PORTLAND, OR—Most patients with advanced Parkinson’s disease who received levodopa–carbidopa intestinal gel in an open-label, continued-access-to-treatment study had, at five years, transitioned to using the therapy outside of the study when it became commercially available or continued to participate in the extension study, according to data presented at the Fourth World Parkinson Congress.

Forty-two percent of the patients in the phase III extension study transitioned to commercially available drug (designated as carbidopa–levodopa enteral suspension in the United States), and 24% of patients remained in the multinational study, said Hubert H. Fernandez, MD, Head of Movement Disorders at the Center for Neurological Restoration at the Cleveland Clinic in Ohio, and colleagues. Patients may remain in the extension study until a commercially available product is available in the country where they live.

Levodopa–carbidopa intestinal gel is infused continuously directly to the jejunum using a portable pump during approximately 16 hours of wakefulness. The therapy is designed to overcome some of the limitations of oral levodopa, which may lose effectiveness as Parkinson’s disease progresses.

Although investigators observed a high incidence of adverse events, long-term use of levodopa–carbidopa intestinal gel was well tolerated, the researchers said. The average discontinuation rate of 9.6% per year, including all causes of death, was relatively low, Dr. Fernandez and colleagues said.

The most frequently reported adverse events were associated with complications related to percutaneous gastrojejunostomy, such as stoma site maintenance. Other adverse events were associated with advanced Parkinson’s disease, aging, or levodopa. Most patients experienced device malfunctions and required pump replacement during the study.

The extension study began in November 2009. Data through September 30, 2015, were used in the present study. The study enrolled 262 patients with advanced Parkinson’s disease from 11 countries who had completed a 12-week double-blind study and its 52-week open-label extension or who had completed a separate 54-week open-label study. Participants attended scheduled study visits every six months.

Patients had a mean age of 64, 62% were male, and mean disease duration was 11.4 years. Mean exposure to levodopa–carbidopa intestinal gel was 3.1 years in the present study. Patients’ mean total exposure to the treatment was 4.1 years. Fifty-six percent of patients were exposed to the treatment for at least five years.

Adverse events led to discontinuation in 62 patients (24%). Device complaints occurred in 244 patients (93%). The most common device complaints included device malfunction (85%), device occlusion (57%), and device dislocation (56%). Thirty-eight patients died during the study. Two patients died as a result of intestinal dilatation and cardiac arrest, which an investigator considered possibly related to the treatment.

As part of an amended study protocol, patients in the United States began completing efficacy assessments in December 2013 (ie, Parkinson’s disease diary, Unified Parkinson’s Disease Rating Scale, and the Parkinson’s Disease Questionnaire). Patients in the United States showed sustained and clinically meaningful benefits of treatment that were demonstrated by decreased off time and increased on time without troublesome dyskinesia, the researchers concluded.

—Jake Remaly

PORTLAND, OR—Most patients with advanced Parkinson’s disease who received levodopa–carbidopa intestinal gel in an open-label, continued-access-to-treatment study had, at five years, transitioned to using the therapy outside of the study when it became commercially available or continued to participate in the extension study, according to data presented at the Fourth World Parkinson Congress.

Forty-two percent of the patients in the phase III extension study transitioned to commercially available drug (designated as carbidopa–levodopa enteral suspension in the United States), and 24% of patients remained in the multinational study, said Hubert H. Fernandez, MD, Head of Movement Disorders at the Center for Neurological Restoration at the Cleveland Clinic in Ohio, and colleagues. Patients may remain in the extension study until a commercially available product is available in the country where they live.

Levodopa–carbidopa intestinal gel is infused continuously directly to the jejunum using a portable pump during approximately 16 hours of wakefulness. The therapy is designed to overcome some of the limitations of oral levodopa, which may lose effectiveness as Parkinson’s disease progresses.

Although investigators observed a high incidence of adverse events, long-term use of levodopa–carbidopa intestinal gel was well tolerated, the researchers said. The average discontinuation rate of 9.6% per year, including all causes of death, was relatively low, Dr. Fernandez and colleagues said.

The most frequently reported adverse events were associated with complications related to percutaneous gastrojejunostomy, such as stoma site maintenance. Other adverse events were associated with advanced Parkinson’s disease, aging, or levodopa. Most patients experienced device malfunctions and required pump replacement during the study.

The extension study began in November 2009. Data through September 30, 2015, were used in the present study. The study enrolled 262 patients with advanced Parkinson’s disease from 11 countries who had completed a 12-week double-blind study and its 52-week open-label extension or who had completed a separate 54-week open-label study. Participants attended scheduled study visits every six months.

Patients had a mean age of 64, 62% were male, and mean disease duration was 11.4 years. Mean exposure to levodopa–carbidopa intestinal gel was 3.1 years in the present study. Patients’ mean total exposure to the treatment was 4.1 years. Fifty-six percent of patients were exposed to the treatment for at least five years.

Adverse events led to discontinuation in 62 patients (24%). Device complaints occurred in 244 patients (93%). The most common device complaints included device malfunction (85%), device occlusion (57%), and device dislocation (56%). Thirty-eight patients died during the study. Two patients died as a result of intestinal dilatation and cardiac arrest, which an investigator considered possibly related to the treatment.

As part of an amended study protocol, patients in the United States began completing efficacy assessments in December 2013 (ie, Parkinson’s disease diary, Unified Parkinson’s Disease Rating Scale, and the Parkinson’s Disease Questionnaire). Patients in the United States showed sustained and clinically meaningful benefits of treatment that were demonstrated by decreased off time and increased on time without troublesome dyskinesia, the researchers concluded.

—Jake Remaly

PORTLAND, OR—Most patients with advanced Parkinson’s disease who received levodopa–carbidopa intestinal gel in an open-label, continued-access-to-treatment study had, at five years, transitioned to using the therapy outside of the study when it became commercially available or continued to participate in the extension study, according to data presented at the Fourth World Parkinson Congress.

Forty-two percent of the patients in the phase III extension study transitioned to commercially available drug (designated as carbidopa–levodopa enteral suspension in the United States), and 24% of patients remained in the multinational study, said Hubert H. Fernandez, MD, Head of Movement Disorders at the Center for Neurological Restoration at the Cleveland Clinic in Ohio, and colleagues. Patients may remain in the extension study until a commercially available product is available in the country where they live.

Levodopa–carbidopa intestinal gel is infused continuously directly to the jejunum using a portable pump during approximately 16 hours of wakefulness. The therapy is designed to overcome some of the limitations of oral levodopa, which may lose effectiveness as Parkinson’s disease progresses.

Although investigators observed a high incidence of adverse events, long-term use of levodopa–carbidopa intestinal gel was well tolerated, the researchers said. The average discontinuation rate of 9.6% per year, including all causes of death, was relatively low, Dr. Fernandez and colleagues said.

The most frequently reported adverse events were associated with complications related to percutaneous gastrojejunostomy, such as stoma site maintenance. Other adverse events were associated with advanced Parkinson’s disease, aging, or levodopa. Most patients experienced device malfunctions and required pump replacement during the study.

The extension study began in November 2009. Data through September 30, 2015, were used in the present study. The study enrolled 262 patients with advanced Parkinson’s disease from 11 countries who had completed a 12-week double-blind study and its 52-week open-label extension or who had completed a separate 54-week open-label study. Participants attended scheduled study visits every six months.

Patients had a mean age of 64, 62% were male, and mean disease duration was 11.4 years. Mean exposure to levodopa–carbidopa intestinal gel was 3.1 years in the present study. Patients’ mean total exposure to the treatment was 4.1 years. Fifty-six percent of patients were exposed to the treatment for at least five years.

Adverse events led to discontinuation in 62 patients (24%). Device complaints occurred in 244 patients (93%). The most common device complaints included device malfunction (85%), device occlusion (57%), and device dislocation (56%). Thirty-eight patients died during the study. Two patients died as a result of intestinal dilatation and cardiac arrest, which an investigator considered possibly related to the treatment.

As part of an amended study protocol, patients in the United States began completing efficacy assessments in December 2013 (ie, Parkinson’s disease diary, Unified Parkinson’s Disease Rating Scale, and the Parkinson’s Disease Questionnaire). Patients in the United States showed sustained and clinically meaningful benefits of treatment that were demonstrated by decreased off time and increased on time without troublesome dyskinesia, the researchers concluded.

—Jake Remaly

It seems like the field of psychiatry has been all over the map when it comes to viewing the importance of parenting with regard to child behavioral problems and disorders. For decades, we heard that parents, particularly mothers, were to blame for everything from childhood autism to excessive temper tantrums.¹ Then, parenting somehow got somewhat pushed aside as the genetic and biological underpinnings of behavior became increasingly appreciated. For a while, parenting was nearly relegated to epiphenomenon status – that is, an almost irrelevant reaction to genetically driven child behavior.

More recently, it appears that some semblance of balance has been restored with parenting behavior being appreciated as critically important in the development of a child, but in the context of many other mutually interacting factors.² There also is a far greater understanding that child behavior and parent behavior is very much a two-way street.

These more nuanced and neuroscience-backed perspectives, however, don’t make bringing up the subject of parenting any easier. In part because of how seriously most mothers, fathers, and other caretakers take their job as a parent, it can be easy to put parents on the defensive, especially when one of their children is struggling behaviorally. At the same time, taking the easy way out by giving boilerplate advice, or even avoiding the topic of parenting completely, is a huge missed opportunity to engage families who often are desperately seeking some guidance.

Case summary

Emily is a healthy 6-year-old girl who comes in with her single mother and her two younger siblings for an annual exam. Her mother proudly reports that she is doing great at school, but seems reluctant to say much about her home life. The mother seems somewhat frazzled, and the interview is difficult because the three siblings are arguing with each other. After Emily and her sister fight over reading the same book, the mother suddenly and quite loudly says, “Can you just let me talk for 1 second!”

Discussion

Pediatricians often have strong suspicions that parents are struggling with a child’s behavior but can have trouble knowing how exactly to bring up the subject of parenting. Some specific suggestions for having productive discussions on parenting include the following:

• Think about the statements embedded in your questions. A screening question about parenting such as, “Can you tell me about the areas of parenting that you are most proud of and the areas where you feel you need the most help?” helps a parent understand that you assume that no parent is perfect and that everyone has areas of strength and weakness.

• Compliment when you can. Related to the above, find those areas of positive parenting, even if it involves effort more than results, and communicate that you have noticed them. This can make talking about the weaknesses a little easier to hear for the parent.

