VIDEO: Let clinical scenario, not imaging, guide sarcoidosis treatment

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Mon, 01/14/2019 - 10:23

 

– Don’t be a slave to imaging when evaluating the patient with sarcoidosis.

“Sometimes, the worst-looking patients [on imaging] have the best prognosis,” Daniel Culver, DO, said at the annual Congress of Clinical Rheumatology. Patients with Löfgren’s syndrome are a very good example of this tenet, he said in an interview. Scans can look alarming, with multiple widespread granulomas. But Löfgren’s is generally a benign condition, despite its threatening mien.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


Instead of imaging, “Let two things drive your decision to treat: danger to an organ, and quality of life,” said Dr. Culver, a pulmonologist and director of the Sarcoidosis Center of Excellence at the Cleveland Clinic in Ohio; he is also president of the World Association for Sarcoidosis.

He agrees with a decision schema published in 2015 (Clin Chest Med. 2015;36[4]:751-67).

Six factors weigh in favor of treatment:

  • Symptomatic disease.
  • Impaired organ function.
  • Disease endangering an organ.
  • Progressive disease.
  • Clear-cut disease activity.
  • Low likelihood of remission.

These must be balanced – with patient input as the fulcrum – against five factors that favor conservative management:

  • Minimal symptoms.
  • Good organ function.
  • Low risk of danger to organs.
  • Inactive disease.
  • Higher likelihood of remission.

The decision to embark on a treatment program, usually starting with a steroid-based regimen, can’t be taken lightly, Dr. Culver said. A 2017 study showed that steroids pose a cumulative risk of toxicities for sarcoidosis patients (Respir Med. 2017 Nov;132:9-14). Patients who started steroids faced more than a doubling in the risk of a toxic side effect by 96 months when compared with those who didn’t. But even short-term steroid use increased the risk of a toxicity, Dr. Culver said. The study noted that problems can begin to occur in as little as 1 month, at a cumulative dose as low as 1 g.

 

 


For patients who fall onto the “treat” side of the risk teeter-totter, Dr. Culver recommended starting with an initial course of prednisone at 20-30 mg daily for no more than 4 weeks. Responders can taper to less than 10 mg/day. Those who continue to do well can maintain low-dose prednisone for up to 12 months and then complete the taper. Patients who relapse can add an immune modulator (methotrexate, azathioprine, leflunomide, or mycophenolate).

Those who have an inadequate response to the initial prednisone course should then get an immune modulator. If they do well, that can be maintained; a second modulator can be brought on board if necessary.

For those who don’t respond at all to the initial prednisone course, it’s necessary to proceed immediately to an immunosuppressive regimen to prevent irreversible fibrosis.

Dr. Culver noted associations with multiple pharmaceutical companies, but said none were relevant to his talk.

SOURCE: Culver D. CCR 2018.

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– Don’t be a slave to imaging when evaluating the patient with sarcoidosis.

“Sometimes, the worst-looking patients [on imaging] have the best prognosis,” Daniel Culver, DO, said at the annual Congress of Clinical Rheumatology. Patients with Löfgren’s syndrome are a very good example of this tenet, he said in an interview. Scans can look alarming, with multiple widespread granulomas. But Löfgren’s is generally a benign condition, despite its threatening mien.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


Instead of imaging, “Let two things drive your decision to treat: danger to an organ, and quality of life,” said Dr. Culver, a pulmonologist and director of the Sarcoidosis Center of Excellence at the Cleveland Clinic in Ohio; he is also president of the World Association for Sarcoidosis.

He agrees with a decision schema published in 2015 (Clin Chest Med. 2015;36[4]:751-67).

Six factors weigh in favor of treatment:

  • Symptomatic disease.
  • Impaired organ function.
  • Disease endangering an organ.
  • Progressive disease.
  • Clear-cut disease activity.
  • Low likelihood of remission.

These must be balanced – with patient input as the fulcrum – against five factors that favor conservative management:

  • Minimal symptoms.
  • Good organ function.
  • Low risk of danger to organs.
  • Inactive disease.
  • Higher likelihood of remission.

The decision to embark on a treatment program, usually starting with a steroid-based regimen, can’t be taken lightly, Dr. Culver said. A 2017 study showed that steroids pose a cumulative risk of toxicities for sarcoidosis patients (Respir Med. 2017 Nov;132:9-14). Patients who started steroids faced more than a doubling in the risk of a toxic side effect by 96 months when compared with those who didn’t. But even short-term steroid use increased the risk of a toxicity, Dr. Culver said. The study noted that problems can begin to occur in as little as 1 month, at a cumulative dose as low as 1 g.

 

 


For patients who fall onto the “treat” side of the risk teeter-totter, Dr. Culver recommended starting with an initial course of prednisone at 20-30 mg daily for no more than 4 weeks. Responders can taper to less than 10 mg/day. Those who continue to do well can maintain low-dose prednisone for up to 12 months and then complete the taper. Patients who relapse can add an immune modulator (methotrexate, azathioprine, leflunomide, or mycophenolate).

Those who have an inadequate response to the initial prednisone course should then get an immune modulator. If they do well, that can be maintained; a second modulator can be brought on board if necessary.

For those who don’t respond at all to the initial prednisone course, it’s necessary to proceed immediately to an immunosuppressive regimen to prevent irreversible fibrosis.

Dr. Culver noted associations with multiple pharmaceutical companies, but said none were relevant to his talk.

SOURCE: Culver D. CCR 2018.

 

– Don’t be a slave to imaging when evaluating the patient with sarcoidosis.

“Sometimes, the worst-looking patients [on imaging] have the best prognosis,” Daniel Culver, DO, said at the annual Congress of Clinical Rheumatology. Patients with Löfgren’s syndrome are a very good example of this tenet, he said in an interview. Scans can look alarming, with multiple widespread granulomas. But Löfgren’s is generally a benign condition, despite its threatening mien.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


Instead of imaging, “Let two things drive your decision to treat: danger to an organ, and quality of life,” said Dr. Culver, a pulmonologist and director of the Sarcoidosis Center of Excellence at the Cleveland Clinic in Ohio; he is also president of the World Association for Sarcoidosis.

He agrees with a decision schema published in 2015 (Clin Chest Med. 2015;36[4]:751-67).

Six factors weigh in favor of treatment:

  • Symptomatic disease.
  • Impaired organ function.
  • Disease endangering an organ.
  • Progressive disease.
  • Clear-cut disease activity.
  • Low likelihood of remission.

These must be balanced – with patient input as the fulcrum – against five factors that favor conservative management:

  • Minimal symptoms.
  • Good organ function.
  • Low risk of danger to organs.
  • Inactive disease.
  • Higher likelihood of remission.

The decision to embark on a treatment program, usually starting with a steroid-based regimen, can’t be taken lightly, Dr. Culver said. A 2017 study showed that steroids pose a cumulative risk of toxicities for sarcoidosis patients (Respir Med. 2017 Nov;132:9-14). Patients who started steroids faced more than a doubling in the risk of a toxic side effect by 96 months when compared with those who didn’t. But even short-term steroid use increased the risk of a toxicity, Dr. Culver said. The study noted that problems can begin to occur in as little as 1 month, at a cumulative dose as low as 1 g.

 

 


For patients who fall onto the “treat” side of the risk teeter-totter, Dr. Culver recommended starting with an initial course of prednisone at 20-30 mg daily for no more than 4 weeks. Responders can taper to less than 10 mg/day. Those who continue to do well can maintain low-dose prednisone for up to 12 months and then complete the taper. Patients who relapse can add an immune modulator (methotrexate, azathioprine, leflunomide, or mycophenolate).

Those who have an inadequate response to the initial prednisone course should then get an immune modulator. If they do well, that can be maintained; a second modulator can be brought on board if necessary.

For those who don’t respond at all to the initial prednisone course, it’s necessary to proceed immediately to an immunosuppressive regimen to prevent irreversible fibrosis.

Dr. Culver noted associations with multiple pharmaceutical companies, but said none were relevant to his talk.

SOURCE: Culver D. CCR 2018.

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Drug-related deaths continue to rise in United States

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Fri, 01/18/2019 - 17:40

 

– Drug-related deaths in America are rising faster than ever.

Rear Adm. Wanda D. Barfield, MD shared recent data from the U.S. National Center for Health Statistics on people aged 15 years and older at the Pediatric Academic Societies annual meeting. Between 1999 and 2016, for example, the number of drug overdose deaths rose more than threefold, from 6.1/100,000 standard population in 1999 to 19.8/100,000 in 2016. For males, the rate increased from 8.2/100,000 in 1999 to 26.2/100,000 in 2016. For females, the rate increased from 3.9/100,000 in 1999 to 13.4/100,000 in 2016.

Fuse/Thinkstock

Dr. Barfield, director of the division of reproductive health at the Centers for Disease Control and Prevention, said that in 2016, the NCHS also found that 22 states and the District of Columbia had drug overdoses that were significantly higher than the national average. The states with the highest number of drug overdose deaths were the District of Columbia, New Hampshire, Pennsylvania, and West Virginia while the states with the lowest observed rates were Nebraska, North Dakota, South Dakota, and Texas.

“Many of these drug overdose deaths are linked to opioids, but not exclusively,” Dr. Barfield said. “In the past, the overall opioid-related overdose deaths were mainly attributed to commonly prescribed opioid medications. However, in recent years, we’re seeing more deaths due to illicit drugs such as heroin and fentanyl.”

