Brain volume patterns vary across psychiatric disorders

Article Type
Changed
Thu, 08/17/2023 - 13:34

A large brain imaging study of adults with six different psychiatric illnesses shows that heterogeneity in regional gray matter volume deviations is a general feature of psychiatric illness, but that these regionally heterogeneous areas are often embedded within common functional circuits and networks.

The findings suggest that “targeting brain circuits, rather than specific brain regions, may be a more effective way of developing new treatments,” study investigator Ashlea Segal said in an email.

The findings also suggest that it’s “unlikely that a single cause or mechanism of a given disorder exists, and that a ‘one-size-fits-all’ approach to treatment is likely only appropriate for a small subset of individuals. In fact, one size doesn’t fit all. It probably doesn’t even fit most,” said Ms. Segal, a PhD candidate with the Turner Institute for Brain and Mental Health’s Neural Systems and Behaviour Lab at Monash University in Melbourne.

“Focusing on brain alterations at an individual level allows us to develop more personally tailored treatments,” Ms. Segal added.

Regional heterogeneity, the authors write, “thus offers a plausible explanation for the well-described clinical heterogeneity observed in psychiatric disorders, while circuit- and network-level aggregation of deviations is a putative neural substrate for phenotypic similarities between patients assigned the same diagnosis.”

The study was published online in Nature Neuroscience
 

Beyond group averages

For decades, researchers have mapped brain areas showing reduced gray matter volume (GMV) in people diagnosed with a variety of mental illnesses, but these maps have only been generated at the level of group averages, Ms. Segal explained.

“This means that we understand how the brains of people with, say, schizophrenia, differ from those without schizophrenia on average, but we can’t really say much about individual people,” Ms. Segal said.

For their study, the researchers used new statistical techniques developed by Andre Marquand, PhD, who co-led the project, to characterize the heterogeneity of GMV differences in 1,294 individuals diagnosed with one of six psychiatric conditions and 1,465 matched controls. Dr. Marquand is affiliated with the Donders Institute for Brain, Cognition, and Behavior in Nijmegen, the Netherlands.

These techniques “allow us to benchmark the size of over 1,000 different brain regions in any given person relative to what we should expect to see in the general population. In this way, we can identify, for any person, brain regions showing unusually small or large volumes, given that person’s age and sex,” Ms. Segal told this news organization.

The clinical sample included 202 individuals with autism spectrum disorder, 153 with attention-deficit/hyperactivity disorder (ADHD), 228 with bipolar disorder, 161 with major depressive disorder, 167 with obsessive-compulsive disorder, and 383 individuals with schizophrenia.

Confirming earlier findings, those with psychiatric illness showed more GMV deviations than healthy controls, the researchers found.

However, at the individual level, deviations from population expectations for regional gray matter volumes were “highly heterogeneous,” affecting the same area in less than 7% of people with the same diagnosis, they note. “This result means that it is difficult to pinpoint treatment targets or causal mechanisms by focusing on group averages alone,” Alex Fornito, PhD, of Monash University, who led the research team, said in a statement.

“It may also explain why people with the same diagnosis show wide variability in their symptom profiles and treatment outcomes,” Dr. Fornito added.

Yet, despite considerable heterogeneity at the regional level across different diagnoses, these deviations were embedded within common functional circuits and networks in up to 56% of cases. 

The salience-ventral attention network, for example, which plays a central role in cognitive control, interoceptive awareness, and switching between internally and externally focused attention, was implicated across diagnoses, with other neural networks selectively involved in depression, bipolar disorder, schizophrenia, and ADHD.

The researchers say the approach they developed opens new opportunities for mapping brain changes in mental illness.

“The framework we have developed allows us to understand the diversity of brain changes in people with mental illness at different levels, from individual regions through to more widespread brain circuits and networks, offering a deeper insight into how the brain is affected in individual people,” Dr. Fornito said in a statement.

The study had no commercial funding. Ms. Segal, Dr. Fornito, and Dr. Marquand report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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A large brain imaging study of adults with six different psychiatric illnesses shows that heterogeneity in regional gray matter volume deviations is a general feature of psychiatric illness, but that these regionally heterogeneous areas are often embedded within common functional circuits and networks.

The findings suggest that “targeting brain circuits, rather than specific brain regions, may be a more effective way of developing new treatments,” study investigator Ashlea Segal said in an email.

The findings also suggest that it’s “unlikely that a single cause or mechanism of a given disorder exists, and that a ‘one-size-fits-all’ approach to treatment is likely only appropriate for a small subset of individuals. In fact, one size doesn’t fit all. It probably doesn’t even fit most,” said Ms. Segal, a PhD candidate with the Turner Institute for Brain and Mental Health’s Neural Systems and Behaviour Lab at Monash University in Melbourne.

“Focusing on brain alterations at an individual level allows us to develop more personally tailored treatments,” Ms. Segal added.

Regional heterogeneity, the authors write, “thus offers a plausible explanation for the well-described clinical heterogeneity observed in psychiatric disorders, while circuit- and network-level aggregation of deviations is a putative neural substrate for phenotypic similarities between patients assigned the same diagnosis.”

The study was published online in Nature Neuroscience
 

Beyond group averages

For decades, researchers have mapped brain areas showing reduced gray matter volume (GMV) in people diagnosed with a variety of mental illnesses, but these maps have only been generated at the level of group averages, Ms. Segal explained.

“This means that we understand how the brains of people with, say, schizophrenia, differ from those without schizophrenia on average, but we can’t really say much about individual people,” Ms. Segal said.

For their study, the researchers used new statistical techniques developed by Andre Marquand, PhD, who co-led the project, to characterize the heterogeneity of GMV differences in 1,294 individuals diagnosed with one of six psychiatric conditions and 1,465 matched controls. Dr. Marquand is affiliated with the Donders Institute for Brain, Cognition, and Behavior in Nijmegen, the Netherlands.

These techniques “allow us to benchmark the size of over 1,000 different brain regions in any given person relative to what we should expect to see in the general population. In this way, we can identify, for any person, brain regions showing unusually small or large volumes, given that person’s age and sex,” Ms. Segal told this news organization.

The clinical sample included 202 individuals with autism spectrum disorder, 153 with attention-deficit/hyperactivity disorder (ADHD), 228 with bipolar disorder, 161 with major depressive disorder, 167 with obsessive-compulsive disorder, and 383 individuals with schizophrenia.

Confirming earlier findings, those with psychiatric illness showed more GMV deviations than healthy controls, the researchers found.

However, at the individual level, deviations from population expectations for regional gray matter volumes were “highly heterogeneous,” affecting the same area in less than 7% of people with the same diagnosis, they note. “This result means that it is difficult to pinpoint treatment targets or causal mechanisms by focusing on group averages alone,” Alex Fornito, PhD, of Monash University, who led the research team, said in a statement.

“It may also explain why people with the same diagnosis show wide variability in their symptom profiles and treatment outcomes,” Dr. Fornito added.

Yet, despite considerable heterogeneity at the regional level across different diagnoses, these deviations were embedded within common functional circuits and networks in up to 56% of cases. 

The salience-ventral attention network, for example, which plays a central role in cognitive control, interoceptive awareness, and switching between internally and externally focused attention, was implicated across diagnoses, with other neural networks selectively involved in depression, bipolar disorder, schizophrenia, and ADHD.

The researchers say the approach they developed opens new opportunities for mapping brain changes in mental illness.

“The framework we have developed allows us to understand the diversity of brain changes in people with mental illness at different levels, from individual regions through to more widespread brain circuits and networks, offering a deeper insight into how the brain is affected in individual people,” Dr. Fornito said in a statement.

The study had no commercial funding. Ms. Segal, Dr. Fornito, and Dr. Marquand report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A large brain imaging study of adults with six different psychiatric illnesses shows that heterogeneity in regional gray matter volume deviations is a general feature of psychiatric illness, but that these regionally heterogeneous areas are often embedded within common functional circuits and networks.

The findings suggest that “targeting brain circuits, rather than specific brain regions, may be a more effective way of developing new treatments,” study investigator Ashlea Segal said in an email.

The findings also suggest that it’s “unlikely that a single cause or mechanism of a given disorder exists, and that a ‘one-size-fits-all’ approach to treatment is likely only appropriate for a small subset of individuals. In fact, one size doesn’t fit all. It probably doesn’t even fit most,” said Ms. Segal, a PhD candidate with the Turner Institute for Brain and Mental Health’s Neural Systems and Behaviour Lab at Monash University in Melbourne.

“Focusing on brain alterations at an individual level allows us to develop more personally tailored treatments,” Ms. Segal added.

Regional heterogeneity, the authors write, “thus offers a plausible explanation for the well-described clinical heterogeneity observed in psychiatric disorders, while circuit- and network-level aggregation of deviations is a putative neural substrate for phenotypic similarities between patients assigned the same diagnosis.”

The study was published online in Nature Neuroscience
 

Beyond group averages

For decades, researchers have mapped brain areas showing reduced gray matter volume (GMV) in people diagnosed with a variety of mental illnesses, but these maps have only been generated at the level of group averages, Ms. Segal explained.

“This means that we understand how the brains of people with, say, schizophrenia, differ from those without schizophrenia on average, but we can’t really say much about individual people,” Ms. Segal said.

For their study, the researchers used new statistical techniques developed by Andre Marquand, PhD, who co-led the project, to characterize the heterogeneity of GMV differences in 1,294 individuals diagnosed with one of six psychiatric conditions and 1,465 matched controls. Dr. Marquand is affiliated with the Donders Institute for Brain, Cognition, and Behavior in Nijmegen, the Netherlands.

These techniques “allow us to benchmark the size of over 1,000 different brain regions in any given person relative to what we should expect to see in the general population. In this way, we can identify, for any person, brain regions showing unusually small or large volumes, given that person’s age and sex,” Ms. Segal told this news organization.

The clinical sample included 202 individuals with autism spectrum disorder, 153 with attention-deficit/hyperactivity disorder (ADHD), 228 with bipolar disorder, 161 with major depressive disorder, 167 with obsessive-compulsive disorder, and 383 individuals with schizophrenia.

Confirming earlier findings, those with psychiatric illness showed more GMV deviations than healthy controls, the researchers found.

However, at the individual level, deviations from population expectations for regional gray matter volumes were “highly heterogeneous,” affecting the same area in less than 7% of people with the same diagnosis, they note. “This result means that it is difficult to pinpoint treatment targets or causal mechanisms by focusing on group averages alone,” Alex Fornito, PhD, of Monash University, who led the research team, said in a statement.

“It may also explain why people with the same diagnosis show wide variability in their symptom profiles and treatment outcomes,” Dr. Fornito added.

Yet, despite considerable heterogeneity at the regional level across different diagnoses, these deviations were embedded within common functional circuits and networks in up to 56% of cases. 

The salience-ventral attention network, for example, which plays a central role in cognitive control, interoceptive awareness, and switching between internally and externally focused attention, was implicated across diagnoses, with other neural networks selectively involved in depression, bipolar disorder, schizophrenia, and ADHD.

The researchers say the approach they developed opens new opportunities for mapping brain changes in mental illness.

“The framework we have developed allows us to understand the diversity of brain changes in people with mental illness at different levels, from individual regions through to more widespread brain circuits and networks, offering a deeper insight into how the brain is affected in individual people,” Dr. Fornito said in a statement.

The study had no commercial funding. Ms. Segal, Dr. Fornito, and Dr. Marquand report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Controversial issue of maintenance therapy for bipolar depression still unresolved

Article Type
Changed
Mon, 08/14/2023 - 12:44

The first randomized controlled trial testing the safety and efficacy of long-term antidepressant maintenance therapy after remission of a depressive episode in adults with bipolar I disorder has yielded mixed results.

Continuing antidepressant therapy for 52 weeks, as opposed to stopping it at 8 weeks, was not more beneficial with regard to the primary outcome of occurrence of any mood episode.

However, a prespecified sensitivity analysis of the primary outcome and of the secondary analyses suggests that continuing antidepressant therapy for 52 weeks may prolong the time to a depressive relapse.

“Because the primary outcome is negative and the prespecified sensitivity analysis is positive and the secondary outcomes are positive, some clinicians will pick the position that they work and some that they don’t work,” lead investigator Lakshmi Yatham, MBBS, with University of British Columbia, Vancouver, told this news organization.

University of British Columbia (UBC) in Vancouver, Canada
University of British Columbia
Dr. Lakshmi Yatham


The study was published online  in the New England Journal of Medicine.
 

Controversial issue

Adjunctive antidepressant therapy – alongside mood stabilizers and/or second-generation antipsychotic medications – are often used to treat acute depressive episodes in patients with bipolar I disorder.

Currently, the Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) advise discontinuing antidepressant treatment 8 weeks after remission of depression.

Yet, the duration of antidepressant therapy for bipolar depression is “highly controversial,” due to a lack of evidence and concerns that antidepressants may induce mania, mixed states, or rapid cycling between mania and depression, Dr. Yatham said.

Dr. Yatham and colleagues assessed the safety and efficacy of continuing adjunctive antidepressant treatment (escitalopram or bupropion XL) for 52 weeks after remission, compared with discontinuing antidepressant therapy at 8 weeks after remission.

