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Experts share tips on minimizing the trauma of skin biopsy in children
DVDs, iPads, and toys. “Sweeties” to suck on. Buffered lidocaine, soothing talk, and a distracting “angel’s pinch.”
These are just a few of the strategies that dermatologists can use to calm children during a skin biopsy, which can be traumatic for everyone in the room. “This procedure, while minor, can be a big deal to kids,” said Robert Sidbury, MD, MPH, chief of the division of dermatology at Seattle Children’s Hospital and professor, department of pediatrics, University of Washington, Seattle. “It’s invasive. And it involves a shot and blood and discomfort, albeit relatively mild – all things that are frightening for anyone, but more so for kids.”
When a biopsy is performed in a child, “the anxiety that they bring to the situation is as much an issue as the pain,” Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and professor of dermatology and pediatrics, University of California, San Diego, said in an interview.
But there are ways to lessen the intensity of the procedures for children, their parents, and medical staff, according to the two pediatric dermatologists. Here are their tips for various age groups:
Infants
Dr. Sidbury is a big fan of papooses or wraps, as long as they are not obstructive. “Babies are used to being wrapped, and it can be an atraumatic way to restrain,” he said. “If parents are comfortable, I will have them present, talking and cooing to the baby throughout. Their voices are soothing.”
Indeed, Dr. Eichenfield says he breaks his rule about allowing parents in the room for biopsies when the children are under age 7 to 8 months. “It’s more unnerving for them to be in the room, and they’re not that calming to the baby.”
Food can be another soothing strategy. Infants may suck on “sweeties,” a glucose-rich solution known as TootSweet sucrose solution, prior to and during the procedure, Dr. Sidbury said. “EMLA cream or some form of topical anesthetic can be helpful, but the provider must remain mindful of the maximum safe amounts to apply as outlined in the package insert.”
He also advises colleagues to remember the thinness of infant skin. “Biopsying ‘down to the hub,’ as one will often do in an adult with a punch biopsy, can be too deep in some places,” he said.
Toddlers and younger children
“Two-to-six-year-olds are the toughest group,” Dr. Eichenfield noted. “They’re afraid of needles, they don’t understand why they have to have the procedure, and they don’t understand that once it’s done, it’s not going to hurt.”
Shifting away their focus is ideal, he said. “Distraction is always great. They’ll sense less pain and have less anxiety if they’re busy.” Distractions like a video on DVD can be helpful, he said, as can a “counterstimulation” technique, like a firm “angel’s pinch” that prevents them from noticing an injection. “Kids are comfortable getting pinched,” he said. “Many times I’ll block their view of the procedure, too.”
Older children
If a child is over age 6 years, Dr. Eichenfield recommends asking parents about whether the child has had any difficulty while undergoing anesthesia for dental procedures. If they don’t, “you know that they’re not coming with a history of anxiety or pain that can definitely amplify their perception and concern about the procedure.”
Dr. Sidbury also recommended distractions like iPads, movie players, video games, and music. Prizes may also help: They can be given as rewards at the end of procedures.
“Try not to show the needle,” he advised. “But this does not mean surprising kids or not letting them know a shot will be involved.”
And be aware that the numbing in older children is often the hardest part. “They will realize once it stops hurting they are OK,” he pointed out. “Hence, this part should be relatively fast. Don’t linger over the child, needle in hand, explaining things. Keep the needle and sharp, scary-looking instruments covered until needed, and then keep the needle itself covered as long as possible. Just the sight of it can be a deal breaker.”
Anesthesia tips
Regardless of the age of the child, careful use of anesthesia is recommended. “I often have the parents apply a topical anesthetic at home for a few hours before their arrival,” said Bernard Cohen, MD, professor of dermatology, Johns Hopkins University, Baltimore. “I inject deeper in the subcutaneous fat first before injecting more superficially, and I try to extend the anesthetic from the first area of injection to minimize the pain.”
For his part, Dr. Sidbury recommends using EMLA or LMX cream, in advance of 1% lidocaine with buffered epinephrine injected locally. Topical EMLA works better if used liberally – albeit within specified safe limits, he said. So instead of applying a small amount and rubbing it in, a thicker layer can be applied without rubbing it in, and when possible, the area can be occluded with a dressing or other type of covering, “while you are waiting the 30-plus minutes for it to work.” Occluding the area with something like “Press ’N’ Seal” wrap that comes off easily, instead of adhesive, is a good idea, he added, since removing an adhesive dressing can be as painful as the procedure.
Like Dr. Cohen and Dr. Eichenfield, Dr. Sidbury also supports physical distraction when the lidocaine is injected, like “having the patient cough if the movement is not problematic. Or rubbing or scratching the adjacent skin to the site of shot, or the opposite arm.”
Dr. Eichenfield, Dr. Sidbury, and Dr. Cohen reported no relevant disclosures.
DVDs, iPads, and toys. “Sweeties” to suck on. Buffered lidocaine, soothing talk, and a distracting “angel’s pinch.”
These are just a few of the strategies that dermatologists can use to calm children during a skin biopsy, which can be traumatic for everyone in the room. “This procedure, while minor, can be a big deal to kids,” said Robert Sidbury, MD, MPH, chief of the division of dermatology at Seattle Children’s Hospital and professor, department of pediatrics, University of Washington, Seattle. “It’s invasive. And it involves a shot and blood and discomfort, albeit relatively mild – all things that are frightening for anyone, but more so for kids.”
When a biopsy is performed in a child, “the anxiety that they bring to the situation is as much an issue as the pain,” Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and professor of dermatology and pediatrics, University of California, San Diego, said in an interview.
But there are ways to lessen the intensity of the procedures for children, their parents, and medical staff, according to the two pediatric dermatologists. Here are their tips for various age groups:
Infants
Dr. Sidbury is a big fan of papooses or wraps, as long as they are not obstructive. “Babies are used to being wrapped, and it can be an atraumatic way to restrain,” he said. “If parents are comfortable, I will have them present, talking and cooing to the baby throughout. Their voices are soothing.”
Indeed, Dr. Eichenfield says he breaks his rule about allowing parents in the room for biopsies when the children are under age 7 to 8 months. “It’s more unnerving for them to be in the room, and they’re not that calming to the baby.”
Food can be another soothing strategy. Infants may suck on “sweeties,” a glucose-rich solution known as TootSweet sucrose solution, prior to and during the procedure, Dr. Sidbury said. “EMLA cream or some form of topical anesthetic can be helpful, but the provider must remain mindful of the maximum safe amounts to apply as outlined in the package insert.”
He also advises colleagues to remember the thinness of infant skin. “Biopsying ‘down to the hub,’ as one will often do in an adult with a punch biopsy, can be too deep in some places,” he said.
Toddlers and younger children
“Two-to-six-year-olds are the toughest group,” Dr. Eichenfield noted. “They’re afraid of needles, they don’t understand why they have to have the procedure, and they don’t understand that once it’s done, it’s not going to hurt.”
Shifting away their focus is ideal, he said. “Distraction is always great. They’ll sense less pain and have less anxiety if they’re busy.” Distractions like a video on DVD can be helpful, he said, as can a “counterstimulation” technique, like a firm “angel’s pinch” that prevents them from noticing an injection. “Kids are comfortable getting pinched,” he said. “Many times I’ll block their view of the procedure, too.”
Older children
If a child is over age 6 years, Dr. Eichenfield recommends asking parents about whether the child has had any difficulty while undergoing anesthesia for dental procedures. If they don’t, “you know that they’re not coming with a history of anxiety or pain that can definitely amplify their perception and concern about the procedure.”
Dr. Sidbury also recommended distractions like iPads, movie players, video games, and music. Prizes may also help: They can be given as rewards at the end of procedures.
“Try not to show the needle,” he advised. “But this does not mean surprising kids or not letting them know a shot will be involved.”
And be aware that the numbing in older children is often the hardest part. “They will realize once it stops hurting they are OK,” he pointed out. “Hence, this part should be relatively fast. Don’t linger over the child, needle in hand, explaining things. Keep the needle and sharp, scary-looking instruments covered until needed, and then keep the needle itself covered as long as possible. Just the sight of it can be a deal breaker.”
Anesthesia tips
Regardless of the age of the child, careful use of anesthesia is recommended. “I often have the parents apply a topical anesthetic at home for a few hours before their arrival,” said Bernard Cohen, MD, professor of dermatology, Johns Hopkins University, Baltimore. “I inject deeper in the subcutaneous fat first before injecting more superficially, and I try to extend the anesthetic from the first area of injection to minimize the pain.”
For his part, Dr. Sidbury recommends using EMLA or LMX cream, in advance of 1% lidocaine with buffered epinephrine injected locally. Topical EMLA works better if used liberally – albeit within specified safe limits, he said. So instead of applying a small amount and rubbing it in, a thicker layer can be applied without rubbing it in, and when possible, the area can be occluded with a dressing or other type of covering, “while you are waiting the 30-plus minutes for it to work.” Occluding the area with something like “Press ’N’ Seal” wrap that comes off easily, instead of adhesive, is a good idea, he added, since removing an adhesive dressing can be as painful as the procedure.
Like Dr. Cohen and Dr. Eichenfield, Dr. Sidbury also supports physical distraction when the lidocaine is injected, like “having the patient cough if the movement is not problematic. Or rubbing or scratching the adjacent skin to the site of shot, or the opposite arm.”
Dr. Eichenfield, Dr. Sidbury, and Dr. Cohen reported no relevant disclosures.
DVDs, iPads, and toys. “Sweeties” to suck on. Buffered lidocaine, soothing talk, and a distracting “angel’s pinch.”
These are just a few of the strategies that dermatologists can use to calm children during a skin biopsy, which can be traumatic for everyone in the room. “This procedure, while minor, can be a big deal to kids,” said Robert Sidbury, MD, MPH, chief of the division of dermatology at Seattle Children’s Hospital and professor, department of pediatrics, University of Washington, Seattle. “It’s invasive. And it involves a shot and blood and discomfort, albeit relatively mild – all things that are frightening for anyone, but more so for kids.”
When a biopsy is performed in a child, “the anxiety that they bring to the situation is as much an issue as the pain,” Lawrence Eichenfield, MD, chief of pediatric and adolescent dermatology at Rady Children’s Hospital–San Diego, and professor of dermatology and pediatrics, University of California, San Diego, said in an interview.
But there are ways to lessen the intensity of the procedures for children, their parents, and medical staff, according to the two pediatric dermatologists. Here are their tips for various age groups:
Infants
Dr. Sidbury is a big fan of papooses or wraps, as long as they are not obstructive. “Babies are used to being wrapped, and it can be an atraumatic way to restrain,” he said. “If parents are comfortable, I will have them present, talking and cooing to the baby throughout. Their voices are soothing.”
Indeed, Dr. Eichenfield says he breaks his rule about allowing parents in the room for biopsies when the children are under age 7 to 8 months. “It’s more unnerving for them to be in the room, and they’re not that calming to the baby.”
Food can be another soothing strategy. Infants may suck on “sweeties,” a glucose-rich solution known as TootSweet sucrose solution, prior to and during the procedure, Dr. Sidbury said. “EMLA cream or some form of topical anesthetic can be helpful, but the provider must remain mindful of the maximum safe amounts to apply as outlined in the package insert.”
He also advises colleagues to remember the thinness of infant skin. “Biopsying ‘down to the hub,’ as one will often do in an adult with a punch biopsy, can be too deep in some places,” he said.
Toddlers and younger children
“Two-to-six-year-olds are the toughest group,” Dr. Eichenfield noted. “They’re afraid of needles, they don’t understand why they have to have the procedure, and they don’t understand that once it’s done, it’s not going to hurt.”
Shifting away their focus is ideal, he said. “Distraction is always great. They’ll sense less pain and have less anxiety if they’re busy.” Distractions like a video on DVD can be helpful, he said, as can a “counterstimulation” technique, like a firm “angel’s pinch” that prevents them from noticing an injection. “Kids are comfortable getting pinched,” he said. “Many times I’ll block their view of the procedure, too.”
Older children
If a child is over age 6 years, Dr. Eichenfield recommends asking parents about whether the child has had any difficulty while undergoing anesthesia for dental procedures. If they don’t, “you know that they’re not coming with a history of anxiety or pain that can definitely amplify their perception and concern about the procedure.”
Dr. Sidbury also recommended distractions like iPads, movie players, video games, and music. Prizes may also help: They can be given as rewards at the end of procedures.
“Try not to show the needle,” he advised. “But this does not mean surprising kids or not letting them know a shot will be involved.”
And be aware that the numbing in older children is often the hardest part. “They will realize once it stops hurting they are OK,” he pointed out. “Hence, this part should be relatively fast. Don’t linger over the child, needle in hand, explaining things. Keep the needle and sharp, scary-looking instruments covered until needed, and then keep the needle itself covered as long as possible. Just the sight of it can be a deal breaker.”
Anesthesia tips
Regardless of the age of the child, careful use of anesthesia is recommended. “I often have the parents apply a topical anesthetic at home for a few hours before their arrival,” said Bernard Cohen, MD, professor of dermatology, Johns Hopkins University, Baltimore. “I inject deeper in the subcutaneous fat first before injecting more superficially, and I try to extend the anesthetic from the first area of injection to minimize the pain.”
For his part, Dr. Sidbury recommends using EMLA or LMX cream, in advance of 1% lidocaine with buffered epinephrine injected locally. Topical EMLA works better if used liberally – albeit within specified safe limits, he said. So instead of applying a small amount and rubbing it in, a thicker layer can be applied without rubbing it in, and when possible, the area can be occluded with a dressing or other type of covering, “while you are waiting the 30-plus minutes for it to work.” Occluding the area with something like “Press ’N’ Seal” wrap that comes off easily, instead of adhesive, is a good idea, he added, since removing an adhesive dressing can be as painful as the procedure.
