Neurology

The estimated prevalence of obstructive sleep apnea in North and South America stands at 170 million, results from a novel epidemiologic analysis showed.

“I would not have thought that there are 170 million people in the Americas with clinically important sleep apnea based on our conservative estimates,” the study’s first author, Atul Malhotra, MD, said in an interview in advance of the annual meeting of the Associated Professional Sleep Societies. “Even if we restrict the conversation to moderate to severe sleep apnea, we still see 81 million people afflicted in the Americas alone. We have recently estimated almost 1 billion patients afflicted with OSA worldwide.”

In an effort to estimate the Americas’ prevalence of adult OSA using existing data from epidemiologic studies, Dr. Malhotra, director of sleep medicine at the University of California, San Diego, senior author Adam V. Benjafield, PhD, and their colleagues contacted authors of important analyses on the topic following an exhaustive review of the literature. For countries where no measurement had been made, they used publicly available data to obtain estimates of age, sex, race, and body mass index. Next, they developed an algorithm to match countries without prevalence estimates with countries from which OSA epidemiologic studies exist. “The situation was complicated given the variable age of the existing studies, the differences in technology used (e.g., nasal pressure vs. thermistor), the changing scoring criteria, and other sources of variability,” the researchers wrote in their abstract.

Dr. Malhotra reported on data from 38 of 40 countries in the Americas. Drawing from American Academy of Sleep Medicine 2012 criteria and using what they characterized as a “somewhat conservative” approach, the researchers estimated the prevalence of adult OSA in the Americas to be 170 million, or 37% of the population. In addition, they estimate that 81 million adults, or 18% of the population, suffer from moderate to severe OSA based on an apnea hypopnea index of 15 or more per hour. The countries with the greatest burden of OSA are the United States (54 million), Brazil (49 million), and Colombia (11 million).

“The findings will hopefully help to raise awareness about the disease but also encourage a strategic conversation regarding how best to address this large burden,” Dr. Malhotra said. “We are unaware of prior efforts to estimate OSA prevalence on a large scale.”

He acknowledged certain limitations of the study, including that the methods, equipment, definitions, and criteria used in existing studies in the medial literature varied widely. “We did our best to harmonize these methods across studies but obviously we can’t change the equipment that was used in previous studies,” he said. “Thus, we view our findings as an estimate requiring further efforts to corroborate.”

The research stemmed from an academic/industry partnership with ResMed, which provided a donation the UCSD Sleep Medicine Center. Dr. Malhotra reported having no financial disclosures. Dr. Benjafield is an employee of ResMed, a medical equipment company that specializes in sleep-related breathing devices.

[email protected]

SOURCE: Malhotra A et al. SLEEP 2019, Abstract 0477.

The estimated prevalence of obstructive sleep apnea in North and South America stands at 170 million, results from a novel epidemiologic analysis showed.

“I would not have thought that there are 170 million people in the Americas with clinically important sleep apnea based on our conservative estimates,” the study’s first author, Atul Malhotra, MD, said in an interview in advance of the annual meeting of the Associated Professional Sleep Societies. “Even if we restrict the conversation to moderate to severe sleep apnea, we still see 81 million people afflicted in the Americas alone. We have recently estimated almost 1 billion patients afflicted with OSA worldwide.”

In an effort to estimate the Americas’ prevalence of adult OSA using existing data from epidemiologic studies, Dr. Malhotra, director of sleep medicine at the University of California, San Diego, senior author Adam V. Benjafield, PhD, and their colleagues contacted authors of important analyses on the topic following an exhaustive review of the literature. For countries where no measurement had been made, they used publicly available data to obtain estimates of age, sex, race, and body mass index. Next, they developed an algorithm to match countries without prevalence estimates with countries from which OSA epidemiologic studies exist. “The situation was complicated given the variable age of the existing studies, the differences in technology used (e.g., nasal pressure vs. thermistor), the changing scoring criteria, and other sources of variability,” the researchers wrote in their abstract.

Dr. Malhotra reported on data from 38 of 40 countries in the Americas. Drawing from American Academy of Sleep Medicine 2012 criteria and using what they characterized as a “somewhat conservative” approach, the researchers estimated the prevalence of adult OSA in the Americas to be 170 million, or 37% of the population. In addition, they estimate that 81 million adults, or 18% of the population, suffer from moderate to severe OSA based on an apnea hypopnea index of 15 or more per hour. The countries with the greatest burden of OSA are the United States (54 million), Brazil (49 million), and Colombia (11 million).

“The findings will hopefully help to raise awareness about the disease but also encourage a strategic conversation regarding how best to address this large burden,” Dr. Malhotra said. “We are unaware of prior efforts to estimate OSA prevalence on a large scale.”

He acknowledged certain limitations of the study, including that the methods, equipment, definitions, and criteria used in existing studies in the medial literature varied widely. “We did our best to harmonize these methods across studies but obviously we can’t change the equipment that was used in previous studies,” he said. “Thus, we view our findings as an estimate requiring further efforts to corroborate.”

The research stemmed from an academic/industry partnership with ResMed, which provided a donation the UCSD Sleep Medicine Center. Dr. Malhotra reported having no financial disclosures. Dr. Benjafield is an employee of ResMed, a medical equipment company that specializes in sleep-related breathing devices.

[email protected]

SOURCE: Malhotra A et al. SLEEP 2019, Abstract 0477.

The estimated prevalence of obstructive sleep apnea in North and South America stands at 170 million, results from a novel epidemiologic analysis showed.

“I would not have thought that there are 170 million people in the Americas with clinically important sleep apnea based on our conservative estimates,” the study’s first author, Atul Malhotra, MD, said in an interview in advance of the annual meeting of the Associated Professional Sleep Societies. “Even if we restrict the conversation to moderate to severe sleep apnea, we still see 81 million people afflicted in the Americas alone. We have recently estimated almost 1 billion patients afflicted with OSA worldwide.”

In an effort to estimate the Americas’ prevalence of adult OSA using existing data from epidemiologic studies, Dr. Malhotra, director of sleep medicine at the University of California, San Diego, senior author Adam V. Benjafield, PhD, and their colleagues contacted authors of important analyses on the topic following an exhaustive review of the literature. For countries where no measurement had been made, they used publicly available data to obtain estimates of age, sex, race, and body mass index. Next, they developed an algorithm to match countries without prevalence estimates with countries from which OSA epidemiologic studies exist. “The situation was complicated given the variable age of the existing studies, the differences in technology used (e.g., nasal pressure vs. thermistor), the changing scoring criteria, and other sources of variability,” the researchers wrote in their abstract.

Dr. Malhotra reported on data from 38 of 40 countries in the Americas. Drawing from American Academy of Sleep Medicine 2012 criteria and using what they characterized as a “somewhat conservative” approach, the researchers estimated the prevalence of adult OSA in the Americas to be 170 million, or 37% of the population. In addition, they estimate that 81 million adults, or 18% of the population, suffer from moderate to severe OSA based on an apnea hypopnea index of 15 or more per hour. The countries with the greatest burden of OSA are the United States (54 million), Brazil (49 million), and Colombia (11 million).

“The findings will hopefully help to raise awareness about the disease but also encourage a strategic conversation regarding how best to address this large burden,” Dr. Malhotra said. “We are unaware of prior efforts to estimate OSA prevalence on a large scale.”

He acknowledged certain limitations of the study, including that the methods, equipment, definitions, and criteria used in existing studies in the medial literature varied widely. “We did our best to harmonize these methods across studies but obviously we can’t change the equipment that was used in previous studies,” he said. “Thus, we view our findings as an estimate requiring further efforts to corroborate.”

The research stemmed from an academic/industry partnership with ResMed, which provided a donation the UCSD Sleep Medicine Center. Dr. Malhotra reported having no financial disclosures. Dr. Benjafield is an employee of ResMed, a medical equipment company that specializes in sleep-related breathing devices.

[email protected]

SOURCE: Malhotra A et al. SLEEP 2019, Abstract 0477.

SEATTLE – Finding a balance between maintaining patient privacy and preventing self-harm is crucial in multiple sclerosis patients at risk for suicide.

“There are some situations where concern for a patient’s safety overrides [confidentiality],” Lauren Sankary, an attorney and neuroethics fellow at the Cleveland Clinic, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “I want to empower you to feel confident to break confidentiality when it makes sense based on your professional judgment.”

It’s not clear whether suicide is more common in patients with MS. A systematic review from 2012 found that most studies reviewed documented a higher rate of suicide in patients with MS, compared with the general population (J Psychosom Res. 2012 Dec;73(6):411-7) while a report from 2017 noted that rates of suicidal intent were elevated in MS (Mult Scler. 2017 Jun;23(7):923-927). Conversely, a French study from 2017 found that excess suicide risk may not be true for MS patients (Mult Scler. 2017 May;23(6):864-871).

When considering breaking confidentiality to seek help for a patient, Ms. Sankary said, “the ethical tension is that on the one hand, disclosing protected health information may protect patient safety. But on the other hand, it may threaten the therapeutic relationship. It’s a true ethical dilemma, and part of what’s difficult is figuring out in which situations are we willing to accept these tradeoffs.”

Consider professional ethical guidelines, federal and local laws, and clinical protocols in the decision making process, she advised.

On the federal level, HIPAA allows the breaking of confidentiality when it “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”

The U.S. Department of Health & Human Services’ Office of Civil Rights notes that “HIPAA permits a covered health care provider to notify a patient’s family members of a serious and imminent threat to the health or safety of the patient or others if those family members are in a position to lessen or avert the threat. Thus, to the extent that a provider determines that there is a serious and imminent threat of a patient physically harming self or others, HIPAA would permit the provider to warn the appropriate person(s) of the threat, consistent with his or her professional ethical obligations and State law requirements.”

Confidential information cannot be disclosed to just anyone, however. HIPAA notes that it must be disclosed only to “a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.”

HIPAA doesn’t require medical professionals to report suicide risk, Ms. Sankary said, but some states require certain professionals to do so. And some states require certain professionals to alert parents if children are suicidal.

The laws mainly affect mental health professionals but may extend to physicians and nurses, according to the National Conference of State Legislators. For example, New Jersey professionals in several fields have a duty to warn in certain situations, including the risk of self-harm.

The American Medical Association’s Code of Medical Ethics suggests physicians must “inform the patient when there has been a significant infringement on privacy of which the patient would otherwise not be aware,” Ms. Sankary said.