The final analysis included 177 patients (mean age 41 years, 48% men) with bipolar I disorder who had remission of depression; 90 patients continued treatment with an antidepressant for 52 weeks and 87 were switched to placebo at 8 weeks. All were taking a mood stabilizer or a second-generation antipsychotic or both.

The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide.

At 52 weeks, 28 patients (31%) in the 52-week group had experienced any mood episode (primary outcome), compared with 40 patients (46%) in the 8-week group.

The primary outcome did not reach statistical significance (hazard ratio, 0.68; 95% confidence interval, 0.43-1.10; P = .12).

The researchers note that the decision by the study team to include relapses that occurred during the first 6 weeks of the study may have affected the primary outcome.

“During the first 6 weeks, both groups were getting the same treatment, and we thought there shouldn’t be any difference in relapse, but sadly, there were more relapses in the 52-week group even though the treatments were identical,” Dr. Yatham said.

However, in a sensitivity analysis of the primary outcome after week 6, when treatment between the two groups differed, patients continuing antidepressant treatment were 40% less likely to experience a relapse of any mood event (HR, 0.60) and 59% less likely to experience a depressive episode (HR, 0.41) relative to the placebo group.

“From the point where the two groups began receiving different treatments, we see a significant benefit for patients who continued treatment with antidepressants,” Dr. Yatham said in a news release.

“Treating depression in bipolar disorder is challenging. Reducing the risk of relapse is important because it can provide patients with a great deal of stability that ultimately lets them get back to the activities they enjoy and can greatly improve their quality of life,” he added.

Although fewer patients in the 52-week group than 8-week group had a depressive episode within 52 weeks (17% vs. 40%; HR, 0.43), more had a manic or hypomanic event (12% vs. 6%; HR, 2.28).

The estimated probability of remaining free of a depressive episode at 52 weeks was 72% in the 52-week group versus 53% in the 8-week group. The estimated probability of remaining free of a manic episode at 52 weeks was 81% and 92%, respectively.

The incidence of adverse events was similar in the two groups, with a low rate of discontinuation due to adverse events and no serious adverse events. Clinically significant weight gain (≥ 7% increase in body weight) was observed in 14% of patients in the 52-week group and 7% of patients in the 8-week group.

Limitations of the trial include the fact that it was stopped early, before the planned sample size was reached, owing to slow recruitment and funding issues.

Other limitations include a lack of ethnic diversity (only 12% were White and < 1% Black) and overrepresentation of patients from India, which may limit generalizability. 

In addition, the findings may not be applicable to treatment with antidepressants other than escitalopram and buproprion XL. Finally, the study population was also enriched for patients who responded to these antidepressants.
 

 

 

Need for an individualized approach

Commenting on the study, Roger McIntyre, MD, professor of psychiatry in pharmacology, University of Toronto, noted the study was not easy to conduct, and the investigators should be credited for conducting a maintenance study in bipolar depression.

Dr. Roger S. McIntyre, University of Toronto
Dr. Roger S. McIntyre

“Although the study reports, as it should, that there is no evidence of maintenance effect, the secondary analysis, which was not adjusted for multiplicity, does suggest that there is a benefit,” said Dr. McIntyre, who was not associated with this research.

“However, the authors are also correct in stating that one cannot draw a conclusion because it was not the primary question and was not adjusted for multiplicity,” he added.

“If anything,” said Dr. McIntyre, “what these results do support is the notion that antidepressants are unlikely to destabilize all patients. Instead, the risk of destabilization seems to be largely limited to some persons, and there is a suggestion, based on the secondary outcome of this study, that maintenance antidepressant benefits can be seen in some people. But again that’s a testable hypothesis.”

Also weighing in on the research, Madhukar H. Trivedi, MD, professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas, said the study is “interesting,” adding that it was “unfortunate that the researchers had to curtail recruitment and reduce the size of the trial.”

professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas
University of Texas Southwestern Medical Center
Dr. Madhukar H. Trivedi


“But the main finding is indeed that there was no significant advantage with 52 [weeks] continuation, except maybe increasing time to relapse. There are indeed a number of interesting findings in the secondary analyses, but sample size may have limited certainty,” Dr. Trivedi said.

“It seems that the results would not suggest a change in the current guidelines, and yet, we have to also mention that, for now, one has to make individual decisions and maybe recommend a more definitive complete trial,” added Dr. Trivedi, who was not involved in the study.

The study was supported by the Canadian Institutes of Health Research. Bausch Health (formerly Valeant), Lundbeck, and Lupin provided trial medications but were not involved in the design or conduct of the trial, data collection or analyses, writing of the manuscript, or decision to submit the manuscript for publication. Disclosures for authors are available at the conclusion of the original article.

A version of this article first appeared on Medscape.com.

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The first randomized controlled trial testing the safety and efficacy of long-term antidepressant maintenance therapy after remission of a depressive episode in adults with bipolar I disorder has yielded mixed results.

Continuing antidepressant therapy for 52 weeks, as opposed to stopping it at 8 weeks, was not more beneficial with regard to the primary outcome of occurrence of any mood episode.

However, a prespecified sensitivity analysis of the primary outcome and of the secondary analyses suggests that continuing antidepressant therapy for 52 weeks may prolong the time to a depressive relapse.

“Because the primary outcome is negative and the prespecified sensitivity analysis is positive and the secondary outcomes are positive, some clinicians will pick the position that they work and some that they don’t work,” lead investigator Lakshmi Yatham, MBBS, with University of British Columbia, Vancouver, told this news organization.

University of British Columbia (UBC) in Vancouver, Canada
University of British Columbia
Dr. Lakshmi Yatham


The study was published online  in the New England Journal of Medicine.
 

Controversial issue

Adjunctive antidepressant therapy – alongside mood stabilizers and/or second-generation antipsychotic medications – are often used to treat acute depressive episodes in patients with bipolar I disorder.

Currently, the Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) advise discontinuing antidepressant treatment 8 weeks after remission of depression.

Yet, the duration of antidepressant therapy for bipolar depression is “highly controversial,” due to a lack of evidence and concerns that antidepressants may induce mania, mixed states, or rapid cycling between mania and depression, Dr. Yatham said.

Dr. Yatham and colleagues assessed the safety and efficacy of continuing adjunctive antidepressant treatment (escitalopram or bupropion XL) for 52 weeks after remission, compared with discontinuing antidepressant therapy at 8 weeks after remission.

The final analysis included 177 patients (mean age 41 years, 48% men) with bipolar I disorder who had remission of depression; 90 patients continued treatment with an antidepressant for 52 weeks and 87 were switched to placebo at 8 weeks. All were taking a mood stabilizer or a second-generation antipsychotic or both.

The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide.

At 52 weeks, 28 patients (31%) in the 52-week group had experienced any mood episode (primary outcome), compared with 40 patients (46%) in the 8-week group.

The primary outcome did not reach statistical significance (hazard ratio, 0.68; 95% confidence interval, 0.43-1.10; P = .12).

The researchers note that the decision by the study team to include relapses that occurred during the first 6 weeks of the study may have affected the primary outcome.

“During the first 6 weeks, both groups were getting the same treatment, and we thought there shouldn’t be any difference in relapse, but sadly, there were more relapses in the 52-week group even though the treatments were identical,” Dr. Yatham said.

However, in a sensitivity analysis of the primary outcome after week 6, when treatment between the two groups differed, patients continuing antidepressant treatment were 40% less likely to experience a relapse of any mood event (HR, 0.60) and 59% less likely to experience a depressive episode (HR, 0.41) relative to the placebo group.

“From the point where the two groups began receiving different treatments, we see a significant benefit for patients who continued treatment with antidepressants,” Dr. Yatham said in a news release.

“Treating depression in bipolar disorder is challenging. Reducing the risk of relapse is important because it can provide patients with a great deal of stability that ultimately lets them get back to the activities they enjoy and can greatly improve their quality of life,” he added.

Although fewer patients in the 52-week group than 8-week group had a depressive episode within 52 weeks (17% vs. 40%; HR, 0.43), more had a manic or hypomanic event (12% vs. 6%; HR, 2.28).

The estimated probability of remaining free of a depressive episode at 52 weeks was 72% in the 52-week group versus 53% in the 8-week group. The estimated probability of remaining free of a manic episode at 52 weeks was 81% and 92%, respectively.

The incidence of adverse events was similar in the two groups, with a low rate of discontinuation due to adverse events and no serious adverse events. Clinically significant weight gain (≥ 7% increase in body weight) was observed in 14% of patients in the 52-week group and 7% of patients in the 8-week group.

Limitations of the trial include the fact that it was stopped early, before the planned sample size was reached, owing to slow recruitment and funding issues.

Other limitations include a lack of ethnic diversity (only 12% were White and < 1% Black) and overrepresentation of patients from India, which may limit generalizability. 

In addition, the findings may not be applicable to treatment with antidepressants other than escitalopram and buproprion XL. Finally, the study population was also enriched for patients who responded to these antidepressants.
 

 

 

Need for an individualized approach

Commenting on the study, Roger McIntyre, MD, professor of psychiatry in pharmacology, University of Toronto, noted the study was not easy to conduct, and the investigators should be credited for conducting a maintenance study in bipolar depression.

Dr. Roger S. McIntyre, University of Toronto
Dr. Roger S. McIntyre

“Although the study reports, as it should, that there is no evidence of maintenance effect, the secondary analysis, which was not adjusted for multiplicity, does suggest that there is a benefit,” said Dr. McIntyre, who was not associated with this research.

“However, the authors are also correct in stating that one cannot draw a conclusion because it was not the primary question and was not adjusted for multiplicity,” he added.

“If anything,” said Dr. McIntyre, “what these results do support is the notion that antidepressants are unlikely to destabilize all patients. Instead, the risk of destabilization seems to be largely limited to some persons, and there is a suggestion, based on the secondary outcome of this study, that maintenance antidepressant benefits can be seen in some people. But again that’s a testable hypothesis.”

Also weighing in on the research, Madhukar H. Trivedi, MD, professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas, said the study is “interesting,” adding that it was “unfortunate that the researchers had to curtail recruitment and reduce the size of the trial.”

professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas
University of Texas Southwestern Medical Center
Dr. Madhukar H. Trivedi


“But the main finding is indeed that there was no significant advantage with 52 [weeks] continuation, except maybe increasing time to relapse. There are indeed a number of interesting findings in the secondary analyses, but sample size may have limited certainty,” Dr. Trivedi said.

“It seems that the results would not suggest a change in the current guidelines, and yet, we have to also mention that, for now, one has to make individual decisions and maybe recommend a more definitive complete trial,” added Dr. Trivedi, who was not involved in the study.

The study was supported by the Canadian Institutes of Health Research. Bausch Health (formerly Valeant), Lundbeck, and Lupin provided trial medications but were not involved in the design or conduct of the trial, data collection or analyses, writing of the manuscript, or decision to submit the manuscript for publication. Disclosures for authors are available at the conclusion of the original article.

A version of this article first appeared on Medscape.com.

The first randomized controlled trial testing the safety and efficacy of long-term antidepressant maintenance therapy after remission of a depressive episode in adults with bipolar I disorder has yielded mixed results.

Continuing antidepressant therapy for 52 weeks, as opposed to stopping it at 8 weeks, was not more beneficial with regard to the primary outcome of occurrence of any mood episode.

However, a prespecified sensitivity analysis of the primary outcome and of the secondary analyses suggests that continuing antidepressant therapy for 52 weeks may prolong the time to a depressive relapse.

“Because the primary outcome is negative and the prespecified sensitivity analysis is positive and the secondary outcomes are positive, some clinicians will pick the position that they work and some that they don’t work,” lead investigator Lakshmi Yatham, MBBS, with University of British Columbia, Vancouver, told this news organization.

University of British Columbia (UBC) in Vancouver, Canada
University of British Columbia
Dr. Lakshmi Yatham


The study was published online  in the New England Journal of Medicine.
 

Controversial issue

Adjunctive antidepressant therapy – alongside mood stabilizers and/or second-generation antipsychotic medications – are often used to treat acute depressive episodes in patients with bipolar I disorder.

Currently, the Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) advise discontinuing antidepressant treatment 8 weeks after remission of depression.

Yet, the duration of antidepressant therapy for bipolar depression is “highly controversial,” due to a lack of evidence and concerns that antidepressants may induce mania, mixed states, or rapid cycling between mania and depression, Dr. Yatham said.

Dr. Yatham and colleagues assessed the safety and efficacy of continuing adjunctive antidepressant treatment (escitalopram or bupropion XL) for 52 weeks after remission, compared with discontinuing antidepressant therapy at 8 weeks after remission.

The final analysis included 177 patients (mean age 41 years, 48% men) with bipolar I disorder who had remission of depression; 90 patients continued treatment with an antidepressant for 52 weeks and 87 were switched to placebo at 8 weeks. All were taking a mood stabilizer or a second-generation antipsychotic or both.

The primary outcome, assessed in a time-to-event analysis, was any mood episode, as defined by scores on scales measuring symptoms of hypomania or mania, depression, suicidality, and mood-episode severity; additional treatment or hospitalization for mood symptoms; or attempted or completed suicide.