The NCHS found that the age-adjusted rate for drug overdose deaths involving synthetic opioids other than methadone doubled from 2015 to 2016, and that drug overdose deaths involving synthetic opioids other than methadone increased from 0.3/100,000 in 1999 to 6.2/100,000 in 2016. The rate increased an average of 18% per year from 1999 to 2006, remained steady from 2006 to 2013, but increased by 88% per year from 2013 to 2016. At the same time, drug overdose deaths involving heroin increased from 0.7/100,000 in 1999 to 1/100,000 in 2010, to 4.9/100,000 in 2016.

According to Dr. Barfield, the spike in opioid use since 1999 stems directly from increased prescribing rates. “In 2015, the number of opioids prescribed was enough so that every American could be medicated around the clock for 3 weeks,” she said. “In addition to the number of prescriptions, the average day’s supply of prescription opioids increased from 2006 to 2015, from 13.3 days in 2006 to 17.7 days in 2015.” What’s more, a recent CDC Vital Signs found that the amount of opioids prescribed per person varied widely among U.S. counties in 2015. “The wide variation among counties suggests a lack of consistency among providers when prescribing opioids,” Dr. Barfield said. “It’s concerning, as higher opioid prescribing puts patients at risk for addiction.”

At the same time, opioid overdose ED visits continue to rise. Data from the CDC’s National Syndromic Surveillance Program found that from July 2016 to September 2017, opioid overdose ED visits increased by 30% for men, by 24% for women, and for all adult age groups (31% among those aged 25-34 years, 36% among those aged 35-54 years, and 32% among those aged 55 years and older).

 

 



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There’s a problem of prescription opioid use among pregnant women. Published estimates indicate that 14%-22% of women filled an opioid prescription during pregnancy, Dr. Barfield said. Among pregnant women, the prevalence of maternal opioid use or dependence during hospitalization for delivery has increased 127%, from 1.7 /1,000 delivery admissions in 1998 to 3.9/1,000 delivery admissions in 2011 (Anesthesiology 2014;121[6]:1158-65). There also has been a significant increase in neonatal abstinence syndrome (NAS), which is most commonly attributed to opioid exposure during pregnancy, from 1.2/1,000 U.S. hospital births in 2000 to 8/1,000 U.S. hospital births in 2014. “NAS is still on the rise,” Dr. Barfield said. “In 2012, we saw one baby with NAS born every 25 minutes. In 2014, that number jumped to one baby born with NAS every 15 minutes. That means about 96 infants with NAS are born daily,” she said. “Where do you think we’re going to be when we look at 2018 data?”
 

Role for pediatricians

Dr. Barfield closed her presentation by underscoring the role pediatricians play in counseling patients about opioid abuse or dependence during pregnancy. “We know that providers have a tremendous impact on patients and their families,” she said. “We also know that issues leading to a newborn having NAS are complex, so adopting a public health approach focused on prevention, expansion of treatment, and improvements in child welfare systems is vital.” Specifically, she said, health care providers can “bridge the gap” between clinical care and public health; lead in their communities, not just within their hospital or practice; work as a team member with colleagues in other fields of medicine such as obstetrics, family medicine, and addiction care when caring for infants with NAS, and by considering the social determinants of health.

“One way to adopt a public health perspective is to remember that the health of the fetus and baby rely on more than just prenatal care,” Dr. Barfield said. “We’re all part of a larger whole, surrounded by our families, communities, regions, state, and even our countries of origin. What’s going on with the mom, her family, and the larger community impacts the baby’s health. In other words, the social determinants of health matter, and are an important part of the conversation on NAS.”

She reported having no financial disclosures.

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– Drug-related deaths in America are rising faster than ever.

Rear Adm. Wanda D. Barfield, MD shared recent data from the U.S. National Center for Health Statistics on people aged 15 years and older at the Pediatric Academic Societies annual meeting. Between 1999 and 2016, for example, the number of drug overdose deaths rose more than threefold, from 6.1/100,000 standard population in 1999 to 19.8/100,000 in 2016. For males, the rate increased from 8.2/100,000 in 1999 to 26.2/100,000 in 2016. For females, the rate increased from 3.9/100,000 in 1999 to 13.4/100,000 in 2016.

Fuse/Thinkstock

Dr. Barfield, director of the division of reproductive health at the Centers for Disease Control and Prevention, said that in 2016, the NCHS also found that 22 states and the District of Columbia had drug overdoses that were significantly higher than the national average. The states with the highest number of drug overdose deaths were the District of Columbia, New Hampshire, Pennsylvania, and West Virginia while the states with the lowest observed rates were Nebraska, North Dakota, South Dakota, and Texas.

“Many of these drug overdose deaths are linked to opioids, but not exclusively,” Dr. Barfield said. “In the past, the overall opioid-related overdose deaths were mainly attributed to commonly prescribed opioid medications. However, in recent years, we’re seeing more deaths due to illicit drugs such as heroin and fentanyl.”

The NCHS found that the age-adjusted rate for drug overdose deaths involving synthetic opioids other than methadone doubled from 2015 to 2016, and that drug overdose deaths involving synthetic opioids other than methadone increased from 0.3/100,000 in 1999 to 6.2/100,000 in 2016. The rate increased an average of 18% per year from 1999 to 2006, remained steady from 2006 to 2013, but increased by 88% per year from 2013 to 2016. At the same time, drug overdose deaths involving heroin increased from 0.7/100,000 in 1999 to 1/100,000 in 2010, to 4.9/100,000 in 2016.

According to Dr. Barfield, the spike in opioid use since 1999 stems directly from increased prescribing rates. “In 2015, the number of opioids prescribed was enough so that every American could be medicated around the clock for 3 weeks,” she said. “In addition to the number of prescriptions, the average day’s supply of prescription opioids increased from 2006 to 2015, from 13.3 days in 2006 to 17.7 days in 2015.” What’s more, a recent CDC Vital Signs found that the amount of opioids prescribed per person varied widely among U.S. counties in 2015. “The wide variation among counties suggests a lack of consistency among providers when prescribing opioids,” Dr. Barfield said. “It’s concerning, as higher opioid prescribing puts patients at risk for addiction.”

At the same time, opioid overdose ED visits continue to rise. Data from the CDC’s National Syndromic Surveillance Program found that from July 2016 to September 2017, opioid overdose ED visits increased by 30% for men, by 24% for women, and for all adult age groups (31% among those aged 25-34 years, 36% among those aged 35-54 years, and 32% among those aged 55 years and older).

 

 



Creatas Images

There’s a problem of prescription opioid use among pregnant women. Published estimates indicate that 14%-22% of women filled an opioid prescription during pregnancy, Dr. Barfield said. Among pregnant women, the prevalence of maternal opioid use or dependence during hospitalization for delivery has increased 127%, from 1.7 /1,000 delivery admissions in 1998 to 3.9/1,000 delivery admissions in 2011 (Anesthesiology 2014;121[6]:1158-65). There also has been a significant increase in neonatal abstinence syndrome (NAS), which is most commonly attributed to opioid exposure during pregnancy, from 1.2/1,000 U.S. hospital births in 2000 to 8/1,000 U.S. hospital births in 2014. “NAS is still on the rise,” Dr. Barfield said. “In 2012, we saw one baby with NAS born every 25 minutes. In 2014, that number jumped to one baby born with NAS every 15 minutes. That means about 96 infants with NAS are born daily,” she said. “Where do you think we’re going to be when we look at 2018 data?”
 

Role for pediatricians

Dr. Barfield closed her presentation by underscoring the role pediatricians play in counseling patients about opioid abuse or dependence during pregnancy. “We know that providers have a tremendous impact on patients and their families,” she said. “We also know that issues leading to a newborn having NAS are complex, so adopting a public health approach focused on prevention, expansion of treatment, and improvements in child welfare systems is vital.” Specifically, she said, health care providers can “bridge the gap” between clinical care and public health; lead in their communities, not just within their hospital or practice; work as a team member with colleagues in other fields of medicine such as obstetrics, family medicine, and addiction care when caring for infants with NAS, and by considering the social determinants of health.

“One way to adopt a public health perspective is to remember that the health of the fetus and baby rely on more than just prenatal care,” Dr. Barfield said. “We’re all part of a larger whole, surrounded by our families, communities, regions, state, and even our countries of origin. What’s going on with the mom, her family, and the larger community impacts the baby’s health. In other words, the social determinants of health matter, and are an important part of the conversation on NAS.”

She reported having no financial disclosures.

 

– Drug-related deaths in America are rising faster than ever.

Rear Adm. Wanda D. Barfield, MD shared recent data from the U.S. National Center for Health Statistics on people aged 15 years and older at the Pediatric Academic Societies annual meeting. Between 1999 and 2016, for example, the number of drug overdose deaths rose more than threefold, from 6.1/100,000 standard population in 1999 to 19.8/100,000 in 2016. For males, the rate increased from 8.2/100,000 in 1999 to 26.2/100,000 in 2016. For females, the rate increased from 3.9/100,000 in 1999 to 13.4/100,000 in 2016.

