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Biologics linked to fewer hospitalizations after asthma exacerbation
In a real-world study of asthma patients,
The data fill a gap, according to Sushan Gupta, MD, who presented the results at the annual meeting of the American College of Chest Physicians. “There’s some ample real-world data that shows that biologics reduce the incidence of asthma exacerbation, but the data regarding what happens after an exacerbation is still lacking, especially real-world data,” said Dr. Gupta, who is a resident at Carle Foundation Hospital in Champaign, Ill.
The findings were encouraging. “Patients with severe asthma on biologics fare well even after an exacerbation event, which includes a reduced incidence of hospitalization, ICU admission, and need for mechanical ventilation. We did not have any patient in the biologic group that required intubation, so that is pretty significant as compared to other patients who did not receive biologics,” said Dr. Gupta.
The results weren’t surprising, but underscore the benefits of biologics, according to Brittany Duchene, MD, who moderated the session where the results were presented. “I think it reinforced that they’re really good drugs,” said Dr. Duchene, who is a pulmonary critical care physician at Northeastern Vermont Regional Hospital, St. Johnsbury.
Although the study was retrospective, it suggests that the threshold for initiating biologics could potentially be lowered for patients with uncontrolled asthma despite adequate use of inhalers, according to Dr. Gupta. “Should that threshold be lower, and would that improve the overall morbidity and eventually the health care cost of utilization? Our study does not prove any of those data, but moving forward that data will also come out.”
Dr. Duchene noted that the accumulating scientific and clinical data for biologics is “really, really strong.” She also speculated that biologics could be used increasingly in the acute setting, which she admitted is a controversial topic. “I think there’s going to be a lot more push to early initiation, and you can see from the [new] study that it decreased a lot of hospitalizations.”
Dr. Gupta emphasized the need for prospective studies, and Dr. Duchene agreed that any such change would need to be patient centric, considering the diversity of available biologics. “It depends what their true issue is. The broader the biologic [mechanism of action], probably the more success you’ll have. I’ve found there’s not a pure allergic or a pure eosinophilic asthma patient. They’re usually more a combination.”
Some key questions remain about biologics treatment, especially in the long term. These include when a patient should be switched from one biologic to another, and whether biologic treatment should be continued over the patient’s lifetime and potential long-term side effects. “I think that data is still evolving and will come to us with time,” said Dr. Gupta.
The researchers analyzed retrospective data from 316 asthma patients treated with biologics and 9,645 treated with nonbiologic therapy between February 2018 and February 2023 at a tertiary care teaching hospital in the Midwest. There was a higher proportion of females in the biologics (69.7%) and nonbiologics groups (63.8%, P = .032), but there was no significant difference in the proportion of Whites in the biologics and nonbiologics groups (78.2% vs. 74.3%, P = .103).
The lack of a difference in racial groups was a surprise, according to Dr. Duchene, especially since other studies have noted disparities in biologic therapy among asthma patients.
Among the biologics group, 0.9% were hospitalized during the study period, compared with 6.5% of the nonbiologics group (P = .00006). They also had fewer ICU visits (0.3% vs. 1.8%; P = .04).
Dr. Gupta’s team attempted to subdivide the data by individual biologic, but there was no statistical significance in outcomes between biologics, perhaps because of the relatively small sample size.
Dr. Gupta noted that his group’s results are generally similar to other studies, including a U.S. study that found a decrease in exacerbation rates after staring or switching biologics and a slightly higher prevalence of biologics use among White patients (77% of biologic users versus 71% of nonbiologics users). A study in southwestern England found fewer ED visits and hospitalizations among patients on biologics.
Dr. Gupta and Dr. Duchene have no relevant financial disclosures.
In a real-world study of asthma patients,
The data fill a gap, according to Sushan Gupta, MD, who presented the results at the annual meeting of the American College of Chest Physicians. “There’s some ample real-world data that shows that biologics reduce the incidence of asthma exacerbation, but the data regarding what happens after an exacerbation is still lacking, especially real-world data,” said Dr. Gupta, who is a resident at Carle Foundation Hospital in Champaign, Ill.
The findings were encouraging. “Patients with severe asthma on biologics fare well even after an exacerbation event, which includes a reduced incidence of hospitalization, ICU admission, and need for mechanical ventilation. We did not have any patient in the biologic group that required intubation, so that is pretty significant as compared to other patients who did not receive biologics,” said Dr. Gupta.
The results weren’t surprising, but underscore the benefits of biologics, according to Brittany Duchene, MD, who moderated the session where the results were presented. “I think it reinforced that they’re really good drugs,” said Dr. Duchene, who is a pulmonary critical care physician at Northeastern Vermont Regional Hospital, St. Johnsbury.
Although the study was retrospective, it suggests that the threshold for initiating biologics could potentially be lowered for patients with uncontrolled asthma despite adequate use of inhalers, according to Dr. Gupta. “Should that threshold be lower, and would that improve the overall morbidity and eventually the health care cost of utilization? Our study does not prove any of those data, but moving forward that data will also come out.”
Dr. Duchene noted that the accumulating scientific and clinical data for biologics is “really, really strong.” She also speculated that biologics could be used increasingly in the acute setting, which she admitted is a controversial topic. “I think there’s going to be a lot more push to early initiation, and you can see from the [new] study that it decreased a lot of hospitalizations.”
Dr. Gupta emphasized the need for prospective studies, and Dr. Duchene agreed that any such change would need to be patient centric, considering the diversity of available biologics. “It depends what their true issue is. The broader the biologic [mechanism of action], probably the more success you’ll have. I’ve found there’s not a pure allergic or a pure eosinophilic asthma patient. They’re usually more a combination.”
Some key questions remain about biologics treatment, especially in the long term. These include when a patient should be switched from one biologic to another, and whether biologic treatment should be continued over the patient’s lifetime and potential long-term side effects. “I think that data is still evolving and will come to us with time,” said Dr. Gupta.
The researchers analyzed retrospective data from 316 asthma patients treated with biologics and 9,645 treated with nonbiologic therapy between February 2018 and February 2023 at a tertiary care teaching hospital in the Midwest. There was a higher proportion of females in the biologics (69.7%) and nonbiologics groups (63.8%, P = .032), but there was no significant difference in the proportion of Whites in the biologics and nonbiologics groups (78.2% vs. 74.3%, P = .103).
The lack of a difference in racial groups was a surprise, according to Dr. Duchene, especially since other studies have noted disparities in biologic therapy among asthma patients.
Among the biologics group, 0.9% were hospitalized during the study period, compared with 6.5% of the nonbiologics group (P = .00006). They also had fewer ICU visits (0.3% vs. 1.8%; P = .04).
Dr. Gupta’s team attempted to subdivide the data by individual biologic, but there was no statistical significance in outcomes between biologics, perhaps because of the relatively small sample size.
Dr. Gupta noted that his group’s results are generally similar to other studies, including a U.S. study that found a decrease in exacerbation rates after staring or switching biologics and a slightly higher prevalence of biologics use among White patients (77% of biologic users versus 71% of nonbiologics users). A study in southwestern England found fewer ED visits and hospitalizations among patients on biologics.
Dr. Gupta and Dr. Duchene have no relevant financial disclosures.
In a real-world study of asthma patients,
The data fill a gap, according to Sushan Gupta, MD, who presented the results at the annual meeting of the American College of Chest Physicians. “There’s some ample real-world data that shows that biologics reduce the incidence of asthma exacerbation, but the data regarding what happens after an exacerbation is still lacking, especially real-world data,” said Dr. Gupta, who is a resident at Carle Foundation Hospital in Champaign, Ill.
The findings were encouraging. “Patients with severe asthma on biologics fare well even after an exacerbation event, which includes a reduced incidence of hospitalization, ICU admission, and need for mechanical ventilation. We did not have any patient in the biologic group that required intubation, so that is pretty significant as compared to other patients who did not receive biologics,” said Dr. Gupta.
The results weren’t surprising, but underscore the benefits of biologics, according to Brittany Duchene, MD, who moderated the session where the results were presented. “I think it reinforced that they’re really good drugs,” said Dr. Duchene, who is a pulmonary critical care physician at Northeastern Vermont Regional Hospital, St. Johnsbury.
Although the study was retrospective, it suggests that the threshold for initiating biologics could potentially be lowered for patients with uncontrolled asthma despite adequate use of inhalers, according to Dr. Gupta. “Should that threshold be lower, and would that improve the overall morbidity and eventually the health care cost of utilization? Our study does not prove any of those data, but moving forward that data will also come out.”
