery may up all-cause mortality risk
Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.
“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.
“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.
Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.
The study was published online in Regional Anesthesia and Pain.
The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.
In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.
This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.
The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).
Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.
The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).
There was a big difference in the results for all-cause mortality.
Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.
A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.
In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.
In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.
“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.
“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.
Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.
The study was published online in Regional Anesthesia and Pain.
The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.
In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.
This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.
The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).
Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.
The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).
There was a big difference in the results for all-cause mortality.
Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.
A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.
In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.
In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.
“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.
“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.
Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.
The study was published online in Regional Anesthesia and Pain.
The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.
In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.
This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.
The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).
Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.
The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).
There was a big difference in the results for all-cause mortality.
Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.
A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.
In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.
In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM REGIONAL ANESTHESIA AND PAIN
Hidradenitis suppurativa
THE COMPARISON
Severe longstanding hidradenitis suppurativa (Hurley stage III) with architectural changes, ropy scarring, granulation tissue, and purulent discharge in the axilla of
A A 35-year-old Black man.
B A 42-year-old Hispanic woman with a light skin tone.
Hidradenitis suppurativa (HS) is a chronic inflammatory condition of the follicular epithelium that most commonly is found in the axillae and buttocks, as well as the inguinal, perianal, and submammary areas. It is characterized by firm and tender chronic nodules, abscesses complicated by sinus tracts, fistulae, and scarring thought to be related to follicular occlusion. Double-open comedones also may be seen.
The Hurley staging system is widely used to characterize the extent of disease in patients with HS:
- Stage I (mild): nodule(s) and abscess(es) without sinus tracts (tunnels) or scarring;
- Stage II (moderate): recurrent nodule(s) and abscess(es) with a limited number of sinus tracts and/or scarring; and
- Stage III (severe): multiple or extensive sinus tracts, abscesses, and/or scarring across the entire area.
Epidemiology
HS is most common in adults and African American patients. It has a prevalence of 1.3% in African Americans.1 When it occurs in children, it generally develops after the onset of puberty. The incidence is higher in females as well as individuals with a history of smoking and obesity (a higher body mass index).2-5
Key clinical features in people with darker skin tones
The erythema associated with HS may be difficult to see in darker skin tones, but violaceous, dark brown, and gray lesions may be present. When active HS lesions subside, intense hyperpigmentation may be left behind, and in some skin tones a pink or violaceous lesion may be apparent.
Worth noting
HS is disfiguring and has a negative impact on quality of life, including social relationships. Mental health support and screening tools are useful. Pain also is a common concern and may warrant referral to a pain specialist.6 In early disease, HS lesions can be misdiagnosed as an infection that recurs in the same location.
Treatments for HS include oral antibiotics (ie, tetracyclines, rifampin, clindamycin), topical antibiotics, immunosuppressing biologics, metformin, and spironolactone.7 Surgical interventions may be considered earlier in HS management and vary based on the location and severity of the lesions.8
Patients with HS are at risk for developing squamous cell carcinoma in scars, even many years later9; therefore, patients should perform skin checks and be referred to a dermatologist. Squamous cell carcinoma is most commonly found on the buttocks of men with HS and has a poor prognosis.
Health disparity highlight
Although those of African American and African descent have the highest rates of HS,1 the clinical trials for adalimumab (the only biologic approved for HS) enrolled a low number of Black patients.
Thirty HS comorbidities have been identified. Garg et al10 recommended that dermatologists perform examinations for comorbid conditions involving the skin and conduct a simple review of systems for extracutaneous comorbidities. Access to medical care is essential, and health care system barriers affect the ability of some patients to receive adequate continuity of care.
The diagnosis of HS often is delayed due to a lack of knowledge about the condition in the medical community at large and delayed presentation to a dermatologist.
1. Sachdeva M, Shah M, Alavi A. Race-specific prevalence of hidradenitis suppurativa. J Cutan Med Surg. 2021;25:177-187. doi:10.1177/1203475420972348
2. Zouboulis CC, Goyal M, Byrd AS. Hidradenitis suppurativa in skin of colour. Exp Dermatol. 2021;30(suppl 1):27-30. doi:10.1111 /exd.14341
3. Shalom G, Cohen AD. The epidemiology of hidradenitis suppurativa: what do we know? Br J Dermatol. 2019;180:712-713.
4. Theut Riis P, Pedersen OB, Sigsgaard V, et al. Prevalence of patients with self-reported hidradenitis suppurativa in a cohort of Danish blood donors: a cross-sectional study. Br J Dermatol. 2019;180:774-781.
5. Jemec GB, Kimball AB. Hidradenitis suppurativa: epidemiology and scope of the problem. J Am Acad Dermatol. 2015;73(5 suppl 1):S4-S7.
6. Savage KT, Singh V, Patel ZS, et al. Pain management in hidradenitis suppurativa and a proposed treatment algorithm. J Am Acad Dermatol. 2021;85:187-199. doi:10.1016/j.jaad.2020.09.039
7. Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations: part II: topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019;81:91-101.
8. Vellaichamy G, Braunberger TL, Nahhas AF, et al. Surgical procedures for hidradenitis suppurativa. Cutis. 2018;102:13-16.
9. Jung JM, Lee KH, Kim Y-J, et al. Assessment of overall and specific cancer risks in patients with hidradenitis suppurativa. JAMA Dermatol. 2020;156:844-853.
10. Garg A, Malviya N, Strunk A, et al. Comorbidity screening in hidradenitis suppurativa: evidence-based recommendations from the US and Canadian Hidradenitis Suppurativa Foundations. J Am Acad Dermatol. 2022;86:1092-1101. doi:10.1016/ j.jaad.2021.01.059
THE COMPARISON
Severe longstanding hidradenitis suppurativa (Hurley stage III) with architectural changes, ropy scarring, granulation tissue, and purulent discharge in the axilla of
A A 35-year-old Black man.
B A 42-year-old Hispanic woman with a light skin tone.
Hidradenitis suppurativa (HS) is a chronic inflammatory condition of the follicular epithelium that most commonly is found in the axillae and buttocks, as well as the inguinal, perianal, and submammary areas. It is characterized by firm and tender chronic nodules, abscesses complicated by sinus tracts, fistulae, and scarring thought to be related to follicular occlusion. Double-open comedones also may be seen.
The Hurley staging system is widely used to characterize the extent of disease in patients with HS:
- Stage I (mild): nodule(s) and abscess(es) without sinus tracts (tunnels) or scarring;
- Stage II (moderate): recurrent nodule(s) and abscess(es) with a limited number of sinus tracts and/or scarring; and
- Stage III (severe): multiple or extensive sinus tracts, abscesses, and/or scarring across the entire area.
Epidemiology
HS is most common in adults and African American patients. It has a prevalence of 1.3% in African Americans.1 When it occurs in children, it generally develops after the onset of puberty. The incidence is higher in females as well as individuals with a history of smoking and obesity (a higher body mass index).2-5
Key clinical features in people with darker skin tones
The erythema associated with HS may be difficult to see in darker skin tones, but violaceous, dark brown, and gray lesions may be present. When active HS lesions subside, intense hyperpigmentation may be left behind, and in some skin tones a pink or violaceous lesion may be apparent.
Worth noting
HS is disfiguring and has a negative impact on quality of life, including social relationships. Mental health support and screening tools are useful. Pain also is a common concern and may warrant referral to a pain specialist.6 In early disease, HS lesions can be misdiagnosed as an infection that recurs in the same location.
Treatments for HS include oral antibiotics (ie, tetracyclines, rifampin, clindamycin), topical antibiotics, immunosuppressing biologics, metformin, and spironolactone.7 Surgical interventions may be considered earlier in HS management and vary based on the location and severity of the lesions.8
Patients with HS are at risk for developing squamous cell carcinoma in scars, even many years later9; therefore, patients should perform skin checks and be referred to a dermatologist. Squamous cell carcinoma is most commonly found on the buttocks of men with HS and has a poor prognosis.
Health disparity highlight
Although those of African American and African descent have the highest rates of HS,1 the clinical trials for adalimumab (the only biologic approved for HS) enrolled a low number of Black patients.
Thirty HS comorbidities have been identified. Garg et al10 recommended that dermatologists perform examinations for comorbid conditions involving the skin and conduct a simple review of systems for extracutaneous comorbidities. Access to medical care is essential, and health care system barriers affect the ability of some patients to receive adequate continuity of care.
The diagnosis of HS often is delayed due to a lack of knowledge about the condition in the medical community at large and delayed presentation to a dermatologist.
THE COMPARISON
Severe longstanding hidradenitis suppurativa (Hurley stage III) with architectural changes, ropy scarring, granulation tissue, and purulent discharge in the axilla of
A A 35-year-old Black man.
B A 42-year-old Hispanic woman with a light skin tone.
Hidradenitis suppurativa (HS) is a chronic inflammatory condition of the follicular epithelium that most commonly is found in the axillae and buttocks, as well as the inguinal, perianal, and submammary areas. It is characterized by firm and tender chronic nodules, abscesses complicated by sinus tracts, fistulae, and scarring thought to be related to follicular occlusion. Double-open comedones also may be seen.
The Hurley staging system is widely used to characterize the extent of disease in patients with HS:
- Stage I (mild): nodule(s) and abscess(es) without sinus tracts (tunnels) or scarring;
- Stage II (moderate): recurrent nodule(s) and abscess(es) with a limited number of sinus tracts and/or scarring; and
- Stage III (severe): multiple or extensive sinus tracts, abscesses, and/or scarring across the entire area.
Epidemiology
HS is most common in adults and African American patients. It has a prevalence of 1.3% in African Americans.1 When it occurs in children, it generally develops after the onset of puberty. The incidence is higher in females as well as individuals with a history of smoking and obesity (a higher body mass index).2-5
Key clinical features in people with darker skin tones
The erythema associated with HS may be difficult to see in darker skin tones, but violaceous, dark brown, and gray lesions may be present. When active HS lesions subside, intense hyperpigmentation may be left behind, and in some skin tones a pink or violaceous lesion may be apparent.
