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From PERT to AI, high-risk PE care evolves
In 2012, a small group of specialists, consisting of a critical care pulmonologist, cardiologist, cardiac surgeon, and vascular specialist, at Massachusetts General Hospital, Boston, met to Monday morning quarterback an acute pulmonary embolism case that didn’t go as well as they’d hoped. They came up with a concept known as the pulmonary embolism response team – PERT for short – an idea that soon took hold in other centers and served as the vanguard to other innovative approaches to managing critical care patients with PE, which is the third-leading cause of cardiovascular death in the United States (Intern Emerg Med. 2023. doi: 10.1007/s11739-022-03180-w).
Three years later the PERT Consortium came together, which today has 102 members, according to the organization’s website (www.pertconsortium.org), and members in South America, Europe, Asia, and Australia. Since then, and apps to expedite diagnosis and treatment. The PERT Consortium, meanwhile, is in the process of creating the PE Centers of Excellence program to certify centers that meet certain requirements.
“Part of the reason we recognized that a discussion across specialties was important was because there weren’t the large clinical trials that could tell us exactly what to do for any given case,” said Christopher Kabrhel, MD, MPH, director of the Center for Vascular Emergencies at Mass General and a professor at Harvard Medical School in Boston, who assembled that formative meeting. “Without a clear basis in data, it was really important to have all the different specialists weigh in and give their perspective and talk about what was the best approach for the patient’s care.”
Filling data gaps
Some of those data gaps persist today, Dr. Kabrhel said. “It’s precisely that lack of head-to-head data that existed in 2012, and to a great extent still exists today, that led us to create this system.” The American Heart Association just this January issued a scientific statement on surgical management and mechanical circulatory support in high-risk PE (Circulation. 2023;147:e628-47).
But the intervening research has been uneven. The Pulmonary Embolism Thrombolysis (PEITHO) trial in 2014 evaluated systemic thrombolysis and anticoagulation alone (N Engl J Med. 2014;370:1402-11), but head-to-head studies of catheter-directed thrombolysis (CDT), which was just emerging in 2012, and either systemic thrombolysis or anticoagulation have been lacking, Dr. Kabrhel said. The Hi-PEITHO trial in high-risk PE patients is evaluating ultrasound-guided CDT plus anticoagulation vs. anticoagulation alone (Am Heart J. 2022:251:43-54), but it isn’t complete.
“The therapeutic landscape for PE is evolving incredibly rapidly,” he said. “When we first started PERT we were just starting to see CDT. Since then, we’ve seen several new thrombolytic catheters come onto the market, but there’s also been a proliferation of suction embolectomy catheters and we’ve seen a potentially larger role for surgery and the use of ECMO [extracorporeal membrane oxygenation] or cardiac bypass to bridge patients to definitive therapy. With the rapid evolution and the seemingly daily addition of new therapeutic options, I think the need for PERT is only increasing.”
A recent study out of the University of Michigan reported that the PERT there led to a decrease in the use of advanced therapies given to acute PE patients without reducing mortality or extending hospital stays (Thromb Res. 2023;221:73-8). A study in Spain reported that patients with high-risk and intermediate high-risk PE who had PERT-coordinated care had half the 12-month mortality rate of non-PERT counterparts, 9% vs. 22.2% (P = .02) (Med Clin [Barc]. 2023;S0025-7753(23)00017-9). And a 2021 study at University Hospitals in Cleveland reported that PERT-managed PE patients had a 60% lower rate of adverse outcomes at 90 days than non–PERT-managed patients (J Invasive Cardiol. 2021;33:E173-E180).
Nelish Ardeshna, MD, MA, the lead author of the Michigan study, said the PERT there was formed in 2017. Besides the multispecialty team that can be summoned to a teleconference on short notice, the protocol includes having at least one noninvasive specialist, such as a cardiologist or hospitalist, and one interventionalist, such as a radiologist, always on call. The PERT gets activated through the paging system after a hospital or emergency department physician identifies a suspected or established high-risk PE.
“High-risk PE patients can present in all settings, including the emergency department, ICU, surgical floor, or medical floor,” said Dr. Ardeshna, an internal medicine resident. “Management for these patients is equally varied from anticoagulation to systemic thrombolytics. Not all providers may be familiar with current guidelines to select the optimal therapy for high-risk pulmonary embolism patients. PERT aims to bridge that gap by providing a multidisciplinary discussion with PE specialists that can help identify the correct therapeutic options for optimal outcomes.”
At Cleveland Clinic, where the PERT has been in place since 2012, the PERT can consist of six to eight different specialties and involve up to 15 providers on a conference call, said Leben Tefera, MD, a vascular specialist and head of the PERT team there.
“Each patient will come in and have certain comorbidities,” Dr. Tefera said. “The unfortunate thing about a majority of the PEs that we see, in particular ones [in patients] that are very sick and require inpatient treatment, is that they don’t really fit into a box; you can’t come up with one kind of generic care routine or care path that treats the majority of patients with PE.”
Evolving to follow-up care
As the PERT protocol led to better inpatient outcomes, the teams became more aware that discharged PE patients were struggling with mental health and other quality-of-life issues – symptoms that have been understudied, according to a protocol Dr. Tefera coauthored for a prospective observational study of psychological distress symptoms in PE survivors. By contrast, the protocol noted, these symptoms have been studied extensively in myocardial infarction and stroke patients (Res Pract Thromb Hemost. 2023. doi: 10.1016/j.rpth.2023.10045). Other studies have found that 35%-50% of patients reported mental health symptoms 3 months after PE (Chest. 2021;159:2428-38; Qual Life Res. 2019;28:2111-24).
“A lot of physicians have known it for quite some time, but it wasn’t really until the last couple of years that physicians started saying psychological stress is something that we need to quantify and that we need to actually treat, that we actually need to address,” Dr. Tefera said. That led Dr. Tefera and his Cleveland Clinic PERT colleagues to set up a follow-up clinic for PE patients.
At their follow-up visits, patients complete validated questionnaires about anxiety, depression, fear of recurrence, PE-specific quality of life, and posttraumatic stress disorder. “If they flag as positive, we give them a referral to an in-house psychologist,” he said. “One thing I can report is that patients absolutely, positively love this, because it’s something that they are all experiencing that a lot of physicians just aren’t addressing.”
Artificial intelligence emerges
At the University of Pittsburgh Medical Center, the PERT has started evaluating artificial intelligence to aid in PE diagnosis. Belinda Rivera-Lebron, MD, director of the acute and chronic embolism program at Pitt, explained that the AI protocol hasn’t been adopted yet, but the concept is to have a platform that’s compatible with the hospital system’s electronic medical record.
She described how AI would work once the PERT is activated. “Once the patient goes through the CT scanner, within 60 seconds of that scan being completed, the scan gets uploaded into the cloud and the app or the platform is able to tell you whether there is PE present or absent, and whether there is right ventricle dilation on that scan. This is even before you probably even think about opening up the computer to look at the scan, and even before radiology opens up the scan to read,” she said. “It’s so fast.”
The idea is to send the scans rapidly to the PERT. “It will send you a text, a notification on your phone that will tell you Mr. Smith is PE positive,” Dr. Rivera-Lebron said. “Then you open it and you are able to scroll through the CT scan in your phone. So, it’s really remarkable.”
Clinical trials worth watching
Meanwhile, a number of clinical trials have started to enroll patients, or will soon, that Dr. Rivera-Lebron said are worth paying attention to.
PEITHO-3 is a randomized, placebo-controlled trial with long-term follow-up comparing the efficacy of a reduced-dose alteplase regimen or standard heparin anticoagulation in patients with intermediate to high-risk PE (Thromb Haemost. 2022;122:867-66).
PEERLESS is a prospective randomized trial comparing mechanical thrombectomy and CDT (ClinicalTrials.gov identifier NCT05111613).
PE-Thrombus Removal with Catheter-directed Therapy (PE-TRACT) is an open-label Phase 3 trial comparing anticoagulation and CDT that’s not yet recruiting (ClinicalTrials.gov identifier NCT05591118).
FlowTriever for Acute Massive Pulmonary Embolism (FLAME) is a prospective cohort study evaluating a clot-retrieving device in high-risk PE patients (ClinicalTrials.gov identifier NCT04795167).
When completed and published, these trials could provide PERTs more evidence for their decision-making.
Dr. Ardeshna and Dr. Tefera have no relevant relationships to disclose. Dr. Rivera-Lebron disclosed relationships with INARI Catheter and Johnson & Johnson. Dr. Kabrhel disclosed relationships with Bristol Myers Squibb and Pfizer.
In 2012, a small group of specialists, consisting of a critical care pulmonologist, cardiologist, cardiac surgeon, and vascular specialist, at Massachusetts General Hospital, Boston, met to Monday morning quarterback an acute pulmonary embolism case that didn’t go as well as they’d hoped. They came up with a concept known as the pulmonary embolism response team – PERT for short – an idea that soon took hold in other centers and served as the vanguard to other innovative approaches to managing critical care patients with PE, which is the third-leading cause of cardiovascular death in the United States (Intern Emerg Med. 2023. doi: 10.1007/s11739-022-03180-w).
Three years later the PERT Consortium came together, which today has 102 members, according to the organization’s website (www.pertconsortium.org), and members in South America, Europe, Asia, and Australia. Since then, and apps to expedite diagnosis and treatment. The PERT Consortium, meanwhile, is in the process of creating the PE Centers of Excellence program to certify centers that meet certain requirements.
“Part of the reason we recognized that a discussion across specialties was important was because there weren’t the large clinical trials that could tell us exactly what to do for any given case,” said Christopher Kabrhel, MD, MPH, director of the Center for Vascular Emergencies at Mass General and a professor at Harvard Medical School in Boston, who assembled that formative meeting. “Without a clear basis in data, it was really important to have all the different specialists weigh in and give their perspective and talk about what was the best approach for the patient’s care.”
Filling data gaps
Some of those data gaps persist today, Dr. Kabrhel said. “It’s precisely that lack of head-to-head data that existed in 2012, and to a great extent still exists today, that led us to create this system.” The American Heart Association just this January issued a scientific statement on surgical management and mechanical circulatory support in high-risk PE (Circulation. 2023;147:e628-47).
But the intervening research has been uneven. The Pulmonary Embolism Thrombolysis (PEITHO) trial in 2014 evaluated systemic thrombolysis and anticoagulation alone (N Engl J Med. 2014;370:1402-11), but head-to-head studies of catheter-directed thrombolysis (CDT), which was just emerging in 2012, and either systemic thrombolysis or anticoagulation have been lacking, Dr. Kabrhel said. The Hi-PEITHO trial in high-risk PE patients is evaluating ultrasound-guided CDT plus anticoagulation vs. anticoagulation alone (Am Heart J. 2022:251:43-54), but it isn’t complete.
“The therapeutic landscape for PE is evolving incredibly rapidly,” he said. “When we first started PERT we were just starting to see CDT. Since then, we’ve seen several new thrombolytic catheters come onto the market, but there’s also been a proliferation of suction embolectomy catheters and we’ve seen a potentially larger role for surgery and the use of ECMO [extracorporeal membrane oxygenation] or cardiac bypass to bridge patients to definitive therapy. With the rapid evolution and the seemingly daily addition of new therapeutic options, I think the need for PERT is only increasing.”
A recent study out of the University of Michigan reported that the PERT there led to a decrease in the use of advanced therapies given to acute PE patients without reducing mortality or extending hospital stays (Thromb Res. 2023;221:73-8). A study in Spain reported that patients with high-risk and intermediate high-risk PE who had PERT-coordinated care had half the 12-month mortality rate of non-PERT counterparts, 9% vs. 22.2% (P = .02) (Med Clin [Barc]. 2023;S0025-7753(23)00017-9). And a 2021 study at University Hospitals in Cleveland reported that PERT-managed PE patients had a 60% lower rate of adverse outcomes at 90 days than non–PERT-managed patients (J Invasive Cardiol. 2021;33:E173-E180).
Nelish Ardeshna, MD, MA, the lead author of the Michigan study, said the PERT there was formed in 2017. Besides the multispecialty team that can be summoned to a teleconference on short notice, the protocol includes having at least one noninvasive specialist, such as a cardiologist or hospitalist, and one interventionalist, such as a radiologist, always on call. The PERT gets activated through the paging system after a hospital or emergency department physician identifies a suspected or established high-risk PE.
“High-risk PE patients can present in all settings, including the emergency department, ICU, surgical floor, or medical floor,” said Dr. Ardeshna, an internal medicine resident. “Management for these patients is equally varied from anticoagulation to systemic thrombolytics. Not all providers may be familiar with current guidelines to select the optimal therapy for high-risk pulmonary embolism patients. PERT aims to bridge that gap by providing a multidisciplinary discussion with PE specialists that can help identify the correct therapeutic options for optimal outcomes.”
At Cleveland Clinic, where the PERT has been in place since 2012, the PERT can consist of six to eight different specialties and involve up to 15 providers on a conference call, said Leben Tefera, MD, a vascular specialist and head of the PERT team there.
“Each patient will come in and have certain comorbidities,” Dr. Tefera said. “The unfortunate thing about a majority of the PEs that we see, in particular ones [in patients] that are very sick and require inpatient treatment, is that they don’t really fit into a box; you can’t come up with one kind of generic care routine or care path that treats the majority of patients with PE.”
Evolving to follow-up care
As the PERT protocol led to better inpatient outcomes, the teams became more aware that discharged PE patients were struggling with mental health and other quality-of-life issues – symptoms that have been understudied, according to a protocol Dr. Tefera coauthored for a prospective observational study of psychological distress symptoms in PE survivors. By contrast, the protocol noted, these symptoms have been studied extensively in myocardial infarction and stroke patients (Res Pract Thromb Hemost. 2023. doi: 10.1016/j.rpth.2023.10045). Other studies have found that 35%-50% of patients reported mental health symptoms 3 months after PE (Chest. 2021;159:2428-38; Qual Life Res. 2019;28:2111-24).
“A lot of physicians have known it for quite some time, but it wasn’t really until the last couple of years that physicians started saying psychological stress is something that we need to quantify and that we need to actually treat, that we actually need to address,” Dr. Tefera said. That led Dr. Tefera and his Cleveland Clinic PERT colleagues to set up a follow-up clinic for PE patients.
At their follow-up visits, patients complete validated questionnaires about anxiety, depression, fear of recurrence, PE-specific quality of life, and posttraumatic stress disorder. “If they flag as positive, we give them a referral to an in-house psychologist,” he said. “One thing I can report is that patients absolutely, positively love this, because it’s something that they are all experiencing that a lot of physicians just aren’t addressing.”