Like Dr. Cohen and Dr. Eichenfield, Dr. Sidbury also supports physical distraction when the lidocaine is injected, like “having the patient cough if the movement is not problematic. Or rubbing or scratching the adjacent skin to the site of shot, or the opposite arm.”
Dr. Eichenfield, Dr. Sidbury, and Dr. Cohen reported no relevant disclosures.
‘Active referrals’ boost HIV testing in Kenyan children
Researchers in Kenya reported that an active referral program significantly boosted the level of HIV testing in children of HIV-positive adults, according to a study published in JAIDS: The Journal of Acquired Immune Deficiency Syndromes. However, 86% of adults with children younger than 12 years of age did not pursue testing for their kids.
“This case detection approach was efficient, but there are still gaps in uptake that need to urgently be addressed,” said Anjuli Wagner, PhD, MPH, lead author of the study and a postdoctoral research fellow with the department of global health at the University of Washington, Seattle. According to Dr. Wagner, such a strategy is now in place in Kenya and is being adopted by other African countries.
During 2013-2014, at Kenyatta National Hospital, Nairobi, Kenya, hospital staff interviewed 10,426 HIV-infected adults over a 9-month period and referred 611 of them for testing of their children under age 12 years.
Only 74 (14%) of the adults accepted referral and completed testing of their children; 7.4% of those 108 children were HIV positive. Still, after statistical adjustment, the hospital saw a 3.8-fold increase in the number of children tested, compared with the previous 10-month period (13.6 vs. 3.5 per month).
Why did so many parents decline to pursue testing for their children? “The most common reasons cited by parents were that they felt that their children seemed healthy and couldn’t possibly have HIV, and also that they feared a positive diagnosis,” Wagner said. “Parents cited logistical and financial barriers to testing their children as a frequent barrier and were also concerned about disclosure issues brought up by testing their children – disclosure of their own status to their child and partner, as well as disclosure of the child’s status to the child.”
The lesson of the study is that “testing children of HIV-positive adults in care should be integrated as part of comprehensive HIV care in Kenya and elsewhere,” Wagner said. “This approach is currently endorsed in the Kenyan national guidelines, partially as a result of this study, but was not present at the time this study was designed. Other African countries are also in the process of either adopting this approach into guidelines or scaling the already endorsed approach.”
The University of Washington and the National Institutes of Health funded the study. The authors reported no relevant disclosures.
On Twitter @idpractitioner
Researchers in Kenya reported that an active referral program significantly boosted the level of HIV testing in children of HIV-positive adults, according to a study published in JAIDS: The Journal of Acquired Immune Deficiency Syndromes. However, 86% of adults with children younger than 12 years of age did not pursue testing for their kids.
“This case detection approach was efficient, but there are still gaps in uptake that need to urgently be addressed,” said Anjuli Wagner, PhD, MPH, lead author of the study and a postdoctoral research fellow with the department of global health at the University of Washington, Seattle. According to Dr. Wagner, such a strategy is now in place in Kenya and is being adopted by other African countries.
During 2013-2014, at Kenyatta National Hospital, Nairobi, Kenya, hospital staff interviewed 10,426 HIV-infected adults over a 9-month period and referred 611 of them for testing of their children under age 12 years.
Only 74 (14%) of the adults accepted referral and completed testing of their children; 7.4% of those 108 children were HIV positive. Still, after statistical adjustment, the hospital saw a 3.8-fold increase in the number of children tested, compared with the previous 10-month period (13.6 vs. 3.5 per month).
Why did so many parents decline to pursue testing for their children? “The most common reasons cited by parents were that they felt that their children seemed healthy and couldn’t possibly have HIV, and also that they feared a positive diagnosis,” Wagner said. “Parents cited logistical and financial barriers to testing their children as a frequent barrier and were also concerned about disclosure issues brought up by testing their children – disclosure of their own status to their child and partner, as well as disclosure of the child’s status to the child.”
The lesson of the study is that “testing children of HIV-positive adults in care should be integrated as part of comprehensive HIV care in Kenya and elsewhere,” Wagner said. “This approach is currently endorsed in the Kenyan national guidelines, partially as a result of this study, but was not present at the time this study was designed. Other African countries are also in the process of either adopting this approach into guidelines or scaling the already endorsed approach.”
The University of Washington and the National Institutes of Health funded the study. The authors reported no relevant disclosures.
On Twitter @idpractitioner
Researchers in Kenya reported that an active referral program significantly boosted the level of HIV testing in children of HIV-positive adults, according to a study published in JAIDS: The Journal of Acquired Immune Deficiency Syndromes. However, 86% of adults with children younger than 12 years of age did not pursue testing for their kids.
“This case detection approach was efficient, but there are still gaps in uptake that need to urgently be addressed,” said Anjuli Wagner, PhD, MPH, lead author of the study and a postdoctoral research fellow with the department of global health at the University of Washington, Seattle. According to Dr. Wagner, such a strategy is now in place in Kenya and is being adopted by other African countries.
During 2013-2014, at Kenyatta National Hospital, Nairobi, Kenya, hospital staff interviewed 10,426 HIV-infected adults over a 9-month period and referred 611 of them for testing of their children under age 12 years.
Only 74 (14%) of the adults accepted referral and completed testing of their children; 7.4% of those 108 children were HIV positive. Still, after statistical adjustment, the hospital saw a 3.8-fold increase in the number of children tested, compared with the previous 10-month period (13.6 vs. 3.5 per month).
Why did so many parents decline to pursue testing for their children? “The most common reasons cited by parents were that they felt that their children seemed healthy and couldn’t possibly have HIV, and also that they feared a positive diagnosis,” Wagner said. “Parents cited logistical and financial barriers to testing their children as a frequent barrier and were also concerned about disclosure issues brought up by testing their children – disclosure of their own status to their child and partner, as well as disclosure of the child’s status to the child.”
The lesson of the study is that “testing children of HIV-positive adults in care should be integrated as part of comprehensive HIV care in Kenya and elsewhere,” Wagner said. “This approach is currently endorsed in the Kenyan national guidelines, partially as a result of this study, but was not present at the time this study was designed. Other African countries are also in the process of either adopting this approach into guidelines or scaling the already endorsed approach.”
The University of Washington and the National Institutes of Health funded the study. The authors reported no relevant disclosures.
On Twitter @idpractitioner
FROM THE JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
Key clinical point: An active referral program boosted HIV testing of Kenyan children of HIV-positive adults and turned up previously undetected HIV cases, but many parents refused to participate.
Major finding: Of 611 HIV-infected adults with children younger than age 12 years of unknown HIV status, 74 (14%) accepted referral and completed testing of their 108 children; 8 children (7.4%) were HIV positive.
Data source: 10,426 HIV-infected adults interviewed at Kenyatta National Hospital over 9 months during 2013-2014.
Disclosures: The University of Washington and the National Institutes of Health funded the study. The authors reported no relevant disclosures.
Phase II trial: Drug reduces sickle cell ‘pain crises’
An industry-funded phase II trial has shown that high doses of the experimental drug crizanlizumab significantly reduced the number of dangerous “pain crises” in subjects with sickle cell disease.
The median per-year rate of pain crises was 45.3% lower among those who took the high dose of crizanlizumab, compared with the placebo group (P = .01) More than a third of the subjects who took the high dose reported no pain crises during the treatment phase, more than double the rate among the placebo group.
The trial findings were released at the annual meeting of the American Society of Hematology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1611770).
The American Society of Hematology estimates that 70,000-100,000 people in the United States have sickle cell anemia and some patients are treated with hydroxyurea (Hydrea) are available. According to background material provided in the trial report, however, hydroxyurea has limited value, and some patients still face the prospect of pain crises which can lead to end-organ damage, and early death.
The SUSTAIN trial focuses on pain crises, also known as vaso-occlusive and sickle cell crises, which can occur without warning when sickle cells block blood flow and decrease oxygen delivery.
Researchers led by Kenneth I. Ataga, MB, of the University of North Carolina, Chapel Hill, recruited 198 subjects who had sickle cell disease and who had experienced 2-10 pain crises related to their condition over the past year. They randomly assigned 67 subjects to receive a low 2.5-mg/kg dose of crizanlizumab (also known as SelG1), 66 to a high 5.0-mg/kg dose, and 65 to a placebo. Crizanlizumab is an antibody against the molecule P-selectin, whose up-regulation in certain cells and platelets is thought to contribute to vaso-occlusion and sickle cell pain crises.
All the doses were administered intravenously 14 times over a year at sites in Brazil, the United States, and Jamaica. Risk groups for sickle cell include people of African and South American descent, among groups.
The first two doses were loading doses given at 2-week intervals, and the rest were given at 4-week intervals.
Subjects were aged 16-63 years; the median age was 29 for the two crizanlizumab groups and 26 for the placebo group. The percentage of black subjects ranged from 90% to 94% in each group, and the percentage of female subjects ranged from 52% to 58%.
Some subjects, but not all, were taking hydroxyurea. If they were taking the drug, they needed to have been on it for at least 6 months prior to the trial, and at least the last 3 months at a steady dose. Those who didn’t take hydroxyurea weren’t allowed to start taking it.
The researchers found that the median number of pain crises per year was 1.63 in the high-dose group, 2.01 in the low-dose group, and 2.98 in the placebo group. That translates to a 45.3% lower rate for the high-dose group than placebo (P = .01) and a 32.6% lower rate for low-dose than placebo (P = .18).
A total of 36% of the subjects in the high-dose group had no pain crises during the treatment phase, compared with 18% and 17% in the low-dose and placebo groups, respectively.
In a per-protocol analysis of 125 subjects, the researchers found similar numbers for median pain crises and no pain crises with one exception: The rate of annual pain crises was only 8.3% lower for the low-dose group than the placebo (P = .13).
Overall, the researchers wrote, the rates of adverse and serious adverse events were “similar” among all the subjects regardless of their randomized group.
Five patients died during the trial: two from the high dose group, one in the low dose group, and two in the placebo group. Among serious adverse events, pyrexia and pneumonia occurred more frequently in at least one of the crizanlizumab groups than in the placebo group, but their levels were low at zero to three cases of each event in the three groups.
The researchers noted that they didn’t detect any antibody response against crizanlizumab. However, “longer follow-up and monitoring are necessary to ensure that late neutralizing antibodies do not emerge that might limit the ability to administer crizanlizumab on a long-term basis.”
The study was funded by Selexys Pharmaceuticals, which received grants from the National Heart, Lung, and Blood Institute and the Food and Drug Administration’s Orphan Products Grant Program. Dr. Ataga reports personal fees from Selexys Pharmaceuticals. The other authors report various disclosures or none. The complete list of disclosures is available at NEJM.org.
An industry-funded phase II trial has shown that high doses of the experimental drug crizanlizumab significantly reduced the number of dangerous “pain crises” in subjects with sickle cell disease.
The median per-year rate of pain crises was 45.3% lower among those who took the high dose of crizanlizumab, compared with the placebo group (P = .01) More than a third of the subjects who took the high dose reported no pain crises during the treatment phase, more than double the rate among the placebo group.
The trial findings were released at the annual meeting of the American Society of Hematology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1611770).
The American Society of Hematology estimates that 70,000-100,000 people in the United States have sickle cell anemia and some patients are treated with hydroxyurea (Hydrea) are available. According to background material provided in the trial report, however, hydroxyurea has limited value, and some patients still face the prospect of pain crises which can lead to end-organ damage, and early death.
The SUSTAIN trial focuses on pain crises, also known as vaso-occlusive and sickle cell crises, which can occur without warning when sickle cells block blood flow and decrease oxygen delivery.
Researchers led by Kenneth I. Ataga, MB, of the University of North Carolina, Chapel Hill, recruited 198 subjects who had sickle cell disease and who had experienced 2-10 pain crises related to their condition over the past year. They randomly assigned 67 subjects to receive a low 2.5-mg/kg dose of crizanlizumab (also known as SelG1), 66 to a high 5.0-mg/kg dose, and 65 to a placebo. Crizanlizumab is an antibody against the molecule P-selectin, whose up-regulation in certain cells and platelets is thought to contribute to vaso-occlusion and sickle cell pain crises.
All the doses were administered intravenously 14 times over a year at sites in Brazil, the United States, and Jamaica. Risk groups for sickle cell include people of African and South American descent, among groups.
The first two doses were loading doses given at 2-week intervals, and the rest were given at 4-week intervals.
Subjects were aged 16-63 years; the median age was 29 for the two crizanlizumab groups and 26 for the placebo group. The percentage of black subjects ranged from 90% to 94% in each group, and the percentage of female subjects ranged from 52% to 58%.
Some subjects, but not all, were taking hydroxyurea. If they were taking the drug, they needed to have been on it for at least 6 months prior to the trial, and at least the last 3 months at a steady dose. Those who didn’t take hydroxyurea weren’t allowed to start taking it.
The researchers found that the median number of pain crises per year was 1.63 in the high-dose group, 2.01 in the low-dose group, and 2.98 in the placebo group. That translates to a 45.3% lower rate for the high-dose group than placebo (P = .01) and a 32.6% lower rate for low-dose than placebo (P = .18).
A total of 36% of the subjects in the high-dose group had no pain crises during the treatment phase, compared with 18% and 17% in the low-dose and placebo groups, respectively.
In a per-protocol analysis of 125 subjects, the researchers found similar numbers for median pain crises and no pain crises with one exception: The rate of annual pain crises was only 8.3% lower for the low-dose group than the placebo (P = .13).
Overall, the researchers wrote, the rates of adverse and serious adverse events were “similar” among all the subjects regardless of their randomized group.
Five patients died during the trial: two from the high dose group, one in the low dose group, and two in the placebo group. Among serious adverse events, pyrexia and pneumonia occurred more frequently in at least one of the crizanlizumab groups than in the placebo group, but their levels were low at zero to three cases of each event in the three groups.