Ms. Sankary reported no relevant disclosures.

SEATTLE – Finding a balance between maintaining patient privacy and preventing self-harm is crucial in multiple sclerosis patients at risk for suicide.

“There are some situations where concern for a patient’s safety overrides [confidentiality],” Lauren Sankary, an attorney and neuroethics fellow at the Cleveland Clinic, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “I want to empower you to feel confident to break confidentiality when it makes sense based on your professional judgment.”

It’s not clear whether suicide is more common in patients with MS. A systematic review from 2012 found that most studies reviewed documented a higher rate of suicide in patients with MS, compared with the general population (J Psychosom Res. 2012 Dec;73(6):411-7) while a report from 2017 noted that rates of suicidal intent were elevated in MS (Mult Scler. 2017 Jun;23(7):923-927). Conversely, a French study from 2017 found that excess suicide risk may not be true for MS patients (Mult Scler. 2017 May;23(6):864-871).

When considering breaking confidentiality to seek help for a patient, Ms. Sankary said, “the ethical tension is that on the one hand, disclosing protected health information may protect patient safety. But on the other hand, it may threaten the therapeutic relationship. It’s a true ethical dilemma, and part of what’s difficult is figuring out in which situations are we willing to accept these tradeoffs.”

Consider professional ethical guidelines, federal and local laws, and clinical protocols in the decision making process, she advised.

On the federal level, HIPAA allows the breaking of confidentiality when it “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”

The U.S. Department of Health & Human Services’ Office of Civil Rights notes that “HIPAA permits a covered health care provider to notify a patient’s family members of a serious and imminent threat to the health or safety of the patient or others if those family members are in a position to lessen or avert the threat. Thus, to the extent that a provider determines that there is a serious and imminent threat of a patient physically harming self or others, HIPAA would permit the provider to warn the appropriate person(s) of the threat, consistent with his or her professional ethical obligations and State law requirements.”

Confidential information cannot be disclosed to just anyone, however. HIPAA notes that it must be disclosed only to “a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.”

HIPAA doesn’t require medical professionals to report suicide risk, Ms. Sankary said, but some states require certain professionals to do so. And some states require certain professionals to alert parents if children are suicidal.

The laws mainly affect mental health professionals but may extend to physicians and nurses, according to the National Conference of State Legislators. For example, New Jersey professionals in several fields have a duty to warn in certain situations, including the risk of self-harm.

The American Medical Association’s Code of Medical Ethics suggests physicians must “inform the patient when there has been a significant infringement on privacy of which the patient would otherwise not be aware,” Ms. Sankary said.

Ms. Sankary reported no relevant disclosures.

SEATTLE – Finding a balance between maintaining patient privacy and preventing self-harm is crucial in multiple sclerosis patients at risk for suicide.

“There are some situations where concern for a patient’s safety overrides [confidentiality],” Lauren Sankary, an attorney and neuroethics fellow at the Cleveland Clinic, said at the annual meeting of the Consortium of Multiple Sclerosis Centers. “I want to empower you to feel confident to break confidentiality when it makes sense based on your professional judgment.”

It’s not clear whether suicide is more common in patients with MS. A systematic review from 2012 found that most studies reviewed documented a higher rate of suicide in patients with MS, compared with the general population (J Psychosom Res. 2012 Dec;73(6):411-7) while a report from 2017 noted that rates of suicidal intent were elevated in MS (Mult Scler. 2017 Jun;23(7):923-927). Conversely, a French study from 2017 found that excess suicide risk may not be true for MS patients (Mult Scler. 2017 May;23(6):864-871).

When considering breaking confidentiality to seek help for a patient, Ms. Sankary said, “the ethical tension is that on the one hand, disclosing protected health information may protect patient safety. But on the other hand, it may threaten the therapeutic relationship. It’s a true ethical dilemma, and part of what’s difficult is figuring out in which situations are we willing to accept these tradeoffs.”

Consider professional ethical guidelines, federal and local laws, and clinical protocols in the decision making process, she advised.

On the federal level, HIPAA allows the breaking of confidentiality when it “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”

The U.S. Department of Health & Human Services’ Office of Civil Rights notes that “HIPAA permits a covered health care provider to notify a patient’s family members of a serious and imminent threat to the health or safety of the patient or others if those family members are in a position to lessen or avert the threat. Thus, to the extent that a provider determines that there is a serious and imminent threat of a patient physically harming self or others, HIPAA would permit the provider to warn the appropriate person(s) of the threat, consistent with his or her professional ethical obligations and State law requirements.”

Confidential information cannot be disclosed to just anyone, however. HIPAA notes that it must be disclosed only to “a person or persons reasonably able to prevent or lessen the threat, including the target of the threat.”

HIPAA doesn’t require medical professionals to report suicide risk, Ms. Sankary said, but some states require certain professionals to do so. And some states require certain professionals to alert parents if children are suicidal.

The laws mainly affect mental health professionals but may extend to physicians and nurses, according to the National Conference of State Legislators. For example, New Jersey professionals in several fields have a duty to warn in certain situations, including the risk of self-harm.

The American Medical Association’s Code of Medical Ethics suggests physicians must “inform the patient when there has been a significant infringement on privacy of which the patient would otherwise not be aware,” Ms. Sankary said.

Ms. Sankary reported no relevant disclosures.

Fewer opioid retail prescriptions are being filled, according to a new report issued by the American Medical Association Opioid Task Force.

AndreyPopov/Getty Images

Opioid prescribing declined by 33% over a 5-year period based on the total number of opioid retail prescriptions filled. Total prescriptions declined from 251.8 million in 2013 to 168.8 million in 2018, according to the report.

The numbers come as the most recent data from the Centers for Disease Control and Prevention show a leveling of deaths involving prescription opioids. The CDC data were most recently updated in January 2019 and cover the period 1999-2017.

A closer look shows that deaths involving prescription opioids, but not other synthetic narcotics, peaked in 2011 and have generally declined since then. Deaths involving other synthetic narcotics, however, have been rising, offsetting the reduction and keeping the total number of deaths involving opioids relatively stable between 2016 and 2017.

Other data released by the AMA Opioid Task Force show that physicians are increasing their use of state-level prescription drug monitoring programs (PDMPs).

In 2017, there were 1.5 million physicians registered to use state PDMPs. That number rose to 1.97 million in 2019. And the physicians are using PDMPs. In 2018, physicians made 460 million PDMP queries, up 56% from 2017 and up 651% from 2014.

More education about opioid prescribing is being sought, with 700,000 physicians completing CME training and accessing other training related to opioid prescribing, pain management, screening for substance use disorders, and other related topics.

While the report does show positive trends, the task force is calling for more action, including more access to naloxone and better access to mental health treatment.

The report notes that more than 66,000 physicians and other health professionals have a federal waiver to prescribe buprenorphine, up more than 28,000 since 2016.

A number of policy recommendations are made in the report, including removing inappropriate administrative burdens or barriers that delay access to medications used in medication-assisted treatment (MAT); removing barriers to comprehensive pain care and rehabilitation programs, and reforming the civil and criminal justice system to help ensure access to high-quality, evidence-based care for opioid use disorder.

“We are at a crossroads in our nation’s efforts to end the opioid epidemic,” AMA Opioid Task Force Chair Patrice A. Harris, MD, stated in the report. “It is time to end delays and barriers to medication-assisted treatment – evidence based care proven to save lives; time for payers, [pharmacy benefit managers] and pharmacy chains to reevaluate and revise policies that restrict opioid therapy to patients based on arbitrary thresholds; and time to commit to helping all patients access evidence-based care for pain and substance use disorders.”

Dr. Harris continued: “Physicians must continue to demonstrate leadership, but unless these actions occur, the progress we are making will not stop patients from dying.”

[email protected]

Fewer opioid retail prescriptions are being filled, according to a new report issued by the American Medical Association Opioid Task Force.

AndreyPopov/Getty Images

Opioid prescribing declined by 33% over a 5-year period based on the total number of opioid retail prescriptions filled. Total prescriptions declined from 251.8 million in 2013 to 168.8 million in 2018, according to the report.

The numbers come as the most recent data from the Centers for Disease Control and Prevention show a leveling of deaths involving prescription opioids. The CDC data were most recently updated in January 2019 and cover the period 1999-2017.

A closer look shows that deaths involving prescription opioids, but not other synthetic narcotics, peaked in 2011 and have generally declined since then. Deaths involving other synthetic narcotics, however, have been rising, offsetting the reduction and keeping the total number of deaths involving opioids relatively stable between 2016 and 2017.

Other data released by the AMA Opioid Task Force show that physicians are increasing their use of state-level prescription drug monitoring programs (PDMPs).

In 2017, there were 1.5 million physicians registered to use state PDMPs. That number rose to 1.97 million in 2019. And the physicians are using PDMPs. In 2018, physicians made 460 million PDMP queries, up 56% from 2017 and up 651% from 2014.

More education about opioid prescribing is being sought, with 700,000 physicians completing CME training and accessing other training related to opioid prescribing, pain management, screening for substance use disorders, and other related topics.

While the report does show positive trends, the task force is calling for more action, including more access to naloxone and better access to mental health treatment.

The report notes that more than 66,000 physicians and other health professionals have a federal waiver to prescribe buprenorphine, up more than 28,000 since 2016.

A number of policy recommendations are made in the report, including removing inappropriate administrative burdens or barriers that delay access to medications used in medication-assisted treatment (MAT); removing barriers to comprehensive pain care and rehabilitation programs, and reforming the civil and criminal justice system to help ensure access to high-quality, evidence-based care for opioid use disorder.

“We are at a crossroads in our nation’s efforts to end the opioid epidemic,” AMA Opioid Task Force Chair Patrice A. Harris, MD, stated in the report. “It is time to end delays and barriers to medication-assisted treatment – evidence based care proven to save lives; time for payers, [pharmacy benefit managers] and pharmacy chains to reevaluate and revise policies that restrict opioid therapy to patients based on arbitrary thresholds; and time to commit to helping all patients access evidence-based care for pain and substance use disorders.”

Dr. Harris continued: “Physicians must continue to demonstrate leadership, but unless these actions occur, the progress we are making will not stop patients from dying.”

[email protected]

Fewer opioid retail prescriptions are being filled, according to a new report issued by the American Medical Association Opioid Task Force.