Artificial intelligence emerges
At the University of Pittsburgh Medical Center, the PERT has started evaluating artificial intelligence to aid in PE diagnosis. Belinda Rivera-Lebron, MD, director of the acute and chronic embolism program at Pitt, explained that the AI protocol hasn’t been adopted yet, but the concept is to have a platform that’s compatible with the hospital system’s electronic medical record.
She described how AI would work once the PERT is activated. “Once the patient goes through the CT scanner, within 60 seconds of that scan being completed, the scan gets uploaded into the cloud and the app or the platform is able to tell you whether there is PE present or absent, and whether there is right ventricle dilation on that scan. This is even before you probably even think about opening up the computer to look at the scan, and even before radiology opens up the scan to read,” she said. “It’s so fast.”
The idea is to send the scans rapidly to the PERT. “It will send you a text, a notification on your phone that will tell you Mr. Smith is PE positive,” Dr. Rivera-Lebron said. “Then you open it and you are able to scroll through the CT scan in your phone. So, it’s really remarkable.”
Clinical trials worth watching
Meanwhile, a number of clinical trials have started to enroll patients, or will soon, that Dr. Rivera-Lebron said are worth paying attention to.
PEITHO-3 is a randomized, placebo-controlled trial with long-term follow-up comparing the efficacy of a reduced-dose alteplase regimen or standard heparin anticoagulation in patients with intermediate to high-risk PE (Thromb Haemost. 2022;122:867-66).
PEERLESS is a prospective randomized trial comparing mechanical thrombectomy and CDT (ClinicalTrials.gov identifier NCT05111613).
PE-Thrombus Removal with Catheter-directed Therapy (PE-TRACT) is an open-label Phase 3 trial comparing anticoagulation and CDT that’s not yet recruiting (ClinicalTrials.gov identifier NCT05591118).
FlowTriever for Acute Massive Pulmonary Embolism (FLAME) is a prospective cohort study evaluating a clot-retrieving device in high-risk PE patients (ClinicalTrials.gov identifier NCT04795167).
When completed and published, these trials could provide PERTs more evidence for their decision-making.
Dr. Ardeshna and Dr. Tefera have no relevant relationships to disclose. Dr. Rivera-Lebron disclosed relationships with INARI Catheter and Johnson & Johnson. Dr. Kabrhel disclosed relationships with Bristol Myers Squibb and Pfizer.
In 2012, a small group of specialists, consisting of a critical care pulmonologist, cardiologist, cardiac surgeon, and vascular specialist, at Massachusetts General Hospital, Boston, met to Monday morning quarterback an acute pulmonary embolism case that didn’t go as well as they’d hoped. They came up with a concept known as the pulmonary embolism response team – PERT for short – an idea that soon took hold in other centers and served as the vanguard to other innovative approaches to managing critical care patients with PE, which is the third-leading cause of cardiovascular death in the United States (Intern Emerg Med. 2023. doi: 10.1007/s11739-022-03180-w).
Three years later the PERT Consortium came together, which today has 102 members, according to the organization’s website (www.pertconsortium.org), and members in South America, Europe, Asia, and Australia. Since then, and apps to expedite diagnosis and treatment. The PERT Consortium, meanwhile, is in the process of creating the PE Centers of Excellence program to certify centers that meet certain requirements.
“Part of the reason we recognized that a discussion across specialties was important was because there weren’t the large clinical trials that could tell us exactly what to do for any given case,” said Christopher Kabrhel, MD, MPH, director of the Center for Vascular Emergencies at Mass General and a professor at Harvard Medical School in Boston, who assembled that formative meeting. “Without a clear basis in data, it was really important to have all the different specialists weigh in and give their perspective and talk about what was the best approach for the patient’s care.”
Filling data gaps
Some of those data gaps persist today, Dr. Kabrhel said. “It’s precisely that lack of head-to-head data that existed in 2012, and to a great extent still exists today, that led us to create this system.” The American Heart Association just this January issued a scientific statement on surgical management and mechanical circulatory support in high-risk PE (Circulation. 2023;147:e628-47).
But the intervening research has been uneven. The Pulmonary Embolism Thrombolysis (PEITHO) trial in 2014 evaluated systemic thrombolysis and anticoagulation alone (N Engl J Med. 2014;370:1402-11), but head-to-head studies of catheter-directed thrombolysis (CDT), which was just emerging in 2012, and either systemic thrombolysis or anticoagulation have been lacking, Dr. Kabrhel said. The Hi-PEITHO trial in high-risk PE patients is evaluating ultrasound-guided CDT plus anticoagulation vs. anticoagulation alone (Am Heart J. 2022:251:43-54), but it isn’t complete.
“The therapeutic landscape for PE is evolving incredibly rapidly,” he said. “When we first started PERT we were just starting to see CDT. Since then, we’ve seen several new thrombolytic catheters come onto the market, but there’s also been a proliferation of suction embolectomy catheters and we’ve seen a potentially larger role for surgery and the use of ECMO [extracorporeal membrane oxygenation] or cardiac bypass to bridge patients to definitive therapy. With the rapid evolution and the seemingly daily addition of new therapeutic options, I think the need for PERT is only increasing.”
A recent study out of the University of Michigan reported that the PERT there led to a decrease in the use of advanced therapies given to acute PE patients without reducing mortality or extending hospital stays (Thromb Res. 2023;221:73-8). A study in Spain reported that patients with high-risk and intermediate high-risk PE who had PERT-coordinated care had half the 12-month mortality rate of non-PERT counterparts, 9% vs. 22.2% (P = .02) (Med Clin [Barc]. 2023;S0025-7753(23)00017-9). And a 2021 study at University Hospitals in Cleveland reported that PERT-managed PE patients had a 60% lower rate of adverse outcomes at 90 days than non–PERT-managed patients (J Invasive Cardiol. 2021;33:E173-E180).
Nelish Ardeshna, MD, MA, the lead author of the Michigan study, said the PERT there was formed in 2017. Besides the multispecialty team that can be summoned to a teleconference on short notice, the protocol includes having at least one noninvasive specialist, such as a cardiologist or hospitalist, and one interventionalist, such as a radiologist, always on call. The PERT gets activated through the paging system after a hospital or emergency department physician identifies a suspected or established high-risk PE.
“High-risk PE patients can present in all settings, including the emergency department, ICU, surgical floor, or medical floor,” said Dr. Ardeshna, an internal medicine resident. “Management for these patients is equally varied from anticoagulation to systemic thrombolytics. Not all providers may be familiar with current guidelines to select the optimal therapy for high-risk pulmonary embolism patients. PERT aims to bridge that gap by providing a multidisciplinary discussion with PE specialists that can help identify the correct therapeutic options for optimal outcomes.”
At Cleveland Clinic, where the PERT has been in place since 2012, the PERT can consist of six to eight different specialties and involve up to 15 providers on a conference call, said Leben Tefera, MD, a vascular specialist and head of the PERT team there.
“Each patient will come in and have certain comorbidities,” Dr. Tefera said. “The unfortunate thing about a majority of the PEs that we see, in particular ones [in patients] that are very sick and require inpatient treatment, is that they don’t really fit into a box; you can’t come up with one kind of generic care routine or care path that treats the majority of patients with PE.”
Evolving to follow-up care
As the PERT protocol led to better inpatient outcomes, the teams became more aware that discharged PE patients were struggling with mental health and other quality-of-life issues – symptoms that have been understudied, according to a protocol Dr. Tefera coauthored for a prospective observational study of psychological distress symptoms in PE survivors. By contrast, the protocol noted, these symptoms have been studied extensively in myocardial infarction and stroke patients (Res Pract Thromb Hemost. 2023. doi: 10.1016/j.rpth.2023.10045). Other studies have found that 35%-50% of patients reported mental health symptoms 3 months after PE (Chest. 2021;159:2428-38; Qual Life Res. 2019;28:2111-24).
“A lot of physicians have known it for quite some time, but it wasn’t really until the last couple of years that physicians started saying psychological stress is something that we need to quantify and that we need to actually treat, that we actually need to address,” Dr. Tefera said. That led Dr. Tefera and his Cleveland Clinic PERT colleagues to set up a follow-up clinic for PE patients.
At their follow-up visits, patients complete validated questionnaires about anxiety, depression, fear of recurrence, PE-specific quality of life, and posttraumatic stress disorder. “If they flag as positive, we give them a referral to an in-house psychologist,” he said. “One thing I can report is that patients absolutely, positively love this, because it’s something that they are all experiencing that a lot of physicians just aren’t addressing.”
Artificial intelligence emerges
At the University of Pittsburgh Medical Center, the PERT has started evaluating artificial intelligence to aid in PE diagnosis. Belinda Rivera-Lebron, MD, director of the acute and chronic embolism program at Pitt, explained that the AI protocol hasn’t been adopted yet, but the concept is to have a platform that’s compatible with the hospital system’s electronic medical record.
She described how AI would work once the PERT is activated. “Once the patient goes through the CT scanner, within 60 seconds of that scan being completed, the scan gets uploaded into the cloud and the app or the platform is able to tell you whether there is PE present or absent, and whether there is right ventricle dilation on that scan. This is even before you probably even think about opening up the computer to look at the scan, and even before radiology opens up the scan to read,” she said. “It’s so fast.”
The idea is to send the scans rapidly to the PERT. “It will send you a text, a notification on your phone that will tell you Mr. Smith is PE positive,” Dr. Rivera-Lebron said. “Then you open it and you are able to scroll through the CT scan in your phone. So, it’s really remarkable.”
Clinical trials worth watching
Meanwhile, a number of clinical trials have started to enroll patients, or will soon, that Dr. Rivera-Lebron said are worth paying attention to.
PEITHO-3 is a randomized, placebo-controlled trial with long-term follow-up comparing the efficacy of a reduced-dose alteplase regimen or standard heparin anticoagulation in patients with intermediate to high-risk PE (Thromb Haemost. 2022;122:867-66).
PEERLESS is a prospective randomized trial comparing mechanical thrombectomy and CDT (ClinicalTrials.gov identifier NCT05111613).
PE-Thrombus Removal with Catheter-directed Therapy (PE-TRACT) is an open-label Phase 3 trial comparing anticoagulation and CDT that’s not yet recruiting (ClinicalTrials.gov identifier NCT05591118).
FlowTriever for Acute Massive Pulmonary Embolism (FLAME) is a prospective cohort study evaluating a clot-retrieving device in high-risk PE patients (ClinicalTrials.gov identifier NCT04795167).
When completed and published, these trials could provide PERTs more evidence for their decision-making.
Dr. Ardeshna and Dr. Tefera have no relevant relationships to disclose. Dr. Rivera-Lebron disclosed relationships with INARI Catheter and Johnson & Johnson. Dr. Kabrhel disclosed relationships with Bristol Myers Squibb and Pfizer.
Artificial pancreas ‘superior’ in young kids with type 1 diabetes
A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.
The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.
Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.
Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.
In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.
Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.
“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.
Their findings were published online in the New England Journal of Medicine.
“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.
“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”
Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
More time-in-range, no hypoglycemia with automated system
The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.
Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.
The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).
The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).
However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups.
There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.
Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”
At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.
Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.
The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.
Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.
Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.
In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.
Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.
“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.
Their findings were published online in the New England Journal of Medicine.
“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.
“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”
Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
More time-in-range, no hypoglycemia with automated system
The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.
Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.
The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).
The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).
However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups.
There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.
Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”
At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.
Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.
The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.
Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.
Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.
In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.
The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.
Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.
“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.
Their findings were published online in the New England Journal of Medicine.
“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.
“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”
Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
More time-in-range, no hypoglycemia with automated system
The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.
Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.
The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).
The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).
However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups.
There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.
Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”
At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.
Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”
The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Physician suicide: Investigating its prevalence and cause
Physicians are admired for their sacrifice and dedication. Yet beneath the surface lies a painful, quiet reality:
The Physicians Foundation says that 55% of physicians know a doctor who considered, attempted, or died by suicide. Doctor’s Burden: Medscape Physician Suicide Report 2023 asked more than 9,000 doctors if they had suicidal thoughts. Nine percent of male physicians and 11% of female physicians said yes.
Why do so many doctors take their own lives?
“It’s not a new phenomenon,” says Rajnish Jaiswal, MD, associate chief of emergency medicine at NYC H+H Metropolitan Hospital and assistant professor of emergency medicine at New York Medical College. “There was a paper 150 years ago, published in England, which commented on the high rates of physician suicides compared to other professionals, and that trend has continued.”
Dr. Jaiswal says that the feeling in the physician community is that the numbers are even higher than what’s reported, unfortunately, which is an opinion echoed by other doctors this news organization spoke with for this story.
A perfect storm
Jodie Eckleberry-Hunt, PhD, a board-certified health psychologist, executive coach, and author, says the most significant culprit historically may be a rigid mindset that many physicians have. “There’s black and white, there’s a right answer and a wrong answer, there’s good and bad, and some physicians have a really hard time flexing,” she says.
Psychological flexibility underlies resilience. Dr. Eckleberry-Hunt says, “Think about your bounce factor and how that resilience is protective. Life isn’t always going to go well. You have to be able to flex and bounce, and some physicians (not all of them, of course) tend to be lower on cognitive flexibility.”
Brad Fern, coach and psychotherapist at Fern Executive and Physician Consulting, Minneapolis, says he uses two analogies that help when he works with physicians. One is the evil twins, and the other is the pressure cooker.
Mr. Fern says that the evil twins are silence and isolation and that several professions, including physicians, fall prey to these. To put any dent in suicidal ideations and suicide, Mr. Fern says, these must be addressed.
“Physicians tend not to talk about what’s bothering them, and that’s for many different reasons. They disproportionally tend to be great at helping other people but not great at receiving help themselves.”
On top of that, there’s a pressure cooker where they work. Mr. Fern doesn’t think anyone would argue that the health care system in the United States is not dysfunctional, at least to some degree. He says that this dysfunction acts like the physicians’ pressure cooker.
Add in circumstances, cultures, and day-to-day issues everyone has, like relational issues, parenting issues, and mental health problems. Then, toss in an individual’s lower resiliency, the inability to receive help, and a predicament for good measure – a loss, a divorce, or financial woes, for instance, which can overwhelm. Mr. Fern says it can be a mathematical equation for suicidal ideation.
Is there a why?
“Some people think there’s a reason for suicide, but often, there’s a spectrum of reasons,” says Mr. Fern. He says that some physicians are trying to escape emotional pain. For others, it can be fear or a revenge thing, like, “the hell with you, I’m going to kill myself.” It can be getting attention the way teens do, as professionals have seen. Then there’s the organic component, like brain trauma, brain imbalance, depression, anxiety, or bipolar disorder. And finally, a drug or alcohol issue.
