Patients sometimes want to give back to their physician or hospital. In recent years, the practice of soliciting donations from these patients has grown into structured fundraising initiatives at some health care organizations. Some employers mandate clinicians solicit donations, while other doctors participate voluntarily.

But the nation’s second-largest physician group is cautioning its members not to ask their patients for donations to the clinician’s workplace.

“In recent decades, more physician practices have become part of large health systems: these arrangements can offer benefits to care but can also lead to interference in the patient-physician relationship and challenges to the physician’s ethical responsibilities to patients,” said Omar T. Atiq, MD, president of the American College of Physicians.

Grateful patient fundraising (GPF) is largely based on models of charitable giving outside of health care and is relatively new to the industry. Simply defined, it is the solicitation of donations by doctors from current and former patients. Funds may be used for operating costs, clinical research, equipment upgrades, or facility improvements.

In a newly published position paper, the ACP, which represents roughly 161,000 physicians, is clear that clinicians should not try to convert their patients into donors.

“Physicians who directly solicit funds from their own patients do risk interfering with the physician-patient relationship, which is supposed to be based on the patient’s best interests, not the physicians’ interests,” said Stacey A. Tovino, JD, PhD, director of health care law programs at the University of Oklahoma, Norman.

Once involved in fundraising, patients may also develop an unrealistic expectation of what kind of care they should receive, according to the ACP.

Another pitfall clinicians may fall into is the HIPAA Privacy Rule. In 2013, HIPAA was expanded to allow hospital fundraisers to access privileged health information, including demographic, health insurance, treating clinician, and data on outcomes. Dr. Atiq said that, since then, electronic health records have been used as tools to aide fundraising efforts. For instance, some health care organizations have embedded a feature inside EHRs to allow physicians to flag development officers when a patient or family member might be a potential donor. 

Patients may be unaware that hospital fundraising departments have access to their electronic health records, or that they have the right to opt out of fundraising solicitations.

“Physicians should not use or reveal patient information for fundraising,” Dr. Atiq said. “Even acknowledging that a person is under one’s care can make it possible for protected health information to be revealed.”

Data-mining EHRs may be legal, Ms. Tovino said, but it hugs a fine ethical line.

“A patient may not expect that their information will be used for these purposes and may not know how to opt out of having their information used in these ways,” Ms. Tovino said.

A clinician’s employment contract, whether it be a full-time position or for specific admitting privileges, may make it hard for them to push back against expectations to ask patients for money or screen for donors. Metrics or expectations to approach potential donors create ethical snares for clinicians – and it pits them between their patient and place of employment.

“GPF does raise ethical concerns, including those surrounding confidentiality and privacy, and whether physicians are being remunerated or evaluated based on their participation,” Ms. Tovino said.

Asked how doctors can avoid being involved in GPF, Dr. Atiq referred to the ACP ethics manual, which separates clinicians from fundraising.

“Redirecting the patient to discuss donations with institutional administrators provides the appropriate venue and firewall,” he said.

An author of the ACP paper reported a paid position on the board of the Government Employees Health Association.

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

Patients sometimes want to give back to their physician or hospital. In recent years, the practice of soliciting donations from these patients has grown into structured fundraising initiatives at some health care organizations. Some employers mandate clinicians solicit donations, while other doctors participate voluntarily.

But the nation’s second-largest physician group is cautioning its members not to ask their patients for donations to the clinician’s workplace.

“In recent decades, more physician practices have become part of large health systems: these arrangements can offer benefits to care but can also lead to interference in the patient-physician relationship and challenges to the physician’s ethical responsibilities to patients,” said Omar T. Atiq, MD, president of the American College of Physicians.

Grateful patient fundraising (GPF) is largely based on models of charitable giving outside of health care and is relatively new to the industry. Simply defined, it is the solicitation of donations by doctors from current and former patients. Funds may be used for operating costs, clinical research, equipment upgrades, or facility improvements.

In a newly published position paper, the ACP, which represents roughly 161,000 physicians, is clear that clinicians should not try to convert their patients into donors.

“Physicians who directly solicit funds from their own patients do risk interfering with the physician-patient relationship, which is supposed to be based on the patient’s best interests, not the physicians’ interests,” said Stacey A. Tovino, JD, PhD, director of health care law programs at the University of Oklahoma, Norman.

Once involved in fundraising, patients may also develop an unrealistic expectation of what kind of care they should receive, according to the ACP.

Another pitfall clinicians may fall into is the HIPAA Privacy Rule. In 2013, HIPAA was expanded to allow hospital fundraisers to access privileged health information, including demographic, health insurance, treating clinician, and data on outcomes. Dr. Atiq said that, since then, electronic health records have been used as tools to aide fundraising efforts. For instance, some health care organizations have embedded a feature inside EHRs to allow physicians to flag development officers when a patient or family member might be a potential donor. 

Patients may be unaware that hospital fundraising departments have access to their electronic health records, or that they have the right to opt out of fundraising solicitations.

“Physicians should not use or reveal patient information for fundraising,” Dr. Atiq said. “Even acknowledging that a person is under one’s care can make it possible for protected health information to be revealed.”

Data-mining EHRs may be legal, Ms. Tovino said, but it hugs a fine ethical line.

“A patient may not expect that their information will be used for these purposes and may not know how to opt out of having their information used in these ways,” Ms. Tovino said.

A clinician’s employment contract, whether it be a full-time position or for specific admitting privileges, may make it hard for them to push back against expectations to ask patients for money or screen for donors. Metrics or expectations to approach potential donors create ethical snares for clinicians – and it pits them between their patient and place of employment.

“GPF does raise ethical concerns, including those surrounding confidentiality and privacy, and whether physicians are being remunerated or evaluated based on their participation,” Ms. Tovino said.

Asked how doctors can avoid being involved in GPF, Dr. Atiq referred to the ACP ethics manual, which separates clinicians from fundraising.

“Redirecting the patient to discuss donations with institutional administrators provides the appropriate venue and firewall,” he said.

An author of the ACP paper reported a paid position on the board of the Government Employees Health Association.

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

Patients sometimes want to give back to their physician or hospital. In recent years, the practice of soliciting donations from these patients has grown into structured fundraising initiatives at some health care organizations. Some employers mandate clinicians solicit donations, while other doctors participate voluntarily.

But the nation’s second-largest physician group is cautioning its members not to ask their patients for donations to the clinician’s workplace.

“In recent decades, more physician practices have become part of large health systems: these arrangements can offer benefits to care but can also lead to interference in the patient-physician relationship and challenges to the physician’s ethical responsibilities to patients,” said Omar T. Atiq, MD, president of the American College of Physicians.

Grateful patient fundraising (GPF) is largely based on models of charitable giving outside of health care and is relatively new to the industry. Simply defined, it is the solicitation of donations by doctors from current and former patients. Funds may be used for operating costs, clinical research, equipment upgrades, or facility improvements.

In a newly published position paper, the ACP, which represents roughly 161,000 physicians, is clear that clinicians should not try to convert their patients into donors.

“Physicians who directly solicit funds from their own patients do risk interfering with the physician-patient relationship, which is supposed to be based on the patient’s best interests, not the physicians’ interests,” said Stacey A. Tovino, JD, PhD, director of health care law programs at the University of Oklahoma, Norman.

Once involved in fundraising, patients may also develop an unrealistic expectation of what kind of care they should receive, according to the ACP.

Another pitfall clinicians may fall into is the HIPAA Privacy Rule. In 2013, HIPAA was expanded to allow hospital fundraisers to access privileged health information, including demographic, health insurance, treating clinician, and data on outcomes. Dr. Atiq said that, since then, electronic health records have been used as tools to aide fundraising efforts. For instance, some health care organizations have embedded a feature inside EHRs to allow physicians to flag development officers when a patient or family member might be a potential donor. 

Patients may be unaware that hospital fundraising departments have access to their electronic health records, or that they have the right to opt out of fundraising solicitations.

“Physicians should not use or reveal patient information for fundraising,” Dr. Atiq said. “Even acknowledging that a person is under one’s care can make it possible for protected health information to be revealed.”

Data-mining EHRs may be legal, Ms. Tovino said, but it hugs a fine ethical line.

“A patient may not expect that their information will be used for these purposes and may not know how to opt out of having their information used in these ways,” Ms. Tovino said.

A clinician’s employment contract, whether it be a full-time position or for specific admitting privileges, may make it hard for them to push back against expectations to ask patients for money or screen for donors. Metrics or expectations to approach potential donors create ethical snares for clinicians – and it pits them between their patient and place of employment.

“GPF does raise ethical concerns, including those surrounding confidentiality and privacy, and whether physicians are being remunerated or evaluated based on their participation,” Ms. Tovino said.

Asked how doctors can avoid being involved in GPF, Dr. Atiq referred to the ACP ethics manual, which separates clinicians from fundraising.

“Redirecting the patient to discuss donations with institutional administrators provides the appropriate venue and firewall,” he said.

An author of the ACP paper reported a paid position on the board of the Government Employees Health Association.

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

Nearly 70% of adolescents and young adults stop taking oral 5-aminosalicylic acid (5-ASA) maintenance therapy within 12 months of ulcerative colitis (UC) diagnosis, new research from the United Kingdom indicates.

“This is concerning as they are at risk of their condition returning and further complications. It can also lead to severe complications such as surgery to remove part of the gut,” Sonia Saxena, MBBS, director, Imperial Child Health Unit, School of Public Health, Imperial College London, said in a news release.

The study “highlights the importance of counseling and education of patients at diagnosis as this is a critical window that influences long-term health behavior,” Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.

“It has not been my experience in U.S.-based practice that the rates of discontinuation are that high, but it would be important to examine this in different locations,” added Dr. Ananthakrishnan, who wasn’t involved with the study.

The study was published online in the British Journal of General Practice.
 

Cases on the rise

Globally, the incidence of UC is increasing fastest in younger populations. It’s estimated that up to 30% of individuals with UC are diagnosed in childhood or young adulthood, and these individuals are more likely to have a severe disease course and years living with disability, compared with peers diagnosed later in life. This makes achieving disease control and maintaining remission “paramount” for those diagnosed in early life, Dr. Saxena and colleagues write.

International UC guidelines recommend starting therapy with 5-ASA, also known as mesalamine, soon after diagnosis and continuing it long term to maintain remission. However, some prior evidence suggests that adherence to UC medication may be less optimal in younger people – findings supported by the U.K. study.

Leveraging data from the UK Clinical Practice Research Datalink, Dr. Saxena and colleagues analyzed data for 607 children and young adults aged 10-24 years starting oral 5-ASA maintenance therapy for UC.

They found that 152 individuals (25%) stopped 5-ASA treatment after 1 month, and 419 (69%) discontinued it within 1 year of starting treatment. The median time to stopping the anti-inflammatory drug was 162 days.

Discontinuation rates were highest in young adults aged 18-24 years (74%). The transition to adult care and loss of support from caregivers who encourage adherence in adolescents and provide financial and practical support could be one explanation for this, the researchers write.

After accounting for other factors, young adults aged 18-24 years starting 5-ASA were 43% more likely to discontinue it in the first year than adolescents aged 10-14 years.

Individuals living in socioeconomically deprived areas were 46% more likely to stop treatment, compared with those living in more affluent areas, a finding that suggests the need to address socioeconomic disparities that could drive discontinuation, the authors say.

They also found that early corticosteroid use for an acute UC flare was associated with a 32% lower likelihood of stopping 5-ASA therapy.
 