• Frame the issue in terms of surpluses rather than deficits. Instead of coming from the perspective that a parent is deficient in their basic parenting skills, reframe the challenge as someone needing “superparent” skills to manage multiple or more challenging children. The often-heard statements that “kids don’t come with instruction books” or “you need to earn a license to drive a car but not raise a child” are almost cliché these days, but still convey to parents that you understand how difficult parenting can be. In some cases, it may be appropriate to disclose some parenting challenges you have experienced firsthand.

• Get details. Before launching into specific recommendations, ask yourself if you are able to really see the issue a parent is describing. Rather than reviewing a laundry list of sleep hygiene recommendations, for example, it can be very worthwhile to ask, “How exactly does bedtime work at your home?” Getting all the details can not only build empathy, but allow you to really see specific areas for improvement. If you can’t paint a picture of how a scene might really look at this patient’s home, there likely is more to learn.

Of course, one of the key challenges here is time. Really giving these parenting concerns the time they deserve usually means going beyond the precious few minutes pediatricians have for a well visit. In these instances, it may be worth scheduling a future appointment that is exclusively devoted to this issue. Alternatively, a referral can be made to a therapist, counselor, or parent “coach” to give a family greater opportunity to work 1:1 with a professional. When you do this, be clear that you are looking for a therapist to work with the whole family, ideally using many of the evidence-based techniques that have been shown to be effective. A list of manual-based treatments as well as some books that parents could read on their own to address oppositional-defiant behavior is available, including a guide for families from the American Academy from Child and Adolescent Psychiatry.³

Case follow-up

The pediatrician finds another book to satisfy the younger sibling and says to the mother, “I’m glad to see that at least they are fighting over a book. That’s great that you have taught them to like reading.” They commiserate about how difficult it is to raise three young children as a single parent, and the mother then begins to open up about Emily’s defiant and disrespectful behavior at home that the mother blames on herself. The pediatrician offers a referral to see a local family therapist, which the mother gratefully accepts.

References

1. Am J Orthopsychiatry. 1985 Jul;55(3):345-53.

2. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):167-78.

3. American Academy of Child and Adolescent Psychiatry. (2009). Oppositional Defiant Disorder: A Guide for Families.

Dr. Rettew is associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Email him at [email protected].

It seems like the field of psychiatry has been all over the map when it comes to viewing the importance of parenting with regard to child behavioral problems and disorders. For decades, we heard that parents, particularly mothers, were to blame for everything from childhood autism to excessive temper tantrums.¹ Then, parenting somehow got somewhat pushed aside as the genetic and biological underpinnings of behavior became increasingly appreciated. For a while, parenting was nearly relegated to epiphenomenon status – that is, an almost irrelevant reaction to genetically driven child behavior.

More recently, it appears that some semblance of balance has been restored with parenting behavior being appreciated as critically important in the development of a child, but in the context of many other mutually interacting factors.² There also is a far greater understanding that child behavior and parent behavior is very much a two-way street.

These more nuanced and neuroscience-backed perspectives, however, don’t make bringing up the subject of parenting any easier. In part because of how seriously most mothers, fathers, and other caretakers take their job as a parent, it can be easy to put parents on the defensive, especially when one of their children is struggling behaviorally. At the same time, taking the easy way out by giving boilerplate advice, or even avoiding the topic of parenting completely, is a huge missed opportunity to engage families who often are desperately seeking some guidance.

Case summary

Emily is a healthy 6-year-old girl who comes in with her single mother and her two younger siblings for an annual exam. Her mother proudly reports that she is doing great at school, but seems reluctant to say much about her home life. The mother seems somewhat frazzled, and the interview is difficult because the three siblings are arguing with each other. After Emily and her sister fight over reading the same book, the mother suddenly and quite loudly says, “Can you just let me talk for 1 second!”

Discussion

Pediatricians often have strong suspicions that parents are struggling with a child’s behavior but can have trouble knowing how exactly to bring up the subject of parenting. Some specific suggestions for having productive discussions on parenting include the following:

• Think about the statements embedded in your questions. A screening question about parenting such as, “Can you tell me about the areas of parenting that you are most proud of and the areas where you feel you need the most help?” helps a parent understand that you assume that no parent is perfect and that everyone has areas of strength and weakness.

• Compliment when you can. Related to the above, find those areas of positive parenting, even if it involves effort more than results, and communicate that you have noticed them. This can make talking about the weaknesses a little easier to hear for the parent.

• Frame the issue in terms of surpluses rather than deficits. Instead of coming from the perspective that a parent is deficient in their basic parenting skills, reframe the challenge as someone needing “superparent” skills to manage multiple or more challenging children. The often-heard statements that “kids don’t come with instruction books” or “you need to earn a license to drive a car but not raise a child” are almost cliché these days, but still convey to parents that you understand how difficult parenting can be. In some cases, it may be appropriate to disclose some parenting challenges you have experienced firsthand.

• Get details. Before launching into specific recommendations, ask yourself if you are able to really see the issue a parent is describing. Rather than reviewing a laundry list of sleep hygiene recommendations, for example, it can be very worthwhile to ask, “How exactly does bedtime work at your home?” Getting all the details can not only build empathy, but allow you to really see specific areas for improvement. If you can’t paint a picture of how a scene might really look at this patient’s home, there likely is more to learn.

Of course, one of the key challenges here is time. Really giving these parenting concerns the time they deserve usually means going beyond the precious few minutes pediatricians have for a well visit. In these instances, it may be worth scheduling a future appointment that is exclusively devoted to this issue. Alternatively, a referral can be made to a therapist, counselor, or parent “coach” to give a family greater opportunity to work 1:1 with a professional. When you do this, be clear that you are looking for a therapist to work with the whole family, ideally using many of the evidence-based techniques that have been shown to be effective. A list of manual-based treatments as well as some books that parents could read on their own to address oppositional-defiant behavior is available, including a guide for families from the American Academy from Child and Adolescent Psychiatry.³

Case follow-up

The pediatrician finds another book to satisfy the younger sibling and says to the mother, “I’m glad to see that at least they are fighting over a book. That’s great that you have taught them to like reading.” They commiserate about how difficult it is to raise three young children as a single parent, and the mother then begins to open up about Emily’s defiant and disrespectful behavior at home that the mother blames on herself. The pediatrician offers a referral to see a local family therapist, which the mother gratefully accepts.

References

1. Am J Orthopsychiatry. 1985 Jul;55(3):345-53.

2. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):167-78.

3. American Academy of Child and Adolescent Psychiatry. (2009). Oppositional Defiant Disorder: A Guide for Families.

Dr. Rettew is associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Email him at [email protected].

It seems like the field of psychiatry has been all over the map when it comes to viewing the importance of parenting with regard to child behavioral problems and disorders. For decades, we heard that parents, particularly mothers, were to blame for everything from childhood autism to excessive temper tantrums.¹ Then, parenting somehow got somewhat pushed aside as the genetic and biological underpinnings of behavior became increasingly appreciated. For a while, parenting was nearly relegated to epiphenomenon status – that is, an almost irrelevant reaction to genetically driven child behavior.

More recently, it appears that some semblance of balance has been restored with parenting behavior being appreciated as critically important in the development of a child, but in the context of many other mutually interacting factors.² There also is a far greater understanding that child behavior and parent behavior is very much a two-way street.

These more nuanced and neuroscience-backed perspectives, however, don’t make bringing up the subject of parenting any easier. In part because of how seriously most mothers, fathers, and other caretakers take their job as a parent, it can be easy to put parents on the defensive, especially when one of their children is struggling behaviorally. At the same time, taking the easy way out by giving boilerplate advice, or even avoiding the topic of parenting completely, is a huge missed opportunity to engage families who often are desperately seeking some guidance.

Case summary

Emily is a healthy 6-year-old girl who comes in with her single mother and her two younger siblings for an annual exam. Her mother proudly reports that she is doing great at school, but seems reluctant to say much about her home life. The mother seems somewhat frazzled, and the interview is difficult because the three siblings are arguing with each other. After Emily and her sister fight over reading the same book, the mother suddenly and quite loudly says, “Can you just let me talk for 1 second!”

Discussion

Pediatricians often have strong suspicions that parents are struggling with a child’s behavior but can have trouble knowing how exactly to bring up the subject of parenting. Some specific suggestions for having productive discussions on parenting include the following:

• Think about the statements embedded in your questions. A screening question about parenting such as, “Can you tell me about the areas of parenting that you are most proud of and the areas where you feel you need the most help?” helps a parent understand that you assume that no parent is perfect and that everyone has areas of strength and weakness.

• Compliment when you can. Related to the above, find those areas of positive parenting, even if it involves effort more than results, and communicate that you have noticed them. This can make talking about the weaknesses a little easier to hear for the parent.

• Frame the issue in terms of surpluses rather than deficits. Instead of coming from the perspective that a parent is deficient in their basic parenting skills, reframe the challenge as someone needing “superparent” skills to manage multiple or more challenging children. The often-heard statements that “kids don’t come with instruction books” or “you need to earn a license to drive a car but not raise a child” are almost cliché these days, but still convey to parents that you understand how difficult parenting can be. In some cases, it may be appropriate to disclose some parenting challenges you have experienced firsthand.

• Get details. Before launching into specific recommendations, ask yourself if you are able to really see the issue a parent is describing. Rather than reviewing a laundry list of sleep hygiene recommendations, for example, it can be very worthwhile to ask, “How exactly does bedtime work at your home?” Getting all the details can not only build empathy, but allow you to really see specific areas for improvement. If you can’t paint a picture of how a scene might really look at this patient’s home, there likely is more to learn.

Of course, one of the key challenges here is time. Really giving these parenting concerns the time they deserve usually means going beyond the precious few minutes pediatricians have for a well visit. In these instances, it may be worth scheduling a future appointment that is exclusively devoted to this issue. Alternatively, a referral can be made to a therapist, counselor, or parent “coach” to give a family greater opportunity to work 1:1 with a professional. When you do this, be clear that you are looking for a therapist to work with the whole family, ideally using many of the evidence-based techniques that have been shown to be effective. A list of manual-based treatments as well as some books that parents could read on their own to address oppositional-defiant behavior is available, including a guide for families from the American Academy from Child and Adolescent Psychiatry.³

Case follow-up

The pediatrician finds another book to satisfy the younger sibling and says to the mother, “I’m glad to see that at least they are fighting over a book. That’s great that you have taught them to like reading.” They commiserate about how difficult it is to raise three young children as a single parent, and the mother then begins to open up about Emily’s defiant and disrespectful behavior at home that the mother blames on herself. The pediatrician offers a referral to see a local family therapist, which the mother gratefully accepts.