At 52 weeks, 28 patients (31%) in the 52-week group had experienced any mood episode (primary outcome), compared with 40 patients (46%) in the 8-week group.

The primary outcome did not reach statistical significance (hazard ratio, 0.68; 95% confidence interval, 0.43-1.10; P = .12).

The researchers note that the decision by the study team to include relapses that occurred during the first 6 weeks of the study may have affected the primary outcome.

“During the first 6 weeks, both groups were getting the same treatment, and we thought there shouldn’t be any difference in relapse, but sadly, there were more relapses in the 52-week group even though the treatments were identical,” Dr. Yatham said.

However, in a sensitivity analysis of the primary outcome after week 6, when treatment between the two groups differed, patients continuing antidepressant treatment were 40% less likely to experience a relapse of any mood event (HR, 0.60) and 59% less likely to experience a depressive episode (HR, 0.41) relative to the placebo group.

“From the point where the two groups began receiving different treatments, we see a significant benefit for patients who continued treatment with antidepressants,” Dr. Yatham said in a news release.

“Treating depression in bipolar disorder is challenging. Reducing the risk of relapse is important because it can provide patients with a great deal of stability that ultimately lets them get back to the activities they enjoy and can greatly improve their quality of life,” he added.

Although fewer patients in the 52-week group than 8-week group had a depressive episode within 52 weeks (17% vs. 40%; HR, 0.43), more had a manic or hypomanic event (12% vs. 6%; HR, 2.28).

The estimated probability of remaining free of a depressive episode at 52 weeks was 72% in the 52-week group versus 53% in the 8-week group. The estimated probability of remaining free of a manic episode at 52 weeks was 81% and 92%, respectively.

The incidence of adverse events was similar in the two groups, with a low rate of discontinuation due to adverse events and no serious adverse events. Clinically significant weight gain (≥ 7% increase in body weight) was observed in 14% of patients in the 52-week group and 7% of patients in the 8-week group.

Limitations of the trial include the fact that it was stopped early, before the planned sample size was reached, owing to slow recruitment and funding issues.

Other limitations include a lack of ethnic diversity (only 12% were White and < 1% Black) and overrepresentation of patients from India, which may limit generalizability. 

In addition, the findings may not be applicable to treatment with antidepressants other than escitalopram and buproprion XL. Finally, the study population was also enriched for patients who responded to these antidepressants.
 

 

 

Need for an individualized approach

Commenting on the study, Roger McIntyre, MD, professor of psychiatry in pharmacology, University of Toronto, noted the study was not easy to conduct, and the investigators should be credited for conducting a maintenance study in bipolar depression.

Dr. Roger S. McIntyre, University of Toronto
Dr. Roger S. McIntyre

“Although the study reports, as it should, that there is no evidence of maintenance effect, the secondary analysis, which was not adjusted for multiplicity, does suggest that there is a benefit,” said Dr. McIntyre, who was not associated with this research.

“However, the authors are also correct in stating that one cannot draw a conclusion because it was not the primary question and was not adjusted for multiplicity,” he added.

“If anything,” said Dr. McIntyre, “what these results do support is the notion that antidepressants are unlikely to destabilize all patients. Instead, the risk of destabilization seems to be largely limited to some persons, and there is a suggestion, based on the secondary outcome of this study, that maintenance antidepressant benefits can be seen in some people. But again that’s a testable hypothesis.”

Also weighing in on the research, Madhukar H. Trivedi, MD, professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas, said the study is “interesting,” adding that it was “unfortunate that the researchers had to curtail recruitment and reduce the size of the trial.”

professor of psychiatry and director, Center for Depression Research and Clinical Care, University of Texas Southwestern Medical Center, Dallas
University of Texas Southwestern Medical Center
Dr. Madhukar H. Trivedi


“But the main finding is indeed that there was no significant advantage with 52 [weeks] continuation, except maybe increasing time to relapse. There are indeed a number of interesting findings in the secondary analyses, but sample size may have limited certainty,” Dr. Trivedi said.

“It seems that the results would not suggest a change in the current guidelines, and yet, we have to also mention that, for now, one has to make individual decisions and maybe recommend a more definitive complete trial,” added Dr. Trivedi, who was not involved in the study.

The study was supported by the Canadian Institutes of Health Research. Bausch Health (formerly Valeant), Lundbeck, and Lupin provided trial medications but were not involved in the design or conduct of the trial, data collection or analyses, writing of the manuscript, or decision to submit the manuscript for publication. Disclosures for authors are available at the conclusion of the original article.

A version of this article first appeared on Medscape.com.

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Nearly 1 in 100 people diagnosed with IBD in the U.S.

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A comprehensive new analysis estimates that 2.4 million Americans have been diagnosed with inflammatory bowel disease (IBD), and up to 56,000 new cases are diagnosed each year.

“The prevalence of IBD in the United States has been gradually increasing over the last decade, and thus the burden of caring for IBD is likely to increase as life expectancy increases,” said co-principal investigator Andrés Hurtado-Lorenzo, PhD, senior vice president, Translational Research and IBD Ventures, Crohn’s & Colitis Foundation.

These data provide “an initial step toward optimizing health care resources allocation and improving care of individuals with IBD,” said Manasi Agrawal, MD, a gastroenterologist at Mount Sinai Hospital, New York, who wasn’t involved in the study.

The study was published online in Gastroenterology.

For the federally funded study, researchers pooled data from commercial, Medicare, and Medicaid insurance plans to derive a population-based estimate of the incidence and prevalence of IBD throughout the United States.

“In essence, we consider this to be the most extensive study of the incidence and prevalence of IBD in the United States based on physician-diagnosed IBD, which is representative of nearly the entire U.S. population with health insurance,” Dr. Hurtado-Lorenzo said.
 

Trends identified

Key findings from the study include the following.

  • The age- and sex-standardized incidence of IBD was 10.9 per 100,000 person years.
  • The incidence of IBD peaks in the third decade of life, decreases to a relatively stable level across the fourth to eighth decades, and declines further beyond age 80.
  • Ulcerative colitis is slightly more common than Crohn’s disease in most age groups, except in children, among whom this trend is reversed.
  • The adjusted prevalence data show that IBD has been diagnosed in more than 0.7% of Americans, with 721 cases per 100,000, or nearly 1 in 100.
  • Historically, IBD was slightly more common in men. Now it’s slightly more common in adult women and male children.
  • IBD prevalence is highest in the Northeast and lowest in the western region of the United States.
  • The overall prevalence of IBD increased gradually from 2011 to 2020.

“Environmental variables, such as ultra-processed foods, pollution, and urbanization, to name a few, are implicated in IBD risk. Shifts in our modern environment and improving diagnostics may be two reasons why we see rising trends in IBD,” said Dr. Agrawal, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai.
 

Prevalence highest among Whites

The data also point to significant differences in prevalence among different racial groups in the United States, with Whites having a rate of IBD that is seven times higher than Blacks, six times higher than Hispanics, and 21 times higher than Asians.

The prevalence of IBD per 100,000 population was 812 in Whites, 504 in Blacks, 403 in Asians, and 458 in Hispanics.

“It’s important to note that the reasons for ethnic disparities in IBD prevalence are complex and multifactorial, and further research is needed to better understand the specific mechanisms underlying these disparities,” said Dr. Hurtado-Lorenzo said.

Factors that could contribute to this disparity include genetic and environmental factors, socioeconomic factors, health care disparities, differences in disease awareness and reporting, and underdiagnosis in some populations.

The data suggest a lower prevalence of IBD among children with Medicaid insurance, “which underscores the need for further investigation into the influence of social determinants of health on IBD care,” Dr. Hurtado-Lorenzo said.
 

 

 

Insights important for planning

Because of the fragmented nature of the health care system, it’s been challenging to get an accurate estimate of how many patients in the United States have IBD, said Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, Boston.

“The authors and involved organizations are to be fully complemented on this really ambitious and important study. Having an idea of how common IBD is and how it is likely to increase in prevalence is important for resource planning for organizations and health care systems,” said Dr. Ananthakrishnan, who was not involved in the study.

Although IBD incidence and prevalence is lower in non-White populations, there is still a “sizeable burden of IBD in those groups, and it’s important to understand the implications of that in terms of disease biology, treatment availability, disparities, and access to care,” he added.

“With the aging of the population and increasing prevalence, it is also important to understand that the ‘face of IBD’ in the coming decades may be different than what we traditionally have estimated it to be. This is also important to incorporate in decision-making,” Dr. Ananthakrishnan said.

Funding for the study was provided by the Centers for Disease Control and Prevention. Dr. Hurtado-Lorenzo, Dr. Agrawal, and Dr. Ananthakrishnan have declared no relevant disclosures.

A version of this article first appeared on Medscape.com.

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A comprehensive new analysis estimates that 2.4 million Americans have been diagnosed with inflammatory bowel disease (IBD), and up to 56,000 new cases are diagnosed each year.

“The prevalence of IBD in the United States has been gradually increasing over the last decade, and thus the burden of caring for IBD is likely to increase as life expectancy increases,” said co-principal investigator Andrés Hurtado-Lorenzo, PhD, senior vice president, Translational Research and IBD Ventures, Crohn’s & Colitis Foundation.

These data provide “an initial step toward optimizing health care resources allocation and improving care of individuals with IBD,” said Manasi Agrawal, MD, a gastroenterologist at Mount Sinai Hospital, New York, who wasn’t involved in the study.

The study was published online in Gastroenterology.

For the federally funded study, researchers pooled data from commercial, Medicare, and Medicaid insurance plans to derive a population-based estimate of the incidence and prevalence of IBD throughout the United States.

“In essence, we consider this to be the most extensive study of the incidence and prevalence of IBD in the United States based on physician-diagnosed IBD, which is representative of nearly the entire U.S. population with health insurance,” Dr. Hurtado-Lorenzo said.
 

Trends identified

Key findings from the study include the following.

  • The age- and sex-standardized incidence of IBD was 10.9 per 100,000 person years.
  • The incidence of IBD peaks in the third decade of life, decreases to a relatively stable level across the fourth to eighth decades, and declines further beyond age 80.
  • Ulcerative colitis is slightly more common than Crohn’s disease in most age groups, except in children, among whom this trend is reversed.
  • The adjusted prevalence data show that IBD has been diagnosed in more than 0.7% of Americans, with 721 cases per 100,000, or nearly 1 in 100.
  • Historically, IBD was slightly more common in men. Now it’s slightly more common in adult women and male children.
  • IBD prevalence is highest in the Northeast and lowest in the western region of the United States.
  • The overall prevalence of IBD increased gradually from 2011 to 2020.

“Environmental variables, such as ultra-processed foods, pollution, and urbanization, to name a few, are implicated in IBD risk. Shifts in our modern environment and improving diagnostics may be two reasons why we see rising trends in IBD,” said Dr. Agrawal, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai.
 

Prevalence highest among Whites

The data also point to significant differences in prevalence among different racial groups in the United States, with Whites having a rate of IBD that is seven times higher than Blacks, six times higher than Hispanics, and 21 times higher than Asians.

The prevalence of IBD per 100,000 population was 812 in Whites, 504 in Blacks, 403 in Asians, and 458 in Hispanics.

“It’s important to note that the reasons for ethnic disparities in IBD prevalence are complex and multifactorial, and further research is needed to better understand the specific mechanisms underlying these disparities,” said Dr. Hurtado-Lorenzo said.

Factors that could contribute to this disparity include genetic and environmental factors, socioeconomic factors, health care disparities, differences in disease awareness and reporting, and underdiagnosis in some populations.

The data suggest a lower prevalence of IBD among children with Medicaid insurance, “which underscores the need for further investigation into the influence of social determinants of health on IBD care,” Dr. Hurtado-Lorenzo said.
 

 

 

Insights important for planning

Because of the fragmented nature of the health care system, it’s been challenging to get an accurate estimate of how many patients in the United States have IBD, said Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, Boston.

“The authors and involved organizations are to be fully complemented on this really ambitious and important study. Having an idea of how common IBD is and how it is likely to increase in prevalence is important for resource planning for organizations and health care systems,” said Dr. Ananthakrishnan, who was not involved in the study.

Although IBD incidence and prevalence is lower in non-White populations, there is still a “sizeable burden of IBD in those groups, and it’s important to understand the implications of that in terms of disease biology, treatment availability, disparities, and access to care,” he added.

“With the aging of the population and increasing prevalence, it is also important to understand that the ‘face of IBD’ in the coming decades may be different than what we traditionally have estimated it to be. This is also important to incorporate in decision-making,” Dr. Ananthakrishnan said.

Funding for the study was provided by the Centers for Disease Control and Prevention. Dr. Hurtado-Lorenzo, Dr. Agrawal, and Dr. Ananthakrishnan have declared no relevant disclosures.

A version of this article first appeared on Medscape.com.

A comprehensive new analysis estimates that 2.4 million Americans have been diagnosed with inflammatory bowel disease (IBD), and up to 56,000 new cases are diagnosed each year.

