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Abatacept efficacy differs in trials of giant cell and Takayasu’s arteritis
A pair of new studies offer mixed results regarding the use of the rheumatoid arthritis drug abatacept to treat two forms of large-vessel vasculitis: It appears to help patients with giant cell arteritis but not those with the rarer Takayasu’s arteritis.
“The results from the GCA [giant cell arteritis] study found that treatment with abatacept [Orencia] combined with prednisone resulted in a lower rate of relapse than treatment with prednisone alone,” said Carol A. Langford, MD, lead author of both studies, which were conducted by the Vasculitis Clinical Research Consortium. She is chair in rheumatic and immunologic diseases and director of the Center for Vasculitis Care and Research at the Cleveland Clinic.
Both studies appear online Jan. 30 in Arthritis & Rheumatology.
“GCA is the most common form of vasculitis with an estimated incidence of 19.8 per 100,000,” she said. “It occurs in people over the age of 50 with the average age of onset in the 70s.” Women are most affected by a 2:1 ratio.
She said the disease affects the cranium (causing headaches, scalp tenderness, and a risk of blindness) and causes signs of systemic inflammation.
“Almost one-third of patients with GCA can have large vessel involvement that specifically include thoracic aortic aneurysms and stenosis of the cervical and subclavian arteries,” she said. Fatal thoracic aneurysms are possible, she said, but “studies have shown that in GCA overall, while short-term mortality may be increased, long-term survival is similar to the age-matched general population.”
TAK is much rarer, she said, affecting 3-9 people per 1,000,000. “TAK has an average age of onset in the 20s with an even stronger female predisposition of up to 9:1.”
The condition affects the aorta, its main branches, and pulmonary arteries, she said, “Some of the more frequent vascular symptoms/signs can include extremity claudication, hypertension, chest pain, and features associated with cerebral hypoperfusion. TAK is associated with substantial morbidity which is influenced by a low rate of sustained remission in 28%-50% of patients. Up to 47% of patients experience permanent disability, which has a significant impact on this young population.”
The mortality from TAK is unclear, she said.
Glucocorticoids are the main treatment for both GCA and TAK, Dr. Langford said, but “while glucocorticoids effectively control disease, they do not prevent relapse and they are associated with significant toxicity.”
For GCA, methotrexate has shown a mild benefit at best, she said, while two studies show promise for tocilizumab (Actemra). As for TAK, she said doctors often turn to the use of immunosuppressants and tumor necrosis factor inhibitors, although their use is based on retrospective studies and small, open-label trials.
Dr. Langford and her colleagues launched the two randomized, double-blind, placebo-controlled, multicenter studies in parallel with the same protocols.
In the GCA trial (doi: 10.1002/art.40044), researchers enrolled 49 patients with newly diagnosed GCA or disease that had relapsed within the 2 prior months to prednisone 40-60 mg/day followed by a standardized tapering schedule plus abatacept 10 mg/kg IV on days 1, 15, 29, and week 8. At 12 weeks, 8 patients had withdrawn, relapsed, or were not in remission, and so 41 were randomized to receive placebo or monthly abatacept until they met criteria for early termination or 12 months had passed after the last patient was enrolled. At the time of the randomization at 12 weeks, all patients were taking prednisone 20 mg/day, which was tapered until discontinuation at week 28.
At 12 months, 48% of those who took abatacept survived without relapse, compared with 31% of those who took placebo (P = .049), and the median remission period was longer for abatacept (9.9 months) than placebo (3.9 months; P = .023).
“This difference between groups is clinically meaningful to patients with GCA, corresponding to a prolonged duration of remission during which time they are not exposed to glucocorticoids and their potential toxicities that can impact quality of life,” Dr. Langford said.
No patients died during the trial, and 23 serious adverse events were reported in 15 patients. The frequency and severity of adverse events and infections didn’t differ between the treatment and placebo groups.
The drug may work in GCA patients by blocking T-cell activation, Dr. Langford said. Physicians could consider the drug in clinical practice, she said, although more research is needed to understand the long-term effects of using the medication.
In the other study (doi: 10.1002/art.40037), researchers used the same protocol to treat 34 patients with TAK; 26 reached the 12-week midpoint and were randomized to placebo or continuing abatacept on a monthly basis.
At 12 months, the relapse-free rate was 22% for the abatacept group and 40% for the placebo group (P = .853). The median duration of remission was similar for the groups at 5.5 months for abatacept and 5.7 months for placebo (P = .125).
The researchers reported no difference in frequency or severity of adverse events such as infection.
Based on the study results, Dr. Langford said abatacept is not appropriate in clinical practice to treat TAK.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases funded the studies, and Bristol-Myers Squibb, which markets abatacept, provided the drug. Dr. Langford disclosed receiving research grants from Bristol-Myers Squibb, Genentech, and GlaxoSmithKline.