Fuse/Thinkstock

Dr. Barfield, director of the division of reproductive health at the Centers for Disease Control and Prevention, said that in 2016, the NCHS also found that 22 states and the District of Columbia had drug overdoses that were significantly higher than the national average. The states with the highest number of drug overdose deaths were the District of Columbia, New Hampshire, Pennsylvania, and West Virginia while the states with the lowest observed rates were Nebraska, North Dakota, South Dakota, and Texas.

“Many of these drug overdose deaths are linked to opioids, but not exclusively,” Dr. Barfield said. “In the past, the overall opioid-related overdose deaths were mainly attributed to commonly prescribed opioid medications. However, in recent years, we’re seeing more deaths due to illicit drugs such as heroin and fentanyl.”

The NCHS found that the age-adjusted rate for drug overdose deaths involving synthetic opioids other than methadone doubled from 2015 to 2016, and that drug overdose deaths involving synthetic opioids other than methadone increased from 0.3/100,000 in 1999 to 6.2/100,000 in 2016. The rate increased an average of 18% per year from 1999 to 2006, remained steady from 2006 to 2013, but increased by 88% per year from 2013 to 2016. At the same time, drug overdose deaths involving heroin increased from 0.7/100,000 in 1999 to 1/100,000 in 2010, to 4.9/100,000 in 2016.

According to Dr. Barfield, the spike in opioid use since 1999 stems directly from increased prescribing rates. “In 2015, the number of opioids prescribed was enough so that every American could be medicated around the clock for 3 weeks,” she said. “In addition to the number of prescriptions, the average day’s supply of prescription opioids increased from 2006 to 2015, from 13.3 days in 2006 to 17.7 days in 2015.” What’s more, a recent CDC Vital Signs found that the amount of opioids prescribed per person varied widely among U.S. counties in 2015. “The wide variation among counties suggests a lack of consistency among providers when prescribing opioids,” Dr. Barfield said. “It’s concerning, as higher opioid prescribing puts patients at risk for addiction.”

At the same time, opioid overdose ED visits continue to rise. Data from the CDC’s National Syndromic Surveillance Program found that from July 2016 to September 2017, opioid overdose ED visits increased by 30% for men, by 24% for women, and for all adult age groups (31% among those aged 25-34 years, 36% among those aged 35-54 years, and 32% among those aged 55 years and older).

 

 



Creatas Images

There’s a problem of prescription opioid use among pregnant women. Published estimates indicate that 14%-22% of women filled an opioid prescription during pregnancy, Dr. Barfield said. Among pregnant women, the prevalence of maternal opioid use or dependence during hospitalization for delivery has increased 127%, from 1.7 /1,000 delivery admissions in 1998 to 3.9/1,000 delivery admissions in 2011 (Anesthesiology 2014;121[6]:1158-65). There also has been a significant increase in neonatal abstinence syndrome (NAS), which is most commonly attributed to opioid exposure during pregnancy, from 1.2/1,000 U.S. hospital births in 2000 to 8/1,000 U.S. hospital births in 2014. “NAS is still on the rise,” Dr. Barfield said. “In 2012, we saw one baby with NAS born every 25 minutes. In 2014, that number jumped to one baby born with NAS every 15 minutes. That means about 96 infants with NAS are born daily,” she said. “Where do you think we’re going to be when we look at 2018 data?”
 

Role for pediatricians

Dr. Barfield closed her presentation by underscoring the role pediatricians play in counseling patients about opioid abuse or dependence during pregnancy. “We know that providers have a tremendous impact on patients and their families,” she said. “We also know that issues leading to a newborn having NAS are complex, so adopting a public health approach focused on prevention, expansion of treatment, and improvements in child welfare systems is vital.” Specifically, she said, health care providers can “bridge the gap” between clinical care and public health; lead in their communities, not just within their hospital or practice; work as a team member with colleagues in other fields of medicine such as obstetrics, family medicine, and addiction care when caring for infants with NAS, and by considering the social determinants of health.

“One way to adopt a public health perspective is to remember that the health of the fetus and baby rely on more than just prenatal care,” Dr. Barfield said. “We’re all part of a larger whole, surrounded by our families, communities, regions, state, and even our countries of origin. What’s going on with the mom, her family, and the larger community impacts the baby’s health. In other words, the social determinants of health matter, and are an important part of the conversation on NAS.”

She reported having no financial disclosures.

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FDA approves Aimovig for migraine prevention

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The Food and Drug Administration has approved Aimovig (erenumab-aooe), delivered once a month via injection, for the prevention of migraines in adults.

Aimovig is the first FDA-approved treatment developed to prevent migraines by blocking the calcitonin gene–related peptide receptor.

Wikimedia Commons/FitzColinGerald/Creative Commons License
Approval for the drug was based on results from three clinical trials. In the first, which included 955 patients with episodic migraine, patients treated with Aimovig over a 6-month period had, on average, 1-2 fewer migraine days per month than those who received placebo. In the second, which included 577 patients with episodic migraine, those treated with Aimovig over a 3-month period had, on average, 1 fewer migraine day per month versus those who received placebo.

The final clinical trial included 667 chronic migraine patients, and over a 3-month period, those treated with Aimovig had, on average, 2.5 fewer migraine days per month, compared with those who received placebo.

The most commonly reported adverse events were injection-site reactions and constipation.

“Aimovig provides patients with a novel option for reducing the number of days with migraine. We need new treatments for this painful and often debilitating condition,” Eric Bastings, MD, deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the press release.

Find the full press release on the FDA website.

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The Food and Drug Administration has approved Aimovig (erenumab-aooe), delivered once a month via injection, for the prevention of migraines in adults.

Aimovig is the first FDA-approved treatment developed to prevent migraines by blocking the calcitonin gene–related peptide receptor.

Wikimedia Commons/FitzColinGerald/Creative Commons License
Approval for the drug was based on results from three clinical trials. In the first, which included 955 patients with episodic migraine, patients treated with Aimovig over a 6-month period had, on average, 1-2 fewer migraine days per month than those who received placebo. In the second, which included 577 patients with episodic migraine, those treated with Aimovig over a 3-month period had, on average, 1 fewer migraine day per month versus those who received placebo.

The final clinical trial included 667 chronic migraine patients, and over a 3-month period, those treated with Aimovig had, on average, 2.5 fewer migraine days per month, compared with those who received placebo.

The most commonly reported adverse events were injection-site reactions and constipation.

“Aimovig provides patients with a novel option for reducing the number of days with migraine. We need new treatments for this painful and often debilitating condition,” Eric Bastings, MD, deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the press release.

Find the full press release on the FDA website.

 

The Food and Drug Administration has approved Aimovig (erenumab-aooe), delivered once a month via injection, for the prevention of migraines in adults.

Aimovig is the first FDA-approved treatment developed to prevent migraines by blocking the calcitonin gene–related peptide receptor.

Wikimedia Commons/FitzColinGerald/Creative Commons License
Approval for the drug was based on results from three clinical trials. In the first, which included 955 patients with episodic migraine, patients treated with Aimovig over a 6-month period had, on average, 1-2 fewer migraine days per month than those who received placebo. In the second, which included 577 patients with episodic migraine, those treated with Aimovig over a 3-month period had, on average, 1 fewer migraine day per month versus those who received placebo.

The final clinical trial included 667 chronic migraine patients, and over a 3-month period, those treated with Aimovig had, on average, 2.5 fewer migraine days per month, compared with those who received placebo.

The most commonly reported adverse events were injection-site reactions and constipation.

“Aimovig provides patients with a novel option for reducing the number of days with migraine. We need new treatments for this painful and often debilitating condition,” Eric Bastings, MD, deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in the press release.

Find the full press release on the FDA website.

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FDA warns of birth defect risks from dolutegravir

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The Food and Drug Administration has issued a Drug Safety Communication alert that serious cases of neural tube birth defects have been reported in babies born to women treated with dolutegravir for human immunodeficiency virus. Reported defects have involved the brain, spine, and spinal cord.

copyright alexskopje/Thinkstock
Evidence of a higher risk of these defects was seen in the preliminary results of an ongoing observational study in Botswana of women treated with the drug from the initiation of pregnancy through early in the first trimester, a critical period in neural tube development. Such birth defects can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly.

To date, in this observational study, there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy, according to the FDA. “We are investigating this new safety issue and will update the public when we have more information,” the alert stated.

Dolutegravir is an FDA-approved antiretroviral used to treat HIV. The drug is available as a single ingredient under the brand name Tivicay and as a combination tablet with other HIV medicines under the brand names Juluca and Triumeq.

Medwatch also released an alert for medical practitioners to report adverse events related to this issue.

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The Food and Drug Administration has issued a Drug Safety Communication alert that serious cases of neural tube birth defects have been reported in babies born to women treated with dolutegravir for human immunodeficiency virus. Reported defects have involved the brain, spine, and spinal cord.

copyright alexskopje/Thinkstock
Evidence of a higher risk of these defects was seen in the preliminary results of an ongoing observational study in Botswana of women treated with the drug from the initiation of pregnancy through early in the first trimester, a critical period in neural tube development. Such birth defects can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly.

To date, in this observational study, there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy, according to the FDA. “We are investigating this new safety issue and will update the public when we have more information,” the alert stated.

Dolutegravir is an FDA-approved antiretroviral used to treat HIV. The drug is available as a single ingredient under the brand name Tivicay and as a combination tablet with other HIV medicines under the brand names Juluca and Triumeq.