“But the reason why physician suicide is elevated, I think, is because there’s this ethos around being silent and, ‘I’m going to listen to and solve everyone else’s problems, but I’m not going to reach out and get help for my own,’ ” says Mr. Fern. “If you take advantage of mental health services, you’re implying that you’re mentally ill. And most physicians aren’t going to do that.”
On the positive side, Dr. Eckleberry-Hunt says that she sees many younger physicians discussing trauma. As a result, they’re more open to receiving help than previous generations. She speculates whether physicians have always had trauma from their past and whether current-day issues are now triggering it or whether they have more trauma these days. “Are they talking about it more, or is it experienced more?”
The failure of the system
The building blocks for physician suicide may have been there from the beginning. “From your first day of medical school and throughout your career, there was a very rigid system in place that is quite unforgiving, is quite stressful, and demands a lot,” says Dr. Jaiswal. And it’s within this system that physicians must operate.
“You have all the corporations, entities, organizations, [and] medical societies talking about physician wellness, burnout, and suicide, but the reality is it’s not making that much of a difference,” he says.
In her report, “What I’ve Learned From 1,710 Doctor Suicides,” Pamelia Wible, MD, who runs a physician suicide helpline that physicians can email and get an immediate callback, likens the current system to assembly line medicine.
Dr. Eckleberry-Hunt thinks the message has been bungled in health care. Everyone discusses burnout, meditation, self-care, and other essential constructs. “But we don’t deal with the root cause [of suicide]. Instead, we teach you soothing strategies.”
Further, Dr. Jaiswal says that not all physicians who commit suicide experience burnout or are experiencing burnout and that the vast majority of physicians who experience burnout don’t have suicidal ideation. “In the sense, that ‘let’s address physician burnout and that will hopefully translate to a reduced number of physician suicides’ – there is a very tenuous argument to be made for that because that is just one aspect in this complex system,” he says.
We need more than just lip service on suicide
Overall, the experts interviewed for this article acknowledged that the system is at least talking about physician suicide, which is a big first step. However, most agree that where big health entities go wrong is that they set up wellness or mental health programs, they implement a wellness officer, they write up talking points for physicians who need mental health care to get that care, and they think they’ve done their job, that they’ve done what’s required to address the problem.
But Dr. Jaiswal thinks these are often mostly public-relations rebuttals. Mr. Fern suggests, “It’s a show that’s not effective.” And Dr. Eckleberry-Hunt says that “even if you had a legit, well-funded well-being program for health care providers, you would still have a baseline rate of physician suicide, and that gets down to having drug and alcohol education and talking about having a system for physicians to access that doesn’t come along with insurance billing” – one that doesn’t create a paper trail and follow physician licensure and job applications for the rest of their career; one that doesn’t associate their mental health care with their work institution; one that offers confidentiality.
“For most folks, there is still a big distrust in the system. As physicians, very few of them feel that the system that they’re operating in has their best interest at heart. And that is why very few physicians will self-report any mental health issues, depression, or even ideation to colleagues, superiors, or managers,” says Dr. Jaiswal. Many more feel skeptical about the confidentiality of the programs in place.
The experts acknowledge that many people are trying to work on this and bring about change on multiple levels – grassroots, department levels, state, and federal. “But I think the biggest thing that the system has to do is earn back the trust of the physician,” Dr. Jaiswal adds.
“Physician suicide is a very visible problem in a very broken system. So, it’ll be very difficult in isolation to treat it without making any systemic changes, because that’s happening right now, and it’s not working,” says Dr. Jaiswal.
“The thing that I am most hopeful about is that I am seeing an influx of younger physicians who seek me out, and granted, their training programs tell them to come and see me, but they are ready and willing to talk about their mental health separate from work. They’re not coming in saying, ‘Here are all the people who I blame.’ They’re saying, ‘These are my struggles, and I want to be a better, happier physician,’ ” says Dr. Eckleberry-Hunt.
A version of this article originally appeared on Medscape.com.
Physicians are admired for their sacrifice and dedication. Yet beneath the surface lies a painful, quiet reality:
The Physicians Foundation says that 55% of physicians know a doctor who considered, attempted, or died by suicide. Doctor’s Burden: Medscape Physician Suicide Report 2023 asked more than 9,000 doctors if they had suicidal thoughts. Nine percent of male physicians and 11% of female physicians said yes.
Why do so many doctors take their own lives?
“It’s not a new phenomenon,” says Rajnish Jaiswal, MD, associate chief of emergency medicine at NYC H+H Metropolitan Hospital and assistant professor of emergency medicine at New York Medical College. “There was a paper 150 years ago, published in England, which commented on the high rates of physician suicides compared to other professionals, and that trend has continued.”
Dr. Jaiswal says that the feeling in the physician community is that the numbers are even higher than what’s reported, unfortunately, which is an opinion echoed by other doctors this news organization spoke with for this story.
A perfect storm
Jodie Eckleberry-Hunt, PhD, a board-certified health psychologist, executive coach, and author, says the most significant culprit historically may be a rigid mindset that many physicians have. “There’s black and white, there’s a right answer and a wrong answer, there’s good and bad, and some physicians have a really hard time flexing,” she says.
Psychological flexibility underlies resilience. Dr. Eckleberry-Hunt says, “Think about your bounce factor and how that resilience is protective. Life isn’t always going to go well. You have to be able to flex and bounce, and some physicians (not all of them, of course) tend to be lower on cognitive flexibility.”
Brad Fern, coach and psychotherapist at Fern Executive and Physician Consulting, Minneapolis, says he uses two analogies that help when he works with physicians. One is the evil twins, and the other is the pressure cooker.
Mr. Fern says that the evil twins are silence and isolation and that several professions, including physicians, fall prey to these. To put any dent in suicidal ideations and suicide, Mr. Fern says, these must be addressed.
“Physicians tend not to talk about what’s bothering them, and that’s for many different reasons. They disproportionally tend to be great at helping other people but not great at receiving help themselves.”
On top of that, there’s a pressure cooker where they work. Mr. Fern doesn’t think anyone would argue that the health care system in the United States is not dysfunctional, at least to some degree. He says that this dysfunction acts like the physicians’ pressure cooker.
Add in circumstances, cultures, and day-to-day issues everyone has, like relational issues, parenting issues, and mental health problems. Then, toss in an individual’s lower resiliency, the inability to receive help, and a predicament for good measure – a loss, a divorce, or financial woes, for instance, which can overwhelm. Mr. Fern says it can be a mathematical equation for suicidal ideation.
Is there a why?
“Some people think there’s a reason for suicide, but often, there’s a spectrum of reasons,” says Mr. Fern. He says that some physicians are trying to escape emotional pain. For others, it can be fear or a revenge thing, like, “the hell with you, I’m going to kill myself.” It can be getting attention the way teens do, as professionals have seen. Then there’s the organic component, like brain trauma, brain imbalance, depression, anxiety, or bipolar disorder. And finally, a drug or alcohol issue.
“But the reason why physician suicide is elevated, I think, is because there’s this ethos around being silent and, ‘I’m going to listen to and solve everyone else’s problems, but I’m not going to reach out and get help for my own,’ ” says Mr. Fern. “If you take advantage of mental health services, you’re implying that you’re mentally ill. And most physicians aren’t going to do that.”
On the positive side, Dr. Eckleberry-Hunt says that she sees many younger physicians discussing trauma. As a result, they’re more open to receiving help than previous generations. She speculates whether physicians have always had trauma from their past and whether current-day issues are now triggering it or whether they have more trauma these days. “Are they talking about it more, or is it experienced more?”
The failure of the system
The building blocks for physician suicide may have been there from the beginning. “From your first day of medical school and throughout your career, there was a very rigid system in place that is quite unforgiving, is quite stressful, and demands a lot,” says Dr. Jaiswal. And it’s within this system that physicians must operate.
“You have all the corporations, entities, organizations, [and] medical societies talking about physician wellness, burnout, and suicide, but the reality is it’s not making that much of a difference,” he says.
In her report, “What I’ve Learned From 1,710 Doctor Suicides,” Pamelia Wible, MD, who runs a physician suicide helpline that physicians can email and get an immediate callback, likens the current system to assembly line medicine.
Dr. Eckleberry-Hunt thinks the message has been bungled in health care. Everyone discusses burnout, meditation, self-care, and other essential constructs. “But we don’t deal with the root cause [of suicide]. Instead, we teach you soothing strategies.”
Further, Dr. Jaiswal says that not all physicians who commit suicide experience burnout or are experiencing burnout and that the vast majority of physicians who experience burnout don’t have suicidal ideation. “In the sense, that ‘let’s address physician burnout and that will hopefully translate to a reduced number of physician suicides’ – there is a very tenuous argument to be made for that because that is just one aspect in this complex system,” he says.
We need more than just lip service on suicide
Overall, the experts interviewed for this article acknowledged that the system is at least talking about physician suicide, which is a big first step. However, most agree that where big health entities go wrong is that they set up wellness or mental health programs, they implement a wellness officer, they write up talking points for physicians who need mental health care to get that care, and they think they’ve done their job, that they’ve done what’s required to address the problem.
But Dr. Jaiswal thinks these are often mostly public-relations rebuttals. Mr. Fern suggests, “It’s a show that’s not effective.” And Dr. Eckleberry-Hunt says that “even if you had a legit, well-funded well-being program for health care providers, you would still have a baseline rate of physician suicide, and that gets down to having drug and alcohol education and talking about having a system for physicians to access that doesn’t come along with insurance billing” – one that doesn’t create a paper trail and follow physician licensure and job applications for the rest of their career; one that doesn’t associate their mental health care with their work institution; one that offers confidentiality.
“For most folks, there is still a big distrust in the system. As physicians, very few of them feel that the system that they’re operating in has their best interest at heart. And that is why very few physicians will self-report any mental health issues, depression, or even ideation to colleagues, superiors, or managers,” says Dr. Jaiswal. Many more feel skeptical about the confidentiality of the programs in place.
The experts acknowledge that many people are trying to work on this and bring about change on multiple levels – grassroots, department levels, state, and federal. “But I think the biggest thing that the system has to do is earn back the trust of the physician,” Dr. Jaiswal adds.
“Physician suicide is a very visible problem in a very broken system. So, it’ll be very difficult in isolation to treat it without making any systemic changes, because that’s happening right now, and it’s not working,” says Dr. Jaiswal.
“The thing that I am most hopeful about is that I am seeing an influx of younger physicians who seek me out, and granted, their training programs tell them to come and see me, but they are ready and willing to talk about their mental health separate from work. They’re not coming in saying, ‘Here are all the people who I blame.’ They’re saying, ‘These are my struggles, and I want to be a better, happier physician,’ ” says Dr. Eckleberry-Hunt.
A version of this article originally appeared on Medscape.com.
Physicians are admired for their sacrifice and dedication. Yet beneath the surface lies a painful, quiet reality:
The Physicians Foundation says that 55% of physicians know a doctor who considered, attempted, or died by suicide. Doctor’s Burden: Medscape Physician Suicide Report 2023 asked more than 9,000 doctors if they had suicidal thoughts. Nine percent of male physicians and 11% of female physicians said yes.
Why do so many doctors take their own lives?
“It’s not a new phenomenon,” says Rajnish Jaiswal, MD, associate chief of emergency medicine at NYC H+H Metropolitan Hospital and assistant professor of emergency medicine at New York Medical College. “There was a paper 150 years ago, published in England, which commented on the high rates of physician suicides compared to other professionals, and that trend has continued.”
Dr. Jaiswal says that the feeling in the physician community is that the numbers are even higher than what’s reported, unfortunately, which is an opinion echoed by other doctors this news organization spoke with for this story.
A perfect storm
Jodie Eckleberry-Hunt, PhD, a board-certified health psychologist, executive coach, and author, says the most significant culprit historically may be a rigid mindset that many physicians have. “There’s black and white, there’s a right answer and a wrong answer, there’s good and bad, and some physicians have a really hard time flexing,” she says.
Psychological flexibility underlies resilience. Dr. Eckleberry-Hunt says, “Think about your bounce factor and how that resilience is protective. Life isn’t always going to go well. You have to be able to flex and bounce, and some physicians (not all of them, of course) tend to be lower on cognitive flexibility.”
Brad Fern, coach and psychotherapist at Fern Executive and Physician Consulting, Minneapolis, says he uses two analogies that help when he works with physicians. One is the evil twins, and the other is the pressure cooker.
Mr. Fern says that the evil twins are silence and isolation and that several professions, including physicians, fall prey to these. To put any dent in suicidal ideations and suicide, Mr. Fern says, these must be addressed.
“Physicians tend not to talk about what’s bothering them, and that’s for many different reasons. They disproportionally tend to be great at helping other people but not great at receiving help themselves.”
On top of that, there’s a pressure cooker where they work. Mr. Fern doesn’t think anyone would argue that the health care system in the United States is not dysfunctional, at least to some degree. He says that this dysfunction acts like the physicians’ pressure cooker.
Add in circumstances, cultures, and day-to-day issues everyone has, like relational issues, parenting issues, and mental health problems. Then, toss in an individual’s lower resiliency, the inability to receive help, and a predicament for good measure – a loss, a divorce, or financial woes, for instance, which can overwhelm. Mr. Fern says it can be a mathematical equation for suicidal ideation.
Is there a why?
“Some people think there’s a reason for suicide, but often, there’s a spectrum of reasons,” says Mr. Fern. He says that some physicians are trying to escape emotional pain. For others, it can be fear or a revenge thing, like, “the hell with you, I’m going to kill myself.” It can be getting attention the way teens do, as professionals have seen. Then there’s the organic component, like brain trauma, brain imbalance, depression, anxiety, or bipolar disorder. And finally, a drug or alcohol issue.
“But the reason why physician suicide is elevated, I think, is because there’s this ethos around being silent and, ‘I’m going to listen to and solve everyone else’s problems, but I’m not going to reach out and get help for my own,’ ” says Mr. Fern. “If you take advantage of mental health services, you’re implying that you’re mentally ill. And most physicians aren’t going to do that.”
On the positive side, Dr. Eckleberry-Hunt says that she sees many younger physicians discussing trauma. As a result, they’re more open to receiving help than previous generations. She speculates whether physicians have always had trauma from their past and whether current-day issues are now triggering it or whether they have more trauma these days. “Are they talking about it more, or is it experienced more?”