Worth noting
HS is disfiguring and has a negative impact on quality of life, including social relationships. Mental health support and screening tools are useful. Pain also is a common concern and may warrant referral to a pain specialist.6 In early disease, HS lesions can be misdiagnosed as an infection that recurs in the same location.
Treatments for HS include oral antibiotics (ie, tetracyclines, rifampin, clindamycin), topical antibiotics, immunosuppressing biologics, metformin, and spironolactone.7 Surgical interventions may be considered earlier in HS management and vary based on the location and severity of the lesions.8
Patients with HS are at risk for developing squamous cell carcinoma in scars, even many years later9; therefore, patients should perform skin checks and be referred to a dermatologist. Squamous cell carcinoma is most commonly found on the buttocks of men with HS and has a poor prognosis.
Health disparity highlight
Although those of African American and African descent have the highest rates of HS,1 the clinical trials for adalimumab (the only biologic approved for HS) enrolled a low number of Black patients.
Thirty HS comorbidities have been identified. Garg et al10 recommended that dermatologists perform examinations for comorbid conditions involving the skin and conduct a simple review of systems for extracutaneous comorbidities. Access to medical care is essential, and health care system barriers affect the ability of some patients to receive adequate continuity of care.
The diagnosis of HS often is delayed due to a lack of knowledge about the condition in the medical community at large and delayed presentation to a dermatologist.
1. Sachdeva M, Shah M, Alavi A. Race-specific prevalence of hidradenitis suppurativa. J Cutan Med Surg. 2021;25:177-187. doi:10.1177/1203475420972348
2. Zouboulis CC, Goyal M, Byrd AS. Hidradenitis suppurativa in skin of colour. Exp Dermatol. 2021;30(suppl 1):27-30. doi:10.1111 /exd.14341
3. Shalom G, Cohen AD. The epidemiology of hidradenitis suppurativa: what do we know? Br J Dermatol. 2019;180:712-713.
4. Theut Riis P, Pedersen OB, Sigsgaard V, et al. Prevalence of patients with self-reported hidradenitis suppurativa in a cohort of Danish blood donors: a cross-sectional study. Br J Dermatol. 2019;180:774-781.
5. Jemec GB, Kimball AB. Hidradenitis suppurativa: epidemiology and scope of the problem. J Am Acad Dermatol. 2015;73(5 suppl 1):S4-S7.
6. Savage KT, Singh V, Patel ZS, et al. Pain management in hidradenitis suppurativa and a proposed treatment algorithm. J Am Acad Dermatol. 2021;85:187-199. doi:10.1016/j.jaad.2020.09.039
7. Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations: part II: topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019;81:91-101.
8. Vellaichamy G, Braunberger TL, Nahhas AF, et al. Surgical procedures for hidradenitis suppurativa. Cutis. 2018;102:13-16.
9. Jung JM, Lee KH, Kim Y-J, et al. Assessment of overall and specific cancer risks in patients with hidradenitis suppurativa. JAMA Dermatol. 2020;156:844-853.
10. Garg A, Malviya N, Strunk A, et al. Comorbidity screening in hidradenitis suppurativa: evidence-based recommendations from the US and Canadian Hidradenitis Suppurativa Foundations. J Am Acad Dermatol. 2022;86:1092-1101. doi:10.1016/ j.jaad.2021.01.059
1. Sachdeva M, Shah M, Alavi A. Race-specific prevalence of hidradenitis suppurativa. J Cutan Med Surg. 2021;25:177-187. doi:10.1177/1203475420972348
2. Zouboulis CC, Goyal M, Byrd AS. Hidradenitis suppurativa in skin of colour. Exp Dermatol. 2021;30(suppl 1):27-30. doi:10.1111 /exd.14341
3. Shalom G, Cohen AD. The epidemiology of hidradenitis suppurativa: what do we know? Br J Dermatol. 2019;180:712-713.
4. Theut Riis P, Pedersen OB, Sigsgaard V, et al. Prevalence of patients with self-reported hidradenitis suppurativa in a cohort of Danish blood donors: a cross-sectional study. Br J Dermatol. 2019;180:774-781.
5. Jemec GB, Kimball AB. Hidradenitis suppurativa: epidemiology and scope of the problem. J Am Acad Dermatol. 2015;73(5 suppl 1):S4-S7.
6. Savage KT, Singh V, Patel ZS, et al. Pain management in hidradenitis suppurativa and a proposed treatment algorithm. J Am Acad Dermatol. 2021;85:187-199. doi:10.1016/j.jaad.2020.09.039
7. Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations: part II: topical, intralesional, and systemic medical management. J Am Acad Dermatol. 2019;81:91-101.
8. Vellaichamy G, Braunberger TL, Nahhas AF, et al. Surgical procedures for hidradenitis suppurativa. Cutis. 2018;102:13-16.
9. Jung JM, Lee KH, Kim Y-J, et al. Assessment of overall and specific cancer risks in patients with hidradenitis suppurativa. JAMA Dermatol. 2020;156:844-853.
10. Garg A, Malviya N, Strunk A, et al. Comorbidity screening in hidradenitis suppurativa: evidence-based recommendations from the US and Canadian Hidradenitis Suppurativa Foundations. J Am Acad Dermatol. 2022;86:1092-1101. doi:10.1016/ j.jaad.2021.01.059
Extravascular ICD surpasses goals in pivotal trial
BARCELONA – A novel “extravascular” implantable cardioverter defibrillator (ICD) that uses substernally placed electrodes surpassed its prespecified efficacy and safety targets in the device’s pivotal trial with 299 patients who received an implant.
The results showed that the extravascular ICD “provides antitachycardia pacing and low energy defibrillation while avoiding the vascular space” for lead placement, Ian Crozier, MD, said at the annual congress of the European Society of Cardiology.
“The results are fantastic; they exceeded our expectations,” said Dr. Crozier in an interview, adding that he expects the new device to receive marketing approval from regulatory agencies based on the findings. “This will be the next generation of ICD going forward,” predicted Dr. Crozier, an electrophysiologist cardiologist at Christchurch (New Zealand) Hospital.
Moving beyond transvenous and subcutaneous ICDs
Traditional ICDs use transvenous leads, which can cause vascular injury, are prone to lead fracture over time, and can produce serious infections as well as other potential complications. The U.S. Food and Drug Administration first approved an alternative-design, subcutaneous ICD in 2012 that avoids the need for transvenous leads and the risks they pose. But subcutaneous ICDs have their own limitations: an inability to provide antitachycardia pacing or chronic pacing; a limited ability to provide bradycardia pacing; and an increased device size with shorter battery life, because of the high shock power needed for effective performance. These drawbacks have collectively hindered uptake, Dr. Crozier said.
This led to development of the extravascular ICD – 10 years in the making – which uses substernally placed leads that allow antitachycardia pacing and backup pacing in a device with the size of and the anticipated battery longevity of a transvenous ICD device, noted Dr. Crozier.
A 98.7% rate of arrhythmia termination at implant
The pivotal trial’s primary efficacy endpoint was successful defibrillation based on terminating an induced, sustained, shockable ventricular arrhythmia at the time of implantation. The rate was 98.7%, compared with a prespecified target of 88%. All patients had a class I or IIa indication for an ICD.
The primary safety endpoint was freedom from major system- or procedure-related complications at 6 months, which occurred at a rate of 92.6%, compared with the study’s prespecified target rate of 79%. Both targets were derived from the historical rates of ICDs with transvenous leads.
Simultaneously with Dr. Crozier’s report at the congress, the results also appeared online in the New England Journal of Medicine.
Although the pivotal study met both prespecified endpoints, the evidence has limitations that make it likely that regulatory bodies will seek additional data, commented Fred Kusumoto, MD, director of heart rhythm services for the Mayo Clinic in Jacksonville, Fla.
Short follow-up; questions remain
“Follow-up was relatively short, less than a year,” and “questions remain” about the extravascular ICD’s performance, Dr. Kusumoto said in an interview. “Inappropriate shocks occurred in nearly 10% of patients after 11 month follow-up,” he noted, and also cited the 29 patients who needed revisions including two cases with lead fractures.
“The extravascular lead strategy has an advantage over transvenous systems because of the lower risk for extraction or explant,” and it also provides the antitachycardia pacing that’s not available with subcutaneous ICDs, he granted. But in the new study, antitachycardia termination was delivered to only 10 patients and had “reasonable” effectiveness by resolving 70% of these episodes. “Wide adoption by clinicians will depend on results from larger studies with longer follow-up,” Dr. Kusumoto maintained. He also wanted to see confirmation of the ease of lead removal after longer periods of implantation.
Implantation ‘is not difficult’
The trial ran at 46 sites in 17 countries during September 2019 to October 2021. It enrolled patients with a class I or IIa indication for an ICD, excluding patients with a prior sternotomy or need for chronic pacing, and those unable to undergo defibrillation testing.
Clinicians attempted an implantation in 316 patients and had successful placement in 299 (314 had successful placement of their substernal leads), with 292 having a functional device after 6 months, and 284 completing their planned 6-month follow-up. The median procedure time was 66 minutes, including the time for defibrillation testing.
All of the cardiologists who did the implants had received a full day of training prior to performing the procedure. “This is not a difficult procedure, but it is not a region [the substernal space] that cardiologists are familiar working in,” noted Dr. Crozier, explaining the rationale behind a policy of required implantation training.
Twenty-five adverse events occurred in 23 patients. Eighteen of these events required a system revision, including nine lead dislodgments and five infections. The seven adverse events that did not require a revision included three wound-related episodes and three hospitalizations for inappropriate shock. No patients died, nor were there any cardiac injuries as result of the implant.