“The prevalence of IBD in the United States has been gradually increasing over the last decade, and thus the burden of caring for IBD is likely to increase as life expectancy increases,” said co-principal investigator Andrés Hurtado-Lorenzo, PhD, senior vice president, Translational Research and IBD Ventures, Crohn’s & Colitis Foundation.

These data provide “an initial step toward optimizing health care resources allocation and improving care of individuals with IBD,” said Manasi Agrawal, MD, a gastroenterologist at Mount Sinai Hospital, New York, who wasn’t involved in the study.

The study was published online in Gastroenterology.

For the federally funded study, researchers pooled data from commercial, Medicare, and Medicaid insurance plans to derive a population-based estimate of the incidence and prevalence of IBD throughout the United States.

“In essence, we consider this to be the most extensive study of the incidence and prevalence of IBD in the United States based on physician-diagnosed IBD, which is representative of nearly the entire U.S. population with health insurance,” Dr. Hurtado-Lorenzo said.
 

Trends identified

Key findings from the study include the following.

  • The age- and sex-standardized incidence of IBD was 10.9 per 100,000 person years.
  • The incidence of IBD peaks in the third decade of life, decreases to a relatively stable level across the fourth to eighth decades, and declines further beyond age 80.
  • Ulcerative colitis is slightly more common than Crohn’s disease in most age groups, except in children, among whom this trend is reversed.
  • The adjusted prevalence data show that IBD has been diagnosed in more than 0.7% of Americans, with 721 cases per 100,000, or nearly 1 in 100.
  • Historically, IBD was slightly more common in men. Now it’s slightly more common in adult women and male children.
  • IBD prevalence is highest in the Northeast and lowest in the western region of the United States.
  • The overall prevalence of IBD increased gradually from 2011 to 2020.

“Environmental variables, such as ultra-processed foods, pollution, and urbanization, to name a few, are implicated in IBD risk. Shifts in our modern environment and improving diagnostics may be two reasons why we see rising trends in IBD,” said Dr. Agrawal, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai.
 

Prevalence highest among Whites

The data also point to significant differences in prevalence among different racial groups in the United States, with Whites having a rate of IBD that is seven times higher than Blacks, six times higher than Hispanics, and 21 times higher than Asians.

The prevalence of IBD per 100,000 population was 812 in Whites, 504 in Blacks, 403 in Asians, and 458 in Hispanics.

“It’s important to note that the reasons for ethnic disparities in IBD prevalence are complex and multifactorial, and further research is needed to better understand the specific mechanisms underlying these disparities,” said Dr. Hurtado-Lorenzo said.

Factors that could contribute to this disparity include genetic and environmental factors, socioeconomic factors, health care disparities, differences in disease awareness and reporting, and underdiagnosis in some populations.

The data suggest a lower prevalence of IBD among children with Medicaid insurance, “which underscores the need for further investigation into the influence of social determinants of health on IBD care,” Dr. Hurtado-Lorenzo said.
 

 

 

Insights important for planning

Because of the fragmented nature of the health care system, it’s been challenging to get an accurate estimate of how many patients in the United States have IBD, said Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, Boston.

“The authors and involved organizations are to be fully complemented on this really ambitious and important study. Having an idea of how common IBD is and how it is likely to increase in prevalence is important for resource planning for organizations and health care systems,” said Dr. Ananthakrishnan, who was not involved in the study.

Although IBD incidence and prevalence is lower in non-White populations, there is still a “sizeable burden of IBD in those groups, and it’s important to understand the implications of that in terms of disease biology, treatment availability, disparities, and access to care,” he added.

“With the aging of the population and increasing prevalence, it is also important to understand that the ‘face of IBD’ in the coming decades may be different than what we traditionally have estimated it to be. This is also important to incorporate in decision-making,” Dr. Ananthakrishnan said.

Funding for the study was provided by the Centers for Disease Control and Prevention. Dr. Hurtado-Lorenzo, Dr. Agrawal, and Dr. Ananthakrishnan have declared no relevant disclosures.

A version of this article first appeared on Medscape.com.

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Another FDA class I recall of Cardiosave Hybrid/Rescue IABPs

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Mon, 08/14/2023 - 11:18

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

FDA icon

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

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Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

FDA icon

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

Datascope/Maquet/Getinge has announced a recall of the Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) because they may shut down unexpectedly due to electrical failures in the power management board or solenoid board (power source path).

“Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (e.g., inadequate blood supply or a vital organ injury), and death,” the Food and Drug Administration said in the recall notice.

FDA icon

The FDA has identified this as a class I recall, the most serious type of recall due to the risk for serious injury or death. To date, Datascope/Maquet/Getinge received 26 complaints, but no reports of injuries or death.

The devices are indicated for acute coronary syndrome, cardiac and noncardiac surgery, and complications of heart failure in adults.

The recall includes a total of 4,586 Cardiosave Hybrid or Rescue IABP units distributed from March 2, 2012, to May 19, 2023. Product model numbers for the recalled Cardiosave Hybrid and Cardiosave Rescue are available online.

On June 5, Datascope/Maquet/Getinge sent an “important medical device advisory” to all affected customers. The letter advises customers to be sure there is an alternative IABP available to continue therapy and provide alternative hemodynamic support if there is no other means to continue counterpulsation therapy.

Customers with questions about this recall should contact their company representative or call technical support at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. ET.

Last March, Datascope/Getinge recalled 2,300 Cardiosave Hybrid or Rescue IABPs because the coiled cable connecting the display and base on some units may fail, causing an unexpected shutdown without warnings or alarms to alert the user.

The Cardiosave IABPs have also been previously flagged by the FDA for subpar battery performance and fluid leaks.

Any adverse events or suspected adverse events related to the recalled Cardiosave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.
 

A version of this article appeared on Medscape.com.

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AHA/ACC issue updated chronic coronary disease guidelines

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The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.

Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.

It was published online in Circulation and the Journal of the American College of Cardiology .

Among the key recommendations were the following.

  • Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
  • Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
  • Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
  • Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
  • The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
  • Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
  • Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
  • Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
  • Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
  • Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.
 

 

Living document

The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.

“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.

“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.

“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.

The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.

The research had no commercial funding.

A version of this article first appeared on Medscape.com.

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The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.

Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.

It was published online in Circulation and the Journal of the American College of Cardiology .

Among the key recommendations were the following.

  • Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
  • Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
  • Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
  • Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
  • The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
  • Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
  • Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
  • Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
  • Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
  • Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.
 

 

Living document

The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.

“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.

“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.

“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.

The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.

The research had no commercial funding.

A version of this article first appeared on Medscape.com.

The latest clinical practice guideline for managing patients with chronic coronary disease (CCD) takes an evidence-based and patient-centered approach to care and includes key updates on revascularization, beta-blocker use, and routine functional and anatomic testing.

Developed by the American Heart Association, the American College of Cardiology, and other specialty societies, the 2023 guideline both updates and consolidates ACC/AHA guidelines previously published in 2012 and 2014 for the management of patients with stable ischemic heart disease.

It was published online in Circulation and the Journal of the American College of Cardiology .

Among the key recommendations were the following.

  • Long-term beta-blocker therapy is no longer recommended for improving outcomes for patients with CCD in the absence of myocardial infarction within the past year, left ventricular ejection fraction (LVEF) less than or equal to 50%, or another primary indication for beta-blocker therapy. Either a calcium channel blocker or a beta-blocker is recommended as first-line antianginal therapy.
  • Sodium glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists are recommended for select groups of patients with CCD, including individuals without diabetes, to improve outcomes.
  • Statins remain first-line therapy for lipid lowering for patients with CCD. Several adjunctive therapies, such as ezetimibe, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, inclisiran, or bempedoic acid, may be used in select populations, although clinical outcomes data are not yet available for novel agents such as inclisiran and bempedoic acid.
  • Shorter durations of dual antiplatelet therapy are safe and effective in many circumstances, particularly when the risk of bleeding is high and the ischemic risk is not high.
  • The use of nonprescription or dietary supplements, including fish oil and omega-3 fatty acids or vitamins, is not recommended for patients with CCD, given the lack of benefit in reducing cardiovascular events.
  • Revascularization is recommended in two scenarios: (1) for patients with lifestyle-limiting angina despite guideline-directed medical therapy and with coronary stenoses amenable to revascularization, with the goal of improving symptoms; and (2) for patients with significant left main disease or multivessel disease with severe LV dysfunction (LVEF ≤ 35%), for whom coronary artery bypass grafting plus medical therapy is recommended over medical therapy alone, with the goal of improving survival.
  • Routine periodic anatomic or ischemic testing in the absence of a change in clinical or functional status is not recommended for risk stratification or to guide therapeutic decision-making for patients with CCD.
  • Nondrug therapies, including healthy dietary habits and exercise, are recommended for all patients with CCD. When possible, patients should participate in regular physical activity, including activities to reduce sitting time and to increase aerobic and resistance exercise.
  • Cardiac rehabilitation for eligible patients provides significant cardiovascular benefits, including decreased morbidity and mortality.
  • Electronic cigarettes increase the odds of successful smoking cessation, but they are not recommended as first-line therapy, owing to the lack of long-term safety data and risks associated with sustained use.
 

 

Living document

The co-authors of a related editorial note that “CCD as defined in the 2023 guideline includes patients who may or may not have classic signs and symptoms of CAD.

“The 2023 guideline reflects this heterogeneity by including patients stabilized after acute coronary syndrome hospitalization, those with ischemic cardiomyopathy, stable angina or equivalent with or without a positive imaging test, vasospasm or microvascular disease, and positive noninvasive screening test leading to a clinician diagnosis of CAD,” write Sunil V. Rao, MD, with NYU Langone Health System, and co-authors.

“The focus of the guideline is on extending life and improving quality of life for CCD patients, taking into account patient priorities and the importance of equitable care. There is emphasis on shared decision-making that involves the patient’s preferences and values when considering treatment options,” they point out.

“Importantly, the guidelines exist to provide guidance and are meant to complement, not supplant, clinical judgment. As the evidence for the management of CCD continues to evolve, the guidelines will need to be a ‘living document’ to ensure that clinicians and patients can achieve their shared therapeutic goals of reducing mortality and improving quality of life,” they add.

The 2023 guideline on management of patients with CCD was developed in collaboration with and was endorsed by the American College of Clinical Pharmacy, the American Society for Preventive Cardiology, the National Lipid Association, and the Preventive Cardiovascular Nurses Association. It has been endorsed by the Society for Cardiovascular Angiography and Interventions.

The research had no commercial funding.

A version of this article first appeared on Medscape.com.

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Sugary drinks may up risk for liver cancer, liver disease death

Article Type
Changed
Wed, 08/16/2023 - 17:18

Drinking sugar-laden beverages on a regular basis may increase the risk for liver cancer and death from chronic liver disease, new research suggests.

The observational analyses revealed that postmenopausal women who consumed at least one sugar-sweetened beverage daily had an 85% higher risk of developing liver cancer and a 68% higher risk of dying from chronic liver disease, compared with those who consumed three servings or fewer per month.

Soda cans (Photo: Lori Martin/Fotolia.com)
Lori Martin/Fotolia.com

“If our findings are confirmed, reducing sugar-sweetened beverage consumption might serve as a public health strategy to reduce liver disease burden,” first author Longgang Zhao, PhD, with Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said in an interview.

When looking at consumption of artificially sweetened drinks, however, Dr. Zhao and colleagues found no strong association between intake and risk for liver cancer or death from chronic liver disease. Because the sample size for the artificially sweetened beverage analysis was limited, Dr. Zhao said, “these results should be interpreted with caution and additional studies are needed to confirm our study findings.”

The new study was published online in JAMA.

About 40% of people with liver cancer do not have one of the well-known disease risk factors, such as chronic hepatitis B or C infection, type 2 diabetes, or obesity. In the current analysis, Dr. Zhao and colleagues wanted to determine whether sugar-sweetened or artificially sweetened beverages, consumed by a large swath of the population, could be a risk factor for liver cancer or chronic liver disease.

Two previous studies have found only a “potential association” between sugar-sweetened beverage intake and a person’s risk for liver cancer, the authors explained.

In July, the International Agency for Research on Cancer officially classified the artificial sweetener aspartame as a possible carcinogen, but cancer epidemiologist Paul Pharoah, MD, PhD, commented that “the evidence that aspartame causes primary liver cancer, or any other cancer in humans, is very weak.”

To provide greater clarity about a potential link, the study team used the Women’s Health Initiative to evaluate sugary beverage consumption among 98,786 postmenopausal women and artificially sweetened drink intake among 64,787 followed for up to a median of 20.9 years. The primary outcomes were liver cancer incidence and mortality from chronic liver disease, defined as nonalcoholic fatty liver disease, liver fibrosis, cirrhosis, alcoholic liver diseases, and chronic hepatitis.

Among these women, nearly 7% consumed at least one sugar-sweetened beverage daily and 13% consumed one or more artificially sweetened beverage servings daily.

Over the follow-up period, 207 women developed liver cancer and 148 died from chronic liver disease in the sugary beverage group while 133 women developed liver cancer and 74 died from chronic liver disease in the artificial sugar group.