The researchers noted that they didn’t detect any antibody response against crizanlizumab. However, “longer follow-up and monitoring are necessary to ensure that late neutralizing antibodies do not emerge that might limit the ability to administer crizanlizumab on a long-term basis.”
The study was funded by Selexys Pharmaceuticals, which received grants from the National Heart, Lung, and Blood Institute and the Food and Drug Administration’s Orphan Products Grant Program. Dr. Ataga reports personal fees from Selexys Pharmaceuticals. The other authors report various disclosures or none. The complete list of disclosures is available at NEJM.org.
An industry-funded phase II trial has shown that high doses of the experimental drug crizanlizumab significantly reduced the number of dangerous “pain crises” in subjects with sickle cell disease.
The median per-year rate of pain crises was 45.3% lower among those who took the high dose of crizanlizumab, compared with the placebo group (P = .01) More than a third of the subjects who took the high dose reported no pain crises during the treatment phase, more than double the rate among the placebo group.
The trial findings were released at the annual meeting of the American Society of Hematology and published simultaneously in the New England Journal of Medicine (doi: 10.1056/NEJMoa1611770).
The American Society of Hematology estimates that 70,000-100,000 people in the United States have sickle cell anemia and some patients are treated with hydroxyurea (Hydrea) are available. According to background material provided in the trial report, however, hydroxyurea has limited value, and some patients still face the prospect of pain crises which can lead to end-organ damage, and early death.
The SUSTAIN trial focuses on pain crises, also known as vaso-occlusive and sickle cell crises, which can occur without warning when sickle cells block blood flow and decrease oxygen delivery.
Researchers led by Kenneth I. Ataga, MB, of the University of North Carolina, Chapel Hill, recruited 198 subjects who had sickle cell disease and who had experienced 2-10 pain crises related to their condition over the past year. They randomly assigned 67 subjects to receive a low 2.5-mg/kg dose of crizanlizumab (also known as SelG1), 66 to a high 5.0-mg/kg dose, and 65 to a placebo. Crizanlizumab is an antibody against the molecule P-selectin, whose up-regulation in certain cells and platelets is thought to contribute to vaso-occlusion and sickle cell pain crises.
All the doses were administered intravenously 14 times over a year at sites in Brazil, the United States, and Jamaica. Risk groups for sickle cell include people of African and South American descent, among groups.
The first two doses were loading doses given at 2-week intervals, and the rest were given at 4-week intervals.
Subjects were aged 16-63 years; the median age was 29 for the two crizanlizumab groups and 26 for the placebo group. The percentage of black subjects ranged from 90% to 94% in each group, and the percentage of female subjects ranged from 52% to 58%.
Some subjects, but not all, were taking hydroxyurea. If they were taking the drug, they needed to have been on it for at least 6 months prior to the trial, and at least the last 3 months at a steady dose. Those who didn’t take hydroxyurea weren’t allowed to start taking it.
The researchers found that the median number of pain crises per year was 1.63 in the high-dose group, 2.01 in the low-dose group, and 2.98 in the placebo group. That translates to a 45.3% lower rate for the high-dose group than placebo (P = .01) and a 32.6% lower rate for low-dose than placebo (P = .18).
A total of 36% of the subjects in the high-dose group had no pain crises during the treatment phase, compared with 18% and 17% in the low-dose and placebo groups, respectively.
In a per-protocol analysis of 125 subjects, the researchers found similar numbers for median pain crises and no pain crises with one exception: The rate of annual pain crises was only 8.3% lower for the low-dose group than the placebo (P = .13).
Overall, the researchers wrote, the rates of adverse and serious adverse events were “similar” among all the subjects regardless of their randomized group.
Five patients died during the trial: two from the high dose group, one in the low dose group, and two in the placebo group. Among serious adverse events, pyrexia and pneumonia occurred more frequently in at least one of the crizanlizumab groups than in the placebo group, but their levels were low at zero to three cases of each event in the three groups.
The researchers noted that they didn’t detect any antibody response against crizanlizumab. However, “longer follow-up and monitoring are necessary to ensure that late neutralizing antibodies do not emerge that might limit the ability to administer crizanlizumab on a long-term basis.”
The study was funded by Selexys Pharmaceuticals, which received grants from the National Heart, Lung, and Blood Institute and the Food and Drug Administration’s Orphan Products Grant Program. Dr. Ataga reports personal fees from Selexys Pharmaceuticals. The other authors report various disclosures or none. The complete list of disclosures is available at NEJM.org.
FROM ASH 2016
Key clinical point: High-dose crizanlizumab significantly lowers, but does not eliminate, dangerous ‘pain crises’ that strike sickle cell patients.
Major finding: Patients who took high-dose crizanlizumab had a median of 1.63 pain crises a year versus 2.98 for the placebo group. (P = .01)
Data source: A phase II, 12-month, multicenter, double-blind, randomized, placebo-controlled study of 198 patients with sickle cell disease; 129 subjects completed the trial.
Disclosures: The study was funded by Selexys Pharmaceuticals, which received grants from the National Heart, Lung, and Blood Institute and the FDA’s Orphan Products Grant Program. Dr. Ataga reports personal fees from Selexys Pharmaceuticals. The other authors report various disclosures or none. The complete list of disclosures is available at NEJM.org.
Ocular rosacea remains a stubborn foe
Few skin disorders have the power to devastate lives like ocular rosacea, a painful condition that disrupts vision and can lead to blindness, according to ophthalmologist Edward Wladis, MD.
“Patients really suffer from this diagnosis,” said Dr. Wladis, who practices in Slingerlands, N.Y.
Charles Slonim, MD, an ophthalmologist who practices in Tampa, Fla., put it this way: “We control the condition more than 50 percent of the time, but frequently patients go into periods of remission only to have a recurrence or exacerbation of their ocular rosacea.”
Dr. Wladis coauthored a 2013 report that examined treatments for ocular rosacea, which noted that estimates of the proportion of people with rosacea in the United States who develop ocular rosacea vary, ranging from 58% to 72% (US Ophthalmic Review, 2013;6[2]:86-8).
“Ocular rosacea is one of the subtypes of this disease of cutaneous inflammation,” Dr. Wladis said. “Once the skin becomes so severely inflamed, the glands that lubricate the eye become damaged, and the tear film evaporates rapidly. As a result, patients complain of the effects of a dry ocular surface, and they suffer from blurred vision, tearing, pain, and problems with glare.”
Dr. Slonim suggests that dermatologists refer rosacea patients to an ophthalmologist if they present with any eye symptom, such as dryness, burning, or itching, foreign body sensation in one or both eyes, or chronic redness of either the eyes or the eyelid margins. “They should be seen should be seen by an ophthalmologist to rule out ocular rosacea,” he said. “The ophthalmologist’s ability to look at the eye and eyelids under high magnification – a slit lamp examination – gives us an advantage in the diagnosis of ocular rosacea.”
If these patients do have ocular rosacea, their prognosis is unclear. “Unfortunately, many of our treatments haven’t been carefully vetted,” Dr. Wladis said.
He tends to begin with simpler treatments to heal the ocular surface, such as artificial tears and plugs in the tear drainage ducts to keep tears from leaving the eye quickly. Eyelid scrubs and warm compresses can also be helpful, he said, along with suggestions about lifestyle modifications to avoid the triggers that may exacerbate rosacea.
If those treatments fail, antibiotics are an option.
A 2015 Cochrane Review of studies of rosacea treatments suggested that for treating ocular rosacea, cyclosporine 0.05% ophthalmic emulsion “appeared to be more effective than artificial tears” (Cochrane Database Syst Rev. 2015 Apr 28;[3]:CD003262). And a 2015 study of 38 patients with ocular rosacea concluded that topical cyclosporine was significantly more effective in relieving symptoms and in the treatment of eyelid signs, compared with oral doxycycline (Int J Ophthalmol. 2015 Jun 18;8[3]:544-9).
Antibiotics seem to improve the eyelid’s health, “although some studies have documented that the cornea often doesn’t benefit from antibiotics, and patients’ visual acuity may not improve,” Dr. Wladis said.
Ophthalmologists also may prescribe nonsteroidal and steroidal anti-inflammatory drops, Dr. Slonim added, although “the use of topical ophthalmic steroids do carry the risk of secondary glaucoma with increased intraocular pressures.”
There are even more alternatives. “Dietary modification with omega-3 fatty acids appears to benefit the quality of the tear film,” Dr. Wladis said, referring to the results of a prospective, placebo-controlled, double-blind, randomized trial of patients with dry eye (Int J Ophthalmol. 2013 Dec 18;[6]:811-6). “Intraductal meibomian gland probing and intense pulsed light therapy have both been shown to improve ocular surface–related quality of life, although these treatments are relatively invasive and can rapidly become quite expensive for the patient.”
What’s on the horizon? Researchers have “started to unlock the mysteries of rosacea at the cellular level,” Dr. Wladis said. “Our efforts have recently focused on the cellular changes in the skin of rosacea patients. Using several methods, we assayed the activation of a wide variety of signals within the cells of the skin of these patients and found a consistent elevation of two specific signals.”
The researchers were especially pleased, he said, “that these signals appear to be activated in the outer layers of the skin, meaning that a topical preparation could be developed to selectively suppress these cell signals to turn off the disease without interfering with normal skin structure and function and without the side effects of oral or intravenous medications.”
His team is now working on a topical medication. “Ideally,” he noted, “future clinicians will be able to shift their focus from nonspecific therapies like antibiotics and steroids to really powerful, meaningful cellular therapeutics.”
Dr. Slonim reported no relevant disclosures. Dr. Wladis shares a provisional patent for the use of topical kinase inhibitors in the management of rosacea and recently co-started a biotechnology company called Praxis Biotechnology that aims to develop and test therapies for the condition. He serves as a consultant for both Bausch & Lomb and Valeant Pharmaceuticals.
Few skin disorders have the power to devastate lives like ocular rosacea, a painful condition that disrupts vision and can lead to blindness, according to ophthalmologist Edward Wladis, MD.
“Patients really suffer from this diagnosis,” said Dr. Wladis, who practices in Slingerlands, N.Y.
Charles Slonim, MD, an ophthalmologist who practices in Tampa, Fla., put it this way: “We control the condition more than 50 percent of the time, but frequently patients go into periods of remission only to have a recurrence or exacerbation of their ocular rosacea.”
Dr. Wladis coauthored a 2013 report that examined treatments for ocular rosacea, which noted that estimates of the proportion of people with rosacea in the United States who develop ocular rosacea vary, ranging from 58% to 72% (US Ophthalmic Review, 2013;6[2]:86-8).
“Ocular rosacea is one of the subtypes of this disease of cutaneous inflammation,” Dr. Wladis said. “Once the skin becomes so severely inflamed, the glands that lubricate the eye become damaged, and the tear film evaporates rapidly. As a result, patients complain of the effects of a dry ocular surface, and they suffer from blurred vision, tearing, pain, and problems with glare.”
Dr. Slonim suggests that dermatologists refer rosacea patients to an ophthalmologist if they present with any eye symptom, such as dryness, burning, or itching, foreign body sensation in one or both eyes, or chronic redness of either the eyes or the eyelid margins. “They should be seen should be seen by an ophthalmologist to rule out ocular rosacea,” he said. “The ophthalmologist’s ability to look at the eye and eyelids under high magnification – a slit lamp examination – gives us an advantage in the diagnosis of ocular rosacea.”
If these patients do have ocular rosacea, their prognosis is unclear. “Unfortunately, many of our treatments haven’t been carefully vetted,” Dr. Wladis said.
He tends to begin with simpler treatments to heal the ocular surface, such as artificial tears and plugs in the tear drainage ducts to keep tears from leaving the eye quickly. Eyelid scrubs and warm compresses can also be helpful, he said, along with suggestions about lifestyle modifications to avoid the triggers that may exacerbate rosacea.
If those treatments fail, antibiotics are an option.
A 2015 Cochrane Review of studies of rosacea treatments suggested that for treating ocular rosacea, cyclosporine 0.05% ophthalmic emulsion “appeared to be more effective than artificial tears” (Cochrane Database Syst Rev. 2015 Apr 28;[3]:CD003262). And a 2015 study of 38 patients with ocular rosacea concluded that topical cyclosporine was significantly more effective in relieving symptoms and in the treatment of eyelid signs, compared with oral doxycycline (Int J Ophthalmol. 2015 Jun 18;8[3]:544-9).
Antibiotics seem to improve the eyelid’s health, “although some studies have documented that the cornea often doesn’t benefit from antibiotics, and patients’ visual acuity may not improve,” Dr. Wladis said.
Ophthalmologists also may prescribe nonsteroidal and steroidal anti-inflammatory drops, Dr. Slonim added, although “the use of topical ophthalmic steroids do carry the risk of secondary glaucoma with increased intraocular pressures.”
There are even more alternatives. “Dietary modification with omega-3 fatty acids appears to benefit the quality of the tear film,” Dr. Wladis said, referring to the results of a prospective, placebo-controlled, double-blind, randomized trial of patients with dry eye (Int J Ophthalmol. 2013 Dec 18;[6]:811-6). “Intraductal meibomian gland probing and intense pulsed light therapy have both been shown to improve ocular surface–related quality of life, although these treatments are relatively invasive and can rapidly become quite expensive for the patient.”
What’s on the horizon? Researchers have “started to unlock the mysteries of rosacea at the cellular level,” Dr. Wladis said. “Our efforts have recently focused on the cellular changes in the skin of rosacea patients. Using several methods, we assayed the activation of a wide variety of signals within the cells of the skin of these patients and found a consistent elevation of two specific signals.”
The researchers were especially pleased, he said, “that these signals appear to be activated in the outer layers of the skin, meaning that a topical preparation could be developed to selectively suppress these cell signals to turn off the disease without interfering with normal skin structure and function and without the side effects of oral or intravenous medications.”