Dr. Duchene noted that the accumulating scientific and clinical data for biologics is “really, really strong.” She also speculated that biologics could be used increasingly in the acute setting, which she admitted is a controversial topic. “I think there’s going to be a lot more push to early initiation, and you can see from the [new] study that it decreased a lot of hospitalizations.”
Dr. Gupta emphasized the need for prospective studies, and Dr. Duchene agreed that any such change would need to be patient centric, considering the diversity of available biologics. “It depends what their true issue is. The broader the biologic [mechanism of action], probably the more success you’ll have. I’ve found there’s not a pure allergic or a pure eosinophilic asthma patient. They’re usually more a combination.”
Some key questions remain about biologics treatment, especially in the long term. These include when a patient should be switched from one biologic to another, and whether biologic treatment should be continued over the patient’s lifetime and potential long-term side effects. “I think that data is still evolving and will come to us with time,” said Dr. Gupta.
The researchers analyzed retrospective data from 316 asthma patients treated with biologics and 9,645 treated with nonbiologic therapy between February 2018 and February 2023 at a tertiary care teaching hospital in the Midwest. There was a higher proportion of females in the biologics (69.7%) and nonbiologics groups (63.8%, P = .032), but there was no significant difference in the proportion of Whites in the biologics and nonbiologics groups (78.2% vs. 74.3%, P = .103).
The lack of a difference in racial groups was a surprise, according to Dr. Duchene, especially since other studies have noted disparities in biologic therapy among asthma patients.
Among the biologics group, 0.9% were hospitalized during the study period, compared with 6.5% of the nonbiologics group (P = .00006). They also had fewer ICU visits (0.3% vs. 1.8%; P = .04).
Dr. Gupta’s team attempted to subdivide the data by individual biologic, but there was no statistical significance in outcomes between biologics, perhaps because of the relatively small sample size.
Dr. Gupta noted that his group’s results are generally similar to other studies, including a U.S. study that found a decrease in exacerbation rates after staring or switching biologics and a slightly higher prevalence of biologics use among White patients (77% of biologic users versus 71% of nonbiologics users). A study in southwestern England found fewer ED visits and hospitalizations among patients on biologics.
Dr. Gupta and Dr. Duchene have no relevant financial disclosures.
FROM CHEST 2023
Talking to your patients: Colorectal cancer screening starts at age 45
Your patients may be confused by conflicting guidance about when to start getting screened for colorectal cancer (CRC). AGA stands firmly behind our Multi-Society Task Force on CRC recommendations, and those of the U.S. Preventive Services Taskforce, the American Cancer Society, and other national medical societies and advocacy organizations, that colorectal cancer screening for average risk individuals should start at age 45.
But
View the talking points below to help your patients understand screening guidelines and why they need to get screened for colorectal cancer.
One outlier medical group says colorectal cancer screening can wait until age 50, but the consensus of the government and multiple expert groups, including the American Gastroenterological Association, is that getting screened starting at age 45 could save your life.
Colorectal cancer will be the leading cause of cancer-related death among 20- to 49-year-olds by 2030. Putting off screening until age 50 is a grave mistake.
Screening for colorectal cancer can help find polyps in your colon and rectum early, sometimes even before they become cancer. A polyp is a mushroom-like or flat growth on the inside wall of your colon or rectum. Polyps grow slowly over many years and not all turn into cancer. I can remove these growths, which might mean that I can help stop the cancer before it starts, remove tissue that shows cancer, or let us start treatment early if cancer has already started.
There are several tests for colorectal cancer screening, including colonoscopy, but there are also tests that are noninvasive, meaning they don’t need tools that enter your body. Let’s talk about each test and which one you feel most comfortable using.
For more resources to share with your patients, visit the AGA GI Patient Center.
Your patients may be confused by conflicting guidance about when to start getting screened for colorectal cancer (CRC). AGA stands firmly behind our Multi-Society Task Force on CRC recommendations, and those of the U.S. Preventive Services Taskforce, the American Cancer Society, and other national medical societies and advocacy organizations, that colorectal cancer screening for average risk individuals should start at age 45.
But
View the talking points below to help your patients understand screening guidelines and why they need to get screened for colorectal cancer.
One outlier medical group says colorectal cancer screening can wait until age 50, but the consensus of the government and multiple expert groups, including the American Gastroenterological Association, is that getting screened starting at age 45 could save your life.
Colorectal cancer will be the leading cause of cancer-related death among 20- to 49-year-olds by 2030. Putting off screening until age 50 is a grave mistake.
Screening for colorectal cancer can help find polyps in your colon and rectum early, sometimes even before they become cancer. A polyp is a mushroom-like or flat growth on the inside wall of your colon or rectum. Polyps grow slowly over many years and not all turn into cancer. I can remove these growths, which might mean that I can help stop the cancer before it starts, remove tissue that shows cancer, or let us start treatment early if cancer has already started.
There are several tests for colorectal cancer screening, including colonoscopy, but there are also tests that are noninvasive, meaning they don’t need tools that enter your body. Let’s talk about each test and which one you feel most comfortable using.
For more resources to share with your patients, visit the AGA GI Patient Center.
Your patients may be confused by conflicting guidance about when to start getting screened for colorectal cancer (CRC). AGA stands firmly behind our Multi-Society Task Force on CRC recommendations, and those of the U.S. Preventive Services Taskforce, the American Cancer Society, and other national medical societies and advocacy organizations, that colorectal cancer screening for average risk individuals should start at age 45.
But
View the talking points below to help your patients understand screening guidelines and why they need to get screened for colorectal cancer.
One outlier medical group says colorectal cancer screening can wait until age 50, but the consensus of the government and multiple expert groups, including the American Gastroenterological Association, is that getting screened starting at age 45 could save your life.
Colorectal cancer will be the leading cause of cancer-related death among 20- to 49-year-olds by 2030. Putting off screening until age 50 is a grave mistake.
Screening for colorectal cancer can help find polyps in your colon and rectum early, sometimes even before they become cancer. A polyp is a mushroom-like or flat growth on the inside wall of your colon or rectum. Polyps grow slowly over many years and not all turn into cancer. I can remove these growths, which might mean that I can help stop the cancer before it starts, remove tissue that shows cancer, or let us start treatment early if cancer has already started.
There are several tests for colorectal cancer screening, including colonoscopy, but there are also tests that are noninvasive, meaning they don’t need tools that enter your body. Let’s talk about each test and which one you feel most comfortable using.
For more resources to share with your patients, visit the AGA GI Patient Center.
Running vs. meds for depression: Is there a clear winner?
BARCELONA – However, running provides greater physical health benefits while adherence is greater with drug treatment.
“Both interventions helped with the depression to around the same extent,” study presenter Brenda W.J.H. Penninx, PhD, professor of psychiatric epidemiology at the VU University Medical Center in Amsterdam said in a release.
However, medication “generally had worse impact on body weight, heart rate variability, and blood pressure, whereas running therapy led to improved effect on general fitness and heart rate,” Dr. Penninx added.
The findings were presented at the annual congress of the European College of Neuropsychopharmacology and recently published in the Journal of Affective Disorders.
Research gap
Previous research suggests exercise interventions can have a therapeutic effect equivalent to antidepressants, but their impact on physical health has been “poorly examined in a psychiatric population, the investigators note.
The authors note that depressive and anxiety disorders “cause immense suffering by compromising both mental and physical health,” and the need for effective treatments is “pressing.”
Although antidepressant medication is considered a “standard first-line treatment” alongside psychotherapy, the drugs are “not effective for all and [are] often associated with side effects.”
The Mood Treatment with Antidepressant or Running (MOTAR) study was a partially randomized pragmatic trial in adults with depression and/or anxiety disorder, as determined using the DSM-IV algorithms with the Composite International Diagnostic Interview (CIDI).
The 16-week intervention study included 141 patients with depression and/or anxiety. The mean age was 38.2 years and 58% were women. Participants were offered a choice of treatment: 16 weeks of treatment with the selective serotonin reuptake inhibitor (SSRI) escitalopram (Lexapro) or a 16-week group-based running therapy.
Patients without a strong preference for treatment allocation were randomly assigned to either antidepressant medication or running therapy, while those unwilling to be randomized were allocated to their preferred intervention.
A total of 22 patients were randomly assigned to receive antidepressant treatment and 13 to running therapy. A total of 36 participants chose antidepressant treatment, while 83 chose the running therapy.
Running therapy involved 16 weeks of supervised 45-minute outdoor running sessions to a target of two to three sessions per week, in line with U.S. Centers for Disease Control and Prevention/American College of Sports Medicine recommendations.