References

1. Am J Orthopsychiatry. 1985 Jul;55(3):345-53.

2. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):167-78.

3. American Academy of Child and Adolescent Psychiatry. (2009). Oppositional Defiant Disorder: A Guide for Families.

Dr. Rettew is associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Email him at [email protected].

DENVER – Undergoing percutaneous coronary intervention (PCI) may impair thyroid function and change the gland’s morphology, probably because of the cumulative effects of handling and exposure to radiation and iodine in the contrast dye, Samir Naim Assaad, MD, said during a poster presentation at the annual meeting of the American Thyroid Association.

Cardiologists should inform their patients of these possible effects as part of their pre- and post-PCI counseling so that they won’t be alarmed by the changes in how they feel, Dr. Assaad, chief of the division of endocrinology at Alexandria (Egypt) University, said in an interview.

Similarly, when a formerly euthyroid patient presents to an endocrinologist with sudden-onset hyperthyroidism, “Have you had a PCI recently?” should be one of the first questions asked. If the answer is yes, then further testing and imaging should be delayed at least 3 months, he noted.

Dr. Assaad and his associates examined 113 clinically euthyroid patients both before and several months after they underwent PCI for management of stable coronary artery disease. The cohort included 93 men, and patients’ ages ranged from 32 years to 73 years.

All the patients underwent a series of tests immediately before PCI, 24 hours after, and 3 months later. Those tests included serum free triiodothyronine (FT₃), free thyroxine (FT₄), thyroid-stimulating hormone (TSH), free T₃/T4 ratio, antithyroperoxidase (anti-TPO), and high-sensitivity C-reactive protein.

The gland’s morphology, including volume, vascularity, nodules, and echogenicity, were assessed on the same timetable using ultrasonography.

One day after PCI, there was a significant increase in serum FT₃ (5.2-0.5 vs. 3.3-0.7 pg/mL, P less than .001), and serum FT₄ (1.3 – 0.5 vs 1.2 – 0.3 ng/dL, P = .04), with no significant change in serum TSH.

Three months after PCI, there was a further significant increase in serum FT₄ (1.5 – 0.3 ng/dL), decrease in serum FT₃ returning to baseline (3.2 – 1.3 pg/mL), and a significant increase in serum TSH, compared with just before PCI (mean, 3.2-5 vs. 1.5-2.1 mIU/L, P less than .001). Serum anti-TPO (AU/mL) showed a significant increase 3 months after PCI.

There was a significant increase in thyroid gland volume 3 months after PCI (13.6-3.9 vs. 13.1-3.5 cm³, P = .02). The measured echogenicity of the thyroid gland showed a significant decrease 3 months after PCI (67.1-10.9 vs. 88.7-25.6 GWE, P less than .001).

Thyroid radiation had a negative effect on serum TSH, anti-TPO, FT₃, and FT₃/FT4 ratio, and an inverse correlation of dye injection time with serum anti-TPO and TSH, judging from the findings of a regression analysis model.

Dr. Assaad was not included on the list of presenters with relevant financial disclosures that was provided by the American Thyroid Association.

[email protected]

DENVER – Undergoing percutaneous coronary intervention (PCI) may impair thyroid function and change the gland’s morphology, probably because of the cumulative effects of handling and exposure to radiation and iodine in the contrast dye, Samir Naim Assaad, MD, said during a poster presentation at the annual meeting of the American Thyroid Association.

Cardiologists should inform their patients of these possible effects as part of their pre- and post-PCI counseling so that they won’t be alarmed by the changes in how they feel, Dr. Assaad, chief of the division of endocrinology at Alexandria (Egypt) University, said in an interview.

Similarly, when a formerly euthyroid patient presents to an endocrinologist with sudden-onset hyperthyroidism, “Have you had a PCI recently?” should be one of the first questions asked. If the answer is yes, then further testing and imaging should be delayed at least 3 months, he noted.

Dr. Assaad and his associates examined 113 clinically euthyroid patients both before and several months after they underwent PCI for management of stable coronary artery disease. The cohort included 93 men, and patients’ ages ranged from 32 years to 73 years.

All the patients underwent a series of tests immediately before PCI, 24 hours after, and 3 months later. Those tests included serum free triiodothyronine (FT₃), free thyroxine (FT₄), thyroid-stimulating hormone (TSH), free T₃/T4 ratio, antithyroperoxidase (anti-TPO), and high-sensitivity C-reactive protein.

The gland’s morphology, including volume, vascularity, nodules, and echogenicity, were assessed on the same timetable using ultrasonography.

One day after PCI, there was a significant increase in serum FT₃ (5.2-0.5 vs. 3.3-0.7 pg/mL, P less than .001), and serum FT₄ (1.3 – 0.5 vs 1.2 – 0.3 ng/dL, P = .04), with no significant change in serum TSH.

Three months after PCI, there was a further significant increase in serum FT₄ (1.5 – 0.3 ng/dL), decrease in serum FT₃ returning to baseline (3.2 – 1.3 pg/mL), and a significant increase in serum TSH, compared with just before PCI (mean, 3.2-5 vs. 1.5-2.1 mIU/L, P less than .001). Serum anti-TPO (AU/mL) showed a significant increase 3 months after PCI.

There was a significant increase in thyroid gland volume 3 months after PCI (13.6-3.9 vs. 13.1-3.5 cm³, P = .02). The measured echogenicity of the thyroid gland showed a significant decrease 3 months after PCI (67.1-10.9 vs. 88.7-25.6 GWE, P less than .001).

Thyroid radiation had a negative effect on serum TSH, anti-TPO, FT₃, and FT₃/FT4 ratio, and an inverse correlation of dye injection time with serum anti-TPO and TSH, judging from the findings of a regression analysis model.

Dr. Assaad was not included on the list of presenters with relevant financial disclosures that was provided by the American Thyroid Association.

[email protected]

DENVER – Undergoing percutaneous coronary intervention (PCI) may impair thyroid function and change the gland’s morphology, probably because of the cumulative effects of handling and exposure to radiation and iodine in the contrast dye, Samir Naim Assaad, MD, said during a poster presentation at the annual meeting of the American Thyroid Association.

Cardiologists should inform their patients of these possible effects as part of their pre- and post-PCI counseling so that they won’t be alarmed by the changes in how they feel, Dr. Assaad, chief of the division of endocrinology at Alexandria (Egypt) University, said in an interview.

Similarly, when a formerly euthyroid patient presents to an endocrinologist with sudden-onset hyperthyroidism, “Have you had a PCI recently?” should be one of the first questions asked. If the answer is yes, then further testing and imaging should be delayed at least 3 months, he noted.

Dr. Assaad and his associates examined 113 clinically euthyroid patients both before and several months after they underwent PCI for management of stable coronary artery disease. The cohort included 93 men, and patients’ ages ranged from 32 years to 73 years.

All the patients underwent a series of tests immediately before PCI, 24 hours after, and 3 months later. Those tests included serum free triiodothyronine (FT₃), free thyroxine (FT₄), thyroid-stimulating hormone (TSH), free T₃/T4 ratio, antithyroperoxidase (anti-TPO), and high-sensitivity C-reactive protein.

The gland’s morphology, including volume, vascularity, nodules, and echogenicity, were assessed on the same timetable using ultrasonography.

One day after PCI, there was a significant increase in serum FT₃ (5.2-0.5 vs. 3.3-0.7 pg/mL, P less than .001), and serum FT₄ (1.3 – 0.5 vs 1.2 – 0.3 ng/dL, P = .04), with no significant change in serum TSH.

Three months after PCI, there was a further significant increase in serum FT₄ (1.5 – 0.3 ng/dL), decrease in serum FT₃ returning to baseline (3.2 – 1.3 pg/mL), and a significant increase in serum TSH, compared with just before PCI (mean, 3.2-5 vs. 1.5-2.1 mIU/L, P less than .001). Serum anti-TPO (AU/mL) showed a significant increase 3 months after PCI.

There was a significant increase in thyroid gland volume 3 months after PCI (13.6-3.9 vs. 13.1-3.5 cm³, P = .02). The measured echogenicity of the thyroid gland showed a significant decrease 3 months after PCI (67.1-10.9 vs. 88.7-25.6 GWE, P less than .001).

Thyroid radiation had a negative effect on serum TSH, anti-TPO, FT₃, and FT₃/FT4 ratio, and an inverse correlation of dye injection time with serum anti-TPO and TSH, judging from the findings of a regression analysis model.

Dr. Assaad was not included on the list of presenters with relevant financial disclosures that was provided by the American Thyroid Association.

[email protected]

The weekly number of pregnant women in the United States with laboratory evidence of Zika virus infection topped 200 for the first time during the week ending Sept. 15, according to the Centers for Disease Control and Prevention.

With the 50 states and the District of Columbia reporting 18 new cases for the week and the U.S. territories reporting 192, there were 210 more pregnant women with Zika for the week ending Sept. 15, the CDC reported Sept. 22. The previous weekly high had been 199 for the week ending Aug. 25.

The CDC also reported two new cases of liveborn infants – both in the 50 states and D.C. – with Zika-related birth defects. No infants with Zika-related birth defects were reported in the territories for the week, and there were no new reports of pregnancy losses related to Zika. The number of pregnancy losses holds at six for the year so far, but the number of U.S. liveborn infants with Zika-related birth defects is now 21, with 20 cases in the states/D.C. and one in the territories, the CDC said. State- or territorial-level data are not being reported to protect the privacy of affected women and children.

There were 182 new cases of Zika infection reported among all Americans in the states/D.C. for the week ending Sept. 21, along with 2,083 new cases in the territories – almost all in Puerto Rico, which continues to retroactively report cases, the CDC noted Sept. 22. The U.S. total for 2015-2016 is 23,135 cases: 3,358 reported in the states/D.C. and 19,777 in the territories. Puerto Rico represents 98% of the territorial total, the CDC said.

Zika-related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.

The figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.

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The weekly number of pregnant women in the United States with laboratory evidence of Zika virus infection topped 200 for the first time during the week ending Sept. 15, according to the Centers for Disease Control and Prevention.