A pair of new studies offer mixed results regarding the use of the rheumatoid arthritis drug abatacept to treat two forms of large-vessel vasculitis: It appears to help patients with giant cell arteritis but not those with the rarer Takayasu’s arteritis.
“The results from the GCA [giant cell arteritis] study found that treatment with abatacept [Orencia] combined with prednisone resulted in a lower rate of relapse than treatment with prednisone alone,” said Carol A. Langford, MD, lead author of both studies, which were conducted by the Vasculitis Clinical Research Consortium. She is chair in rheumatic and immunologic diseases and director of the Center for Vasculitis Care and Research at the Cleveland Clinic.
Both studies appear online Jan. 30 in Arthritis & Rheumatology.
“GCA is the most common form of vasculitis with an estimated incidence of 19.8 per 100,000,” she said. “It occurs in people over the age of 50 with the average age of onset in the 70s.” Women are most affected by a 2:1 ratio.
She said the disease affects the cranium (causing headaches, scalp tenderness, and a risk of blindness) and causes signs of systemic inflammation.
“Almost one-third of patients with GCA can have large vessel involvement that specifically include thoracic aortic aneurysms and stenosis of the cervical and subclavian arteries,” she said. Fatal thoracic aneurysms are possible, she said, but “studies have shown that in GCA overall, while short-term mortality may be increased, long-term survival is similar to the age-matched general population.”
TAK is much rarer, she said, affecting 3-9 people per 1,000,000. “TAK has an average age of onset in the 20s with an even stronger female predisposition of up to 9:1.”
The condition affects the aorta, its main branches, and pulmonary arteries, she said, “Some of the more frequent vascular symptoms/signs can include extremity claudication, hypertension, chest pain, and features associated with cerebral hypoperfusion. TAK is associated with substantial morbidity which is influenced by a low rate of sustained remission in 28%-50% of patients. Up to 47% of patients experience permanent disability, which has a significant impact on this young population.”
The mortality from TAK is unclear, she said.
Glucocorticoids are the main treatment for both GCA and TAK, Dr. Langford said, but “while glucocorticoids effectively control disease, they do not prevent relapse and they are associated with significant toxicity.”
For GCA, methotrexate has shown a mild benefit at best, she said, while two studies show promise for tocilizumab (Actemra). As for TAK, she said doctors often turn to the use of immunosuppressants and tumor necrosis factor inhibitors, although their use is based on retrospective studies and small, open-label trials.
Dr. Langford and her colleagues launched the two randomized, double-blind, placebo-controlled, multicenter studies in parallel with the same protocols.
In the GCA trial (doi: 10.1002/art.40044), researchers enrolled 49 patients with newly diagnosed GCA or disease that had relapsed within the 2 prior months to prednisone 40-60 mg/day followed by a standardized tapering schedule plus abatacept 10 mg/kg IV on days 1, 15, 29, and week 8. At 12 weeks, 8 patients had withdrawn, relapsed, or were not in remission, and so 41 were randomized to receive placebo or monthly abatacept until they met criteria for early termination or 12 months had passed after the last patient was enrolled. At the time of the randomization at 12 weeks, all patients were taking prednisone 20 mg/day, which was tapered until discontinuation at week 28.
At 12 months, 48% of those who took abatacept survived without relapse, compared with 31% of those who took placebo (P = .049), and the median remission period was longer for abatacept (9.9 months) than placebo (3.9 months; P = .023).
“This difference between groups is clinically meaningful to patients with GCA, corresponding to a prolonged duration of remission during which time they are not exposed to glucocorticoids and their potential toxicities that can impact quality of life,” Dr. Langford said.
No patients died during the trial, and 23 serious adverse events were reported in 15 patients. The frequency and severity of adverse events and infections didn’t differ between the treatment and placebo groups.
The drug may work in GCA patients by blocking T-cell activation, Dr. Langford said. Physicians could consider the drug in clinical practice, she said, although more research is needed to understand the long-term effects of using the medication.
In the other study (doi: 10.1002/art.40037), researchers used the same protocol to treat 34 patients with TAK; 26 reached the 12-week midpoint and were randomized to placebo or continuing abatacept on a monthly basis.
At 12 months, the relapse-free rate was 22% for the abatacept group and 40% for the placebo group (P = .853). The median duration of remission was similar for the groups at 5.5 months for abatacept and 5.7 months for placebo (P = .125).
The researchers reported no difference in frequency or severity of adverse events such as infection.
Based on the study results, Dr. Langford said abatacept is not appropriate in clinical practice to treat TAK.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases funded the studies, and Bristol-Myers Squibb, which markets abatacept, provided the drug. Dr. Langford disclosed receiving research grants from Bristol-Myers Squibb, Genentech, and GlaxoSmithKline.