Medwatch also released an alert for medical practitioners to report adverse events related to this issue.

 

The Food and Drug Administration has issued a Drug Safety Communication alert that serious cases of neural tube birth defects have been reported in babies born to women treated with dolutegravir for human immunodeficiency virus. Reported defects have involved the brain, spine, and spinal cord.

copyright alexskopje/Thinkstock
Evidence of a higher risk of these defects was seen in the preliminary results of an ongoing observational study in Botswana of women treated with the drug from the initiation of pregnancy through early in the first trimester, a critical period in neural tube development. Such birth defects can occur early in pregnancy when the spinal cord, brain, and related structures do not form properly.

To date, in this observational study, there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy, according to the FDA. “We are investigating this new safety issue and will update the public when we have more information,” the alert stated.

Dolutegravir is an FDA-approved antiretroviral used to treat HIV. The drug is available as a single ingredient under the brand name Tivicay and as a combination tablet with other HIV medicines under the brand names Juluca and Triumeq.

Medwatch also released an alert for medical practitioners to report adverse events related to this issue.

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Legalization of marijuana debate moving away from medical need

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Wed, 03/27/2019 - 11:44

 

The risk curve of societal harm from marijuana when graphed from a policy of complete prohibition to one of unregulated access is U shaped, according to a panel of experts who participated in a workshop on the harms and benefits of cannabis at the annual meeting of the American Psychiatric Association.

Based on more than 80 years of experience, it is clear that prohibition supports criminal activity but does not eliminate use, said Jason Hershberger, MD, chair of the department of psychiatry at Brookdale University Hospital Medical Center, New York. With progressive degrees of decriminalization, the harms to society associated with criminal distribution and the criminalization of use decreases, but they are replaced with increasing societal risks imposed by the availability of an intoxicating substance.

Ted Bosworth/MDedge News
(From left) Dr. Jason E. Hershberger, Dr. Stephan M. Carlson, Dr. Manuel Lopez-Leon, and Dr. Jose P. Vitor
“From a public health perspective, there is an inflection point somewhere along this curve,” Dr. Hershberger said.

Theoretically, one argument is that the inflection point occurs where cannabis has been decriminalized for medical indications but prohibited for recreational use. But this is a tenuous position. Clinicians, including psychiatrists, might support the use of cannabis to reduce stress, but it is well known that the pleasant intoxication provided by cannabis is relaxing – whether or not this is characterized as stress relief.

“The conversation has to start with the basic realization that cannabis is perceived by many people to have beneficial effects,” reported Stephan M. Carlson, MD, who also is affiliated with Brookdale University Hospital Medical Center. Based on his belief that marijuana, after alcohol and tobacco, may soon be the third legal drug where it isn’t already, “physicians have just a temporary role” in mediating the debate about medical legalization from a legal or political standpoint. Why? Because this part of the debate is growing irrelevant.

This does not mean medical indications or medical harms are not valid topics of discussion, Dr. Hershberger and Dr. Carlson said. The problem is that recreational use is supplanting medical use as the central issue in making this drug available.

The road toward U.S. legalization started in 1996, when California voters approved the use of marijuana for medical indications. Other states followed. Then, in 2012, Colorado and Washington became the first states to approve the drug for recreational use. In total, 29 states now permit some form of legal use of marijuana. In addition, marijuana possession has been decriminalized in several states where it remains illegal.

 

 


“From the federal perspective, marijuana is still a Schedule I drug. This means that it is easier to conduct research on cocaine, which is a Schedule II drug, than it is on marijuana,” Dr. Hershberger said. While the current presidential administration has adopted a tougher stance on distribution and use of marijuana than the previous, more than 60% of Americans in surveys support decriminalization of marijuana, according to Dr. Hershberger. He suggested that the current acceptability of marijuana is the reason that a recent survey indicated that more U.S. high school seniors than ever before have tried marijuana.

In light of the perceptions that the marijuana ban was ineffective, that marijuana is acceptable, and that profits from marijuana sales and distributions have been going to criminals, depriving government of tax dollars, continued decriminalization appears to be inevitable, Dr. Hershberger said. However, he believes that complete deregulation poses important risk, including an inevitable increase in accidents produced by motor impairment. It is also reasonable to anticipate more substance use in vulnerable populations. The risk to the development of children and adolescents who are likely to gain easier access to cannabis is unknown.

For psychiatrists and other medical specialists who wish to participate in the debate about the degree to which marijuana is decriminalized, both Dr. Hershberger and Dr. Carlson argued that a clear and realistic view of the landscape is essential.

“One of the reasons we are in this state we are in is that many people have declared the war on drugs a failure,” Dr. Hershberger said. Although he acknowledged that recognizing the limited efficacy of a marijuana ban is a reasonable starting point for discussion, he also expressed concern about large corporations being permitted to market cannabis in a way that obscures its risks or encourages use by those at greatest risk of harm, such as minors.
 

 


“We have to ask ourselves, is America ready for a cannabis commercial during the Super Bowl?” Dr. Hershberger said. He believes that an important trade-off exists for risks regardless of the degree to which marijuana is legalized.

“We have to approach this in the context of our current reality,” Dr. Carlson agreed. He, like Dr. Hershberger, cautioned that there are no simple answers.

Dr. Hershberger and Dr. Carlson reported no potential conflicts of interest.
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The risk curve of societal harm from marijuana when graphed from a policy of complete prohibition to one of unregulated access is U shaped, according to a panel of experts who participated in a workshop on the harms and benefits of cannabis at the annual meeting of the American Psychiatric Association.

Based on more than 80 years of experience, it is clear that prohibition supports criminal activity but does not eliminate use, said Jason Hershberger, MD, chair of the department of psychiatry at Brookdale University Hospital Medical Center, New York. With progressive degrees of decriminalization, the harms to society associated with criminal distribution and the criminalization of use decreases, but they are replaced with increasing societal risks imposed by the availability of an intoxicating substance.

Ted Bosworth/MDedge News
(From left) Dr. Jason E. Hershberger, Dr. Stephan M. Carlson, Dr. Manuel Lopez-Leon, and Dr. Jose P. Vitor
“From a public health perspective, there is an inflection point somewhere along this curve,” Dr. Hershberger said.

Theoretically, one argument is that the inflection point occurs where cannabis has been decriminalized for medical indications but prohibited for recreational use. But this is a tenuous position. Clinicians, including psychiatrists, might support the use of cannabis to reduce stress, but it is well known that the pleasant intoxication provided by cannabis is relaxing – whether or not this is characterized as stress relief.

“The conversation has to start with the basic realization that cannabis is perceived by many people to have beneficial effects,” reported Stephan M. Carlson, MD, who also is affiliated with Brookdale University Hospital Medical Center. Based on his belief that marijuana, after alcohol and tobacco, may soon be the third legal drug where it isn’t already, “physicians have just a temporary role” in mediating the debate about medical legalization from a legal or political standpoint. Why? Because this part of the debate is growing irrelevant.

This does not mean medical indications or medical harms are not valid topics of discussion, Dr. Hershberger and Dr. Carlson said. The problem is that recreational use is supplanting medical use as the central issue in making this drug available.

The road toward U.S. legalization started in 1996, when California voters approved the use of marijuana for medical indications. Other states followed. Then, in 2012, Colorado and Washington became the first states to approve the drug for recreational use. In total, 29 states now permit some form of legal use of marijuana. In addition, marijuana possession has been decriminalized in several states where it remains illegal.

 

 


“From the federal perspective, marijuana is still a Schedule I drug. This means that it is easier to conduct research on cocaine, which is a Schedule II drug, than it is on marijuana,” Dr. Hershberger said. While the current presidential administration has adopted a tougher stance on distribution and use of marijuana than the previous, more than 60% of Americans in surveys support decriminalization of marijuana, according to Dr. Hershberger. He suggested that the current acceptability of marijuana is the reason that a recent survey indicated that more U.S. high school seniors than ever before have tried marijuana.

In light of the perceptions that the marijuana ban was ineffective, that marijuana is acceptable, and that profits from marijuana sales and distributions have been going to criminals, depriving government of tax dollars, continued decriminalization appears to be inevitable, Dr. Hershberger said. However, he believes that complete deregulation poses important risk, including an inevitable increase in accidents produced by motor impairment. It is also reasonable to anticipate more substance use in vulnerable populations. The risk to the development of children and adolescents who are likely to gain easier access to cannabis is unknown.

For psychiatrists and other medical specialists who wish to participate in the debate about the degree to which marijuana is decriminalized, both Dr. Hershberger and Dr. Carlson argued that a clear and realistic view of the landscape is essential.

“One of the reasons we are in this state we are in is that many people have declared the war on drugs a failure,” Dr. Hershberger said. Although he acknowledged that recognizing the limited efficacy of a marijuana ban is a reasonable starting point for discussion, he also expressed concern about large corporations being permitted to market cannabis in a way that obscures its risks or encourages use by those at greatest risk of harm, such as minors.
 

 


“We have to ask ourselves, is America ready for a cannabis commercial during the Super Bowl?” Dr. Hershberger said. He believes that an important trade-off exists for risks regardless of the degree to which marijuana is legalized.

“We have to approach this in the context of our current reality,” Dr. Carlson agreed. He, like Dr. Hershberger, cautioned that there are no simple answers.