With the 50 states and the District of Columbia reporting 18 new cases for the week and the U.S. territories reporting 192, there were 210 more pregnant women with Zika for the week ending Sept. 15, the CDC reported Sept. 22. The previous weekly high had been 199 for the week ending Aug. 25.

The CDC also reported two new cases of liveborn infants – both in the 50 states and D.C. – with Zika-related birth defects. No infants with Zika-related birth defects were reported in the territories for the week, and there were no new reports of pregnancy losses related to Zika. The number of pregnancy losses holds at six for the year so far, but the number of U.S. liveborn infants with Zika-related birth defects is now 21, with 20 cases in the states/D.C. and one in the territories, the CDC said. State- or territorial-level data are not being reported to protect the privacy of affected women and children.

There were 182 new cases of Zika infection reported among all Americans in the states/D.C. for the week ending Sept. 21, along with 2,083 new cases in the territories – almost all in Puerto Rico, which continues to retroactively report cases, the CDC noted Sept. 22. The U.S. total for 2015-2016 is 23,135 cases: 3,358 reported in the states/D.C. and 19,777 in the territories. Puerto Rico represents 98% of the territorial total, the CDC said.

Zika-related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.

The figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.

[email protected]

The weekly number of pregnant women in the United States with laboratory evidence of Zika virus infection topped 200 for the first time during the week ending Sept. 15, according to the Centers for Disease Control and Prevention.

With the 50 states and the District of Columbia reporting 18 new cases for the week and the U.S. territories reporting 192, there were 210 more pregnant women with Zika for the week ending Sept. 15, the CDC reported Sept. 22. The previous weekly high had been 199 for the week ending Aug. 25.

The CDC also reported two new cases of liveborn infants – both in the 50 states and D.C. – with Zika-related birth defects. No infants with Zika-related birth defects were reported in the territories for the week, and there were no new reports of pregnancy losses related to Zika. The number of pregnancy losses holds at six for the year so far, but the number of U.S. liveborn infants with Zika-related birth defects is now 21, with 20 cases in the states/D.C. and one in the territories, the CDC said. State- or territorial-level data are not being reported to protect the privacy of affected women and children.

There were 182 new cases of Zika infection reported among all Americans in the states/D.C. for the week ending Sept. 21, along with 2,083 new cases in the territories – almost all in Puerto Rico, which continues to retroactively report cases, the CDC noted Sept. 22. The U.S. total for 2015-2016 is 23,135 cases: 3,358 reported in the states/D.C. and 19,777 in the territories. Puerto Rico represents 98% of the territorial total, the CDC said.

Zika-related birth defects recorded by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.

The figures for states, territories, and D.C. reflect reporting to the U.S. Zika Pregnancy Registry; data for Puerto Rico are reported to the U.S. Zika Active Pregnancy Surveillance System.

[email protected]

The skin phenotype of new-onset pediatric atopic dermatitis differs substantially from that in adult AD, according to an assessment of biopsy findings in infants and children.

The study findings have important therapeutic implications, especially in light of the fact that much of the work in this area has been based on adult biomarkers, reflecting “decades of disease activity and chronic use of immunosuppressants in adults,” the investigators reported. Little is known about alterations in early lesions in children, which limits the advancement of targeted therapies, Hitokazu Esaki, MD, of the Icahn School of Medicine at Mount Sinai in New York City, and colleagues reported online in the Journal of Allergy and Clinical Immunology (2016 Sep 22. doi: 10.1016/j.jaci.2016.07.013).

LucaLorenzelli/Thinkstock

To characterize early pediatric AD skin phenotype, the investigators assessed lesional and nonlesional biopsies from 19 children under age 5 years (mean, 1.3 years) within 6 months of moderate to severe disease onset, as well as those from age-matched controls and adults, and found that, compared with adult AD, early AD involves comparable or greater epidermal hyperplasia and cellular infiltration, similar strong activation of Th2 and Th22 axes, and some Th1 skewing.

In addition, early AD involves significantly higher induction of Th17-related cytokines, compared with adult AD. Expression of filaggrin – an abundant barrier differentiation protein – was similar in AD and healthy children, whereas down-regulation is characteristic in adult AD, the investigators noted.

Nonlesional skin biopsies from the children showed both higher levels of inflammation and epidermal proliferation markers, they said.

The “surprising findings” of an early multicytokine response in new-onset pediatric AD, characterized by marked Th17, Th9, Th2, and Th22 activation, suggest that targeting of multiple cytokine axes may be needed in children with early-onset AD, one of the lead authors on the study, Emma Guttman-Yassky, MD, also of the Icahn School of Medicine at Mount Sinai, said in an interview.

Dr. Guttman-Yassky, who noted that the study was conducted in close collaboration with Amy S. Paller, MD, of Northwestern University, Chicago, explained that early AD, compared with adult AD, involves differential immune skewing and barrier responses with features that are in some ways comparable to those of psoriasis – particularly with respect to the consistently higher levels of Th17-related mediators in childhood AD, as psoriasis is considered a Th17-centered disease.

Further, the findings with respect to filaggrin represent another important aspect of the study, she said, noting that they represent a possible challenge to the notion that filaggrin is integral to disease elicitation and instigation of the “atopic march.”

The study findings may suggest novel targets for pediatric AD, and they also suggest a need for early immune intervention, not only to treat the AD, but also to prevent the atopic march, she said.

“These findings are likely to result in both different understanding of AD onset and distinct treatment approaches for infants and children,” she and her colleagues concluded.

This work was funded by a research grant from the LEO Foundation. Individual authors were supported by grants from the National Center for Advancing Translational Sciences and the National Institutes of Health Clinical and Translational Science Award program. Dr. Esaki reported having no disclosures. Dr. Guttman-Yassky reported financial relationships with numerous pharmaceutical companies.

[email protected]

The skin phenotype of new-onset pediatric atopic dermatitis differs substantially from that in adult AD, according to an assessment of biopsy findings in infants and children.

The study findings have important therapeutic implications, especially in light of the fact that much of the work in this area has been based on adult biomarkers, reflecting “decades of disease activity and chronic use of immunosuppressants in adults,” the investigators reported. Little is known about alterations in early lesions in children, which limits the advancement of targeted therapies, Hitokazu Esaki, MD, of the Icahn School of Medicine at Mount Sinai in New York City, and colleagues reported online in the Journal of Allergy and Clinical Immunology (2016 Sep 22. doi: 10.1016/j.jaci.2016.07.013).

LucaLorenzelli/Thinkstock

To characterize early pediatric AD skin phenotype, the investigators assessed lesional and nonlesional biopsies from 19 children under age 5 years (mean, 1.3 years) within 6 months of moderate to severe disease onset, as well as those from age-matched controls and adults, and found that, compared with adult AD, early AD involves comparable or greater epidermal hyperplasia and cellular infiltration, similar strong activation of Th2 and Th22 axes, and some Th1 skewing.

In addition, early AD involves significantly higher induction of Th17-related cytokines, compared with adult AD. Expression of filaggrin – an abundant barrier differentiation protein – was similar in AD and healthy children, whereas down-regulation is characteristic in adult AD, the investigators noted.

Nonlesional skin biopsies from the children showed both higher levels of inflammation and epidermal proliferation markers, they said.

The “surprising findings” of an early multicytokine response in new-onset pediatric AD, characterized by marked Th17, Th9, Th2, and Th22 activation, suggest that targeting of multiple cytokine axes may be needed in children with early-onset AD, one of the lead authors on the study, Emma Guttman-Yassky, MD, also of the Icahn School of Medicine at Mount Sinai, said in an interview.

Dr. Guttman-Yassky, who noted that the study was conducted in close collaboration with Amy S. Paller, MD, of Northwestern University, Chicago, explained that early AD, compared with adult AD, involves differential immune skewing and barrier responses with features that are in some ways comparable to those of psoriasis – particularly with respect to the consistently higher levels of Th17-related mediators in childhood AD, as psoriasis is considered a Th17-centered disease.

Further, the findings with respect to filaggrin represent another important aspect of the study, she said, noting that they represent a possible challenge to the notion that filaggrin is integral to disease elicitation and instigation of the “atopic march.”

The study findings may suggest novel targets for pediatric AD, and they also suggest a need for early immune intervention, not only to treat the AD, but also to prevent the atopic march, she said.

“These findings are likely to result in both different understanding of AD onset and distinct treatment approaches for infants and children,” she and her colleagues concluded.

This work was funded by a research grant from the LEO Foundation. Individual authors were supported by grants from the National Center for Advancing Translational Sciences and the National Institutes of Health Clinical and Translational Science Award program. Dr. Esaki reported having no disclosures. Dr. Guttman-Yassky reported financial relationships with numerous pharmaceutical companies.

[email protected]

The skin phenotype of new-onset pediatric atopic dermatitis differs substantially from that in adult AD, according to an assessment of biopsy findings in infants and children.

The study findings have important therapeutic implications, especially in light of the fact that much of the work in this area has been based on adult biomarkers, reflecting “decades of disease activity and chronic use of immunosuppressants in adults,” the investigators reported. Little is known about alterations in early lesions in children, which limits the advancement of targeted therapies, Hitokazu Esaki, MD, of the Icahn School of Medicine at Mount Sinai in New York City, and colleagues reported online in the Journal of Allergy and Clinical Immunology (2016 Sep 22. doi: 10.1016/j.jaci.2016.07.013).

LucaLorenzelli/Thinkstock

To characterize early pediatric AD skin phenotype, the investigators assessed lesional and nonlesional biopsies from 19 children under age 5 years (mean, 1.3 years) within 6 months of moderate to severe disease onset, as well as those from age-matched controls and adults, and found that, compared with adult AD, early AD involves comparable or greater epidermal hyperplasia and cellular infiltration, similar strong activation of Th2 and Th22 axes, and some Th1 skewing.

In addition, early AD involves significantly higher induction of Th17-related cytokines, compared with adult AD. Expression of filaggrin – an abundant barrier differentiation protein – was similar in AD and healthy children, whereas down-regulation is characteristic in adult AD, the investigators noted.

Nonlesional skin biopsies from the children showed both higher levels of inflammation and epidermal proliferation markers, they said.

The “surprising findings” of an early multicytokine response in new-onset pediatric AD, characterized by marked Th17, Th9, Th2, and Th22 activation, suggest that targeting of multiple cytokine axes may be needed in children with early-onset AD, one of the lead authors on the study, Emma Guttman-Yassky, MD, also of the Icahn School of Medicine at Mount Sinai, said in an interview.