Physical health benefits
Treatment adherence in the antidepressant group, defined as still using treatment at the posttreatment assessment, was 82.2% vs. 52.1% among running therapy participants, where adherence was specified as completing more than 22 sessions.
Remission was defined as no longer meeting the criteria of a current depressive or anxiety disorder via CIDI at week 16.
On intention-to-treat analysis, this requirement was met by 44.8% of patients taking antidepressants and 43.3% of those in the running therapy group (P = .88).
However, running therapy patients showed significant improvements in weight (P = .001), waist circumference (P = .011), systolic and diastolic blood pressure (P = .011 and P = .002, respectively), heart rate (P = .033), and heart rate variability (P = .006).
The investigators note the more favorable physical health changes in the running therapy group were attributable to “larger improvements in the running therapy group but also due to larger deterioration in the antidepressant group.”
Antidepressants are generally safe and effective and work for most people, said Dr. Penninx. She also noted that untreated depression leads to worse outcomes, so “antidepressants are generally a good choice.”
Nevertheless, she said, “we need to extend our treatment arsenal as not all patients respond to antidepressants or are willing to take them.”
The study’s results, she added, suggest that “implementing exercise therapy is something we should take much more seriously, as it could be a good, and maybe even better, choice for some of our patients.”
Francesca Cirulli, PhD, senior researcher and group leader at the National Institute of Health, Rome, said in an interview that the study is notable because it is one of the first to prospectively measure the effects of antidepressants and running on physical health.
Dr. Cirulli suggested that running therapy could be tried ahead of treatment with antidepressants if patients prefer physical exercise and can adhere to it. However, she said, the findings also suggest that an increase in physical activity should accompany treatment with antidepressant medications.
Overall, Dr. Cirulli said “the message should not be that everyone can be helped by running and antidepressants are bad,” but rather “these are both helpful, but not excellent, interventions against depression.”
‘Important limitations’
In a comment, Eduard Vieta, MD, PhD, chair of the department of psychiatry and psychology at the University of Barcelona Hospital Clinic, noted the study has “very important limitations.”
Among the limitations: the inclusion of nonrandomized patients who received the treatment of their choice, causing obvious bias and the “lack of binding and power issues” over the number of patients enrolled.
Dr. Vieta also said that the results “seem obvious, because it is known that exercise improves physical health.”
The trial therefore shows, “if you can find people who are able to do exercise while depressed and adhere to it, those would benefit from that practice,” he noted.
Also commenting on the research, Eric Ruhe, MD, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, said the results are confirmatory and “again show physical health can influence mental health.”
However, Dr. Ruhe underlined, while it is “common practice” to allow patients to follow their treatment preference and is “understandable from a pragmatic point of view,” the group comparison may be “biased,” compared with a “truly randomized study.”
“For example, patients in the antidepressant group were more depressed, which might be associated with less chance of persisting engagement in the exercises,” he said. “So, we have to be careful not to overinterpret the comparisons between groups, which the authors acknowledge properly.”
Turning to the difference in adherence between the two interventions, Dr. Ruhe said the results show adopting, and adhering to, a lifestyle habit is more difficult than taking a pill.
“This is not exclusively found in psychiatry, indicating that we also have to focus on how to improve compliance to healthy behavior. This could have tremendous impact on health care more generally, but also on psychiatric diseases,” Dr. Ruhe said.
The MOTAR study was funded by a NWO-VICI grant. Funding for the inflammatory markers was provided by ZonMw: The Netherlands Organization for Health Research and Development. The study authors and clinicians interviewed for this story declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BARCELONA – However, running provides greater physical health benefits while adherence is greater with drug treatment.
“Both interventions helped with the depression to around the same extent,” study presenter Brenda W.J.H. Penninx, PhD, professor of psychiatric epidemiology at the VU University Medical Center in Amsterdam said in a release.
However, medication “generally had worse impact on body weight, heart rate variability, and blood pressure, whereas running therapy led to improved effect on general fitness and heart rate,” Dr. Penninx added.
The findings were presented at the annual congress of the European College of Neuropsychopharmacology and recently published in the Journal of Affective Disorders.
Research gap
Previous research suggests exercise interventions can have a therapeutic effect equivalent to antidepressants, but their impact on physical health has been “poorly examined in a psychiatric population, the investigators note.
The authors note that depressive and anxiety disorders “cause immense suffering by compromising both mental and physical health,” and the need for effective treatments is “pressing.”
Although antidepressant medication is considered a “standard first-line treatment” alongside psychotherapy, the drugs are “not effective for all and [are] often associated with side effects.”
The Mood Treatment with Antidepressant or Running (MOTAR) study was a partially randomized pragmatic trial in adults with depression and/or anxiety disorder, as determined using the DSM-IV algorithms with the Composite International Diagnostic Interview (CIDI).
The 16-week intervention study included 141 patients with depression and/or anxiety. The mean age was 38.2 years and 58% were women. Participants were offered a choice of treatment: 16 weeks of treatment with the selective serotonin reuptake inhibitor (SSRI) escitalopram (Lexapro) or a 16-week group-based running therapy.
Patients without a strong preference for treatment allocation were randomly assigned to either antidepressant medication or running therapy, while those unwilling to be randomized were allocated to their preferred intervention.
A total of 22 patients were randomly assigned to receive antidepressant treatment and 13 to running therapy. A total of 36 participants chose antidepressant treatment, while 83 chose the running therapy.
Running therapy involved 16 weeks of supervised 45-minute outdoor running sessions to a target of two to three sessions per week, in line with U.S. Centers for Disease Control and Prevention/American College of Sports Medicine recommendations.
Physical health benefits
Treatment adherence in the antidepressant group, defined as still using treatment at the posttreatment assessment, was 82.2% vs. 52.1% among running therapy participants, where adherence was specified as completing more than 22 sessions.
Remission was defined as no longer meeting the criteria of a current depressive or anxiety disorder via CIDI at week 16.
On intention-to-treat analysis, this requirement was met by 44.8% of patients taking antidepressants and 43.3% of those in the running therapy group (P = .88).
However, running therapy patients showed significant improvements in weight (P = .001), waist circumference (P = .011), systolic and diastolic blood pressure (P = .011 and P = .002, respectively), heart rate (P = .033), and heart rate variability (P = .006).
The investigators note the more favorable physical health changes in the running therapy group were attributable to “larger improvements in the running therapy group but also due to larger deterioration in the antidepressant group.”
Antidepressants are generally safe and effective and work for most people, said Dr. Penninx. She also noted that untreated depression leads to worse outcomes, so “antidepressants are generally a good choice.”
Nevertheless, she said, “we need to extend our treatment arsenal as not all patients respond to antidepressants or are willing to take them.”
The study’s results, she added, suggest that “implementing exercise therapy is something we should take much more seriously, as it could be a good, and maybe even better, choice for some of our patients.”
Francesca Cirulli, PhD, senior researcher and group leader at the National Institute of Health, Rome, said in an interview that the study is notable because it is one of the first to prospectively measure the effects of antidepressants and running on physical health.
Dr. Cirulli suggested that running therapy could be tried ahead of treatment with antidepressants if patients prefer physical exercise and can adhere to it. However, she said, the findings also suggest that an increase in physical activity should accompany treatment with antidepressant medications.
Overall, Dr. Cirulli said “the message should not be that everyone can be helped by running and antidepressants are bad,” but rather “these are both helpful, but not excellent, interventions against depression.”
‘Important limitations’
In a comment, Eduard Vieta, MD, PhD, chair of the department of psychiatry and psychology at the University of Barcelona Hospital Clinic, noted the study has “very important limitations.”
Among the limitations: the inclusion of nonrandomized patients who received the treatment of their choice, causing obvious bias and the “lack of binding and power issues” over the number of patients enrolled.
Dr. Vieta also said that the results “seem obvious, because it is known that exercise improves physical health.”
The trial therefore shows, “if you can find people who are able to do exercise while depressed and adhere to it, those would benefit from that practice,” he noted.
Also commenting on the research, Eric Ruhe, MD, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, said the results are confirmatory and “again show physical health can influence mental health.”
However, Dr. Ruhe underlined, while it is “common practice” to allow patients to follow their treatment preference and is “understandable from a pragmatic point of view,” the group comparison may be “biased,” compared with a “truly randomized study.”
“For example, patients in the antidepressant group were more depressed, which might be associated with less chance of persisting engagement in the exercises,” he said. “So, we have to be careful not to overinterpret the comparisons between groups, which the authors acknowledge properly.”
Turning to the difference in adherence between the two interventions, Dr. Ruhe said the results show adopting, and adhering to, a lifestyle habit is more difficult than taking a pill.