His team is now working on a topical medication. “Ideally,” he noted, “future clinicians will be able to shift their focus from nonspecific therapies like antibiotics and steroids to really powerful, meaningful cellular therapeutics.”
Dr. Slonim reported no relevant disclosures. Dr. Wladis shares a provisional patent for the use of topical kinase inhibitors in the management of rosacea and recently co-started a biotechnology company called Praxis Biotechnology that aims to develop and test therapies for the condition. He serves as a consultant for both Bausch & Lomb and Valeant Pharmaceuticals.
Few skin disorders have the power to devastate lives like ocular rosacea, a painful condition that disrupts vision and can lead to blindness, according to ophthalmologist Edward Wladis, MD.
“Patients really suffer from this diagnosis,” said Dr. Wladis, who practices in Slingerlands, N.Y.
Charles Slonim, MD, an ophthalmologist who practices in Tampa, Fla., put it this way: “We control the condition more than 50 percent of the time, but frequently patients go into periods of remission only to have a recurrence or exacerbation of their ocular rosacea.”
Dr. Wladis coauthored a 2013 report that examined treatments for ocular rosacea, which noted that estimates of the proportion of people with rosacea in the United States who develop ocular rosacea vary, ranging from 58% to 72% (US Ophthalmic Review, 2013;6[2]:86-8).
“Ocular rosacea is one of the subtypes of this disease of cutaneous inflammation,” Dr. Wladis said. “Once the skin becomes so severely inflamed, the glands that lubricate the eye become damaged, and the tear film evaporates rapidly. As a result, patients complain of the effects of a dry ocular surface, and they suffer from blurred vision, tearing, pain, and problems with glare.”
Dr. Slonim suggests that dermatologists refer rosacea patients to an ophthalmologist if they present with any eye symptom, such as dryness, burning, or itching, foreign body sensation in one or both eyes, or chronic redness of either the eyes or the eyelid margins. “They should be seen should be seen by an ophthalmologist to rule out ocular rosacea,” he said. “The ophthalmologist’s ability to look at the eye and eyelids under high magnification – a slit lamp examination – gives us an advantage in the diagnosis of ocular rosacea.”
If these patients do have ocular rosacea, their prognosis is unclear. “Unfortunately, many of our treatments haven’t been carefully vetted,” Dr. Wladis said.
He tends to begin with simpler treatments to heal the ocular surface, such as artificial tears and plugs in the tear drainage ducts to keep tears from leaving the eye quickly. Eyelid scrubs and warm compresses can also be helpful, he said, along with suggestions about lifestyle modifications to avoid the triggers that may exacerbate rosacea.
If those treatments fail, antibiotics are an option.
A 2015 Cochrane Review of studies of rosacea treatments suggested that for treating ocular rosacea, cyclosporine 0.05% ophthalmic emulsion “appeared to be more effective than artificial tears” (Cochrane Database Syst Rev. 2015 Apr 28;[3]:CD003262). And a 2015 study of 38 patients with ocular rosacea concluded that topical cyclosporine was significantly more effective in relieving symptoms and in the treatment of eyelid signs, compared with oral doxycycline (Int J Ophthalmol. 2015 Jun 18;8[3]:544-9).
Antibiotics seem to improve the eyelid’s health, “although some studies have documented that the cornea often doesn’t benefit from antibiotics, and patients’ visual acuity may not improve,” Dr. Wladis said.
Ophthalmologists also may prescribe nonsteroidal and steroidal anti-inflammatory drops, Dr. Slonim added, although “the use of topical ophthalmic steroids do carry the risk of secondary glaucoma with increased intraocular pressures.”
There are even more alternatives. “Dietary modification with omega-3 fatty acids appears to benefit the quality of the tear film,” Dr. Wladis said, referring to the results of a prospective, placebo-controlled, double-blind, randomized trial of patients with dry eye (Int J Ophthalmol. 2013 Dec 18;[6]:811-6). “Intraductal meibomian gland probing and intense pulsed light therapy have both been shown to improve ocular surface–related quality of life, although these treatments are relatively invasive and can rapidly become quite expensive for the patient.”
What’s on the horizon? Researchers have “started to unlock the mysteries of rosacea at the cellular level,” Dr. Wladis said. “Our efforts have recently focused on the cellular changes in the skin of rosacea patients. Using several methods, we assayed the activation of a wide variety of signals within the cells of the skin of these patients and found a consistent elevation of two specific signals.”
The researchers were especially pleased, he said, “that these signals appear to be activated in the outer layers of the skin, meaning that a topical preparation could be developed to selectively suppress these cell signals to turn off the disease without interfering with normal skin structure and function and without the side effects of oral or intravenous medications.”
His team is now working on a topical medication. “Ideally,” he noted, “future clinicians will be able to shift their focus from nonspecific therapies like antibiotics and steroids to really powerful, meaningful cellular therapeutics.”
Dr. Slonim reported no relevant disclosures. Dr. Wladis shares a provisional patent for the use of topical kinase inhibitors in the management of rosacea and recently co-started a biotechnology company called Praxis Biotechnology that aims to develop and test therapies for the condition. He serves as a consultant for both Bausch & Lomb and Valeant Pharmaceuticals.
How social media solved a skin outbreak
Several teens who came home from a trip abroad with ugly ulcerated skin lesions in 2014 got vague and unhelpful diagnoses: Physicians thought they had bug bites. True, but that was only part of the story. It took an alert dermatologist and Facebook to identify the true cause, spread the word, and stop the outbreak.
“Social media facilitated communication between patients, crowd sourcing a diagnosis,” said Kanokporn Mongkolrattanothai, MD, who treated three of the teens at Children’s Hospital Los Angeles.
What did the kids have? Read on and see if you can make the diagnosis yourself.
Upon their return, pruritic red papules appeared on a 16-year-old girl’s ankle and thigh. They transformed into ulcers with raised edges and a central crater, according to a report that published online in Pediatric Dermatology (2016 Sep;33[5]:e276-7. doi: 10.1111/pde.12910). At least 12 teens from the trip had similar ulcerated lesions, mostly in exposed areas like arms and legs, said Dr. Mongkolrattanothai, an infectious disease specialist at Children’s Hospital Los Angeles and a coauthor of the report.
Six patients received a diagnosis of insect bites, and one was diagnosed with a bacterial skin infection, noted Dr. Mongkolrattanothai of the University of Southern California, Los Angeles. But these diagnoses were incorrect.
“The light bulb really came on when she mentioned that the lesions were still present several months after the trip to Israel,” said Dr. Krakowski, who was at Rady Children’s Hospital–San Diego at the time. “On physical exam, the lesions were ulcerated and eroded and did not look to be typical bug bite reactions.” The Centers for Disease Control and Prevention confirmed the diagnosis.
On Facebook, the teenager posted a picture of a T-shirt with the words “I went to Israel, and all I got was leishmaniasis.” At the same time, another traveler on the same trip posted pictures of lesions. This set off a wave of awareness that sent affected teens to seek care at Children’s Hospital Los Angeles, Mattel Children’s Hospital UCLA, Cedars-Sinai Medical Center, Kaiser Permanente Woodland Hills Medical Center, and Rady Children’s Hospital–San Diego.
“It is likely that our patients became infected with leishmaniasis while camping in the Negev Desert, sleeping on sand dunes at night without use of mosquito netting or tents,” Dr. Mongkolrattanothai said in an interview. “Most of the affected teens did not take precautions against insect bites, which would have included appropriate clothing to minimize areas of exposed skin and the use of repellent products. This placed them at risk for sand fly bites, as sand flies are most active in twilight, evening, and nighttime hours.”
Cutaneous leishmaniasis can lead to permanent scarring, and another form, visceral leishmaniasis, can be fatal.
What helped Dr. Krakowski crack the case? “Training at the University of California at San Diego, in such close proximity to the Navy’s Balboa Medical Center, we are taught from day 1 to think outside of the box because ‘there are zebras in Africa,’ ” he said. “With so much international travel in and out of the region, including to locations where leishmaniasis is endemic, it is warranted to consider that specific diagnosis on the differential. Normally, I do not have to biopsy ‘bug bites,’ but considering the patient’s entire presentation, you almost have to do a biopsy to make sure the lesions were not leishmaniasis.”
Dr. Krakowski praised the CDC. “They have a tremendous amount of resources dedicated to helping investigators work through diagnostic dilemmas such as this, and they helped us – free of charge – to confirm the diagnosis, type the leishmaniasis, and plot a treatment course to resolution,” he said. “They also were instrumental in helping us identify and educate other potentially exposed patients from the camping trip.”
In November, the Infectious Diseases Society of America and the American Society of Tropical Medicine and Hygiene published new guidelines about leishmaniasis in Clinical Infectious Diseases (doi: 10.1093/cid/ciw670). The societies warn that leishmaniasis is becoming more common in the United States, in part because of ecotourists infected in Central and South America and returning soldiers infected in Afghanistan and Iraq.
Dr. Mongkolrattanothai and Dr. Krakowski reported no relevant financial disclosures.
Several teens who came home from a trip abroad with ugly ulcerated skin lesions in 2014 got vague and unhelpful diagnoses: Physicians thought they had bug bites. True, but that was only part of the story. It took an alert dermatologist and Facebook to identify the true cause, spread the word, and stop the outbreak.
“Social media facilitated communication between patients, crowd sourcing a diagnosis,” said Kanokporn Mongkolrattanothai, MD, who treated three of the teens at Children’s Hospital Los Angeles.
What did the kids have? Read on and see if you can make the diagnosis yourself.
Upon their return, pruritic red papules appeared on a 16-year-old girl’s ankle and thigh. They transformed into ulcers with raised edges and a central crater, according to a report that published online in Pediatric Dermatology (2016 Sep;33[5]:e276-7. doi: 10.1111/pde.12910). At least 12 teens from the trip had similar ulcerated lesions, mostly in exposed areas like arms and legs, said Dr. Mongkolrattanothai, an infectious disease specialist at Children’s Hospital Los Angeles and a coauthor of the report.
Six patients received a diagnosis of insect bites, and one was diagnosed with a bacterial skin infection, noted Dr. Mongkolrattanothai of the University of Southern California, Los Angeles. But these diagnoses were incorrect.
“The light bulb really came on when she mentioned that the lesions were still present several months after the trip to Israel,” said Dr. Krakowski, who was at Rady Children’s Hospital–San Diego at the time. “On physical exam, the lesions were ulcerated and eroded and did not look to be typical bug bite reactions.” The Centers for Disease Control and Prevention confirmed the diagnosis.
On Facebook, the teenager posted a picture of a T-shirt with the words “I went to Israel, and all I got was leishmaniasis.” At the same time, another traveler on the same trip posted pictures of lesions. This set off a wave of awareness that sent affected teens to seek care at Children’s Hospital Los Angeles, Mattel Children’s Hospital UCLA, Cedars-Sinai Medical Center, Kaiser Permanente Woodland Hills Medical Center, and Rady Children’s Hospital–San Diego.
“It is likely that our patients became infected with leishmaniasis while camping in the Negev Desert, sleeping on sand dunes at night without use of mosquito netting or tents,” Dr. Mongkolrattanothai said in an interview. “Most of the affected teens did not take precautions against insect bites, which would have included appropriate clothing to minimize areas of exposed skin and the use of repellent products. This placed them at risk for sand fly bites, as sand flies are most active in twilight, evening, and nighttime hours.”
Cutaneous leishmaniasis can lead to permanent scarring, and another form, visceral leishmaniasis, can be fatal.
What helped Dr. Krakowski crack the case? “Training at the University of California at San Diego, in such close proximity to the Navy’s Balboa Medical Center, we are taught from day 1 to think outside of the box because ‘there are zebras in Africa,’ ” he said. “With so much international travel in and out of the region, including to locations where leishmaniasis is endemic, it is warranted to consider that specific diagnosis on the differential. Normally, I do not have to biopsy ‘bug bites,’ but considering the patient’s entire presentation, you almost have to do a biopsy to make sure the lesions were not leishmaniasis.”
Dr. Krakowski praised the CDC. “They have a tremendous amount of resources dedicated to helping investigators work through diagnostic dilemmas such as this, and they helped us – free of charge – to confirm the diagnosis, type the leishmaniasis, and plot a treatment course to resolution,” he said. “They also were instrumental in helping us identify and educate other potentially exposed patients from the camping trip.”
In November, the Infectious Diseases Society of America and the American Society of Tropical Medicine and Hygiene published new guidelines about leishmaniasis in Clinical Infectious Diseases (doi: 10.1093/cid/ciw670). The societies warn that leishmaniasis is becoming more common in the United States, in part because of ecotourists infected in Central and South America and returning soldiers infected in Afghanistan and Iraq.
Dr. Mongkolrattanothai and Dr. Krakowski reported no relevant financial disclosures.
Several teens who came home from a trip abroad with ugly ulcerated skin lesions in 2014 got vague and unhelpful diagnoses: Physicians thought they had bug bites. True, but that was only part of the story. It took an alert dermatologist and Facebook to identify the true cause, spread the word, and stop the outbreak.
“Social media facilitated communication between patients, crowd sourcing a diagnosis,” said Kanokporn Mongkolrattanothai, MD, who treated three of the teens at Children’s Hospital Los Angeles.
What did the kids have? Read on and see if you can make the diagnosis yourself.
Upon their return, pruritic red papules appeared on a 16-year-old girl’s ankle and thigh. They transformed into ulcers with raised edges and a central crater, according to a report that published online in Pediatric Dermatology (2016 Sep;33[5]:e276-7. doi: 10.1111/pde.12910). At least 12 teens from the trip had similar ulcerated lesions, mostly in exposed areas like arms and legs, said Dr. Mongkolrattanothai, an infectious disease specialist at Children’s Hospital Los Angeles and a coauthor of the report.