The failure of the system
The building blocks for physician suicide may have been there from the beginning. “From your first day of medical school and throughout your career, there was a very rigid system in place that is quite unforgiving, is quite stressful, and demands a lot,” says Dr. Jaiswal. And it’s within this system that physicians must operate.
“You have all the corporations, entities, organizations, [and] medical societies talking about physician wellness, burnout, and suicide, but the reality is it’s not making that much of a difference,” he says.
In her report, “What I’ve Learned From 1,710 Doctor Suicides,” Pamelia Wible, MD, who runs a physician suicide helpline that physicians can email and get an immediate callback, likens the current system to assembly line medicine.
Dr. Eckleberry-Hunt thinks the message has been bungled in health care. Everyone discusses burnout, meditation, self-care, and other essential constructs. “But we don’t deal with the root cause [of suicide]. Instead, we teach you soothing strategies.”
Further, Dr. Jaiswal says that not all physicians who commit suicide experience burnout or are experiencing burnout and that the vast majority of physicians who experience burnout don’t have suicidal ideation. “In the sense, that ‘let’s address physician burnout and that will hopefully translate to a reduced number of physician suicides’ – there is a very tenuous argument to be made for that because that is just one aspect in this complex system,” he says.
We need more than just lip service on suicide
Overall, the experts interviewed for this article acknowledged that the system is at least talking about physician suicide, which is a big first step. However, most agree that where big health entities go wrong is that they set up wellness or mental health programs, they implement a wellness officer, they write up talking points for physicians who need mental health care to get that care, and they think they’ve done their job, that they’ve done what’s required to address the problem.
But Dr. Jaiswal thinks these are often mostly public-relations rebuttals. Mr. Fern suggests, “It’s a show that’s not effective.” And Dr. Eckleberry-Hunt says that “even if you had a legit, well-funded well-being program for health care providers, you would still have a baseline rate of physician suicide, and that gets down to having drug and alcohol education and talking about having a system for physicians to access that doesn’t come along with insurance billing” – one that doesn’t create a paper trail and follow physician licensure and job applications for the rest of their career; one that doesn’t associate their mental health care with their work institution; one that offers confidentiality.
“For most folks, there is still a big distrust in the system. As physicians, very few of them feel that the system that they’re operating in has their best interest at heart. And that is why very few physicians will self-report any mental health issues, depression, or even ideation to colleagues, superiors, or managers,” says Dr. Jaiswal. Many more feel skeptical about the confidentiality of the programs in place.
The experts acknowledge that many people are trying to work on this and bring about change on multiple levels – grassroots, department levels, state, and federal. “But I think the biggest thing that the system has to do is earn back the trust of the physician,” Dr. Jaiswal adds.
“Physician suicide is a very visible problem in a very broken system. So, it’ll be very difficult in isolation to treat it without making any systemic changes, because that’s happening right now, and it’s not working,” says Dr. Jaiswal.
“The thing that I am most hopeful about is that I am seeing an influx of younger physicians who seek me out, and granted, their training programs tell them to come and see me, but they are ready and willing to talk about their mental health separate from work. They’re not coming in saying, ‘Here are all the people who I blame.’ They’re saying, ‘These are my struggles, and I want to be a better, happier physician,’ ” says Dr. Eckleberry-Hunt.
A version of this article originally appeared on Medscape.com.
Ulcerative colitis cases projected to top 2 million in eight countries by 2031
The data and analytics company’s report offers projections for diagnosed incident and prevalent cases of UC in the United States, United Kingdom, Germany, Spain, Japan, Italy, France, and Canada.
In 2031, the United States will have the highest number of diagnosed prevalent cases of UC, with 655,317 cases, whereas Canada will have the fewest, with 91,186 cases, the company projects.
“UC can occur at any age, although most people are diagnosed in their mid-thirties. Men and women are equally likely to be affected, but older men are more likely to be diagnosed than older women,” Bharti Prabhakar, MPH, associate project manager at GlobalData, said in a statement.
In all eight countries, adults aged 30-69 years accounted for more than 65% of the diagnosed prevalent cases of UC, whereas those younger than 20 years made up less than 3% of the cases, GlobalData noted.
Incidence also rising
Diagnosed incident cases of UC in the eight countries are expected to increase from 160,122 cases in 2021 to 168,467 cases in 2031, at an annual growth rate of 0.52%, the company said.
In 2031, the United States will have the highest number of diagnosed incident cases of UC, with 104,795 cases, and France will have the fewest, with 2972 cases, the company predicted.
GlobalData epidemiologists attribute the predicted increases in UC prevalence and incidence to changes in population dynamics in each country.
The forecast is supported by historical data obtained from peer-reviewed articles and population-based studies, the firm noted.
The methodology was kept consistent across the eight countries to allow for a meaningful comparison of the forecast incident and prevalent cases of UC across these markets, GlobalData added.
“UC can affect people of any racial or ethnic group,” Ms. Prabhakar stated. “Genes, abnormal immune reactions, the microbiome, diet, stress, and the environment have all been suggested as triggers, but there is no definite evidence that any one of these factors is the cause of UC.”
Western countries have reported high incidence and prevalence of UC, Ms. Prabhaker noted. “Therefore, environmental factors may either suppress or reinforce inherent predispositions for UC and might also be crucial in triggering disease onset.”
A version of this article originally appeared on Medscape.com.
The data and analytics company’s report offers projections for diagnosed incident and prevalent cases of UC in the United States, United Kingdom, Germany, Spain, Japan, Italy, France, and Canada.
In 2031, the United States will have the highest number of diagnosed prevalent cases of UC, with 655,317 cases, whereas Canada will have the fewest, with 91,186 cases, the company projects.
“UC can occur at any age, although most people are diagnosed in their mid-thirties. Men and women are equally likely to be affected, but older men are more likely to be diagnosed than older women,” Bharti Prabhakar, MPH, associate project manager at GlobalData, said in a statement.
In all eight countries, adults aged 30-69 years accounted for more than 65% of the diagnosed prevalent cases of UC, whereas those younger than 20 years made up less than 3% of the cases, GlobalData noted.
Incidence also rising
Diagnosed incident cases of UC in the eight countries are expected to increase from 160,122 cases in 2021 to 168,467 cases in 2031, at an annual growth rate of 0.52%, the company said.
In 2031, the United States will have the highest number of diagnosed incident cases of UC, with 104,795 cases, and France will have the fewest, with 2972 cases, the company predicted.
GlobalData epidemiologists attribute the predicted increases in UC prevalence and incidence to changes in population dynamics in each country.
The forecast is supported by historical data obtained from peer-reviewed articles and population-based studies, the firm noted.
The methodology was kept consistent across the eight countries to allow for a meaningful comparison of the forecast incident and prevalent cases of UC across these markets, GlobalData added.
“UC can affect people of any racial or ethnic group,” Ms. Prabhakar stated. “Genes, abnormal immune reactions, the microbiome, diet, stress, and the environment have all been suggested as triggers, but there is no definite evidence that any one of these factors is the cause of UC.”
Western countries have reported high incidence and prevalence of UC, Ms. Prabhaker noted. “Therefore, environmental factors may either suppress or reinforce inherent predispositions for UC and might also be crucial in triggering disease onset.”
A version of this article originally appeared on Medscape.com.
The data and analytics company’s report offers projections for diagnosed incident and prevalent cases of UC in the United States, United Kingdom, Germany, Spain, Japan, Italy, France, and Canada.
In 2031, the United States will have the highest number of diagnosed prevalent cases of UC, with 655,317 cases, whereas Canada will have the fewest, with 91,186 cases, the company projects.
“UC can occur at any age, although most people are diagnosed in their mid-thirties. Men and women are equally likely to be affected, but older men are more likely to be diagnosed than older women,” Bharti Prabhakar, MPH, associate project manager at GlobalData, said in a statement.
In all eight countries, adults aged 30-69 years accounted for more than 65% of the diagnosed prevalent cases of UC, whereas those younger than 20 years made up less than 3% of the cases, GlobalData noted.
Incidence also rising
Diagnosed incident cases of UC in the eight countries are expected to increase from 160,122 cases in 2021 to 168,467 cases in 2031, at an annual growth rate of 0.52%, the company said.
In 2031, the United States will have the highest number of diagnosed incident cases of UC, with 104,795 cases, and France will have the fewest, with 2972 cases, the company predicted.
GlobalData epidemiologists attribute the predicted increases in UC prevalence and incidence to changes in population dynamics in each country.
The forecast is supported by historical data obtained from peer-reviewed articles and population-based studies, the firm noted.
The methodology was kept consistent across the eight countries to allow for a meaningful comparison of the forecast incident and prevalent cases of UC across these markets, GlobalData added.
“UC can affect people of any racial or ethnic group,” Ms. Prabhakar stated. “Genes, abnormal immune reactions, the microbiome, diet, stress, and the environment have all been suggested as triggers, but there is no definite evidence that any one of these factors is the cause of UC.”
Western countries have reported high incidence and prevalence of UC, Ms. Prabhaker noted. “Therefore, environmental factors may either suppress or reinforce inherent predispositions for UC and might also be crucial in triggering disease onset.”
A version of this article originally appeared on Medscape.com.
Oral PCSK9 inhibitor shows encouraging LDL lowering
A new oral formulation of a PCSK9-inhibiting, cholesterol-lowering drug in development by Merck has shown encouraging results in a phase 2 study.
The study was presented by Christie Ballantyne, MD, Baylor College of Medicine, Houston, at the joint scientific sessions of the American College of Cardiology and the World Heart Federation.
“In this diverse population of hypercholesterolemic patients, all doses of MK-0616 showed superior reduction of LDL vs. placebo up to a 60.9% placebo-adjusted reduction from baseline to week 8, which was consistent across subgroups,” Dr. Ballantyne reported.
“Reduction in ApoB and non-HDL cholesterol were consistent with that of LDL cholesterol, with up to a 51.8% reduction in ApoB and a 55.8% reduction in non-HDL,” he noted.
He added that the drug was well tolerated with no difference in adverse events across the treatment groups, compared with placebo.
“These data support the further development of MK-0616, an oral PCSK9 inhibitor that may improve access to effective LDL-cholesterol lowering therapies and improve attainment of guideline-recommended LDL goals aimed at reducing cardiovascular risk,” Dr. Ballantyne concluded. “The results are encouraging for a phase 3 program that is now being designed.”
He explained that elevated LDL is a primary causative factor for atherosclerotic cardiovascular disease (ASCVD), and despite effective treatments (statins), a large proportion of patients fail to achieve guideline-recommended LDL levels. Injectable treatments targeting PCSK9 have demonstrated large reductions in LDL and decreased risk of ASCVD events, but access barriers and need for repeat injections have led to poor adoption. An oral PCSK9 inhibitor may widen access and improve attainment of guideline-recommended treatment goals.
Dr. Ballantyne described the new drug, MK-0616, as a “macrocyclic peptide that can bind PCSK9 with monoclonal antibody-like affinity at 1/100th of the molecular weight.”
The current phase 2 study included 381 adult patients (49% female; median age 62 years) with a wide range of ASCVD risk. Average LDL-C level was 119.5 mg/dL at baseline. Around 40% of patients were not taking statins, 35% were on low- to moderate-intensity statin therapy, and 26% were on high-intensity statin therapy.
They were randomly assigned to four different doses of MK-0616 (6, 12, 18, or 30 mg once daily) or matching placebo.
Results showed that all doses of MK-0616 demonstrated statistically significant differences in percentage change in LDL-C from baseline to week 8 vs. placebo: –41.2% (6 mg), –55.7% (12 mg), –59.1% (18 mg), and –60.9% (30 mg).
The mean percentage changes in ApoB from baseline vs. placebo were –32.8%, –45.8%, –48.7%, and 51.8% for the four escalating doses of the drug. And non-HDL cholesterol changes were –35.9%, –50.5%, –53.2%, and –55.8% respectively.
The proportion of participants at protocol-defined goals for LDL reduction was 80.5%, 85.5%, 90.8%, and 90.8% with MK-0616 at the 6-mg, 12-mg, 18-mg, and 30-mg doses, compared with 9.3% with placebo.
Dr. Ballantyne reported that the efficacy looked similar in all subgroups, and regardless of baseline therapy.
“This was a dose-finding study, which will help select a dose to be taken forward in larger studies, and it looks from these results as though you get most of the efficacy by 12 mg,” he added.
Adverse events occurred in a proportion of participants in the MK-0616 groups (39.5% to 43.4%) similar to that of placebo (44.0%), and discontinuations as a result of adverse events occurred in two or fewer participants in any treatment group.
‘Super exciting’
Putting the results of his study into perspective at an ACC press conference, Rhonda Cooper-DeHoff, PharmD, associate professor in the department of pharmacotherapy and translational research at the University of Florida in Gainesville, commented.
“For the last quarter of a century we have had statins available to treat elevated LDL and atherosclerosis and despite that we have many patients who refuse to take statins or are afraid to take statins,” she said. “This is not about cost as the statins are all available generically now. But many patients claim to be intolerant or unresponsive.”
She noted that in 2015/2016 the first injectable PCSK9 inhibitors became available “which really were very exciting molecules, but they have a high cost and access issues, and patients often do not like injections so there are still a lot of issues.”
Dr. Cooper-DeHoff pointed out that this oral PCSK9 inhibitor seems to be as effective at lowering LDL as the injectable products regardless of whether statins are on board or not, which she said was “super exciting.”
She added: “We are all going to be waiting excitedly for the outcome data with this oral PCSK9 inhibitor.”
She also noted that another study (CLEAR Outcomes) presented at the ACC meeting showed good lipid-lowering results and a reduction in cardiovascular outcomes in statin-intolerant patients with another oral lipid lowering drug, bempedoic acid (Nexletol).
She said the two oral drugs promised a “very bright for the future for LDL lowering and the treatment of atherosclerosis in our patients,” adding that “we are now really chipping away at the barriers to achieving the holy grail of guideline-directed LDL lowering to prevent hard outcomes.”
The results were published online in the Journal of the American College of Cardiology at the time of presentation.
This study was funded by Merck. Dr. Ballantyne has received grant/research support through his institution from Abbott Diagnostic, Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, New Amsterdam, Novartis, Novo Nordisk, Regeneron, and Roche Diagnostics and has been a consultant for 89Bio, Abbott Diagnostics, Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Denka Seiken, Esperion, Genentech, Gilead, Illumina, Ionis, Matinas BioPharma, Merck, New Amsterdam, Novartis, Novo Nordisk, Pfizer, Regeneron, and Roche Diagnostics.
A version of this article first appeared on Medscape.com.