Compared with women consuming three servings or fewer of sugar-sweetened beverages per month, those consuming one or more servings per day had a significantly higher risk for liver cancer (18.0 vs. 10.3 per 100,000; adjusted hazard ratio, 1.85; P = .01) and for chronic liver disease mortality (17.7 vs. 7.1 per 100,000; aHR, 1.68; P = .04).

Compared with women consuming three servings or fewer of artificially sweetened beverages per month, those drinking one or more servings per day did not have a significantly increased risk for liver cancer (11.8 vs. 10.2 per 100,000; aHR, 1.17; P = .55) or chronic liver disease mortality (7.1 vs. 5.3 per 100,000; aHR 0.95; P = .88).

The authors noted several limitations to the study, including not tracking potential changes in beverage consumption over time or details on the specific sugar content or sweetener types consumed.

Corresponding author Xuehong Zhang, ScD, also with Brigham and Women’s Hospital and Harvard Medical School, said it’s not surprising that sugar-sweetened beverages may raise the risk of adverse liver outcomes.

“Intake of sugar-sweetened beverage[s], a postulated risk factor for obesity, diabetes, and cardiovascular disease, may drive insulin resistance and inflammation, which are strongly implicated in liver carcinogenesis and liver health,” Dr. Zhang said in an interview.

The lack of an association between artificially sweetened beverages and liver outcomes is also not particularly surprising, Dr. Zhang said, “given that the consumption level of artificially sweetened beverages is low, the sample size is relatively small,” and “the dose response relationship remains unknown.”

Nancy S. Reau, MD, who was not involved in the research, said the authors should be “congratulated for trying to clarify liver-related health risk related to artificial or sugar-sweetened beverages.”

In her view, the most important finding is the association between daily consumption of sugar-sweetened beverages and liver health.

“Regardless of whether this is a surrogate marker for liver disease risk (such as fatty liver disease) or a consequence of the drink itself, it is an easy measure for clinicians to capture and an easy behavior for patients to modify,” Dr. Reau, a hepatologist at Rush Medical College, Chicago, said in an interview.

However, Dr. Reau noted, “I do not feel that this article can be used to advocate for artificially sweetened beverages as a substitute.”

It is possible, she explained, that this population was too small to see a significant signal between artificially sweetened beverages and liver health. Plus, “natural, low-caloric beverages as part of a healthy diet combined with exercise are always going to be ideal.”

Weighing in as well, Dale Shepard, MD, PhD, a medical oncologist at the Cleveland Clinic, noted that “this is another study that points to the need for moderation.”

In his view, avoiding excess consumption of sugary or artificially sweetened drinks is the best course of action, but other factors, such as smoking, excessive alcohol, sun exposure without adequate sunscreen, obesity, and inactivity “are more likely to increase one’s risk for cancer,” Dr. Shepard said.

In a statement from the U.K.-based Science Media Centre, Pauline Emmett, PhD, from the University of Bristol (England), commented that this is a “good-quality” study and “the authors have been very careful not to speculate.”

“The main limitation is that this is observational data which provides associations which suggest a relationship but cannot tell if it is causal,” Dr. Emmett said. However, “we know from a body of evidence that it is worth thinking twice before choosing to drink sugar-sweetened beverages every day.”

The study had no commercial funding. Dr. Zhao, Dr. Zhang, Dr. Reau, and Dr. Shepard reported no relevant financial relationships. Dr. Emmett is a member of the European Food Safety Authority working group on dietary sugars.

A version of this article appeared on Medscape.com.

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Drinking sugar-laden beverages on a regular basis may increase the risk for liver cancer and death from chronic liver disease, new research suggests.

The observational analyses revealed that postmenopausal women who consumed at least one sugar-sweetened beverage daily had an 85% higher risk of developing liver cancer and a 68% higher risk of dying from chronic liver disease, compared with those who consumed three servings or fewer per month.

Soda cans (Photo: Lori Martin/Fotolia.com)
Lori Martin/Fotolia.com

“If our findings are confirmed, reducing sugar-sweetened beverage consumption might serve as a public health strategy to reduce liver disease burden,” first author Longgang Zhao, PhD, with Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said in an interview.

When looking at consumption of artificially sweetened drinks, however, Dr. Zhao and colleagues found no strong association between intake and risk for liver cancer or death from chronic liver disease. Because the sample size for the artificially sweetened beverage analysis was limited, Dr. Zhao said, “these results should be interpreted with caution and additional studies are needed to confirm our study findings.”

The new study was published online in JAMA.

About 40% of people with liver cancer do not have one of the well-known disease risk factors, such as chronic hepatitis B or C infection, type 2 diabetes, or obesity. In the current analysis, Dr. Zhao and colleagues wanted to determine whether sugar-sweetened or artificially sweetened beverages, consumed by a large swath of the population, could be a risk factor for liver cancer or chronic liver disease.

Two previous studies have found only a “potential association” between sugar-sweetened beverage intake and a person’s risk for liver cancer, the authors explained.

In July, the International Agency for Research on Cancer officially classified the artificial sweetener aspartame as a possible carcinogen, but cancer epidemiologist Paul Pharoah, MD, PhD, commented that “the evidence that aspartame causes primary liver cancer, or any other cancer in humans, is very weak.”

To provide greater clarity about a potential link, the study team used the Women’s Health Initiative to evaluate sugary beverage consumption among 98,786 postmenopausal women and artificially sweetened drink intake among 64,787 followed for up to a median of 20.9 years. The primary outcomes were liver cancer incidence and mortality from chronic liver disease, defined as nonalcoholic fatty liver disease, liver fibrosis, cirrhosis, alcoholic liver diseases, and chronic hepatitis.

Among these women, nearly 7% consumed at least one sugar-sweetened beverage daily and 13% consumed one or more artificially sweetened beverage servings daily.

Over the follow-up period, 207 women developed liver cancer and 148 died from chronic liver disease in the sugary beverage group while 133 women developed liver cancer and 74 died from chronic liver disease in the artificial sugar group.

Compared with women consuming three servings or fewer of sugar-sweetened beverages per month, those consuming one or more servings per day had a significantly higher risk for liver cancer (18.0 vs. 10.3 per 100,000; adjusted hazard ratio, 1.85; P = .01) and for chronic liver disease mortality (17.7 vs. 7.1 per 100,000; aHR, 1.68; P = .04).

Compared with women consuming three servings or fewer of artificially sweetened beverages per month, those drinking one or more servings per day did not have a significantly increased risk for liver cancer (11.8 vs. 10.2 per 100,000; aHR, 1.17; P = .55) or chronic liver disease mortality (7.1 vs. 5.3 per 100,000; aHR 0.95; P = .88).

The authors noted several limitations to the study, including not tracking potential changes in beverage consumption over time or details on the specific sugar content or sweetener types consumed.

Corresponding author Xuehong Zhang, ScD, also with Brigham and Women’s Hospital and Harvard Medical School, said it’s not surprising that sugar-sweetened beverages may raise the risk of adverse liver outcomes.

“Intake of sugar-sweetened beverage[s], a postulated risk factor for obesity, diabetes, and cardiovascular disease, may drive insulin resistance and inflammation, which are strongly implicated in liver carcinogenesis and liver health,” Dr. Zhang said in an interview.

The lack of an association between artificially sweetened beverages and liver outcomes is also not particularly surprising, Dr. Zhang said, “given that the consumption level of artificially sweetened beverages is low, the sample size is relatively small,” and “the dose response relationship remains unknown.”

Nancy S. Reau, MD, who was not involved in the research, said the authors should be “congratulated for trying to clarify liver-related health risk related to artificial or sugar-sweetened beverages.”

In her view, the most important finding is the association between daily consumption of sugar-sweetened beverages and liver health.

“Regardless of whether this is a surrogate marker for liver disease risk (such as fatty liver disease) or a consequence of the drink itself, it is an easy measure for clinicians to capture and an easy behavior for patients to modify,” Dr. Reau, a hepatologist at Rush Medical College, Chicago, said in an interview.

However, Dr. Reau noted, “I do not feel that this article can be used to advocate for artificially sweetened beverages as a substitute.”

It is possible, she explained, that this population was too small to see a significant signal between artificially sweetened beverages and liver health. Plus, “natural, low-caloric beverages as part of a healthy diet combined with exercise are always going to be ideal.”

Weighing in as well, Dale Shepard, MD, PhD, a medical oncologist at the Cleveland Clinic, noted that “this is another study that points to the need for moderation.”

In his view, avoiding excess consumption of sugary or artificially sweetened drinks is the best course of action, but other factors, such as smoking, excessive alcohol, sun exposure without adequate sunscreen, obesity, and inactivity “are more likely to increase one’s risk for cancer,” Dr. Shepard said.

In a statement from the U.K.-based Science Media Centre, Pauline Emmett, PhD, from the University of Bristol (England), commented that this is a “good-quality” study and “the authors have been very careful not to speculate.”

“The main limitation is that this is observational data which provides associations which suggest a relationship but cannot tell if it is causal,” Dr. Emmett said. However, “we know from a body of evidence that it is worth thinking twice before choosing to drink sugar-sweetened beverages every day.”

The study had no commercial funding. Dr. Zhao, Dr. Zhang, Dr. Reau, and Dr. Shepard reported no relevant financial relationships. Dr. Emmett is a member of the European Food Safety Authority working group on dietary sugars.

A version of this article appeared on Medscape.com.

Drinking sugar-laden beverages on a regular basis may increase the risk for liver cancer and death from chronic liver disease, new research suggests.

The observational analyses revealed that postmenopausal women who consumed at least one sugar-sweetened beverage daily had an 85% higher risk of developing liver cancer and a 68% higher risk of dying from chronic liver disease, compared with those who consumed three servings or fewer per month.

Soda cans (Photo: Lori Martin/Fotolia.com)
Lori Martin/Fotolia.com

“If our findings are confirmed, reducing sugar-sweetened beverage consumption might serve as a public health strategy to reduce liver disease burden,” first author Longgang Zhao, PhD, with Brigham and Women’s Hospital and Harvard Medical School, both in Boston, said in an interview.

When looking at consumption of artificially sweetened drinks, however, Dr. Zhao and colleagues found no strong association between intake and risk for liver cancer or death from chronic liver disease. Because the sample size for the artificially sweetened beverage analysis was limited, Dr. Zhao said, “these results should be interpreted with caution and additional studies are needed to confirm our study findings.”

The new study was published online in JAMA.

About 40% of people with liver cancer do not have one of the well-known disease risk factors, such as chronic hepatitis B or C infection, type 2 diabetes, or obesity. In the current analysis, Dr. Zhao and colleagues wanted to determine whether sugar-sweetened or artificially sweetened beverages, consumed by a large swath of the population, could be a risk factor for liver cancer or chronic liver disease.

Two previous studies have found only a “potential association” between sugar-sweetened beverage intake and a person’s risk for liver cancer, the authors explained.

In July, the International Agency for Research on Cancer officially classified the artificial sweetener aspartame as a possible carcinogen, but cancer epidemiologist Paul Pharoah, MD, PhD, commented that “the evidence that aspartame causes primary liver cancer, or any other cancer in humans, is very weak.”

To provide greater clarity about a potential link, the study team used the Women’s Health Initiative to evaluate sugary beverage consumption among 98,786 postmenopausal women and artificially sweetened drink intake among 64,787 followed for up to a median of 20.9 years. The primary outcomes were liver cancer incidence and mortality from chronic liver disease, defined as nonalcoholic fatty liver disease, liver fibrosis, cirrhosis, alcoholic liver diseases, and chronic hepatitis.

Among these women, nearly 7% consumed at least one sugar-sweetened beverage daily and 13% consumed one or more artificially sweetened beverage servings daily.

Over the follow-up period, 207 women developed liver cancer and 148 died from chronic liver disease in the sugary beverage group while 133 women developed liver cancer and 74 died from chronic liver disease in the artificial sugar group.

Compared with women consuming three servings or fewer of sugar-sweetened beverages per month, those consuming one or more servings per day had a significantly higher risk for liver cancer (18.0 vs. 10.3 per 100,000; adjusted hazard ratio, 1.85; P = .01) and for chronic liver disease mortality (17.7 vs. 7.1 per 100,000; aHR, 1.68; P = .04).

Compared with women consuming three servings or fewer of artificially sweetened beverages per month, those drinking one or more servings per day did not have a significantly increased risk for liver cancer (11.8 vs. 10.2 per 100,000; aHR, 1.17; P = .55) or chronic liver disease mortality (7.1 vs. 5.3 per 100,000; aHR 0.95; P = .88).

The authors noted several limitations to the study, including not tracking potential changes in beverage consumption over time or details on the specific sugar content or sweetener types consumed.

Corresponding author Xuehong Zhang, ScD, also with Brigham and Women’s Hospital and Harvard Medical School, said it’s not surprising that sugar-sweetened beverages may raise the risk of adverse liver outcomes.

“Intake of sugar-sweetened beverage[s], a postulated risk factor for obesity, diabetes, and cardiovascular disease, may drive insulin resistance and inflammation, which are strongly implicated in liver carcinogenesis and liver health,” Dr. Zhang said in an interview.

The lack of an association between artificially sweetened beverages and liver outcomes is also not particularly surprising, Dr. Zhang said, “given that the consumption level of artificially sweetened beverages is low, the sample size is relatively small,” and “the dose response relationship remains unknown.”