Adherence falls short

In terms of adherence, defined as the proportion of days covered by 5-ASA medication, the mean was 72%, equivalent to just under 9 months. Adherence fell with older age at initiation of therapy. Adherence was 80% among those 10-14 years, 78% among those 15-17 years, and 69% among those 18-24 years. Prior research has shown that nonadherence to UC medication – defined as proportion of days covered less than 80% – has been associated with a five-fold risk of disease, compared with adherence above 80%, the investigators note.

“If clinicians are unaware of suboptimal adherence to first-line medication, they may incorrectly assume therapy has failed, which may lead to unnecessary escalation in treatment and avoidable steroid use that remains high in UC,” the researchers write.

Psychiatric comorbidity (depression, anxiety, or antidepressant use) was not associated with discontinuation or adherence to treatment.

“As doctors, this study shows we need to be keeping a close eye on patients, particularly within that first year of starting medication,” Dr. Saxena said in the release.

“We should check if these patients are getting their medications and whether they have difficulty paying for them. We should also use the opportunity to talk through any recurring symptoms and how to access advice from providers such as a nurse specialist,” Dr. Saxena said.
 

Effectiveness of therapy in young adults

Reached for comment, Michael Dolinger, MD, assistant professor of pediatric gastroenterology, Icahn School of Medicine and Mount Sinai Kravis Children’s Hospital, both in New York, said he has seen 5-ASA stoppage among his younger patients.

“Generally, what we see is that the majority of patients over time are not able to be sustained on oral mesalamine treatment, and they need a more advanced therapy,” Dr. Dolinger said in an interview.

And while the U.K. study did not delve into the reasons for discontinuation, ineffectiveness of therapy is likely a main cause, Dr. Dolinger said.

“We especially see this in our younger adolescent and young adult patients. In these younger patients, the immune system is potentially driving inflammation a bit more than in older patients, often going beyond the inner lining of the colon to the entire bowel wall, even in ulcerative colitis, and therefore mesalamine may be ineffective over the first year,” Dr. Dolinger explained.

When choosing a more advanced therapy, Dr. Dolinger said, “it’s all about having that conversation in a shared decision-making process about what may be the most effective short- and long-term treatment options with the best safety for that patient. It’s a very individualized discussion.”

“One of the main things we preach and talk about is control of inflammation, getting into early deep remission, because the longer you have inflammation, even if it’s just smoldering, the harder it is to get into deep remission,” Dr. Dolinger added.

The study had no commercial funding. Dr. Saxena, Dr. Ananthakrishnan, and Dr. Dolinger have disclosed no relevant financial relationships.

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

Nearly 70% of adolescents and young adults stop taking oral 5-aminosalicylic acid (5-ASA) maintenance therapy within 12 months of ulcerative colitis (UC) diagnosis, new research from the United Kingdom indicates.

“This is concerning as they are at risk of their condition returning and further complications. It can also lead to severe complications such as surgery to remove part of the gut,” Sonia Saxena, MBBS, director, Imperial Child Health Unit, School of Public Health, Imperial College London, said in a news release.

The study “highlights the importance of counseling and education of patients at diagnosis as this is a critical window that influences long-term health behavior,” Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.

“It has not been my experience in U.S.-based practice that the rates of discontinuation are that high, but it would be important to examine this in different locations,” added Dr. Ananthakrishnan, who wasn’t involved with the study.

The study was published online in the British Journal of General Practice.
 

Cases on the rise

Globally, the incidence of UC is increasing fastest in younger populations. It’s estimated that up to 30% of individuals with UC are diagnosed in childhood or young adulthood, and these individuals are more likely to have a severe disease course and years living with disability, compared with peers diagnosed later in life. This makes achieving disease control and maintaining remission “paramount” for those diagnosed in early life, Dr. Saxena and colleagues write.

International UC guidelines recommend starting therapy with 5-ASA, also known as mesalamine, soon after diagnosis and continuing it long term to maintain remission. However, some prior evidence suggests that adherence to UC medication may be less optimal in younger people – findings supported by the U.K. study.

Leveraging data from the UK Clinical Practice Research Datalink, Dr. Saxena and colleagues analyzed data for 607 children and young adults aged 10-24 years starting oral 5-ASA maintenance therapy for UC.

They found that 152 individuals (25%) stopped 5-ASA treatment after 1 month, and 419 (69%) discontinued it within 1 year of starting treatment. The median time to stopping the anti-inflammatory drug was 162 days.

Discontinuation rates were highest in young adults aged 18-24 years (74%). The transition to adult care and loss of support from caregivers who encourage adherence in adolescents and provide financial and practical support could be one explanation for this, the researchers write.

After accounting for other factors, young adults aged 18-24 years starting 5-ASA were 43% more likely to discontinue it in the first year than adolescents aged 10-14 years.

Individuals living in socioeconomically deprived areas were 46% more likely to stop treatment, compared with those living in more affluent areas, a finding that suggests the need to address socioeconomic disparities that could drive discontinuation, the authors say.

They also found that early corticosteroid use for an acute UC flare was associated with a 32% lower likelihood of stopping 5-ASA therapy.
 

Adherence falls short

In terms of adherence, defined as the proportion of days covered by 5-ASA medication, the mean was 72%, equivalent to just under 9 months. Adherence fell with older age at initiation of therapy. Adherence was 80% among those 10-14 years, 78% among those 15-17 years, and 69% among those 18-24 years. Prior research has shown that nonadherence to UC medication – defined as proportion of days covered less than 80% – has been associated with a five-fold risk of disease, compared with adherence above 80%, the investigators note.

“If clinicians are unaware of suboptimal adherence to first-line medication, they may incorrectly assume therapy has failed, which may lead to unnecessary escalation in treatment and avoidable steroid use that remains high in UC,” the researchers write.

Psychiatric comorbidity (depression, anxiety, or antidepressant use) was not associated with discontinuation or adherence to treatment.

“As doctors, this study shows we need to be keeping a close eye on patients, particularly within that first year of starting medication,” Dr. Saxena said in the release.

“We should check if these patients are getting their medications and whether they have difficulty paying for them. We should also use the opportunity to talk through any recurring symptoms and how to access advice from providers such as a nurse specialist,” Dr. Saxena said.
 

Effectiveness of therapy in young adults

Reached for comment, Michael Dolinger, MD, assistant professor of pediatric gastroenterology, Icahn School of Medicine and Mount Sinai Kravis Children’s Hospital, both in New York, said he has seen 5-ASA stoppage among his younger patients.

“Generally, what we see is that the majority of patients over time are not able to be sustained on oral mesalamine treatment, and they need a more advanced therapy,” Dr. Dolinger said in an interview.

And while the U.K. study did not delve into the reasons for discontinuation, ineffectiveness of therapy is likely a main cause, Dr. Dolinger said.

“We especially see this in our younger adolescent and young adult patients. In these younger patients, the immune system is potentially driving inflammation a bit more than in older patients, often going beyond the inner lining of the colon to the entire bowel wall, even in ulcerative colitis, and therefore mesalamine may be ineffective over the first year,” Dr. Dolinger explained.

When choosing a more advanced therapy, Dr. Dolinger said, “it’s all about having that conversation in a shared decision-making process about what may be the most effective short- and long-term treatment options with the best safety for that patient. It’s a very individualized discussion.”

“One of the main things we preach and talk about is control of inflammation, getting into early deep remission, because the longer you have inflammation, even if it’s just smoldering, the harder it is to get into deep remission,” Dr. Dolinger added.

The study had no commercial funding. Dr. Saxena, Dr. Ananthakrishnan, and Dr. Dolinger have disclosed no relevant financial relationships.

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

Nearly 70% of adolescents and young adults stop taking oral 5-aminosalicylic acid (5-ASA) maintenance therapy within 12 months of ulcerative colitis (UC) diagnosis, new research from the United Kingdom indicates.

“This is concerning as they are at risk of their condition returning and further complications. It can also lead to severe complications such as surgery to remove part of the gut,” Sonia Saxena, MBBS, director, Imperial Child Health Unit, School of Public Health, Imperial College London, said in a news release.

The study “highlights the importance of counseling and education of patients at diagnosis as this is a critical window that influences long-term health behavior,” Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.

“It has not been my experience in U.S.-based practice that the rates of discontinuation are that high, but it would be important to examine this in different locations,” added Dr. Ananthakrishnan, who wasn’t involved with the study.

The study was published online in the British Journal of General Practice.
 

Cases on the rise

Globally, the incidence of UC is increasing fastest in younger populations. It’s estimated that up to 30% of individuals with UC are diagnosed in childhood or young adulthood, and these individuals are more likely to have a severe disease course and years living with disability, compared with peers diagnosed later in life. This makes achieving disease control and maintaining remission “paramount” for those diagnosed in early life, Dr. Saxena and colleagues write.

International UC guidelines recommend starting therapy with 5-ASA, also known as mesalamine, soon after diagnosis and continuing it long term to maintain remission. However, some prior evidence suggests that adherence to UC medication may be less optimal in younger people – findings supported by the U.K. study.

Leveraging data from the UK Clinical Practice Research Datalink, Dr. Saxena and colleagues analyzed data for 607 children and young adults aged 10-24 years starting oral 5-ASA maintenance therapy for UC.

They found that 152 individuals (25%) stopped 5-ASA treatment after 1 month, and 419 (69%) discontinued it within 1 year of starting treatment. The median time to stopping the anti-inflammatory drug was 162 days.

Discontinuation rates were highest in young adults aged 18-24 years (74%). The transition to adult care and loss of support from caregivers who encourage adherence in adolescents and provide financial and practical support could be one explanation for this, the researchers write.

After accounting for other factors, young adults aged 18-24 years starting 5-ASA were 43% more likely to discontinue it in the first year than adolescents aged 10-14 years.

Individuals living in socioeconomically deprived areas were 46% more likely to stop treatment, compared with those living in more affluent areas, a finding that suggests the need to address socioeconomic disparities that could drive discontinuation, the authors say.

They also found that early corticosteroid use for an acute UC flare was associated with a 32% lower likelihood of stopping 5-ASA therapy.
 

Adherence falls short

In terms of adherence, defined as the proportion of days covered by 5-ASA medication, the mean was 72%, equivalent to just under 9 months. Adherence fell with older age at initiation of therapy. Adherence was 80% among those 10-14 years, 78% among those 15-17 years, and 69% among those 18-24 years. Prior research has shown that nonadherence to UC medication – defined as proportion of days covered less than 80% – has been associated with a five-fold risk of disease, compared with adherence above 80%, the investigators note.

“If clinicians are unaware of suboptimal adherence to first-line medication, they may incorrectly assume therapy has failed, which may lead to unnecessary escalation in treatment and avoidable steroid use that remains high in UC,” the researchers write.

Psychiatric comorbidity (depression, anxiety, or antidepressant use) was not associated with discontinuation or adherence to treatment.

“As doctors, this study shows we need to be keeping a close eye on patients, particularly within that first year of starting medication,” Dr. Saxena said in the release.

“We should check if these patients are getting their medications and whether they have difficulty paying for them. We should also use the opportunity to talk through any recurring symptoms and how to access advice from providers such as a nurse specialist,” Dr. Saxena said.
 

Effectiveness of therapy in young adults

Reached for comment, Michael Dolinger, MD, assistant professor of pediatric gastroenterology, Icahn School of Medicine and Mount Sinai Kravis Children’s Hospital, both in New York, said he has seen 5-ASA stoppage among his younger patients.

“Generally, what we see is that the majority of patients over time are not able to be sustained on oral mesalamine treatment, and they need a more advanced therapy,” Dr. Dolinger said in an interview.