A new oral formulation of a PCSK9-inhibiting, cholesterol-lowering drug in development by Merck has shown encouraging results in a phase 2 study.
The study was presented by Christie Ballantyne, MD, Baylor College of Medicine, Houston, at the joint scientific sessions of the American College of Cardiology and the World Heart Federation.
“In this diverse population of hypercholesterolemic patients, all doses of MK-0616 showed superior reduction of LDL vs. placebo up to a 60.9% placebo-adjusted reduction from baseline to week 8, which was consistent across subgroups,” Dr. Ballantyne reported.
“Reduction in ApoB and non-HDL cholesterol were consistent with that of LDL cholesterol, with up to a 51.8% reduction in ApoB and a 55.8% reduction in non-HDL,” he noted.
He added that the drug was well tolerated with no difference in adverse events across the treatment groups, compared with placebo.
“These data support the further development of MK-0616, an oral PCSK9 inhibitor that may improve access to effective LDL-cholesterol lowering therapies and improve attainment of guideline-recommended LDL goals aimed at reducing cardiovascular risk,” Dr. Ballantyne concluded. “The results are encouraging for a phase 3 program that is now being designed.”
He explained that elevated LDL is a primary causative factor for atherosclerotic cardiovascular disease (ASCVD), and despite effective treatments (statins), a large proportion of patients fail to achieve guideline-recommended LDL levels. Injectable treatments targeting PCSK9 have demonstrated large reductions in LDL and decreased risk of ASCVD events, but access barriers and need for repeat injections have led to poor adoption. An oral PCSK9 inhibitor may widen access and improve attainment of guideline-recommended treatment goals.
Dr. Ballantyne described the new drug, MK-0616, as a “macrocyclic peptide that can bind PCSK9 with monoclonal antibody-like affinity at 1/100th of the molecular weight.”
The current phase 2 study included 381 adult patients (49% female; median age 62 years) with a wide range of ASCVD risk. Average LDL-C level was 119.5 mg/dL at baseline. Around 40% of patients were not taking statins, 35% were on low- to moderate-intensity statin therapy, and 26% were on high-intensity statin therapy.
They were randomly assigned to four different doses of MK-0616 (6, 12, 18, or 30 mg once daily) or matching placebo.
Results showed that all doses of MK-0616 demonstrated statistically significant differences in percentage change in LDL-C from baseline to week 8 vs. placebo: –41.2% (6 mg), –55.7% (12 mg), –59.1% (18 mg), and –60.9% (30 mg).
The mean percentage changes in ApoB from baseline vs. placebo were –32.8%, –45.8%, –48.7%, and 51.8% for the four escalating doses of the drug. And non-HDL cholesterol changes were –35.9%, –50.5%, –53.2%, and –55.8% respectively.
The proportion of participants at protocol-defined goals for LDL reduction was 80.5%, 85.5%, 90.8%, and 90.8% with MK-0616 at the 6-mg, 12-mg, 18-mg, and 30-mg doses, compared with 9.3% with placebo.
Dr. Ballantyne reported that the efficacy looked similar in all subgroups, and regardless of baseline therapy.
“This was a dose-finding study, which will help select a dose to be taken forward in larger studies, and it looks from these results as though you get most of the efficacy by 12 mg,” he added.
Adverse events occurred in a proportion of participants in the MK-0616 groups (39.5% to 43.4%) similar to that of placebo (44.0%), and discontinuations as a result of adverse events occurred in two or fewer participants in any treatment group.
‘Super exciting’
Putting the results of his study into perspective at an ACC press conference, Rhonda Cooper-DeHoff, PharmD, associate professor in the department of pharmacotherapy and translational research at the University of Florida in Gainesville, commented.
“For the last quarter of a century we have had statins available to treat elevated LDL and atherosclerosis and despite that we have many patients who refuse to take statins or are afraid to take statins,” she said. “This is not about cost as the statins are all available generically now. But many patients claim to be intolerant or unresponsive.”
She noted that in 2015/2016 the first injectable PCSK9 inhibitors became available “which really were very exciting molecules, but they have a high cost and access issues, and patients often do not like injections so there are still a lot of issues.”
Dr. Cooper-DeHoff pointed out that this oral PCSK9 inhibitor seems to be as effective at lowering LDL as the injectable products regardless of whether statins are on board or not, which she said was “super exciting.”
She added: “We are all going to be waiting excitedly for the outcome data with this oral PCSK9 inhibitor.”
She also noted that another study (CLEAR Outcomes) presented at the ACC meeting showed good lipid-lowering results and a reduction in cardiovascular outcomes in statin-intolerant patients with another oral lipid lowering drug, bempedoic acid (Nexletol).
She said the two oral drugs promised a “very bright for the future for LDL lowering and the treatment of atherosclerosis in our patients,” adding that “we are now really chipping away at the barriers to achieving the holy grail of guideline-directed LDL lowering to prevent hard outcomes.”
The results were published online in the Journal of the American College of Cardiology at the time of presentation.
This study was funded by Merck. Dr. Ballantyne has received grant/research support through his institution from Abbott Diagnostic, Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, New Amsterdam, Novartis, Novo Nordisk, Regeneron, and Roche Diagnostics and has been a consultant for 89Bio, Abbott Diagnostics, Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Denka Seiken, Esperion, Genentech, Gilead, Illumina, Ionis, Matinas BioPharma, Merck, New Amsterdam, Novartis, Novo Nordisk, Pfizer, Regeneron, and Roche Diagnostics.
A version of this article first appeared on Medscape.com.
A new oral formulation of a PCSK9-inhibiting, cholesterol-lowering drug in development by Merck has shown encouraging results in a phase 2 study.
The study was presented by Christie Ballantyne, MD, Baylor College of Medicine, Houston, at the joint scientific sessions of the American College of Cardiology and the World Heart Federation.
“In this diverse population of hypercholesterolemic patients, all doses of MK-0616 showed superior reduction of LDL vs. placebo up to a 60.9% placebo-adjusted reduction from baseline to week 8, which was consistent across subgroups,” Dr. Ballantyne reported.
“Reduction in ApoB and non-HDL cholesterol were consistent with that of LDL cholesterol, with up to a 51.8% reduction in ApoB and a 55.8% reduction in non-HDL,” he noted.
He added that the drug was well tolerated with no difference in adverse events across the treatment groups, compared with placebo.
“These data support the further development of MK-0616, an oral PCSK9 inhibitor that may improve access to effective LDL-cholesterol lowering therapies and improve attainment of guideline-recommended LDL goals aimed at reducing cardiovascular risk,” Dr. Ballantyne concluded. “The results are encouraging for a phase 3 program that is now being designed.”
He explained that elevated LDL is a primary causative factor for atherosclerotic cardiovascular disease (ASCVD), and despite effective treatments (statins), a large proportion of patients fail to achieve guideline-recommended LDL levels. Injectable treatments targeting PCSK9 have demonstrated large reductions in LDL and decreased risk of ASCVD events, but access barriers and need for repeat injections have led to poor adoption. An oral PCSK9 inhibitor may widen access and improve attainment of guideline-recommended treatment goals.
Dr. Ballantyne described the new drug, MK-0616, as a “macrocyclic peptide that can bind PCSK9 with monoclonal antibody-like affinity at 1/100th of the molecular weight.”
The current phase 2 study included 381 adult patients (49% female; median age 62 years) with a wide range of ASCVD risk. Average LDL-C level was 119.5 mg/dL at baseline. Around 40% of patients were not taking statins, 35% were on low- to moderate-intensity statin therapy, and 26% were on high-intensity statin therapy.
They were randomly assigned to four different doses of MK-0616 (6, 12, 18, or 30 mg once daily) or matching placebo.
Results showed that all doses of MK-0616 demonstrated statistically significant differences in percentage change in LDL-C from baseline to week 8 vs. placebo: –41.2% (6 mg), –55.7% (12 mg), –59.1% (18 mg), and –60.9% (30 mg).
The mean percentage changes in ApoB from baseline vs. placebo were –32.8%, –45.8%, –48.7%, and 51.8% for the four escalating doses of the drug. And non-HDL cholesterol changes were –35.9%, –50.5%, –53.2%, and –55.8% respectively.
The proportion of participants at protocol-defined goals for LDL reduction was 80.5%, 85.5%, 90.8%, and 90.8% with MK-0616 at the 6-mg, 12-mg, 18-mg, and 30-mg doses, compared with 9.3% with placebo.
Dr. Ballantyne reported that the efficacy looked similar in all subgroups, and regardless of baseline therapy.
“This was a dose-finding study, which will help select a dose to be taken forward in larger studies, and it looks from these results as though you get most of the efficacy by 12 mg,” he added.
Adverse events occurred in a proportion of participants in the MK-0616 groups (39.5% to 43.4%) similar to that of placebo (44.0%), and discontinuations as a result of adverse events occurred in two or fewer participants in any treatment group.
‘Super exciting’
Putting the results of his study into perspective at an ACC press conference, Rhonda Cooper-DeHoff, PharmD, associate professor in the department of pharmacotherapy and translational research at the University of Florida in Gainesville, commented.
“For the last quarter of a century we have had statins available to treat elevated LDL and atherosclerosis and despite that we have many patients who refuse to take statins or are afraid to take statins,” she said. “This is not about cost as the statins are all available generically now. But many patients claim to be intolerant or unresponsive.”
She noted that in 2015/2016 the first injectable PCSK9 inhibitors became available “which really were very exciting molecules, but they have a high cost and access issues, and patients often do not like injections so there are still a lot of issues.”
Dr. Cooper-DeHoff pointed out that this oral PCSK9 inhibitor seems to be as effective at lowering LDL as the injectable products regardless of whether statins are on board or not, which she said was “super exciting.”
She added: “We are all going to be waiting excitedly for the outcome data with this oral PCSK9 inhibitor.”
She also noted that another study (CLEAR Outcomes) presented at the ACC meeting showed good lipid-lowering results and a reduction in cardiovascular outcomes in statin-intolerant patients with another oral lipid lowering drug, bempedoic acid (Nexletol).
She said the two oral drugs promised a “very bright for the future for LDL lowering and the treatment of atherosclerosis in our patients,” adding that “we are now really chipping away at the barriers to achieving the holy grail of guideline-directed LDL lowering to prevent hard outcomes.”
The results were published online in the Journal of the American College of Cardiology at the time of presentation.
This study was funded by Merck. Dr. Ballantyne has received grant/research support through his institution from Abbott Diagnostic, Akcea, Amgen, Arrowhead, Esperion, Ionis, Merck, New Amsterdam, Novartis, Novo Nordisk, Regeneron, and Roche Diagnostics and has been a consultant for 89Bio, Abbott Diagnostics, Alnylam Pharmaceuticals, Althera, Amarin, Amgen, Arrowhead, AstraZeneca, Denka Seiken, Esperion, Genentech, Gilead, Illumina, Ionis, Matinas BioPharma, Merck, New Amsterdam, Novartis, Novo Nordisk, Pfizer, Regeneron, and Roche Diagnostics.
A version of this article first appeared on Medscape.com.
FROM ACC 2023
Some, not all, ultraprocessed foods linked to type 2 diabetes
High total intake of ultraprocessed food (UPF) is associated with an increased risk of developing type 2 diabetes, suggests a large-scale analysis that nevertheless revealed that the risk applies only to certain such foods.
The research was recently published in Diabetes Care by Zhangling Chen, PhD, Erasmus MC Rotterdam, Netherlands, and colleagues.
Examining almost 200,000 participants in three U.S. studies, yielding more than 5 million person-years of follow-up, the scientists found that high intake of UPF was associated with a 28% increased risk of type 2 diabetes, after statistical adjustments.
However, the increased risk was restricted to certain UPFs, including ready meals, refined breads, sweetened beverages, and sauces and condiments, with other foods considered UPFs, such as cereals, dark- and whole grain breads, and packaged sweet and savory snacks, among others, associated with a reduced risk of diabetes.
Senior author Jean-Philippe Drouin-Chartier, PhD, Nutrition Center, Laval University, Quebec City, told this news organization: “While whole grain breads can be considered as ultraprocessed foods, their consumption should not be discouraged. In our study, we observed that whole grain breads consumption is inversely associated with type 2 diabetes risk. This is supported by many studies linking dietary fiber consumption to better cardiometabolic health.”
Ultraprocessed food intake higher in the U.S. than in Europe
The researchers note that a handful of European studies have also reported an association between UPF consumption and increased type 2 diabetes risk, with the effect ranging from 15% to 53%, depending on the level of intake and the cohort of patients studied.
They note, however, that total UPF intake in the U.S. is “much higher than in Europe,” particularly in the case of ultraprocessed breads and cereals and artificially or sugar-sweetened beverages.
In the current study, they examined data on 71,781 women from the Nurses’ Health Study, 87,918 women from the NHS II, and 38,847 men from the Health Professional Follow-up Study, none of whom had cardiovascular disease, cancer, or diabetes at baseline.
In all three studies, questionnaires were administered every 2 years to collect demographic, lifestyle, and medical information, and a validated food frequency questionnaire was used every 2-4 years to assess participants’ diets over 30 years of follow-up.
Using the NOVA Food Classification system, the items on the food frequency questionnaire were categorized into one of four groups: unprocessed or minimally processed foods; processed culinary ingredients; processed foods; or UPFs, which were subdivided into nine mutually exclusive subgroups.
Servings per day were then used to determine individual UPF intake.
Higher total UPF intake was associated with a greater total energy intake, body mass index, and prevalence of hypercholesterolemia and/or hypertension, as well as lower healthy eating scores and physical activity.
The researchers calculated that, over 5,187,678 person-years of follow-up, there were 19,503 cases of type 2 diabetes across the three study cohorts.
Multivariate analysis taking into consideration a range of potential risk factors, including BMI, revealed that, across the three study cohorts, the highest quintile of UPF intake was associated with a significantly increased risk of type 2 diabetes.
Compared with the lowest quintile of UPF intake, the hazard ratio for incident type 2 diabetes was 1.28 (P < .0001), with an increase in risk per additional serving per day of 3%.
The UPFs associated with a higher type 2 diabetes risk were as previously described and also included animal-based products and ready-to-eat mixed dishes.
In contrast, intake of UPFs including cereals, dark and whole grain breads, packaged sweet and savory snacks, fruit-based products, and yogurt and dairy-based desserts were linked to a reduced risk of type 2 diabetes.
Then to further validate their findings, the researchers conducted a meta-analysis of their own and four additional studies, comprising 415,554 participants and 21,932 events, with a follow-up of 3.4-32.0 years.