“This is not exclusively found in psychiatry, indicating that we also have to focus on how to improve compliance to healthy behavior. This could have tremendous impact on health care more generally, but also on psychiatric diseases,” Dr. Ruhe said.
The MOTAR study was funded by a NWO-VICI grant. Funding for the inflammatory markers was provided by ZonMw: The Netherlands Organization for Health Research and Development. The study authors and clinicians interviewed for this story declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BARCELONA – However, running provides greater physical health benefits while adherence is greater with drug treatment.
“Both interventions helped with the depression to around the same extent,” study presenter Brenda W.J.H. Penninx, PhD, professor of psychiatric epidemiology at the VU University Medical Center in Amsterdam said in a release.
However, medication “generally had worse impact on body weight, heart rate variability, and blood pressure, whereas running therapy led to improved effect on general fitness and heart rate,” Dr. Penninx added.
The findings were presented at the annual congress of the European College of Neuropsychopharmacology and recently published in the Journal of Affective Disorders.
Research gap
Previous research suggests exercise interventions can have a therapeutic effect equivalent to antidepressants, but their impact on physical health has been “poorly examined in a psychiatric population, the investigators note.
The authors note that depressive and anxiety disorders “cause immense suffering by compromising both mental and physical health,” and the need for effective treatments is “pressing.”
Although antidepressant medication is considered a “standard first-line treatment” alongside psychotherapy, the drugs are “not effective for all and [are] often associated with side effects.”
The Mood Treatment with Antidepressant or Running (MOTAR) study was a partially randomized pragmatic trial in adults with depression and/or anxiety disorder, as determined using the DSM-IV algorithms with the Composite International Diagnostic Interview (CIDI).
The 16-week intervention study included 141 patients with depression and/or anxiety. The mean age was 38.2 years and 58% were women. Participants were offered a choice of treatment: 16 weeks of treatment with the selective serotonin reuptake inhibitor (SSRI) escitalopram (Lexapro) or a 16-week group-based running therapy.
Patients without a strong preference for treatment allocation were randomly assigned to either antidepressant medication or running therapy, while those unwilling to be randomized were allocated to their preferred intervention.
A total of 22 patients were randomly assigned to receive antidepressant treatment and 13 to running therapy. A total of 36 participants chose antidepressant treatment, while 83 chose the running therapy.
Running therapy involved 16 weeks of supervised 45-minute outdoor running sessions to a target of two to three sessions per week, in line with U.S. Centers for Disease Control and Prevention/American College of Sports Medicine recommendations.
Physical health benefits
Treatment adherence in the antidepressant group, defined as still using treatment at the posttreatment assessment, was 82.2% vs. 52.1% among running therapy participants, where adherence was specified as completing more than 22 sessions.
Remission was defined as no longer meeting the criteria of a current depressive or anxiety disorder via CIDI at week 16.
On intention-to-treat analysis, this requirement was met by 44.8% of patients taking antidepressants and 43.3% of those in the running therapy group (P = .88).
However, running therapy patients showed significant improvements in weight (P = .001), waist circumference (P = .011), systolic and diastolic blood pressure (P = .011 and P = .002, respectively), heart rate (P = .033), and heart rate variability (P = .006).
The investigators note the more favorable physical health changes in the running therapy group were attributable to “larger improvements in the running therapy group but also due to larger deterioration in the antidepressant group.”
Antidepressants are generally safe and effective and work for most people, said Dr. Penninx. She also noted that untreated depression leads to worse outcomes, so “antidepressants are generally a good choice.”
Nevertheless, she said, “we need to extend our treatment arsenal as not all patients respond to antidepressants or are willing to take them.”
The study’s results, she added, suggest that “implementing exercise therapy is something we should take much more seriously, as it could be a good, and maybe even better, choice for some of our patients.”
Francesca Cirulli, PhD, senior researcher and group leader at the National Institute of Health, Rome, said in an interview that the study is notable because it is one of the first to prospectively measure the effects of antidepressants and running on physical health.
Dr. Cirulli suggested that running therapy could be tried ahead of treatment with antidepressants if patients prefer physical exercise and can adhere to it. However, she said, the findings also suggest that an increase in physical activity should accompany treatment with antidepressant medications.
Overall, Dr. Cirulli said “the message should not be that everyone can be helped by running and antidepressants are bad,” but rather “these are both helpful, but not excellent, interventions against depression.”
‘Important limitations’
In a comment, Eduard Vieta, MD, PhD, chair of the department of psychiatry and psychology at the University of Barcelona Hospital Clinic, noted the study has “very important limitations.”
Among the limitations: the inclusion of nonrandomized patients who received the treatment of their choice, causing obvious bias and the “lack of binding and power issues” over the number of patients enrolled.
Dr. Vieta also said that the results “seem obvious, because it is known that exercise improves physical health.”
The trial therefore shows, “if you can find people who are able to do exercise while depressed and adhere to it, those would benefit from that practice,” he noted.
Also commenting on the research, Eric Ruhe, MD, PhD, Radboud University Medical Center, Nijmegen, the Netherlands, said the results are confirmatory and “again show physical health can influence mental health.”
However, Dr. Ruhe underlined, while it is “common practice” to allow patients to follow their treatment preference and is “understandable from a pragmatic point of view,” the group comparison may be “biased,” compared with a “truly randomized study.”
“For example, patients in the antidepressant group were more depressed, which might be associated with less chance of persisting engagement in the exercises,” he said. “So, we have to be careful not to overinterpret the comparisons between groups, which the authors acknowledge properly.”
Turning to the difference in adherence between the two interventions, Dr. Ruhe said the results show adopting, and adhering to, a lifestyle habit is more difficult than taking a pill.
“This is not exclusively found in psychiatry, indicating that we also have to focus on how to improve compliance to healthy behavior. This could have tremendous impact on health care more generally, but also on psychiatric diseases,” Dr. Ruhe said.
The MOTAR study was funded by a NWO-VICI grant. Funding for the inflammatory markers was provided by ZonMw: The Netherlands Organization for Health Research and Development. The study authors and clinicians interviewed for this story declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ECNP 2023
Breast reconstruction post mastectomy: What matters most to women?
TOPLINE:
, a new survey suggests.
METHODOLOGY:
- As many as 40% of women feel dissatisfied after breast reconstruction because of unexpected outcomes that are poorly aligned with their personal preferences. Identifying what women value when considering breast reconstruction surgery could improve shared decision-making.
- Researchers used an adaptive choice-based conjoint analysis, a survey-based method used in marketing research, to identify attributes of breast reconstruction that are most important to women considering it.
- A total of 406 women completed the survey, which assessed the relative importance of breast appearance (flap or implant), abdominal morbidity, recovery time, additional operations, and complications of breast reconstruction.
- The survey included 105 women from Duke University, Durham, N.C., who had a new diagnosis of, or genetic predisposition to, breast cancer and were considering mastectomy with reconstruction. The survey also included another 301 women, identified through the Love Research Army registry, who had a history of breast cancer or a genetic predisposition.
TAKEAWAY:
- Overall, the risk for abdominal morbidity was most important to patients (mean relative importance, 28%); women also rated the chance for major complications (RI, 25%), the number of additional surgeries (RI, 23%), breast appearance (RI, 13%), and recovery time (RI, 11%) as important factors.
- Most women preferred implant-based reconstruction (85%), and these women cared most about abdominal morbidity (RI, 30%), risk for complications (RI, 26%), and added operations (RI, 21%).
- Women who preferred flap reconstruction cared most about additional operations (RI, 31%), followed by breast appearance (RI, 27%) and risk of complications (RI, 18%), which suggests that the appearance of the reconstruction procedure was particularly important, the authors noted.
- Participants who preferred the flap appearance were willing to accept an increased risk for abdominal morbidity and a slightly higher risk for complications; among the participants who preferred the implant option, one-third actually preferred the flap appearance.
IN PRACTICE:
“This study provides information on how women value different aspects of their care when making decisions for breast reconstruction,” the authors conclude, adding that “developing decision aids that elicit individual-level preferences and align patient values with treatment may provide an avenue to improve patient-centered care.”
SOURCE:
The study, led by first author Ronnie Shammas, MD, of Duke University, Durham, N.C., was published online in JAMA Surgery.
LIMITATIONS:
The attributes included in the survey may not represent all factors that women consider during the decision-making process. The cohort was composed of predominately upper-middle class and White women, which may reflect an increased preference toward implant, compared with flap reconstruction, as suggested in previous studies.
DISCLOSURES:
Funding for the research was provided by a grant from the National Endowment for Plastic Surgery awarded by the Plastic Surgery Foundation. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, a new survey suggests.