During average follow-up of 10.6 months, the implanted devices delivered antitachycardia pacing to 10 patients, successfully terminating 32 of 46 episodes (70%), a rate that Dr. Crozier called “very good, and very comparable to transvenous devices.” The devices also delivered 18 appropriate shocks that successfully converted all 18 episodes.
A 10% rate of inappropriate shocks
However, 29 patients (10% of the study cohort) received inappropriate shocks in 81 episodes, with a total of 118 inappropriate shocks delivered, including 34 episodes (42%) triggered by oversensing of a P wave.
“We fully acknowledge that the inappropriate shock rate is higher than what’s seen with transvenous ICDs, but the rate is comparable to what was seen in the early trials with subcutaneous ICDs,” said Dr. Crozier. “We have a number of strategies to reduce the inappropriate shock rate to what we’d expect with conventional devices,” such as making sure that P waves are not detected by the device at the time of implantation, using new algorithms to mitigate P wave sensing, and other programming changes, he added.
Two patients had lead fractures that Dr. Crozier attributed to atypical lead locations and that are likely avoidable in the future. He expressed optimism that the extravascular ICD will avoid the high lead fracture rate over time that remains a problem for ICDs with transvenous leads.
The study also followed a subgroup of 36 patients who underwent a prespecified protocol of chronic defibrillation testing that was successful in all 36.
Dr. Crozier conceded that the extravascular ICD cannot currently deliver chronic pacing, but he expressed optimism that this capability will be available in the future.
“This innovative [extravascular] ICD system would be particularly beneficial for patients with ventricular arrhythmias that can be reliably pace terminated and avoid a transvenous endocardial lead, but more information is required,” concluded Dr. Kusumoto.
The study was sponsored by Medtronic, the company that is developing the extravascular ICD. Dr. Crozier is a consultant to and has received research funding from Medtronic. Dr. Kusumoto had no disclosures.
BARCELONA – A novel “extravascular” implantable cardioverter defibrillator (ICD) that uses substernally placed electrodes surpassed its prespecified efficacy and safety targets in the device’s pivotal trial with 299 patients who received an implant.
The results showed that the extravascular ICD “provides antitachycardia pacing and low energy defibrillation while avoiding the vascular space” for lead placement, Ian Crozier, MD, said at the annual congress of the European Society of Cardiology.
“The results are fantastic; they exceeded our expectations,” said Dr. Crozier in an interview, adding that he expects the new device to receive marketing approval from regulatory agencies based on the findings. “This will be the next generation of ICD going forward,” predicted Dr. Crozier, an electrophysiologist cardiologist at Christchurch (New Zealand) Hospital.
Moving beyond transvenous and subcutaneous ICDs
Traditional ICDs use transvenous leads, which can cause vascular injury, are prone to lead fracture over time, and can produce serious infections as well as other potential complications. The U.S. Food and Drug Administration first approved an alternative-design, subcutaneous ICD in 2012 that avoids the need for transvenous leads and the risks they pose. But subcutaneous ICDs have their own limitations: an inability to provide antitachycardia pacing or chronic pacing; a limited ability to provide bradycardia pacing; and an increased device size with shorter battery life, because of the high shock power needed for effective performance. These drawbacks have collectively hindered uptake, Dr. Crozier said.
This led to development of the extravascular ICD – 10 years in the making – which uses substernally placed leads that allow antitachycardia pacing and backup pacing in a device with the size of and the anticipated battery longevity of a transvenous ICD device, noted Dr. Crozier.
A 98.7% rate of arrhythmia termination at implant
The pivotal trial’s primary efficacy endpoint was successful defibrillation based on terminating an induced, sustained, shockable ventricular arrhythmia at the time of implantation. The rate was 98.7%, compared with a prespecified target of 88%. All patients had a class I or IIa indication for an ICD.
The primary safety endpoint was freedom from major system- or procedure-related complications at 6 months, which occurred at a rate of 92.6%, compared with the study’s prespecified target rate of 79%. Both targets were derived from the historical rates of ICDs with transvenous leads.
Simultaneously with Dr. Crozier’s report at the congress, the results also appeared online in the New England Journal of Medicine.
Although the pivotal study met both prespecified endpoints, the evidence has limitations that make it likely that regulatory bodies will seek additional data, commented Fred Kusumoto, MD, director of heart rhythm services for the Mayo Clinic in Jacksonville, Fla.
Short follow-up; questions remain
“Follow-up was relatively short, less than a year,” and “questions remain” about the extravascular ICD’s performance, Dr. Kusumoto said in an interview. “Inappropriate shocks occurred in nearly 10% of patients after 11 month follow-up,” he noted, and also cited the 29 patients who needed revisions including two cases with lead fractures.
“The extravascular lead strategy has an advantage over transvenous systems because of the lower risk for extraction or explant,” and it also provides the antitachycardia pacing that’s not available with subcutaneous ICDs, he granted. But in the new study, antitachycardia termination was delivered to only 10 patients and had “reasonable” effectiveness by resolving 70% of these episodes. “Wide adoption by clinicians will depend on results from larger studies with longer follow-up,” Dr. Kusumoto maintained. He also wanted to see confirmation of the ease of lead removal after longer periods of implantation.
Implantation ‘is not difficult’
The trial ran at 46 sites in 17 countries during September 2019 to October 2021. It enrolled patients with a class I or IIa indication for an ICD, excluding patients with a prior sternotomy or need for chronic pacing, and those unable to undergo defibrillation testing.
Clinicians attempted an implantation in 316 patients and had successful placement in 299 (314 had successful placement of their substernal leads), with 292 having a functional device after 6 months, and 284 completing their planned 6-month follow-up. The median procedure time was 66 minutes, including the time for defibrillation testing.
All of the cardiologists who did the implants had received a full day of training prior to performing the procedure. “This is not a difficult procedure, but it is not a region [the substernal space] that cardiologists are familiar working in,” noted Dr. Crozier, explaining the rationale behind a policy of required implantation training.
Twenty-five adverse events occurred in 23 patients. Eighteen of these events required a system revision, including nine lead dislodgments and five infections. The seven adverse events that did not require a revision included three wound-related episodes and three hospitalizations for inappropriate shock. No patients died, nor were there any cardiac injuries as result of the implant.
During average follow-up of 10.6 months, the implanted devices delivered antitachycardia pacing to 10 patients, successfully terminating 32 of 46 episodes (70%), a rate that Dr. Crozier called “very good, and very comparable to transvenous devices.” The devices also delivered 18 appropriate shocks that successfully converted all 18 episodes.
A 10% rate of inappropriate shocks
However, 29 patients (10% of the study cohort) received inappropriate shocks in 81 episodes, with a total of 118 inappropriate shocks delivered, including 34 episodes (42%) triggered by oversensing of a P wave.
“We fully acknowledge that the inappropriate shock rate is higher than what’s seen with transvenous ICDs, but the rate is comparable to what was seen in the early trials with subcutaneous ICDs,” said Dr. Crozier. “We have a number of strategies to reduce the inappropriate shock rate to what we’d expect with conventional devices,” such as making sure that P waves are not detected by the device at the time of implantation, using new algorithms to mitigate P wave sensing, and other programming changes, he added.
Two patients had lead fractures that Dr. Crozier attributed to atypical lead locations and that are likely avoidable in the future. He expressed optimism that the extravascular ICD will avoid the high lead fracture rate over time that remains a problem for ICDs with transvenous leads.
The study also followed a subgroup of 36 patients who underwent a prespecified protocol of chronic defibrillation testing that was successful in all 36.
Dr. Crozier conceded that the extravascular ICD cannot currently deliver chronic pacing, but he expressed optimism that this capability will be available in the future.
“This innovative [extravascular] ICD system would be particularly beneficial for patients with ventricular arrhythmias that can be reliably pace terminated and avoid a transvenous endocardial lead, but more information is required,” concluded Dr. Kusumoto.
The study was sponsored by Medtronic, the company that is developing the extravascular ICD. Dr. Crozier is a consultant to and has received research funding from Medtronic. Dr. Kusumoto had no disclosures.
BARCELONA – A novel “extravascular” implantable cardioverter defibrillator (ICD) that uses substernally placed electrodes surpassed its prespecified efficacy and safety targets in the device’s pivotal trial with 299 patients who received an implant.
The results showed that the extravascular ICD “provides antitachycardia pacing and low energy defibrillation while avoiding the vascular space” for lead placement, Ian Crozier, MD, said at the annual congress of the European Society of Cardiology.
“The results are fantastic; they exceeded our expectations,” said Dr. Crozier in an interview, adding that he expects the new device to receive marketing approval from regulatory agencies based on the findings. “This will be the next generation of ICD going forward,” predicted Dr. Crozier, an electrophysiologist cardiologist at Christchurch (New Zealand) Hospital.
Moving beyond transvenous and subcutaneous ICDs
Traditional ICDs use transvenous leads, which can cause vascular injury, are prone to lead fracture over time, and can produce serious infections as well as other potential complications. The U.S. Food and Drug Administration first approved an alternative-design, subcutaneous ICD in 2012 that avoids the need for transvenous leads and the risks they pose. But subcutaneous ICDs have their own limitations: an inability to provide antitachycardia pacing or chronic pacing; a limited ability to provide bradycardia pacing; and an increased device size with shorter battery life, because of the high shock power needed for effective performance. These drawbacks have collectively hindered uptake, Dr. Crozier said.
This led to development of the extravascular ICD – 10 years in the making – which uses substernally placed leads that allow antitachycardia pacing and backup pacing in a device with the size of and the anticipated battery longevity of a transvenous ICD device, noted Dr. Crozier.
A 98.7% rate of arrhythmia termination at implant
The pivotal trial’s primary efficacy endpoint was successful defibrillation based on terminating an induced, sustained, shockable ventricular arrhythmia at the time of implantation. The rate was 98.7%, compared with a prespecified target of 88%. All patients had a class I or IIa indication for an ICD.