And while the U.K. study did not delve into the reasons for discontinuation, ineffectiveness of therapy is likely a main cause, Dr. Dolinger said.

“We especially see this in our younger adolescent and young adult patients. In these younger patients, the immune system is potentially driving inflammation a bit more than in older patients, often going beyond the inner lining of the colon to the entire bowel wall, even in ulcerative colitis, and therefore mesalamine may be ineffective over the first year,” Dr. Dolinger explained.

When choosing a more advanced therapy, Dr. Dolinger said, “it’s all about having that conversation in a shared decision-making process about what may be the most effective short- and long-term treatment options with the best safety for that patient. It’s a very individualized discussion.”

“One of the main things we preach and talk about is control of inflammation, getting into early deep remission, because the longer you have inflammation, even if it’s just smoldering, the harder it is to get into deep remission,” Dr. Dolinger added.

The study had no commercial funding. Dr. Saxena, Dr. Ananthakrishnan, and Dr. Dolinger have disclosed no relevant financial relationships.

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

The U.S. Food and Drug Administration has approved bosutinib (Bosulif, Pfizer) for pediatric patients aged 1 year or older with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) that is either newly diagnosed or resistant/intolerant to prior therapy.

The agency also approved new 50-mg and 100-mg capsules to help treat children.

For newly diagnosed disease, the dose is 300 mg/m² once daily with food. For resistant/intolerant disease, the dose is 400 mg/m² once daily. For children who cannot swallow capsules, the contents can be mixed into applesauce or yogurt, the FDA said in a press release announcing the approval.

The tyrosine kinase inhibitor (TKI) was previously approved for adults. Three other TKIs were previously approved for pediatric CML.

The approval was based on the BCHILD trial, a pediatric dose-finding study involving patients aged 1 year or older. Among the 21 children with newly diagnosed chronic phase, Ph+ CML treated with 300 mg/m², the rate of major cytogenetic response was 76.2%, the rate of complete cytogenetic response was 71.4%, and the rate of major molecular response rate was 28.6% over a median duration of 14.2 months.

Among the 28 children with relapsed/intolerant disease treated with up to 400 mg/m², the rate of major cytogenetic response was 82.1%, the rate of complete cytogenetic response was 78.6%, and the rate of major molecular response was 50% over a median duration of 23.2 months. Among the 14 patients who had a major molecular response, two lost it – one after 13.6 months of treatment, and the other after 24.7 months of treatment.

Adverse events that occurred in 20% or more of children included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. Overall, 45% or more of patients experienced an increase in creatinine, alanine aminotransferase, or aspartate aminotransferase levels, or a decrease in white blood cell count or platelet count.

The full labeling information is available online.

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

The U.S. Food and Drug Administration has approved bosutinib (Bosulif, Pfizer) for pediatric patients aged 1 year or older with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) that is either newly diagnosed or resistant/intolerant to prior therapy.

The agency also approved new 50-mg and 100-mg capsules to help treat children.

For newly diagnosed disease, the dose is 300 mg/m² once daily with food. For resistant/intolerant disease, the dose is 400 mg/m² once daily. For children who cannot swallow capsules, the contents can be mixed into applesauce or yogurt, the FDA said in a press release announcing the approval.

The tyrosine kinase inhibitor (TKI) was previously approved for adults. Three other TKIs were previously approved for pediatric CML.

The approval was based on the BCHILD trial, a pediatric dose-finding study involving patients aged 1 year or older. Among the 21 children with newly diagnosed chronic phase, Ph+ CML treated with 300 mg/m², the rate of major cytogenetic response was 76.2%, the rate of complete cytogenetic response was 71.4%, and the rate of major molecular response rate was 28.6% over a median duration of 14.2 months.

Among the 28 children with relapsed/intolerant disease treated with up to 400 mg/m², the rate of major cytogenetic response was 82.1%, the rate of complete cytogenetic response was 78.6%, and the rate of major molecular response was 50% over a median duration of 23.2 months. Among the 14 patients who had a major molecular response, two lost it – one after 13.6 months of treatment, and the other after 24.7 months of treatment.

Adverse events that occurred in 20% or more of children included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. Overall, 45% or more of patients experienced an increase in creatinine, alanine aminotransferase, or aspartate aminotransferase levels, or a decrease in white blood cell count or platelet count.

The full labeling information is available online.

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

The U.S. Food and Drug Administration has approved bosutinib (Bosulif, Pfizer) for pediatric patients aged 1 year or older with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) that is either newly diagnosed or resistant/intolerant to prior therapy.

The agency also approved new 50-mg and 100-mg capsules to help treat children.

For newly diagnosed disease, the dose is 300 mg/m² once daily with food. For resistant/intolerant disease, the dose is 400 mg/m² once daily. For children who cannot swallow capsules, the contents can be mixed into applesauce or yogurt, the FDA said in a press release announcing the approval.

The tyrosine kinase inhibitor (TKI) was previously approved for adults. Three other TKIs were previously approved for pediatric CML.

The approval was based on the BCHILD trial, a pediatric dose-finding study involving patients aged 1 year or older. Among the 21 children with newly diagnosed chronic phase, Ph+ CML treated with 300 mg/m², the rate of major cytogenetic response was 76.2%, the rate of complete cytogenetic response was 71.4%, and the rate of major molecular response rate was 28.6% over a median duration of 14.2 months.

Among the 28 children with relapsed/intolerant disease treated with up to 400 mg/m², the rate of major cytogenetic response was 82.1%, the rate of complete cytogenetic response was 78.6%, and the rate of major molecular response was 50% over a median duration of 23.2 months. Among the 14 patients who had a major molecular response, two lost it – one after 13.6 months of treatment, and the other after 24.7 months of treatment.

Adverse events that occurred in 20% or more of children included diarrhea, abdominal pain, vomiting, nausea, rash, fatigue, hepatic dysfunction, headache, pyrexia, decreased appetite, and constipation. Overall, 45% or more of patients experienced an increase in creatinine, alanine aminotransferase, or aspartate aminotransferase levels, or a decrease in white blood cell count or platelet count.

The full labeling information is available online.

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

Nonmenstruating women were more likely to experience unexpected vaginal bleeding after receiving COVID-19 vaccinations, according to a new study.

The researchers suggested it could have been connected to the SARS-CoV-2 spike protein in the vaccines. The study was published in Science Advances.

After vaccinations became widely available, many women reported heavier menstrual bleeding than normal. Researchers at the Norwegian Institute of Public Health in Oslo examined the data, particularly among women who do not have periods, such as those who have been through menopause or are taking contraceptives.

The researchers used an ongoing population health survey called the Norwegian Mother, Father, and Child Cohort Study, Nature reported. They examined more than 21,000 responses from postmenopausal, perimenopausal, and nonmenstruating premenopausal women. Some were on long-term hormonal contraceptives.

They learned that 252 postmenopausal women, 1,008 perimenopausal women, and 924 premenopausal women reported having unexpected vaginal bleeding.

About half said the bleeding occurred within 4 weeks of the first or second shot or both. The risk of bleeding was up three to five times for premenopausal and perimenopausal women, and two to three times for postmenopausal women, the researchers found.

Postmenopausal bleeding is usually serious and can be a sign of cancer. “Knowing a patient’s vaccination status could put their bleeding incidence into context,” said Kate Clancy, a biological anthropologist at the University of Illinois at Urbana-Champaign.

The study received funding through the Norwegian Institute of Public Health and Research Council of Norway. The researchers reported no conflicts of interest.

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

Nonmenstruating women were more likely to experience unexpected vaginal bleeding after receiving COVID-19 vaccinations, according to a new study.

The researchers suggested it could have been connected to the SARS-CoV-2 spike protein in the vaccines. The study was published in Science Advances.

After vaccinations became widely available, many women reported heavier menstrual bleeding than normal. Researchers at the Norwegian Institute of Public Health in Oslo examined the data, particularly among women who do not have periods, such as those who have been through menopause or are taking contraceptives.

The researchers used an ongoing population health survey called the Norwegian Mother, Father, and Child Cohort Study, Nature reported. They examined more than 21,000 responses from postmenopausal, perimenopausal, and nonmenstruating premenopausal women. Some were on long-term hormonal contraceptives.

They learned that 252 postmenopausal women, 1,008 perimenopausal women, and 924 premenopausal women reported having unexpected vaginal bleeding.

About half said the bleeding occurred within 4 weeks of the first or second shot or both. The risk of bleeding was up three to five times for premenopausal and perimenopausal women, and two to three times for postmenopausal women, the researchers found.

Postmenopausal bleeding is usually serious and can be a sign of cancer. “Knowing a patient’s vaccination status could put their bleeding incidence into context,” said Kate Clancy, a biological anthropologist at the University of Illinois at Urbana-Champaign.

The study received funding through the Norwegian Institute of Public Health and Research Council of Norway. The researchers reported no conflicts of interest.

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

Nonmenstruating women were more likely to experience unexpected vaginal bleeding after receiving COVID-19 vaccinations, according to a new study.

The researchers suggested it could have been connected to the SARS-CoV-2 spike protein in the vaccines. The study was published in Science Advances.

After vaccinations became widely available, many women reported heavier menstrual bleeding than normal. Researchers at the Norwegian Institute of Public Health in Oslo examined the data, particularly among women who do not have periods, such as those who have been through menopause or are taking contraceptives.

The researchers used an ongoing population health survey called the Norwegian Mother, Father, and Child Cohort Study, Nature reported. They examined more than 21,000 responses from postmenopausal, perimenopausal, and nonmenstruating premenopausal women. Some were on long-term hormonal contraceptives.

They learned that 252 postmenopausal women, 1,008 perimenopausal women, and 924 premenopausal women reported having unexpected vaginal bleeding.

About half said the bleeding occurred within 4 weeks of the first or second shot or both. The risk of bleeding was up three to five times for premenopausal and perimenopausal women, and two to three times for postmenopausal women, the researchers found.

Postmenopausal bleeding is usually serious and can be a sign of cancer. “Knowing a patient’s vaccination status could put their bleeding incidence into context,” said Kate Clancy, a biological anthropologist at the University of Illinois at Urbana-Champaign.

The study received funding through the Norwegian Institute of Public Health and Research Council of Norway. The researchers reported no conflicts of interest.

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

Despite recent strides in the management and treatment of sickle cell disease (SCD), persistent misconceptions and ongoing issues – such as low utilization of important new therapies – reveal a pressing need to better inform both clinicians and patients about this condition.

Affecting more than 20 million people globally and 100,000 people nationwide, SCD is the most common inherited blood disorder in the United States. It occurs largely but not exclusively among people of African descent.

Patients with SCD develop crescent-shaped or “sickled” red blood cells that, unlike normally round cells, can potentially block blood flow and thus cause a host of problems ranging from a risk of stroke or infections to sometimes severe pain crises, called vaso-occlusive episodes.

To help ward off such complications, some key preventative measures and an array of therapies have become available in recent years: Newborn screening and prophylaxis, including the introduction of pneumococcal vaccines, have substantially reduced rates of invasive pneumococcal infection, which previously accounted for 32% of all causes of death in patients with SCD under the age of 20.

And while hydroxyurea was the only medication from 1998 to 2017 to alleviate acute pain episodes in SCD, newer options have become available in recent years, with l-glutamine, voxelotor, and crizanlizumab gaining FDA approval to further help prevent the episodes.

However, studies show that many if not most patients fail to receive adequate treatment, with one recent report indicating that, between 2016 and 2020, hydroxyurea was prescribed to fewer than 25% of patients with SCD, and fewer than 4% of people with the disease who experience chronic pain episodes had prescriptions for the newer FDA-approved drugs.
 