Dr. Hershberger and Dr. Carlson reported no potential conflicts of interest.

 

The risk curve of societal harm from marijuana when graphed from a policy of complete prohibition to one of unregulated access is U shaped, according to a panel of experts who participated in a workshop on the harms and benefits of cannabis at the annual meeting of the American Psychiatric Association.

Based on more than 80 years of experience, it is clear that prohibition supports criminal activity but does not eliminate use, said Jason Hershberger, MD, chair of the department of psychiatry at Brookdale University Hospital Medical Center, New York. With progressive degrees of decriminalization, the harms to society associated with criminal distribution and the criminalization of use decreases, but they are replaced with increasing societal risks imposed by the availability of an intoxicating substance.

Ted Bosworth/MDedge News
(From left) Dr. Jason E. Hershberger, Dr. Stephan M. Carlson, Dr. Manuel Lopez-Leon, and Dr. Jose P. Vitor
“From a public health perspective, there is an inflection point somewhere along this curve,” Dr. Hershberger said.

Theoretically, one argument is that the inflection point occurs where cannabis has been decriminalized for medical indications but prohibited for recreational use. But this is a tenuous position. Clinicians, including psychiatrists, might support the use of cannabis to reduce stress, but it is well known that the pleasant intoxication provided by cannabis is relaxing – whether or not this is characterized as stress relief.

“The conversation has to start with the basic realization that cannabis is perceived by many people to have beneficial effects,” reported Stephan M. Carlson, MD, who also is affiliated with Brookdale University Hospital Medical Center. Based on his belief that marijuana, after alcohol and tobacco, may soon be the third legal drug where it isn’t already, “physicians have just a temporary role” in mediating the debate about medical legalization from a legal or political standpoint. Why? Because this part of the debate is growing irrelevant.

This does not mean medical indications or medical harms are not valid topics of discussion, Dr. Hershberger and Dr. Carlson said. The problem is that recreational use is supplanting medical use as the central issue in making this drug available.

The road toward U.S. legalization started in 1996, when California voters approved the use of marijuana for medical indications. Other states followed. Then, in 2012, Colorado and Washington became the first states to approve the drug for recreational use. In total, 29 states now permit some form of legal use of marijuana. In addition, marijuana possession has been decriminalized in several states where it remains illegal.

 

 


“From the federal perspective, marijuana is still a Schedule I drug. This means that it is easier to conduct research on cocaine, which is a Schedule II drug, than it is on marijuana,” Dr. Hershberger said. While the current presidential administration has adopted a tougher stance on distribution and use of marijuana than the previous, more than 60% of Americans in surveys support decriminalization of marijuana, according to Dr. Hershberger. He suggested that the current acceptability of marijuana is the reason that a recent survey indicated that more U.S. high school seniors than ever before have tried marijuana.

In light of the perceptions that the marijuana ban was ineffective, that marijuana is acceptable, and that profits from marijuana sales and distributions have been going to criminals, depriving government of tax dollars, continued decriminalization appears to be inevitable, Dr. Hershberger said. However, he believes that complete deregulation poses important risk, including an inevitable increase in accidents produced by motor impairment. It is also reasonable to anticipate more substance use in vulnerable populations. The risk to the development of children and adolescents who are likely to gain easier access to cannabis is unknown.

For psychiatrists and other medical specialists who wish to participate in the debate about the degree to which marijuana is decriminalized, both Dr. Hershberger and Dr. Carlson argued that a clear and realistic view of the landscape is essential.

“One of the reasons we are in this state we are in is that many people have declared the war on drugs a failure,” Dr. Hershberger said. Although he acknowledged that recognizing the limited efficacy of a marijuana ban is a reasonable starting point for discussion, he also expressed concern about large corporations being permitted to market cannabis in a way that obscures its risks or encourages use by those at greatest risk of harm, such as minors.
 

 


“We have to ask ourselves, is America ready for a cannabis commercial during the Super Bowl?” Dr. Hershberger said. He believes that an important trade-off exists for risks regardless of the degree to which marijuana is legalized.

“We have to approach this in the context of our current reality,” Dr. Carlson agreed. He, like Dr. Hershberger, cautioned that there are no simple answers.

Dr. Hershberger and Dr. Carlson reported no potential conflicts of interest.
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Physical inactivity linked to lymphoma risk

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A lifetime of physical inactivity could significantly increase the risk of developing both Hodgkin and non-Hodgkin lymphoma, according to a case-control study.

Researchers examined self-reported lifetime physical activity in 87 patients with Hodgkin lymphoma and 236 patients with non-Hodgkin lymphoma, as well as 1,300 cancer-free controls.

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They found a significant positive association between physical inactivity – defined as less than one session of exercise per week across a lifetime – and both lymphomas. Participants who were classed as “physically inactive” had a significant 90% greater risk of Hodgkin lymphoma (P = .012) and a 35% greater risk of non-Hodgkin lymphoma (P = .046), after adjustment for age, sex, family history, body mass index, smoking, and education, John Lewis Etter and his colleagues from the Roswell Park Comprehensive Cancer Center in Buffalo, N.Y. reported in Leukemia Research.

Researchers also found a nearly threefold higher risk of Hodgkin lymphoma among overweight and obese individuals who were physically inactive, compared with those who were active (odds ratio, 2.79; P = .01). Similarly, physically inactive individuals who had never smoked had a greater than threefold increase in risk, compared with never-smokers who were active (OR, 3.30; P less than .001). But despite these significant associations for smoking and weight, the small samples sizes meant they were not significant in multivariable-adjusted models, the researchers noted. For non-Hodgkin lymphoma, the associations between obesity/overweight and smoking status were also not statistically significant in multivariable-adjusted models.

Previous studies looking at the role of physical activity in Hodgkin and non-Hodgkin lymphoma had yielded mixed and inconclusive results. Since then, researchers have begun to specifically consider the role of physical inactivity, rather than physical activity, as the exposure of interest.

“An additional advantage of identifying inactivity as the exposure of interest is that a body of literature suggests that those who are at the lower end of the physical activity continuum are less likely to overreport physical activity than those who engage in greater levels of physical activity,” the researchers wrote.

They acknowledged that relying on self-reported levels of physical activity was a limitation of their study. However, they also pointed out that previous research suggested that simplified physical activity questionnaires that took a dichotomous approach to activity/inactivity were effective at identifying the most physically inactivity individuals in a population.

 

 


“Continued evidence for adverse associations between physical inactivity and cancer endpoints substantiate a powerful public health message that any amount of regular activity appears to associate with decreased cancer risk,” they wrote.

One researcher was supported by the New York State Department of Health. No conflicts of interest were reported.

SOURCE: Etter JL et al. Leuk Res. 2018 Mar 27;69:7-11.

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A lifetime of physical inactivity could significantly increase the risk of developing both Hodgkin and non-Hodgkin lymphoma, according to a case-control study.

Researchers examined self-reported lifetime physical activity in 87 patients with Hodgkin lymphoma and 236 patients with non-Hodgkin lymphoma, as well as 1,300 cancer-free controls.

pojoslaw/ThinkStock
They found a significant positive association between physical inactivity – defined as less than one session of exercise per week across a lifetime – and both lymphomas. Participants who were classed as “physically inactive” had a significant 90% greater risk of Hodgkin lymphoma (P = .012) and a 35% greater risk of non-Hodgkin lymphoma (P = .046), after adjustment for age, sex, family history, body mass index, smoking, and education, John Lewis Etter and his colleagues from the Roswell Park Comprehensive Cancer Center in Buffalo, N.Y. reported in Leukemia Research.

Researchers also found a nearly threefold higher risk of Hodgkin lymphoma among overweight and obese individuals who were physically inactive, compared with those who were active (odds ratio, 2.79; P = .01). Similarly, physically inactive individuals who had never smoked had a greater than threefold increase in risk, compared with never-smokers who were active (OR, 3.30; P less than .001). But despite these significant associations for smoking and weight, the small samples sizes meant they were not significant in multivariable-adjusted models, the researchers noted. For non-Hodgkin lymphoma, the associations between obesity/overweight and smoking status were also not statistically significant in multivariable-adjusted models.

Previous studies looking at the role of physical activity in Hodgkin and non-Hodgkin lymphoma had yielded mixed and inconclusive results. Since then, researchers have begun to specifically consider the role of physical inactivity, rather than physical activity, as the exposure of interest.

“An additional advantage of identifying inactivity as the exposure of interest is that a body of literature suggests that those who are at the lower end of the physical activity continuum are less likely to overreport physical activity than those who engage in greater levels of physical activity,” the researchers wrote.

They acknowledged that relying on self-reported levels of physical activity was a limitation of their study. However, they also pointed out that previous research suggested that simplified physical activity questionnaires that took a dichotomous approach to activity/inactivity were effective at identifying the most physically inactivity individuals in a population.

 

 


“Continued evidence for adverse associations between physical inactivity and cancer endpoints substantiate a powerful public health message that any amount of regular activity appears to associate with decreased cancer risk,” they wrote.

One researcher was supported by the New York State Department of Health. No conflicts of interest were reported.

SOURCE: Etter JL et al. Leuk Res. 2018 Mar 27;69:7-11.

 

A lifetime of physical inactivity could significantly increase the risk of developing both Hodgkin and non-Hodgkin lymphoma, according to a case-control study.