METHODOLOGY:
- As many as 40% of women feel dissatisfied after breast reconstruction because of unexpected outcomes that are poorly aligned with their personal preferences. Identifying what women value when considering breast reconstruction surgery could improve shared decision-making.
- Researchers used an adaptive choice-based conjoint analysis, a survey-based method used in marketing research, to identify attributes of breast reconstruction that are most important to women considering it.
- A total of 406 women completed the survey, which assessed the relative importance of breast appearance (flap or implant), abdominal morbidity, recovery time, additional operations, and complications of breast reconstruction.
- The survey included 105 women from Duke University, Durham, N.C., who had a new diagnosis of, or genetic predisposition to, breast cancer and were considering mastectomy with reconstruction. The survey also included another 301 women, identified through the Love Research Army registry, who had a history of breast cancer or a genetic predisposition.
TAKEAWAY:
- Overall, the risk for abdominal morbidity was most important to patients (mean relative importance, 28%); women also rated the chance for major complications (RI, 25%), the number of additional surgeries (RI, 23%), breast appearance (RI, 13%), and recovery time (RI, 11%) as important factors.
- Most women preferred implant-based reconstruction (85%), and these women cared most about abdominal morbidity (RI, 30%), risk for complications (RI, 26%), and added operations (RI, 21%).
- Women who preferred flap reconstruction cared most about additional operations (RI, 31%), followed by breast appearance (RI, 27%) and risk of complications (RI, 18%), which suggests that the appearance of the reconstruction procedure was particularly important, the authors noted.
- Participants who preferred the flap appearance were willing to accept an increased risk for abdominal morbidity and a slightly higher risk for complications; among the participants who preferred the implant option, one-third actually preferred the flap appearance.
IN PRACTICE:
“This study provides information on how women value different aspects of their care when making decisions for breast reconstruction,” the authors conclude, adding that “developing decision aids that elicit individual-level preferences and align patient values with treatment may provide an avenue to improve patient-centered care.”
SOURCE:
The study, led by first author Ronnie Shammas, MD, of Duke University, Durham, N.C., was published online in JAMA Surgery.
LIMITATIONS:
The attributes included in the survey may not represent all factors that women consider during the decision-making process. The cohort was composed of predominately upper-middle class and White women, which may reflect an increased preference toward implant, compared with flap reconstruction, as suggested in previous studies.
DISCLOSURES:
Funding for the research was provided by a grant from the National Endowment for Plastic Surgery awarded by the Plastic Surgery Foundation. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, a new survey suggests.
METHODOLOGY:
- As many as 40% of women feel dissatisfied after breast reconstruction because of unexpected outcomes that are poorly aligned with their personal preferences. Identifying what women value when considering breast reconstruction surgery could improve shared decision-making.
- Researchers used an adaptive choice-based conjoint analysis, a survey-based method used in marketing research, to identify attributes of breast reconstruction that are most important to women considering it.
- A total of 406 women completed the survey, which assessed the relative importance of breast appearance (flap or implant), abdominal morbidity, recovery time, additional operations, and complications of breast reconstruction.
- The survey included 105 women from Duke University, Durham, N.C., who had a new diagnosis of, or genetic predisposition to, breast cancer and were considering mastectomy with reconstruction. The survey also included another 301 women, identified through the Love Research Army registry, who had a history of breast cancer or a genetic predisposition.
TAKEAWAY:
- Overall, the risk for abdominal morbidity was most important to patients (mean relative importance, 28%); women also rated the chance for major complications (RI, 25%), the number of additional surgeries (RI, 23%), breast appearance (RI, 13%), and recovery time (RI, 11%) as important factors.
- Most women preferred implant-based reconstruction (85%), and these women cared most about abdominal morbidity (RI, 30%), risk for complications (RI, 26%), and added operations (RI, 21%).
- Women who preferred flap reconstruction cared most about additional operations (RI, 31%), followed by breast appearance (RI, 27%) and risk of complications (RI, 18%), which suggests that the appearance of the reconstruction procedure was particularly important, the authors noted.
- Participants who preferred the flap appearance were willing to accept an increased risk for abdominal morbidity and a slightly higher risk for complications; among the participants who preferred the implant option, one-third actually preferred the flap appearance.
IN PRACTICE:
“This study provides information on how women value different aspects of their care when making decisions for breast reconstruction,” the authors conclude, adding that “developing decision aids that elicit individual-level preferences and align patient values with treatment may provide an avenue to improve patient-centered care.”
SOURCE:
The study, led by first author Ronnie Shammas, MD, of Duke University, Durham, N.C., was published online in JAMA Surgery.
LIMITATIONS:
The attributes included in the survey may not represent all factors that women consider during the decision-making process. The cohort was composed of predominately upper-middle class and White women, which may reflect an increased preference toward implant, compared with flap reconstruction, as suggested in previous studies.
DISCLOSURES:
Funding for the research was provided by a grant from the National Endowment for Plastic Surgery awarded by the Plastic Surgery Foundation. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AGA patient and physician advocates visit Capitol Hill to push for prior authorization reform
In our first in-person Advocacy Day on Capitol Hill since 2019, AGA leaders and patient advocates from 22 total states met with House and Senate offices to educate members of Congress and their staff about policies affecting GI patient care such as prior authorization and step therapy. Federal research funding and Medicare reimbursement were also on the agenda.
In the meetings, the patient shared their stories of living with various gastrointestinal diseases, including ulcerative colitis and Crohn’s disease, and the struggles they’ve gone through to get treatments approved by their insurers. AGA physicians shared the provider perspective of how policies like prior authorization negatively impact practices. According to a 2023 AGA member survey, 95% of respondents say that prior authorization restrictions have impacted patient access to clinically appropriate treatments and patient clinical outcomes and 84% described that the burden associated with prior authorization policies have increased “significantly” or “somewhat” over the last 5 years. AGA’s advocacy day came not long after UnitedHealthcare’s announcement of a new “Gold Card” prior authorization policy to be implemented in 2024, which will impact most colonoscopies and endoscopies for its 27 million commercial beneficiaries. The group expressed serious concerns about the proposed policy to lawmakers.
“It was a wonderful and empowering experience to share my personal story with my Representative/Senator and know that they were really listening to my concerns about insurer overreach,” said Aaron Blocker, a Crohn’s disease patient and advocate. “I hope Congress acts swiftly on passing prior authorization reform, so no more patients are forced to live in pain while they wait for treatments to be approved.” As gastroenterologists, too much administrative time is spent submitting onerous prior authorization requests on a near daily basis. We hope Congress takes our concerns seriously and comes together to rein in prior authorization.
AGA thanks the patient and physician advocates who participated in this year’s Advocacy Day and looks forward to continuing our work to ensure timely access to care.
In our first in-person Advocacy Day on Capitol Hill since 2019, AGA leaders and patient advocates from 22 total states met with House and Senate offices to educate members of Congress and their staff about policies affecting GI patient care such as prior authorization and step therapy. Federal research funding and Medicare reimbursement were also on the agenda.
In the meetings, the patient shared their stories of living with various gastrointestinal diseases, including ulcerative colitis and Crohn’s disease, and the struggles they’ve gone through to get treatments approved by their insurers. AGA physicians shared the provider perspective of how policies like prior authorization negatively impact practices. According to a 2023 AGA member survey, 95% of respondents say that prior authorization restrictions have impacted patient access to clinically appropriate treatments and patient clinical outcomes and 84% described that the burden associated with prior authorization policies have increased “significantly” or “somewhat” over the last 5 years. AGA’s advocacy day came not long after UnitedHealthcare’s announcement of a new “Gold Card” prior authorization policy to be implemented in 2024, which will impact most colonoscopies and endoscopies for its 27 million commercial beneficiaries. The group expressed serious concerns about the proposed policy to lawmakers.
“It was a wonderful and empowering experience to share my personal story with my Representative/Senator and know that they were really listening to my concerns about insurer overreach,” said Aaron Blocker, a Crohn’s disease patient and advocate. “I hope Congress acts swiftly on passing prior authorization reform, so no more patients are forced to live in pain while they wait for treatments to be approved.” As gastroenterologists, too much administrative time is spent submitting onerous prior authorization requests on a near daily basis. We hope Congress takes our concerns seriously and comes together to rein in prior authorization.
AGA thanks the patient and physician advocates who participated in this year’s Advocacy Day and looks forward to continuing our work to ensure timely access to care.
In our first in-person Advocacy Day on Capitol Hill since 2019, AGA leaders and patient advocates from 22 total states met with House and Senate offices to educate members of Congress and their staff about policies affecting GI patient care such as prior authorization and step therapy. Federal research funding and Medicare reimbursement were also on the agenda.