Myths and truths

To help clarify some common misconceptions that contribute to the problems, Lewis Hsu, MD, PhD, chief medical officer of the Sickle Cell Disease Association of America, detailed some of the most prevalent and persistent myths among clinicians about SCD:

courtesy University of Illinois

Pain level

Myths: Firstly, that sickle cell pain is not that bad, and patients therefore don’t really need opioid pain treatment, and secondly, that sickle cell pain is measurable by lab tests, such as the number of sickled red blood cells on a blood smear, reticulocytes, or hemoglobin level.

Truths: “Sickle cell vaso-occlusive pain can be very severe – a 10 on a scale of 10 – but the pain is usually only known by subjective report,” said Dr. Hsu, a pediatric hematologist who serves as director of the Sickle Cell Center and professor of pediatrics for the University of Illinois at Chicago.

“No lab test can be used to measure pain,” he said. “Other lab tests can be abnormal, and some have statistical correlation with lifetime severity of disease course, but the lab tests are not for determination of acute level of pain or absence of pain.”

Blacks only

Myth: SCD only affects Black people.

Truth: People who have sickle cell disease from many ethnic backgrounds and skin colors.

“Around the Mediterranean, there are sickle cell patients from Greece, Turkey, Italy, and Spain. Some are blond and blue-eyed. People in India and Pakistan have sickle cell disease,” Dr. Hsu explained.

In addition, “people from the Arabian Peninsula have sickle cell disease; some Malaysians have sickle cell disease; one child who is about third generation in Hong Kong has sickle cell disease.”

Parental link

Myth: Sickle cell disease only occurs in individuals both of whose parents have the sickle gene.

Truth: “There are types of sickle cell disease [involving] a sickle cell gene from one parent and a gene for hemoglobin C from the other parent,” Dr. Hsu noted. “Others inherited one sickle gene [from one parent] and inherited from the other parent a gene for beta thalassemia. Others involve an inherited sickle gene and hemoglobin E; others have inherited one sickle gene and inherited a gene for hemoglobin D-Punjab, while others have sickle and hemoglobin O-Arab.”

Effects beyond pain

Myth: A person who is not having sickle cell pain is otherwise not significantly affected by their disease.

Truth: “Organs can be damaged silently every day,” Dr. Hsu said. “Kidney failure, retina damage, and pulmonary hypertension are the most notable of organ systems that can suffer damage for a long time without symptoms, then develop symptoms when it is too late to intervene.”

“For this reason, individuals with sickle cell disease should have regular expert care for health maintenance that is disease specific,” Dr. Hsu added.
 

Consult guidelines

One final concern is a basic failure to utilize critical information sources and guidelines, especially by primary care providers and/or other nonspecialists from whom patients with SCD may often seek treatment. “Awareness of these guidelines is low,” Dr. Hsu said.

Key resources that can be helpful include evidence-based guidelines developed by an expert panel of the National Heart, Lung, and Blood Institute, and the American Society of Hematology has a Pocket Guide app on management of sickle cell disease.

Another key resource being highlighted in September, which is National Sickle Cell Disease Awareness Month, is the NHLBI’s comprehensive website, providing information ranging from fact sheets on the disease and treatments to social media resources and inspiring stories of people with SCD.

“We are trying to bring more sickle cell information and case studies into medical school curricula, nursing curricula, social workers and community health workers awareness, [and] apps and online guidelines are proliferating,” Dr. Hsu says.

He goes on to say, “We need more recognition and resources from insurance providers that quality care for sickle cell disease is measured and rewarded.”

Dr. Hsu coauthored “Hope and Destiny: The Patient and Parent’s Guide to Sickle Cell Disease and Sickle Cell Trait.” He reported relationships with Novartis, Emmaus, Forma Therapeutic, Dupont/Nemours Children’s Hospital, Hilton Publishing, Asklepion, Bayer, CRISPR/Vertex, Cyclerion, Pfizer, and Aruvant.
 

Despite recent strides in the management and treatment of sickle cell disease (SCD), persistent misconceptions and ongoing issues – such as low utilization of important new therapies – reveal a pressing need to better inform both clinicians and patients about this condition.

Affecting more than 20 million people globally and 100,000 people nationwide, SCD is the most common inherited blood disorder in the United States. It occurs largely but not exclusively among people of African descent.

Patients with SCD develop crescent-shaped or “sickled” red blood cells that, unlike normally round cells, can potentially block blood flow and thus cause a host of problems ranging from a risk of stroke or infections to sometimes severe pain crises, called vaso-occlusive episodes.

To help ward off such complications, some key preventative measures and an array of therapies have become available in recent years: Newborn screening and prophylaxis, including the introduction of pneumococcal vaccines, have substantially reduced rates of invasive pneumococcal infection, which previously accounted for 32% of all causes of death in patients with SCD under the age of 20.

And while hydroxyurea was the only medication from 1998 to 2017 to alleviate acute pain episodes in SCD, newer options have become available in recent years, with l-glutamine, voxelotor, and crizanlizumab gaining FDA approval to further help prevent the episodes.

However, studies show that many if not most patients fail to receive adequate treatment, with one recent report indicating that, between 2016 and 2020, hydroxyurea was prescribed to fewer than 25% of patients with SCD, and fewer than 4% of people with the disease who experience chronic pain episodes had prescriptions for the newer FDA-approved drugs.
 

Myths and truths

To help clarify some common misconceptions that contribute to the problems, Lewis Hsu, MD, PhD, chief medical officer of the Sickle Cell Disease Association of America, detailed some of the most prevalent and persistent myths among clinicians about SCD:

courtesy University of Illinois

Pain level

Myths: Firstly, that sickle cell pain is not that bad, and patients therefore don’t really need opioid pain treatment, and secondly, that sickle cell pain is measurable by lab tests, such as the number of sickled red blood cells on a blood smear, reticulocytes, or hemoglobin level.

Truths: “Sickle cell vaso-occlusive pain can be very severe – a 10 on a scale of 10 – but the pain is usually only known by subjective report,” said Dr. Hsu, a pediatric hematologist who serves as director of the Sickle Cell Center and professor of pediatrics for the University of Illinois at Chicago.

“No lab test can be used to measure pain,” he said. “Other lab tests can be abnormal, and some have statistical correlation with lifetime severity of disease course, but the lab tests are not for determination of acute level of pain or absence of pain.”

Blacks only

Myth: SCD only affects Black people.

Truth: People who have sickle cell disease from many ethnic backgrounds and skin colors.

“Around the Mediterranean, there are sickle cell patients from Greece, Turkey, Italy, and Spain. Some are blond and blue-eyed. People in India and Pakistan have sickle cell disease,” Dr. Hsu explained.

In addition, “people from the Arabian Peninsula have sickle cell disease; some Malaysians have sickle cell disease; one child who is about third generation in Hong Kong has sickle cell disease.”

Parental link

Myth: Sickle cell disease only occurs in individuals both of whose parents have the sickle gene.

Truth: “There are types of sickle cell disease [involving] a sickle cell gene from one parent and a gene for hemoglobin C from the other parent,” Dr. Hsu noted. “Others inherited one sickle gene [from one parent] and inherited from the other parent a gene for beta thalassemia. Others involve an inherited sickle gene and hemoglobin E; others have inherited one sickle gene and inherited a gene for hemoglobin D-Punjab, while others have sickle and hemoglobin O-Arab.”

Effects beyond pain

Myth: A person who is not having sickle cell pain is otherwise not significantly affected by their disease.

Truth: “Organs can be damaged silently every day,” Dr. Hsu said. “Kidney failure, retina damage, and pulmonary hypertension are the most notable of organ systems that can suffer damage for a long time without symptoms, then develop symptoms when it is too late to intervene.”

“For this reason, individuals with sickle cell disease should have regular expert care for health maintenance that is disease specific,” Dr. Hsu added.
 

Consult guidelines

One final concern is a basic failure to utilize critical information sources and guidelines, especially by primary care providers and/or other nonspecialists from whom patients with SCD may often seek treatment. “Awareness of these guidelines is low,” Dr. Hsu said.

Key resources that can be helpful include evidence-based guidelines developed by an expert panel of the National Heart, Lung, and Blood Institute, and the American Society of Hematology has a Pocket Guide app on management of sickle cell disease.

Another key resource being highlighted in September, which is National Sickle Cell Disease Awareness Month, is the NHLBI’s comprehensive website, providing information ranging from fact sheets on the disease and treatments to social media resources and inspiring stories of people with SCD.

“We are trying to bring more sickle cell information and case studies into medical school curricula, nursing curricula, social workers and community health workers awareness, [and] apps and online guidelines are proliferating,” Dr. Hsu says.

He goes on to say, “We need more recognition and resources from insurance providers that quality care for sickle cell disease is measured and rewarded.”

Dr. Hsu coauthored “Hope and Destiny: The Patient and Parent’s Guide to Sickle Cell Disease and Sickle Cell Trait.” He reported relationships with Novartis, Emmaus, Forma Therapeutic, Dupont/Nemours Children’s Hospital, Hilton Publishing, Asklepion, Bayer, CRISPR/Vertex, Cyclerion, Pfizer, and Aruvant.
 

Despite recent strides in the management and treatment of sickle cell disease (SCD), persistent misconceptions and ongoing issues – such as low utilization of important new therapies – reveal a pressing need to better inform both clinicians and patients about this condition.

Affecting more than 20 million people globally and 100,000 people nationwide, SCD is the most common inherited blood disorder in the United States. It occurs largely but not exclusively among people of African descent.

Patients with SCD develop crescent-shaped or “sickled” red blood cells that, unlike normally round cells, can potentially block blood flow and thus cause a host of problems ranging from a risk of stroke or infections to sometimes severe pain crises, called vaso-occlusive episodes.

To help ward off such complications, some key preventative measures and an array of therapies have become available in recent years: Newborn screening and prophylaxis, including the introduction of pneumococcal vaccines, have substantially reduced rates of invasive pneumococcal infection, which previously accounted for 32% of all causes of death in patients with SCD under the age of 20.

And while hydroxyurea was the only medication from 1998 to 2017 to alleviate acute pain episodes in SCD, newer options have become available in recent years, with l-glutamine, voxelotor, and crizanlizumab gaining FDA approval to further help prevent the episodes.

However, studies show that many if not most patients fail to receive adequate treatment, with one recent report indicating that, between 2016 and 2020, hydroxyurea was prescribed to fewer than 25% of patients with SCD, and fewer than 4% of people with the disease who experience chronic pain episodes had prescriptions for the newer FDA-approved drugs.
 

Myths and truths

To help clarify some common misconceptions that contribute to the problems, Lewis Hsu, MD, PhD, chief medical officer of the Sickle Cell Disease Association of America, detailed some of the most prevalent and persistent myths among clinicians about SCD:

courtesy University of Illinois

Pain level

Myths: Firstly, that sickle cell pain is not that bad, and patients therefore don’t really need opioid pain treatment, and secondly, that sickle cell pain is measurable by lab tests, such as the number of sickled red blood cells on a blood smear, reticulocytes, or hemoglobin level.

Truths: “Sickle cell vaso-occlusive pain can be very severe – a 10 on a scale of 10 – but the pain is usually only known by subjective report,” said Dr. Hsu, a pediatric hematologist who serves as director of the Sickle Cell Center and professor of pediatrics for the University of Illinois at Chicago.

“No lab test can be used to measure pain,” he said. “Other lab tests can be abnormal, and some have statistical correlation with lifetime severity of disease course, but the lab tests are not for determination of acute level of pain or absence of pain.”