AndreyPopov/Getty Images

Opioid prescribing declined by 33% over a 5-year period based on the total number of opioid retail prescriptions filled. Total prescriptions declined from 251.8 million in 2013 to 168.8 million in 2018, according to the report.

The numbers come as the most recent data from the Centers for Disease Control and Prevention show a leveling of deaths involving prescription opioids. The CDC data were most recently updated in January 2019 and cover the period 1999-2017.

A closer look shows that deaths involving prescription opioids, but not other synthetic narcotics, peaked in 2011 and have generally declined since then. Deaths involving other synthetic narcotics, however, have been rising, offsetting the reduction and keeping the total number of deaths involving opioids relatively stable between 2016 and 2017.

Other data released by the AMA Opioid Task Force show that physicians are increasing their use of state-level prescription drug monitoring programs (PDMPs).

In 2017, there were 1.5 million physicians registered to use state PDMPs. That number rose to 1.97 million in 2019. And the physicians are using PDMPs. In 2018, physicians made 460 million PDMP queries, up 56% from 2017 and up 651% from 2014.

More education about opioid prescribing is being sought, with 700,000 physicians completing CME training and accessing other training related to opioid prescribing, pain management, screening for substance use disorders, and other related topics.

While the report does show positive trends, the task force is calling for more action, including more access to naloxone and better access to mental health treatment.

The report notes that more than 66,000 physicians and other health professionals have a federal waiver to prescribe buprenorphine, up more than 28,000 since 2016.

A number of policy recommendations are made in the report, including removing inappropriate administrative burdens or barriers that delay access to medications used in medication-assisted treatment (MAT); removing barriers to comprehensive pain care and rehabilitation programs, and reforming the civil and criminal justice system to help ensure access to high-quality, evidence-based care for opioid use disorder.

“We are at a crossroads in our nation’s efforts to end the opioid epidemic,” AMA Opioid Task Force Chair Patrice A. Harris, MD, stated in the report. “It is time to end delays and barriers to medication-assisted treatment – evidence based care proven to save lives; time for payers, [pharmacy benefit managers] and pharmacy chains to reevaluate and revise policies that restrict opioid therapy to patients based on arbitrary thresholds; and time to commit to helping all patients access evidence-based care for pain and substance use disorders.”

Dr. Harris continued: “Physicians must continue to demonstrate leadership, but unless these actions occur, the progress we are making will not stop patients from dying.”

[email protected]

SEATTLE – About 65% of patients with pediatric multiple sclerosis (MS) do not receive disease-modifying therapy (DMT) within 1 year of diagnosis, according to an analysis of insurance claims data. Females may be more likely than males to receive DMT during this time, said Chinmay Deshpande, PhD, at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Pediatric onset of MS occurs in 3-5% of patients with the disease, and the median age of pediatric onset is 15 years. This population tends to have a high relapse rate and may develop disability at a younger age, said Dr. Deshpande, associate director of health economics and outcomes research at Novartis. “There have been very few studies done on this population, especially in the clinical trial setting. ... Physicians face considerable uncertainty in how to treat these patients.”
 

Observational data

To assess the proportion of patients with pediatric MS who receive DMT in the year after diagnosis, Dr. Deshpande and colleagues analyzed retrospective observational data from the Truven Health Marketscan Commercial and Encounters administrative claims databases. They studied patients who received an MS diagnosis between Jan. 1, 2010, and Dec. 31, 2016. In addition, they examined which DMTs were used as first-line therapies, whether prescribing patterns changed between 2010 and 2017, and time to treatment discontinuation or switch.

The databases included data from more than 182,000 patients with two or more claims of MS diagnosis. After including only patients age 17 years or younger at the index diagnosis date who had insurance during the 6 months prior to the index date and 12 months after the index date and who did not use DMT during the 6 months prior to the index date, 288 patients remained in the analysis. Patients had an average age of about 14 years.

The primary outcome was the proportion of patients who started DMT in the year after MS diagnosis. “The proportion of untreated patients within their first year of diagnosis was around 65%,” said Dr. Deshpande. On average, treated patients were slightly older than untreated patients (15.0 years vs. 13.3 years). Among treated patients, 75% were female, and 25% were male. Overall, however, 61% were female and 39% were male. The difference in treatment by gender was surprising and the reason for it is not understood, Dr. Deshpande said. One possibility is that the difference relates to earlier maturation in females, but that is only a hypothesis, he said.

Glatiramer acetate and interferon beta-1a were first-line DMTs for 48% and 30.6% of the treated patients, respectively. Dimethyl fumarate (7.1%), natalizumab (5.1%), fingolimod (4.1%), interferon beta-1b (4.1%), and peginterferon beta-1a (1%) also were used as first-line therapy.

Twenty percent of patients who received DMT switched to another medication during the follow-up period. The median time of switching was within 6 months of starting first-line therapy. Most patients who discontinued DMT – that is, they did not have any DMT for 60 days after stopping their first DMT – did so within 10 months of diagnosis.
 

Use of newer medications

Overall, the use of glatiramer acetate and interferons has decreased over time, and while the use of newer DMTs has increased, the trend is not consistent. “With the growing uptake of newer oral and infusible DMTs over the recent years, there is a need to increase treatment awareness in the pediatric MS population and to inform currently approved treatment options to the prescribers,” Dr. Deshpande and colleagues said.

The claims database is generalizable and nationally representative, but it does not include clinical or MRI data. “It’s hard to understand the reasoning why they discontinued or why they are switching,” Dr. Deshpande said. In addition, the sample size was relatively small, and the results should be interpreted accordingly, he said.

Novartis funded the study, and Dr. Deshpande and a coauthor are employees of Novartis. Other coauthors reported consulting fees from Novartis, as well as consulting fees and grant funding from other pharmaceutical companies.

[email protected]

SOURCE: Greenberg B et al. CMSC 2019, Abstract DXM02.


 

SEATTLE – About 65% of patients with pediatric multiple sclerosis (MS) do not receive disease-modifying therapy (DMT) within 1 year of diagnosis, according to an analysis of insurance claims data. Females may be more likely than males to receive DMT during this time, said Chinmay Deshpande, PhD, at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Pediatric onset of MS occurs in 3-5% of patients with the disease, and the median age of pediatric onset is 15 years. This population tends to have a high relapse rate and may develop disability at a younger age, said Dr. Deshpande, associate director of health economics and outcomes research at Novartis. “There have been very few studies done on this population, especially in the clinical trial setting. ... Physicians face considerable uncertainty in how to treat these patients.”
 

Observational data

To assess the proportion of patients with pediatric MS who receive DMT in the year after diagnosis, Dr. Deshpande and colleagues analyzed retrospective observational data from the Truven Health Marketscan Commercial and Encounters administrative claims databases. They studied patients who received an MS diagnosis between Jan. 1, 2010, and Dec. 31, 2016. In addition, they examined which DMTs were used as first-line therapies, whether prescribing patterns changed between 2010 and 2017, and time to treatment discontinuation or switch.

The databases included data from more than 182,000 patients with two or more claims of MS diagnosis. After including only patients age 17 years or younger at the index diagnosis date who had insurance during the 6 months prior to the index date and 12 months after the index date and who did not use DMT during the 6 months prior to the index date, 288 patients remained in the analysis. Patients had an average age of about 14 years.

The primary outcome was the proportion of patients who started DMT in the year after MS diagnosis. “The proportion of untreated patients within their first year of diagnosis was around 65%,” said Dr. Deshpande. On average, treated patients were slightly older than untreated patients (15.0 years vs. 13.3 years). Among treated patients, 75% were female, and 25% were male. Overall, however, 61% were female and 39% were male. The difference in treatment by gender was surprising and the reason for it is not understood, Dr. Deshpande said. One possibility is that the difference relates to earlier maturation in females, but that is only a hypothesis, he said.

Glatiramer acetate and interferon beta-1a were first-line DMTs for 48% and 30.6% of the treated patients, respectively. Dimethyl fumarate (7.1%), natalizumab (5.1%), fingolimod (4.1%), interferon beta-1b (4.1%), and peginterferon beta-1a (1%) also were used as first-line therapy.

Twenty percent of patients who received DMT switched to another medication during the follow-up period. The median time of switching was within 6 months of starting first-line therapy. Most patients who discontinued DMT – that is, they did not have any DMT for 60 days after stopping their first DMT – did so within 10 months of diagnosis.
 

Use of newer medications

Overall, the use of glatiramer acetate and interferons has decreased over time, and while the use of newer DMTs has increased, the trend is not consistent. “With the growing uptake of newer oral and infusible DMTs over the recent years, there is a need to increase treatment awareness in the pediatric MS population and to inform currently approved treatment options to the prescribers,” Dr. Deshpande and colleagues said.

The claims database is generalizable and nationally representative, but it does not include clinical or MRI data. “It’s hard to understand the reasoning why they discontinued or why they are switching,” Dr. Deshpande said. In addition, the sample size was relatively small, and the results should be interpreted accordingly, he said.

Novartis funded the study, and Dr. Deshpande and a coauthor are employees of Novartis. Other coauthors reported consulting fees from Novartis, as well as consulting fees and grant funding from other pharmaceutical companies.

[email protected]

SOURCE: Greenberg B et al. CMSC 2019, Abstract DXM02.


 

SEATTLE – About 65% of patients with pediatric multiple sclerosis (MS) do not receive disease-modifying therapy (DMT) within 1 year of diagnosis, according to an analysis of insurance claims data. Females may be more likely than males to receive DMT during this time, said Chinmay Deshpande, PhD, at the annual meeting of the Consortium of Multiple Sclerosis Centers.

Pediatric onset of MS occurs in 3-5% of patients with the disease, and the median age of pediatric onset is 15 years. This population tends to have a high relapse rate and may develop disability at a younger age, said Dr. Deshpande, associate director of health economics and outcomes research at Novartis. “There have been very few studies done on this population, especially in the clinical trial setting. ... Physicians face considerable uncertainty in how to treat these patients.”
 

Observational data

To assess the proportion of patients with pediatric MS who receive DMT in the year after diagnosis, Dr. Deshpande and colleagues analyzed retrospective observational data from the Truven Health Marketscan Commercial and Encounters administrative claims databases. They studied patients who received an MS diagnosis between Jan. 1, 2010, and Dec. 31, 2016. In addition, they examined which DMTs were used as first-line therapies, whether prescribing patterns changed between 2010 and 2017, and time to treatment discontinuation or switch.