In the meetings, the patient shared their stories of living with various gastrointestinal diseases, including ulcerative colitis and Crohn’s disease, and the struggles they’ve gone through to get treatments approved by their insurers. AGA physicians shared the provider perspective of how policies like prior authorization negatively impact practices. According to a 2023 AGA member survey, 95% of respondents say that prior authorization restrictions have impacted patient access to clinically appropriate treatments and patient clinical outcomes and 84% described that the burden associated with prior authorization policies have increased “significantly” or “somewhat” over the last 5 years. AGA’s advocacy day came not long after UnitedHealthcare’s announcement of a new “Gold Card” prior authorization policy to be implemented in 2024, which will impact most colonoscopies and endoscopies for its 27 million commercial beneficiaries. The group expressed serious concerns about the proposed policy to lawmakers.
“It was a wonderful and empowering experience to share my personal story with my Representative/Senator and know that they were really listening to my concerns about insurer overreach,” said Aaron Blocker, a Crohn’s disease patient and advocate. “I hope Congress acts swiftly on passing prior authorization reform, so no more patients are forced to live in pain while they wait for treatments to be approved.” As gastroenterologists, too much administrative time is spent submitting onerous prior authorization requests on a near daily basis. We hope Congress takes our concerns seriously and comes together to rein in prior authorization.
AGA thanks the patient and physician advocates who participated in this year’s Advocacy Day and looks forward to continuing our work to ensure timely access to care.
Proton pump inhibitors linked to increased dementia risk
TOPLINE:
and was highest among those diagnosed before age 70 years regardless of when PPI treatment was initiated.
METHODOLOGY:
- Researchers used four Danish registries to collect data on dementia diagnoses and prescription PPI use among 1,983,785 individuals aged 60-75 years between 2000 and 2018.
- The median follow-up time was 10.3 years.
TAKEAWAY:
- There were 99,384 (5.0%) cases of all-cause dementia during follow-up, with a median age of diagnosis of 79 years.
- Twenty-one-point-two percent of dementia cases and 18.9% of controls reported a history of PPI use.
- Risk for all-cause dementia before age 90 years was 36% higher with PPI use in people aged 60-69 years at baseline (adjusted incidence rate ratio, 1.36; 95% confidence interval, 1.29-1.43) and 6% higher in those who were age 80-89 years at baseline (aIRR, 1.06; 95% CI, 1.03-1.09).
- Investigators found significant increased dementia risk before age 90 years with PPI use regardless of when PPI treatment began and found no link between PPI use and dementia diagnoses after age 90 years.
IN PRACTICE:
“The association between PPI use and dementia was unambiguously largest among the youngest cases of dementia, potentially suggestive of a critical window of exposure where midlife PPI use affects dementia risk to a larger degree compared to late-life use,” the authors wrote. “Further, the finding could signify a declining impact of individual risk factors with advancing age owing to lengthy ongoing neuropathological processes.”
SOURCE:
Lead author of the study was Nelsan Pourhadi, MD, Danish Dementia Research Centre, department of neurology, Copenhagen University Hospital–Rigshospitalet. It was published online in Alzheimer’s and Dementia.
LIMITATIONS:
The study did not include data on PPI prescriptions before 1995, over-the-counter PPI use, and in-hospital intravenous use of PPI during the study period.
DISCLOSURES:
The study was funded by the Danish Ministry of Health. The authors reported no relevant conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
and was highest among those diagnosed before age 70 years regardless of when PPI treatment was initiated.
METHODOLOGY:
- Researchers used four Danish registries to collect data on dementia diagnoses and prescription PPI use among 1,983,785 individuals aged 60-75 years between 2000 and 2018.
- The median follow-up time was 10.3 years.
TAKEAWAY:
- There were 99,384 (5.0%) cases of all-cause dementia during follow-up, with a median age of diagnosis of 79 years.
- Twenty-one-point-two percent of dementia cases and 18.9% of controls reported a history of PPI use.
- Risk for all-cause dementia before age 90 years was 36% higher with PPI use in people aged 60-69 years at baseline (adjusted incidence rate ratio, 1.36; 95% confidence interval, 1.29-1.43) and 6% higher in those who were age 80-89 years at baseline (aIRR, 1.06; 95% CI, 1.03-1.09).
- Investigators found significant increased dementia risk before age 90 years with PPI use regardless of when PPI treatment began and found no link between PPI use and dementia diagnoses after age 90 years.
IN PRACTICE:
“The association between PPI use and dementia was unambiguously largest among the youngest cases of dementia, potentially suggestive of a critical window of exposure where midlife PPI use affects dementia risk to a larger degree compared to late-life use,” the authors wrote. “Further, the finding could signify a declining impact of individual risk factors with advancing age owing to lengthy ongoing neuropathological processes.”
SOURCE:
Lead author of the study was Nelsan Pourhadi, MD, Danish Dementia Research Centre, department of neurology, Copenhagen University Hospital–Rigshospitalet. It was published online in Alzheimer’s and Dementia.
LIMITATIONS:
The study did not include data on PPI prescriptions before 1995, over-the-counter PPI use, and in-hospital intravenous use of PPI during the study period.
DISCLOSURES:
The study was funded by the Danish Ministry of Health. The authors reported no relevant conflicts.
A version of this article first appeared on Medscape.com.
TOPLINE:
and was highest among those diagnosed before age 70 years regardless of when PPI treatment was initiated.
METHODOLOGY:
- Researchers used four Danish registries to collect data on dementia diagnoses and prescription PPI use among 1,983,785 individuals aged 60-75 years between 2000 and 2018.
- The median follow-up time was 10.3 years.
TAKEAWAY:
- There were 99,384 (5.0%) cases of all-cause dementia during follow-up, with a median age of diagnosis of 79 years.
- Twenty-one-point-two percent of dementia cases and 18.9% of controls reported a history of PPI use.
- Risk for all-cause dementia before age 90 years was 36% higher with PPI use in people aged 60-69 years at baseline (adjusted incidence rate ratio, 1.36; 95% confidence interval, 1.29-1.43) and 6% higher in those who were age 80-89 years at baseline (aIRR, 1.06; 95% CI, 1.03-1.09).
- Investigators found significant increased dementia risk before age 90 years with PPI use regardless of when PPI treatment began and found no link between PPI use and dementia diagnoses after age 90 years.
IN PRACTICE:
“The association between PPI use and dementia was unambiguously largest among the youngest cases of dementia, potentially suggestive of a critical window of exposure where midlife PPI use affects dementia risk to a larger degree compared to late-life use,” the authors wrote. “Further, the finding could signify a declining impact of individual risk factors with advancing age owing to lengthy ongoing neuropathological processes.”
SOURCE:
Lead author of the study was Nelsan Pourhadi, MD, Danish Dementia Research Centre, department of neurology, Copenhagen University Hospital–Rigshospitalet. It was published online in Alzheimer’s and Dementia.
LIMITATIONS:
The study did not include data on PPI prescriptions before 1995, over-the-counter PPI use, and in-hospital intravenous use of PPI during the study period.
DISCLOSURES:
The study was funded by the Danish Ministry of Health. The authors reported no relevant conflicts.
A version of this article first appeared on Medscape.com.
ADHD rates holding steady in U.S. children
TOPLINE:
While the prevalence of attention-deficit/hyperactivity disorder in U.S. children increased from the late 1990s to 2016,
METHODOLOGY:
- Based on prior data, the prevalence of ADHD in children rose from 6.1% in 1997-1998 to 10.2% in 2015-2016, with a 42.0% increase from 2003 to 2011. The new report provides updated prevalence data for 2017-2022.
- The cross-sectional analysis used data from the National Health Interview Survey (NHIS) from 2017 to 2022 for more than 37,609 U.S. children and adolescents 4-17 years old (52% male, 53% non-Hispanic White, 24% Hispanic, 11% non-Hispanic Black, and 12% non-Hispanic other race).
- Information on health care provider–diagnosed ADHD was reported by a parent or guardian.
TAKEAWAY:
- A total of 4,098 children and adolescents (10.9%) were reported to have an ADHD diagnosis during the study period.
- The weighted prevalence of ADHD ranged from 10.08% to 10.47% from 2017 to 2022, which is similar to the prevalence in 2015-2016 (10.20%).
- There was no significant change on an annual basis or in all subgroups evaluated. Notably, the estimated prevalence of ADHD among U.S. children and adolescents was higher than worldwide estimates (5.3%) in earlier years (1978-2005).