Blacks only

Myth: SCD only affects Black people.

Truth: People who have sickle cell disease from many ethnic backgrounds and skin colors.

“Around the Mediterranean, there are sickle cell patients from Greece, Turkey, Italy, and Spain. Some are blond and blue-eyed. People in India and Pakistan have sickle cell disease,” Dr. Hsu explained.

In addition, “people from the Arabian Peninsula have sickle cell disease; some Malaysians have sickle cell disease; one child who is about third generation in Hong Kong has sickle cell disease.”

Parental link

Myth: Sickle cell disease only occurs in individuals both of whose parents have the sickle gene.

Truth: “There are types of sickle cell disease [involving] a sickle cell gene from one parent and a gene for hemoglobin C from the other parent,” Dr. Hsu noted. “Others inherited one sickle gene [from one parent] and inherited from the other parent a gene for beta thalassemia. Others involve an inherited sickle gene and hemoglobin E; others have inherited one sickle gene and inherited a gene for hemoglobin D-Punjab, while others have sickle and hemoglobin O-Arab.”

Effects beyond pain

Myth: A person who is not having sickle cell pain is otherwise not significantly affected by their disease.

Truth: “Organs can be damaged silently every day,” Dr. Hsu said. “Kidney failure, retina damage, and pulmonary hypertension are the most notable of organ systems that can suffer damage for a long time without symptoms, then develop symptoms when it is too late to intervene.”

“For this reason, individuals with sickle cell disease should have regular expert care for health maintenance that is disease specific,” Dr. Hsu added.
 

Consult guidelines

One final concern is a basic failure to utilize critical information sources and guidelines, especially by primary care providers and/or other nonspecialists from whom patients with SCD may often seek treatment. “Awareness of these guidelines is low,” Dr. Hsu said.

Key resources that can be helpful include evidence-based guidelines developed by an expert panel of the National Heart, Lung, and Blood Institute, and the American Society of Hematology has a Pocket Guide app on management of sickle cell disease.

Another key resource being highlighted in September, which is National Sickle Cell Disease Awareness Month, is the NHLBI’s comprehensive website, providing information ranging from fact sheets on the disease and treatments to social media resources and inspiring stories of people with SCD.

“We are trying to bring more sickle cell information and case studies into medical school curricula, nursing curricula, social workers and community health workers awareness, [and] apps and online guidelines are proliferating,” Dr. Hsu says.

He goes on to say, “We need more recognition and resources from insurance providers that quality care for sickle cell disease is measured and rewarded.”

Dr. Hsu coauthored “Hope and Destiny: The Patient and Parent’s Guide to Sickle Cell Disease and Sickle Cell Trait.” He reported relationships with Novartis, Emmaus, Forma Therapeutic, Dupont/Nemours Children’s Hospital, Hilton Publishing, Asklepion, Bayer, CRISPR/Vertex, Cyclerion, Pfizer, and Aruvant.
 

TOPLINE:

Ultrasonography may serve as an alternative to radiography for diagnosing pediatric forearm fractures, thus reducing the number of children undergoing radiography at initial emergency department presentation, as well as their waiting time in ED.

METHODOLOGY:

• After the World Health Organization reported a lack of access to any diagnostic imaging in approximately two-thirds of the world population in 2010, ultrasonography has gained popularity in low- and middle-income countries.
• The initial use of ultrasonography is in accordance with the principle of maintaining radiation levels as low as reasonably achievable.
• The BUCKLED trial was conducted, including 270 pediatric patients (age, 5-15 years) who presented to the ED with isolated, acute, clinically nondeformed distal forearm fractures.
• The participants were randomly assigned to receive initial point-of-care ultrasonography (n = 135) or radiography (n = 135) in the ED.
• The primary outcome was the physical function of the affected arm at 4 weeks evaluated using the Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) tool.

TAKEAWAY:

• At 4 weeks, mean PROMIS scores were 36.4 and 36.3 points in ultrasonography and radiography groups, respectively (mean difference, 0.1 point; 95% confidence interval, − 1.3 to 1.4), indicating noninferiority of ultrasonography over radiography.
• Ultrasonography and radiography groups showed similar efficacy in terms of PROMIS scores at 1 week (MD, 0.7 points; 95% CI, − 1.4 to 2.8) and 8 weeks (MD, 0.1 points; 95% CI, − 0.5 to 0.7).
• Participants in the ultrasonography group had a shorter length of stay in the ED (median difference, 15 minutes; 95% CI, 1-29) and a shorter treatment time (median difference, 28 minutes; 95% CI, 17-40) than those in the radiography group.
• No important fractures were missed with ultrasonography, and no significant difference was observed in the frequency of adverse events or unplanned returns to the ED between the two groups.

IN PRACTICE:

Noting the benefit-risk profile of an ultrasound-first approach in an ED setting, the lead author, Peter J. Snelling, MB, BS, MPH&TM, from Menzies Health Institute Queensland, Gold Coast, Australia, said: “It is highly unlikely that any important fractures would be missed using the protocol that we trained clinicians. The risk is low and the benefit is moderate, such as reducing length of stay and increased level of patient satisfaction.”

He further added that, “with an ultrasound-first approach, clinicians can scan the patient at time of review and may even be able to discharge them immediately (two-thirds of instances in our NEJM trial). This places the patient at the center of care being provided.”
 

SOURCE: 

Authors from the BUCKLED Trial Group published their study in the New England Journal of Medicine.

LIMITATIONS:

PROMIS scores may have been affected by variations in subsequent therapeutic interventions rather than the initial diagnostic method. PROMIS tool was not validated in children younger than 5 years of age.

DISCLOSURES:

The study was funded by the Emergency Medicine Foundation and others. The authors have declared no relevant interests to disclose.

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

TOPLINE:

Ultrasonography may serve as an alternative to radiography for diagnosing pediatric forearm fractures, thus reducing the number of children undergoing radiography at initial emergency department presentation, as well as their waiting time in ED.

METHODOLOGY:

• After the World Health Organization reported a lack of access to any diagnostic imaging in approximately two-thirds of the world population in 2010, ultrasonography has gained popularity in low- and middle-income countries.
• The initial use of ultrasonography is in accordance with the principle of maintaining radiation levels as low as reasonably achievable.
• The BUCKLED trial was conducted, including 270 pediatric patients (age, 5-15 years) who presented to the ED with isolated, acute, clinically nondeformed distal forearm fractures.
• The participants were randomly assigned to receive initial point-of-care ultrasonography (n = 135) or radiography (n = 135) in the ED.
• The primary outcome was the physical function of the affected arm at 4 weeks evaluated using the Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) tool.

TAKEAWAY:

• At 4 weeks, mean PROMIS scores were 36.4 and 36.3 points in ultrasonography and radiography groups, respectively (mean difference, 0.1 point; 95% confidence interval, − 1.3 to 1.4), indicating noninferiority of ultrasonography over radiography.
• Ultrasonography and radiography groups showed similar efficacy in terms of PROMIS scores at 1 week (MD, 0.7 points; 95% CI, − 1.4 to 2.8) and 8 weeks (MD, 0.1 points; 95% CI, − 0.5 to 0.7).
• Participants in the ultrasonography group had a shorter length of stay in the ED (median difference, 15 minutes; 95% CI, 1-29) and a shorter treatment time (median difference, 28 minutes; 95% CI, 17-40) than those in the radiography group.
• No important fractures were missed with ultrasonography, and no significant difference was observed in the frequency of adverse events or unplanned returns to the ED between the two groups.

IN PRACTICE:

Noting the benefit-risk profile of an ultrasound-first approach in an ED setting, the lead author, Peter J. Snelling, MB, BS, MPH&TM, from Menzies Health Institute Queensland, Gold Coast, Australia, said: “It is highly unlikely that any important fractures would be missed using the protocol that we trained clinicians. The risk is low and the benefit is moderate, such as reducing length of stay and increased level of patient satisfaction.”

He further added that, “with an ultrasound-first approach, clinicians can scan the patient at time of review and may even be able to discharge them immediately (two-thirds of instances in our NEJM trial). This places the patient at the center of care being provided.”
 

SOURCE: 

Authors from the BUCKLED Trial Group published their study in the New England Journal of Medicine.

LIMITATIONS:

PROMIS scores may have been affected by variations in subsequent therapeutic interventions rather than the initial diagnostic method. PROMIS tool was not validated in children younger than 5 years of age.

DISCLOSURES:

The study was funded by the Emergency Medicine Foundation and others. The authors have declared no relevant interests to disclose.

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

TOPLINE:

Ultrasonography may serve as an alternative to radiography for diagnosing pediatric forearm fractures, thus reducing the number of children undergoing radiography at initial emergency department presentation, as well as their waiting time in ED.

METHODOLOGY:

• After the World Health Organization reported a lack of access to any diagnostic imaging in approximately two-thirds of the world population in 2010, ultrasonography has gained popularity in low- and middle-income countries.
• The initial use of ultrasonography is in accordance with the principle of maintaining radiation levels as low as reasonably achievable.
• The BUCKLED trial was conducted, including 270 pediatric patients (age, 5-15 years) who presented to the ED with isolated, acute, clinically nondeformed distal forearm fractures.
• The participants were randomly assigned to receive initial point-of-care ultrasonography (n = 135) or radiography (n = 135) in the ED.
• The primary outcome was the physical function of the affected arm at 4 weeks evaluated using the Pediatric Upper Extremity Short Patient-Reported Outcomes Measurement Information System (PROMIS) tool.

TAKEAWAY:

• At 4 weeks, mean PROMIS scores were 36.4 and 36.3 points in ultrasonography and radiography groups, respectively (mean difference, 0.1 point; 95% confidence interval, − 1.3 to 1.4), indicating noninferiority of ultrasonography over radiography.
• Ultrasonography and radiography groups showed similar efficacy in terms of PROMIS scores at 1 week (MD, 0.7 points; 95% CI, − 1.4 to 2.8) and 8 weeks (MD, 0.1 points; 95% CI, − 0.5 to 0.7).
• Participants in the ultrasonography group had a shorter length of stay in the ED (median difference, 15 minutes; 95% CI, 1-29) and a shorter treatment time (median difference, 28 minutes; 95% CI, 17-40) than those in the radiography group.
• No important fractures were missed with ultrasonography, and no significant difference was observed in the frequency of adverse events or unplanned returns to the ED between the two groups.

IN PRACTICE:

Noting the benefit-risk profile of an ultrasound-first approach in an ED setting, the lead author, Peter J. Snelling, MB, BS, MPH&TM, from Menzies Health Institute Queensland, Gold Coast, Australia, said: “It is highly unlikely that any important fractures would be missed using the protocol that we trained clinicians. The risk is low and the benefit is moderate, such as reducing length of stay and increased level of patient satisfaction.”

He further added that, “with an ultrasound-first approach, clinicians can scan the patient at time of review and may even be able to discharge them immediately (two-thirds of instances in our NEJM trial). This places the patient at the center of care being provided.”
 

SOURCE: 

Authors from the BUCKLED Trial Group published their study in the New England Journal of Medicine.

LIMITATIONS:

PROMIS scores may have been affected by variations in subsequent therapeutic interventions rather than the initial diagnostic method. PROMIS tool was not validated in children younger than 5 years of age.

DISCLOSURES:

The study was funded by the Emergency Medicine Foundation and others. The authors have declared no relevant interests to disclose.

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

TOPLINE:

A minority of Black dermatologists hold leadership positions in academia.