The databases included data from more than 182,000 patients with two or more claims of MS diagnosis. After including only patients age 17 years or younger at the index diagnosis date who had insurance during the 6 months prior to the index date and 12 months after the index date and who did not use DMT during the 6 months prior to the index date, 288 patients remained in the analysis. Patients had an average age of about 14 years.

The primary outcome was the proportion of patients who started DMT in the year after MS diagnosis. “The proportion of untreated patients within their first year of diagnosis was around 65%,” said Dr. Deshpande. On average, treated patients were slightly older than untreated patients (15.0 years vs. 13.3 years). Among treated patients, 75% were female, and 25% were male. Overall, however, 61% were female and 39% were male. The difference in treatment by gender was surprising and the reason for it is not understood, Dr. Deshpande said. One possibility is that the difference relates to earlier maturation in females, but that is only a hypothesis, he said.

Glatiramer acetate and interferon beta-1a were first-line DMTs for 48% and 30.6% of the treated patients, respectively. Dimethyl fumarate (7.1%), natalizumab (5.1%), fingolimod (4.1%), interferon beta-1b (4.1%), and peginterferon beta-1a (1%) also were used as first-line therapy.

Twenty percent of patients who received DMT switched to another medication during the follow-up period. The median time of switching was within 6 months of starting first-line therapy. Most patients who discontinued DMT – that is, they did not have any DMT for 60 days after stopping their first DMT – did so within 10 months of diagnosis.
 

Use of newer medications

Overall, the use of glatiramer acetate and interferons has decreased over time, and while the use of newer DMTs has increased, the trend is not consistent. “With the growing uptake of newer oral and infusible DMTs over the recent years, there is a need to increase treatment awareness in the pediatric MS population and to inform currently approved treatment options to the prescribers,” Dr. Deshpande and colleagues said.

The claims database is generalizable and nationally representative, but it does not include clinical or MRI data. “It’s hard to understand the reasoning why they discontinued or why they are switching,” Dr. Deshpande said. In addition, the sample size was relatively small, and the results should be interpreted accordingly, he said.

Novartis funded the study, and Dr. Deshpande and a coauthor are employees of Novartis. Other coauthors reported consulting fees from Novartis, as well as consulting fees and grant funding from other pharmaceutical companies.

[email protected]

SOURCE: Greenberg B et al. CMSC 2019, Abstract DXM02.


 

Among patients with hepatitis C virus, antiviral treatment is associated with a reduced risk of Parkinson’s disease, according to a cohort study published online June 5 in JAMA Neurology. The results provide evidence that hepatitis C virus is a risk factor for Parkinson’s disease.

In the past several years, epidemiologic studies have suggested an association between hepatitis C virus infection and Parkinson’s disease. A study published in 2017, however, found no association between the two. In addition, these investigations did not consider antiviral therapy as a potential modifying factor.

Wey-Yil Lin, MD, a neurologist at Landseed International Hospital in Taoyuan, Taiwan, and colleagues examined claims data from the Taiwan National Health Insurance Research Database to identify the risk of incident Parkinson’s disease in patients with hepatitis C virus infection who received antiviral treatment, compared with those who did not receive treatment.

The investigators selected all patients with a new diagnosis of hepatitis C virus infection with or without hepatitis from January 1, 2003, to December 31, 2013. They excluded patients who were aged 20 years or younger; had Parkinson’s disease, dementia, or stroke; or had had major hepatic diseases on the index date. To ensure that treated patients had had an effective course of therapy, the researchers excluded patients who were lost to follow-up within 6 months of the index date, received antiviral therapy for fewer than 16 weeks, or developed Parkinson’s disease within 6 months of the index date.

The primary outcome was incident Parkinson’s disease. Dr. Lin and colleagues excluded participants with a diagnosis of stroke and dementia before the index date to reduce the possibility of enrolling participants with secondary and atypical parkinsonism.

To minimize the potential selection bias to which observational studies are subject, the investigators performed propensity score matching with sex, age, comorbidities, and medication as covariates. This method was intended to create treated and untreated cohorts with comparable characteristics.

Dr. Lin and colleagues included 188,152 patients in their analysis. After matching, each group included 39,936 participants. In the group that received antiviral treatment, 45.0% of participants were female, and mean age was 52.8 years. In the untreated group, 44.4% of participants were female, and mean age was 52.5 years.

The incidence density of Parkinson’s disease per 1,000 person-years was 1.00 in the treated group and 1.39 in the untreated group. The difference in risk of Parkinson’s disease between the treated and untreated groups was statistically significant at year 5 of follow-up (hazard ratio [HR], 0.75) and at the end of the cohort (HR, 0.71). The risk did not differ significantly at year 1 and year 3, however. A subgroup analysis found a greater benefit of antiviral therapy among patients who concurrently used dihydropyridine calcium channel blockers.

“To our knowledge, this is the first cohort study to investigate the association between antiviral therapy and risk of Parkinson’s disease in patients with chronic hepatitis C viral infection,” said Dr. Lin and colleagues. Although it is possible that interferon-based antiviral therapy directly protected against the development of Parkinson’s disease, the short time of exposure to the antiviral agent “makes protecting against Parkinson’s disease development in 5 years less likely,” they added.

Among the study limitations that the authors acknowledged was the lack of data about hepatic function profile, serum virologic response, viral genotype, and hepatitis C virus RNA-level. The database that the investigators used also lacked data about behavioral factors (e.g., smoking status, coffee consumption, and alcohol consumption) that may have affected the incidence of Parkinson’s disease in the cohort. Investigations with longer follow-up periods will be needed to provide clearer information, they concluded.

The authors reported no conflicts of interest. The study was funded by grants from Chang Gung Medical Research Fund and from Chang Gung Memorial Hospital.

[email protected]

SOURCE: Lin W-Y et al. JAMA Neurol. 2019 Jun 5. doi: 10.1001/jamaneurol.2019.1368.

Among patients with hepatitis C virus, antiviral treatment is associated with a reduced risk of Parkinson’s disease, according to a cohort study published online June 5 in JAMA Neurology. The results provide evidence that hepatitis C virus is a risk factor for Parkinson’s disease.

In the past several years, epidemiologic studies have suggested an association between hepatitis C virus infection and Parkinson’s disease. A study published in 2017, however, found no association between the two. In addition, these investigations did not consider antiviral therapy as a potential modifying factor.

Wey-Yil Lin, MD, a neurologist at Landseed International Hospital in Taoyuan, Taiwan, and colleagues examined claims data from the Taiwan National Health Insurance Research Database to identify the risk of incident Parkinson’s disease in patients with hepatitis C virus infection who received antiviral treatment, compared with those who did not receive treatment.

The investigators selected all patients with a new diagnosis of hepatitis C virus infection with or without hepatitis from January 1, 2003, to December 31, 2013. They excluded patients who were aged 20 years or younger; had Parkinson’s disease, dementia, or stroke; or had had major hepatic diseases on the index date. To ensure that treated patients had had an effective course of therapy, the researchers excluded patients who were lost to follow-up within 6 months of the index date, received antiviral therapy for fewer than 16 weeks, or developed Parkinson’s disease within 6 months of the index date.

The primary outcome was incident Parkinson’s disease. Dr. Lin and colleagues excluded participants with a diagnosis of stroke and dementia before the index date to reduce the possibility of enrolling participants with secondary and atypical parkinsonism.

To minimize the potential selection bias to which observational studies are subject, the investigators performed propensity score matching with sex, age, comorbidities, and medication as covariates. This method was intended to create treated and untreated cohorts with comparable characteristics.

Dr. Lin and colleagues included 188,152 patients in their analysis. After matching, each group included 39,936 participants. In the group that received antiviral treatment, 45.0% of participants were female, and mean age was 52.8 years. In the untreated group, 44.4% of participants were female, and mean age was 52.5 years.

The incidence density of Parkinson’s disease per 1,000 person-years was 1.00 in the treated group and 1.39 in the untreated group. The difference in risk of Parkinson’s disease between the treated and untreated groups was statistically significant at year 5 of follow-up (hazard ratio [HR], 0.75) and at the end of the cohort (HR, 0.71). The risk did not differ significantly at year 1 and year 3, however. A subgroup analysis found a greater benefit of antiviral therapy among patients who concurrently used dihydropyridine calcium channel blockers.

“To our knowledge, this is the first cohort study to investigate the association between antiviral therapy and risk of Parkinson’s disease in patients with chronic hepatitis C viral infection,” said Dr. Lin and colleagues. Although it is possible that interferon-based antiviral therapy directly protected against the development of Parkinson’s disease, the short time of exposure to the antiviral agent “makes protecting against Parkinson’s disease development in 5 years less likely,” they added.

Among the study limitations that the authors acknowledged was the lack of data about hepatic function profile, serum virologic response, viral genotype, and hepatitis C virus RNA-level. The database that the investigators used also lacked data about behavioral factors (e.g., smoking status, coffee consumption, and alcohol consumption) that may have affected the incidence of Parkinson’s disease in the cohort. Investigations with longer follow-up periods will be needed to provide clearer information, they concluded.

The authors reported no conflicts of interest. The study was funded by grants from Chang Gung Medical Research Fund and from Chang Gung Memorial Hospital.

[email protected]

SOURCE: Lin W-Y et al. JAMA Neurol. 2019 Jun 5. doi: 10.1001/jamaneurol.2019.1368.

Among patients with hepatitis C virus, antiviral treatment is associated with a reduced risk of Parkinson’s disease, according to a cohort study published online June 5 in JAMA Neurology. The results provide evidence that hepatitis C virus is a risk factor for Parkinson’s disease.

In the past several years, epidemiologic studies have suggested an association between hepatitis C virus infection and Parkinson’s disease. A study published in 2017, however, found no association between the two. In addition, these investigations did not consider antiviral therapy as a potential modifying factor.

Wey-Yil Lin, MD, a neurologist at Landseed International Hospital in Taoyuan, Taiwan, and colleagues examined claims data from the Taiwan National Health Insurance Research Database to identify the risk of incident Parkinson’s disease in patients with hepatitis C virus infection who received antiviral treatment, compared with those who did not receive treatment.