The primary safety endpoint was freedom from major system- or procedure-related complications at 6 months, which occurred at a rate of 92.6%, compared with the study’s prespecified target rate of 79%. Both targets were derived from the historical rates of ICDs with transvenous leads.
Simultaneously with Dr. Crozier’s report at the congress, the results also appeared online in the New England Journal of Medicine.
Although the pivotal study met both prespecified endpoints, the evidence has limitations that make it likely that regulatory bodies will seek additional data, commented Fred Kusumoto, MD, director of heart rhythm services for the Mayo Clinic in Jacksonville, Fla.
Short follow-up; questions remain
“Follow-up was relatively short, less than a year,” and “questions remain” about the extravascular ICD’s performance, Dr. Kusumoto said in an interview. “Inappropriate shocks occurred in nearly 10% of patients after 11 month follow-up,” he noted, and also cited the 29 patients who needed revisions including two cases with lead fractures.
“The extravascular lead strategy has an advantage over transvenous systems because of the lower risk for extraction or explant,” and it also provides the antitachycardia pacing that’s not available with subcutaneous ICDs, he granted. But in the new study, antitachycardia termination was delivered to only 10 patients and had “reasonable” effectiveness by resolving 70% of these episodes. “Wide adoption by clinicians will depend on results from larger studies with longer follow-up,” Dr. Kusumoto maintained. He also wanted to see confirmation of the ease of lead removal after longer periods of implantation.
Implantation ‘is not difficult’
The trial ran at 46 sites in 17 countries during September 2019 to October 2021. It enrolled patients with a class I or IIa indication for an ICD, excluding patients with a prior sternotomy or need for chronic pacing, and those unable to undergo defibrillation testing.
Clinicians attempted an implantation in 316 patients and had successful placement in 299 (314 had successful placement of their substernal leads), with 292 having a functional device after 6 months, and 284 completing their planned 6-month follow-up. The median procedure time was 66 minutes, including the time for defibrillation testing.
All of the cardiologists who did the implants had received a full day of training prior to performing the procedure. “This is not a difficult procedure, but it is not a region [the substernal space] that cardiologists are familiar working in,” noted Dr. Crozier, explaining the rationale behind a policy of required implantation training.
Twenty-five adverse events occurred in 23 patients. Eighteen of these events required a system revision, including nine lead dislodgments and five infections. The seven adverse events that did not require a revision included three wound-related episodes and three hospitalizations for inappropriate shock. No patients died, nor were there any cardiac injuries as result of the implant.
During average follow-up of 10.6 months, the implanted devices delivered antitachycardia pacing to 10 patients, successfully terminating 32 of 46 episodes (70%), a rate that Dr. Crozier called “very good, and very comparable to transvenous devices.” The devices also delivered 18 appropriate shocks that successfully converted all 18 episodes.
A 10% rate of inappropriate shocks
However, 29 patients (10% of the study cohort) received inappropriate shocks in 81 episodes, with a total of 118 inappropriate shocks delivered, including 34 episodes (42%) triggered by oversensing of a P wave.
“We fully acknowledge that the inappropriate shock rate is higher than what’s seen with transvenous ICDs, but the rate is comparable to what was seen in the early trials with subcutaneous ICDs,” said Dr. Crozier. “We have a number of strategies to reduce the inappropriate shock rate to what we’d expect with conventional devices,” such as making sure that P waves are not detected by the device at the time of implantation, using new algorithms to mitigate P wave sensing, and other programming changes, he added.
Two patients had lead fractures that Dr. Crozier attributed to atypical lead locations and that are likely avoidable in the future. He expressed optimism that the extravascular ICD will avoid the high lead fracture rate over time that remains a problem for ICDs with transvenous leads.
The study also followed a subgroup of 36 patients who underwent a prespecified protocol of chronic defibrillation testing that was successful in all 36.
Dr. Crozier conceded that the extravascular ICD cannot currently deliver chronic pacing, but he expressed optimism that this capability will be available in the future.
“This innovative [extravascular] ICD system would be particularly beneficial for patients with ventricular arrhythmias that can be reliably pace terminated and avoid a transvenous endocardial lead, but more information is required,” concluded Dr. Kusumoto.
The study was sponsored by Medtronic, the company that is developing the extravascular ICD. Dr. Crozier is a consultant to and has received research funding from Medtronic. Dr. Kusumoto had no disclosures.
AT ESC CONGRESS 2022
Hidradenitis Suppurativa Pathophysiology
Autoimmune diseases linked to spike in post-MI events
, in a large propensity-matched analysis.
At a median of 2 years after their MI, Medicare beneficiaries with an IMID had adjusted risks that were:
- 15% higher for all-cause death (hazard ratio, 1.15);
- 12% higher for heart failure (HR, 1.12);
- 8% higher for recurrent MI (HR, 1.08); and
- 6% higher risk for coronary reintervention (HR, 1.06; P < .05 for all).
In addition, interventions known to improve outcomes in this context, such as coronary revascularization, were less common in patients with IMID.
“This could be because they usually are sicker and have more risk factors when they present, like kidney disease, so maybe they’re not eligible for the therapy. But by itself, it was surprising they’re not offered these interventions as common[ly] as people who don’t have the disease,” Amgad Mentias, MD, a clinical cardiologist at the Cleveland Clinic, said in an interview.
The study was published Sept. 14 in the Journal of the American Heart Association, with Dr. Mentias as senior author and Heba Wassif, MD, MPH, also with Cleveland Clinic, as first author.
IMIDs, such as rheumatoid arthritis, psoriasis, lupus, and inflammatory bowel disease, are known to be associated with significantly higher cardiovascular disease (CVD) risk due to a greater prevalence of traditional CVD risk factors and chronic systemic inflammation.
Certain disease-modifying agents may also increase patients’ cardiovascular risk. This has been a long-simmering issue for the arthritis and ulcerative colitis drug tofacitinib (Xeljanz, Xeljanz XR), resulting in an updated boxed warning in 2021.
Many of these patients also have joint disease, pain, and fatigue, which can limit physical activity, Dr. Mentias said. “So these small nuances of how to manage these patients, or balance between controlling the inflammation but also improv[ing] cardiac risk factors, is not an easy task.”
Evidence regarding post-MI events has been inconsistent and limited to smaller single-center studies, he said. After propensity-score matching, the present study included 59,820 patients with and 178,547 patients without rheumatic IMIDs followed for a maximum of 6 years.
They were drawn from a cohort of 1.6 million persons aged 65 or older in the Medicare Provider Analysis and Review (MedPAR) file who had been admitted for an MI between 2014 and 2019. Of these, 60,072 had a prior history of rheumatic IMIDs, most commonly rheumatoid arthritis (77.8%), followed by systemic lupus erythematosus (12.2%), psoriasis (5.1%), systemic sclerosis (2.8%), and myositis/dermatomyositis (1.8%).
Patients with an IMID were more often women; had a higher prevalence of valve disease, pulmonary hypertension, hypothyroidism, and anemia; and were more likely to present with non–ST-segment MI (NSTEMI).
Rates of coronary angiography (46.1% vs. 51.5%), percutaneous coronary intervention (31.6% vs. 33.6%), and coronary artery bypass grafting (7.7% vs. 10.7%) were significantly lower in patients with IMIDs who had NSTEMI, compared with patients without an IMID who had NSTEMI. Rates of these interventions were also lower in patients with IMIDs who presented with STEMI versus their peers without an IMID, at 78.2% vs. 80.7%, 70.2% vs. 71.5%, and 4.9% vs. 6.4%, respectively.
Dr. Mentias pointed out that the emerging subspecialty of cardiorheumatology is gaining traction, especially at large hospitals and academic centers, but that less than one-third of persons in the United States with an IMID are likely to be under the care of such specialists.
“It’s important before developing an MI to try and control the different risk factors and improve the risk profile for these patients as much as possible by both specialties, and then, after an unfortunate event like MI happens, it’s important to make sure we offer therapies and treatments that are known to improve outcomes,” he said.
Commenting for this article, Jon Tyler Giles, MD, a clinical researcher who focuses on cardiovascular diseases in rheumatology at Columbia University Vagelos College of Physicians and Surgeons, New York, said that “at least for rheumatoid arthritis, this is something that we already knew. People with rheumatic arthritis, when they have a heart attack, are less likely to get the standard kind of treatments and have worse outcomes. This is a little larger sample, but it’s not a surprise, not a surprise at all.”
He noted that the study could have answered questions regarding potential drivers, but “they didn’t dig down into any of the factors that were associated with the poorer outcomes in the patients with rheumatoid arthritis and lupus and scleroderma.”
Indeed, the investigators acknowledge that the study lacked information on coronary anatomy, duration and severity of the autoimmune disease, imaging data, and medications such as anti-inflammatory or immune-targeted therapies.
Dr. Giles highlighted several factors that can contribute to a poorer post-MI prognosis in patients with rheumatic diseases; these include frailty, being more hypercoaguable, increased rates of myocardial dysfunction and other heart and blood vessel diseases, and chronic treatment with steroids and nonsteroidal anti-inflammatory drugs that often interferes with anticoagulation after a MI or when putting in a stent. “So, there’s lot of moving parts, and not one single thing that is likely the answer.”
In addition, he said, “there’s always going to be a portion of these patients who, despite doing the best that we can with treatment, are going to have very severe disease. That may or may not be the subset of patients that did the worst, but likely they’re overrepresented in those patients.”
Finally, the inability to move the needle may lie with the lack of evidence-based screening and management guidelines for cardiovascular disease in any rheumatic disease, Dr. Giles observed. “There’s no guideline for us to use to decide who needs screening over and above what’s recommended for the general population, and then, even if you do screen, what do you do other than what you would normally?”
Rheumatologists are often reluctant to take up the cardiovascular screening side of things because visits are short, and a lot of that time is spent trying to manage the inflammatory components of a patient’s disease, he said. There’s also a barrier in getting some patients to add a cardiologist to the mix of physicians they already see, especially if they don’t have any symptoms.