Researchers examined self-reported lifetime physical activity in 87 patients with Hodgkin lymphoma and 236 patients with non-Hodgkin lymphoma, as well as 1,300 cancer-free controls.

pojoslaw/ThinkStock
They found a significant positive association between physical inactivity – defined as less than one session of exercise per week across a lifetime – and both lymphomas. Participants who were classed as “physically inactive” had a significant 90% greater risk of Hodgkin lymphoma (P = .012) and a 35% greater risk of non-Hodgkin lymphoma (P = .046), after adjustment for age, sex, family history, body mass index, smoking, and education, John Lewis Etter and his colleagues from the Roswell Park Comprehensive Cancer Center in Buffalo, N.Y. reported in Leukemia Research.

Researchers also found a nearly threefold higher risk of Hodgkin lymphoma among overweight and obese individuals who were physically inactive, compared with those who were active (odds ratio, 2.79; P = .01). Similarly, physically inactive individuals who had never smoked had a greater than threefold increase in risk, compared with never-smokers who were active (OR, 3.30; P less than .001). But despite these significant associations for smoking and weight, the small samples sizes meant they were not significant in multivariable-adjusted models, the researchers noted. For non-Hodgkin lymphoma, the associations between obesity/overweight and smoking status were also not statistically significant in multivariable-adjusted models.

Previous studies looking at the role of physical activity in Hodgkin and non-Hodgkin lymphoma had yielded mixed and inconclusive results. Since then, researchers have begun to specifically consider the role of physical inactivity, rather than physical activity, as the exposure of interest.

“An additional advantage of identifying inactivity as the exposure of interest is that a body of literature suggests that those who are at the lower end of the physical activity continuum are less likely to overreport physical activity than those who engage in greater levels of physical activity,” the researchers wrote.

They acknowledged that relying on self-reported levels of physical activity was a limitation of their study. However, they also pointed out that previous research suggested that simplified physical activity questionnaires that took a dichotomous approach to activity/inactivity were effective at identifying the most physically inactivity individuals in a population.

 

 


“Continued evidence for adverse associations between physical inactivity and cancer endpoints substantiate a powerful public health message that any amount of regular activity appears to associate with decreased cancer risk,” they wrote.

One researcher was supported by the New York State Department of Health. No conflicts of interest were reported.

SOURCE: Etter JL et al. Leuk Res. 2018 Mar 27;69:7-11.

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Key clinical point: Lack of exercise may increase the risk of Hodgkin and non-Hodgkin lymphoma.

Major finding: A lifetime of physical inactivity is associated with a 90% increased risk of Hodgkin lymphoma and a 35% increased risk of non-Hodgkin lymphoma.Study details: A case-control study in 323 patients with Hodgkin or non-Hodgkin lymphoma and 1,300 cancer-free controls.

Disclosures: One researcher was supported by the New York State Department of Health. No conflicts of interest were declared.

Source: Etter JL et al. Leuk Res. 2018 Mar 27;69:7-11.

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Transgender care mandates endocrinologists share their expertise

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Fri, 01/18/2019 - 17:40

 

BOSTON – Endocrinologists need to be familiar with new practice guidelines and changes in the landscape of transgender health care, Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York, said in a video interview at the annual meeting of the American Association of Clinical Endocrinologists.

“We endocrinologists ... need to be able to help (gender-dysphoric/gender-incongruent) individuals, even if it’s just an occasional patient, to do what is safe and to be expert (in transgender health care), just as we are with other hormone treatments,” he said in a discussion of aspects of the Endocrine Society clinical practice guideline on endocrine treatment of gender-dysphoric/gender-incongruent individuals.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


The new guidelines, published in November 2017, update 2009 guidance from the society. Among the big changes are the recognition that there may be “compelling reasons” to start cross-sex hormonal therapy prior to the old age cutoff of 16 years, which is “very late if you’re thinking about it from a biological perspective,” said Dr. Safer.

Another major change challenges the idea that a mental health professional is necessary to diagnose adults. Rather, any knowledgeable clinician could make the diagnosis, according to Dr. Safer.

The guidelines also recommend that endocrinologists provide education regarding onset and time course of physical changes induced by sex hormone treatments to transgender individuals undergoing treatment.

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BOSTON – Endocrinologists need to be familiar with new practice guidelines and changes in the landscape of transgender health care, Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York, said in a video interview at the annual meeting of the American Association of Clinical Endocrinologists.

“We endocrinologists ... need to be able to help (gender-dysphoric/gender-incongruent) individuals, even if it’s just an occasional patient, to do what is safe and to be expert (in transgender health care), just as we are with other hormone treatments,” he said in a discussion of aspects of the Endocrine Society clinical practice guideline on endocrine treatment of gender-dysphoric/gender-incongruent individuals.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


The new guidelines, published in November 2017, update 2009 guidance from the society. Among the big changes are the recognition that there may be “compelling reasons” to start cross-sex hormonal therapy prior to the old age cutoff of 16 years, which is “very late if you’re thinking about it from a biological perspective,” said Dr. Safer.

Another major change challenges the idea that a mental health professional is necessary to diagnose adults. Rather, any knowledgeable clinician could make the diagnosis, according to Dr. Safer.

The guidelines also recommend that endocrinologists provide education regarding onset and time course of physical changes induced by sex hormone treatments to transgender individuals undergoing treatment.

 

BOSTON – Endocrinologists need to be familiar with new practice guidelines and changes in the landscape of transgender health care, Joshua D. Safer, MD, executive director of the Mount Sinai Center for Transgender Medicine and Surgery, New York, said in a video interview at the annual meeting of the American Association of Clinical Endocrinologists.

“We endocrinologists ... need to be able to help (gender-dysphoric/gender-incongruent) individuals, even if it’s just an occasional patient, to do what is safe and to be expert (in transgender health care), just as we are with other hormone treatments,” he said in a discussion of aspects of the Endocrine Society clinical practice guideline on endocrine treatment of gender-dysphoric/gender-incongruent individuals.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


The new guidelines, published in November 2017, update 2009 guidance from the society. Among the big changes are the recognition that there may be “compelling reasons” to start cross-sex hormonal therapy prior to the old age cutoff of 16 years, which is “very late if you’re thinking about it from a biological perspective,” said Dr. Safer.

Another major change challenges the idea that a mental health professional is necessary to diagnose adults. Rather, any knowledgeable clinician could make the diagnosis, according to Dr. Safer.

The guidelines also recommend that endocrinologists provide education regarding onset and time course of physical changes induced by sex hormone treatments to transgender individuals undergoing treatment.

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Calcium, PTH predict permanent hypoparathyroidism

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Wed, 01/02/2019 - 10:09

– Low postoperative calcium serum and parathyroid hormone (PTH) levels may be strong predictors of permanent hypoparathyroidism in total thyroidectomy patients, according to results of a study presented at the annual meeting of the American Association of Clinical Endocrinologists.

With incidence of transient hypoparathyroidism at 20-30%, being able to predict at-risk patients can significantly help clinicians with postoperative management, according to Steven Brown, DO, of the University of Arizona, Phoenix.

“It’s very important to draw the preoperative lab and postoperative lab in order to help those patients who are at risk,” said Dr. Brown in an oral abstract session.

To test the predictive accuracy of PTH and calcium levels, investigators conducted a single-center, retrospective study of 176 total thyroidectomy patients recorded during 1999-2013.

Patients with hypoparathyroidism had an average age of about 47 years, was almost entirely composed of females, was majority hispanic, and had mean postop calcium and PTH levels of 7.6 mg/dL and 8.0 pg/mL, respectively.

Those without hypoparathyroidism averaged about 51 years old, were equally hispanic and white, and had postop calcium and PTH levels of 8.08 mg/dL and 30.8 pg/dL, respectively.

Patients were split into four groups: Group 1 had low calcium and PTH levels (66), group 2 had low calcium and normal PTH levels (30), group 3 had normal calcium and low PTH levels (31), and group 4 had normal levels of both (49).

Over the study period, hypoparathyroidism developed in 30% of patients in group 1, 10% in group 2, 15% in group 3, and 2% in group 4.

 

 

Permanent hypothyroidism was defined as persistently low PTH (less than 12 pg/mL), low serum calcium (less than 8.0 mg/dL), and/or requiring calcitriol to maintain a normal calcium level for more than 6 months after total thyroidectomy.

Those with both low calcium and PTH levels were 4.3 times more likely to develop permanent hypoparathyroidism than those in the other groups, according to Dr. Brown.

Patients in the permanent hypoparathyroid group had a PTH drop of 70%, compared with 39% in the nonhypoparathyroid group. There was also a significant difference in respective drops of calcium levels (17.8% vs. 14.3%).
 

 

By comparing the levels before and after a thyroidectomy, physicians can act faster and more accurately when determining how best to treat patients to prevent hypoparathyroidism, a practice which, according to Dr. Brown, has already begun to be put into place.

“We’re starting to incorporate some of the practices into our patient care routine,” said Dr. Brown. “The next part of our project is going to be to actually do a prospective study at three different institution sites in order to evaluate this further.”

Dr. Brown reported no relevant financial disclosures.

SOURCE: Brown S et al. AACE 2018, Abstract 720.

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– Low postoperative calcium serum and parathyroid hormone (PTH) levels may be strong predictors of permanent hypoparathyroidism in total thyroidectomy patients, according to results of a study presented at the annual meeting of the American Association of Clinical Endocrinologists.