The investigators selected all patients with a new diagnosis of hepatitis C virus infection with or without hepatitis from January 1, 2003, to December 31, 2013. They excluded patients who were aged 20 years or younger; had Parkinson’s disease, dementia, or stroke; or had had major hepatic diseases on the index date. To ensure that treated patients had had an effective course of therapy, the researchers excluded patients who were lost to follow-up within 6 months of the index date, received antiviral therapy for fewer than 16 weeks, or developed Parkinson’s disease within 6 months of the index date.

The primary outcome was incident Parkinson’s disease. Dr. Lin and colleagues excluded participants with a diagnosis of stroke and dementia before the index date to reduce the possibility of enrolling participants with secondary and atypical parkinsonism.

To minimize the potential selection bias to which observational studies are subject, the investigators performed propensity score matching with sex, age, comorbidities, and medication as covariates. This method was intended to create treated and untreated cohorts with comparable characteristics.

Dr. Lin and colleagues included 188,152 patients in their analysis. After matching, each group included 39,936 participants. In the group that received antiviral treatment, 45.0% of participants were female, and mean age was 52.8 years. In the untreated group, 44.4% of participants were female, and mean age was 52.5 years.

The incidence density of Parkinson’s disease per 1,000 person-years was 1.00 in the treated group and 1.39 in the untreated group. The difference in risk of Parkinson’s disease between the treated and untreated groups was statistically significant at year 5 of follow-up (hazard ratio [HR], 0.75) and at the end of the cohort (HR, 0.71). The risk did not differ significantly at year 1 and year 3, however. A subgroup analysis found a greater benefit of antiviral therapy among patients who concurrently used dihydropyridine calcium channel blockers.

“To our knowledge, this is the first cohort study to investigate the association between antiviral therapy and risk of Parkinson’s disease in patients with chronic hepatitis C viral infection,” said Dr. Lin and colleagues. Although it is possible that interferon-based antiviral therapy directly protected against the development of Parkinson’s disease, the short time of exposure to the antiviral agent “makes protecting against Parkinson’s disease development in 5 years less likely,” they added.

Among the study limitations that the authors acknowledged was the lack of data about hepatic function profile, serum virologic response, viral genotype, and hepatitis C virus RNA-level. The database that the investigators used also lacked data about behavioral factors (e.g., smoking status, coffee consumption, and alcohol consumption) that may have affected the incidence of Parkinson’s disease in the cohort. Investigations with longer follow-up periods will be needed to provide clearer information, they concluded.

The authors reported no conflicts of interest. The study was funded by grants from Chang Gung Medical Research Fund and from Chang Gung Memorial Hospital.

[email protected]

SOURCE: Lin W-Y et al. JAMA Neurol. 2019 Jun 5. doi: 10.1001/jamaneurol.2019.1368.

The Food and Drug Administration has approved galcanezumab-gnlm (Emgality) for the preventive treatment of episodic cluster headache in adults. The drug, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), is administered by self-injection in 300-mg doses.

Galcanezumab is the first medication for episodic cluster headache that reduces the frequency of attacks, the agency said in an announcement.

Cluster headache can be more intense than migraine. The pain is unilateral and occurs in the orbital, supraorbital, or temporal regions. It reaches its peak intensity within 5-10 minutes and generally lasts for 30-90 minutes. Symptoms include a burning sensation, conjunctival injection, rhinorrhea, and photosensitivity. Patients often have one to three of these headaches per day, and the headaches appear to be linked to the circadian rhythm. An episodic cluster cycle can last for weeks to months of daily or near daily attacks.

A study presented at the recent meeting of the American Academy of Neurology provided evidence of the drug’s efficacy in cluster headache. In this trial, researchers randomized 106 patients with episodic cluster headache to galcanezumab or placebo. The baseline cluster headache frequency was 17.3 attacks per week, and galcanezumab reduced this frequency to 9.1 attacks per week, compared with 12.1 attacks per week with placebo. The most common side effect reported in this and other clinical trials was injection-site reactions.

Galcanezumab entails a risk of hypersensitivity reactions, according to the FDA. These reactions may occur several days after administration and may be prolonged. “If a serious hypersensitivity reaction occurs, treatment should be discontinued,” the agency said.

“It’s a very exciting day. There had never been a drug approved for prevention of cluster headache,” said Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth and director of the Dartmouth Headache Center, Dartmouth-Hitchcock Medical Center, Lebanon, N.H.

Bruce Jancin/MDedge News

When asked for comment, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said “If this monoclonal antibody to the CGRP ligand works as well in real life as in the trial, it will be an important advance in the treatment of cluster headache.”

Prior to the approval of galcanezumab, noninvasive vagal nerve stimulation was approved in November 2018 for adjunctive use in the preventive treatment of cluster headache in adults.

The FDA granted the application for galcanezumab using a Priority Review and Breakthrough Therapy designation. The agency approved galcanezumab for the preventive treatment of migraine in adults in September 2018. The drug appears to have a similar safety profile in both patient populations. Eli Lilly, which is based in Indianapolis, Indiana, manufactures the drug.

[email protected]

This article was updated June 5, 2019.

The Food and Drug Administration has approved galcanezumab-gnlm (Emgality) for the preventive treatment of episodic cluster headache in adults. The drug, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), is administered by self-injection in 300-mg doses.

Galcanezumab is the first medication for episodic cluster headache that reduces the frequency of attacks, the agency said in an announcement.

Cluster headache can be more intense than migraine. The pain is unilateral and occurs in the orbital, supraorbital, or temporal regions. It reaches its peak intensity within 5-10 minutes and generally lasts for 30-90 minutes. Symptoms include a burning sensation, conjunctival injection, rhinorrhea, and photosensitivity. Patients often have one to three of these headaches per day, and the headaches appear to be linked to the circadian rhythm. An episodic cluster cycle can last for weeks to months of daily or near daily attacks.

A study presented at the recent meeting of the American Academy of Neurology provided evidence of the drug’s efficacy in cluster headache. In this trial, researchers randomized 106 patients with episodic cluster headache to galcanezumab or placebo. The baseline cluster headache frequency was 17.3 attacks per week, and galcanezumab reduced this frequency to 9.1 attacks per week, compared with 12.1 attacks per week with placebo. The most common side effect reported in this and other clinical trials was injection-site reactions.

Galcanezumab entails a risk of hypersensitivity reactions, according to the FDA. These reactions may occur several days after administration and may be prolonged. “If a serious hypersensitivity reaction occurs, treatment should be discontinued,” the agency said.

“It’s a very exciting day. There had never been a drug approved for prevention of cluster headache,” said Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth and director of the Dartmouth Headache Center, Dartmouth-Hitchcock Medical Center, Lebanon, N.H.

Bruce Jancin/MDedge News

When asked for comment, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said “If this monoclonal antibody to the CGRP ligand works as well in real life as in the trial, it will be an important advance in the treatment of cluster headache.”

Prior to the approval of galcanezumab, noninvasive vagal nerve stimulation was approved in November 2018 for adjunctive use in the preventive treatment of cluster headache in adults.

The FDA granted the application for galcanezumab using a Priority Review and Breakthrough Therapy designation. The agency approved galcanezumab for the preventive treatment of migraine in adults in September 2018. The drug appears to have a similar safety profile in both patient populations. Eli Lilly, which is based in Indianapolis, Indiana, manufactures the drug.

[email protected]

This article was updated June 5, 2019.

The Food and Drug Administration has approved galcanezumab-gnlm (Emgality) for the preventive treatment of episodic cluster headache in adults. The drug, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), is administered by self-injection in 300-mg doses.

Galcanezumab is the first medication for episodic cluster headache that reduces the frequency of attacks, the agency said in an announcement.

Cluster headache can be more intense than migraine. The pain is unilateral and occurs in the orbital, supraorbital, or temporal regions. It reaches its peak intensity within 5-10 minutes and generally lasts for 30-90 minutes. Symptoms include a burning sensation, conjunctival injection, rhinorrhea, and photosensitivity. Patients often have one to three of these headaches per day, and the headaches appear to be linked to the circadian rhythm. An episodic cluster cycle can last for weeks to months of daily or near daily attacks.

A study presented at the recent meeting of the American Academy of Neurology provided evidence of the drug’s efficacy in cluster headache. In this trial, researchers randomized 106 patients with episodic cluster headache to galcanezumab or placebo. The baseline cluster headache frequency was 17.3 attacks per week, and galcanezumab reduced this frequency to 9.1 attacks per week, compared with 12.1 attacks per week with placebo. The most common side effect reported in this and other clinical trials was injection-site reactions.

Galcanezumab entails a risk of hypersensitivity reactions, according to the FDA. These reactions may occur several days after administration and may be prolonged. “If a serious hypersensitivity reaction occurs, treatment should be discontinued,” the agency said.

“It’s a very exciting day. There had never been a drug approved for prevention of cluster headache,” said Stewart J. Tepper, MD, professor of neurology at the Geisel School of Medicine at Dartmouth and director of the Dartmouth Headache Center, Dartmouth-Hitchcock Medical Center, Lebanon, N.H.

Bruce Jancin/MDedge News

When asked for comment, Alan M. Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, said “If this monoclonal antibody to the CGRP ligand works as well in real life as in the trial, it will be an important advance in the treatment of cluster headache.”

Prior to the approval of galcanezumab, noninvasive vagal nerve stimulation was approved in November 2018 for adjunctive use in the preventive treatment of cluster headache in adults.

The FDA granted the application for galcanezumab using a Priority Review and Breakthrough Therapy designation. The agency approved galcanezumab for the preventive treatment of migraine in adults in September 2018. The drug appears to have a similar safety profile in both patient populations. Eli Lilly, which is based in Indianapolis, Indiana, manufactures the drug.

[email protected]

This article was updated June 5, 2019.

SAN FRANCISCO – The direct-acting anticoagulants, as a class, were more effective and at least as safe as warfarin in low-weight and very-low-weight patients with atrial fibrillation in an adjusted analysis of real-world outcomes data from more than 21,000 Korean patients.

Mitchel L. Zoler/MDedge News

The analysis also showed that the direct-acting oral anticoagulants (DOACs) had the best safety and efficacy on low-weight patients when used at the labeled dosages, with blunted efficacy and safety at dosages that either exceeded or fell short of labeled levels, So-Ryoung Lee, MD, said at the annual scientific sessions of the Heart Rhythm Society.