“If someone has had an event, it’s a lot easier for people to be convinced to go see the cardiologist, obviously, but prior to having an event, the preventative side of things is something that often gets missed or goes to the wayside,” Dr. Giles said.
The study was partly funded by philanthropic gifts by the Haslam family, Bailey family, and Khouri family to the Cleveland Clinic for coauthor Dr. Milind Desai’s research. Dr. Desai is a consultant for Medtronic and Bristol Myers Squibb and serves on an executive steering committee of a BMS-sponsored trial. The remaining authors report having no relevant disclosures. Dr. Giles is a consultant on drug cardiovascular safety for Pfizer, AbbVie, and Eli Lilly.
A version of this article first appeared on Medscape.com.
, in a large propensity-matched analysis.
At a median of 2 years after their MI, Medicare beneficiaries with an IMID had adjusted risks that were:
- 15% higher for all-cause death (hazard ratio, 1.15);
- 12% higher for heart failure (HR, 1.12);
- 8% higher for recurrent MI (HR, 1.08); and
- 6% higher risk for coronary reintervention (HR, 1.06; P < .05 for all).
In addition, interventions known to improve outcomes in this context, such as coronary revascularization, were less common in patients with IMID.
“This could be because they usually are sicker and have more risk factors when they present, like kidney disease, so maybe they’re not eligible for the therapy. But by itself, it was surprising they’re not offered these interventions as common[ly] as people who don’t have the disease,” Amgad Mentias, MD, a clinical cardiologist at the Cleveland Clinic, said in an interview.
The study was published Sept. 14 in the Journal of the American Heart Association, with Dr. Mentias as senior author and Heba Wassif, MD, MPH, also with Cleveland Clinic, as first author.
IMIDs, such as rheumatoid arthritis, psoriasis, lupus, and inflammatory bowel disease, are known to be associated with significantly higher cardiovascular disease (CVD) risk due to a greater prevalence of traditional CVD risk factors and chronic systemic inflammation.
Certain disease-modifying agents may also increase patients’ cardiovascular risk. This has been a long-simmering issue for the arthritis and ulcerative colitis drug tofacitinib (Xeljanz, Xeljanz XR), resulting in an updated boxed warning in 2021.
Many of these patients also have joint disease, pain, and fatigue, which can limit physical activity, Dr. Mentias said. “So these small nuances of how to manage these patients, or balance between controlling the inflammation but also improv[ing] cardiac risk factors, is not an easy task.”
Evidence regarding post-MI events has been inconsistent and limited to smaller single-center studies, he said. After propensity-score matching, the present study included 59,820 patients with and 178,547 patients without rheumatic IMIDs followed for a maximum of 6 years.
They were drawn from a cohort of 1.6 million persons aged 65 or older in the Medicare Provider Analysis and Review (MedPAR) file who had been admitted for an MI between 2014 and 2019. Of these, 60,072 had a prior history of rheumatic IMIDs, most commonly rheumatoid arthritis (77.8%), followed by systemic lupus erythematosus (12.2%), psoriasis (5.1%), systemic sclerosis (2.8%), and myositis/dermatomyositis (1.8%).
Patients with an IMID were more often women; had a higher prevalence of valve disease, pulmonary hypertension, hypothyroidism, and anemia; and were more likely to present with non–ST-segment MI (NSTEMI).
Rates of coronary angiography (46.1% vs. 51.5%), percutaneous coronary intervention (31.6% vs. 33.6%), and coronary artery bypass grafting (7.7% vs. 10.7%) were significantly lower in patients with IMIDs who had NSTEMI, compared with patients without an IMID who had NSTEMI. Rates of these interventions were also lower in patients with IMIDs who presented with STEMI versus their peers without an IMID, at 78.2% vs. 80.7%, 70.2% vs. 71.5%, and 4.9% vs. 6.4%, respectively.
Dr. Mentias pointed out that the emerging subspecialty of cardiorheumatology is gaining traction, especially at large hospitals and academic centers, but that less than one-third of persons in the United States with an IMID are likely to be under the care of such specialists.
“It’s important before developing an MI to try and control the different risk factors and improve the risk profile for these patients as much as possible by both specialties, and then, after an unfortunate event like MI happens, it’s important to make sure we offer therapies and treatments that are known to improve outcomes,” he said.
Commenting for this article, Jon Tyler Giles, MD, a clinical researcher who focuses on cardiovascular diseases in rheumatology at Columbia University Vagelos College of Physicians and Surgeons, New York, said that “at least for rheumatoid arthritis, this is something that we already knew. People with rheumatic arthritis, when they have a heart attack, are less likely to get the standard kind of treatments and have worse outcomes. This is a little larger sample, but it’s not a surprise, not a surprise at all.”
He noted that the study could have answered questions regarding potential drivers, but “they didn’t dig down into any of the factors that were associated with the poorer outcomes in the patients with rheumatoid arthritis and lupus and scleroderma.”
Indeed, the investigators acknowledge that the study lacked information on coronary anatomy, duration and severity of the autoimmune disease, imaging data, and medications such as anti-inflammatory or immune-targeted therapies.
Dr. Giles highlighted several factors that can contribute to a poorer post-MI prognosis in patients with rheumatic diseases; these include frailty, being more hypercoaguable, increased rates of myocardial dysfunction and other heart and blood vessel diseases, and chronic treatment with steroids and nonsteroidal anti-inflammatory drugs that often interferes with anticoagulation after a MI or when putting in a stent. “So, there’s lot of moving parts, and not one single thing that is likely the answer.”
In addition, he said, “there’s always going to be a portion of these patients who, despite doing the best that we can with treatment, are going to have very severe disease. That may or may not be the subset of patients that did the worst, but likely they’re overrepresented in those patients.”
Finally, the inability to move the needle may lie with the lack of evidence-based screening and management guidelines for cardiovascular disease in any rheumatic disease, Dr. Giles observed. “There’s no guideline for us to use to decide who needs screening over and above what’s recommended for the general population, and then, even if you do screen, what do you do other than what you would normally?”
Rheumatologists are often reluctant to take up the cardiovascular screening side of things because visits are short, and a lot of that time is spent trying to manage the inflammatory components of a patient’s disease, he said. There’s also a barrier in getting some patients to add a cardiologist to the mix of physicians they already see, especially if they don’t have any symptoms.
“If someone has had an event, it’s a lot easier for people to be convinced to go see the cardiologist, obviously, but prior to having an event, the preventative side of things is something that often gets missed or goes to the wayside,” Dr. Giles said.
The study was partly funded by philanthropic gifts by the Haslam family, Bailey family, and Khouri family to the Cleveland Clinic for coauthor Dr. Milind Desai’s research. Dr. Desai is a consultant for Medtronic and Bristol Myers Squibb and serves on an executive steering committee of a BMS-sponsored trial. The remaining authors report having no relevant disclosures. Dr. Giles is a consultant on drug cardiovascular safety for Pfizer, AbbVie, and Eli Lilly.
A version of this article first appeared on Medscape.com.
, in a large propensity-matched analysis.
At a median of 2 years after their MI, Medicare beneficiaries with an IMID had adjusted risks that were:
- 15% higher for all-cause death (hazard ratio, 1.15);
- 12% higher for heart failure (HR, 1.12);
- 8% higher for recurrent MI (HR, 1.08); and
- 6% higher risk for coronary reintervention (HR, 1.06; P < .05 for all).
In addition, interventions known to improve outcomes in this context, such as coronary revascularization, were less common in patients with IMID.
“This could be because they usually are sicker and have more risk factors when they present, like kidney disease, so maybe they’re not eligible for the therapy. But by itself, it was surprising they’re not offered these interventions as common[ly] as people who don’t have the disease,” Amgad Mentias, MD, a clinical cardiologist at the Cleveland Clinic, said in an interview.
The study was published Sept. 14 in the Journal of the American Heart Association, with Dr. Mentias as senior author and Heba Wassif, MD, MPH, also with Cleveland Clinic, as first author.
IMIDs, such as rheumatoid arthritis, psoriasis, lupus, and inflammatory bowel disease, are known to be associated with significantly higher cardiovascular disease (CVD) risk due to a greater prevalence of traditional CVD risk factors and chronic systemic inflammation.
Certain disease-modifying agents may also increase patients’ cardiovascular risk. This has been a long-simmering issue for the arthritis and ulcerative colitis drug tofacitinib (Xeljanz, Xeljanz XR), resulting in an updated boxed warning in 2021.
Many of these patients also have joint disease, pain, and fatigue, which can limit physical activity, Dr. Mentias said. “So these small nuances of how to manage these patients, or balance between controlling the inflammation but also improv[ing] cardiac risk factors, is not an easy task.”
Evidence regarding post-MI events has been inconsistent and limited to smaller single-center studies, he said. After propensity-score matching, the present study included 59,820 patients with and 178,547 patients without rheumatic IMIDs followed for a maximum of 6 years.
They were drawn from a cohort of 1.6 million persons aged 65 or older in the Medicare Provider Analysis and Review (MedPAR) file who had been admitted for an MI between 2014 and 2019. Of these, 60,072 had a prior history of rheumatic IMIDs, most commonly rheumatoid arthritis (77.8%), followed by systemic lupus erythematosus (12.2%), psoriasis (5.1%), systemic sclerosis (2.8%), and myositis/dermatomyositis (1.8%).
Patients with an IMID were more often women; had a higher prevalence of valve disease, pulmonary hypertension, hypothyroidism, and anemia; and were more likely to present with non–ST-segment MI (NSTEMI).
Rates of coronary angiography (46.1% vs. 51.5%), percutaneous coronary intervention (31.6% vs. 33.6%), and coronary artery bypass grafting (7.7% vs. 10.7%) were significantly lower in patients with IMIDs who had NSTEMI, compared with patients without an IMID who had NSTEMI. Rates of these interventions were also lower in patients with IMIDs who presented with STEMI versus their peers without an IMID, at 78.2% vs. 80.7%, 70.2% vs. 71.5%, and 4.9% vs. 6.4%, respectively.