Nancy S. Reau, MD, who was not involved in the research, said the authors should be “congratulated for trying to clarify liver-related health risk related to artificial or sugar-sweetened beverages.”

In her view, the most important finding is the association between daily consumption of sugar-sweetened beverages and liver health.

“Regardless of whether this is a surrogate marker for liver disease risk (such as fatty liver disease) or a consequence of the drink itself, it is an easy measure for clinicians to capture and an easy behavior for patients to modify,” Dr. Reau, a hepatologist at Rush Medical College, Chicago, said in an interview.

However, Dr. Reau noted, “I do not feel that this article can be used to advocate for artificially sweetened beverages as a substitute.”

It is possible, she explained, that this population was too small to see a significant signal between artificially sweetened beverages and liver health. Plus, “natural, low-caloric beverages as part of a healthy diet combined with exercise are always going to be ideal.”

Weighing in as well, Dale Shepard, MD, PhD, a medical oncologist at the Cleveland Clinic, noted that “this is another study that points to the need for moderation.”

In his view, avoiding excess consumption of sugary or artificially sweetened drinks is the best course of action, but other factors, such as smoking, excessive alcohol, sun exposure without adequate sunscreen, obesity, and inactivity “are more likely to increase one’s risk for cancer,” Dr. Shepard said.

In a statement from the U.K.-based Science Media Centre, Pauline Emmett, PhD, from the University of Bristol (England), commented that this is a “good-quality” study and “the authors have been very careful not to speculate.”

“The main limitation is that this is observational data which provides associations which suggest a relationship but cannot tell if it is causal,” Dr. Emmett said. However, “we know from a body of evidence that it is worth thinking twice before choosing to drink sugar-sweetened beverages every day.”

The study had no commercial funding. Dr. Zhao, Dr. Zhang, Dr. Reau, and Dr. Shepard reported no relevant financial relationships. Dr. Emmett is a member of the European Food Safety Authority working group on dietary sugars.

A version of this article appeared on Medscape.com.

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‘Emerging’ biomarker may predict mild cognitive impairment years before symptoms

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Changed
Wed, 08/09/2023 - 14:41

 

Measuring levels of the synaptic protein NPTX2 in cerebrospinal fluid (CSF) may serve as an early predictor of mild cognitive impairment (MCI) years before symptoms appear, new research indicates.

“Our study shows that low NPTX2 levels are predictive of MCI symptom onset more than 7 years in advance, including among individuals who are in late middle age,” said study investigator Anja Soldan, PhD, associate professor of neurology, Johns Hopkins University School of Medicine, Baltimore.

NPTX2 is still considered an “emerging biomarker” because knowledge about this protein is limited, Dr. Soldan noted.

Prior studies have shown that levels of NPTX2 are lower in people with MCI and dementia than in those with normal cognition and that low levels of this protein in people with MCI are associated with an increased risk of developing dementia.

“Our study extends these prior findings by showing that low protein levels are also associated with the onset of MCI symptoms,” Dr. Soldan said.

The study was published online in Annals of Neurology.
 

New therapeutic target?

The researchers measured NPTX2, as well as amyloid beta 42/40, phosphorylated (p)-tau181, and total (t)-tau in CSF collected longitudinally from 269 cognitively normal adults from the BIOCARD study.

The average age at baseline was 57.7 years. Nearly all were White, 59% were women, most were college educated, and three-quarters had a close relative with Alzheimer’s disease.

During a mean follow-up average of 16 years, 77 participants progressed to MCI or dementia within or after 7 years of baseline measurements.

In Cox regression models, lower baseline NPTX2 levels were associated with an earlier time to MCI symptom onset (hazard ratio, 0.76; P = .023). This association was significant for progression within 7 years (P = .036) and after 7 years from baseline (P = .001), the investigators reported.

Adults who progressed to MCI had, on average, about 15% lower levels of NPTX2 at baseline, compared with adults who remained cognitively normal.

Baseline NPTX2 levels improved prediction of time to MCI symptom onset after accounting for baseline Alzheimer’s disease biomarker levels (P < .01), and NPTX2 did not interact with the CSF Alzheimer’s disease biomarkers or APOE-ε4 genetic status.

Higher baseline levels of p-tau181 and t-tau were associated with higher baseline NPTX2 levels (both P < .001) and with greater declines in NPTX2 over time, suggesting that NPTX2 may decline in response to tau pathology, the investigators suggested.

Dr. Soldan said NPTX2 may be “a novel target” for developing new therapeutics for Alzheimer’s disease and other dementing and neurodegenerative disorders, as it is not an Alzheimer’s disease–specific protein.

“Efforts are underway for developing a sensitive way to measure NPTX2 brain levels in blood, which could then help clinicians identify individuals at greatest risk for cognitive decline,” she explained.

“Other next steps are to examine how changes in NPTX2 over time relate to changes in brain structure and function and to identify factors that alter levels of NPTX2, including genetic factors and potentially modifiable lifestyle factors,” Dr. Soldan said.

“If having higher levels of NPTX2 in the brain provides some resilience against developing symptoms of Alzheimer’s disease, it would be great if we could somehow increase levels of the protein,” she noted.
 

 

 

Caveats, cautionary notes

Commenting on this research, Christopher Weber, PhD, Alzheimer’s Association director of global science initiatives, said, “Research has shown that when NPTX2 levels are low, it may lead to weaker connections between neurons and could potentially affect cognitive functions, including memory and learning.”

“This new study found an association between lower levels of NPTX2 in CSF and earlier time to MCI symptom onset, and when combined with other established Alzheimer’s biomarkers, they found that NPTX2 improved the prediction of Alzheimer’s symptom onset,” Dr. Weber said.

“This is in line with previous research that suggests NPTX2 levels are associated with an increased risk of progression from MCI to Alzheimer’s dementia,” Dr. Weber said.

However, he noted some limitations of the study. “Participants were primarily White [and] highly educated, and therefore findings may not be generalizable to a real-world population,” he cautioned.

Dr. Weber said it’s also important to note that NPTX2 is not considered an Alzheimer’s-specific biomarker but rather a marker of synaptic activity and neurodegeneration. “The exact role of NPTX2 in predicting dementia is unknown,” Dr. Weber said.

He said that more studies with larger, more diverse cohorts are needed to fully understand its significance as a biomarker or therapeutic target for neurodegenerative diseases, as well as to develop a blood test for NPTX2.  

The study was supported by the National Institutes of Health. Dr. Soldan and Dr. Weber report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Measuring levels of the synaptic protein NPTX2 in cerebrospinal fluid (CSF) may serve as an early predictor of mild cognitive impairment (MCI) years before symptoms appear, new research indicates.

“Our study shows that low NPTX2 levels are predictive of MCI symptom onset more than 7 years in advance, including among individuals who are in late middle age,” said study investigator Anja Soldan, PhD, associate professor of neurology, Johns Hopkins University School of Medicine, Baltimore.

NPTX2 is still considered an “emerging biomarker” because knowledge about this protein is limited, Dr. Soldan noted.

Prior studies have shown that levels of NPTX2 are lower in people with MCI and dementia than in those with normal cognition and that low levels of this protein in people with MCI are associated with an increased risk of developing dementia.

“Our study extends these prior findings by showing that low protein levels are also associated with the onset of MCI symptoms,” Dr. Soldan said.

The study was published online in Annals of Neurology.
 

New therapeutic target?

The researchers measured NPTX2, as well as amyloid beta 42/40, phosphorylated (p)-tau181, and total (t)-tau in CSF collected longitudinally from 269 cognitively normal adults from the BIOCARD study.

The average age at baseline was 57.7 years. Nearly all were White, 59% were women, most were college educated, and three-quarters had a close relative with Alzheimer’s disease.

During a mean follow-up average of 16 years, 77 participants progressed to MCI or dementia within or after 7 years of baseline measurements.

In Cox regression models, lower baseline NPTX2 levels were associated with an earlier time to MCI symptom onset (hazard ratio, 0.76; P = .023). This association was significant for progression within 7 years (P = .036) and after 7 years from baseline (P = .001), the investigators reported.

Adults who progressed to MCI had, on average, about 15% lower levels of NPTX2 at baseline, compared with adults who remained cognitively normal.

Baseline NPTX2 levels improved prediction of time to MCI symptom onset after accounting for baseline Alzheimer’s disease biomarker levels (P < .01), and NPTX2 did not interact with the CSF Alzheimer’s disease biomarkers or APOE-ε4 genetic status.

Higher baseline levels of p-tau181 and t-tau were associated with higher baseline NPTX2 levels (both P < .001) and with greater declines in NPTX2 over time, suggesting that NPTX2 may decline in response to tau pathology, the investigators suggested.

Dr. Soldan said NPTX2 may be “a novel target” for developing new therapeutics for Alzheimer’s disease and other dementing and neurodegenerative disorders, as it is not an Alzheimer’s disease–specific protein.

“Efforts are underway for developing a sensitive way to measure NPTX2 brain levels in blood, which could then help clinicians identify individuals at greatest risk for cognitive decline,” she explained.

“Other next steps are to examine how changes in NPTX2 over time relate to changes in brain structure and function and to identify factors that alter levels of NPTX2, including genetic factors and potentially modifiable lifestyle factors,” Dr. Soldan said.

“If having higher levels of NPTX2 in the brain provides some resilience against developing symptoms of Alzheimer’s disease, it would be great if we could somehow increase levels of the protein,” she noted.
 

 

 

Caveats, cautionary notes

Commenting on this research, Christopher Weber, PhD, Alzheimer’s Association director of global science initiatives, said, “Research has shown that when NPTX2 levels are low, it may lead to weaker connections between neurons and could potentially affect cognitive functions, including memory and learning.”

“This new study found an association between lower levels of NPTX2 in CSF and earlier time to MCI symptom onset, and when combined with other established Alzheimer’s biomarkers, they found that NPTX2 improved the prediction of Alzheimer’s symptom onset,” Dr. Weber said.

“This is in line with previous research that suggests NPTX2 levels are associated with an increased risk of progression from MCI to Alzheimer’s dementia,” Dr. Weber said.

However, he noted some limitations of the study. “Participants were primarily White [and] highly educated, and therefore findings may not be generalizable to a real-world population,” he cautioned.

Dr. Weber said it’s also important to note that NPTX2 is not considered an Alzheimer’s-specific biomarker but rather a marker of synaptic activity and neurodegeneration. “The exact role of NPTX2 in predicting dementia is unknown,” Dr. Weber said.

He said that more studies with larger, more diverse cohorts are needed to fully understand its significance as a biomarker or therapeutic target for neurodegenerative diseases, as well as to develop a blood test for NPTX2.  

The study was supported by the National Institutes of Health. Dr. Soldan and Dr. Weber report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

 

Measuring levels of the synaptic protein NPTX2 in cerebrospinal fluid (CSF) may serve as an early predictor of mild cognitive impairment (MCI) years before symptoms appear, new research indicates.

“Our study shows that low NPTX2 levels are predictive of MCI symptom onset more than 7 years in advance, including among individuals who are in late middle age,” said study investigator Anja Soldan, PhD, associate professor of neurology, Johns Hopkins University School of Medicine, Baltimore.

NPTX2 is still considered an “emerging biomarker” because knowledge about this protein is limited, Dr. Soldan noted.

Prior studies have shown that levels of NPTX2 are lower in people with MCI and dementia than in those with normal cognition and that low levels of this protein in people with MCI are associated with an increased risk of developing dementia.

“Our study extends these prior findings by showing that low protein levels are also associated with the onset of MCI symptoms,” Dr. Soldan said.

The study was published online in Annals of Neurology.
 

New therapeutic target?

The researchers measured NPTX2, as well as amyloid beta 42/40, phosphorylated (p)-tau181, and total (t)-tau in CSF collected longitudinally from 269 cognitively normal adults from the BIOCARD study.

The average age at baseline was 57.7 years. Nearly all were White, 59% were women, most were college educated, and three-quarters had a close relative with Alzheimer’s disease.

During a mean follow-up average of 16 years, 77 participants progressed to MCI or dementia within or after 7 years of baseline measurements.

In Cox regression models, lower baseline NPTX2 levels were associated with an earlier time to MCI symptom onset (hazard ratio, 0.76; P = .023). This association was significant for progression within 7 years (P = .036) and after 7 years from baseline (P = .001), the investigators reported.

Adults who progressed to MCI had, on average, about 15% lower levels of NPTX2 at baseline, compared with adults who remained cognitively normal.

Baseline NPTX2 levels improved prediction of time to MCI symptom onset after accounting for baseline Alzheimer’s disease biomarker levels (P < .01), and NPTX2 did not interact with the CSF Alzheimer’s disease biomarkers or APOE-ε4 genetic status.

Higher baseline levels of p-tau181 and t-tau were associated with higher baseline NPTX2 levels (both P < .001) and with greater declines in NPTX2 over time, suggesting that NPTX2 may decline in response to tau pathology, the investigators suggested.

Dr. Soldan said NPTX2 may be “a novel target” for developing new therapeutics for Alzheimer’s disease and other dementing and neurodegenerative disorders, as it is not an Alzheimer’s disease–specific protein.