With incidence of transient hypoparathyroidism at 20-30%, being able to predict at-risk patients can significantly help clinicians with postoperative management, according to Steven Brown, DO, of the University of Arizona, Phoenix.

“It’s very important to draw the preoperative lab and postoperative lab in order to help those patients who are at risk,” said Dr. Brown in an oral abstract session.

To test the predictive accuracy of PTH and calcium levels, investigators conducted a single-center, retrospective study of 176 total thyroidectomy patients recorded during 1999-2013.

Patients with hypoparathyroidism had an average age of about 47 years, was almost entirely composed of females, was majority hispanic, and had mean postop calcium and PTH levels of 7.6 mg/dL and 8.0 pg/mL, respectively.

Those without hypoparathyroidism averaged about 51 years old, were equally hispanic and white, and had postop calcium and PTH levels of 8.08 mg/dL and 30.8 pg/dL, respectively.

Patients were split into four groups: Group 1 had low calcium and PTH levels (66), group 2 had low calcium and normal PTH levels (30), group 3 had normal calcium and low PTH levels (31), and group 4 had normal levels of both (49).

Over the study period, hypoparathyroidism developed in 30% of patients in group 1, 10% in group 2, 15% in group 3, and 2% in group 4.

 

 

Permanent hypothyroidism was defined as persistently low PTH (less than 12 pg/mL), low serum calcium (less than 8.0 mg/dL), and/or requiring calcitriol to maintain a normal calcium level for more than 6 months after total thyroidectomy.

Those with both low calcium and PTH levels were 4.3 times more likely to develop permanent hypoparathyroidism than those in the other groups, according to Dr. Brown.

Patients in the permanent hypoparathyroid group had a PTH drop of 70%, compared with 39% in the nonhypoparathyroid group. There was also a significant difference in respective drops of calcium levels (17.8% vs. 14.3%).
 

 

By comparing the levels before and after a thyroidectomy, physicians can act faster and more accurately when determining how best to treat patients to prevent hypoparathyroidism, a practice which, according to Dr. Brown, has already begun to be put into place.

“We’re starting to incorporate some of the practices into our patient care routine,” said Dr. Brown. “The next part of our project is going to be to actually do a prospective study at three different institution sites in order to evaluate this further.”

Dr. Brown reported no relevant financial disclosures.

SOURCE: Brown S et al. AACE 2018, Abstract 720.

– Low postoperative calcium serum and parathyroid hormone (PTH) levels may be strong predictors of permanent hypoparathyroidism in total thyroidectomy patients, according to results of a study presented at the annual meeting of the American Association of Clinical Endocrinologists.

With incidence of transient hypoparathyroidism at 20-30%, being able to predict at-risk patients can significantly help clinicians with postoperative management, according to Steven Brown, DO, of the University of Arizona, Phoenix.

“It’s very important to draw the preoperative lab and postoperative lab in order to help those patients who are at risk,” said Dr. Brown in an oral abstract session.

To test the predictive accuracy of PTH and calcium levels, investigators conducted a single-center, retrospective study of 176 total thyroidectomy patients recorded during 1999-2013.

Patients with hypoparathyroidism had an average age of about 47 years, was almost entirely composed of females, was majority hispanic, and had mean postop calcium and PTH levels of 7.6 mg/dL and 8.0 pg/mL, respectively.

Those without hypoparathyroidism averaged about 51 years old, were equally hispanic and white, and had postop calcium and PTH levels of 8.08 mg/dL and 30.8 pg/dL, respectively.

Patients were split into four groups: Group 1 had low calcium and PTH levels (66), group 2 had low calcium and normal PTH levels (30), group 3 had normal calcium and low PTH levels (31), and group 4 had normal levels of both (49).

Over the study period, hypoparathyroidism developed in 30% of patients in group 1, 10% in group 2, 15% in group 3, and 2% in group 4.

 

 

Permanent hypothyroidism was defined as persistently low PTH (less than 12 pg/mL), low serum calcium (less than 8.0 mg/dL), and/or requiring calcitriol to maintain a normal calcium level for more than 6 months after total thyroidectomy.

Those with both low calcium and PTH levels were 4.3 times more likely to develop permanent hypoparathyroidism than those in the other groups, according to Dr. Brown.

Patients in the permanent hypoparathyroid group had a PTH drop of 70%, compared with 39% in the nonhypoparathyroid group. There was also a significant difference in respective drops of calcium levels (17.8% vs. 14.3%).
 

 

By comparing the levels before and after a thyroidectomy, physicians can act faster and more accurately when determining how best to treat patients to prevent hypoparathyroidism, a practice which, according to Dr. Brown, has already begun to be put into place.

“We’re starting to incorporate some of the practices into our patient care routine,” said Dr. Brown. “The next part of our project is going to be to actually do a prospective study at three different institution sites in order to evaluate this further.”

Dr. Brown reported no relevant financial disclosures.

SOURCE: Brown S et al. AACE 2018, Abstract 720.

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Key clinical point: Measuring calcium and parathyroid hormone can help predict permanent hypoparathyroidism.

Major finding: Patients with low calcium and low PTH were 4.3 times as likely as those without to develop permanent hypoparathyroidism after total thyroidectomy.

Study details: Retrospective, single center study of 176 total thyroidectomy patients during 1999-2013.

Disclosures: The presenter reported no relevant financial disclosures.

Source: Brown S et al. AACE 2018, Abstract 720.

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Multiple myeloma rates rising fastest in East Asia

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The global incidence of multiple myeloma rose by 126% from 1990 to 2016, with the largest regional increases occurring in East Asia and tropical Latin America, according to data from the Global Burden of Disease 2016 study.

East Asia (China, North Korea, and Taiwan) saw incident cases of multiple myeloma jump by 262% – up to 1.0 per 100,000 population – from 1990 to 2016, which was the largest increase among any of the 21 global regions; tropical Latin America’s 256% rise took its age-standardized incidence rate to 1.8 per 100,000. Worldwide, incidence of multiple myeloma was 2.1 cases per 100,000 in 2016, Andrew J. Cowan, MD, and his associates reported in JAMA Oncology.

Regionally, the highest incidence in 2016 – 5.8 per 100,000 – was found in Australasia, with high-income North America next at 5.2 per 100,000 and Western Europe third at 4.6. Those three regions also had the highest age-standardized death rates: 3.0 per 100,000 in high-income North America, 2.8 in Australasia, and 2.6 in Western Europe. The United States had the most new cases (24,407) and the most deaths (14,212), with China second and India third in both measures, the investigators said.

They also looked at treatment availability, with data on stem cell transplants for 2010 coming from the Worldwide Network for Blood & Marrow Transplantation (Lancet Haematol. 2015 Mar;2[3]:e91-100). The countries with the highest rates for all indications that year were Israel (814 per 10 million population), Italy (671), Germany (665), Sweden (625), and the Netherlands (614).

“Some regions of the world lack access to stem cell transplantation entirely, particularly sub-Saharan Africa (with the exception of South Africa),” wrote Dr. Cowan of the University of Washington, Seattle, and his associates.

The approval status of lenalidomide (Revlimid) and bortezomib (Velcade) in 2016 was used as a surrogate for availability of drug treatment: Lenalidomide had been approved in 73 countries out of 195 countries and territories and bortezomib in 103 countries. “On a global level, there are marked discrepancies in the availability of effective therapies. In addition to ensuring universal access to health care … it is imperative to at least ensure access to highly effective medications,” they wrote.

Dr. Cowan reported that he has received research funding from Janssen and AbbVie.

SOURCE: Cowan AJ et al. JAMA Oncol. 2018 May 16. doi: 10.1001/jamaoncol.2018.2128.

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The global incidence of multiple myeloma rose by 126% from 1990 to 2016, with the largest regional increases occurring in East Asia and tropical Latin America, according to data from the Global Burden of Disease 2016 study.

East Asia (China, North Korea, and Taiwan) saw incident cases of multiple myeloma jump by 262% – up to 1.0 per 100,000 population – from 1990 to 2016, which was the largest increase among any of the 21 global regions; tropical Latin America’s 256% rise took its age-standardized incidence rate to 1.8 per 100,000. Worldwide, incidence of multiple myeloma was 2.1 cases per 100,000 in 2016, Andrew J. Cowan, MD, and his associates reported in JAMA Oncology.

Regionally, the highest incidence in 2016 – 5.8 per 100,000 – was found in Australasia, with high-income North America next at 5.2 per 100,000 and Western Europe third at 4.6. Those three regions also had the highest age-standardized death rates: 3.0 per 100,000 in high-income North America, 2.8 in Australasia, and 2.6 in Western Europe. The United States had the most new cases (24,407) and the most deaths (14,212), with China second and India third in both measures, the investigators said.

They also looked at treatment availability, with data on stem cell transplants for 2010 coming from the Worldwide Network for Blood & Marrow Transplantation (Lancet Haematol. 2015 Mar;2[3]:e91-100). The countries with the highest rates for all indications that year were Israel (814 per 10 million population), Italy (671), Germany (665), Sweden (625), and the Netherlands (614).

“Some regions of the world lack access to stem cell transplantation entirely, particularly sub-Saharan Africa (with the exception of South Africa),” wrote Dr. Cowan of the University of Washington, Seattle, and his associates.