Dr. Guttman-Yassky, who noted that the study was conducted in close collaboration with Amy S. Paller, MD, of Northwestern University, Chicago, explained that early AD, compared with adult AD, involves differential immune skewing and barrier responses with features that are in some ways comparable to those of psoriasis – particularly with respect to the consistently higher levels of Th17-related mediators in childhood AD, as psoriasis is considered a Th17-centered disease.

Further, the findings with respect to filaggrin represent another important aspect of the study, she said, noting that they represent a possible challenge to the notion that filaggrin is integral to disease elicitation and instigation of the “atopic march.”

The study findings may suggest novel targets for pediatric AD, and they also suggest a need for early immune intervention, not only to treat the AD, but also to prevent the atopic march, she said.

“These findings are likely to result in both different understanding of AD onset and distinct treatment approaches for infants and children,” she and her colleagues concluded.

This work was funded by a research grant from the LEO Foundation. Individual authors were supported by grants from the National Center for Advancing Translational Sciences and the National Institutes of Health Clinical and Translational Science Award program. Dr. Esaki reported having no disclosures. Dr. Guttman-Yassky reported financial relationships with numerous pharmaceutical companies.

[email protected]

Grants made possible by the “Million Dollar Bike Ride” and rare disease patient organizations are now available through the University of Pennsylvania Orphan Disease Center. September 16 is the deadline for letters of intent.

The diseases for which research funding is available are: adult polyglucosan body disease; ataxia-telangiectasia; Castleman disease; CFTR nonsense mutations; congenital hyperinsulinism; congenital muscular dystrophy; CRB1 degenerative retinal disease; nonsense mutations in cystic fibrosis; dyskeratosis congenital & telomere biology disorders; fibrous dysplasia/McCune Albright syndrome; generalized lymphatic anomaly and Gorham-Stout disease; Glut 1 deficiency; lymphangioleiomyomatosis; mucolipidosis type IV; mucopolysaccharidoses; Niemann Pick type C; Pitt Hopkins syndrome; RASopathies; Tay-Sachs, Sandhoff, GM1, or Canavan disease; and Snyder-Robinson syndrome.

Grants made possible by the “Million Dollar Bike Ride” and rare disease patient organizations are now available through the University of Pennsylvania Orphan Disease Center. September 16 is the deadline for letters of intent.

The diseases for which research funding is available are: adult polyglucosan body disease; ataxia-telangiectasia; Castleman disease; CFTR nonsense mutations; congenital hyperinsulinism; congenital muscular dystrophy; CRB1 degenerative retinal disease; nonsense mutations in cystic fibrosis; dyskeratosis congenital & telomere biology disorders; fibrous dysplasia/McCune Albright syndrome; generalized lymphatic anomaly and Gorham-Stout disease; Glut 1 deficiency; lymphangioleiomyomatosis; mucolipidosis type IV; mucopolysaccharidoses; Niemann Pick type C; Pitt Hopkins syndrome; RASopathies; Tay-Sachs, Sandhoff, GM1, or Canavan disease; and Snyder-Robinson syndrome.

Grants made possible by the “Million Dollar Bike Ride” and rare disease patient organizations are now available through the University of Pennsylvania Orphan Disease Center. September 16 is the deadline for letters of intent.

The diseases for which research funding is available are: adult polyglucosan body disease; ataxia-telangiectasia; Castleman disease; CFTR nonsense mutations; congenital hyperinsulinism; congenital muscular dystrophy; CRB1 degenerative retinal disease; nonsense mutations in cystic fibrosis; dyskeratosis congenital & telomere biology disorders; fibrous dysplasia/McCune Albright syndrome; generalized lymphatic anomaly and Gorham-Stout disease; Glut 1 deficiency; lymphangioleiomyomatosis; mucolipidosis type IV; mucopolysaccharidoses; Niemann Pick type C; Pitt Hopkins syndrome; RASopathies; Tay-Sachs, Sandhoff, GM1, or Canavan disease; and Snyder-Robinson syndrome.

The Pediatric Obesity Algorithm – a free state-of-the-science management review from the Obesity Medicine Association – should help clinicians weed through the options for overweight kids, according to Texas pediatrician and lead author Suzanne Cuda, MD.

The group put the latest thinking into one place to serve as a handy guide, and plans to update it every 2 years. The idea was to present choices, not push particular approaches. “Many of my colleagues have expressed concern [that] they do not have the resources to provide the kind of support these kids need,” said Dr. Cuda, director of the weight management clinic at the Children’s Hospital of San Antonio and associate professor of pediatrics at the Baylor College of Medicine. Clinicians can find the guide at www.PediatricObesityAlgorithm.org.

©SolStock/iStock

The effort also will help clinicians prepare for American Board of Obesity Medicine certification, since it was “designed to address the content on the exam. A lot of tools out there for children [emphasize] prevention. Our starting point was children who are already overweight,“ she said.

The document covers risk factors, differential diagnoses, assessment, diet, appropriate activity levels, medications, surgery, comorbidity management, and other issues, often broken down by age and body mass index.

Nothing is particularly controversial, although some clinicians are reluctant to move beyond diet and exercise for kids, Dr. Cuda said.

The Obesity Medicine Association (OMA) was aware of that, and so was careful to note, for instance, which obesity medications are approved for pediatric use – orlistat (Xenical), metformin, and phentermine – and their real-world effect.

“We didn’t cover all the drugs out there” because many haven’t been tested in children, Dr. Cuda said. The group also highlights antiseizure and other drugs that put on weight.

The guide covers birth to adulthood. There can be signs of problems even before the first birthday, such as weight above the 95th percentile. In those cases, evidence supports exclusive breast feeding for as long as possible, and no more than 24 ounces per day in formula-fed children, with no cereal or media watching.

OMA hasn’t submitted its work for endorsement by other groups, so other associations haven’t signed onto it. “We didn’t want to prolong putting it out there to go through that whole process,” Dr. Cuda said.

Even so, some organizations are aware of the contents and support the effort. “It aligns with the resources we have already developed on this topic. These are core competencies ... all physicians should have, regardless of whether they are certified in obesity medicine,” said an American Academy of Pediatrics staff member.

Until recently, OMA was known as the American Society of Bariatric Physicians. It rebranded itself to avoid being mistaken for a bariatric surgery group.

Dr. Cuda and the other authors had no disclosures. There was no industry funding for the work.

[email protected]

The Pediatric Obesity Algorithm – a free state-of-the-science management review from the Obesity Medicine Association – should help clinicians weed through the options for overweight kids, according to Texas pediatrician and lead author Suzanne Cuda, MD.

The group put the latest thinking into one place to serve as a handy guide, and plans to update it every 2 years. The idea was to present choices, not push particular approaches. “Many of my colleagues have expressed concern [that] they do not have the resources to provide the kind of support these kids need,” said Dr. Cuda, director of the weight management clinic at the Children’s Hospital of San Antonio and associate professor of pediatrics at the Baylor College of Medicine. Clinicians can find the guide at www.PediatricObesityAlgorithm.org.

©SolStock/iStock

The effort also will help clinicians prepare for American Board of Obesity Medicine certification, since it was “designed to address the content on the exam. A lot of tools out there for children [emphasize] prevention. Our starting point was children who are already overweight,“ she said.

The document covers risk factors, differential diagnoses, assessment, diet, appropriate activity levels, medications, surgery, comorbidity management, and other issues, often broken down by age and body mass index.

Nothing is particularly controversial, although some clinicians are reluctant to move beyond diet and exercise for kids, Dr. Cuda said.

The Obesity Medicine Association (OMA) was aware of that, and so was careful to note, for instance, which obesity medications are approved for pediatric use – orlistat (Xenical), metformin, and phentermine – and their real-world effect.

“We didn’t cover all the drugs out there” because many haven’t been tested in children, Dr. Cuda said. The group also highlights antiseizure and other drugs that put on weight.

The guide covers birth to adulthood. There can be signs of problems even before the first birthday, such as weight above the 95th percentile. In those cases, evidence supports exclusive breast feeding for as long as possible, and no more than 24 ounces per day in formula-fed children, with no cereal or media watching.

OMA hasn’t submitted its work for endorsement by other groups, so other associations haven’t signed onto it. “We didn’t want to prolong putting it out there to go through that whole process,” Dr. Cuda said.

Even so, some organizations are aware of the contents and support the effort. “It aligns with the resources we have already developed on this topic. These are core competencies ... all physicians should have, regardless of whether they are certified in obesity medicine,” said an American Academy of Pediatrics staff member.

Until recently, OMA was known as the American Society of Bariatric Physicians. It rebranded itself to avoid being mistaken for a bariatric surgery group.

Dr. Cuda and the other authors had no disclosures. There was no industry funding for the work.

[email protected]

The Pediatric Obesity Algorithm – a free state-of-the-science management review from the Obesity Medicine Association – should help clinicians weed through the options for overweight kids, according to Texas pediatrician and lead author Suzanne Cuda, MD.

The group put the latest thinking into one place to serve as a handy guide, and plans to update it every 2 years. The idea was to present choices, not push particular approaches. “Many of my colleagues have expressed concern [that] they do not have the resources to provide the kind of support these kids need,” said Dr. Cuda, director of the weight management clinic at the Children’s Hospital of San Antonio and associate professor of pediatrics at the Baylor College of Medicine. Clinicians can find the guide at www.PediatricObesityAlgorithm.org.

©SolStock/iStock

The effort also will help clinicians prepare for American Board of Obesity Medicine certification, since it was “designed to address the content on the exam. A lot of tools out there for children [emphasize] prevention. Our starting point was children who are already overweight,“ she said.

The document covers risk factors, differential diagnoses, assessment, diet, appropriate activity levels, medications, surgery, comorbidity management, and other issues, often broken down by age and body mass index.

Nothing is particularly controversial, although some clinicians are reluctant to move beyond diet and exercise for kids, Dr. Cuda said.

The Obesity Medicine Association (OMA) was aware of that, and so was careful to note, for instance, which obesity medications are approved for pediatric use – orlistat (Xenical), metformin, and phentermine – and their real-world effect.

“We didn’t cover all the drugs out there” because many haven’t been tested in children, Dr. Cuda said. The group also highlights antiseizure and other drugs that put on weight.

The guide covers birth to adulthood. There can be signs of problems even before the first birthday, such as weight above the 95th percentile. In those cases, evidence supports exclusive breast feeding for as long as possible, and no more than 24 ounces per day in formula-fed children, with no cereal or media watching.