Six patients received a diagnosis of insect bites, and one was diagnosed with a bacterial skin infection, noted Dr. Mongkolrattanothai of the University of Southern California, Los Angeles. But these diagnoses were incorrect.
“The light bulb really came on when she mentioned that the lesions were still present several months after the trip to Israel,” said Dr. Krakowski, who was at Rady Children’s Hospital–San Diego at the time. “On physical exam, the lesions were ulcerated and eroded and did not look to be typical bug bite reactions.” The Centers for Disease Control and Prevention confirmed the diagnosis.
On Facebook, the teenager posted a picture of a T-shirt with the words “I went to Israel, and all I got was leishmaniasis.” At the same time, another traveler on the same trip posted pictures of lesions. This set off a wave of awareness that sent affected teens to seek care at Children’s Hospital Los Angeles, Mattel Children’s Hospital UCLA, Cedars-Sinai Medical Center, Kaiser Permanente Woodland Hills Medical Center, and Rady Children’s Hospital–San Diego.
“It is likely that our patients became infected with leishmaniasis while camping in the Negev Desert, sleeping on sand dunes at night without use of mosquito netting or tents,” Dr. Mongkolrattanothai said in an interview. “Most of the affected teens did not take precautions against insect bites, which would have included appropriate clothing to minimize areas of exposed skin and the use of repellent products. This placed them at risk for sand fly bites, as sand flies are most active in twilight, evening, and nighttime hours.”
Cutaneous leishmaniasis can lead to permanent scarring, and another form, visceral leishmaniasis, can be fatal.
What helped Dr. Krakowski crack the case? “Training at the University of California at San Diego, in such close proximity to the Navy’s Balboa Medical Center, we are taught from day 1 to think outside of the box because ‘there are zebras in Africa,’ ” he said. “With so much international travel in and out of the region, including to locations where leishmaniasis is endemic, it is warranted to consider that specific diagnosis on the differential. Normally, I do not have to biopsy ‘bug bites,’ but considering the patient’s entire presentation, you almost have to do a biopsy to make sure the lesions were not leishmaniasis.”
Dr. Krakowski praised the CDC. “They have a tremendous amount of resources dedicated to helping investigators work through diagnostic dilemmas such as this, and they helped us – free of charge – to confirm the diagnosis, type the leishmaniasis, and plot a treatment course to resolution,” he said. “They also were instrumental in helping us identify and educate other potentially exposed patients from the camping trip.”
In November, the Infectious Diseases Society of America and the American Society of Tropical Medicine and Hygiene published new guidelines about leishmaniasis in Clinical Infectious Diseases (doi: 10.1093/cid/ciw670). The societies warn that leishmaniasis is becoming more common in the United States, in part because of ecotourists infected in Central and South America and returning soldiers infected in Afghanistan and Iraq.
Dr. Mongkolrattanothai and Dr. Krakowski reported no relevant financial disclosures.
Fighting back against psoriasis bullies
Dallas dermatologist Alan Menter, MD, doesn’t boast bullying-prevention superpowers, but what he does have is close enough: An eagerness to get the word out to anyone – parent or principal, psychologist or pediatrician – who can help prevent a child with psoriasis from being bullied.
Over his long career, Dr. Menter has made many calls to adults in positions of influence over children. “I’ve talked to pediatricians, and I’ve even called up schools and talked to principals to try get the bullying situation reduced to an extent where the kids can live happy, normal lives without kids taunting them.”
Dr. Menter, chief of dermatology at Baylor University in Dallas, has plenty of company. Other dermatologists are paying close attention to their youngest patients with psoriasis as researchers work to get a better handle on the bullying problem.
“We really want to identify this early on and do whatever is required to turn it around,” said Amy Paller, MD, professor of dermatology and pediatrics and chair of the department of dermatology at Northwestern University, Chicago. “These visible skin lesions can have a very significant effect on how children feel about themselves and others. When this is going on early in life, during childhood or teen years, there’s really a risk for lifelong issues.”
Dr. Menter’s interest in psoriasis and bullying began during his childhood in South Africa when he watched children bully his brother, who had the condition. “I’ve always had a great desire to improve the quality of life in psoriasis patients,” he said, and that passion grew as he worked in a day care center for children with psoriasis. “I had an opportunity to talk to children and recognize the impact that psoriasis has on them.”
Research from across the world reveals that children with psoriasis face an extraordinary burden from bullying. “They’re teased incessantly and bullied because they’ve got such a visible disease,” he said.
The introspective and depressed nature of many children with psoriasis makes the situation even more difficult, he noted, since their emotional makeup prevents them from responding easily to taunting.
The extent of the bullying problem, however, isn’t fully understood. Research into bullying and skin disorders is “very limited,” said Kelly Cordoro, MD, of the departments of dermatology and pediatrics at the University of California, San Francisco. “What little evidence does exist suggests that kids with visible skin disease, including psoriasis, are often bullied, and this can impact them significantly,” she said, pointing to a 2013 study that suggested those with acne, psoriasis, and atopic dermatitis are especially vulnerable (Clin Dermatol. 2013;31[1]:66-71).
Sports are a special area of concern. “They don’t want to get into gym shorts, and they don’t want to engage in sports because they get hot and itchy,” Dr. Paller said. “Or people stay away from them because they think there’s something they can catch, so they’re not chosen for sports activities.”
Indeed, children with psoriasis may be left out of games like tag and contact sports because other children are afraid of touching them, Dr. Cordoro observed. “Other kids do not want to be near them. It is truly heartbreaking and derives largely from ignorance.”
What can dermatologists do? Dr. Cordoro recommends that they take time to ask their youngest patients about their lives: “Is your psoriasis affecting your friendships?” “How are things going at school?” “Do kids ask you about your psoriasis? What do you say?”
“We can identify at-risk kids this way and work with parents, schools, coaches, and counselors towards productive interventions like educational programs,” Dr. Cordoro said. “Education is the key. As kids, parents, and adults become educated, the psoriatic child is less likely to be teased and excluded. Kids with psoriasis may lack the confidence to defend themselves, and arming them with one-liners and basic educational points about their condition empowers them to address it directly.”
Dr. Paller, who is also director of the Northwestern University Skin Disease Research Center, said it’s a good idea to add questions to the usual list of queries about subjects like sleep and itching. In cases when a child is bullied, it may help to reach out to teachers and principals, and to counselors and social workers if needed, she noted.
Parents play an important role, too, Dr. Menter said, although they may be in the dark about bullying. “What I’ve learned is that kids will seldom come home and tell their parent they’ve been bullied.”
He urges both children and their parents to understand the nature of psoriasis and be open about it. “Don’t hide it,” he suggested. “Tell people that ‘I’ve got psoriasis, and it’s not contagious.’ ” And then, hopefully, the healing can begin.
Dr. Paller and Dr. Cordoro reported no relevant disclosures. Dr. Menter disclosed relationships with many pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis and Pfizer.
Dallas dermatologist Alan Menter, MD, doesn’t boast bullying-prevention superpowers, but what he does have is close enough: An eagerness to get the word out to anyone – parent or principal, psychologist or pediatrician – who can help prevent a child with psoriasis from being bullied.
Over his long career, Dr. Menter has made many calls to adults in positions of influence over children. “I’ve talked to pediatricians, and I’ve even called up schools and talked to principals to try get the bullying situation reduced to an extent where the kids can live happy, normal lives without kids taunting them.”
Dr. Menter, chief of dermatology at Baylor University in Dallas, has plenty of company. Other dermatologists are paying close attention to their youngest patients with psoriasis as researchers work to get a better handle on the bullying problem.
“We really want to identify this early on and do whatever is required to turn it around,” said Amy Paller, MD, professor of dermatology and pediatrics and chair of the department of dermatology at Northwestern University, Chicago. “These visible skin lesions can have a very significant effect on how children feel about themselves and others. When this is going on early in life, during childhood or teen years, there’s really a risk for lifelong issues.”
Dr. Menter’s interest in psoriasis and bullying began during his childhood in South Africa when he watched children bully his brother, who had the condition. “I’ve always had a great desire to improve the quality of life in psoriasis patients,” he said, and that passion grew as he worked in a day care center for children with psoriasis. “I had an opportunity to talk to children and recognize the impact that psoriasis has on them.”
Research from across the world reveals that children with psoriasis face an extraordinary burden from bullying. “They’re teased incessantly and bullied because they’ve got such a visible disease,” he said.
The introspective and depressed nature of many children with psoriasis makes the situation even more difficult, he noted, since their emotional makeup prevents them from responding easily to taunting.
The extent of the bullying problem, however, isn’t fully understood. Research into bullying and skin disorders is “very limited,” said Kelly Cordoro, MD, of the departments of dermatology and pediatrics at the University of California, San Francisco. “What little evidence does exist suggests that kids with visible skin disease, including psoriasis, are often bullied, and this can impact them significantly,” she said, pointing to a 2013 study that suggested those with acne, psoriasis, and atopic dermatitis are especially vulnerable (Clin Dermatol. 2013;31[1]:66-71).
Sports are a special area of concern. “They don’t want to get into gym shorts, and they don’t want to engage in sports because they get hot and itchy,” Dr. Paller said. “Or people stay away from them because they think there’s something they can catch, so they’re not chosen for sports activities.”
Indeed, children with psoriasis may be left out of games like tag and contact sports because other children are afraid of touching them, Dr. Cordoro observed. “Other kids do not want to be near them. It is truly heartbreaking and derives largely from ignorance.”
What can dermatologists do? Dr. Cordoro recommends that they take time to ask their youngest patients about their lives: “Is your psoriasis affecting your friendships?” “How are things going at school?” “Do kids ask you about your psoriasis? What do you say?”
“We can identify at-risk kids this way and work with parents, schools, coaches, and counselors towards productive interventions like educational programs,” Dr. Cordoro said. “Education is the key. As kids, parents, and adults become educated, the psoriatic child is less likely to be teased and excluded. Kids with psoriasis may lack the confidence to defend themselves, and arming them with one-liners and basic educational points about their condition empowers them to address it directly.”
Dr. Paller, who is also director of the Northwestern University Skin Disease Research Center, said it’s a good idea to add questions to the usual list of queries about subjects like sleep and itching. In cases when a child is bullied, it may help to reach out to teachers and principals, and to counselors and social workers if needed, she noted.
Parents play an important role, too, Dr. Menter said, although they may be in the dark about bullying. “What I’ve learned is that kids will seldom come home and tell their parent they’ve been bullied.”
He urges both children and their parents to understand the nature of psoriasis and be open about it. “Don’t hide it,” he suggested. “Tell people that ‘I’ve got psoriasis, and it’s not contagious.’ ” And then, hopefully, the healing can begin.
Dr. Paller and Dr. Cordoro reported no relevant disclosures. Dr. Menter disclosed relationships with many pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis and Pfizer.
Dallas dermatologist Alan Menter, MD, doesn’t boast bullying-prevention superpowers, but what he does have is close enough: An eagerness to get the word out to anyone – parent or principal, psychologist or pediatrician – who can help prevent a child with psoriasis from being bullied.
Over his long career, Dr. Menter has made many calls to adults in positions of influence over children. “I’ve talked to pediatricians, and I’ve even called up schools and talked to principals to try get the bullying situation reduced to an extent where the kids can live happy, normal lives without kids taunting them.”
Dr. Menter, chief of dermatology at Baylor University in Dallas, has plenty of company. Other dermatologists are paying close attention to their youngest patients with psoriasis as researchers work to get a better handle on the bullying problem.
“We really want to identify this early on and do whatever is required to turn it around,” said Amy Paller, MD, professor of dermatology and pediatrics and chair of the department of dermatology at Northwestern University, Chicago. “These visible skin lesions can have a very significant effect on how children feel about themselves and others. When this is going on early in life, during childhood or teen years, there’s really a risk for lifelong issues.”
Dr. Menter’s interest in psoriasis and bullying began during his childhood in South Africa when he watched children bully his brother, who had the condition. “I’ve always had a great desire to improve the quality of life in psoriasis patients,” he said, and that passion grew as he worked in a day care center for children with psoriasis. “I had an opportunity to talk to children and recognize the impact that psoriasis has on them.”
Research from across the world reveals that children with psoriasis face an extraordinary burden from bullying. “They’re teased incessantly and bullied because they’ve got such a visible disease,” he said.
The introspective and depressed nature of many children with psoriasis makes the situation even more difficult, he noted, since their emotional makeup prevents them from responding easily to taunting.
The extent of the bullying problem, however, isn’t fully understood. Research into bullying and skin disorders is “very limited,” said Kelly Cordoro, MD, of the departments of dermatology and pediatrics at the University of California, San Francisco. “What little evidence does exist suggests that kids with visible skin disease, including psoriasis, are often bullied, and this can impact them significantly,” she said, pointing to a 2013 study that suggested those with acne, psoriasis, and atopic dermatitis are especially vulnerable (Clin Dermatol. 2013;31[1]:66-71).
Sports are a special area of concern. “They don’t want to get into gym shorts, and they don’t want to engage in sports because they get hot and itchy,” Dr. Paller said. “Or people stay away from them because they think there’s something they can catch, so they’re not chosen for sports activities.”
Indeed, children with psoriasis may be left out of games like tag and contact sports because other children are afraid of touching them, Dr. Cordoro observed. “Other kids do not want to be near them. It is truly heartbreaking and derives largely from ignorance.”
What can dermatologists do? Dr. Cordoro recommends that they take time to ask their youngest patients about their lives: “Is your psoriasis affecting your friendships?” “How are things going at school?” “Do kids ask you about your psoriasis? What do you say?”
“We can identify at-risk kids this way and work with parents, schools, coaches, and counselors towards productive interventions like educational programs,” Dr. Cordoro said. “Education is the key. As kids, parents, and adults become educated, the psoriatic child is less likely to be teased and excluded. Kids with psoriasis may lack the confidence to defend themselves, and arming them with one-liners and basic educational points about their condition empowers them to address it directly.”