They determined that the pooled relative risk of type 2 diabetes with the highest versus lowest levels of UPF consumption was 1.40, with each 10% increase in total UPF intake associated with a 12% increase in diabetes risk.
Ideal is to have access to minimally processed foods
The NOVA food classification system states that UPFs are industrial formulations “made mostly or entirely with substances extracted from foods, often chemically modified, with additives and with little, if any, whole foods added.”
A recent study questioned the value of the NOVA classification after finding that it had “low consistency” when assigning foods.
Previous studies have nevertheless revealed that UPFs and their constituents negatively affect the gut microbiota and can cause systemic inflammation, insulin resistance, and increased body weight.
Dr. Drouin-Chartier concluded: “There is a need to facilitate ... access to minimally processed foods. This encompasses [appropriate] pricing and physical access [to such foods], that is, addressing the issue of food deserts.”
The NHS I and II and HPFS studies are supported by National Institutes of Health. Dr. Drouin-Chartier has reported a relationship with the Dairy Farmers of Canada. No other financial relationships were declared.
A version of this article first appeared on Medscape.com.
High total intake of ultraprocessed food (UPF) is associated with an increased risk of developing type 2 diabetes, suggests a large-scale analysis that nevertheless revealed that the risk applies only to certain such foods.
The research was recently published in Diabetes Care by Zhangling Chen, PhD, Erasmus MC Rotterdam, Netherlands, and colleagues.
Examining almost 200,000 participants in three U.S. studies, yielding more than 5 million person-years of follow-up, the scientists found that high intake of UPF was associated with a 28% increased risk of type 2 diabetes, after statistical adjustments.
However, the increased risk was restricted to certain UPFs, including ready meals, refined breads, sweetened beverages, and sauces and condiments, with other foods considered UPFs, such as cereals, dark- and whole grain breads, and packaged sweet and savory snacks, among others, associated with a reduced risk of diabetes.
Senior author Jean-Philippe Drouin-Chartier, PhD, Nutrition Center, Laval University, Quebec City, told this news organization: “While whole grain breads can be considered as ultraprocessed foods, their consumption should not be discouraged. In our study, we observed that whole grain breads consumption is inversely associated with type 2 diabetes risk. This is supported by many studies linking dietary fiber consumption to better cardiometabolic health.”
Ultraprocessed food intake higher in the U.S. than in Europe
The researchers note that a handful of European studies have also reported an association between UPF consumption and increased type 2 diabetes risk, with the effect ranging from 15% to 53%, depending on the level of intake and the cohort of patients studied.
They note, however, that total UPF intake in the U.S. is “much higher than in Europe,” particularly in the case of ultraprocessed breads and cereals and artificially or sugar-sweetened beverages.
In the current study, they examined data on 71,781 women from the Nurses’ Health Study, 87,918 women from the NHS II, and 38,847 men from the Health Professional Follow-up Study, none of whom had cardiovascular disease, cancer, or diabetes at baseline.
In all three studies, questionnaires were administered every 2 years to collect demographic, lifestyle, and medical information, and a validated food frequency questionnaire was used every 2-4 years to assess participants’ diets over 30 years of follow-up.
Using the NOVA Food Classification system, the items on the food frequency questionnaire were categorized into one of four groups: unprocessed or minimally processed foods; processed culinary ingredients; processed foods; or UPFs, which were subdivided into nine mutually exclusive subgroups.
Servings per day were then used to determine individual UPF intake.
Higher total UPF intake was associated with a greater total energy intake, body mass index, and prevalence of hypercholesterolemia and/or hypertension, as well as lower healthy eating scores and physical activity.
The researchers calculated that, over 5,187,678 person-years of follow-up, there were 19,503 cases of type 2 diabetes across the three study cohorts.
Multivariate analysis taking into consideration a range of potential risk factors, including BMI, revealed that, across the three study cohorts, the highest quintile of UPF intake was associated with a significantly increased risk of type 2 diabetes.
Compared with the lowest quintile of UPF intake, the hazard ratio for incident type 2 diabetes was 1.28 (P < .0001), with an increase in risk per additional serving per day of 3%.
The UPFs associated with a higher type 2 diabetes risk were as previously described and also included animal-based products and ready-to-eat mixed dishes.
In contrast, intake of UPFs including cereals, dark and whole grain breads, packaged sweet and savory snacks, fruit-based products, and yogurt and dairy-based desserts were linked to a reduced risk of type 2 diabetes.
Then to further validate their findings, the researchers conducted a meta-analysis of their own and four additional studies, comprising 415,554 participants and 21,932 events, with a follow-up of 3.4-32.0 years.
They determined that the pooled relative risk of type 2 diabetes with the highest versus lowest levels of UPF consumption was 1.40, with each 10% increase in total UPF intake associated with a 12% increase in diabetes risk.
Ideal is to have access to minimally processed foods
The NOVA food classification system states that UPFs are industrial formulations “made mostly or entirely with substances extracted from foods, often chemically modified, with additives and with little, if any, whole foods added.”
A recent study questioned the value of the NOVA classification after finding that it had “low consistency” when assigning foods.
Previous studies have nevertheless revealed that UPFs and their constituents negatively affect the gut microbiota and can cause systemic inflammation, insulin resistance, and increased body weight.
Dr. Drouin-Chartier concluded: “There is a need to facilitate ... access to minimally processed foods. This encompasses [appropriate] pricing and physical access [to such foods], that is, addressing the issue of food deserts.”
The NHS I and II and HPFS studies are supported by National Institutes of Health. Dr. Drouin-Chartier has reported a relationship with the Dairy Farmers of Canada. No other financial relationships were declared.
A version of this article first appeared on Medscape.com.
High total intake of ultraprocessed food (UPF) is associated with an increased risk of developing type 2 diabetes, suggests a large-scale analysis that nevertheless revealed that the risk applies only to certain such foods.
The research was recently published in Diabetes Care by Zhangling Chen, PhD, Erasmus MC Rotterdam, Netherlands, and colleagues.
Examining almost 200,000 participants in three U.S. studies, yielding more than 5 million person-years of follow-up, the scientists found that high intake of UPF was associated with a 28% increased risk of type 2 diabetes, after statistical adjustments.
However, the increased risk was restricted to certain UPFs, including ready meals, refined breads, sweetened beverages, and sauces and condiments, with other foods considered UPFs, such as cereals, dark- and whole grain breads, and packaged sweet and savory snacks, among others, associated with a reduced risk of diabetes.
Senior author Jean-Philippe Drouin-Chartier, PhD, Nutrition Center, Laval University, Quebec City, told this news organization: “While whole grain breads can be considered as ultraprocessed foods, their consumption should not be discouraged. In our study, we observed that whole grain breads consumption is inversely associated with type 2 diabetes risk. This is supported by many studies linking dietary fiber consumption to better cardiometabolic health.”
Ultraprocessed food intake higher in the U.S. than in Europe
The researchers note that a handful of European studies have also reported an association between UPF consumption and increased type 2 diabetes risk, with the effect ranging from 15% to 53%, depending on the level of intake and the cohort of patients studied.
They note, however, that total UPF intake in the U.S. is “much higher than in Europe,” particularly in the case of ultraprocessed breads and cereals and artificially or sugar-sweetened beverages.
In the current study, they examined data on 71,781 women from the Nurses’ Health Study, 87,918 women from the NHS II, and 38,847 men from the Health Professional Follow-up Study, none of whom had cardiovascular disease, cancer, or diabetes at baseline.
In all three studies, questionnaires were administered every 2 years to collect demographic, lifestyle, and medical information, and a validated food frequency questionnaire was used every 2-4 years to assess participants’ diets over 30 years of follow-up.
Using the NOVA Food Classification system, the items on the food frequency questionnaire were categorized into one of four groups: unprocessed or minimally processed foods; processed culinary ingredients; processed foods; or UPFs, which were subdivided into nine mutually exclusive subgroups.
Servings per day were then used to determine individual UPF intake.
Higher total UPF intake was associated with a greater total energy intake, body mass index, and prevalence of hypercholesterolemia and/or hypertension, as well as lower healthy eating scores and physical activity.
The researchers calculated that, over 5,187,678 person-years of follow-up, there were 19,503 cases of type 2 diabetes across the three study cohorts.
Multivariate analysis taking into consideration a range of potential risk factors, including BMI, revealed that, across the three study cohorts, the highest quintile of UPF intake was associated with a significantly increased risk of type 2 diabetes.
Compared with the lowest quintile of UPF intake, the hazard ratio for incident type 2 diabetes was 1.28 (P < .0001), with an increase in risk per additional serving per day of 3%.
The UPFs associated with a higher type 2 diabetes risk were as previously described and also included animal-based products and ready-to-eat mixed dishes.
In contrast, intake of UPFs including cereals, dark and whole grain breads, packaged sweet and savory snacks, fruit-based products, and yogurt and dairy-based desserts were linked to a reduced risk of type 2 diabetes.
Then to further validate their findings, the researchers conducted a meta-analysis of their own and four additional studies, comprising 415,554 participants and 21,932 events, with a follow-up of 3.4-32.0 years.
They determined that the pooled relative risk of type 2 diabetes with the highest versus lowest levels of UPF consumption was 1.40, with each 10% increase in total UPF intake associated with a 12% increase in diabetes risk.
Ideal is to have access to minimally processed foods
The NOVA food classification system states that UPFs are industrial formulations “made mostly or entirely with substances extracted from foods, often chemically modified, with additives and with little, if any, whole foods added.”
A recent study questioned the value of the NOVA classification after finding that it had “low consistency” when assigning foods.
Previous studies have nevertheless revealed that UPFs and their constituents negatively affect the gut microbiota and can cause systemic inflammation, insulin resistance, and increased body weight.
Dr. Drouin-Chartier concluded: “There is a need to facilitate ... access to minimally processed foods. This encompasses [appropriate] pricing and physical access [to such foods], that is, addressing the issue of food deserts.”
The NHS I and II and HPFS studies are supported by National Institutes of Health. Dr. Drouin-Chartier has reported a relationship with the Dairy Farmers of Canada. No other financial relationships were declared.
A version of this article first appeared on Medscape.com.
FROM DIABETES CARE
Spironolactone: an ‘inexpensive, effective’ option for acne in women
HONOLULU – In the clinical experience of Julie C. Harper, MD, an increasing number of women with acne are turning to off-label, long-term treatment with spironolactone.
“Spironolactone is fairly accessible, inexpensive, and effective for our patients,” Dr. Harper, a dermatologist who practices in Birmingham, Ala., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE!
An aldosterone receptor antagonist commonly used to treat high blood pressure and heart failure, spironolactone also has antiandrogenic properties with a proven track record for treating acne and hirsutism. It reduces androgen production, inhibits 5-alpha reductase, and increases sex hormone binding globulin. The dosing range for treating acne is 25 mg to 200 mg per day, but Dr. Harper prefers a maximum dose of 100 mg per day.
According to a systematic review of its use for acne in adult women, the most common side effect is menstrual irregularity, while other common side effects include breast tenderness/swelling, fatigue, and headaches.
“The higher the dose, the higher the rate of side effects,” she said. Concomitant use of an oral contraceptive lessens menstrual irregularities and prevents pregnancies, to avoid exposure during pregnancy and the hypothetical risk of feminization of the male fetus with exposure late in the first trimester. “Early in my career, I used to say if you’re going to be on spironolactone you’re also going to be on an oral contraceptive. But the longer I’ve practiced, I’ve learned that women who have a contraindication to birth control pills or who don’t want to take it can still benefit from an oral antiandrogen by being on spironolactone.”
A large retrospective analysis of 14-year data concluded that routine potassium monitoring is unnecessary for healthy women taking spironolactone for acne. “If you’re between the ages of 18 and 45, healthy, and not taking other medications where I’m worried about potassium levels, I’m not checking those levels at all,” Dr. Harper said.
Spironolactone labeling includes a boxed warning regarding the potential for tumorigenicity based on rat studies, but the dosages used in those studies were 25-250 times higher than the exposure dose in humans, Dr. Harper said.
Results from a systematic review and meta-analysis of seven studies in the medical literature found no evidence of an increased risk of breast cancer in women with exposure to spironolactone. “However, the certainty of the evidence was low and future studies are needed, including among diverse populations such as younger individuals and those with acne or hirsutism,” the study authors wrote.
In a separate study, researchers drew from patients in the Humana Insurance database from 2005 to 2017 to address whether spironolactone is associated with an increased risk of recurrence of breast cancer. Recurrent breast cancer was examined in 29,146 women with continuous health insurance for 2 years after a diagnosis of breast cancer. Of these, 746 were prescribed spironolactone, and the remainder were not. The researchers found that 123 women (16.5%) who were prescribed spironolactone had a breast cancer recurrence, compared with 3,649 women (12.8%) with a breast cancer recurrence who had not been prescribed spironolactone (P = .004). Adjusted Cox regression analysis following propensity matching showed no association between spironolactone and increased breast cancer recurrence (adjusted hazard ratio, 0.966; P = .953).
According to Dr. Harper, spironolactone may take about 3 months to kick in. “Likely this is a long-term treatment, and most of the time we’re going to be using it in combination with other acne treatments such as topical retinoids or topical benzoyl peroxide, oral antibiotics, or even isotretinoin.”
A study of long-term spironolactone use in 403 women found that the most common dose prescribed was 100 mg/day, and 68% of the women were concurrently prescribed a topical retinoid, 2.2% an oral antibiotic, and 40.7% an oral contraceptive.
The study population included 32 patients with a history of polycystic ovarian syndrome, 1 with a history of breast cancer, and 5 were hypercoagulable. Patients took the drug for a mean of 471 days. “As opposed to our antibiotics, where the course for patients is generally 3-4 months, when you start someone on spironolactone, they may end up staying on it,” Dr. Harper said.
Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, Cassiopeia, Cutera, EPI, Galderma, L’Oreal, Ortho Dermatologics, Sol Gel, and Vyne. She also serves as a speaker or member of a speaker’s bureau for Almirall, Cassiopeia, Cutera, EPI, Galderma, Journey Almirall, L’Oreal, Ortho Dermatologics, Sun Pharmaceutical Industries, and Vyne.
Medscape and this news organization are owned by the same parent company.
HONOLULU – In the clinical experience of Julie C. Harper, MD, an increasing number of women with acne are turning to off-label, long-term treatment with spironolactone.
“Spironolactone is fairly accessible, inexpensive, and effective for our patients,” Dr. Harper, a dermatologist who practices in Birmingham, Ala., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE!