The overall superiority of DOACs by both efficacy and safety also generally extended to the subgroup of very-low-weight patients, those with weights of less than 50 kg. In this subgroup, which was 28% of the total population studied, the composite adverse event outcome occurred 33% less often among patients treated with a DOAC relative to patients treated with warfarin, a statistically significant difference, said Dr. Lee, a cardiologist at Seoul (South Korea) National University Hospital. Among all patients with weights of 60 kg (132 pounds) or less, the composite outcome occurred 34% less often in the DOAC-treated patients relative to the warfarin-treated patients, also a statistically significant difference.

Dr. Lee and colleagues used a Korean National Health Insurance database that included information on more than 600,000 adults with atrial fibrillation (AFib) as of January 2013. The researchers whittled this down to 21,678 patients who began for the first time treatment with an oral anticoagulant starting during or after January 2014; had no history of a stroke, intracranial hemorrhage, or gastrointestinal bleed; and weighed no more than 60 kg. This cohort included 7,575 (35%) who received warfarin treatment, and 14,103 (65%) who received a DOAC. Within the DOAC-treated group, 42% received rivaroxaban (Xarelto), 26% dabigatran (Pradaxa), 24% apixaban (Eliquis), and 8% edoxaban (Savaysa).


To account for baseline differences in demographics and comorbidities between the patients treated with a DOAC and those who received warfarin, Dr. Lee and her associates did propensity score adjustment, which resulted in similar cohorts of 6,692 patients treated with warfarin and 12,810 patients treated with a DOAC. The average age of these patients was 73 years, a third were men, and the average body mass index was just over 22 kg/m².

The events that the researchers tallied during follow-up through December 2016 included rates of all-cause death, ischemic stroke, intracranial hemorrhage, hospitalization for GI bleeding, hospitalization for major bleeding, and the composite of these five outcomes.

In the propensity-score adjusted full cohort of all patients who weighed 60 kg or less, the rate of each of these five outcomes, as well as the composite outcome, occurred statistically significantly less often among the DOAC-treated patients than in those on warfarin. The reductions ranged from a 41% lower incidence of ischemic stroke on DOAC treatment compared with warfarin treatment, to an 18% reduced rate of hospitalization for a GI bleed, compared with warfarin-treated patients. In the subgroup of patients who weighed less than 50 kg (110 pounds), the reductions ranged from a 41% cut in ischemic stroke on a DOAC compared with warfarin to a 24% relative reduction in the rate of hospitalization for a major bleed, a difference that just reached statistical significance. The outcome of hospitalization for a GI bleed showed no significant between-group difference among very-low-weight patients, but the rates of intracranial hemorrhage and all-cause death also showed statistically significant lower rates among DOAC-treated patients.

Nearly two-thirds of the patients on a DOAC received the label-appropriate dose of the drug, but 31% received a dosage that was below the labeled level while 4% received a dosage above the labeled level. An analysis that divided the NOAC patients by the appropriateness of their treatment dosages showed that patients on the correct dosages fared best. For example, in the total cohort of patients who weighed 60 kg or less, those on the correct DOAC dosage had a 9.1% rate of the combined endpoint. Patients on a low DOAC dosage did about as well as did the patients on warfarin, with a combined event rate of 11.6% in each of these subgroups. The worst outcomes occurred among the small number of patients on an inappropriately-high DOAC dosage, with a combined event rate of 15.4%. The researchers found a similar pattern among patients who weighed less than 50 kg.

Dr. Lee had no disclosures.

[email protected]

SOURCE: Lee SR et al. HRS 2019, Abstract S-AB30-05.

SAN FRANCISCO – The direct-acting anticoagulants, as a class, were more effective and at least as safe as warfarin in low-weight and very-low-weight patients with atrial fibrillation in an adjusted analysis of real-world outcomes data from more than 21,000 Korean patients.

Mitchel L. Zoler/MDedge News

The analysis also showed that the direct-acting oral anticoagulants (DOACs) had the best safety and efficacy on low-weight patients when used at the labeled dosages, with blunted efficacy and safety at dosages that either exceeded or fell short of labeled levels, So-Ryoung Lee, MD, said at the annual scientific sessions of the Heart Rhythm Society.

The overall superiority of DOACs by both efficacy and safety also generally extended to the subgroup of very-low-weight patients, those with weights of less than 50 kg. In this subgroup, which was 28% of the total population studied, the composite adverse event outcome occurred 33% less often among patients treated with a DOAC relative to patients treated with warfarin, a statistically significant difference, said Dr. Lee, a cardiologist at Seoul (South Korea) National University Hospital. Among all patients with weights of 60 kg (132 pounds) or less, the composite outcome occurred 34% less often in the DOAC-treated patients relative to the warfarin-treated patients, also a statistically significant difference.

Dr. Lee and colleagues used a Korean National Health Insurance database that included information on more than 600,000 adults with atrial fibrillation (AFib) as of January 2013. The researchers whittled this down to 21,678 patients who began for the first time treatment with an oral anticoagulant starting during or after January 2014; had no history of a stroke, intracranial hemorrhage, or gastrointestinal bleed; and weighed no more than 60 kg. This cohort included 7,575 (35%) who received warfarin treatment, and 14,103 (65%) who received a DOAC. Within the DOAC-treated group, 42% received rivaroxaban (Xarelto), 26% dabigatran (Pradaxa), 24% apixaban (Eliquis), and 8% edoxaban (Savaysa).


To account for baseline differences in demographics and comorbidities between the patients treated with a DOAC and those who received warfarin, Dr. Lee and her associates did propensity score adjustment, which resulted in similar cohorts of 6,692 patients treated with warfarin and 12,810 patients treated with a DOAC. The average age of these patients was 73 years, a third were men, and the average body mass index was just over 22 kg/m².

The events that the researchers tallied during follow-up through December 2016 included rates of all-cause death, ischemic stroke, intracranial hemorrhage, hospitalization for GI bleeding, hospitalization for major bleeding, and the composite of these five outcomes.

In the propensity-score adjusted full cohort of all patients who weighed 60 kg or less, the rate of each of these five outcomes, as well as the composite outcome, occurred statistically significantly less often among the DOAC-treated patients than in those on warfarin. The reductions ranged from a 41% lower incidence of ischemic stroke on DOAC treatment compared with warfarin treatment, to an 18% reduced rate of hospitalization for a GI bleed, compared with warfarin-treated patients. In the subgroup of patients who weighed less than 50 kg (110 pounds), the reductions ranged from a 41% cut in ischemic stroke on a DOAC compared with warfarin to a 24% relative reduction in the rate of hospitalization for a major bleed, a difference that just reached statistical significance. The outcome of hospitalization for a GI bleed showed no significant between-group difference among very-low-weight patients, but the rates of intracranial hemorrhage and all-cause death also showed statistically significant lower rates among DOAC-treated patients.

Nearly two-thirds of the patients on a DOAC received the label-appropriate dose of the drug, but 31% received a dosage that was below the labeled level while 4% received a dosage above the labeled level. An analysis that divided the NOAC patients by the appropriateness of their treatment dosages showed that patients on the correct dosages fared best. For example, in the total cohort of patients who weighed 60 kg or less, those on the correct DOAC dosage had a 9.1% rate of the combined endpoint. Patients on a low DOAC dosage did about as well as did the patients on warfarin, with a combined event rate of 11.6% in each of these subgroups. The worst outcomes occurred among the small number of patients on an inappropriately-high DOAC dosage, with a combined event rate of 15.4%. The researchers found a similar pattern among patients who weighed less than 50 kg.

Dr. Lee had no disclosures.

[email protected]

SOURCE: Lee SR et al. HRS 2019, Abstract S-AB30-05.

SAN FRANCISCO – The direct-acting anticoagulants, as a class, were more effective and at least as safe as warfarin in low-weight and very-low-weight patients with atrial fibrillation in an adjusted analysis of real-world outcomes data from more than 21,000 Korean patients.

Mitchel L. Zoler/MDedge News

The analysis also showed that the direct-acting oral anticoagulants (DOACs) had the best safety and efficacy on low-weight patients when used at the labeled dosages, with blunted efficacy and safety at dosages that either exceeded or fell short of labeled levels, So-Ryoung Lee, MD, said at the annual scientific sessions of the Heart Rhythm Society.

The overall superiority of DOACs by both efficacy and safety also generally extended to the subgroup of very-low-weight patients, those with weights of less than 50 kg. In this subgroup, which was 28% of the total population studied, the composite adverse event outcome occurred 33% less often among patients treated with a DOAC relative to patients treated with warfarin, a statistically significant difference, said Dr. Lee, a cardiologist at Seoul (South Korea) National University Hospital. Among all patients with weights of 60 kg (132 pounds) or less, the composite outcome occurred 34% less often in the DOAC-treated patients relative to the warfarin-treated patients, also a statistically significant difference.

Dr. Lee and colleagues used a Korean National Health Insurance database that included information on more than 600,000 adults with atrial fibrillation (AFib) as of January 2013. The researchers whittled this down to 21,678 patients who began for the first time treatment with an oral anticoagulant starting during or after January 2014; had no history of a stroke, intracranial hemorrhage, or gastrointestinal bleed; and weighed no more than 60 kg. This cohort included 7,575 (35%) who received warfarin treatment, and 14,103 (65%) who received a DOAC. Within the DOAC-treated group, 42% received rivaroxaban (Xarelto), 26% dabigatran (Pradaxa), 24% apixaban (Eliquis), and 8% edoxaban (Savaysa).


To account for baseline differences in demographics and comorbidities between the patients treated with a DOAC and those who received warfarin, Dr. Lee and her associates did propensity score adjustment, which resulted in similar cohorts of 6,692 patients treated with warfarin and 12,810 patients treated with a DOAC. The average age of these patients was 73 years, a third were men, and the average body mass index was just over 22 kg/m².

The events that the researchers tallied during follow-up through December 2016 included rates of all-cause death, ischemic stroke, intracranial hemorrhage, hospitalization for GI bleeding, hospitalization for major bleeding, and the composite of these five outcomes.