Dr. Paller, who is also director of the Northwestern University Skin Disease Research Center, said it’s a good idea to add questions to the usual list of queries about subjects like sleep and itching. In cases when a child is bullied, it may help to reach out to teachers and principals, and to counselors and social workers if needed, she noted.
Parents play an important role, too, Dr. Menter said, although they may be in the dark about bullying. “What I’ve learned is that kids will seldom come home and tell their parent they’ve been bullied.”
He urges both children and their parents to understand the nature of psoriasis and be open about it. “Don’t hide it,” he suggested. “Tell people that ‘I’ve got psoriasis, and it’s not contagious.’ ” And then, hopefully, the healing can begin.
Dr. Paller and Dr. Cordoro reported no relevant disclosures. Dr. Menter disclosed relationships with many pharmaceutical companies, including AbbVie, Allergan, Amgen, Boehringer Ingelheim, Eli Lilly, Merck, Novartis and Pfizer.
Cystic fibrosis–related diabetes requires unique treatment
SAN DIEGO – according to Katie Larson Ode, MD.
Medical advances have dramatically boosted life expectancy for people with cystic fibrosis, allowing some to survive into middle age. “As more of our patients live longer, [cystic fibrosis–related diabetes (CFRD)] will become a much more common problem for endocrinologists, educators, nurses, and nutritionists to address,” said Dr. Ode, a pediatrician at the University of Iowa in Iowa City. “Proper management of cystic fibrosis-related diabetes is lifesaving for our CF patients.”
“CF is caused by a defect in an important chloride channel that regulates the salt and water content of secretions,” said Antoinette Moran, MD, professor and division chief of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis, while speaking at the annual meeting of the American Association of Diabetes Educators. “This affects many organs, but death is generally due to chronic obstructive lung disease.”
In the 1950s, few children with CF lived past elementary school age. Now, researchers estimate that the median life span for babies born and diagnosed in 2010 could reach more than 50 years (Ann Intern Med. 2014 Aug 19;161[4]:233-41), according to the Cystic Fibrosis Foundation.
But as they age, CF patients’ risk for CFRD also increases.
A 2009 study led by Dr. Moran (Diabetes Care 2009 Sep;32[9]: 1626-31) tracked 872 CF patients from three periods in the 1990s and 2000s and found CFRD in 2% of children, 19% of adolescents, and 40%-50% of adults. “For a typical CF patient, the chances of developing CFRD by age 40 are roughly 80%,” said Andrew Norris, MD, PhD, of the departments of pediatrics and biochemistry at the University of Iowa.
CF patients aren’t limited to one form of diabetes. “Occasionally a patient may be unlucky enough to have more than one type,” Dr. Moran said, since the diseases have separate pathophysiologies. While rare, type 1 appears to be more common than type 2, which is often linked to obesity; CF patients struggle to put on weight. “It would be highly unusual for a CF patient to develop type 2 diabetes,” Dr. Norris said.
The specialists said patients with CFRD are unique among diabetics for several reasons:
• Microvascular complications are rare. “After many years of diabetes, CFRD patients are at risk for microvascular complications, but they tend to be less common and less severe than in other forms of diabetes, likely because CF patients still make some of their own insulin,” Dr. Moran said.
• Macrovascular complications are not seen. “This is important because recommendations given to people with other forms of the diabetes to reduce risk of macrovascular complications – weight loss, low-fat diet, low-salt diet, etc.– do no apply in CF and can actually be harmful,” Dr. Moran said.
• Insulin is especially crucial. “Maintaining weight and lean body mass is critical for survival in CF, so the chief clinical concern with CFRD is nutrition and the potential impact of insulin insufficiency on mortality,” Dr. Moran said. “Insulin replacement is the only approved therapy for CFRD. Treatment is very similar to that of type 1 diabetic patients in a honeymoon state. Very early on, patients may receive a single dose of basal insulin only or of premeal rapid-acting insulin only. Eventually most CF patients require basal-bolus insulin therapy.”
Doses tend to be lower than in other diabetics, she said, “except for when CF patients are acutely ill. During acute illness, CF patients become insulin resistant and require high insulin doses.”
Still, “once I start insulin, my goal is to deliver as large a dose as the patient can safely tolerate, to maximize anabolic impact,” she said.
The physicians offered these tips about tracking and treating CF patients:
• Screen CF patients via oral glucose tolerance testing on an annual basis, starting no later than age 10. Don’t trust hemoglobin A1c levels or fasting glucose levels, Dr. Norris said, because they are not sensitive enough. In fact, Dr. Moran said, “HbA1cis spuriously low in CF. “Even mild diabetes can be immediately detrimental to a CF patient’s lung health and mortality risk,” Dr. Norris said. “If you wait until the onset of classic diabetes symptoms or until the fasting glucose or hemoglobin A1c is elevated, you will have done a great disservice to the CF patient, as preventable potentially life-threatening lung damage may have already occurred.”
• Check into your center’s testing protocol. “Unfortunately, current screening rates are markedly insufficient at many centers,” Dr. Norris said. “I encourage endocrine teams to reach out to their affiliated CF treatment center to discuss and help implement screening.”
What’s next? The University of Iowa’s Dr. Larson said he is hopeful about advances in medical care. “Currently, patients must follow an extremely complex regimen of airway clearance, inhaled antibiotics, and oral medications, typically with recurrent hospitalization with increasing age and eventual death from lung disease or lung transplant,” she said. “However, in the past few years, we have had a dramatic change for a percentage of our patients with the development of small molecules that can actually fix the chloride-channel defect itself.”
The treatment seems to arrest and even improve lung disease in eligible patients, she said. “So the future seems very bright for CF.”
The Cystic Fibrosis Foundation has developed a 3-year Envision program to train adult and pediatric endocrinologists in the care of CFRD and endocrine issues.
Dr. Moran had no relevant disclosures. Dr. Norris has consulted for Vertex Pharmaceuticals, which makes cystic fibrosis therapeutics, in the past year. Dr. Larson Ode reports that her research is funded by the National Institutes of Health and the Cystic Fibrosis Foundation.
SAN DIEGO – according to Katie Larson Ode, MD.
Medical advances have dramatically boosted life expectancy for people with cystic fibrosis, allowing some to survive into middle age. “As more of our patients live longer, [cystic fibrosis–related diabetes (CFRD)] will become a much more common problem for endocrinologists, educators, nurses, and nutritionists to address,” said Dr. Ode, a pediatrician at the University of Iowa in Iowa City. “Proper management of cystic fibrosis-related diabetes is lifesaving for our CF patients.”
“CF is caused by a defect in an important chloride channel that regulates the salt and water content of secretions,” said Antoinette Moran, MD, professor and division chief of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis, while speaking at the annual meeting of the American Association of Diabetes Educators. “This affects many organs, but death is generally due to chronic obstructive lung disease.”
In the 1950s, few children with CF lived past elementary school age. Now, researchers estimate that the median life span for babies born and diagnosed in 2010 could reach more than 50 years (Ann Intern Med. 2014 Aug 19;161[4]:233-41), according to the Cystic Fibrosis Foundation.
But as they age, CF patients’ risk for CFRD also increases.
A 2009 study led by Dr. Moran (Diabetes Care 2009 Sep;32[9]: 1626-31) tracked 872 CF patients from three periods in the 1990s and 2000s and found CFRD in 2% of children, 19% of adolescents, and 40%-50% of adults. “For a typical CF patient, the chances of developing CFRD by age 40 are roughly 80%,” said Andrew Norris, MD, PhD, of the departments of pediatrics and biochemistry at the University of Iowa.
CF patients aren’t limited to one form of diabetes. “Occasionally a patient may be unlucky enough to have more than one type,” Dr. Moran said, since the diseases have separate pathophysiologies. While rare, type 1 appears to be more common than type 2, which is often linked to obesity; CF patients struggle to put on weight. “It would be highly unusual for a CF patient to develop type 2 diabetes,” Dr. Norris said.
The specialists said patients with CFRD are unique among diabetics for several reasons:
• Microvascular complications are rare. “After many years of diabetes, CFRD patients are at risk for microvascular complications, but they tend to be less common and less severe than in other forms of diabetes, likely because CF patients still make some of their own insulin,” Dr. Moran said.
• Macrovascular complications are not seen. “This is important because recommendations given to people with other forms of the diabetes to reduce risk of macrovascular complications – weight loss, low-fat diet, low-salt diet, etc.– do no apply in CF and can actually be harmful,” Dr. Moran said.
• Insulin is especially crucial. “Maintaining weight and lean body mass is critical for survival in CF, so the chief clinical concern with CFRD is nutrition and the potential impact of insulin insufficiency on mortality,” Dr. Moran said. “Insulin replacement is the only approved therapy for CFRD. Treatment is very similar to that of type 1 diabetic patients in a honeymoon state. Very early on, patients may receive a single dose of basal insulin only or of premeal rapid-acting insulin only. Eventually most CF patients require basal-bolus insulin therapy.”
Doses tend to be lower than in other diabetics, she said, “except for when CF patients are acutely ill. During acute illness, CF patients become insulin resistant and require high insulin doses.”
Still, “once I start insulin, my goal is to deliver as large a dose as the patient can safely tolerate, to maximize anabolic impact,” she said.
The physicians offered these tips about tracking and treating CF patients:
• Screen CF patients via oral glucose tolerance testing on an annual basis, starting no later than age 10. Don’t trust hemoglobin A1c levels or fasting glucose levels, Dr. Norris said, because they are not sensitive enough. In fact, Dr. Moran said, “HbA1cis spuriously low in CF. “Even mild diabetes can be immediately detrimental to a CF patient’s lung health and mortality risk,” Dr. Norris said. “If you wait until the onset of classic diabetes symptoms or until the fasting glucose or hemoglobin A1c is elevated, you will have done a great disservice to the CF patient, as preventable potentially life-threatening lung damage may have already occurred.”
• Check into your center’s testing protocol. “Unfortunately, current screening rates are markedly insufficient at many centers,” Dr. Norris said. “I encourage endocrine teams to reach out to their affiliated CF treatment center to discuss and help implement screening.”
What’s next? The University of Iowa’s Dr. Larson said he is hopeful about advances in medical care. “Currently, patients must follow an extremely complex regimen of airway clearance, inhaled antibiotics, and oral medications, typically with recurrent hospitalization with increasing age and eventual death from lung disease or lung transplant,” she said. “However, in the past few years, we have had a dramatic change for a percentage of our patients with the development of small molecules that can actually fix the chloride-channel defect itself.”
The treatment seems to arrest and even improve lung disease in eligible patients, she said. “So the future seems very bright for CF.”
The Cystic Fibrosis Foundation has developed a 3-year Envision program to train adult and pediatric endocrinologists in the care of CFRD and endocrine issues.
Dr. Moran had no relevant disclosures. Dr. Norris has consulted for Vertex Pharmaceuticals, which makes cystic fibrosis therapeutics, in the past year. Dr. Larson Ode reports that her research is funded by the National Institutes of Health and the Cystic Fibrosis Foundation.
SAN DIEGO – according to Katie Larson Ode, MD.
Medical advances have dramatically boosted life expectancy for people with cystic fibrosis, allowing some to survive into middle age. “As more of our patients live longer, [cystic fibrosis–related diabetes (CFRD)] will become a much more common problem for endocrinologists, educators, nurses, and nutritionists to address,” said Dr. Ode, a pediatrician at the University of Iowa in Iowa City. “Proper management of cystic fibrosis-related diabetes is lifesaving for our CF patients.”
“CF is caused by a defect in an important chloride channel that regulates the salt and water content of secretions,” said Antoinette Moran, MD, professor and division chief of pediatric endocrinology and diabetes at the University of Minnesota, Minneapolis, while speaking at the annual meeting of the American Association of Diabetes Educators. “This affects many organs, but death is generally due to chronic obstructive lung disease.”
In the 1950s, few children with CF lived past elementary school age. Now, researchers estimate that the median life span for babies born and diagnosed in 2010 could reach more than 50 years (Ann Intern Med. 2014 Aug 19;161[4]:233-41), according to the Cystic Fibrosis Foundation.
But as they age, CF patients’ risk for CFRD also increases.
A 2009 study led by Dr. Moran (Diabetes Care 2009 Sep;32[9]: 1626-31) tracked 872 CF patients from three periods in the 1990s and 2000s and found CFRD in 2% of children, 19% of adolescents, and 40%-50% of adults. “For a typical CF patient, the chances of developing CFRD by age 40 are roughly 80%,” said Andrew Norris, MD, PhD, of the departments of pediatrics and biochemistry at the University of Iowa.
CF patients aren’t limited to one form of diabetes. “Occasionally a patient may be unlucky enough to have more than one type,” Dr. Moran said, since the diseases have separate pathophysiologies. While rare, type 1 appears to be more common than type 2, which is often linked to obesity; CF patients struggle to put on weight. “It would be highly unusual for a CF patient to develop type 2 diabetes,” Dr. Norris said.
The specialists said patients with CFRD are unique among diabetics for several reasons:
• Microvascular complications are rare. “After many years of diabetes, CFRD patients are at risk for microvascular complications, but they tend to be less common and less severe than in other forms of diabetes, likely because CF patients still make some of their own insulin,” Dr. Moran said.
• Macrovascular complications are not seen. “This is important because recommendations given to people with other forms of the diabetes to reduce risk of macrovascular complications – weight loss, low-fat diet, low-salt diet, etc.– do no apply in CF and can actually be harmful,” Dr. Moran said.
• Insulin is especially crucial. “Maintaining weight and lean body mass is critical for survival in CF, so the chief clinical concern with CFRD is nutrition and the potential impact of insulin insufficiency on mortality,” Dr. Moran said. “Insulin replacement is the only approved therapy for CFRD. Treatment is very similar to that of type 1 diabetic patients in a honeymoon state. Very early on, patients may receive a single dose of basal insulin only or of premeal rapid-acting insulin only. Eventually most CF patients require basal-bolus insulin therapy.”