Dr. Mentias pointed out that the emerging subspecialty of cardiorheumatology is gaining traction, especially at large hospitals and academic centers, but that less than one-third of persons in the United States with an IMID are likely to be under the care of such specialists.
“It’s important before developing an MI to try and control the different risk factors and improve the risk profile for these patients as much as possible by both specialties, and then, after an unfortunate event like MI happens, it’s important to make sure we offer therapies and treatments that are known to improve outcomes,” he said.
Commenting for this article, Jon Tyler Giles, MD, a clinical researcher who focuses on cardiovascular diseases in rheumatology at Columbia University Vagelos College of Physicians and Surgeons, New York, said that “at least for rheumatoid arthritis, this is something that we already knew. People with rheumatic arthritis, when they have a heart attack, are less likely to get the standard kind of treatments and have worse outcomes. This is a little larger sample, but it’s not a surprise, not a surprise at all.”
He noted that the study could have answered questions regarding potential drivers, but “they didn’t dig down into any of the factors that were associated with the poorer outcomes in the patients with rheumatoid arthritis and lupus and scleroderma.”
Indeed, the investigators acknowledge that the study lacked information on coronary anatomy, duration and severity of the autoimmune disease, imaging data, and medications such as anti-inflammatory or immune-targeted therapies.
Dr. Giles highlighted several factors that can contribute to a poorer post-MI prognosis in patients with rheumatic diseases; these include frailty, being more hypercoaguable, increased rates of myocardial dysfunction and other heart and blood vessel diseases, and chronic treatment with steroids and nonsteroidal anti-inflammatory drugs that often interferes with anticoagulation after a MI or when putting in a stent. “So, there’s lot of moving parts, and not one single thing that is likely the answer.”
In addition, he said, “there’s always going to be a portion of these patients who, despite doing the best that we can with treatment, are going to have very severe disease. That may or may not be the subset of patients that did the worst, but likely they’re overrepresented in those patients.”
Finally, the inability to move the needle may lie with the lack of evidence-based screening and management guidelines for cardiovascular disease in any rheumatic disease, Dr. Giles observed. “There’s no guideline for us to use to decide who needs screening over and above what’s recommended for the general population, and then, even if you do screen, what do you do other than what you would normally?”
Rheumatologists are often reluctant to take up the cardiovascular screening side of things because visits are short, and a lot of that time is spent trying to manage the inflammatory components of a patient’s disease, he said. There’s also a barrier in getting some patients to add a cardiologist to the mix of physicians they already see, especially if they don’t have any symptoms.
“If someone has had an event, it’s a lot easier for people to be convinced to go see the cardiologist, obviously, but prior to having an event, the preventative side of things is something that often gets missed or goes to the wayside,” Dr. Giles said.
The study was partly funded by philanthropic gifts by the Haslam family, Bailey family, and Khouri family to the Cleveland Clinic for coauthor Dr. Milind Desai’s research. Dr. Desai is a consultant for Medtronic and Bristol Myers Squibb and serves on an executive steering committee of a BMS-sponsored trial. The remaining authors report having no relevant disclosures. Dr. Giles is a consultant on drug cardiovascular safety for Pfizer, AbbVie, and Eli Lilly.
A version of this article first appeared on Medscape.com.
FROM JOURNAL OF THE AMERICAN HEART ASSOCIATION
Low-dose oral minoxidil for the treatment of alopecia
Other than oral finasteride, vitamins, and topicals, there has been little advancement in the treatment of AGA leaving many (including me) desperate for anything remotely new.
Oral minoxidil is a peripheral vasodilator approved by the Food and Drug Administration for use in patients with hypertensive disease taken at doses ranging between 10 mg to 40 mg daily. Animal studies have shown that minoxidil affects the hair growth cycle by shortening the telogen phase and prolonging the anagen phase.
Recent case studies have also shown growing evidence for the off-label use of low-dose oral minoxidil (LDOM) for treating different types of alopecia. Topical minoxidil is metabolized into its active metabolite minoxidil sulfate, by sulfotransferase enzymes located in the outer root sheath of hair follicles. The expression of sulfotransferase varies greatly in the scalp of different individuals, and this difference is directly correlated to the wide range of responses to minoxidil treatment. LDOM is, however, more widely effective because it requires decreased follicular enzymatic activity to form its active metabolite as compared with its topical form.
In a retrospective series by Beach and colleagues evaluating the efficacy and tolerability of LDOM for treating AGA, there was increased scalp hair growth in 33 of 51 patients (65%) and decreased hair shedding in 14 of the 51 patients (27%) with LDOM. Patients with nonscarring alopecia were most likely to show improvement. Side effects were dose dependent and infrequent. The most frequent adverse effects were hypertrichosis, lightheadedness, edema, and tachycardia. No life-threatening adverse effects were observed. Although there has been a recently reported case report of severe pericardial effusion, edema, and anasarca in a woman with frontal fibrosing alopecia treated with LDOM, life threatening side effects are rare.3
To compare the efficacy of topical versus oral minoxidil, Ramos and colleagues performed a 24-week prospective study of low-dose (1 mg/day) oral minoxidil, compared with topical 5% minoxidil, in the treatment of 52 women with female pattern hair loss. Blinded analysis of trichoscopic images were evaluated to compare the change in total hair density in a target area from baseline to week 24 by three dermatologists.
Results after 24 weeks of treatment showed an increase in total hair density (12%) among the women taking oral minoxidil, compared with 7.2% in women who applied topical minoxidil (P =.09).
In the armamentarium of hair-loss treatments, dermatologists have limited choices. LDOM can be used in patients with both scarring and nonscarring alopecia if monitored regularly. Treatment doses I recommend are 1.25-5 mg daily titrated up slowly in properly selected patients without contraindications and those who are not taking other vasodilators. Self-reported dizziness, edema, and headache are common and treatments for facial hypertrichosis in women are always discussed. Clinical efficacy can be evaluated after 10-12 months of therapy and concomitant spironolactone can be given to mitigate the side effect of hypertrichosis.Patient selection is crucial as patients with severe scarring alopecia and those with active inflammatory diseases of the scalp may not see similar results. Similar to other hair loss treatments, treatment courses of 10-12 months are often needed to see visible signs of hair growth.
Dr. Talakoub and Naissan O. Wesley, MD, are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. Write to them at [email protected]. Dr. Talakoub had no relevant disclosures.
References
Beach RA et al. J Am Acad Dermatol. 2021 Mar;84(3):761-3.
Dlova et al. JAAD Case Reports. 2022 Oct;28:94-6.
Jimenez-Cauhe J et al. J Am Acad Dermatol. 2021 Jan;84(1):222-3.
Ramos PM et al. J Eur Acad Dermatol Venereol. 2020 Jan;34(1):e40-1.
Ramos PM et al. J Am Acad Dermatol. 2020 Jan;82(1):252-3.
Randolph M and Tosti A. J Am Acad Dermatol. 2021 Mar;84(3):737-46.
Vañó-Galván S et al. J Am Acad Dermatol. 2021 Jun;84(6):1644-51.
Other than oral finasteride, vitamins, and topicals, there has been little advancement in the treatment of AGA leaving many (including me) desperate for anything remotely new.
Oral minoxidil is a peripheral vasodilator approved by the Food and Drug Administration for use in patients with hypertensive disease taken at doses ranging between 10 mg to 40 mg daily. Animal studies have shown that minoxidil affects the hair growth cycle by shortening the telogen phase and prolonging the anagen phase.
Recent case studies have also shown growing evidence for the off-label use of low-dose oral minoxidil (LDOM) for treating different types of alopecia. Topical minoxidil is metabolized into its active metabolite minoxidil sulfate, by sulfotransferase enzymes located in the outer root sheath of hair follicles. The expression of sulfotransferase varies greatly in the scalp of different individuals, and this difference is directly correlated to the wide range of responses to minoxidil treatment. LDOM is, however, more widely effective because it requires decreased follicular enzymatic activity to form its active metabolite as compared with its topical form.
In a retrospective series by Beach and colleagues evaluating the efficacy and tolerability of LDOM for treating AGA, there was increased scalp hair growth in 33 of 51 patients (65%) and decreased hair shedding in 14 of the 51 patients (27%) with LDOM. Patients with nonscarring alopecia were most likely to show improvement. Side effects were dose dependent and infrequent. The most frequent adverse effects were hypertrichosis, lightheadedness, edema, and tachycardia. No life-threatening adverse effects were observed. Although there has been a recently reported case report of severe pericardial effusion, edema, and anasarca in a woman with frontal fibrosing alopecia treated with LDOM, life threatening side effects are rare.3
To compare the efficacy of topical versus oral minoxidil, Ramos and colleagues performed a 24-week prospective study of low-dose (1 mg/day) oral minoxidil, compared with topical 5% minoxidil, in the treatment of 52 women with female pattern hair loss. Blinded analysis of trichoscopic images were evaluated to compare the change in total hair density in a target area from baseline to week 24 by three dermatologists.
Results after 24 weeks of treatment showed an increase in total hair density (12%) among the women taking oral minoxidil, compared with 7.2% in women who applied topical minoxidil (P =.09).
In the armamentarium of hair-loss treatments, dermatologists have limited choices. LDOM can be used in patients with both scarring and nonscarring alopecia if monitored regularly. Treatment doses I recommend are 1.25-5 mg daily titrated up slowly in properly selected patients without contraindications and those who are not taking other vasodilators. Self-reported dizziness, edema, and headache are common and treatments for facial hypertrichosis in women are always discussed. Clinical efficacy can be evaluated after 10-12 months of therapy and concomitant spironolactone can be given to mitigate the side effect of hypertrichosis.Patient selection is crucial as patients with severe scarring alopecia and those with active inflammatory diseases of the scalp may not see similar results. Similar to other hair loss treatments, treatment courses of 10-12 months are often needed to see visible signs of hair growth.