In the propensity-score adjusted full cohort of all patients who weighed 60 kg or less, the rate of each of these five outcomes, as well as the composite outcome, occurred statistically significantly less often among the DOAC-treated patients than in those on warfarin. The reductions ranged from a 41% lower incidence of ischemic stroke on DOAC treatment compared with warfarin treatment, to an 18% reduced rate of hospitalization for a GI bleed, compared with warfarin-treated patients. In the subgroup of patients who weighed less than 50 kg (110 pounds), the reductions ranged from a 41% cut in ischemic stroke on a DOAC compared with warfarin to a 24% relative reduction in the rate of hospitalization for a major bleed, a difference that just reached statistical significance. The outcome of hospitalization for a GI bleed showed no significant between-group difference among very-low-weight patients, but the rates of intracranial hemorrhage and all-cause death also showed statistically significant lower rates among DOAC-treated patients.

Nearly two-thirds of the patients on a DOAC received the label-appropriate dose of the drug, but 31% received a dosage that was below the labeled level while 4% received a dosage above the labeled level. An analysis that divided the NOAC patients by the appropriateness of their treatment dosages showed that patients on the correct dosages fared best. For example, in the total cohort of patients who weighed 60 kg or less, those on the correct DOAC dosage had a 9.1% rate of the combined endpoint. Patients on a low DOAC dosage did about as well as did the patients on warfarin, with a combined event rate of 11.6% in each of these subgroups. The worst outcomes occurred among the small number of patients on an inappropriately-high DOAC dosage, with a combined event rate of 15.4%. The researchers found a similar pattern among patients who weighed less than 50 kg.

Dr. Lee had no disclosures.

[email protected]

SOURCE: Lee SR et al. HRS 2019, Abstract S-AB30-05.

SEATTLE – A new study finds that patients with both multiple sclerosis (MS) and restless legs syndrome (RLS) were more likely to suffer from self-perceived cognitive impairment. The results suggest that sleep dysfunction exacerbated by RLS could affect cognition in patients with MS, study lead author Katie L. Cederberg, CPT, a doctoral student in the department of physical therapy at the University of Alabama at Birmingham, said in an interview. She spoke at the annual meeting of the Consortium of Multiple Sclerosis Centers, where she presented the findings.

“RLS severity did predict cognitive impairment,” she said. However, she added, “this is just a snapshot, and we need to do more research.”

Sleep problems, including RLS, are more common in patients with MS than in the general population. “Current research suggests that anywhere from 19% to 67% of individuals with MS experience some sort of sleep difficulty, with rates as high as 80% in some samples,” a 2015 report noted.

As for RLS, a 2018 systematic review and meta-analysis found that “pooled RLS prevalence among MS patients of various ethnicities was 26%, and prevalence was lower in Asia (20%) than outside Asia (27%). Prevalence was higher among cross-sectional studies (30%) than among case-control studies (23%). RLS prevalence was higher among female than among male MS patients (26% vs. 17%), and it was higher among MS patients than among healthy controls (odds ratio, 3.96, 95% confidence interval, 3.29-4.77, P less than .001) (Sleep Med. 2018 Oct;50:97-104).

Ms. Cederberg said the frequency of RLS in patients with MS spurred her and colleagues to explore whether it may affect cognitive function.

For their study, the researchers surveyed 275 patients with MS (mean age = 60, 81% female, 33% employed, 95% white, 66% with relapsing-remitting MS). Of the 275, 75 appeared to have RLS. These patients were similar to the non-RLS patients in multiple areas, but they diverged in scores on the brief Multiple Sclerosis Neuropsychological Questionnaire, which measures self-perception of cognition.

Those with both MS and RLS scored 21.9 (± 11.7) on the test, while those with MS scored 18.0 (± 11.0), P = 0.023.

Analyses linked greater RLS severity to worse self-perceived cognitive impairment and sleep quality. “The diagnosis and treatment of RLS symptoms and other effectors of sleep quality could improve cognitive consequences of MS,” the authors concluded.

The National MS Society funded the study. The study authors reported no relevant disclosures.

SEATTLE – A new study finds that patients with both multiple sclerosis (MS) and restless legs syndrome (RLS) were more likely to suffer from self-perceived cognitive impairment. The results suggest that sleep dysfunction exacerbated by RLS could affect cognition in patients with MS, study lead author Katie L. Cederberg, CPT, a doctoral student in the department of physical therapy at the University of Alabama at Birmingham, said in an interview. She spoke at the annual meeting of the Consortium of Multiple Sclerosis Centers, where she presented the findings.

“RLS severity did predict cognitive impairment,” she said. However, she added, “this is just a snapshot, and we need to do more research.”

Sleep problems, including RLS, are more common in patients with MS than in the general population. “Current research suggests that anywhere from 19% to 67% of individuals with MS experience some sort of sleep difficulty, with rates as high as 80% in some samples,” a 2015 report noted.

As for RLS, a 2018 systematic review and meta-analysis found that “pooled RLS prevalence among MS patients of various ethnicities was 26%, and prevalence was lower in Asia (20%) than outside Asia (27%). Prevalence was higher among cross-sectional studies (30%) than among case-control studies (23%). RLS prevalence was higher among female than among male MS patients (26% vs. 17%), and it was higher among MS patients than among healthy controls (odds ratio, 3.96, 95% confidence interval, 3.29-4.77, P less than .001) (Sleep Med. 2018 Oct;50:97-104).

Ms. Cederberg said the frequency of RLS in patients with MS spurred her and colleagues to explore whether it may affect cognitive function.

For their study, the researchers surveyed 275 patients with MS (mean age = 60, 81% female, 33% employed, 95% white, 66% with relapsing-remitting MS). Of the 275, 75 appeared to have RLS. These patients were similar to the non-RLS patients in multiple areas, but they diverged in scores on the brief Multiple Sclerosis Neuropsychological Questionnaire, which measures self-perception of cognition.

Those with both MS and RLS scored 21.9 (± 11.7) on the test, while those with MS scored 18.0 (± 11.0), P = 0.023.

Analyses linked greater RLS severity to worse self-perceived cognitive impairment and sleep quality. “The diagnosis and treatment of RLS symptoms and other effectors of sleep quality could improve cognitive consequences of MS,” the authors concluded.

The National MS Society funded the study. The study authors reported no relevant disclosures.

SEATTLE – A new study finds that patients with both multiple sclerosis (MS) and restless legs syndrome (RLS) were more likely to suffer from self-perceived cognitive impairment. The results suggest that sleep dysfunction exacerbated by RLS could affect cognition in patients with MS, study lead author Katie L. Cederberg, CPT, a doctoral student in the department of physical therapy at the University of Alabama at Birmingham, said in an interview. She spoke at the annual meeting of the Consortium of Multiple Sclerosis Centers, where she presented the findings.

“RLS severity did predict cognitive impairment,” she said. However, she added, “this is just a snapshot, and we need to do more research.”

Sleep problems, including RLS, are more common in patients with MS than in the general population. “Current research suggests that anywhere from 19% to 67% of individuals with MS experience some sort of sleep difficulty, with rates as high as 80% in some samples,” a 2015 report noted.

As for RLS, a 2018 systematic review and meta-analysis found that “pooled RLS prevalence among MS patients of various ethnicities was 26%, and prevalence was lower in Asia (20%) than outside Asia (27%). Prevalence was higher among cross-sectional studies (30%) than among case-control studies (23%). RLS prevalence was higher among female than among male MS patients (26% vs. 17%), and it was higher among MS patients than among healthy controls (odds ratio, 3.96, 95% confidence interval, 3.29-4.77, P less than .001) (Sleep Med. 2018 Oct;50:97-104).

Ms. Cederberg said the frequency of RLS in patients with MS spurred her and colleagues to explore whether it may affect cognitive function.

For their study, the researchers surveyed 275 patients with MS (mean age = 60, 81% female, 33% employed, 95% white, 66% with relapsing-remitting MS). Of the 275, 75 appeared to have RLS. These patients were similar to the non-RLS patients in multiple areas, but they diverged in scores on the brief Multiple Sclerosis Neuropsychological Questionnaire, which measures self-perception of cognition.

Those with both MS and RLS scored 21.9 (± 11.7) on the test, while those with MS scored 18.0 (± 11.0), P = 0.023.

Analyses linked greater RLS severity to worse self-perceived cognitive impairment and sleep quality. “The diagnosis and treatment of RLS symptoms and other effectors of sleep quality could improve cognitive consequences of MS,” the authors concluded.

The National MS Society funded the study. The study authors reported no relevant disclosures.

SEATTLE – Researchers are working on new tools to objectively measure several domains affected by multiple sclerosis (MS) in hope of improving patient care, according to Jared Srinivasan.

Mr. Srinivasan, a research coordinator at South Shore Neurologic Associates in Patchogue, N.Y., sat down at the annual meeting of the Consortium of Multiple Sclerosis Centers for a video interview summarizing his work on new measurement tools for assessing disease status in MS patients with Mark Gudesblatt, MD, and other colleagues at South Shore Neurologic Associates.

“We are trying to find better ways of measuring disease status, rather than the EDSS [Expanded Disability Status Scale] ... It is not as sensitive as some other measures can be,” Mr. Srinivasan said. “We are trying to shed light on some new tools regarding objectively measuring cognition, manual dexterity, gait, and ocular coherence tomography.”

The overall goal, he said, “is to use a combination of these granular outcome measures to create a bigger picture of a patient’s disease so we can better treat them.”

One of the tools is called Neurotrax, which measures cognition in multiple dimensions (e.g., attention, information processing, motor skills, verbal functioning). With this and other new tools for manual dexterity and its cognitive aspects, as well as other dimensions of MS, the researchers are trying capture a fuller picture of MS in individual patients.

“The end goal of this is that if we can show that MS is such a complex disease that the current tools we are using do not quite capture the full nuances and granularity in it, then we can move toward using better measures that will capture that, which will move patient care forward.”

Mr. Srinivasan had nothing to disclose.

[email protected]

SEATTLE – Researchers are working on new tools to objectively measure several domains affected by multiple sclerosis (MS) in hope of improving patient care, according to Jared Srinivasan.

Mr. Srinivasan, a research coordinator at South Shore Neurologic Associates in Patchogue, N.Y., sat down at the annual meeting of the Consortium of Multiple Sclerosis Centers for a video interview summarizing his work on new measurement tools for assessing disease status in MS patients with Mark Gudesblatt, MD, and other colleagues at South Shore Neurologic Associates.

“We are trying to find better ways of measuring disease status, rather than the EDSS [Expanded Disability Status Scale] ... It is not as sensitive as some other measures can be,” Mr. Srinivasan said. “We are trying to shed light on some new tools regarding objectively measuring cognition, manual dexterity, gait, and ocular coherence tomography.”