- The prevalence of ADHD in U.S. children differed significantly by age, sex, race/ethnicity, and family income, in line with previous findings, with higher rates in those 12-17 years (vs. 4-11 years), males, non-Hispanic populations, and those with higher family income.
IN PRACTICE:
The estimated ADHD prevalence remains “high” and “further investigation is warranted to assess potentially modifiable risk factors and provide adequate resources for treatment of individuals with ADHD in the future,” the authors write.
SOURCE:
The study, with first author Yanmei Li, Guangdong Pharmaceutical University, Guangzhou, China, was published online in JAMA Network Open.
LIMITATIONS:
Information on ADHD relied on parent-reported diagnosis, which may lead to misreporting and recall bias. The NHIS underwent a major redesign in 2019, which may affect comparability with prior years, and the COVID-19 pandemic affected collection in 2020.
DISCLOSURES:
The study had no specific funding. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
While the prevalence of attention-deficit/hyperactivity disorder in U.S. children increased from the late 1990s to 2016,
METHODOLOGY:
- Based on prior data, the prevalence of ADHD in children rose from 6.1% in 1997-1998 to 10.2% in 2015-2016, with a 42.0% increase from 2003 to 2011. The new report provides updated prevalence data for 2017-2022.
- The cross-sectional analysis used data from the National Health Interview Survey (NHIS) from 2017 to 2022 for more than 37,609 U.S. children and adolescents 4-17 years old (52% male, 53% non-Hispanic White, 24% Hispanic, 11% non-Hispanic Black, and 12% non-Hispanic other race).
- Information on health care provider–diagnosed ADHD was reported by a parent or guardian.
TAKEAWAY:
- A total of 4,098 children and adolescents (10.9%) were reported to have an ADHD diagnosis during the study period.
- The weighted prevalence of ADHD ranged from 10.08% to 10.47% from 2017 to 2022, which is similar to the prevalence in 2015-2016 (10.20%).
- There was no significant change on an annual basis or in all subgroups evaluated. Notably, the estimated prevalence of ADHD among U.S. children and adolescents was higher than worldwide estimates (5.3%) in earlier years (1978-2005).
- The prevalence of ADHD in U.S. children differed significantly by age, sex, race/ethnicity, and family income, in line with previous findings, with higher rates in those 12-17 years (vs. 4-11 years), males, non-Hispanic populations, and those with higher family income.
IN PRACTICE:
The estimated ADHD prevalence remains “high” and “further investigation is warranted to assess potentially modifiable risk factors and provide adequate resources for treatment of individuals with ADHD in the future,” the authors write.
SOURCE:
The study, with first author Yanmei Li, Guangdong Pharmaceutical University, Guangzhou, China, was published online in JAMA Network Open.
LIMITATIONS:
Information on ADHD relied on parent-reported diagnosis, which may lead to misreporting and recall bias. The NHIS underwent a major redesign in 2019, which may affect comparability with prior years, and the COVID-19 pandemic affected collection in 2020.
DISCLOSURES:
The study had no specific funding. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
While the prevalence of attention-deficit/hyperactivity disorder in U.S. children increased from the late 1990s to 2016,
METHODOLOGY:
- Based on prior data, the prevalence of ADHD in children rose from 6.1% in 1997-1998 to 10.2% in 2015-2016, with a 42.0% increase from 2003 to 2011. The new report provides updated prevalence data for 2017-2022.
- The cross-sectional analysis used data from the National Health Interview Survey (NHIS) from 2017 to 2022 for more than 37,609 U.S. children and adolescents 4-17 years old (52% male, 53% non-Hispanic White, 24% Hispanic, 11% non-Hispanic Black, and 12% non-Hispanic other race).
- Information on health care provider–diagnosed ADHD was reported by a parent or guardian.
TAKEAWAY:
- A total of 4,098 children and adolescents (10.9%) were reported to have an ADHD diagnosis during the study period.
- The weighted prevalence of ADHD ranged from 10.08% to 10.47% from 2017 to 2022, which is similar to the prevalence in 2015-2016 (10.20%).
- There was no significant change on an annual basis or in all subgroups evaluated. Notably, the estimated prevalence of ADHD among U.S. children and adolescents was higher than worldwide estimates (5.3%) in earlier years (1978-2005).
- The prevalence of ADHD in U.S. children differed significantly by age, sex, race/ethnicity, and family income, in line with previous findings, with higher rates in those 12-17 years (vs. 4-11 years), males, non-Hispanic populations, and those with higher family income.
IN PRACTICE:
The estimated ADHD prevalence remains “high” and “further investigation is warranted to assess potentially modifiable risk factors and provide adequate resources for treatment of individuals with ADHD in the future,” the authors write.
SOURCE:
The study, with first author Yanmei Li, Guangdong Pharmaceutical University, Guangzhou, China, was published online in JAMA Network Open.
LIMITATIONS:
Information on ADHD relied on parent-reported diagnosis, which may lead to misreporting and recall bias. The NHIS underwent a major redesign in 2019, which may affect comparability with prior years, and the COVID-19 pandemic affected collection in 2020.
DISCLOSURES:
The study had no specific funding. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Nintedanib dose reductions in IPF may do no harm
HONOLULU – nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.
An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.
Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.
“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.
“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
Hard to take
Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.
However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.
To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.
They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.
There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).
“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
Not so sure
Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.
“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.
It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.
In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.
“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.
The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
HONOLULU – nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.
An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.
Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.
“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.
“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
Hard to take
Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.
However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.
To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.
They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.
There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).
“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
Not so sure
Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.
“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.
It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.
In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.
“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.
The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
HONOLULU – nintedanib (Ofev) for patients with idiopathic pulmonary fibrosis (IPF) who can’t tolerate the full 150-mg twice-daily dose.
An analysis of data from a large administrative claims database showed that there were no significant differences in either all-cause mortality or hospitalization rates between patients with IPF treated at the full 150-mg twice-daily dose and those treated with a reduced twice-daily dose of 100 mg nintedanib.
Although the results need to be confirmed by additional prospective and registry studies, they suggest that patients with IPF can still fare just as well with a reduced-dose nintedanib regimen, ideally with fewer gastrointestinal side effects such as diarrhea, reported Andrew Limper, MD, of the Mayo Clinic in Rochester, Minn.
“At least on this preliminary data you could ... rest assured,” Dr. Limper told his colleagues in an oral abstract session at the American College of Chest Physicians (CHEST) 2023 annual meeting.
“This is not definitive proof, I’m not making more out of this than it is, but we all put people on 100 mg twice daily because their guts don’t tolerate it; they live in the bathroom and they don’t want to live that way,” Dr. Limper said.
Hard to take
Nintedanib is approved in the United States for the treatment of IPF, chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype, and systemic sclerosis-associated ILD. For IPF, the standard dose established in randomized clinical trials is 150 mg twice daily.
However, nintedanib is associated with a number of side effects, including hepatic and other gastrointestinal toxicities, arterial thromboembolic events, and proteinuria within the nephrotic range. As a result, clinicians often reduce the dose to 100 mg twice daily, but there is a lack of data to indicate whether it’s safe to do so or if efficacy will be compromised.
To see whether dose reductions might result in poorer outcomes for patients with IPF, Dr. Limper and colleagues analyzed data from the OptumLabs Data Warehouse, a large administrative claims database, to compare outcomes for patients treated with IPF at either the 150-mg or 100-mg twice-daily doses.
They used propensity-score matching to account for differences among individuals according to age, sex, race/ethnicity, residence, insurance type, additional medication use, oxygen use, smoking status, health care use, and comorbidities. The final cohort included 346 patients in each dosing group.
There was no difference between the dosing groups for the primary outcome of all-cause mortality at 18 months, with a nonsignificant hazard ratio of 0.65 (P = .313), and no significant difference over 24 months in risk of hospitalization, with a hazard ratio of 0.98 (P = .899).
“This is not randomized controlled data; I doubt that [nintedanib maker Boehringer Ingelheim] is ever going to do a 150 vs. 100 milligram head-to-head trial, but it does give us some ground to start to look at this,” Dr. Limper said.
Not so sure
Session comoderator Misbah Baqir, MBBS, also from the Mayo Clinic, told this news organization that she would need to see more data from prospective studies using endpoints other than mortality before she could be convinced that nintedanib dose reductions do not adversely affect efficacy. She was not involved in the study.
“I feel that the endpoint should be different, either it should be forced vital capacity change, quality of life, or something else. The problem with a database study is that you don’t have everything in it. You have to play with what you have, and you don’t have forced vital capacity. You have to go into the charts to get it,” she said.
It would be more helpful to objectively compare, for example, diarrhea episodes or other adverse events to see whether they were significantly reduced with the 100-mg dose, she added.