Dr. Talakoub and Naissan O. Wesley, MD, are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. Write to them at [email protected]. Dr. Talakoub had no relevant disclosures.
References
Beach RA et al. J Am Acad Dermatol. 2021 Mar;84(3):761-3.
Dlova et al. JAAD Case Reports. 2022 Oct;28:94-6.
Jimenez-Cauhe J et al. J Am Acad Dermatol. 2021 Jan;84(1):222-3.
Ramos PM et al. J Eur Acad Dermatol Venereol. 2020 Jan;34(1):e40-1.
Ramos PM et al. J Am Acad Dermatol. 2020 Jan;82(1):252-3.
Randolph M and Tosti A. J Am Acad Dermatol. 2021 Mar;84(3):737-46.
Vañó-Galván S et al. J Am Acad Dermatol. 2021 Jun;84(6):1644-51.
Other than oral finasteride, vitamins, and topicals, there has been little advancement in the treatment of AGA leaving many (including me) desperate for anything remotely new.
Oral minoxidil is a peripheral vasodilator approved by the Food and Drug Administration for use in patients with hypertensive disease taken at doses ranging between 10 mg to 40 mg daily. Animal studies have shown that minoxidil affects the hair growth cycle by shortening the telogen phase and prolonging the anagen phase.
Recent case studies have also shown growing evidence for the off-label use of low-dose oral minoxidil (LDOM) for treating different types of alopecia. Topical minoxidil is metabolized into its active metabolite minoxidil sulfate, by sulfotransferase enzymes located in the outer root sheath of hair follicles. The expression of sulfotransferase varies greatly in the scalp of different individuals, and this difference is directly correlated to the wide range of responses to minoxidil treatment. LDOM is, however, more widely effective because it requires decreased follicular enzymatic activity to form its active metabolite as compared with its topical form.
In a retrospective series by Beach and colleagues evaluating the efficacy and tolerability of LDOM for treating AGA, there was increased scalp hair growth in 33 of 51 patients (65%) and decreased hair shedding in 14 of the 51 patients (27%) with LDOM. Patients with nonscarring alopecia were most likely to show improvement. Side effects were dose dependent and infrequent. The most frequent adverse effects were hypertrichosis, lightheadedness, edema, and tachycardia. No life-threatening adverse effects were observed. Although there has been a recently reported case report of severe pericardial effusion, edema, and anasarca in a woman with frontal fibrosing alopecia treated with LDOM, life threatening side effects are rare.3
To compare the efficacy of topical versus oral minoxidil, Ramos and colleagues performed a 24-week prospective study of low-dose (1 mg/day) oral minoxidil, compared with topical 5% minoxidil, in the treatment of 52 women with female pattern hair loss. Blinded analysis of trichoscopic images were evaluated to compare the change in total hair density in a target area from baseline to week 24 by three dermatologists.
Results after 24 weeks of treatment showed an increase in total hair density (12%) among the women taking oral minoxidil, compared with 7.2% in women who applied topical minoxidil (P =.09).
In the armamentarium of hair-loss treatments, dermatologists have limited choices. LDOM can be used in patients with both scarring and nonscarring alopecia if monitored regularly. Treatment doses I recommend are 1.25-5 mg daily titrated up slowly in properly selected patients without contraindications and those who are not taking other vasodilators. Self-reported dizziness, edema, and headache are common and treatments for facial hypertrichosis in women are always discussed. Clinical efficacy can be evaluated after 10-12 months of therapy and concomitant spironolactone can be given to mitigate the side effect of hypertrichosis.Patient selection is crucial as patients with severe scarring alopecia and those with active inflammatory diseases of the scalp may not see similar results. Similar to other hair loss treatments, treatment courses of 10-12 months are often needed to see visible signs of hair growth.
Dr. Talakoub and Naissan O. Wesley, MD, are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. Write to them at [email protected]. Dr. Talakoub had no relevant disclosures.
References
Beach RA et al. J Am Acad Dermatol. 2021 Mar;84(3):761-3.
Dlova et al. JAAD Case Reports. 2022 Oct;28:94-6.
Jimenez-Cauhe J et al. J Am Acad Dermatol. 2021 Jan;84(1):222-3.
Ramos PM et al. J Eur Acad Dermatol Venereol. 2020 Jan;34(1):e40-1.
Ramos PM et al. J Am Acad Dermatol. 2020 Jan;82(1):252-3.
Randolph M and Tosti A. J Am Acad Dermatol. 2021 Mar;84(3):737-46.
Vañó-Galván S et al. J Am Acad Dermatol. 2021 Jun;84(6):1644-51.
Sustained response at 2 years reported for newly approved oral psoriasis agent
MILAN – The day after deucravacitinib became the first TYK2 inhibitor approved for the treatment of moderate to severe psoriasis, long-term data were presented at the annual congress of the European Academy of Dermatology and Venereology, suggesting that a high degree of benefit persists for at least 2 years, making this oral drug a potential competitor for biologics.
,” said Mark G. Lebwohl, MD, professor of dermatology and dean of clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York.
Just 2 months after the 52-week data from the phase 3 POETYK PSO-1 trial were published online in the Journal of the American Academy of Dermatology, a long-term extension study found essentially no loss of benefit at 112 weeks, according to Dr. Lebwohl.
One of the two co-primary endpoints was a 75% clearance on the Psoriasis and Severity Index (PASI75) score. At 52 weeks, 80.2% of patients on deucravacitinib had met this criterion of benefit. At 112 weeks, the proportion was 84.4%.
The other primary endpoint was a static Physician’s Global Assessment (sPGA) score of clear or almost clear skin. The proportion of patients meeting this criterion at weeks 52 and 112 weeks were 65.6% and 67.6%, respectively.
When assessed by Treatment Failure Rule (TFR) or modified nonresponder imputation (mNRI), results were similar. For both, the primary endpoints at every time interval were just one or two percentage points lower but not clinically meaningfully different, according to Dr. Lebwohl.
The same type of sustained response out to 112 weeks was observed in multiple analyses. When the researchers isolated the subgroup of patients who had achieved a PASI 75 response at 16 weeks (100%), there was a modest decline in the PASI 75 rate at week 52 (90.2%) but then no additional decline at week 112 (91.3%).
There were essentially no changes in the PASI 90 rates at week 16 (63%), week 52 (65.3%), and week 112 (63.1%), Dr. Lebwohl reported. PASI 100 rates, once achieved, were sustained long term.
The target, TYK2, is one of four Janus kinase (JAK) inhibitors. Until now, almost all JAK inhibitors have had greater relative specificity for JAK 1, JAK 2, and JAK 3, but several inhibitors of TYK2 inhibitors other than deucravacitinib are in development for inflammatory diseases. Deucravacitinib (Sotyktu), approved by the Food and Drug Administration on Sept. 9, is the only TYK2 inhibitor with regulatory approval for plaque psoriasis.
In the POETYK PSO-1 trial, 666 patients were initially randomized in a 2:1:1 ratio to 6 mg deucravacitinib (now the approved dose), placebo, or the oral phosphodiesterase 4 inhibitor apremilast. At week 16, patients on placebo were switched over to deucravacitinib. At week 24, patients who did not achieve a PASI 50 on apremilast (which had been titrated to 10 mg daily to 30 mg twice a day over the first 5 days of dosing) were switched to deucravacitinib.
In the previously reported data, deucravacitinib was superior for all efficacy endpoints at week 16, including an analysis of quality of life when compared with placebo (P < .0001) or apremilast (P = .0088). At week 52, after having been switched to deucravacitinib at week 16, patients on placebo achieved comparable responses on the efficacy measures in this study, including PASI75.
Relative to JAK inhibitors commonly used in rheumatoid arthritis and other inflammatory diseases, the greater specificity of deucravacitinib for TYK2 appears to have meaningful safety advantages, according to Dr. Lebwohl. Targeted mostly on the TYK2 regulatory domain, deucravacitinib largely avoids inhibition of the JAK 1, 2, and 3 subtypes. Dr. Lebwohl said this explains why deucravacitinib labeling does not share the boxed warnings about off-target effects, such as those on the cardiovascular system, that can be found in the labeling of other JAK inhibitors.
In the published 52-week data, the discontinuation rate for adverse events was lower in the group randomized to deucravacitinib arm than in the placebo arm. In the extended follow-up, there were no new signals for adverse events, including those involving the CV system or immune function.
The key message so far from the long-term follow-up, which is ongoing, is that “continuous treatment with deucravacitinib is associated with durable efficacy,” Dr. Lebwohl said. It is this combination of sustained efficacy and safety that led Dr. Lebwohl to suggest it as a reasonable oral competitor to injectable biologics.
“Patients now have a choice,” he said.
Jashin J. Wu, MD, a board member of the National Psoriasis Foundation and an associate professor in the department of dermatology, University of Miami, has been following the development of deucravacitinib. He said that the recent FDA approval validates the clinical evidence of benefit and safety, while the long-term data presented at the EADV congress support its role in expanding treatment options.
“Deucravacitinib is a very effective oral agent for moderate to severe plaque psoriasis with strong maintenance of effect through week 112,” he said. Differentiating it from other JAK inhibitors, the FDA approval “confirms the safety of this agent as there is no boxed warning,” he added.
Dr. Lebwohl reports financial relationships with more than 30 pharmaceutical companies, including Bristol-Myers Squibb, the manufacturer of deucravacitinib. Dr. Wu has financial relationships with 14 pharmaceutical companies, including Bristol-Myers Squibb, but he was not an investigator for the phase 3 trials of deucravacitinib.