“Efforts are underway for developing a sensitive way to measure NPTX2 brain levels in blood, which could then help clinicians identify individuals at greatest risk for cognitive decline,” she explained.

“Other next steps are to examine how changes in NPTX2 over time relate to changes in brain structure and function and to identify factors that alter levels of NPTX2, including genetic factors and potentially modifiable lifestyle factors,” Dr. Soldan said.

“If having higher levels of NPTX2 in the brain provides some resilience against developing symptoms of Alzheimer’s disease, it would be great if we could somehow increase levels of the protein,” she noted.
 

 

 

Caveats, cautionary notes

Commenting on this research, Christopher Weber, PhD, Alzheimer’s Association director of global science initiatives, said, “Research has shown that when NPTX2 levels are low, it may lead to weaker connections between neurons and could potentially affect cognitive functions, including memory and learning.”

“This new study found an association between lower levels of NPTX2 in CSF and earlier time to MCI symptom onset, and when combined with other established Alzheimer’s biomarkers, they found that NPTX2 improved the prediction of Alzheimer’s symptom onset,” Dr. Weber said.

“This is in line with previous research that suggests NPTX2 levels are associated with an increased risk of progression from MCI to Alzheimer’s dementia,” Dr. Weber said.

However, he noted some limitations of the study. “Participants were primarily White [and] highly educated, and therefore findings may not be generalizable to a real-world population,” he cautioned.

Dr. Weber said it’s also important to note that NPTX2 is not considered an Alzheimer’s-specific biomarker but rather a marker of synaptic activity and neurodegeneration. “The exact role of NPTX2 in predicting dementia is unknown,” Dr. Weber said.

He said that more studies with larger, more diverse cohorts are needed to fully understand its significance as a biomarker or therapeutic target for neurodegenerative diseases, as well as to develop a blood test for NPTX2.  

The study was supported by the National Institutes of Health. Dr. Soldan and Dr. Weber report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Top U.S. hospitals for psychiatric care ranked

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Tue, 08/08/2023 - 09:34

Once again, McLean Hospital in Belmont, Mass., is ranked as the best U.S. hospital for psychiatric care, according to U.S. News & World Report.
 

McLean Hospital claimed the top spot in the 2022-2023 ranking as well.

Massachusetts General Hospital in Boston holds the No. 2 spot in the 2023-2024 U.S. News ranking for best psychiatry hospitals, up from No. 3 in 2022-2023.

New York–Presbyterian Hospital–Columbia and Cornell sits at No. 3 in 2023-2024, up from No. 4 in 2022-2023, while Johns Hopkins Hospital, Baltimore is ranked No. 4, down from No. 2.

Resnick Neuropsychiatric Hospital at the University of California, Los Angeles, is ranked No. 5 in 2023-2024 (up from No. 6 in 2022-2023), while UCSF Health–UCSF Medical Center, San Francisco, dropped to No. 6 in 2023-2024 (from No. 5 in 2022-2023).

No. 7 in 2023-2024 is Menninger Clinic, Houston, which held the No. 10 spot in 2022-2023.

According to U.S. News, the psychiatry rating is based on the expert opinion of surveyed psychiatrists. The seven ranked hospitals in psychiatry or psychiatric care were recommended by at least 5% of the psychiatric specialists responding to the magazine’s surveys in 2021, 2022, and 2023 as a facility where they would refer their patients.

“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.

“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
 

Honor roll

This year, as in prior years, U.S. News also recognized “honor roll” hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making the honor roll. Instead, they are listed in alphabetical order.

In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate the magazine’s website.

Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.

With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024 there are 22.
 

2023-2024 Honor Roll Hospitals

  • Barnes-Jewish Hospital, St. Louis
  • Brigham and Women’s Hospital, Boston
  • Cedars-Sinai Medical Center, Los Angeles
  • Cleveland Clinic
  • Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
  • Houston Methodist Hospital
  • Johns Hopkins Hospital, Baltimore
  • Massachusetts General Hospital, Boston
  • Mayo Clinic, Rochester, Minn.
  • Mount Sinai Hospital, New York
  • New York–Presbyterian Hospital–Columbia and Cornell
  • North Shore University Hospital at Northwell Health, Manhasset, N.Y.
  • Northwestern Memorial Hospital, Chicago
  • NYU Langone Hospitals, New York 
  • Rush University Medical Center, Chicago
  • Stanford (Calif.) Health Care–Stanford Hospital
  • UC San Diego Health–La Jolla and Hillcrest Hospitals
  • UCLA Medical Center, Los Angeles
  • UCSF Health–UCSF Medical Center, San Francisco
  • University of Michigan Health–Ann Arbor
  • UT Southwestern Medical Center, Dallas
  • Vanderbilt University Medical Center, Nashville, Tenn.
 

 

According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.

These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion. 

In addition, hospital profiles on USNews.com feature refined health equity measures, including a new measure of racial disparities in outcomes.

The full report for best hospitals, best specialty hospitals, and methodology is available online.

A version of this article first appeared on Medscape.com.

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Once again, McLean Hospital in Belmont, Mass., is ranked as the best U.S. hospital for psychiatric care, according to U.S. News & World Report.
 

McLean Hospital claimed the top spot in the 2022-2023 ranking as well.

Massachusetts General Hospital in Boston holds the No. 2 spot in the 2023-2024 U.S. News ranking for best psychiatry hospitals, up from No. 3 in 2022-2023.

New York–Presbyterian Hospital–Columbia and Cornell sits at No. 3 in 2023-2024, up from No. 4 in 2022-2023, while Johns Hopkins Hospital, Baltimore is ranked No. 4, down from No. 2.

Resnick Neuropsychiatric Hospital at the University of California, Los Angeles, is ranked No. 5 in 2023-2024 (up from No. 6 in 2022-2023), while UCSF Health–UCSF Medical Center, San Francisco, dropped to No. 6 in 2023-2024 (from No. 5 in 2022-2023).

No. 7 in 2023-2024 is Menninger Clinic, Houston, which held the No. 10 spot in 2022-2023.

According to U.S. News, the psychiatry rating is based on the expert opinion of surveyed psychiatrists. The seven ranked hospitals in psychiatry or psychiatric care were recommended by at least 5% of the psychiatric specialists responding to the magazine’s surveys in 2021, 2022, and 2023 as a facility where they would refer their patients.

“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.

“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
 

Honor roll

This year, as in prior years, U.S. News also recognized “honor roll” hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making the honor roll. Instead, they are listed in alphabetical order.

In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate the magazine’s website.

Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.

With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024 there are 22.
 

2023-2024 Honor Roll Hospitals

  • Barnes-Jewish Hospital, St. Louis
  • Brigham and Women’s Hospital, Boston
  • Cedars-Sinai Medical Center, Los Angeles
  • Cleveland Clinic
  • Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
  • Houston Methodist Hospital
  • Johns Hopkins Hospital, Baltimore
  • Massachusetts General Hospital, Boston
  • Mayo Clinic, Rochester, Minn.
  • Mount Sinai Hospital, New York
  • New York–Presbyterian Hospital–Columbia and Cornell
  • North Shore University Hospital at Northwell Health, Manhasset, N.Y.
  • Northwestern Memorial Hospital, Chicago
  • NYU Langone Hospitals, New York 
  • Rush University Medical Center, Chicago
  • Stanford (Calif.) Health Care–Stanford Hospital
  • UC San Diego Health–La Jolla and Hillcrest Hospitals
  • UCLA Medical Center, Los Angeles
  • UCSF Health–UCSF Medical Center, San Francisco
  • University of Michigan Health–Ann Arbor
  • UT Southwestern Medical Center, Dallas
  • Vanderbilt University Medical Center, Nashville, Tenn.
 

 

According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.

These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion. 

In addition, hospital profiles on USNews.com feature refined health equity measures, including a new measure of racial disparities in outcomes.

The full report for best hospitals, best specialty hospitals, and methodology is available online.

A version of this article first appeared on Medscape.com.

Once again, McLean Hospital in Belmont, Mass., is ranked as the best U.S. hospital for psychiatric care, according to U.S. News & World Report.
 

McLean Hospital claimed the top spot in the 2022-2023 ranking as well.

Massachusetts General Hospital in Boston holds the No. 2 spot in the 2023-2024 U.S. News ranking for best psychiatry hospitals, up from No. 3 in 2022-2023.

New York–Presbyterian Hospital–Columbia and Cornell sits at No. 3 in 2023-2024, up from No. 4 in 2022-2023, while Johns Hopkins Hospital, Baltimore is ranked No. 4, down from No. 2.

Resnick Neuropsychiatric Hospital at the University of California, Los Angeles, is ranked No. 5 in 2023-2024 (up from No. 6 in 2022-2023), while UCSF Health–UCSF Medical Center, San Francisco, dropped to No. 6 in 2023-2024 (from No. 5 in 2022-2023).

No. 7 in 2023-2024 is Menninger Clinic, Houston, which held the No. 10 spot in 2022-2023.

According to U.S. News, the psychiatry rating is based on the expert opinion of surveyed psychiatrists. The seven ranked hospitals in psychiatry or psychiatric care were recommended by at least 5% of the psychiatric specialists responding to the magazine’s surveys in 2021, 2022, and 2023 as a facility where they would refer their patients.

“Consumers want useful resources to help them assess which hospital can best meet their specific care needs,” Ben Harder, chief of health analysis and managing editor at U.S. News, said in a statement.

“The 2023-2024 Best Hospitals rankings offer patients and the physicians with whom they consult a data-driven source for comparing performance in outcomes, patient satisfaction, and other metrics that matter to them,” Mr. Harder said.
 

Honor roll

This year, as in prior years, U.S. News also recognized “honor roll” hospitals that have excelled across multiple areas of care. However, in 2023-2024, for the first time, there is no ordinal ranking of hospitals making the honor roll. Instead, they are listed in alphabetical order.

In a letter to hospital leaders, U.S. News explained that the major change in format came after months of deliberation, feedback from health care organizations and professionals, and an analysis of how consumers navigate the magazine’s website.

Ordinal ranking of hospitals that make the honor roll “obscures the fact that all of the Honor Roll hospitals have attained the highest standard of care in the nation,” the letter reads.

With the new format, honor roll hospitals are listed in alphabetical order. In 2023-2024 there are 22.
 

2023-2024 Honor Roll Hospitals

  • Barnes-Jewish Hospital, St. Louis
  • Brigham and Women’s Hospital, Boston
  • Cedars-Sinai Medical Center, Los Angeles
  • Cleveland Clinic
  • Hospitals of the University of Pennsylvania–Penn Medicine, Philadelphia
  • Houston Methodist Hospital
  • Johns Hopkins Hospital, Baltimore
  • Massachusetts General Hospital, Boston
  • Mayo Clinic, Rochester, Minn.
  • Mount Sinai Hospital, New York
  • New York–Presbyterian Hospital–Columbia and Cornell
  • North Shore University Hospital at Northwell Health, Manhasset, N.Y.
  • Northwestern Memorial Hospital, Chicago
  • NYU Langone Hospitals, New York 
  • Rush University Medical Center, Chicago
  • Stanford (Calif.) Health Care–Stanford Hospital
  • UC San Diego Health–La Jolla and Hillcrest Hospitals
  • UCLA Medical Center, Los Angeles
  • UCSF Health–UCSF Medical Center, San Francisco
  • University of Michigan Health–Ann Arbor
  • UT Southwestern Medical Center, Dallas
  • Vanderbilt University Medical Center, Nashville, Tenn.
 

 

According to U.S. News, to keep pace with consumers’ needs and the ever-evolving landscape of health care, “several refinements” are reflected in the latest best hospitals rankings.

These include the introduction of outpatient outcomes in key specialty rankings and surgical ratings, the expanded inclusion of other outpatient data, an increased weight on objective quality measures, and a reduced weight on expert opinion. 

In addition, hospital profiles on USNews.com feature refined health equity measures, including a new measure of racial disparities in outcomes.

The full report for best hospitals, best specialty hospitals, and methodology is available online.

A version of this article first appeared on Medscape.com.

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PPIs may curb benefits of palbociclib in breast cancer

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Changed
Fri, 08/11/2023 - 10:16

 

TOPLINE:
 

Taking a proton pump inhibitor (PPI) with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib could diminish the full therapeutic benefit of palbociclib in women with breast cancer and lead to worse progression-free survival (PFS) and overall survival, new data suggest.

METHODOLOGY:

  • The study retrospectively identified 1,310 women with advanced breast cancer receiving palbociclib using South Korean nationwide claims data.
  • Overall, 344 women in the concomitant group, those who were coadministered a PPI for more than one-third of their palbociclib treatment duration, were propensity-score matched to 966 women who did not have PPI exposure: the nonconcomitant group.
  • Main outcomes were time to progression and death, presented as PFS and overall survival.