METHODOLOGY:

• To assess the prevalence of Black dermatologists in academic dermatology programs, researchers obtained an inventory of all 142 U.S.-accredited dermatology residency programs from the Accreditation Council for Graduate Medical Education.
• The researchers drew from institutional websites, the Black Derm Directory (an online repository of Black dermatologists), and other sources to identify full- and part-time Black faculty.
• Variables of interest for each Black dermatologist included gender, institution, department title, academic and nonacademic leadership roles, publication number, National Institutes of Health grant funding, degrees, subspecialties, medical school attended, place of residency, and fellowship training.
• The researchers used Pearson’s chi-squared testing to calculate associations.

TAKEAWAY:

• Of the 86 Black faculty identified, 81.4% were female; most (42.4%) were in the southern United States, followed by the Midwest (23.5%); and 83% held full-time positions.
• Slightly more than one-quarter (26.7%) of the Black faculty attended a top 10 medical school, 16.3% graduated from a historically Black college and university medical school, and 43.5% of those with 25 or more research publications had attended a top 10 medical school.
• Only three dermatology department chairs were Black, and all were female. In addition, more than half of Black faculty (59.2%) were assistant professors, 37.7% held leadership positions at their institutions, and 32.6% held outside leadership roles in dermatology (such as leadership titles at professional dermatology organizations or editorial positions at a journal).

IN PRACTICE:

“Greater efforts are needed to recruit Black dermatology graduates into academic faculty positions,” and “faculty development programs offered by academic institutions and dermatologic associations ... should continue to be expanded,” the authors conclude.

SOURCE:

Corresponding author Nada Elbuluk, MD, MSc, director of the skin of color and pigmentary disorders program and the diversity and inclusion program in the department of dermatology at the University of Southern California, Los Angeles, led the research. The study was published in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The process for identifying Black faculty and insufficient or outdated information on department websites were limitations.

DISCLOSURES:

Dr. Elbuluk disclosed that she has served as a consultant for Avita, Scientis, Incyte, VisualDx, La Roche Posay, Beiersdorf, and Unilever. She has served on advisory boards for Allergan, Eli Lilly, Galderma, Incyte, Pfizer, Janssen, La Roche Posay, L’Oreal, McGraw Hill, and Dior. She has been a speaker for La Roche Posay, Scientis, Medscape, Beiersdorf, and Dior, and has served as investigator for Avita. Another author is an investigator and speaker for Castle Biosciences.

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

TOPLINE:

A minority of Black dermatologists hold leadership positions in academia.

METHODOLOGY:

• To assess the prevalence of Black dermatologists in academic dermatology programs, researchers obtained an inventory of all 142 U.S.-accredited dermatology residency programs from the Accreditation Council for Graduate Medical Education.
• The researchers drew from institutional websites, the Black Derm Directory (an online repository of Black dermatologists), and other sources to identify full- and part-time Black faculty.
• Variables of interest for each Black dermatologist included gender, institution, department title, academic and nonacademic leadership roles, publication number, National Institutes of Health grant funding, degrees, subspecialties, medical school attended, place of residency, and fellowship training.
• The researchers used Pearson’s chi-squared testing to calculate associations.

TAKEAWAY:

• Of the 86 Black faculty identified, 81.4% were female; most (42.4%) were in the southern United States, followed by the Midwest (23.5%); and 83% held full-time positions.
• Slightly more than one-quarter (26.7%) of the Black faculty attended a top 10 medical school, 16.3% graduated from a historically Black college and university medical school, and 43.5% of those with 25 or more research publications had attended a top 10 medical school.
• Only three dermatology department chairs were Black, and all were female. In addition, more than half of Black faculty (59.2%) were assistant professors, 37.7% held leadership positions at their institutions, and 32.6% held outside leadership roles in dermatology (such as leadership titles at professional dermatology organizations or editorial positions at a journal).

IN PRACTICE:

“Greater efforts are needed to recruit Black dermatology graduates into academic faculty positions,” and “faculty development programs offered by academic institutions and dermatologic associations ... should continue to be expanded,” the authors conclude.

SOURCE:

Corresponding author Nada Elbuluk, MD, MSc, director of the skin of color and pigmentary disorders program and the diversity and inclusion program in the department of dermatology at the University of Southern California, Los Angeles, led the research. The study was published in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The process for identifying Black faculty and insufficient or outdated information on department websites were limitations.

DISCLOSURES:

Dr. Elbuluk disclosed that she has served as a consultant for Avita, Scientis, Incyte, VisualDx, La Roche Posay, Beiersdorf, and Unilever. She has served on advisory boards for Allergan, Eli Lilly, Galderma, Incyte, Pfizer, Janssen, La Roche Posay, L’Oreal, McGraw Hill, and Dior. She has been a speaker for La Roche Posay, Scientis, Medscape, Beiersdorf, and Dior, and has served as investigator for Avita. Another author is an investigator and speaker for Castle Biosciences.

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

TOPLINE:

A minority of Black dermatologists hold leadership positions in academia.

METHODOLOGY:

• To assess the prevalence of Black dermatologists in academic dermatology programs, researchers obtained an inventory of all 142 U.S.-accredited dermatology residency programs from the Accreditation Council for Graduate Medical Education.
• The researchers drew from institutional websites, the Black Derm Directory (an online repository of Black dermatologists), and other sources to identify full- and part-time Black faculty.
• Variables of interest for each Black dermatologist included gender, institution, department title, academic and nonacademic leadership roles, publication number, National Institutes of Health grant funding, degrees, subspecialties, medical school attended, place of residency, and fellowship training.
• The researchers used Pearson’s chi-squared testing to calculate associations.

TAKEAWAY:

• Of the 86 Black faculty identified, 81.4% were female; most (42.4%) were in the southern United States, followed by the Midwest (23.5%); and 83% held full-time positions.
• Slightly more than one-quarter (26.7%) of the Black faculty attended a top 10 medical school, 16.3% graduated from a historically Black college and university medical school, and 43.5% of those with 25 or more research publications had attended a top 10 medical school.
• Only three dermatology department chairs were Black, and all were female. In addition, more than half of Black faculty (59.2%) were assistant professors, 37.7% held leadership positions at their institutions, and 32.6% held outside leadership roles in dermatology (such as leadership titles at professional dermatology organizations or editorial positions at a journal).

IN PRACTICE:

“Greater efforts are needed to recruit Black dermatology graduates into academic faculty positions,” and “faculty development programs offered by academic institutions and dermatologic associations ... should continue to be expanded,” the authors conclude.

SOURCE:

Corresponding author Nada Elbuluk, MD, MSc, director of the skin of color and pigmentary disorders program and the diversity and inclusion program in the department of dermatology at the University of Southern California, Los Angeles, led the research. The study was published in the Journal of the American Academy of Dermatology.

LIMITATIONS:

The process for identifying Black faculty and insufficient or outdated information on department websites were limitations.

DISCLOSURES:

Dr. Elbuluk disclosed that she has served as a consultant for Avita, Scientis, Incyte, VisualDx, La Roche Posay, Beiersdorf, and Unilever. She has served on advisory boards for Allergan, Eli Lilly, Galderma, Incyte, Pfizer, Janssen, La Roche Posay, L’Oreal, McGraw Hill, and Dior. She has been a speaker for La Roche Posay, Scientis, Medscape, Beiersdorf, and Dior, and has served as investigator for Avita. Another author is an investigator and speaker for Castle Biosciences.

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

TOPLINE:

Nearly three-quarters of adults with alopecia areata (AA) were not receiving treatment 1 year after diagnosis, according to a retrospective cohort study using data from more than 45,000 individuals.

METHODOLOGY:

• The study population included 45,483 adults aged 18 years and older with new diagnoses of AA between Oct. 15, 2015, and Feb. 28, 2020. Data were from a large U.S. health care database that included medical and pharmacy claims.
• The mean age of the participants was 43.8 years, and 65.7% were female.
• The researchers measured variables that might relate to AA and its treatment patterns within 1 year of starting the study and during the first year of the study, with data collected at 1, 42, 84, and 365 days after study entry.

TAKEAWAYS:

• During the first year after diagnosis, 66.4% of patients received at least one treatment for AA at one or more time points.
• At 1 year, 71.8% of patients were not receiving any active treatment for AA.
• Among those who received treatment, intralesional injections were the most often prescribed therapy (41.8% of patients), followed by topical corticosteroids (40.9%), intramuscular corticosteroids (38.1%), and oral corticosteroids (20.6%).
• Patients diagnosed with either alopecia totalis or alopecia universalis were significantly less likely to receive intralesional steroids and significantly more likely to receive topical corticosteroids than those without these diagnoses (11.1% vs. 44.1% and 25.4% vs. 42.1, respectively).

IN PRACTICE:

The results highlight the need to determine why so many alopecia patients with AA were no longer on treatment after 1 year, although treatment trends may change with the emergence of new therapies, such as JAK inhibitors and others, according to the authors.

SOURCE:

The lead author of the study was Hemin Lee, MD, MPH, Brigham and Women’s Hospital, Boston. The study was published online in JAMA Dermatology.

LIMITATIONS:

The use of insurance claims data did not allow analysis of over-the-counter medications and treatments, and the lack of a single ICD-10 code for defining AA could have resulted in misclassification of outcomes.

DISCLOSURES:

The study received no outside funding, and Dr. Lee had no disclosures. One author had disclosures that included receiving personal fees from Pfizer and Concert outside of the submitted study and participating in alopecia-related trials with Lilly, Concert, Aclaris, and Incyte. Another author’s disclosures included receiving personal fees from companies that included Pfizer, Concert, Lilly, and AbbVie. No other disclosures were reported.

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

TOPLINE:

Nearly three-quarters of adults with alopecia areata (AA) were not receiving treatment 1 year after diagnosis, according to a retrospective cohort study using data from more than 45,000 individuals.

METHODOLOGY:

• The study population included 45,483 adults aged 18 years and older with new diagnoses of AA between Oct. 15, 2015, and Feb. 28, 2020. Data were from a large U.S. health care database that included medical and pharmacy claims.
• The mean age of the participants was 43.8 years, and 65.7% were female.
• The researchers measured variables that might relate to AA and its treatment patterns within 1 year of starting the study and during the first year of the study, with data collected at 1, 42, 84, and 365 days after study entry.

TAKEAWAYS:

• During the first year after diagnosis, 66.4% of patients received at least one treatment for AA at one or more time points.
• At 1 year, 71.8% of patients were not receiving any active treatment for AA.
• Among those who received treatment, intralesional injections were the most often prescribed therapy (41.8% of patients), followed by topical corticosteroids (40.9%), intramuscular corticosteroids (38.1%), and oral corticosteroids (20.6%).
• Patients diagnosed with either alopecia totalis or alopecia universalis were significantly less likely to receive intralesional steroids and significantly more likely to receive topical corticosteroids than those without these diagnoses (11.1% vs. 44.1% and 25.4% vs. 42.1, respectively).

IN PRACTICE:

The results highlight the need to determine why so many alopecia patients with AA were no longer on treatment after 1 year, although treatment trends may change with the emergence of new therapies, such as JAK inhibitors and others, according to the authors.

SOURCE:

The lead author of the study was Hemin Lee, MD, MPH, Brigham and Women’s Hospital, Boston. The study was published online in JAMA Dermatology.

LIMITATIONS:

The use of insurance claims data did not allow analysis of over-the-counter medications and treatments, and the lack of a single ICD-10 code for defining AA could have resulted in misclassification of outcomes.

DISCLOSURES:

The study received no outside funding, and Dr. Lee had no disclosures. One author had disclosures that included receiving personal fees from Pfizer and Concert outside of the submitted study and participating in alopecia-related trials with Lilly, Concert, Aclaris, and Incyte. Another author’s disclosures included receiving personal fees from companies that included Pfizer, Concert, Lilly, and AbbVie. No other disclosures were reported.