OMA hasn’t submitted its work for endorsement by other groups, so other associations haven’t signed onto it. “We didn’t want to prolong putting it out there to go through that whole process,” Dr. Cuda said.

Even so, some organizations are aware of the contents and support the effort. “It aligns with the resources we have already developed on this topic. These are core competencies ... all physicians should have, regardless of whether they are certified in obesity medicine,” said an American Academy of Pediatrics staff member.

Until recently, OMA was known as the American Society of Bariatric Physicians. It rebranded itself to avoid being mistaken for a bariatric surgery group.

Dr. Cuda and the other authors had no disclosures. There was no industry funding for the work.

[email protected]

BOSTON – A medication management strategy to minimize the effect of drug-drug interactions (DDIs) between warfarin and common antimicrobials resulted in significantly greater time within therapeutic range for anticoagulation, as well as a numerically smaller, but nonsignificant, number of bleeding events.

After implementation of a comprehensive inpatient and postdischarge guideline to manage DDIs between warfarin and 16 antibiotics, antivirals, or antifungal medications, patients’ in-hospital time within therapeutic range (TWTR) increased to 72% from 50% preimplementation (P = .043). Warfarin TWTR also improved across care transitions after the guidelines were implemented, rising to 70% from 46% (P = .012). No bleeding events occurred in the group studied after the guidelines were instituted, compared with four events in the comparator preguidelines group (P = .11).

Nghi Ha, PharmD, MPH, and his collaborators sought to determine whether formalizing a process to manage potentially dangerous antimicrobial-warfarin DDIs made a difference in achieving more TWTR for patients, as determined by international normalized ratio (INR) values. Dr. Ha, a clinical pharmacist at University of Michigan Health System, Ann Arbor, presented the results during a poster session at the annual meeting of the American Society for Microbiology.

Secondary outcome measures studied by Dr. Ha and his associates included the incidence of thrombosis or major bleeding events, as well as tracking documentation of medications and the anticoagulation plan in progress and discharge notes.

Patients were included if they were at least 18 years old, and if they were on 3 days or more of an antimicrobial with potential for DDI with warfarin. Patients who were also newly on other medications with the potential for significant DDI with warfarin were excluded to minimize the potential for confounding.

Dr. Ha and his collaborators characterized the study as a retrospective, single-center, quasi-experimental design of a pharmacist-run anticoagulation service. The study examined endpoints before and after implementation of comprehensive guidelines, and included 78 preguideline and 31 postguideline patients.

The guidelines drafted by the investigators and tested in their study included empiric adjustment of warfarin dosing for patients who were placed on an antibiotic with high potential to increase INR. These included many azoles and sulfamethoxazole/trimethoprim, for which initial warfarin doses were empirically reduced 20%-30% for patients whose INRs were therapeutic at the start of antimicrobial therapy. For ciprofloxacin, erythromycin, clarithromycin, and isoniazid, the guidelines recommended initial empiric warfarin dose reductions of 10%-15%.

Patients whose INRs were subtherapeutic at the beginning of therapy and who received these antimicrobials were continued on their maintenance warfarin dosing, but were monitored for rising INRs over the first 48 hours, for consideration of dosing adjustment as needed. Individuals with supratherapeutic INRs at the beginning of antimicrobial dosing had their warfarin doses reduced or held by a more aggressive algorithm based on their initial INR, and based on the potential of the antimicrobial to increase INR.

On discharge, patients were either reverted to their previous warfarin regimen if they had been stable on that regimen, or had their inpatient warfarin dosing increased by 10%-20%.

Drugs that were deemed to have moderate potential to increase INR included doxycycline, levofloxacin, moxifloxacin, quinupristin/dalfopristin, telaprevir, boceprevir, and simeprevir. For these medications, the protocol recommended no initial dose adjustment, but recommended monitoring of INR to consider a dose reduction if needed. On hospital discharge, patients who had been on these medications were to resume their previous warfarin dosing.

Antimicrobials with potential to decrease INR included nafcillin, for which the protocol recommended empiric warfarin dose increases of 25%-50%, starting 3-5 days after nafcillin was begun. Patients on rifampin or rifabutin were to increase their warfarin by 20%-30%, also 3-5 days after beginning the antibiotics. Patients on ritonavir alone, or any protease inhibitor given for HIV along with ritonavir, were closely monitored, but no empiric dosing adjustments were made.

Patients with initial subtherapeutic INRs had dosing increased by 30%-50% for nafcillin and 20%-30% for rifampin and rifabutin. A stepped algorithm for dose adjustment or withholding was also developed for these medications to treat patients with initial supratherapeutic INRs. Patients on these medications were to resume their previous warfarin dosing, with monitoring and adjustment if they had not been previously stable.

Documentation of antimicrobial-warfarin DDI in the anticoagulation service discharge summary improved significantly once the guidelines were implemented (40% compared with 14%, P = .02). There was not a significant improvement in DDI documentation in daily progress notes.

The comprehensive intervention included the formulation of guidelines and requirements to document the medication interaction in the medical chart. Other interventions included training for clinical pharmacists and the development of pocket cards and flyers to educate team members about the new guidelines. The electronic health record had triggers built and implemented to prompt consideration of warfarin/antimicrobial DDIs as well.

Dr. Ha and his coauthors noted that the uncontrolled nature of the pre-post study design was one limitation of the study. Also, the real-world design of the study meant that investigators could not control for diet, comorbidities, and other factors that have the potential to affect INR. “Implementing a process to identify high-risk antimicrobial-warfarin DDIs and provide guidelines for empiric warfarin dose adjustment … can improve INR time within therapeutic range,” noted Dr. Ha and his coauthors.

The study authors reported no external sources of funding and no conflicts of interest.

[email protected]

On Twitter @karioakes

BOSTON – A medication management strategy to minimize the effect of drug-drug interactions (DDIs) between warfarin and common antimicrobials resulted in significantly greater time within therapeutic range for anticoagulation, as well as a numerically smaller, but nonsignificant, number of bleeding events.

After implementation of a comprehensive inpatient and postdischarge guideline to manage DDIs between warfarin and 16 antibiotics, antivirals, or antifungal medications, patients’ in-hospital time within therapeutic range (TWTR) increased to 72% from 50% preimplementation (P = .043). Warfarin TWTR also improved across care transitions after the guidelines were implemented, rising to 70% from 46% (P = .012). No bleeding events occurred in the group studied after the guidelines were instituted, compared with four events in the comparator preguidelines group (P = .11).

Nghi Ha, PharmD, MPH, and his collaborators sought to determine whether formalizing a process to manage potentially dangerous antimicrobial-warfarin DDIs made a difference in achieving more TWTR for patients, as determined by international normalized ratio (INR) values. Dr. Ha, a clinical pharmacist at University of Michigan Health System, Ann Arbor, presented the results during a poster session at the annual meeting of the American Society for Microbiology.

Secondary outcome measures studied by Dr. Ha and his associates included the incidence of thrombosis or major bleeding events, as well as tracking documentation of medications and the anticoagulation plan in progress and discharge notes.

Patients were included if they were at least 18 years old, and if they were on 3 days or more of an antimicrobial with potential for DDI with warfarin. Patients who were also newly on other medications with the potential for significant DDI with warfarin were excluded to minimize the potential for confounding.

Dr. Ha and his collaborators characterized the study as a retrospective, single-center, quasi-experimental design of a pharmacist-run anticoagulation service. The study examined endpoints before and after implementation of comprehensive guidelines, and included 78 preguideline and 31 postguideline patients.

The guidelines drafted by the investigators and tested in their study included empiric adjustment of warfarin dosing for patients who were placed on an antibiotic with high potential to increase INR. These included many azoles and sulfamethoxazole/trimethoprim, for which initial warfarin doses were empirically reduced 20%-30% for patients whose INRs were therapeutic at the start of antimicrobial therapy. For ciprofloxacin, erythromycin, clarithromycin, and isoniazid, the guidelines recommended initial empiric warfarin dose reductions of 10%-15%.

Patients whose INRs were subtherapeutic at the beginning of therapy and who received these antimicrobials were continued on their maintenance warfarin dosing, but were monitored for rising INRs over the first 48 hours, for consideration of dosing adjustment as needed. Individuals with supratherapeutic INRs at the beginning of antimicrobial dosing had their warfarin doses reduced or held by a more aggressive algorithm based on their initial INR, and based on the potential of the antimicrobial to increase INR.

On discharge, patients were either reverted to their previous warfarin regimen if they had been stable on that regimen, or had their inpatient warfarin dosing increased by 10%-20%.

Drugs that were deemed to have moderate potential to increase INR included doxycycline, levofloxacin, moxifloxacin, quinupristin/dalfopristin, telaprevir, boceprevir, and simeprevir. For these medications, the protocol recommended no initial dose adjustment, but recommended monitoring of INR to consider a dose reduction if needed. On hospital discharge, patients who had been on these medications were to resume their previous warfarin dosing.

Antimicrobials with potential to decrease INR included nafcillin, for which the protocol recommended empiric warfarin dose increases of 25%-50%, starting 3-5 days after nafcillin was begun. Patients on rifampin or rifabutin were to increase their warfarin by 20%-30%, also 3-5 days after beginning the antibiotics. Patients on ritonavir alone, or any protease inhibitor given for HIV along with ritonavir, were closely monitored, but no empiric dosing adjustments were made.

Patients with initial subtherapeutic INRs had dosing increased by 30%-50% for nafcillin and 20%-30% for rifampin and rifabutin. A stepped algorithm for dose adjustment or withholding was also developed for these medications to treat patients with initial supratherapeutic INRs. Patients on these medications were to resume their previous warfarin dosing, with monitoring and adjustment if they had not been previously stable.

Documentation of antimicrobial-warfarin DDI in the anticoagulation service discharge summary improved significantly once the guidelines were implemented (40% compared with 14%, P = .02). There was not a significant improvement in DDI documentation in daily progress notes.

The comprehensive intervention included the formulation of guidelines and requirements to document the medication interaction in the medical chart. Other interventions included training for clinical pharmacists and the development of pocket cards and flyers to educate team members about the new guidelines. The electronic health record had triggers built and implemented to prompt consideration of warfarin/antimicrobial DDIs as well.