MILAN – The day after deucravacitinib became the first TYK2 inhibitor approved for the treatment of moderate to severe psoriasis, long-term data were presented at the annual congress of the European Academy of Dermatology and Venereology, suggesting that a high degree of benefit persists for at least 2 years, making this oral drug a potential competitor for biologics.
,” said Mark G. Lebwohl, MD, professor of dermatology and dean of clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York.
Just 2 months after the 52-week data from the phase 3 POETYK PSO-1 trial were published online in the Journal of the American Academy of Dermatology, a long-term extension study found essentially no loss of benefit at 112 weeks, according to Dr. Lebwohl.
One of the two co-primary endpoints was a 75% clearance on the Psoriasis and Severity Index (PASI75) score. At 52 weeks, 80.2% of patients on deucravacitinib had met this criterion of benefit. At 112 weeks, the proportion was 84.4%.
The other primary endpoint was a static Physician’s Global Assessment (sPGA) score of clear or almost clear skin. The proportion of patients meeting this criterion at weeks 52 and 112 weeks were 65.6% and 67.6%, respectively.
When assessed by Treatment Failure Rule (TFR) or modified nonresponder imputation (mNRI), results were similar. For both, the primary endpoints at every time interval were just one or two percentage points lower but not clinically meaningfully different, according to Dr. Lebwohl.
The same type of sustained response out to 112 weeks was observed in multiple analyses. When the researchers isolated the subgroup of patients who had achieved a PASI 75 response at 16 weeks (100%), there was a modest decline in the PASI 75 rate at week 52 (90.2%) but then no additional decline at week 112 (91.3%).
There were essentially no changes in the PASI 90 rates at week 16 (63%), week 52 (65.3%), and week 112 (63.1%), Dr. Lebwohl reported. PASI 100 rates, once achieved, were sustained long term.
The target, TYK2, is one of four Janus kinase (JAK) inhibitors. Until now, almost all JAK inhibitors have had greater relative specificity for JAK 1, JAK 2, and JAK 3, but several inhibitors of TYK2 inhibitors other than deucravacitinib are in development for inflammatory diseases. Deucravacitinib (Sotyktu), approved by the Food and Drug Administration on Sept. 9, is the only TYK2 inhibitor with regulatory approval for plaque psoriasis.
In the POETYK PSO-1 trial, 666 patients were initially randomized in a 2:1:1 ratio to 6 mg deucravacitinib (now the approved dose), placebo, or the oral phosphodiesterase 4 inhibitor apremilast. At week 16, patients on placebo were switched over to deucravacitinib. At week 24, patients who did not achieve a PASI 50 on apremilast (which had been titrated to 10 mg daily to 30 mg twice a day over the first 5 days of dosing) were switched to deucravacitinib.
In the previously reported data, deucravacitinib was superior for all efficacy endpoints at week 16, including an analysis of quality of life when compared with placebo (P < .0001) or apremilast (P = .0088). At week 52, after having been switched to deucravacitinib at week 16, patients on placebo achieved comparable responses on the efficacy measures in this study, including PASI75.
Relative to JAK inhibitors commonly used in rheumatoid arthritis and other inflammatory diseases, the greater specificity of deucravacitinib for TYK2 appears to have meaningful safety advantages, according to Dr. Lebwohl. Targeted mostly on the TYK2 regulatory domain, deucravacitinib largely avoids inhibition of the JAK 1, 2, and 3 subtypes. Dr. Lebwohl said this explains why deucravacitinib labeling does not share the boxed warnings about off-target effects, such as those on the cardiovascular system, that can be found in the labeling of other JAK inhibitors.
In the published 52-week data, the discontinuation rate for adverse events was lower in the group randomized to deucravacitinib arm than in the placebo arm. In the extended follow-up, there were no new signals for adverse events, including those involving the CV system or immune function.
The key message so far from the long-term follow-up, which is ongoing, is that “continuous treatment with deucravacitinib is associated with durable efficacy,” Dr. Lebwohl said. It is this combination of sustained efficacy and safety that led Dr. Lebwohl to suggest it as a reasonable oral competitor to injectable biologics.
“Patients now have a choice,” he said.
Jashin J. Wu, MD, a board member of the National Psoriasis Foundation and an associate professor in the department of dermatology, University of Miami, has been following the development of deucravacitinib. He said that the recent FDA approval validates the clinical evidence of benefit and safety, while the long-term data presented at the EADV congress support its role in expanding treatment options.
“Deucravacitinib is a very effective oral agent for moderate to severe plaque psoriasis with strong maintenance of effect through week 112,” he said. Differentiating it from other JAK inhibitors, the FDA approval “confirms the safety of this agent as there is no boxed warning,” he added.
Dr. Lebwohl reports financial relationships with more than 30 pharmaceutical companies, including Bristol-Myers Squibb, the manufacturer of deucravacitinib. Dr. Wu has financial relationships with 14 pharmaceutical companies, including Bristol-Myers Squibb, but he was not an investigator for the phase 3 trials of deucravacitinib.
MILAN – The day after deucravacitinib became the first TYK2 inhibitor approved for the treatment of moderate to severe psoriasis, long-term data were presented at the annual congress of the European Academy of Dermatology and Venereology, suggesting that a high degree of benefit persists for at least 2 years, making this oral drug a potential competitor for biologics.
,” said Mark G. Lebwohl, MD, professor of dermatology and dean of clinical therapeutics, Icahn School of Medicine at Mount Sinai, New York.
Just 2 months after the 52-week data from the phase 3 POETYK PSO-1 trial were published online in the Journal of the American Academy of Dermatology, a long-term extension study found essentially no loss of benefit at 112 weeks, according to Dr. Lebwohl.
One of the two co-primary endpoints was a 75% clearance on the Psoriasis and Severity Index (PASI75) score. At 52 weeks, 80.2% of patients on deucravacitinib had met this criterion of benefit. At 112 weeks, the proportion was 84.4%.
The other primary endpoint was a static Physician’s Global Assessment (sPGA) score of clear or almost clear skin. The proportion of patients meeting this criterion at weeks 52 and 112 weeks were 65.6% and 67.6%, respectively.
When assessed by Treatment Failure Rule (TFR) or modified nonresponder imputation (mNRI), results were similar. For both, the primary endpoints at every time interval were just one or two percentage points lower but not clinically meaningfully different, according to Dr. Lebwohl.
The same type of sustained response out to 112 weeks was observed in multiple analyses. When the researchers isolated the subgroup of patients who had achieved a PASI 75 response at 16 weeks (100%), there was a modest decline in the PASI 75 rate at week 52 (90.2%) but then no additional decline at week 112 (91.3%).
There were essentially no changes in the PASI 90 rates at week 16 (63%), week 52 (65.3%), and week 112 (63.1%), Dr. Lebwohl reported. PASI 100 rates, once achieved, were sustained long term.
The target, TYK2, is one of four Janus kinase (JAK) inhibitors. Until now, almost all JAK inhibitors have had greater relative specificity for JAK 1, JAK 2, and JAK 3, but several inhibitors of TYK2 inhibitors other than deucravacitinib are in development for inflammatory diseases. Deucravacitinib (Sotyktu), approved by the Food and Drug Administration on Sept. 9, is the only TYK2 inhibitor with regulatory approval for plaque psoriasis.
In the POETYK PSO-1 trial, 666 patients were initially randomized in a 2:1:1 ratio to 6 mg deucravacitinib (now the approved dose), placebo, or the oral phosphodiesterase 4 inhibitor apremilast. At week 16, patients on placebo were switched over to deucravacitinib. At week 24, patients who did not achieve a PASI 50 on apremilast (which had been titrated to 10 mg daily to 30 mg twice a day over the first 5 days of dosing) were switched to deucravacitinib.
In the previously reported data, deucravacitinib was superior for all efficacy endpoints at week 16, including an analysis of quality of life when compared with placebo (P < .0001) or apremilast (P = .0088). At week 52, after having been switched to deucravacitinib at week 16, patients on placebo achieved comparable responses on the efficacy measures in this study, including PASI75.
Relative to JAK inhibitors commonly used in rheumatoid arthritis and other inflammatory diseases, the greater specificity of deucravacitinib for TYK2 appears to have meaningful safety advantages, according to Dr. Lebwohl. Targeted mostly on the TYK2 regulatory domain, deucravacitinib largely avoids inhibition of the JAK 1, 2, and 3 subtypes. Dr. Lebwohl said this explains why deucravacitinib labeling does not share the boxed warnings about off-target effects, such as those on the cardiovascular system, that can be found in the labeling of other JAK inhibitors.
In the published 52-week data, the discontinuation rate for adverse events was lower in the group randomized to deucravacitinib arm than in the placebo arm. In the extended follow-up, there were no new signals for adverse events, including those involving the CV system or immune function.
The key message so far from the long-term follow-up, which is ongoing, is that “continuous treatment with deucravacitinib is associated with durable efficacy,” Dr. Lebwohl said. It is this combination of sustained efficacy and safety that led Dr. Lebwohl to suggest it as a reasonable oral competitor to injectable biologics.
“Patients now have a choice,” he said.
Jashin J. Wu, MD, a board member of the National Psoriasis Foundation and an associate professor in the department of dermatology, University of Miami, has been following the development of deucravacitinib. He said that the recent FDA approval validates the clinical evidence of benefit and safety, while the long-term data presented at the EADV congress support its role in expanding treatment options.
“Deucravacitinib is a very effective oral agent for moderate to severe plaque psoriasis with strong maintenance of effect through week 112,” he said. Differentiating it from other JAK inhibitors, the FDA approval “confirms the safety of this agent as there is no boxed warning,” he added.
Dr. Lebwohl reports financial relationships with more than 30 pharmaceutical companies, including Bristol-Myers Squibb, the manufacturer of deucravacitinib. Dr. Wu has financial relationships with 14 pharmaceutical companies, including Bristol-Myers Squibb, but he was not an investigator for the phase 3 trials of deucravacitinib.
AT THE EADV CONGRESS