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

TOPLINE:

Nearly three-quarters of adults with alopecia areata (AA) were not receiving treatment 1 year after diagnosis, according to a retrospective cohort study using data from more than 45,000 individuals.

METHODOLOGY:

• The study population included 45,483 adults aged 18 years and older with new diagnoses of AA between Oct. 15, 2015, and Feb. 28, 2020. Data were from a large U.S. health care database that included medical and pharmacy claims.
• The mean age of the participants was 43.8 years, and 65.7% were female.
• The researchers measured variables that might relate to AA and its treatment patterns within 1 year of starting the study and during the first year of the study, with data collected at 1, 42, 84, and 365 days after study entry.

TAKEAWAYS:

• During the first year after diagnosis, 66.4% of patients received at least one treatment for AA at one or more time points.
• At 1 year, 71.8% of patients were not receiving any active treatment for AA.
• Among those who received treatment, intralesional injections were the most often prescribed therapy (41.8% of patients), followed by topical corticosteroids (40.9%), intramuscular corticosteroids (38.1%), and oral corticosteroids (20.6%).
• Patients diagnosed with either alopecia totalis or alopecia universalis were significantly less likely to receive intralesional steroids and significantly more likely to receive topical corticosteroids than those without these diagnoses (11.1% vs. 44.1% and 25.4% vs. 42.1, respectively).

IN PRACTICE:

The results highlight the need to determine why so many alopecia patients with AA were no longer on treatment after 1 year, although treatment trends may change with the emergence of new therapies, such as JAK inhibitors and others, according to the authors.

SOURCE:

The lead author of the study was Hemin Lee, MD, MPH, Brigham and Women’s Hospital, Boston. The study was published online in JAMA Dermatology.

LIMITATIONS:

The use of insurance claims data did not allow analysis of over-the-counter medications and treatments, and the lack of a single ICD-10 code for defining AA could have resulted in misclassification of outcomes.

DISCLOSURES:

The study received no outside funding, and Dr. Lee had no disclosures. One author had disclosures that included receiving personal fees from Pfizer and Concert outside of the submitted study and participating in alopecia-related trials with Lilly, Concert, Aclaris, and Incyte. Another author’s disclosures included receiving personal fees from companies that included Pfizer, Concert, Lilly, and AbbVie. No other disclosures were reported.

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

TOPLINE:

Patients older than age 70 years have a 23% lower risk of a first major vascular events with each 1 mmol/L lowering of low-density lipoprotein (LDL) cholesterol, which is similar to the benefit seen among younger patients in primary prevention, new research shows.

METHODOLOGY:

• Using various cross-linked Danish registries, researchers analyzed 65,190 participants aged 50 years and older (49,155 aged 50-69 and 16,035 aged 70+) without a history of atherosclerotic cardiovascular disease (ASCVD) who initiated new lipid-lowering treatment and had a baseline LDL cholesterol measurement and a subsequent measurement within a year.
• The primary outcome was hospitalization for a major vascular event, defined as a composite of acute coronary syndrome, nonhemorrhagic stroke, and coronary revascularization. Secondary outcomes included individual cardiovascular components of the primary outcome and all-cause mortality.

TAKEAWAY:

• During a median follow-up of 2.5 years, 626 older (70 years and over) and 1,123 younger (aged 50-69) participants had a major vascular event, with crude incidence rates of 13.4 and 7.1 per 1000 person-years, respectively.
• After adjustment for potential confounders, each 1-mmol/L reduction in LDL cholesterol in people aged 70 and older was associated with a significant 23% lower risk for major vascular events (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.71-0.83), similar to results for those younger than 70 (HR, 0.76; 95% CI, 0.71-0.80; P value for the difference between the age groups, 0.79).
• Results across all cardiovascular secondary analyses supported the main findings, and there was no significant difference between older and younger participants across all subgroup analyses, including using 75 years as the age cutoff.
• There was no association with all-cause mortality for either the older (HR, 1.03; 95% CI, 0.98-1.09) or younger (HR, 1.00; 95% CI, 0.95-1.06) groups.

IN PRACTICE:

“Our results, based on a substantial sample size representative of a contemporary general population, may contribute to informing future guideline recommendations,” and to discussions with older patients about the benefits of LDL lowering therapy, the authors wrote. They stressed that any potential benefits should be balanced against potential harms in this population, as these individuals may have comorbidities and may be taking multiple medications.

In an accompanying editorial, Safi U. Khan, MD, from the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, said the study “contributes valuable insights regarding the effects of LDL-C-lowering therapy, especially as the burgeoning aging population faces escalating burden of ASCVD,” and added future research “should focus on corroborating these findings and addressing the safety of lipid-lowering treatments in older individuals.”
 

SOURCE:

The study was conducted by Niklas Worm Andersson, MD, department of epidemiology research, Statens Serum Institut, Copenhagen, and colleagues. It was published online Journal of the American College of Cardiology.

LIMITATIONS:

The results may not apply to individuals without LDL monitoring when receiving lipid-lowering treatment. Outcomes relied on the validity of recorded diagnostic codes in the registries, and medical record review of cases was not done. Residual confounding can’t be ruled out, in part because data on potentially important risk factors such as smoking, blood pressure, and body mass index weren’t available. The results may not generalize to clinical scenarios or subpopulations not directly studied.

DISCLOSURES:

Dr. Andersson has no relevant conflicts of interest. Author Tine Lovsø Dohlmann, PhD, was employed by Statens Serum Institut during the study, but has been employed by Novo Nordisk since January 2023. All other study authors and the editorialist Dr. Khan have no relevant conflicts of interest.

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

TOPLINE:

Patients older than age 70 years have a 23% lower risk of a first major vascular events with each 1 mmol/L lowering of low-density lipoprotein (LDL) cholesterol, which is similar to the benefit seen among younger patients in primary prevention, new research shows.

METHODOLOGY:

• Using various cross-linked Danish registries, researchers analyzed 65,190 participants aged 50 years and older (49,155 aged 50-69 and 16,035 aged 70+) without a history of atherosclerotic cardiovascular disease (ASCVD) who initiated new lipid-lowering treatment and had a baseline LDL cholesterol measurement and a subsequent measurement within a year.
• The primary outcome was hospitalization for a major vascular event, defined as a composite of acute coronary syndrome, nonhemorrhagic stroke, and coronary revascularization. Secondary outcomes included individual cardiovascular components of the primary outcome and all-cause mortality.

TAKEAWAY:

• During a median follow-up of 2.5 years, 626 older (70 years and over) and 1,123 younger (aged 50-69) participants had a major vascular event, with crude incidence rates of 13.4 and 7.1 per 1000 person-years, respectively.
• After adjustment for potential confounders, each 1-mmol/L reduction in LDL cholesterol in people aged 70 and older was associated with a significant 23% lower risk for major vascular events (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.71-0.83), similar to results for those younger than 70 (HR, 0.76; 95% CI, 0.71-0.80; P value for the difference between the age groups, 0.79).
• Results across all cardiovascular secondary analyses supported the main findings, and there was no significant difference between older and younger participants across all subgroup analyses, including using 75 years as the age cutoff.
• There was no association with all-cause mortality for either the older (HR, 1.03; 95% CI, 0.98-1.09) or younger (HR, 1.00; 95% CI, 0.95-1.06) groups.

IN PRACTICE:

“Our results, based on a substantial sample size representative of a contemporary general population, may contribute to informing future guideline recommendations,” and to discussions with older patients about the benefits of LDL lowering therapy, the authors wrote. They stressed that any potential benefits should be balanced against potential harms in this population, as these individuals may have comorbidities and may be taking multiple medications.

In an accompanying editorial, Safi U. Khan, MD, from the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, said the study “contributes valuable insights regarding the effects of LDL-C-lowering therapy, especially as the burgeoning aging population faces escalating burden of ASCVD,” and added future research “should focus on corroborating these findings and addressing the safety of lipid-lowering treatments in older individuals.”
 

SOURCE:

The study was conducted by Niklas Worm Andersson, MD, department of epidemiology research, Statens Serum Institut, Copenhagen, and colleagues. It was published online Journal of the American College of Cardiology.

LIMITATIONS:

The results may not apply to individuals without LDL monitoring when receiving lipid-lowering treatment. Outcomes relied on the validity of recorded diagnostic codes in the registries, and medical record review of cases was not done. Residual confounding can’t be ruled out, in part because data on potentially important risk factors such as smoking, blood pressure, and body mass index weren’t available. The results may not generalize to clinical scenarios or subpopulations not directly studied.

DISCLOSURES:

Dr. Andersson has no relevant conflicts of interest. Author Tine Lovsø Dohlmann, PhD, was employed by Statens Serum Institut during the study, but has been employed by Novo Nordisk since January 2023. All other study authors and the editorialist Dr. Khan have no relevant conflicts of interest.

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

TOPLINE:

Patients older than age 70 years have a 23% lower risk of a first major vascular events with each 1 mmol/L lowering of low-density lipoprotein (LDL) cholesterol, which is similar to the benefit seen among younger patients in primary prevention, new research shows.

METHODOLOGY:

• Using various cross-linked Danish registries, researchers analyzed 65,190 participants aged 50 years and older (49,155 aged 50-69 and 16,035 aged 70+) without a history of atherosclerotic cardiovascular disease (ASCVD) who initiated new lipid-lowering treatment and had a baseline LDL cholesterol measurement and a subsequent measurement within a year.
• The primary outcome was hospitalization for a major vascular event, defined as a composite of acute coronary syndrome, nonhemorrhagic stroke, and coronary revascularization. Secondary outcomes included individual cardiovascular components of the primary outcome and all-cause mortality.

TAKEAWAY:

• During a median follow-up of 2.5 years, 626 older (70 years and over) and 1,123 younger (aged 50-69) participants had a major vascular event, with crude incidence rates of 13.4 and 7.1 per 1000 person-years, respectively.
• After adjustment for potential confounders, each 1-mmol/L reduction in LDL cholesterol in people aged 70 and older was associated with a significant 23% lower risk for major vascular events (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.71-0.83), similar to results for those younger than 70 (HR, 0.76; 95% CI, 0.71-0.80; P value for the difference between the age groups, 0.79).
• Results across all cardiovascular secondary analyses supported the main findings, and there was no significant difference between older and younger participants across all subgroup analyses, including using 75 years as the age cutoff.
• There was no association with all-cause mortality for either the older (HR, 1.03; 95% CI, 0.98-1.09) or younger (HR, 1.00; 95% CI, 0.95-1.06) groups.

IN PRACTICE:

“Our results, based on a substantial sample size representative of a contemporary general population, may contribute to informing future guideline recommendations,” and to discussions with older patients about the benefits of LDL lowering therapy, the authors wrote. They stressed that any potential benefits should be balanced against potential harms in this population, as these individuals may have comorbidities and may be taking multiple medications.

In an accompanying editorial, Safi U. Khan, MD, from the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, said the study “contributes valuable insights regarding the effects of LDL-C-lowering therapy, especially as the burgeoning aging population faces escalating burden of ASCVD,” and added future research “should focus on corroborating these findings and addressing the safety of lipid-lowering treatments in older individuals.”
 

SOURCE:

The study was conducted by Niklas Worm Andersson, MD, department of epidemiology research, Statens Serum Institut, Copenhagen, and colleagues. It was published online Journal of the American College of Cardiology.