An aldosterone receptor antagonist commonly used to treat high blood pressure and heart failure, spironolactone also has antiandrogenic properties with a proven track record for treating acne and hirsutism. It reduces androgen production, inhibits 5-alpha reductase, and increases sex hormone binding globulin. The dosing range for treating acne is 25 mg to 200 mg per day, but Dr. Harper prefers a maximum dose of 100 mg per day.
According to a systematic review of its use for acne in adult women, the most common side effect is menstrual irregularity, while other common side effects include breast tenderness/swelling, fatigue, and headaches.
“The higher the dose, the higher the rate of side effects,” she said. Concomitant use of an oral contraceptive lessens menstrual irregularities and prevents pregnancies, to avoid exposure during pregnancy and the hypothetical risk of feminization of the male fetus with exposure late in the first trimester. “Early in my career, I used to say if you’re going to be on spironolactone you’re also going to be on an oral contraceptive. But the longer I’ve practiced, I’ve learned that women who have a contraindication to birth control pills or who don’t want to take it can still benefit from an oral antiandrogen by being on spironolactone.”
A large retrospective analysis of 14-year data concluded that routine potassium monitoring is unnecessary for healthy women taking spironolactone for acne. “If you’re between the ages of 18 and 45, healthy, and not taking other medications where I’m worried about potassium levels, I’m not checking those levels at all,” Dr. Harper said.
Spironolactone labeling includes a boxed warning regarding the potential for tumorigenicity based on rat studies, but the dosages used in those studies were 25-250 times higher than the exposure dose in humans, Dr. Harper said.
Results from a systematic review and meta-analysis of seven studies in the medical literature found no evidence of an increased risk of breast cancer in women with exposure to spironolactone. “However, the certainty of the evidence was low and future studies are needed, including among diverse populations such as younger individuals and those with acne or hirsutism,” the study authors wrote.
In a separate study, researchers drew from patients in the Humana Insurance database from 2005 to 2017 to address whether spironolactone is associated with an increased risk of recurrence of breast cancer. Recurrent breast cancer was examined in 29,146 women with continuous health insurance for 2 years after a diagnosis of breast cancer. Of these, 746 were prescribed spironolactone, and the remainder were not. The researchers found that 123 women (16.5%) who were prescribed spironolactone had a breast cancer recurrence, compared with 3,649 women (12.8%) with a breast cancer recurrence who had not been prescribed spironolactone (P = .004). Adjusted Cox regression analysis following propensity matching showed no association between spironolactone and increased breast cancer recurrence (adjusted hazard ratio, 0.966; P = .953).
According to Dr. Harper, spironolactone may take about 3 months to kick in. “Likely this is a long-term treatment, and most of the time we’re going to be using it in combination with other acne treatments such as topical retinoids or topical benzoyl peroxide, oral antibiotics, or even isotretinoin.”
A study of long-term spironolactone use in 403 women found that the most common dose prescribed was 100 mg/day, and 68% of the women were concurrently prescribed a topical retinoid, 2.2% an oral antibiotic, and 40.7% an oral contraceptive.
The study population included 32 patients with a history of polycystic ovarian syndrome, 1 with a history of breast cancer, and 5 were hypercoagulable. Patients took the drug for a mean of 471 days. “As opposed to our antibiotics, where the course for patients is generally 3-4 months, when you start someone on spironolactone, they may end up staying on it,” Dr. Harper said.
Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, Cassiopeia, Cutera, EPI, Galderma, L’Oreal, Ortho Dermatologics, Sol Gel, and Vyne. She also serves as a speaker or member of a speaker’s bureau for Almirall, Cassiopeia, Cutera, EPI, Galderma, Journey Almirall, L’Oreal, Ortho Dermatologics, Sun Pharmaceutical Industries, and Vyne.
Medscape and this news organization are owned by the same parent company.
HONOLULU – In the clinical experience of Julie C. Harper, MD, an increasing number of women with acne are turning to off-label, long-term treatment with spironolactone.
“Spironolactone is fairly accessible, inexpensive, and effective for our patients,” Dr. Harper, a dermatologist who practices in Birmingham, Ala., said at the Hawaii Dermatology Seminar provided by MedscapeLIVE!
An aldosterone receptor antagonist commonly used to treat high blood pressure and heart failure, spironolactone also has antiandrogenic properties with a proven track record for treating acne and hirsutism. It reduces androgen production, inhibits 5-alpha reductase, and increases sex hormone binding globulin. The dosing range for treating acne is 25 mg to 200 mg per day, but Dr. Harper prefers a maximum dose of 100 mg per day.
According to a systematic review of its use for acne in adult women, the most common side effect is menstrual irregularity, while other common side effects include breast tenderness/swelling, fatigue, and headaches.
“The higher the dose, the higher the rate of side effects,” she said. Concomitant use of an oral contraceptive lessens menstrual irregularities and prevents pregnancies, to avoid exposure during pregnancy and the hypothetical risk of feminization of the male fetus with exposure late in the first trimester. “Early in my career, I used to say if you’re going to be on spironolactone you’re also going to be on an oral contraceptive. But the longer I’ve practiced, I’ve learned that women who have a contraindication to birth control pills or who don’t want to take it can still benefit from an oral antiandrogen by being on spironolactone.”
A large retrospective analysis of 14-year data concluded that routine potassium monitoring is unnecessary for healthy women taking spironolactone for acne. “If you’re between the ages of 18 and 45, healthy, and not taking other medications where I’m worried about potassium levels, I’m not checking those levels at all,” Dr. Harper said.
Spironolactone labeling includes a boxed warning regarding the potential for tumorigenicity based on rat studies, but the dosages used in those studies were 25-250 times higher than the exposure dose in humans, Dr. Harper said.
Results from a systematic review and meta-analysis of seven studies in the medical literature found no evidence of an increased risk of breast cancer in women with exposure to spironolactone. “However, the certainty of the evidence was low and future studies are needed, including among diverse populations such as younger individuals and those with acne or hirsutism,” the study authors wrote.
In a separate study, researchers drew from patients in the Humana Insurance database from 2005 to 2017 to address whether spironolactone is associated with an increased risk of recurrence of breast cancer. Recurrent breast cancer was examined in 29,146 women with continuous health insurance for 2 years after a diagnosis of breast cancer. Of these, 746 were prescribed spironolactone, and the remainder were not. The researchers found that 123 women (16.5%) who were prescribed spironolactone had a breast cancer recurrence, compared with 3,649 women (12.8%) with a breast cancer recurrence who had not been prescribed spironolactone (P = .004). Adjusted Cox regression analysis following propensity matching showed no association between spironolactone and increased breast cancer recurrence (adjusted hazard ratio, 0.966; P = .953).
According to Dr. Harper, spironolactone may take about 3 months to kick in. “Likely this is a long-term treatment, and most of the time we’re going to be using it in combination with other acne treatments such as topical retinoids or topical benzoyl peroxide, oral antibiotics, or even isotretinoin.”
A study of long-term spironolactone use in 403 women found that the most common dose prescribed was 100 mg/day, and 68% of the women were concurrently prescribed a topical retinoid, 2.2% an oral antibiotic, and 40.7% an oral contraceptive.
The study population included 32 patients with a history of polycystic ovarian syndrome, 1 with a history of breast cancer, and 5 were hypercoagulable. Patients took the drug for a mean of 471 days. “As opposed to our antibiotics, where the course for patients is generally 3-4 months, when you start someone on spironolactone, they may end up staying on it,” Dr. Harper said.
Dr. Harper disclosed that she serves as an advisor or consultant for Almirall, Cassiopeia, Cutera, EPI, Galderma, L’Oreal, Ortho Dermatologics, Sol Gel, and Vyne. She also serves as a speaker or member of a speaker’s bureau for Almirall, Cassiopeia, Cutera, EPI, Galderma, Journey Almirall, L’Oreal, Ortho Dermatologics, Sun Pharmaceutical Industries, and Vyne.
Medscape and this news organization are owned by the same parent company.
AT THE MEDSCAPELIVE! HAWAII DERMATOLOGY SEMINAR
SCD meds: Why such ‘slow uptake’?
“There are several factors that are contributing to the slow uptake in these medications. Firstly, some newer medications are expensive and can require complicated insurance approvals as well as trips to doctors’ offices or infusion sites that are difficult to access for rural populations. Secondly, there are major challenges in transitioning pediatric SCD patients to receiving adequate care as adults,” lead study author Robert M. Cronin, MD, of the department of internal medicine at the Ohio State University, Columbus, said in an interview.
The retrospective study, published in Blood Advances, looked at private insurance claims of patients with SCD in the United States from 2016 to 2020. A total of 7,957 participants were included in the analysis (all were ≥ 18 years, median age 37, 61.2% female). Primary outcomes analyzed were the utilization of hydroxyurea, l-glutamine, and crizanlizumab (all shown in clinical trials to decrease acute vaso-occlusive pain), and voxelotor (approved for patients with SCD with lower hemoglobin levels).
Among study participants who had two or more pain episodes in a year, 31.5% were prescribed hydroxyurea, 3.2% l-glutamine, 2.3% crizanlizumab, and 2.9% voxelotor. Any combination therapy of drugs to decrease vaso-occlusive pain was used in about 3% of the study participants, and combinations of newer therapies were used in only 0.3%.
In contrast to these statistics, Dr. Cronin said, “All adults with sickle cell anemia should be at least offered treatment with hydroxyurea, and up to 63% of individuals with SCD have at least one vaso-occlusive pain episode in a year, making them eligible for crizanlizumab, l-glutamine, or both.”
As patients with SCD grew older, their odds of being prescribed hydroxyurea, l-glutamine, and crizanlizumab all decreased. Dr. Cronin speculated about the reasons for this decline. “It’s a huge problem to find adult providers who are knowledgeable about SCD. When pediatric patients become adults, they often can’t find anybody who knows about their disease,” he said.
Study results supported the hypothesis that rural location was a barrier to care. Not residing in a “super rural” geographic location was associated with nearly three times the likelihood of crizanlizumab prescription (odds ratio, 2.93; 95% confidence interval, 1.16-7.42).
“There is geographic variability as expected, with limitations in rural areas,” said Nirmish R. Shah, MD, director of the sickle cell transition program at Duke Health in Durham, N.C. Dr. Shah was not associated with the study.
Dr. Shah commented that he found the study’s findings unsurprising. He also noted that its results were based solely on data from private insurance databases and that some of the drugs included in the study were approved just before the COVID-19 pandemic began – another possible factor in their being underprescribed for patients with SCD.
Dr. Cronin warned that despite the study’s limitations, the actual situation for patients with SCD in the United States may be even worse than the data indicate, saying “A lot of people with SCD are actually on governmental insurance, and they may be even less likely to be getting access to these newer drugs, due to less robust coverage and more hurdles to jump through before getting treatment approved.”
Dr. Cronin disclosed no conflicts of interest. Dr. Shah reported ties with Emmaus, Novartis, GBT, Forma, Agios, Vertex, and Bluebird Bio.
“There are several factors that are contributing to the slow uptake in these medications. Firstly, some newer medications are expensive and can require complicated insurance approvals as well as trips to doctors’ offices or infusion sites that are difficult to access for rural populations. Secondly, there are major challenges in transitioning pediatric SCD patients to receiving adequate care as adults,” lead study author Robert M. Cronin, MD, of the department of internal medicine at the Ohio State University, Columbus, said in an interview.
The retrospective study, published in Blood Advances, looked at private insurance claims of patients with SCD in the United States from 2016 to 2020. A total of 7,957 participants were included in the analysis (all were ≥ 18 years, median age 37, 61.2% female). Primary outcomes analyzed were the utilization of hydroxyurea, l-glutamine, and crizanlizumab (all shown in clinical trials to decrease acute vaso-occlusive pain), and voxelotor (approved for patients with SCD with lower hemoglobin levels).
Among study participants who had two or more pain episodes in a year, 31.5% were prescribed hydroxyurea, 3.2% l-glutamine, 2.3% crizanlizumab, and 2.9% voxelotor. Any combination therapy of drugs to decrease vaso-occlusive pain was used in about 3% of the study participants, and combinations of newer therapies were used in only 0.3%.
In contrast to these statistics, Dr. Cronin said, “All adults with sickle cell anemia should be at least offered treatment with hydroxyurea, and up to 63% of individuals with SCD have at least one vaso-occlusive pain episode in a year, making them eligible for crizanlizumab, l-glutamine, or both.”
As patients with SCD grew older, their odds of being prescribed hydroxyurea, l-glutamine, and crizanlizumab all decreased. Dr. Cronin speculated about the reasons for this decline. “It’s a huge problem to find adult providers who are knowledgeable about SCD. When pediatric patients become adults, they often can’t find anybody who knows about their disease,” he said.
Study results supported the hypothesis that rural location was a barrier to care. Not residing in a “super rural” geographic location was associated with nearly three times the likelihood of crizanlizumab prescription (odds ratio, 2.93; 95% confidence interval, 1.16-7.42).
“There is geographic variability as expected, with limitations in rural areas,” said Nirmish R. Shah, MD, director of the sickle cell transition program at Duke Health in Durham, N.C. Dr. Shah was not associated with the study.
Dr. Shah commented that he found the study’s findings unsurprising. He also noted that its results were based solely on data from private insurance databases and that some of the drugs included in the study were approved just before the COVID-19 pandemic began – another possible factor in their being underprescribed for patients with SCD.
Dr. Cronin warned that despite the study’s limitations, the actual situation for patients with SCD in the United States may be even worse than the data indicate, saying “A lot of people with SCD are actually on governmental insurance, and they may be even less likely to be getting access to these newer drugs, due to less robust coverage and more hurdles to jump through before getting treatment approved.”
Dr. Cronin disclosed no conflicts of interest. Dr. Shah reported ties with Emmaus, Novartis, GBT, Forma, Agios, Vertex, and Bluebird Bio.
“There are several factors that are contributing to the slow uptake in these medications. Firstly, some newer medications are expensive and can require complicated insurance approvals as well as trips to doctors’ offices or infusion sites that are difficult to access for rural populations. Secondly, there are major challenges in transitioning pediatric SCD patients to receiving adequate care as adults,” lead study author Robert M. Cronin, MD, of the department of internal medicine at the Ohio State University, Columbus, said in an interview.
The retrospective study, published in Blood Advances, looked at private insurance claims of patients with SCD in the United States from 2016 to 2020. A total of 7,957 participants were included in the analysis (all were ≥ 18 years, median age 37, 61.2% female). Primary outcomes analyzed were the utilization of hydroxyurea, l-glutamine, and crizanlizumab (all shown in clinical trials to decrease acute vaso-occlusive pain), and voxelotor (approved for patients with SCD with lower hemoglobin levels).