Dr. Ha and his coauthors noted that the uncontrolled nature of the pre-post study design was one limitation of the study. Also, the real-world design of the study meant that investigators could not control for diet, comorbidities, and other factors that have the potential to affect INR. “Implementing a process to identify high-risk antimicrobial-warfarin DDIs and provide guidelines for empiric warfarin dose adjustment … can improve INR time within therapeutic range,” noted Dr. Ha and his coauthors.

The study authors reported no external sources of funding and no conflicts of interest.

[email protected]

On Twitter @karioakes

BOSTON – A medication management strategy to minimize the effect of drug-drug interactions (DDIs) between warfarin and common antimicrobials resulted in significantly greater time within therapeutic range for anticoagulation, as well as a numerically smaller, but nonsignificant, number of bleeding events.

After implementation of a comprehensive inpatient and postdischarge guideline to manage DDIs between warfarin and 16 antibiotics, antivirals, or antifungal medications, patients’ in-hospital time within therapeutic range (TWTR) increased to 72% from 50% preimplementation (P = .043). Warfarin TWTR also improved across care transitions after the guidelines were implemented, rising to 70% from 46% (P = .012). No bleeding events occurred in the group studied after the guidelines were instituted, compared with four events in the comparator preguidelines group (P = .11).

Nghi Ha, PharmD, MPH, and his collaborators sought to determine whether formalizing a process to manage potentially dangerous antimicrobial-warfarin DDIs made a difference in achieving more TWTR for patients, as determined by international normalized ratio (INR) values. Dr. Ha, a clinical pharmacist at University of Michigan Health System, Ann Arbor, presented the results during a poster session at the annual meeting of the American Society for Microbiology.

Secondary outcome measures studied by Dr. Ha and his associates included the incidence of thrombosis or major bleeding events, as well as tracking documentation of medications and the anticoagulation plan in progress and discharge notes.

Patients were included if they were at least 18 years old, and if they were on 3 days or more of an antimicrobial with potential for DDI with warfarin. Patients who were also newly on other medications with the potential for significant DDI with warfarin were excluded to minimize the potential for confounding.

Dr. Ha and his collaborators characterized the study as a retrospective, single-center, quasi-experimental design of a pharmacist-run anticoagulation service. The study examined endpoints before and after implementation of comprehensive guidelines, and included 78 preguideline and 31 postguideline patients.

The guidelines drafted by the investigators and tested in their study included empiric adjustment of warfarin dosing for patients who were placed on an antibiotic with high potential to increase INR. These included many azoles and sulfamethoxazole/trimethoprim, for which initial warfarin doses were empirically reduced 20%-30% for patients whose INRs were therapeutic at the start of antimicrobial therapy. For ciprofloxacin, erythromycin, clarithromycin, and isoniazid, the guidelines recommended initial empiric warfarin dose reductions of 10%-15%.

Patients whose INRs were subtherapeutic at the beginning of therapy and who received these antimicrobials were continued on their maintenance warfarin dosing, but were monitored for rising INRs over the first 48 hours, for consideration of dosing adjustment as needed. Individuals with supratherapeutic INRs at the beginning of antimicrobial dosing had their warfarin doses reduced or held by a more aggressive algorithm based on their initial INR, and based on the potential of the antimicrobial to increase INR.

On discharge, patients were either reverted to their previous warfarin regimen if they had been stable on that regimen, or had their inpatient warfarin dosing increased by 10%-20%.

Drugs that were deemed to have moderate potential to increase INR included doxycycline, levofloxacin, moxifloxacin, quinupristin/dalfopristin, telaprevir, boceprevir, and simeprevir. For these medications, the protocol recommended no initial dose adjustment, but recommended monitoring of INR to consider a dose reduction if needed. On hospital discharge, patients who had been on these medications were to resume their previous warfarin dosing.

Antimicrobials with potential to decrease INR included nafcillin, for which the protocol recommended empiric warfarin dose increases of 25%-50%, starting 3-5 days after nafcillin was begun. Patients on rifampin or rifabutin were to increase their warfarin by 20%-30%, also 3-5 days after beginning the antibiotics. Patients on ritonavir alone, or any protease inhibitor given for HIV along with ritonavir, were closely monitored, but no empiric dosing adjustments were made.

Patients with initial subtherapeutic INRs had dosing increased by 30%-50% for nafcillin and 20%-30% for rifampin and rifabutin. A stepped algorithm for dose adjustment or withholding was also developed for these medications to treat patients with initial supratherapeutic INRs. Patients on these medications were to resume their previous warfarin dosing, with monitoring and adjustment if they had not been previously stable.

Documentation of antimicrobial-warfarin DDI in the anticoagulation service discharge summary improved significantly once the guidelines were implemented (40% compared with 14%, P = .02). There was not a significant improvement in DDI documentation in daily progress notes.

The comprehensive intervention included the formulation of guidelines and requirements to document the medication interaction in the medical chart. Other interventions included training for clinical pharmacists and the development of pocket cards and flyers to educate team members about the new guidelines. The electronic health record had triggers built and implemented to prompt consideration of warfarin/antimicrobial DDIs as well.

Dr. Ha and his coauthors noted that the uncontrolled nature of the pre-post study design was one limitation of the study. Also, the real-world design of the study meant that investigators could not control for diet, comorbidities, and other factors that have the potential to affect INR. “Implementing a process to identify high-risk antimicrobial-warfarin DDIs and provide guidelines for empiric warfarin dose adjustment … can improve INR time within therapeutic range,” noted Dr. Ha and his coauthors.

The study authors reported no external sources of funding and no conflicts of interest.

[email protected]

On Twitter @karioakes

SEATTLE – A longer course of dexamethasone was a bit better than the usual single intraoperative dose for controlling pain and dysphagia after transoral robotic surgery in a randomized trial from the Oregon Health and Science University, Portland.

Thirty-five subjects were randomized to the standard 10-mg intraoperative dexamethasone dose plus 8 mg every 8 hours for up to 4 days; 33 others were randomized to the intraoperative dose plus placebo. All the subjects had transoral robotic surgery (TORS) resection for T1 or T2 oropharyngeal squamous cell carcinoma, either partial pharyngectomy/radical tonsillectomy, base of tongue resection, or both.

The dexamethasone group had significantly less pain on postop day 3 (about 1.5 points less on the 10-point visual analogue scale) and were discharged, on average, a day earlier. They also advanced more quickly toward solid food at 1- and 3-weeks’ follow-up. “They were much more likely to be on a full-soft diet, while the placebo group was mostly still on purees, and just starting into soft foods,” said lead investigator Daniel Clayburgh, MD, a head and neck cancer specialist at the university.

Otherwise, however, the extra dexamethasone wasn’t much help; pain scores were the same in both groups for the first couple days after surgery and at follow-up, and both groups used the same amount of post-op opioids. Other than food tolerance, dysphagia metrics were pretty much the same.

“I was actually anticipating a little bit more of a benefit, but there are potentially some benefits to extended corticosteroid courses after TORS. It’s safe, and well tolerated so long as you screen out diabetes and other problems with hyperglycemia,” as was done in the study, he said. “It does decrease post-op length of stay and may provide a modest decrease in post-op pain, and may slightly accelerate advancement of dietary consistency,” Dr. Clayburgh said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

Although he and his colleagues are mulling over what to do with the findings in light of other initiatives to reduce post-TORS pain, they are now likely to extend dexamethasone courses when significant post-op pain seems likely, and doing so is not otherwise contraindicated, he said.

Intraoperative corticosteroids are now routine for TORS, based on the strength of benefit in the tonsillectomy literature. The team decided to try an extended course because “being rather simple minded surgeons, we thought that if one dose is good, more should be better,” Dr. Clayburgh said.

The dexamethasone group was slightly younger than the placebo group (56 vs. 61 years) but otherwise similar; most were men. In addition to patients with hyperglycemia issues, those with confounders for post-op speech and swallowing recovery were among those excluded from the trial. Subjects required nasogastric feeding tubes for a median of 6.5 days postoperatively, lost a mean of 10 pounds in the first 2 post-op weeks, and were hospitalized for a mean of about 5 days. Dexamethasone was delivered orally or by nasogastric tube.

There was no external funding for the study, and Dr. Clayburgh had no relevant financial disclosures.

[email protected]

SEATTLE – A longer course of dexamethasone was a bit better than the usual single intraoperative dose for controlling pain and dysphagia after transoral robotic surgery in a randomized trial from the Oregon Health and Science University, Portland.

Thirty-five subjects were randomized to the standard 10-mg intraoperative dexamethasone dose plus 8 mg every 8 hours for up to 4 days; 33 others were randomized to the intraoperative dose plus placebo. All the subjects had transoral robotic surgery (TORS) resection for T1 or T2 oropharyngeal squamous cell carcinoma, either partial pharyngectomy/radical tonsillectomy, base of tongue resection, or both.

The dexamethasone group had significantly less pain on postop day 3 (about 1.5 points less on the 10-point visual analogue scale) and were discharged, on average, a day earlier. They also advanced more quickly toward solid food at 1- and 3-weeks’ follow-up. “They were much more likely to be on a full-soft diet, while the placebo group was mostly still on purees, and just starting into soft foods,” said lead investigator Daniel Clayburgh, MD, a head and neck cancer specialist at the university.

Otherwise, however, the extra dexamethasone wasn’t much help; pain scores were the same in both groups for the first couple days after surgery and at follow-up, and both groups used the same amount of post-op opioids. Other than food tolerance, dysphagia metrics were pretty much the same.

“I was actually anticipating a little bit more of a benefit, but there are potentially some benefits to extended corticosteroid courses after TORS. It’s safe, and well tolerated so long as you screen out diabetes and other problems with hyperglycemia,” as was done in the study, he said. “It does decrease post-op length of stay and may provide a modest decrease in post-op pain, and may slightly accelerate advancement of dietary consistency,” Dr. Clayburgh said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

Although he and his colleagues are mulling over what to do with the findings in light of other initiatives to reduce post-TORS pain, they are now likely to extend dexamethasone courses when significant post-op pain seems likely, and doing so is not otherwise contraindicated, he said.

Intraoperative corticosteroids are now routine for TORS, based on the strength of benefit in the tonsillectomy literature. The team decided to try an extended course because “being rather simple minded surgeons, we thought that if one dose is good, more should be better,” Dr. Clayburgh said.