The overall goal, he said, “is to use a combination of these granular outcome measures to create a bigger picture of a patient’s disease so we can better treat them.”

One of the tools is called Neurotrax, which measures cognition in multiple dimensions (e.g., attention, information processing, motor skills, verbal functioning). With this and other new tools for manual dexterity and its cognitive aspects, as well as other dimensions of MS, the researchers are trying capture a fuller picture of MS in individual patients.

“The end goal of this is that if we can show that MS is such a complex disease that the current tools we are using do not quite capture the full nuances and granularity in it, then we can move toward using better measures that will capture that, which will move patient care forward.”

Mr. Srinivasan had nothing to disclose.

[email protected]

SEATTLE – Researchers are working on new tools to objectively measure several domains affected by multiple sclerosis (MS) in hope of improving patient care, according to Jared Srinivasan.

Mr. Srinivasan, a research coordinator at South Shore Neurologic Associates in Patchogue, N.Y., sat down at the annual meeting of the Consortium of Multiple Sclerosis Centers for a video interview summarizing his work on new measurement tools for assessing disease status in MS patients with Mark Gudesblatt, MD, and other colleagues at South Shore Neurologic Associates.

“We are trying to find better ways of measuring disease status, rather than the EDSS [Expanded Disability Status Scale] ... It is not as sensitive as some other measures can be,” Mr. Srinivasan said. “We are trying to shed light on some new tools regarding objectively measuring cognition, manual dexterity, gait, and ocular coherence tomography.”

The overall goal, he said, “is to use a combination of these granular outcome measures to create a bigger picture of a patient’s disease so we can better treat them.”

One of the tools is called Neurotrax, which measures cognition in multiple dimensions (e.g., attention, information processing, motor skills, verbal functioning). With this and other new tools for manual dexterity and its cognitive aspects, as well as other dimensions of MS, the researchers are trying capture a fuller picture of MS in individual patients.

“The end goal of this is that if we can show that MS is such a complex disease that the current tools we are using do not quite capture the full nuances and granularity in it, then we can move toward using better measures that will capture that, which will move patient care forward.”

Mr. Srinivasan had nothing to disclose.

[email protected]

SEATTLE – Patients with multiple sclerosis (MS) may be able to improve cognitive function through a brief course in mindfulness meditation, a new report suggests.

“The present study demonstrated significant improvement in processing speed, a core area of impairment in individuals with MS, following 4 weeks of mindfulness meditation,” said lead author Heena R. Manglani, a graduate student at the Ohio State University, Columbus. She spoke in an interview and in a presentation about the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

An estimated 43%-70% of people with MS experience cognitive decline. This decline “has a sophisticated neuroanatomic and pathophysiologic background and disturbs such vital cognitive domains as speed of information processing, memory, attention, executive functions, and visual perceptual function,” reported the authors of a 2017 review (Rev Neurosci. 2017 Nov 27;28[8]:845-860).

For the new study, researchers tested two strategies for cognitive enhancement in patients with MS. All study participants were aged 31-59 years and relapse free within the previous 30 days; most had relapsing remitting MS, and most did not show signs of cognitive decline.

The researchers assigned 20 patients to a 4-week adaptive computerized cognitive training program and 20 patients to a 4-week mindfulness meditation training program. Another 21 patients were assigned to a control group.

The adaptive training program relied on computerized games designed to boost processing speed, attention, and working memory. The mindfulness training focused on components such as awareness of breathing and of bodily sensations.

Researchers found that “the magnitude of cognitive gain from pre- to post training was greatest in participants in the mindfulness group, who did better than participants in either of the other two groups,” Ms. Manglani said.

Compared with the adaptive cognitive training and the control group, she said, the mindfulness meditation group showed statistically significant improvement in processing speed per scores on the Symbol Digit Modalities Test, which rose from 52.2 before training to 58.4 post training.

The interventions did not appear to have any effect on Paced Auditory Serial Addition scores, which measure working memory.

The findings suggest that “less than 20 hours of mindfulness may be effective in significantly improving processing speed in MS,” Ms. Manglani said. “It is much shorter than a typically delivered program. We hypothesize that you are training attention with mindfulness training. Attention has a lot of overlap with processing speed.”

Ms. Manglani noted that this was a pilot study, and she acknowledged that fairly few participants – only five or six in each group – showed signs of cognitive decline. The study also did not explore whether cognitive improvements translated to real-life changes in cognition.

“This effect needs to be replicated in a larger sample,” Ms. Manglani said, “and future studies are needed to establish the lasting effects of such training and how improvements in cognitive function may generalize to greater engagement in vocational and leisure activities and higher quality of life.”

The study was funded by the National Multiple Sclerosis Society and the National Institutes of Health. The authors reported no relevant disclosures except for one coauthor who received honoraria from Sanofi Genzyme and funding from the National Multiple Sclerosis Society and the NIH.
 

SEATTLE – Patients with multiple sclerosis (MS) may be able to improve cognitive function through a brief course in mindfulness meditation, a new report suggests.

“The present study demonstrated significant improvement in processing speed, a core area of impairment in individuals with MS, following 4 weeks of mindfulness meditation,” said lead author Heena R. Manglani, a graduate student at the Ohio State University, Columbus. She spoke in an interview and in a presentation about the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

An estimated 43%-70% of people with MS experience cognitive decline. This decline “has a sophisticated neuroanatomic and pathophysiologic background and disturbs such vital cognitive domains as speed of information processing, memory, attention, executive functions, and visual perceptual function,” reported the authors of a 2017 review (Rev Neurosci. 2017 Nov 27;28[8]:845-860).

For the new study, researchers tested two strategies for cognitive enhancement in patients with MS. All study participants were aged 31-59 years and relapse free within the previous 30 days; most had relapsing remitting MS, and most did not show signs of cognitive decline.

The researchers assigned 20 patients to a 4-week adaptive computerized cognitive training program and 20 patients to a 4-week mindfulness meditation training program. Another 21 patients were assigned to a control group.

The adaptive training program relied on computerized games designed to boost processing speed, attention, and working memory. The mindfulness training focused on components such as awareness of breathing and of bodily sensations.

Researchers found that “the magnitude of cognitive gain from pre- to post training was greatest in participants in the mindfulness group, who did better than participants in either of the other two groups,” Ms. Manglani said.

Compared with the adaptive cognitive training and the control group, she said, the mindfulness meditation group showed statistically significant improvement in processing speed per scores on the Symbol Digit Modalities Test, which rose from 52.2 before training to 58.4 post training.

The interventions did not appear to have any effect on Paced Auditory Serial Addition scores, which measure working memory.

The findings suggest that “less than 20 hours of mindfulness may be effective in significantly improving processing speed in MS,” Ms. Manglani said. “It is much shorter than a typically delivered program. We hypothesize that you are training attention with mindfulness training. Attention has a lot of overlap with processing speed.”

Ms. Manglani noted that this was a pilot study, and she acknowledged that fairly few participants – only five or six in each group – showed signs of cognitive decline. The study also did not explore whether cognitive improvements translated to real-life changes in cognition.

“This effect needs to be replicated in a larger sample,” Ms. Manglani said, “and future studies are needed to establish the lasting effects of such training and how improvements in cognitive function may generalize to greater engagement in vocational and leisure activities and higher quality of life.”

The study was funded by the National Multiple Sclerosis Society and the National Institutes of Health. The authors reported no relevant disclosures except for one coauthor who received honoraria from Sanofi Genzyme and funding from the National Multiple Sclerosis Society and the NIH.
 

SEATTLE – Patients with multiple sclerosis (MS) may be able to improve cognitive function through a brief course in mindfulness meditation, a new report suggests.

“The present study demonstrated significant improvement in processing speed, a core area of impairment in individuals with MS, following 4 weeks of mindfulness meditation,” said lead author Heena R. Manglani, a graduate student at the Ohio State University, Columbus. She spoke in an interview and in a presentation about the study findings at the annual meeting of the Consortium of Multiple Sclerosis Centers.

An estimated 43%-70% of people with MS experience cognitive decline. This decline “has a sophisticated neuroanatomic and pathophysiologic background and disturbs such vital cognitive domains as speed of information processing, memory, attention, executive functions, and visual perceptual function,” reported the authors of a 2017 review (Rev Neurosci. 2017 Nov 27;28[8]:845-860).

For the new study, researchers tested two strategies for cognitive enhancement in patients with MS. All study participants were aged 31-59 years and relapse free within the previous 30 days; most had relapsing remitting MS, and most did not show signs of cognitive decline.

The researchers assigned 20 patients to a 4-week adaptive computerized cognitive training program and 20 patients to a 4-week mindfulness meditation training program. Another 21 patients were assigned to a control group.

The adaptive training program relied on computerized games designed to boost processing speed, attention, and working memory. The mindfulness training focused on components such as awareness of breathing and of bodily sensations.

Researchers found that “the magnitude of cognitive gain from pre- to post training was greatest in participants in the mindfulness group, who did better than participants in either of the other two groups,” Ms. Manglani said.

Compared with the adaptive cognitive training and the control group, she said, the mindfulness meditation group showed statistically significant improvement in processing speed per scores on the Symbol Digit Modalities Test, which rose from 52.2 before training to 58.4 post training.

The interventions did not appear to have any effect on Paced Auditory Serial Addition scores, which measure working memory.

The findings suggest that “less than 20 hours of mindfulness may be effective in significantly improving processing speed in MS,” Ms. Manglani said. “It is much shorter than a typically delivered program. We hypothesize that you are training attention with mindfulness training. Attention has a lot of overlap with processing speed.”

Ms. Manglani noted that this was a pilot study, and she acknowledged that fairly few participants – only five or six in each group – showed signs of cognitive decline. The study also did not explore whether cognitive improvements translated to real-life changes in cognition.

“This effect needs to be replicated in a larger sample,” Ms. Manglani said, “and future studies are needed to establish the lasting effects of such training and how improvements in cognitive function may generalize to greater engagement in vocational and leisure activities and higher quality of life.”

The study was funded by the National Multiple Sclerosis Society and the National Institutes of Health. The authors reported no relevant disclosures except for one coauthor who received honoraria from Sanofi Genzyme and funding from the National Multiple Sclerosis Society and the NIH.