Among study participants who had two or more pain episodes in a year, 31.5% were prescribed hydroxyurea, 3.2% l-glutamine, 2.3% crizanlizumab, and 2.9% voxelotor. Any combination therapy of drugs to decrease vaso-occlusive pain was used in about 3% of the study participants, and combinations of newer therapies were used in only 0.3%.
In contrast to these statistics, Dr. Cronin said, “All adults with sickle cell anemia should be at least offered treatment with hydroxyurea, and up to 63% of individuals with SCD have at least one vaso-occlusive pain episode in a year, making them eligible for crizanlizumab, l-glutamine, or both.”
As patients with SCD grew older, their odds of being prescribed hydroxyurea, l-glutamine, and crizanlizumab all decreased. Dr. Cronin speculated about the reasons for this decline. “It’s a huge problem to find adult providers who are knowledgeable about SCD. When pediatric patients become adults, they often can’t find anybody who knows about their disease,” he said.
Study results supported the hypothesis that rural location was a barrier to care. Not residing in a “super rural” geographic location was associated with nearly three times the likelihood of crizanlizumab prescription (odds ratio, 2.93; 95% confidence interval, 1.16-7.42).
“There is geographic variability as expected, with limitations in rural areas,” said Nirmish R. Shah, MD, director of the sickle cell transition program at Duke Health in Durham, N.C. Dr. Shah was not associated with the study.
Dr. Shah commented that he found the study’s findings unsurprising. He also noted that its results were based solely on data from private insurance databases and that some of the drugs included in the study were approved just before the COVID-19 pandemic began – another possible factor in their being underprescribed for patients with SCD.
Dr. Cronin warned that despite the study’s limitations, the actual situation for patients with SCD in the United States may be even worse than the data indicate, saying “A lot of people with SCD are actually on governmental insurance, and they may be even less likely to be getting access to these newer drugs, due to less robust coverage and more hurdles to jump through before getting treatment approved.”
Dr. Cronin disclosed no conflicts of interest. Dr. Shah reported ties with Emmaus, Novartis, GBT, Forma, Agios, Vertex, and Bluebird Bio.
Plant-based diet linked to better outcomes in prostate cancer
The findings, which were reported at the 2023 ASCO Genitourinary Cancers Symposium in February, are based on a study of 2,038 men (median age, 64 years) with prostate cancer at stage T1, T2, or T3a.
“Consuming a whole foods plant-based diet may be an option to decrease risk for recurrence and improve overall survivorship,” said Vivian N. Liu, a clinical research coordinator at the University of California, San Francisco, who presented the findings.
The patients were interviewed about their diets at about 31.5 months after diagnosis. The study group was broken down into four groups based on how much of their diet consisted of a plant-based diet. Men in the highest quintile group who consumed at least 2.4 servings daily of fruit, 4.2 servings of vegetables, 2.6 servings of dairy, and 1.2 servings of meat (not seafood), had a 52% lower risk of progression (hazard ratio, 0.48; 95% confidence interval, 0.36-0.65; P-trend < 0.001) and a 53% lower risk of recurrence (HR, 0.47; 95% CI, 0.32-0.68; P-trend < 0.001), which was statistically significant. This compares with men in the lowest quintile who consumed 0.8 servings a day of fruit, 2.1 servings of vegetables, 3.1 servings of dairy, and 1.4 servings of meat. The findings were adjusted for total caloric intake, race, and smoking status.
For men over 65 years old, researchers found that a plant-based diet was associated with lower risk of recurrence (HR, 0.41; 95% CI, 0.24-0.7; P-trend = 0.03). And for those who exercised daily – in this case walking at a fast pace more than 3 times a week – a plant-based diet had a 56% (HR, 0.33; 95% CI, 0.26-0.73) lower risk of progression in the highest quintile group and a 59% decrease in recurrence (HR, 0.41; 95% CI, 0.25-0.68).
A new analysis like this, Ms. Liu said, “could guide people to make better, more healthful choices across their whole diet rather than adding or removing select foods.”
The primary endpoint was progression including recurrence, secondary treatment, bone metastases, and death due to prostate cancer, and the secondary endpoint was recurrence (PSA > 0.2ng/mL at 2 consecutive follow-up visits or during secondary treatment). At 7.4 years follow-up, there were 204 cases of progression.
“Fruits and vegetables contain antioxidants and anti-inflammatory components as well as dietary fiber that improve glucose control and reduce inflammation,” Ms. Liu said. In contrast, she said, animal-based foods may increase insulin resistance and insulin levels and boost levels of insulin-like growth factor 1, which is associated with prostate cancer risk. More studies, especially randomized controlled trials, are needed to provide evidence whether healthful plant-based foods and prostate cancer progression are connected.
NYU Langone Health urologist Natasha Gupta, MD, published a systematic review in 2022 on the impact of a plant-based diet on prostate cancer.* The review, which included 5 interventional studies and 11 observational studies, found that consuming a plant-based diet was associated with improvements in general health for men with prostate cancer. The observational studies found either a lower risk of prostate cancer or no significant difference.
“Patients often ask if there is anything that they can do to reduce the risk of recurrence, and it is great to be able to tell patients that a healthy lifestyle including plant-based foods and physical activity is helpful,” Dr. Gupta said.
The review’s coauthor, Stacy Loeb, MD, also of NYU Langone Health, said the new study was “a well-done observational study by experts in nutritional epidemiology from UCSF. It adds to a large body of evidence showing that plant-based diets improve health outcomes.”
“In the short-term, purchasing plant-based protein sources, such as beans and lentils, is less expensive than buying meat. Plant-based diets also reduce the risk of obesity, diabetes, and cardiovascular disease, which are associated with hundreds of thousands of dollars over a lifetime,” she said.
Limitations of the new study included the small number of non-White participants and self-reporting of diet. The study doesn’t examine the cost of various diets or the availability of plant-based foods like fresh produce, which can be limited in some neighborhoods.
Ms. Liu and colleagues plan to conduct a study that examines postdiagnostic plant-based diets in relation to prostate cancer–specific mortality. She and her team will also examine the plant-based dietary indices in relation to prostate cancer–specific quality of life at 2, 5, and 10 years from baseline.
The study authors, Dr. Loeb, and Dr. Gupta report no disclosures.
Correction, 3/17/23: An earlier version of this article misstated the name of NYU Langone Health.
The findings, which were reported at the 2023 ASCO Genitourinary Cancers Symposium in February, are based on a study of 2,038 men (median age, 64 years) with prostate cancer at stage T1, T2, or T3a.
“Consuming a whole foods plant-based diet may be an option to decrease risk for recurrence and improve overall survivorship,” said Vivian N. Liu, a clinical research coordinator at the University of California, San Francisco, who presented the findings.
The patients were interviewed about their diets at about 31.5 months after diagnosis. The study group was broken down into four groups based on how much of their diet consisted of a plant-based diet. Men in the highest quintile group who consumed at least 2.4 servings daily of fruit, 4.2 servings of vegetables, 2.6 servings of dairy, and 1.2 servings of meat (not seafood), had a 52% lower risk of progression (hazard ratio, 0.48; 95% confidence interval, 0.36-0.65; P-trend < 0.001) and a 53% lower risk of recurrence (HR, 0.47; 95% CI, 0.32-0.68; P-trend < 0.001), which was statistically significant. This compares with men in the lowest quintile who consumed 0.8 servings a day of fruit, 2.1 servings of vegetables, 3.1 servings of dairy, and 1.4 servings of meat. The findings were adjusted for total caloric intake, race, and smoking status.
For men over 65 years old, researchers found that a plant-based diet was associated with lower risk of recurrence (HR, 0.41; 95% CI, 0.24-0.7; P-trend = 0.03). And for those who exercised daily – in this case walking at a fast pace more than 3 times a week – a plant-based diet had a 56% (HR, 0.33; 95% CI, 0.26-0.73) lower risk of progression in the highest quintile group and a 59% decrease in recurrence (HR, 0.41; 95% CI, 0.25-0.68).
A new analysis like this, Ms. Liu said, “could guide people to make better, more healthful choices across their whole diet rather than adding or removing select foods.”
The primary endpoint was progression including recurrence, secondary treatment, bone metastases, and death due to prostate cancer, and the secondary endpoint was recurrence (PSA > 0.2ng/mL at 2 consecutive follow-up visits or during secondary treatment). At 7.4 years follow-up, there were 204 cases of progression.
“Fruits and vegetables contain antioxidants and anti-inflammatory components as well as dietary fiber that improve glucose control and reduce inflammation,” Ms. Liu said. In contrast, she said, animal-based foods may increase insulin resistance and insulin levels and boost levels of insulin-like growth factor 1, which is associated with prostate cancer risk. More studies, especially randomized controlled trials, are needed to provide evidence whether healthful plant-based foods and prostate cancer progression are connected.
NYU Langone Health urologist Natasha Gupta, MD, published a systematic review in 2022 on the impact of a plant-based diet on prostate cancer.* The review, which included 5 interventional studies and 11 observational studies, found that consuming a plant-based diet was associated with improvements in general health for men with prostate cancer. The observational studies found either a lower risk of prostate cancer or no significant difference.
“Patients often ask if there is anything that they can do to reduce the risk of recurrence, and it is great to be able to tell patients that a healthy lifestyle including plant-based foods and physical activity is helpful,” Dr. Gupta said.
The review’s coauthor, Stacy Loeb, MD, also of NYU Langone Health, said the new study was “a well-done observational study by experts in nutritional epidemiology from UCSF. It adds to a large body of evidence showing that plant-based diets improve health outcomes.”
“In the short-term, purchasing plant-based protein sources, such as beans and lentils, is less expensive than buying meat. Plant-based diets also reduce the risk of obesity, diabetes, and cardiovascular disease, which are associated with hundreds of thousands of dollars over a lifetime,” she said.
Limitations of the new study included the small number of non-White participants and self-reporting of diet. The study doesn’t examine the cost of various diets or the availability of plant-based foods like fresh produce, which can be limited in some neighborhoods.
Ms. Liu and colleagues plan to conduct a study that examines postdiagnostic plant-based diets in relation to prostate cancer–specific mortality. She and her team will also examine the plant-based dietary indices in relation to prostate cancer–specific quality of life at 2, 5, and 10 years from baseline.
The study authors, Dr. Loeb, and Dr. Gupta report no disclosures.
Correction, 3/17/23: An earlier version of this article misstated the name of NYU Langone Health.
The findings, which were reported at the 2023 ASCO Genitourinary Cancers Symposium in February, are based on a study of 2,038 men (median age, 64 years) with prostate cancer at stage T1, T2, or T3a.
“Consuming a whole foods plant-based diet may be an option to decrease risk for recurrence and improve overall survivorship,” said Vivian N. Liu, a clinical research coordinator at the University of California, San Francisco, who presented the findings.
The patients were interviewed about their diets at about 31.5 months after diagnosis. The study group was broken down into four groups based on how much of their diet consisted of a plant-based diet. Men in the highest quintile group who consumed at least 2.4 servings daily of fruit, 4.2 servings of vegetables, 2.6 servings of dairy, and 1.2 servings of meat (not seafood), had a 52% lower risk of progression (hazard ratio, 0.48; 95% confidence interval, 0.36-0.65; P-trend < 0.001) and a 53% lower risk of recurrence (HR, 0.47; 95% CI, 0.32-0.68; P-trend < 0.001), which was statistically significant. This compares with men in the lowest quintile who consumed 0.8 servings a day of fruit, 2.1 servings of vegetables, 3.1 servings of dairy, and 1.4 servings of meat. The findings were adjusted for total caloric intake, race, and smoking status.
For men over 65 years old, researchers found that a plant-based diet was associated with lower risk of recurrence (HR, 0.41; 95% CI, 0.24-0.7; P-trend = 0.03). And for those who exercised daily – in this case walking at a fast pace more than 3 times a week – a plant-based diet had a 56% (HR, 0.33; 95% CI, 0.26-0.73) lower risk of progression in the highest quintile group and a 59% decrease in recurrence (HR, 0.41; 95% CI, 0.25-0.68).
A new analysis like this, Ms. Liu said, “could guide people to make better, more healthful choices across their whole diet rather than adding or removing select foods.”
The primary endpoint was progression including recurrence, secondary treatment, bone metastases, and death due to prostate cancer, and the secondary endpoint was recurrence (PSA > 0.2ng/mL at 2 consecutive follow-up visits or during secondary treatment). At 7.4 years follow-up, there were 204 cases of progression.
“Fruits and vegetables contain antioxidants and anti-inflammatory components as well as dietary fiber that improve glucose control and reduce inflammation,” Ms. Liu said. In contrast, she said, animal-based foods may increase insulin resistance and insulin levels and boost levels of insulin-like growth factor 1, which is associated with prostate cancer risk. More studies, especially randomized controlled trials, are needed to provide evidence whether healthful plant-based foods and prostate cancer progression are connected.
NYU Langone Health urologist Natasha Gupta, MD, published a systematic review in 2022 on the impact of a plant-based diet on prostate cancer.* The review, which included 5 interventional studies and 11 observational studies, found that consuming a plant-based diet was associated with improvements in general health for men with prostate cancer. The observational studies found either a lower risk of prostate cancer or no significant difference.
“Patients often ask if there is anything that they can do to reduce the risk of recurrence, and it is great to be able to tell patients that a healthy lifestyle including plant-based foods and physical activity is helpful,” Dr. Gupta said.
The review’s coauthor, Stacy Loeb, MD, also of NYU Langone Health, said the new study was “a well-done observational study by experts in nutritional epidemiology from UCSF. It adds to a large body of evidence showing that plant-based diets improve health outcomes.”
“In the short-term, purchasing plant-based protein sources, such as beans and lentils, is less expensive than buying meat. Plant-based diets also reduce the risk of obesity, diabetes, and cardiovascular disease, which are associated with hundreds of thousands of dollars over a lifetime,” she said.
Limitations of the new study included the small number of non-White participants and self-reporting of diet. The study doesn’t examine the cost of various diets or the availability of plant-based foods like fresh produce, which can be limited in some neighborhoods.
Ms. Liu and colleagues plan to conduct a study that examines postdiagnostic plant-based diets in relation to prostate cancer–specific mortality. She and her team will also examine the plant-based dietary indices in relation to prostate cancer–specific quality of life at 2, 5, and 10 years from baseline.
The study authors, Dr. Loeb, and Dr. Gupta report no disclosures.
Correction, 3/17/23: An earlier version of this article misstated the name of NYU Langone Health.
FROM ASCO GU 2023