TAKEAWAY:

  • Median clinical PFS was significantly shorter by about 15 months in the concomitant PPI group vs. the nonconcomitant group (25.3 vs. 39.8 months; adjusted hazard ratio, 1.76).
  • Concomitant PPI use was also associated with shorter overall survival (HR, 2.71).
  • Overall, 83.1% of patients in the concomitant group were alive at 1 year vs. 94.0% in the nonconcomitant group (P < .001), and 69.5% vs. 89.3%, respectively, were alive at 2 years (P < .001), though the median overall survival was not reached in either group.
  • In a subgroup analysis, concomitant PPI use was associated with shorter clinical PFS (HR, 1.75 for those receiving endocrine-sensitive treatment and 1.82 for those receiving endocrine-resistant treatment), and shorter overall survival (HR, 2.68 in the endocrine-sensitive subgroup and 2.98 in the endocrine-resistant subgroup).

IN PRACTICE:

“The findings suggest that taking PPIs with palbociclib may interrupt the full therapeutic benefits of palbociclib,” the authors conclude. “Physicians should be cautious when prescribing PPIs to patients who are receiving palbociclib.”

SOURCE:

The study, led by Ju-Eun Lee, MS, PharmD, School of Pharmacy, Sungkyunkwan University, South Korea, was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by its retrospective design and use of claims data as well as the inability to confirm whether patients actually took the PPI medication.

DISCLOSURES:

The authors report no relevant financial relationships. The study reported no commercial funding.

A version of this article first appeared on Medscape.com.

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TOPLINE:
 

Taking a proton pump inhibitor (PPI) with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib could diminish the full therapeutic benefit of palbociclib in women with breast cancer and lead to worse progression-free survival (PFS) and overall survival, new data suggest.

METHODOLOGY:

  • The study retrospectively identified 1,310 women with advanced breast cancer receiving palbociclib using South Korean nationwide claims data.
  • Overall, 344 women in the concomitant group, those who were coadministered a PPI for more than one-third of their palbociclib treatment duration, were propensity-score matched to 966 women who did not have PPI exposure: the nonconcomitant group.
  • Main outcomes were time to progression and death, presented as PFS and overall survival.

TAKEAWAY:

  • Median clinical PFS was significantly shorter by about 15 months in the concomitant PPI group vs. the nonconcomitant group (25.3 vs. 39.8 months; adjusted hazard ratio, 1.76).
  • Concomitant PPI use was also associated with shorter overall survival (HR, 2.71).
  • Overall, 83.1% of patients in the concomitant group were alive at 1 year vs. 94.0% in the nonconcomitant group (P < .001), and 69.5% vs. 89.3%, respectively, were alive at 2 years (P < .001), though the median overall survival was not reached in either group.
  • In a subgroup analysis, concomitant PPI use was associated with shorter clinical PFS (HR, 1.75 for those receiving endocrine-sensitive treatment and 1.82 for those receiving endocrine-resistant treatment), and shorter overall survival (HR, 2.68 in the endocrine-sensitive subgroup and 2.98 in the endocrine-resistant subgroup).

IN PRACTICE:

“The findings suggest that taking PPIs with palbociclib may interrupt the full therapeutic benefits of palbociclib,” the authors conclude. “Physicians should be cautious when prescribing PPIs to patients who are receiving palbociclib.”

SOURCE:

The study, led by Ju-Eun Lee, MS, PharmD, School of Pharmacy, Sungkyunkwan University, South Korea, was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by its retrospective design and use of claims data as well as the inability to confirm whether patients actually took the PPI medication.

DISCLOSURES:

The authors report no relevant financial relationships. The study reported no commercial funding.

A version of this article first appeared on Medscape.com.

 

TOPLINE:
 

Taking a proton pump inhibitor (PPI) with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib could diminish the full therapeutic benefit of palbociclib in women with breast cancer and lead to worse progression-free survival (PFS) and overall survival, new data suggest.

METHODOLOGY:

  • The study retrospectively identified 1,310 women with advanced breast cancer receiving palbociclib using South Korean nationwide claims data.
  • Overall, 344 women in the concomitant group, those who were coadministered a PPI for more than one-third of their palbociclib treatment duration, were propensity-score matched to 966 women who did not have PPI exposure: the nonconcomitant group.
  • Main outcomes were time to progression and death, presented as PFS and overall survival.

TAKEAWAY:

  • Median clinical PFS was significantly shorter by about 15 months in the concomitant PPI group vs. the nonconcomitant group (25.3 vs. 39.8 months; adjusted hazard ratio, 1.76).
  • Concomitant PPI use was also associated with shorter overall survival (HR, 2.71).
  • Overall, 83.1% of patients in the concomitant group were alive at 1 year vs. 94.0% in the nonconcomitant group (P < .001), and 69.5% vs. 89.3%, respectively, were alive at 2 years (P < .001), though the median overall survival was not reached in either group.
  • In a subgroup analysis, concomitant PPI use was associated with shorter clinical PFS (HR, 1.75 for those receiving endocrine-sensitive treatment and 1.82 for those receiving endocrine-resistant treatment), and shorter overall survival (HR, 2.68 in the endocrine-sensitive subgroup and 2.98 in the endocrine-resistant subgroup).

IN PRACTICE:

“The findings suggest that taking PPIs with palbociclib may interrupt the full therapeutic benefits of palbociclib,” the authors conclude. “Physicians should be cautious when prescribing PPIs to patients who are receiving palbociclib.”

SOURCE:

The study, led by Ju-Eun Lee, MS, PharmD, School of Pharmacy, Sungkyunkwan University, South Korea, was published online in JAMA Network Open.

LIMITATIONS:

The study was limited by its retrospective design and use of claims data as well as the inability to confirm whether patients actually took the PPI medication.

DISCLOSURES:

The authors report no relevant financial relationships. The study reported no commercial funding.

A version of this article first appeared on Medscape.com.

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Early-life antibiotic use may raise risk of early-onset CRC

Article Type
Changed
Tue, 08/08/2023 - 12:43

 

TOPLINE:

Long-term and recurrent use of antibiotics early in life may raise the risk of early-onset colorectal cancer (CRC) and adenomas, particularly in people with a variant in a specific gut microbiota regulatory gene, a new analysis found.

METHODOLOGY:

  • Researchers analyzed data from UK Biobank participants who were recruited between 2006 and 2010 and were followed up to February 2022.
  • They evaluated associations between early-life factors and early-onset CRC risk overall, focusing on long-term and recurrent antibiotic use.
  • The team also estimated associations between long-term and recurrent antibiotic use in early life and CRC risk by polygenic risk score using 127 CRC-related genetic variants, as well as a particular gut microbiota regulatory gene FUT2.
  • Associations for early-onset colorectal adenomas, as precursor to CRC, were also evaluated.
  • The study included 113,256 participants. There were 165 early-onset CRC cases and 719 early-onset adenoma cases.

TAKEAWAY:

  • Early-life, long-term, and recurrent antibiotic use was “nominally” associated with an increased risk of early-onset CRC (odds ratio, 1.48; P = .046) and adenomas (OR, 1.40; P < .001).
  • Regarding variants of FUT2, the risk of early-onset CRC appeared to be greater for individuals with the rs281377 TT genotype (OR, 2.74) in comparison with those with the CT and TT genotypes, but none of the estimates reached statistical significance.
  • The researchers found a strong positive association between long-term and recurrent antibiotic use and adenomas, largely in patients with rs281377 TT (OR, 1.75) and CT genotypes (OR, 1.51).
  • Individuals with a high polygenic risk score were at higher risk of early-onset CRC (OR, 1.72; P = .019), while those with low polygenic risk scores were not at higher risk (OR, 1.05; P = .889). The association between antibiotic use and early-onset CRC risk by family history was also higher (OR, 2.34).

IN PRACTICE:

“Our findings suggested that individuals with genetic risk factors (i.e., family history of CRC) who have experienced early-life antibiotics use on a long-term basis are probably at increased early-onset CRC risk,” the authors concluded. “Given that antibiotics remain valuable in the management of bacterial infections during early life, investigating the pros and cons of early-life antibiotic use is of great significance.”

SOURCE:

The study, led by Fangyuan Jiang, with Zhejiang University, Hangzhou, China, was published online in the International Journal of Cancer.

LIMITATIONS:

The study relied on participants’ recall of early-life antibiotics use, which could introduce recall bias and misclassification of this exposure.

DISCLOSURES:

No conflicts of interest were reported.

A version of this article first appeared on Medscape.com.

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TOPLINE:

Long-term and recurrent use of antibiotics early in life may raise the risk of early-onset colorectal cancer (CRC) and adenomas, particularly in people with a variant in a specific gut microbiota regulatory gene, a new analysis found.

METHODOLOGY:

  • Researchers analyzed data from UK Biobank participants who were recruited between 2006 and 2010 and were followed up to February 2022.
  • They evaluated associations between early-life factors and early-onset CRC risk overall, focusing on long-term and recurrent antibiotic use.
  • The team also estimated associations between long-term and recurrent antibiotic use in early life and CRC risk by polygenic risk score using 127 CRC-related genetic variants, as well as a particular gut microbiota regulatory gene FUT2.
  • Associations for early-onset colorectal adenomas, as precursor to CRC, were also evaluated.
  • The study included 113,256 participants. There were 165 early-onset CRC cases and 719 early-onset adenoma cases.

TAKEAWAY:

  • Early-life, long-term, and recurrent antibiotic use was “nominally” associated with an increased risk of early-onset CRC (odds ratio, 1.48; P = .046) and adenomas (OR, 1.40; P < .001).
  • Regarding variants of FUT2, the risk of early-onset CRC appeared to be greater for individuals with the rs281377 TT genotype (OR, 2.74) in comparison with those with the CT and TT genotypes, but none of the estimates reached statistical significance.
  • The researchers found a strong positive association between long-term and recurrent antibiotic use and adenomas, largely in patients with rs281377 TT (OR, 1.75) and CT genotypes (OR, 1.51).
  • Individuals with a high polygenic risk score were at higher risk of early-onset CRC (OR, 1.72; P = .019), while those with low polygenic risk scores were not at higher risk (OR, 1.05; P = .889). The association between antibiotic use and early-onset CRC risk by family history was also higher (OR, 2.34).

IN PRACTICE:

“Our findings suggested that individuals with genetic risk factors (i.e., family history of CRC) who have experienced early-life antibiotics use on a long-term basis are probably at increased early-onset CRC risk,” the authors concluded. “Given that antibiotics remain valuable in the management of bacterial infections during early life, investigating the pros and cons of early-life antibiotic use is of great significance.”

SOURCE:

The study, led by Fangyuan Jiang, with Zhejiang University, Hangzhou, China, was published online in the International Journal of Cancer.

LIMITATIONS:

The study relied on participants’ recall of early-life antibiotics use, which could introduce recall bias and misclassification of this exposure.

DISCLOSURES:

No conflicts of interest were reported.

A version of this article first appeared on Medscape.com.

 

TOPLINE:

Long-term and recurrent use of antibiotics early in life may raise the risk of early-onset colorectal cancer (CRC) and adenomas, particularly in people with a variant in a specific gut microbiota regulatory gene, a new analysis found.

METHODOLOGY:

  • Researchers analyzed data from UK Biobank participants who were recruited between 2006 and 2010 and were followed up to February 2022.
  • They evaluated associations between early-life factors and early-onset CRC risk overall, focusing on long-term and recurrent antibiotic use.
  • The team also estimated associations between long-term and recurrent antibiotic use in early life and CRC risk by polygenic risk score using 127 CRC-related genetic variants, as well as a particular gut microbiota regulatory gene FUT2.
  • Associations for early-onset colorectal adenomas, as precursor to CRC, were also evaluated.
  • The study included 113,256 participants. There were 165 early-onset CRC cases and 719 early-onset adenoma cases.

TAKEAWAY:

  • Early-life, long-term, and recurrent antibiotic use was “nominally” associated with an increased risk of early-onset CRC (odds ratio, 1.48; P = .046) and adenomas (OR, 1.40; P < .001).
  • Regarding variants of FUT2, the risk of early-onset CRC appeared to be greater for individuals with the rs281377 TT genotype (OR, 2.74) in comparison with those with the CT and TT genotypes, but none of the estimates reached statistical significance.
  • The researchers found a strong positive association between long-term and recurrent antibiotic use and adenomas, largely in patients with rs281377 TT (OR, 1.75) and CT genotypes (OR, 1.51).
  • Individuals with a high polygenic risk score were at higher risk of early-onset CRC (OR, 1.72; P = .019), while those with low polygenic risk scores were not at higher risk (OR, 1.05; P = .889). The association between antibiotic use and early-onset CRC risk by family history was also higher (OR, 2.34).

IN PRACTICE:

“Our findings suggested that individuals with genetic risk factors (i.e., family history of CRC) who have experienced early-life antibiotics use on a long-term basis are probably at increased early-onset CRC risk,” the authors concluded. “Given that antibiotics remain valuable in the management of bacterial infections during early life, investigating the pros and cons of early-life antibiotic use is of great significance.”

SOURCE:

The study, led by Fangyuan Jiang, with Zhejiang University, Hangzhou, China, was published online in the International Journal of Cancer.

LIMITATIONS:

The study relied on participants’ recall of early-life antibiotics use, which could introduce recall bias and misclassification of this exposure.

DISCLOSURES:

No conflicts of interest were reported.

A version of this article first appeared on Medscape.com.

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