LIMITATIONS:

The results may not apply to individuals without LDL monitoring when receiving lipid-lowering treatment. Outcomes relied on the validity of recorded diagnostic codes in the registries, and medical record review of cases was not done. Residual confounding can’t be ruled out, in part because data on potentially important risk factors such as smoking, blood pressure, and body mass index weren’t available. The results may not generalize to clinical scenarios or subpopulations not directly studied.

DISCLOSURES:

Dr. Andersson has no relevant conflicts of interest. Author Tine Lovsø Dohlmann, PhD, was employed by Statens Serum Institut during the study, but has been employed by Novo Nordisk since January 2023. All other study authors and the editorialist Dr. Khan have no relevant conflicts of interest.

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

Sentinel lymph node biopsy (SLNB) is the standard of care for axillary node staging in early breast cancer, but previous studies have shown that removal of axillary lymph nodes has no therapeutic effect.

The finding raises a question: Is SLNB even necessary when preoperative axillary imaging is negative?

A new randomized trial addresses the question and brings much “welcome clarity” to the issue, Seema Khan, MD, a surgical oncologist and breast cancer researcher at Northwestern University, Chicago, said in an editorial to the trial, both of which were published in JAMA Oncology.

In short, European investigators found that it’s safe to skip SLNBs in women with breast cancers no larger than 2 cm if preoperative ultrasounds of the axilla show no evidence of nodal disease.

At a median of follow-up of 5.7 years, distant disease-free survival and other outcomes were essentially equivalent between 708 women randomized to SLNB followed by full axillary dissection if nodes are positive and 697 other women randomized to observation without SLNB.

Adjuvant therapies were not significantly different between the two groups largely because adjuvant decisions were driven by tumor characteristics, not axillary studies.

The results support “the argument that sentinel node positivity is not, in and of itself, a critical parameter that determines therapeutic plans and outcomes in patients with stage I breast cancer. This is a major accomplishment of the SOUND [Sentinel Node vs. Observation After Axillary Ultra-Sound] trial, which will be strengthened when longer-term data become available” at 10-year follow up, Dr. Khan said.

Investigators led by Oreste Davide Gentilini, MD, a breast cancer surgeon at San Raffaele Scientific and Research Hospital, Milan, estimated that, of the 2.3 million breast cancers diagnosed globally each year, the study suggests “that approximately 500,000 patients might be able to take advantage of the total omission of axillary surgery,” sparing women lymphedema and other serious side effects and saving health care systems substantial dollars.
 

A case-by-case decision

The study included women of all ages, with a median age of 60 years.

Subjects had a single tumor 0.8-1.5 cm across with negative preoperative axillary ultrasonography. Almost 90% had estrogen receptor ERBB2 (formerly HER2) positive tumors. Almost all of the subjects had radiotherapy, and about 20% of women in each arm also had chemotherapy.

The trial was conducted in 18 sites, most in Italy with other sites in Switzerland, Spain, and Chile.

Overall, 13.7% of women in the SLNB group turned out to have positive axillary nodes, with 0.6% having four or more positive nodes.

However, it didn’t seem to make a difference in the overall study results.

Five-year distant disease-free survival was 97.7% in the SLNB group and 98% in the observation arm (P for noninferiority = .02).

Secondary outcomes were also essentially identical, including local/regional relapse (1.7% with SLNB versus 1.6% without); distant metastases (1.8% vs. 2%), and death from breast cancer (1% vs. 0.6%). The cumulative incidence of axillary lymph node recurrences in the observation arm was just 0.4%.

“These findings suggest that patients with BC of a diameter equal to or smaller than 2 cm and a negative result on preoperative axillary lymph node ultrasonography can be safely spared any axillary surgery whenever the lack of pathological information does not affect the postoperative treatment plan,” Dr. Gentilini and associates concluded.

The team cautioned that decision to forgo SLNB must be made on a case-by-case basis in a multidisciplinary setting because there are still situations where nodal pathology is relevant, for instance when deciding to add chemotherapy to endocrine treatments in premenopausal women with endocrine-responsive disease.

Only about 20% of the subjects were under 50 years old and the team didn’t break down their results by age, which makes it difficult to apply their results to the situation.

The work was funded by the European Institute of Oncology. Dr. Khan didn’t have any disclosures. Dr. Gentilini reported personal fees from AstraZeneca, Bayer, BD, Eli Lilly, and MSD. Two other investigators also reported personal fees from those and/or other companies.

Sentinel lymph node biopsy (SLNB) is the standard of care for axillary node staging in early breast cancer, but previous studies have shown that removal of axillary lymph nodes has no therapeutic effect.

The finding raises a question: Is SLNB even necessary when preoperative axillary imaging is negative?

A new randomized trial addresses the question and brings much “welcome clarity” to the issue, Seema Khan, MD, a surgical oncologist and breast cancer researcher at Northwestern University, Chicago, said in an editorial to the trial, both of which were published in JAMA Oncology.

In short, European investigators found that it’s safe to skip SLNBs in women with breast cancers no larger than 2 cm if preoperative ultrasounds of the axilla show no evidence of nodal disease.

At a median of follow-up of 5.7 years, distant disease-free survival and other outcomes were essentially equivalent between 708 women randomized to SLNB followed by full axillary dissection if nodes are positive and 697 other women randomized to observation without SLNB.

Adjuvant therapies were not significantly different between the two groups largely because adjuvant decisions were driven by tumor characteristics, not axillary studies.

The results support “the argument that sentinel node positivity is not, in and of itself, a critical parameter that determines therapeutic plans and outcomes in patients with stage I breast cancer. This is a major accomplishment of the SOUND [Sentinel Node vs. Observation After Axillary Ultra-Sound] trial, which will be strengthened when longer-term data become available” at 10-year follow up, Dr. Khan said.

Investigators led by Oreste Davide Gentilini, MD, a breast cancer surgeon at San Raffaele Scientific and Research Hospital, Milan, estimated that, of the 2.3 million breast cancers diagnosed globally each year, the study suggests “that approximately 500,000 patients might be able to take advantage of the total omission of axillary surgery,” sparing women lymphedema and other serious side effects and saving health care systems substantial dollars.
 

A case-by-case decision

The study included women of all ages, with a median age of 60 years.

Subjects had a single tumor 0.8-1.5 cm across with negative preoperative axillary ultrasonography. Almost 90% had estrogen receptor ERBB2 (formerly HER2) positive tumors. Almost all of the subjects had radiotherapy, and about 20% of women in each arm also had chemotherapy.

The trial was conducted in 18 sites, most in Italy with other sites in Switzerland, Spain, and Chile.

Overall, 13.7% of women in the SLNB group turned out to have positive axillary nodes, with 0.6% having four or more positive nodes.

However, it didn’t seem to make a difference in the overall study results.

Five-year distant disease-free survival was 97.7% in the SLNB group and 98% in the observation arm (P for noninferiority = .02).

Secondary outcomes were also essentially identical, including local/regional relapse (1.7% with SLNB versus 1.6% without); distant metastases (1.8% vs. 2%), and death from breast cancer (1% vs. 0.6%). The cumulative incidence of axillary lymph node recurrences in the observation arm was just 0.4%.

“These findings suggest that patients with BC of a diameter equal to or smaller than 2 cm and a negative result on preoperative axillary lymph node ultrasonography can be safely spared any axillary surgery whenever the lack of pathological information does not affect the postoperative treatment plan,” Dr. Gentilini and associates concluded.

The team cautioned that decision to forgo SLNB must be made on a case-by-case basis in a multidisciplinary setting because there are still situations where nodal pathology is relevant, for instance when deciding to add chemotherapy to endocrine treatments in premenopausal women with endocrine-responsive disease.

Only about 20% of the subjects were under 50 years old and the team didn’t break down their results by age, which makes it difficult to apply their results to the situation.

The work was funded by the European Institute of Oncology. Dr. Khan didn’t have any disclosures. Dr. Gentilini reported personal fees from AstraZeneca, Bayer, BD, Eli Lilly, and MSD. Two other investigators also reported personal fees from those and/or other companies.

Sentinel lymph node biopsy (SLNB) is the standard of care for axillary node staging in early breast cancer, but previous studies have shown that removal of axillary lymph nodes has no therapeutic effect.

The finding raises a question: Is SLNB even necessary when preoperative axillary imaging is negative?

A new randomized trial addresses the question and brings much “welcome clarity” to the issue, Seema Khan, MD, a surgical oncologist and breast cancer researcher at Northwestern University, Chicago, said in an editorial to the trial, both of which were published in JAMA Oncology.

In short, European investigators found that it’s safe to skip SLNBs in women with breast cancers no larger than 2 cm if preoperative ultrasounds of the axilla show no evidence of nodal disease.

At a median of follow-up of 5.7 years, distant disease-free survival and other outcomes were essentially equivalent between 708 women randomized to SLNB followed by full axillary dissection if nodes are positive and 697 other women randomized to observation without SLNB.

Adjuvant therapies were not significantly different between the two groups largely because adjuvant decisions were driven by tumor characteristics, not axillary studies.

The results support “the argument that sentinel node positivity is not, in and of itself, a critical parameter that determines therapeutic plans and outcomes in patients with stage I breast cancer. This is a major accomplishment of the SOUND [Sentinel Node vs. Observation After Axillary Ultra-Sound] trial, which will be strengthened when longer-term data become available” at 10-year follow up, Dr. Khan said.

Investigators led by Oreste Davide Gentilini, MD, a breast cancer surgeon at San Raffaele Scientific and Research Hospital, Milan, estimated that, of the 2.3 million breast cancers diagnosed globally each year, the study suggests “that approximately 500,000 patients might be able to take advantage of the total omission of axillary surgery,” sparing women lymphedema and other serious side effects and saving health care systems substantial dollars.
 

A case-by-case decision

The study included women of all ages, with a median age of 60 years.

Subjects had a single tumor 0.8-1.5 cm across with negative preoperative axillary ultrasonography. Almost 90% had estrogen receptor ERBB2 (formerly HER2) positive tumors. Almost all of the subjects had radiotherapy, and about 20% of women in each arm also had chemotherapy.

The trial was conducted in 18 sites, most in Italy with other sites in Switzerland, Spain, and Chile.

Overall, 13.7% of women in the SLNB group turned out to have positive axillary nodes, with 0.6% having four or more positive nodes.

However, it didn’t seem to make a difference in the overall study results.

Five-year distant disease-free survival was 97.7% in the SLNB group and 98% in the observation arm (P for noninferiority = .02).

Secondary outcomes were also essentially identical, including local/regional relapse (1.7% with SLNB versus 1.6% without); distant metastases (1.8% vs. 2%), and death from breast cancer (1% vs. 0.6%). The cumulative incidence of axillary lymph node recurrences in the observation arm was just 0.4%.

“These findings suggest that patients with BC of a diameter equal to or smaller than 2 cm and a negative result on preoperative axillary lymph node ultrasonography can be safely spared any axillary surgery whenever the lack of pathological information does not affect the postoperative treatment plan,” Dr. Gentilini and associates concluded.

The team cautioned that decision to forgo SLNB must be made on a case-by-case basis in a multidisciplinary setting because there are still situations where nodal pathology is relevant, for instance when deciding to add chemotherapy to endocrine treatments in premenopausal women with endocrine-responsive disease.

Only about 20% of the subjects were under 50 years old and the team didn’t break down their results by age, which makes it difficult to apply their results to the situation.

The work was funded by the European Institute of Oncology. Dr. Khan didn’t have any disclosures. Dr. Gentilini reported personal fees from AstraZeneca, Bayer, BD, Eli Lilly, and MSD. Two other investigators also reported personal fees from those and/or other companies.