In an interview, Dr. Limper said that he and his colleagues plan to gather additional observational data including the newly available Medicare fee-for-service data set, registry data, and other sources.
“If we get all of that, and it really still looks compelling – and that’s an if – then I think that would be the foothold to go back to the manufacturer and say, ‘Hey, maybe you ought to think about doing a prospective trial to prove it with lung function and other endpoints such as 6-minute walks,’ ” he said.
The study was supported by a grant from Three Lakes Foundation. Dr. Limper and Dr. Baqir have disclosed no relevant financial relationships.
A version of this article appeared on Medscape.com.
AT CHEST 2023
Anemia, iron deficit common in rheumatic disease pregnancy
TOPLINE:
, according to findings from a longitudinal cohort study.
METHODOLOGY:
- Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
- Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
- Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.
TAKEAWAY:
- The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
- The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
- There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
- Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).
IN PRACTICE:
“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.
SOURCE:
The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.
LIMITATIONS:
The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.
DISCLOSURES:
The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, according to findings from a longitudinal cohort study.
METHODOLOGY:
- Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
- Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
- Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.
TAKEAWAY:
- The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
- The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
- There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
- Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).
IN PRACTICE:
“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.
SOURCE:
The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.
LIMITATIONS:
The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.
DISCLOSURES:
The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
, according to findings from a longitudinal cohort study.
METHODOLOGY:
- Researchers analyzed data from 368 pregnancies in women with rheumatic diseases during the period 2014-2022; nearly two-thirds (62%) had a connective tissue disease, 16% had rheumatoid arthritis or juvenile idiopathic arthritis, 14% had spondyloarthritis, 3% had vasculitis, and 7% had other diseases.
- Patients were aged 17-44 years, with a median age of 32 years at the time of birth.
- Researchers examined the frequency of anemia and iron deficiency and the impact of anemia on adverse maternal and child outcomes.
TAKEAWAY:
- The prevalence of iron deficiency was 28%, 51%, and 62% in the first, second, and third trimesters, respectively.
- The prevalence of anemia was 18%, 27%, and 33% in the first, second, and third trimesters, respectively.
- There was an increased risk for fetal complications such as malformation, infections, small for gestational age, neonatal lupus, preterm birth, and abortion or stillbirth in association with maternal connective tissue disease (odds ratio, 2.14) and also with low maternal hemoglobin levels and maternal iron deficiency (ORs, 0.52 and 0.86, respectively).
- Lower maternal hemoglobin levels were associated with an increased risk for maternal complications (OR, 1.47) such as flare with adaption of rheumatic medication and pregnancy-related adverse events (preeclampsia, gestational diabetes, bleeding complications, and thromboembolism), but patients with connective tissue disease had a lower risk for maternal complications (OR, 0.51); mean serum ferritin had no significant impact on maternal complications (OR, 1.02).
IN PRACTICE:
“Patients with rheumatic diseases suffer more often and already in early pregnancy from iron deficiency,” the researchers write. Therefore, early identification of anemia and iron deficiency in this population could inform prepregnancy counseling.
SOURCE:
The lead author on the study was Ann-Christin Pecher, MD, of University Hospital Tübingen, Germany. The study was published online in Joint Bone Spine.
LIMITATIONS:
The findings were limited by the use of a single dataset that might not be representative of all pregnant patients with rheumatic diseases. Other limitations included the lack of a standardized approach to iron supplementation.
DISCLOSURES:
The study was supported by a grant from the Medical Faculty of Tübingen Clinician-Scientist to the lead author. The researchers report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FDA denies approval for patisiran in ATTR cardiomyopathy, despite panel nod
the company has announced.
ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.
In September, the FDA Cardiovascular and Renal Drugs Advisory Committee voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy on the basis of the results of the APOLLO-B phase 3 study.
However, many panel members questioned whether the benefits are clinically meaningful – a view shared by the FDA in a complete response letter (CRL) the FDA sent to Alnylam.
According to the company, the FDA indicated in the letter that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis have “not been established,” and therefore, the supplemental new drug application for patisiran “could not be approved in its present form.”
The FDA did not identify any issues with respect to clinical safety, study conduct, drug quality, or manufacturing.
Nonetheless, as a result of the CRL, the company said it will no longer pursue an expanded indication for patisiran in cardiomyopathy of ATTR amyloidosis in the United States.
The company said it will continue to make patisiran available for patients with cardiomyopathy of ATTR amyloidosis who are enrolled in the open-label extension period of the APOLLO-B study and the patisiran expanded access protocol.
The company also said it will continue to focus on the HELIOS-B phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of cardiomyopathy of ATTR amyloidosis.
“We remain confident in the HELIOS-B phase 3 study of vutrisiran and look forward to sharing topline results in early 2024. If successful, we believe vutrisiran will offer convenient, quarterly subcutaneous dosing with a therapeutic profile that may potentially include cardiovascular outcome benefits,” Alnylam CEO Yvonne Greenstreet, MBChB, said in the statement.
Intravenously administered patisiran is already approved in the United States and Canada for the treatment of polyneuropathy of hereditary ATTR amyloidosis in adults.
A version of this article first appeared on Medscape.com.
the company has announced.
ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.
In September, the FDA Cardiovascular and Renal Drugs Advisory Committee voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy on the basis of the results of the APOLLO-B phase 3 study.
However, many panel members questioned whether the benefits are clinically meaningful – a view shared by the FDA in a complete response letter (CRL) the FDA sent to Alnylam.
According to the company, the FDA indicated in the letter that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis have “not been established,” and therefore, the supplemental new drug application for patisiran “could not be approved in its present form.”
The FDA did not identify any issues with respect to clinical safety, study conduct, drug quality, or manufacturing.
Nonetheless, as a result of the CRL, the company said it will no longer pursue an expanded indication for patisiran in cardiomyopathy of ATTR amyloidosis in the United States.
The company said it will continue to make patisiran available for patients with cardiomyopathy of ATTR amyloidosis who are enrolled in the open-label extension period of the APOLLO-B study and the patisiran expanded access protocol.
The company also said it will continue to focus on the HELIOS-B phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of cardiomyopathy of ATTR amyloidosis.
“We remain confident in the HELIOS-B phase 3 study of vutrisiran and look forward to sharing topline results in early 2024. If successful, we believe vutrisiran will offer convenient, quarterly subcutaneous dosing with a therapeutic profile that may potentially include cardiovascular outcome benefits,” Alnylam CEO Yvonne Greenstreet, MBChB, said in the statement.
Intravenously administered patisiran is already approved in the United States and Canada for the treatment of polyneuropathy of hereditary ATTR amyloidosis in adults.
A version of this article first appeared on Medscape.com.
the company has announced.
ATTR amyloidosis is an underdiagnosed, rapidly progressive, debilitating, fatal disease caused by misfolded TTR proteins, which accumulate as amyloid deposits in various parts of the body, including the heart.
In September, the FDA Cardiovascular and Renal Drugs Advisory Committee voted 9 to 3 that the benefits of patisiran outweigh the risks for the treatment of ATTR amyloidosis cardiomyopathy on the basis of the results of the APOLLO-B phase 3 study.
However, many panel members questioned whether the benefits are clinically meaningful – a view shared by the FDA in a complete response letter (CRL) the FDA sent to Alnylam.
According to the company, the FDA indicated in the letter that the clinical meaningfulness of patisiran’s treatment effects for the cardiomyopathy of ATTR amyloidosis have “not been established,” and therefore, the supplemental new drug application for patisiran “could not be approved in its present form.”
The FDA did not identify any issues with respect to clinical safety, study conduct, drug quality, or manufacturing.
Nonetheless, as a result of the CRL, the company said it will no longer pursue an expanded indication for patisiran in cardiomyopathy of ATTR amyloidosis in the United States.
The company said it will continue to make patisiran available for patients with cardiomyopathy of ATTR amyloidosis who are enrolled in the open-label extension period of the APOLLO-B study and the patisiran expanded access protocol.
The company also said it will continue to focus on the HELIOS-B phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of cardiomyopathy of ATTR amyloidosis.
“We remain confident in the HELIOS-B phase 3 study of vutrisiran and look forward to sharing topline results in early 2024. If successful, we believe vutrisiran will offer convenient, quarterly subcutaneous dosing with a therapeutic profile that may potentially include cardiovascular outcome benefits,” Alnylam CEO Yvonne Greenstreet, MBChB, said in the statement.
Intravenously administered patisiran is already approved in the United States and Canada for the treatment of polyneuropathy of hereditary ATTR amyloidosis in adults.
A version of this article first appeared on Medscape.com.