The dexamethasone group was slightly younger than the placebo group (56 vs. 61 years) but otherwise similar; most were men. In addition to patients with hyperglycemia issues, those with confounders for post-op speech and swallowing recovery were among those excluded from the trial. Subjects required nasogastric feeding tubes for a median of 6.5 days postoperatively, lost a mean of 10 pounds in the first 2 post-op weeks, and were hospitalized for a mean of about 5 days. Dexamethasone was delivered orally or by nasogastric tube.

There was no external funding for the study, and Dr. Clayburgh had no relevant financial disclosures.

[email protected]

SEATTLE – A longer course of dexamethasone was a bit better than the usual single intraoperative dose for controlling pain and dysphagia after transoral robotic surgery in a randomized trial from the Oregon Health and Science University, Portland.

Thirty-five subjects were randomized to the standard 10-mg intraoperative dexamethasone dose plus 8 mg every 8 hours for up to 4 days; 33 others were randomized to the intraoperative dose plus placebo. All the subjects had transoral robotic surgery (TORS) resection for T1 or T2 oropharyngeal squamous cell carcinoma, either partial pharyngectomy/radical tonsillectomy, base of tongue resection, or both.

The dexamethasone group had significantly less pain on postop day 3 (about 1.5 points less on the 10-point visual analogue scale) and were discharged, on average, a day earlier. They also advanced more quickly toward solid food at 1- and 3-weeks’ follow-up. “They were much more likely to be on a full-soft diet, while the placebo group was mostly still on purees, and just starting into soft foods,” said lead investigator Daniel Clayburgh, MD, a head and neck cancer specialist at the university.

Otherwise, however, the extra dexamethasone wasn’t much help; pain scores were the same in both groups for the first couple days after surgery and at follow-up, and both groups used the same amount of post-op opioids. Other than food tolerance, dysphagia metrics were pretty much the same.

“I was actually anticipating a little bit more of a benefit, but there are potentially some benefits to extended corticosteroid courses after TORS. It’s safe, and well tolerated so long as you screen out diabetes and other problems with hyperglycemia,” as was done in the study, he said. “It does decrease post-op length of stay and may provide a modest decrease in post-op pain, and may slightly accelerate advancement of dietary consistency,” Dr. Clayburgh said at the International Conference on Head and Neck Cancer, held by the American Head and Neck Society.

Although he and his colleagues are mulling over what to do with the findings in light of other initiatives to reduce post-TORS pain, they are now likely to extend dexamethasone courses when significant post-op pain seems likely, and doing so is not otherwise contraindicated, he said.

Intraoperative corticosteroids are now routine for TORS, based on the strength of benefit in the tonsillectomy literature. The team decided to try an extended course because “being rather simple minded surgeons, we thought that if one dose is good, more should be better,” Dr. Clayburgh said.

The dexamethasone group was slightly younger than the placebo group (56 vs. 61 years) but otherwise similar; most were men. In addition to patients with hyperglycemia issues, those with confounders for post-op speech and swallowing recovery were among those excluded from the trial. Subjects required nasogastric feeding tubes for a median of 6.5 days postoperatively, lost a mean of 10 pounds in the first 2 post-op weeks, and were hospitalized for a mean of about 5 days. Dexamethasone was delivered orally or by nasogastric tube.

There was no external funding for the study, and Dr. Clayburgh had no relevant financial disclosures.

[email protected]

DENVER – Patients put on lenvatinib for the management of radioactive iodine–resistant differentiated thyroid cancer need to be taught how to monitor their blood pressure, be given a cuff with which to do so, and be called daily by someone on the medical staff for at least the first 2 weeks, according to Sina A. Jasim, MD, reporting on real world use of the drug since its approval in February 2015.

For now, oncologists prescribe and manage this drug. But as lenvatinib (Lenvima, Eisai) becomes more widely used, endocrinologists can expect to be the ones prescribing it sometimes and counseling patients in the practical aspects of using this drug, Dr. Jasim of the Mayo Clinic, Rochester, Minn., said in an interview.

It was with endocrinologists in mind that Dr. Jasim and her associates compiled postapproval data on adverse events and patient quality of life. To date, no such data – including those from Mayo – have been published, she said during her presentation at the American Thyroid Association’s annual meeting.

While lenvatinib seems to be a promising therapeutic agent, adverse events are common with its use and occur early. Patients treated with it at Mayo get called by someone on the medical staff daily for the first 2 weeks of therapy, are given a blood pressure cuff, and are taught how to use it. They also receive the cell phone number of a member of the medical staff to consult with about sudden symptoms.

This retrospective analysis involved 25 sequentially treated patients given lenvatinib for RAI-resistant differentiated thyroid cancer (14 papillary, 7 poorly differentiated, 3 Hürthle cell, and 1 follicular). While all had received RAI, 11 also had received radiotherapy, 8 had been given at least one other kinase inhibitor previously, and 3 had received two. Fourteen were on an antihypertensive medication at baseline.

All patients initiated lenvatinib at the full dose, but it was reduced in four patients because of old age, renal impairment, or prior colitis. Twenty-one patients developed adverse events within the first month of being on the drug. Hypertension occurred in 16. Six of these required either a raising of the dose of antihypertensive drug they were on at baseline or initiation of antihypertensive therapy.

Adverse events were pronounced enough that the lenvatinib dose had to be lowered in 11 within a median 33 days of starting the drug. Drug treatment had to be interrupted for at least 3 weeks in four patients (two cases of cholecystitis, one case of diverticulitis, and one case of skin lesions).

Patients reported that their quality of life was stable at 2 months, but that their fatigue was worse.

The mean duration of lenvatinib therapy was 6.5 months. Twenty patients are alive at the time of this report.

The study was sponsored by the Mayo Clinic. Dr. Jasim reported that she had no relevant financial disclosures.

[email protected]

DENVER – Patients put on lenvatinib for the management of radioactive iodine–resistant differentiated thyroid cancer need to be taught how to monitor their blood pressure, be given a cuff with which to do so, and be called daily by someone on the medical staff for at least the first 2 weeks, according to Sina A. Jasim, MD, reporting on real world use of the drug since its approval in February 2015.

For now, oncologists prescribe and manage this drug. But as lenvatinib (Lenvima, Eisai) becomes more widely used, endocrinologists can expect to be the ones prescribing it sometimes and counseling patients in the practical aspects of using this drug, Dr. Jasim of the Mayo Clinic, Rochester, Minn., said in an interview.

It was with endocrinologists in mind that Dr. Jasim and her associates compiled postapproval data on adverse events and patient quality of life. To date, no such data – including those from Mayo – have been published, she said during her presentation at the American Thyroid Association’s annual meeting.

While lenvatinib seems to be a promising therapeutic agent, adverse events are common with its use and occur early. Patients treated with it at Mayo get called by someone on the medical staff daily for the first 2 weeks of therapy, are given a blood pressure cuff, and are taught how to use it. They also receive the cell phone number of a member of the medical staff to consult with about sudden symptoms.

This retrospective analysis involved 25 sequentially treated patients given lenvatinib for RAI-resistant differentiated thyroid cancer (14 papillary, 7 poorly differentiated, 3 Hürthle cell, and 1 follicular). While all had received RAI, 11 also had received radiotherapy, 8 had been given at least one other kinase inhibitor previously, and 3 had received two. Fourteen were on an antihypertensive medication at baseline.

All patients initiated lenvatinib at the full dose, but it was reduced in four patients because of old age, renal impairment, or prior colitis. Twenty-one patients developed adverse events within the first month of being on the drug. Hypertension occurred in 16. Six of these required either a raising of the dose of antihypertensive drug they were on at baseline or initiation of antihypertensive therapy.

Adverse events were pronounced enough that the lenvatinib dose had to be lowered in 11 within a median 33 days of starting the drug. Drug treatment had to be interrupted for at least 3 weeks in four patients (two cases of cholecystitis, one case of diverticulitis, and one case of skin lesions).

Patients reported that their quality of life was stable at 2 months, but that their fatigue was worse.

The mean duration of lenvatinib therapy was 6.5 months. Twenty patients are alive at the time of this report.

The study was sponsored by the Mayo Clinic. Dr. Jasim reported that she had no relevant financial disclosures.

[email protected]

DENVER – Patients put on lenvatinib for the management of radioactive iodine–resistant differentiated thyroid cancer need to be taught how to monitor their blood pressure, be given a cuff with which to do so, and be called daily by someone on the medical staff for at least the first 2 weeks, according to Sina A. Jasim, MD, reporting on real world use of the drug since its approval in February 2015.

For now, oncologists prescribe and manage this drug. But as lenvatinib (Lenvima, Eisai) becomes more widely used, endocrinologists can expect to be the ones prescribing it sometimes and counseling patients in the practical aspects of using this drug, Dr. Jasim of the Mayo Clinic, Rochester, Minn., said in an interview.

It was with endocrinologists in mind that Dr. Jasim and her associates compiled postapproval data on adverse events and patient quality of life. To date, no such data – including those from Mayo – have been published, she said during her presentation at the American Thyroid Association’s annual meeting.

While lenvatinib seems to be a promising therapeutic agent, adverse events are common with its use and occur early. Patients treated with it at Mayo get called by someone on the medical staff daily for the first 2 weeks of therapy, are given a blood pressure cuff, and are taught how to use it. They also receive the cell phone number of a member of the medical staff to consult with about sudden symptoms.

This retrospective analysis involved 25 sequentially treated patients given lenvatinib for RAI-resistant differentiated thyroid cancer (14 papillary, 7 poorly differentiated, 3 Hürthle cell, and 1 follicular). While all had received RAI, 11 also had received radiotherapy, 8 had been given at least one other kinase inhibitor previously, and 3 had received two. Fourteen were on an antihypertensive medication at baseline.

All patients initiated lenvatinib at the full dose, but it was reduced in four patients because of old age, renal impairment, or prior colitis. Twenty-one patients developed adverse events within the first month of being on the drug. Hypertension occurred in 16. Six of these required either a raising of the dose of antihypertensive drug they were on at baseline or initiation of antihypertensive therapy.

Adverse events were pronounced enough that the lenvatinib dose had to be lowered in 11 within a median 33 days of starting the drug. Drug treatment had to be interrupted for at least 3 weeks in four patients (two cases of cholecystitis, one case of diverticulitis, and one case of skin lesions).

Patients reported that their quality of life was stable at 2 months, but that their fatigue was worse.

The mean duration of lenvatinib therapy was 6.5 months. Twenty patients are alive at the time of this report.

The study was sponsored by the Mayo Clinic. Dr. Jasim reported that she had no relevant financial disclosures.

[email protected]