Doses tend to be lower than in other diabetics, she said, “except for when CF patients are acutely ill. During acute illness, CF patients become insulin resistant and require high insulin doses.”
Still, “once I start insulin, my goal is to deliver as large a dose as the patient can safely tolerate, to maximize anabolic impact,” she said.
The physicians offered these tips about tracking and treating CF patients:
• Screen CF patients via oral glucose tolerance testing on an annual basis, starting no later than age 10. Don’t trust hemoglobin A1c levels or fasting glucose levels, Dr. Norris said, because they are not sensitive enough. In fact, Dr. Moran said, “HbA1cis spuriously low in CF. “Even mild diabetes can be immediately detrimental to a CF patient’s lung health and mortality risk,” Dr. Norris said. “If you wait until the onset of classic diabetes symptoms or until the fasting glucose or hemoglobin A1c is elevated, you will have done a great disservice to the CF patient, as preventable potentially life-threatening lung damage may have already occurred.”
• Check into your center’s testing protocol. “Unfortunately, current screening rates are markedly insufficient at many centers,” Dr. Norris said. “I encourage endocrine teams to reach out to their affiliated CF treatment center to discuss and help implement screening.”
What’s next? The University of Iowa’s Dr. Larson said he is hopeful about advances in medical care. “Currently, patients must follow an extremely complex regimen of airway clearance, inhaled antibiotics, and oral medications, typically with recurrent hospitalization with increasing age and eventual death from lung disease or lung transplant,” she said. “However, in the past few years, we have had a dramatic change for a percentage of our patients with the development of small molecules that can actually fix the chloride-channel defect itself.”
The treatment seems to arrest and even improve lung disease in eligible patients, she said. “So the future seems very bright for CF.”
The Cystic Fibrosis Foundation has developed a 3-year Envision program to train adult and pediatric endocrinologists in the care of CFRD and endocrine issues.
Dr. Moran had no relevant disclosures. Dr. Norris has consulted for Vertex Pharmaceuticals, which makes cystic fibrosis therapeutics, in the past year. Dr. Larson Ode reports that her research is funded by the National Institutes of Health and the Cystic Fibrosis Foundation.
EXPERT ANALYSIS FROM AADE 16
The eyelids have it: bug bites 101
NEWPORT BEACH, CA. – Bed bugs rise when night falls. Drawn by the carbon dioxide of sleeping humans, they gather to feast, leaving bites galore.
But other insects dine on people, too. Telling their bites apart is an important – and sometimes difficult – job for dermatologists who treat children. Fortunately, there are clinical signs to look for, a pediatric dermatologist told an audience of colleagues, including one that she herself helped introduce.
It’s called the “Eyelid Sign,” a clinical clue, Andrea Zaenglein, MD, said at Skin Diseases Education Foundation’s Women & Pediatric Dermatology Seminar.
Dr. Zaenglein, professor of dermatology and pediatric dermatology at Penn State University, Hershey, has often seen children with bites on their eyelids since they’re being bitten by bed bugs while they’re asleep. “You don’t get a lot of eyelid bites with other things,” she said. “Think about bed bugs whenever you see eyelid bites.”
She and a colleague reported on the “Eyelid Sign” in a study published in 2014, describing papules on the upper eyelid or eyelids associated with erythema and edema in six patients (Pediatr Dermatol. 2014 May-Jun;31[3]:353-5).
During her presentation, Dr. Zaenglein offered more tips on detecting bed bugs:
• Keep in mind that they’re probably not going to be sitting there under the pillow, waiting for your patients to find them. “They like to hide in nooks and crannies,” she said. “They don’t really stay in your bed.” Common hiding places include mattresses, floorboards, and wallpaper.
• Bed bugs are about the size of an apple seed. Stains and dark spots on bed sheets and mattresses can be signs of crushed bed bugs and bed bug excrement.
• They’re more common in urban areas, but “bed bugs are a problem in probably all of our communities,” Dr. Zaenglein noted.
• Some children can develop a reaction to bed bugs and other insects known as papular urticaria. “I have to explain to parents that this is a hypersensitivity response that’s abnormal,” Dr. Zaenglein said.
She noted that papular urticaria tends to be worse in summer and rarely involves the face. Treatments include antihistamines, strong topical steroids, and prevention of insect bites.
As for bed bug bites in general, the Centers for Disease Control and Prevention recommends antiseptic creams or lotions and antihistamine use.
How can bed bugs be killed off for good? The CDC suggests insecticide spraying to eliminate bed bugs, and states that “the best way to prevent bed bugs is regular inspection for the signs of an infestation.”
During the presentation, Dr. Zaenglein also spoke about scabies, focusing on the unique traits of the condition in babies.
“They always present with a lot of rash,” she said. “They won’t have a few papules on their hands and feet like older kids.” The rash will be “dirty-looking,” she continued, and more asymmetric than symmetric. Also, “you’ll almost always get a lot of mites burden if you scrape a baby,” she said. “It’s much harder to find a mite in older kids and young adults.”
Affected babies may be referred from an emergency department or primary care doctor with an incorrect diagnosis of eczema, she said, adding that scabies is extremely contagious. “If a baby has scabies,” she said, “you inevitably have to get your prescription pad. Treat all the household members.”
Babies may be itchy, but itchiness is much more common in older kids and young adults, keeping them up at night, she said. “College students come home over the break with a couple of papules on the belly, and they say it’s driving them crazy. They say it’s crazy, crazy itchy. If you hear that, think scabies.”
Another scabies clue in older kids: hand involvement. “Always look at the wrist, between the fingers. You get these generalized eruptions there.”
Scabies bites can be treated with a topical corticosteroid and, in children aged 2 months and older, permethrin 5% cream. Dr. Zaenglein said there’s concern about a leukemia risk associated with permethrin, but that applies to industrial use and overuse. Ivermectin is an alternative for stubborn and institutional cases.
As for prevention, she said pesticide sprays and fogs are generally discouraged. She advises families to wash recently used clothing and bedding in hot water. Clothing and bedding, including pillows, can also be stored in a closed plastic bag for up to a week.
“You could dry clean it all too,” she said, “but I’ll bet your dry cleaner won’t be too happy about it.”
Dr. Zaenglein disclosed serving as a consultant and researcher for Ranbaxy Laboratories Limited.
SDEF and this news organization are owned by the same parent company.
NEWPORT BEACH, CA. – Bed bugs rise when night falls. Drawn by the carbon dioxide of sleeping humans, they gather to feast, leaving bites galore.
But other insects dine on people, too. Telling their bites apart is an important – and sometimes difficult – job for dermatologists who treat children. Fortunately, there are clinical signs to look for, a pediatric dermatologist told an audience of colleagues, including one that she herself helped introduce.
It’s called the “Eyelid Sign,” a clinical clue, Andrea Zaenglein, MD, said at Skin Diseases Education Foundation’s Women & Pediatric Dermatology Seminar.
Dr. Zaenglein, professor of dermatology and pediatric dermatology at Penn State University, Hershey, has often seen children with bites on their eyelids since they’re being bitten by bed bugs while they’re asleep. “You don’t get a lot of eyelid bites with other things,” she said. “Think about bed bugs whenever you see eyelid bites.”
She and a colleague reported on the “Eyelid Sign” in a study published in 2014, describing papules on the upper eyelid or eyelids associated with erythema and edema in six patients (Pediatr Dermatol. 2014 May-Jun;31[3]:353-5).
During her presentation, Dr. Zaenglein offered more tips on detecting bed bugs:
• Keep in mind that they’re probably not going to be sitting there under the pillow, waiting for your patients to find them. “They like to hide in nooks and crannies,” she said. “They don’t really stay in your bed.” Common hiding places include mattresses, floorboards, and wallpaper.
• Bed bugs are about the size of an apple seed. Stains and dark spots on bed sheets and mattresses can be signs of crushed bed bugs and bed bug excrement.
• They’re more common in urban areas, but “bed bugs are a problem in probably all of our communities,” Dr. Zaenglein noted.
• Some children can develop a reaction to bed bugs and other insects known as papular urticaria. “I have to explain to parents that this is a hypersensitivity response that’s abnormal,” Dr. Zaenglein said.
She noted that papular urticaria tends to be worse in summer and rarely involves the face. Treatments include antihistamines, strong topical steroids, and prevention of insect bites.
As for bed bug bites in general, the Centers for Disease Control and Prevention recommends antiseptic creams or lotions and antihistamine use.
How can bed bugs be killed off for good? The CDC suggests insecticide spraying to eliminate bed bugs, and states that “the best way to prevent bed bugs is regular inspection for the signs of an infestation.”
During the presentation, Dr. Zaenglein also spoke about scabies, focusing on the unique traits of the condition in babies.
“They always present with a lot of rash,” she said. “They won’t have a few papules on their hands and feet like older kids.” The rash will be “dirty-looking,” she continued, and more asymmetric than symmetric. Also, “you’ll almost always get a lot of mites burden if you scrape a baby,” she said. “It’s much harder to find a mite in older kids and young adults.”
Affected babies may be referred from an emergency department or primary care doctor with an incorrect diagnosis of eczema, she said, adding that scabies is extremely contagious. “If a baby has scabies,” she said, “you inevitably have to get your prescription pad. Treat all the household members.”
Babies may be itchy, but itchiness is much more common in older kids and young adults, keeping them up at night, she said. “College students come home over the break with a couple of papules on the belly, and they say it’s driving them crazy. They say it’s crazy, crazy itchy. If you hear that, think scabies.”
Another scabies clue in older kids: hand involvement. “Always look at the wrist, between the fingers. You get these generalized eruptions there.”
Scabies bites can be treated with a topical corticosteroid and, in children aged 2 months and older, permethrin 5% cream. Dr. Zaenglein said there’s concern about a leukemia risk associated with permethrin, but that applies to industrial use and overuse. Ivermectin is an alternative for stubborn and institutional cases.
As for prevention, she said pesticide sprays and fogs are generally discouraged. She advises families to wash recently used clothing and bedding in hot water. Clothing and bedding, including pillows, can also be stored in a closed plastic bag for up to a week.
“You could dry clean it all too,” she said, “but I’ll bet your dry cleaner won’t be too happy about it.”
Dr. Zaenglein disclosed serving as a consultant and researcher for Ranbaxy Laboratories Limited.
SDEF and this news organization are owned by the same parent company.
NEWPORT BEACH, CA. – Bed bugs rise when night falls. Drawn by the carbon dioxide of sleeping humans, they gather to feast, leaving bites galore.
But other insects dine on people, too. Telling their bites apart is an important – and sometimes difficult – job for dermatologists who treat children. Fortunately, there are clinical signs to look for, a pediatric dermatologist told an audience of colleagues, including one that she herself helped introduce.
It’s called the “Eyelid Sign,” a clinical clue, Andrea Zaenglein, MD, said at Skin Diseases Education Foundation’s Women & Pediatric Dermatology Seminar.
Dr. Zaenglein, professor of dermatology and pediatric dermatology at Penn State University, Hershey, has often seen children with bites on their eyelids since they’re being bitten by bed bugs while they’re asleep. “You don’t get a lot of eyelid bites with other things,” she said. “Think about bed bugs whenever you see eyelid bites.”
She and a colleague reported on the “Eyelid Sign” in a study published in 2014, describing papules on the upper eyelid or eyelids associated with erythema and edema in six patients (Pediatr Dermatol. 2014 May-Jun;31[3]:353-5).
During her presentation, Dr. Zaenglein offered more tips on detecting bed bugs:
• Keep in mind that they’re probably not going to be sitting there under the pillow, waiting for your patients to find them. “They like to hide in nooks and crannies,” she said. “They don’t really stay in your bed.” Common hiding places include mattresses, floorboards, and wallpaper.
• Bed bugs are about the size of an apple seed. Stains and dark spots on bed sheets and mattresses can be signs of crushed bed bugs and bed bug excrement.
• They’re more common in urban areas, but “bed bugs are a problem in probably all of our communities,” Dr. Zaenglein noted.
• Some children can develop a reaction to bed bugs and other insects known as papular urticaria. “I have to explain to parents that this is a hypersensitivity response that’s abnormal,” Dr. Zaenglein said.
She noted that papular urticaria tends to be worse in summer and rarely involves the face. Treatments include antihistamines, strong topical steroids, and prevention of insect bites.
As for bed bug bites in general, the Centers for Disease Control and Prevention recommends antiseptic creams or lotions and antihistamine use.
How can bed bugs be killed off for good? The CDC suggests insecticide spraying to eliminate bed bugs, and states that “the best way to prevent bed bugs is regular inspection for the signs of an infestation.”
During the presentation, Dr. Zaenglein also spoke about scabies, focusing on the unique traits of the condition in babies.
“They always present with a lot of rash,” she said. “They won’t have a few papules on their hands and feet like older kids.” The rash will be “dirty-looking,” she continued, and more asymmetric than symmetric. Also, “you’ll almost always get a lot of mites burden if you scrape a baby,” she said. “It’s much harder to find a mite in older kids and young adults.”
Affected babies may be referred from an emergency department or primary care doctor with an incorrect diagnosis of eczema, she said, adding that scabies is extremely contagious. “If a baby has scabies,” she said, “you inevitably have to get your prescription pad. Treat all the household members.”
Babies may be itchy, but itchiness is much more common in older kids and young adults, keeping them up at night, she said. “College students come home over the break with a couple of papules on the belly, and they say it’s driving them crazy. They say it’s crazy, crazy itchy. If you hear that, think scabies.”
Another scabies clue in older kids: hand involvement. “Always look at the wrist, between the fingers. You get these generalized eruptions there.”