The approval status of lenalidomide (Revlimid) and bortezomib (Velcade) in 2016 was used as a surrogate for availability of drug treatment: Lenalidomide had been approved in 73 countries out of 195 countries and territories and bortezomib in 103 countries. “On a global level, there are marked discrepancies in the availability of effective therapies. In addition to ensuring universal access to health care … it is imperative to at least ensure access to highly effective medications,” they wrote.

Dr. Cowan reported that he has received research funding from Janssen and AbbVie.

SOURCE: Cowan AJ et al. JAMA Oncol. 2018 May 16. doi: 10.1001/jamaoncol.2018.2128.

 

The global incidence of multiple myeloma rose by 126% from 1990 to 2016, with the largest regional increases occurring in East Asia and tropical Latin America, according to data from the Global Burden of Disease 2016 study.

East Asia (China, North Korea, and Taiwan) saw incident cases of multiple myeloma jump by 262% – up to 1.0 per 100,000 population – from 1990 to 2016, which was the largest increase among any of the 21 global regions; tropical Latin America’s 256% rise took its age-standardized incidence rate to 1.8 per 100,000. Worldwide, incidence of multiple myeloma was 2.1 cases per 100,000 in 2016, Andrew J. Cowan, MD, and his associates reported in JAMA Oncology.

Regionally, the highest incidence in 2016 – 5.8 per 100,000 – was found in Australasia, with high-income North America next at 5.2 per 100,000 and Western Europe third at 4.6. Those three regions also had the highest age-standardized death rates: 3.0 per 100,000 in high-income North America, 2.8 in Australasia, and 2.6 in Western Europe. The United States had the most new cases (24,407) and the most deaths (14,212), with China second and India third in both measures, the investigators said.

They also looked at treatment availability, with data on stem cell transplants for 2010 coming from the Worldwide Network for Blood & Marrow Transplantation (Lancet Haematol. 2015 Mar;2[3]:e91-100). The countries with the highest rates for all indications that year were Israel (814 per 10 million population), Italy (671), Germany (665), Sweden (625), and the Netherlands (614).

“Some regions of the world lack access to stem cell transplantation entirely, particularly sub-Saharan Africa (with the exception of South Africa),” wrote Dr. Cowan of the University of Washington, Seattle, and his associates.

The approval status of lenalidomide (Revlimid) and bortezomib (Velcade) in 2016 was used as a surrogate for availability of drug treatment: Lenalidomide had been approved in 73 countries out of 195 countries and territories and bortezomib in 103 countries. “On a global level, there are marked discrepancies in the availability of effective therapies. In addition to ensuring universal access to health care … it is imperative to at least ensure access to highly effective medications,” they wrote.

Dr. Cowan reported that he has received research funding from Janssen and AbbVie.

SOURCE: Cowan AJ et al. JAMA Oncol. 2018 May 16. doi: 10.1001/jamaoncol.2018.2128.

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Palliative care may reduce suicide among lung cancer patients

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Veterans with advanced-stage lung cancer who received palliative care were less likely to commit suicide, according to new research that will be presented at an international conference of the American Thoracic Society.

“Suicide is a significant national public health problem, especially among lung cancer patients and among veterans,” said lead author, Donald R. Sullivan, MD, of the division of pulmonary and critical care medicine at Oregon Health & Science University and a member of the OHSU Knight Cancer Institute, in a statement.

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Dr. Sullivan, who also is a core investigator at the Center to Improve Veteran Involvement in Care at Portland Veterans Affairs, and his colleagues analyzed data on patients in the VA Healthcare System who were diagnosed with advanced-stage lung cancer (IIIB & IV) from January 2007 to December 2013.

The investigators found that veterans who experienced at least one “palliative care encounter” after learning they had lung cancer were 82% less likely to die by suicide (odds ratio, 0.18; 95% confidence interval, 0.07-0.46; P less than .001), when compared with veterans who were diagnosed with lung cancer but did not receive palliative care.

The suicide rate for the advanced-stage lung cancer patients was 200/100,000 patient-years, which was more than five times higher than the suicide rate – adjusted for age, sex, and year – for all veterans using VA health care (37.5/100,000), according to the study abstract.

Of the 20,900 lung cancer patients analyzed, 30 committed suicide. Only six (20%) of the patients who died by suicide had received palliative care. Overall, most patients (18,192 or 87%) in the registry died of lung cancer. Other cancers, heart disease, and chronic obstructive pulmonary disease were some of the other common causes of death for the lung cancer patients, according to the abstract.

While several medical societies recommend palliative care for all patients with advanced-stage lung cancer, there is a gap between those recommendations and practice, noted Dr. Sullivan. “There are many barriers to palliative care, and unfortunately, some are related to clinician referrals. Not all doctors are aware of the benefits of palliative care,” he said in the statement.

Dr. Sullivan added that palliative care should be offered to all patients shortly after receiving a diagnosis of advanced-stage lung cancer.

More details on this study will be presented at the conference on Monday, May 21, at 2:30 p.m. in Room 14 A-B (Mezzanine Level) of the San Diego Convention Center.

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Veterans with advanced-stage lung cancer who received palliative care were less likely to commit suicide, according to new research that will be presented at an international conference of the American Thoracic Society.

“Suicide is a significant national public health problem, especially among lung cancer patients and among veterans,” said lead author, Donald R. Sullivan, MD, of the division of pulmonary and critical care medicine at Oregon Health & Science University and a member of the OHSU Knight Cancer Institute, in a statement.

xrender/thinkstock.com
Dr. Sullivan, who also is a core investigator at the Center to Improve Veteran Involvement in Care at Portland Veterans Affairs, and his colleagues analyzed data on patients in the VA Healthcare System who were diagnosed with advanced-stage lung cancer (IIIB & IV) from January 2007 to December 2013.

The investigators found that veterans who experienced at least one “palliative care encounter” after learning they had lung cancer were 82% less likely to die by suicide (odds ratio, 0.18; 95% confidence interval, 0.07-0.46; P less than .001), when compared with veterans who were diagnosed with lung cancer but did not receive palliative care.

The suicide rate for the advanced-stage lung cancer patients was 200/100,000 patient-years, which was more than five times higher than the suicide rate – adjusted for age, sex, and year – for all veterans using VA health care (37.5/100,000), according to the study abstract.

Of the 20,900 lung cancer patients analyzed, 30 committed suicide. Only six (20%) of the patients who died by suicide had received palliative care. Overall, most patients (18,192 or 87%) in the registry died of lung cancer. Other cancers, heart disease, and chronic obstructive pulmonary disease were some of the other common causes of death for the lung cancer patients, according to the abstract.

While several medical societies recommend palliative care for all patients with advanced-stage lung cancer, there is a gap between those recommendations and practice, noted Dr. Sullivan. “There are many barriers to palliative care, and unfortunately, some are related to clinician referrals. Not all doctors are aware of the benefits of palliative care,” he said in the statement.

Dr. Sullivan added that palliative care should be offered to all patients shortly after receiving a diagnosis of advanced-stage lung cancer.

More details on this study will be presented at the conference on Monday, May 21, at 2:30 p.m. in Room 14 A-B (Mezzanine Level) of the San Diego Convention Center.

 

Veterans with advanced-stage lung cancer who received palliative care were less likely to commit suicide, according to new research that will be presented at an international conference of the American Thoracic Society.

“Suicide is a significant national public health problem, especially among lung cancer patients and among veterans,” said lead author, Donald R. Sullivan, MD, of the division of pulmonary and critical care medicine at Oregon Health & Science University and a member of the OHSU Knight Cancer Institute, in a statement.

xrender/thinkstock.com
Dr. Sullivan, who also is a core investigator at the Center to Improve Veteran Involvement in Care at Portland Veterans Affairs, and his colleagues analyzed data on patients in the VA Healthcare System who were diagnosed with advanced-stage lung cancer (IIIB & IV) from January 2007 to December 2013.

The investigators found that veterans who experienced at least one “palliative care encounter” after learning they had lung cancer were 82% less likely to die by suicide (odds ratio, 0.18; 95% confidence interval, 0.07-0.46; P less than .001), when compared with veterans who were diagnosed with lung cancer but did not receive palliative care.

The suicide rate for the advanced-stage lung cancer patients was 200/100,000 patient-years, which was more than five times higher than the suicide rate – adjusted for age, sex, and year – for all veterans using VA health care (37.5/100,000), according to the study abstract.

Of the 20,900 lung cancer patients analyzed, 30 committed suicide. Only six (20%) of the patients who died by suicide had received palliative care. Overall, most patients (18,192 or 87%) in the registry died of lung cancer. Other cancers, heart disease, and chronic obstructive pulmonary disease were some of the other common causes of death for the lung cancer patients, according to the abstract.

While several medical societies recommend palliative care for all patients with advanced-stage lung cancer, there is a gap between those recommendations and practice, noted Dr. Sullivan. “There are many barriers to palliative care, and unfortunately, some are related to clinician referrals. Not all doctors are aware of the benefits of palliative care,” he said in the statement.

Dr. Sullivan added that palliative care should be offered to all patients shortly after receiving a diagnosis of advanced-stage lung cancer.

More details on this study will be presented at the conference on Monday, May 21, at 2:30 p.m. in Room 14 A-B (Mezzanine Level) of the San Diego Convention Center.

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