Scabies bites can be treated with a topical corticosteroid and, in children aged 2 months and older, permethrin 5% cream. Dr. Zaenglein said there’s concern about a leukemia risk associated with permethrin, but that applies to industrial use and overuse. Ivermectin is an alternative for stubborn and institutional cases.
As for prevention, she said pesticide sprays and fogs are generally discouraged. She advises families to wash recently used clothing and bedding in hot water. Clothing and bedding, including pillows, can also be stored in a closed plastic bag for up to a week.
“You could dry clean it all too,” she said, “but I’ll bet your dry cleaner won’t be too happy about it.”
Dr. Zaenglein disclosed serving as a consultant and researcher for Ranbaxy Laboratories Limited.
SDEF and this news organization are owned by the same parent company.
AT SDEF WOMEN'S & PEDIATRIC DERMATOLOGY SEMINAR
Pharmacists: Weight-loss drugs and diabetes can mix
SAN DIEGO –
In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.
The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”
Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.
These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”
According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”
Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).
There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.
Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”
As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.
Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”
Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.
If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”
Dr. Rochester and Dr. Meade report no relevant disclosures.
SAN DIEGO –
In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.
The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”
Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.
These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”
According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”
Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).
There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.
Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”
As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.
Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”
Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.
If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”
Dr. Rochester and Dr. Meade report no relevant disclosures.
SAN DIEGO –
In light of their side effects and other complications, weight-loss drugs haven’t reached their full diet-in-a-pill potential. Diet drugs remain controversial even as the Food and Drug Administration continues to approve new formulations. Such weight-loss medications can still play a role in the care of diabetic patient, according to a pair of diabetes educators.
The key, they say, is to understand the limits of their potential and their not-so-limited drawbacks. “There is no magic pill,” said Charmaine Rochester, PharmD, an associate professor of pharmacy with the University of Maryland School of Pharmacy, Baltimore. “Patients need to know that it is not an easy fix. They still have to change their lifestyles with the medications.”
Dr. Rochester and Lisa Meade, PharmD, CDE, an associate professor of pharmacy at Wingate (N.C.) University School of Pharmacy, spoke about weight loss medications and diabetes care at the annual meeting of the American Association of Diabetes Educators and in later interviews.
These medications produce weight loss in the 5%-10% range. Still, “weight loss as little as 5% can significantly improve glycemic control, and modest weight loss of 5% to under 10% has been associated with significant improvements in cardiovascular disease risk factors at 1 year – decreased inflammation, improvement in insulin resistance, improved blood pressure, and improved cholesterol,” Dr. Meade said. “Also, weight loss may decrease the amount of medication needed to achieve glycemic control.”
According to Dr. Meade, it’s common for diabetic patients to ask about weight-loss drugs. “They have heard about them from friends or have seen advertisements on TV or the Internet or in magazines,” she said. However, “in general we do not encourage the use of medications for weight loss until the patient has demonstrated weight loss on their own. Counseling is very important so patients realize they will have more weight loss if combined with diet and exercise.”
Dr. Meade noted that the newer weight-loss medications – Qsymia (phentermine and topiramate), Belviq (lorcaserin HCl), Contrave (naltrexone HCl/bupropion HCl), and Saxenda (liraglutide) – are indicated in obese adults with a body mass index of 30 or above or those with a BMI of 27 with at least one comorbid condition, such as hypertension, type 2 diabetes, or dyslipidemia. Contrave is unusual: It’s a mix of the antidepressant bupropion (Wellbutrin) and the addiction drug naltrexone (Revia).
There are several other weight-loss drugs, including orlistat, which is available both by prescription (Xenical) and over-the-counter (Alli). Orlistat is famously linked to “anal leakage” – GI problems and oily and fatty stools.
Weight-loss drugs are controversial. Consumer Reports has warned against using Alli, Xenical, Belviq, Qsymia, and Saxenda “because they don’t help most people lose much, if any, weight, and they all carry potentially serious risks.” Earlier this year, Consumer Reports took aim at Contrave, too: “Nearly 1 in 4 people in the clinical trials stopped taking the prescription weight loss pill because they couldn’t tolerate the common side effects, including nausea, headache, and vomiting.”
As for other side effects, Dr. Meade noted that weight loss can cause hypoglycemia, so diabetes medications may need to be reduced. “Educators need to know that phentermine [in Qsymia and other weight-loss medications] is contraindicated for patients with any type of coronary artery disease [uncontrolled hypertension, stroke, arrhythmias or heart failure],” she said. There are concerns about cardiac issues in patients who take other weight-loss drugs, too.
Also, Belviq is not recommended in patients who are taking certain medications for depression, Dr. Meade said, “and some medications for depression and smoking cessation would be contraindicated with Contrave.”
Dr. Meade cautioned that the new drugs often aren’t covered by insurance and can be too expensive for patients. Goodrx.com estimates the cash price for a month’s supply of Contrave at $264-$295, although discounts and coupons can reduce that amount.
If patients do want to try the weight-loss drugs, Dr. Rochester urges educators to inform them about “the reality of the weight loss expected and remind patients that the research was completed in patients who also incorporated diet and exercise.”
Dr. Rochester and Dr. Meade report no relevant disclosures.
EXPERT ANALYSIS FROM AADE 16
Caution is key when prescribing spironolactone for adult acne
NEWPORT BEACH, CALIF. – While off-label use of spironolactone for treatment of acne is quite common, it should be prescribed with special caution, advised Julie C. Harper, MD.
“The vast majority of you write this for acne,” Dr. Harper, a dermatologist in private practice in Birmingham, Ala., said during a presentation on adult acne at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
She offered this blunt advice about one potential patient group: “Do not use this in men.” She cited a 2006 Japanese study of 139 patients with acne, treated with oral spironolactone, which found that 3 of the 23 males in the study developed gynecomastia within 4-6 weeks. Subsequently, the treatment was stopped in all male patients (Aesthetic Plast Surg. 2006 Nov-Dec;30[6]:689-94).
In the same study, 80% of the 116 females in the study experienced menstrual irregularities. “We have to tell our patients that’s a possible side effect, that they may get breast tenderness or menstrual irregularities,” Dr. Harper said. “If you don’t tell them, they’re not thinking of acne drugs as causing this.”
What about the risk of hyperkalemia in patients who take spironolactone, which is a diuretic? A retrospective study found similar hyperkalemia rates among healthy young women taking spironolactone for acne or an endocrine disorder with associated acne (mean age 26-27 years) and among healthy young women not taking spironolactone. The authors concluded that routine potassium testing was not necessary in healthy young women who take the drug (JAMA Dermatol. 2015 Sep;151[9]:941-4).
Dr. Harper recommended testing, however, if patients are older, have a history of renal or cardiac disease, have impaired hepatic function, or are taking higher doses of spironolactone.
She also cautioned that spironolactone should not be taken with lithium, and that it boosts the risk of digoxin toxicity.
Research doesn’t indicate that the risk of breast cancer is increased in women taking spironolactone, she said, nor does there appear to be a risk in lactating mothers. But the drug should not be taken during pregnancy or by women who could become pregnant, she noted.
Dr. Harper warned against the use of tetracyclines and erythromycin estolate when treating pregnant women with acne. She avoids using topical retinoids, although she said they are probably safe in small areas. Benzoyl peroxide is acceptable for small areas, as are topical azelaic acid and clindamycin, she added.
For information about acne treatment in lactating mothers, she cited a 2014 review (J Am Acad Dermatol. 2014 Mar;70[3]:417.e1-417.e10.). Erythromycin, azithromycin, and clarithromycin are considered appropriate for short-term use, she said, as are tetracyclines, but for less than 3 weeks only. Oral clindamycin is acceptable, but may cause gastrointestinal side effects in the nursing infant; topical use appears to be appropriate, she said.
Topical treatment with benzoyl peroxide is also appropriate for lactating women, she said, and topical retinoids are probably safe on small areas. Topical azelaic acid is considered a low risk to the nursing infant, she added.
Dr. Harper disclosed financial relationships of various types with Allergan, Bayer, BiopharmX, Galderma, Novan, Promius and Valeant.
SDEF and this news organization are owned by Frontline Medical Communications.
NEWPORT BEACH, CALIF. – While off-label use of spironolactone for treatment of acne is quite common, it should be prescribed with special caution, advised Julie C. Harper, MD.
“The vast majority of you write this for acne,” Dr. Harper, a dermatologist in private practice in Birmingham, Ala., said during a presentation on adult acne at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
She offered this blunt advice about one potential patient group: “Do not use this in men.” She cited a 2006 Japanese study of 139 patients with acne, treated with oral spironolactone, which found that 3 of the 23 males in the study developed gynecomastia within 4-6 weeks. Subsequently, the treatment was stopped in all male patients (Aesthetic Plast Surg. 2006 Nov-Dec;30[6]:689-94).
In the same study, 80% of the 116 females in the study experienced menstrual irregularities. “We have to tell our patients that’s a possible side effect, that they may get breast tenderness or menstrual irregularities,” Dr. Harper said. “If you don’t tell them, they’re not thinking of acne drugs as causing this.”
What about the risk of hyperkalemia in patients who take spironolactone, which is a diuretic? A retrospective study found similar hyperkalemia rates among healthy young women taking spironolactone for acne or an endocrine disorder with associated acne (mean age 26-27 years) and among healthy young women not taking spironolactone. The authors concluded that routine potassium testing was not necessary in healthy young women who take the drug (JAMA Dermatol. 2015 Sep;151[9]:941-4).
Dr. Harper recommended testing, however, if patients are older, have a history of renal or cardiac disease, have impaired hepatic function, or are taking higher doses of spironolactone.
She also cautioned that spironolactone should not be taken with lithium, and that it boosts the risk of digoxin toxicity.
Research doesn’t indicate that the risk of breast cancer is increased in women taking spironolactone, she said, nor does there appear to be a risk in lactating mothers. But the drug should not be taken during pregnancy or by women who could become pregnant, she noted.
Dr. Harper warned against the use of tetracyclines and erythromycin estolate when treating pregnant women with acne. She avoids using topical retinoids, although she said they are probably safe in small areas. Benzoyl peroxide is acceptable for small areas, as are topical azelaic acid and clindamycin, she added.
For information about acne treatment in lactating mothers, she cited a 2014 review (J Am Acad Dermatol. 2014 Mar;70[3]:417.e1-417.e10.). Erythromycin, azithromycin, and clarithromycin are considered appropriate for short-term use, she said, as are tetracyclines, but for less than 3 weeks only. Oral clindamycin is acceptable, but may cause gastrointestinal side effects in the nursing infant; topical use appears to be appropriate, she said.
Topical treatment with benzoyl peroxide is also appropriate for lactating women, she said, and topical retinoids are probably safe on small areas. Topical azelaic acid is considered a low risk to the nursing infant, she added.
Dr. Harper disclosed financial relationships of various types with Allergan, Bayer, BiopharmX, Galderma, Novan, Promius and Valeant.
SDEF and this news organization are owned by Frontline Medical Communications.
NEWPORT BEACH, CALIF. – While off-label use of spironolactone for treatment of acne is quite common, it should be prescribed with special caution, advised Julie C. Harper, MD.
“The vast majority of you write this for acne,” Dr. Harper, a dermatologist in private practice in Birmingham, Ala., said during a presentation on adult acne at the Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.
She offered this blunt advice about one potential patient group: “Do not use this in men.” She cited a 2006 Japanese study of 139 patients with acne, treated with oral spironolactone, which found that 3 of the 23 males in the study developed gynecomastia within 4-6 weeks. Subsequently, the treatment was stopped in all male patients (Aesthetic Plast Surg. 2006 Nov-Dec;30[6]:689-94).
In the same study, 80% of the 116 females in the study experienced menstrual irregularities. “We have to tell our patients that’s a possible side effect, that they may get breast tenderness or menstrual irregularities,” Dr. Harper said. “If you don’t tell them, they’re not thinking of acne drugs as causing this.”
What about the risk of hyperkalemia in patients who take spironolactone, which is a diuretic? A retrospective study found similar hyperkalemia rates among healthy young women taking spironolactone for acne or an endocrine disorder with associated acne (mean age 26-27 years) and among healthy young women not taking spironolactone. The authors concluded that routine potassium testing was not necessary in healthy young women who take the drug (JAMA Dermatol. 2015 Sep;151[9]:941-4).
Dr. Harper recommended testing, however, if patients are older, have a history of renal or cardiac disease, have impaired hepatic function, or are taking higher doses of spironolactone.
She also cautioned that spironolactone should not be taken with lithium, and that it boosts the risk of digoxin toxicity.
Research doesn’t indicate that the risk of breast cancer is increased in women taking spironolactone, she said, nor does there appear to be a risk in lactating mothers. But the drug should not be taken during pregnancy or by women who could become pregnant, she noted.
Dr. Harper warned against the use of tetracyclines and erythromycin estolate when treating pregnant women with acne. She avoids using topical retinoids, although she said they are probably safe in small areas. Benzoyl peroxide is acceptable for small areas, as are topical azelaic acid and clindamycin, she added.
For information about acne treatment in lactating mothers, she cited a 2014 review (J Am Acad Dermatol. 2014 Mar;70[3]:417.e1-417.e10.). Erythromycin, azithromycin, and clarithromycin are considered appropriate for short-term use, she said, as are tetracyclines, but for less than 3 weeks only. Oral clindamycin is acceptable, but may cause gastrointestinal side effects in the nursing infant; topical use appears to be appropriate, she said.
Topical treatment with benzoyl peroxide is also appropriate for lactating women, she said, and topical retinoids are probably safe on small areas. Topical azelaic acid is considered a low risk to the nursing infant, she added.
Dr. Harper disclosed financial relationships of various types with Allergan, Bayer, BiopharmX, Galderma, Novan, Promius and Valeant.
SDEF and this news organization are owned by Frontline Medical Communications.
AT SDEF WOMEN’S & PEDIATRIC DERMATOLOGY SEMINAR