A pair of new studies offer mixed results regarding the use of the rheumatoid arthritis drug abatacept to treat two forms of large-vessel vasculitis: It appears to help patients with giant cell arteritis but not those with the rarer Takayasu’s arteritis.
“The results from the GCA [giant cell arteritis] study found that treatment with abatacept [Orencia] combined with prednisone resulted in a lower rate of relapse than treatment with prednisone alone,” said Carol A. Langford, MD, lead author of both studies, which were conducted by the Vasculitis Clinical Research Consortium. She is chair in rheumatic and immunologic diseases and director of the Center for Vasculitis Care and Research at the Cleveland Clinic.
Both studies appear online Jan. 30 in Arthritis & Rheumatology.
“GCA is the most common form of vasculitis with an estimated incidence of 19.8 per 100,000,” she said. “It occurs in people over the age of 50 with the average age of onset in the 70s.” Women are most affected by a 2:1 ratio.
She said the disease affects the cranium (causing headaches, scalp tenderness, and a risk of blindness) and causes signs of systemic inflammation.
“Almost one-third of patients with GCA can have large vessel involvement that specifically include thoracic aortic aneurysms and stenosis of the cervical and subclavian arteries,” she said. Fatal thoracic aneurysms are possible, she said, but “studies have shown that in GCA overall, while short-term mortality may be increased, long-term survival is similar to the age-matched general population.”
TAK is much rarer, she said, affecting 3-9 people per 1,000,000. “TAK has an average age of onset in the 20s with an even stronger female predisposition of up to 9:1.”
The condition affects the aorta, its main branches, and pulmonary arteries, she said, “Some of the more frequent vascular symptoms/signs can include extremity claudication, hypertension, chest pain, and features associated with cerebral hypoperfusion. TAK is associated with substantial morbidity which is influenced by a low rate of sustained remission in 28%-50% of patients. Up to 47% of patients experience permanent disability, which has a significant impact on this young population.”
The mortality from TAK is unclear, she said.
Glucocorticoids are the main treatment for both GCA and TAK, Dr. Langford said, but “while glucocorticoids effectively control disease, they do not prevent relapse and they are associated with significant toxicity.”
For GCA, methotrexate has shown a mild benefit at best, she said, while two studies show promise for tocilizumab (Actemra). As for TAK, she said doctors often turn to the use of immunosuppressants and tumor necrosis factor inhibitors, although their use is based on retrospective studies and small, open-label trials.
Dr. Langford and her colleagues launched the two randomized, double-blind, placebo-controlled, multicenter studies in parallel with the same protocols.
In the GCA trial (doi: 10.1002/art.40044), researchers enrolled 49 patients with newly diagnosed GCA or disease that had relapsed within the 2 prior months to prednisone 40-60 mg/day followed by a standardized tapering schedule plus abatacept 10 mg/kg IV on days 1, 15, 29, and week 8. At 12 weeks, 8 patients had withdrawn, relapsed, or were not in remission, and so 41 were randomized to receive placebo or monthly abatacept until they met criteria for early termination or 12 months had passed after the last patient was enrolled. At the time of the randomization at 12 weeks, all patients were taking prednisone 20 mg/day, which was tapered until discontinuation at week 28.
At 12 months, 48% of those who took abatacept survived without relapse, compared with 31% of those who took placebo (P = .049), and the median remission period was longer for abatacept (9.9 months) than placebo (3.9 months; P = .023).
“This difference between groups is clinically meaningful to patients with GCA, corresponding to a prolonged duration of remission during which time they are not exposed to glucocorticoids and their potential toxicities that can impact quality of life,” Dr. Langford said.
No patients died during the trial, and 23 serious adverse events were reported in 15 patients. The frequency and severity of adverse events and infections didn’t differ between the treatment and placebo groups.
The drug may work in GCA patients by blocking T-cell activation, Dr. Langford said. Physicians could consider the drug in clinical practice, she said, although more research is needed to understand the long-term effects of using the medication.
In the other study (doi: 10.1002/art.40037), researchers used the same protocol to treat 34 patients with TAK; 26 reached the 12-week midpoint and were randomized to placebo or continuing abatacept on a monthly basis.
At 12 months, the relapse-free rate was 22% for the abatacept group and 40% for the placebo group (P = .853). The median duration of remission was similar for the groups at 5.5 months for abatacept and 5.7 months for placebo (P = .125).
The researchers reported no difference in frequency or severity of adverse events such as infection.
Based on the study results, Dr. Langford said abatacept is not appropriate in clinical practice to treat TAK.
The National Institute of Arthritis and Musculoskeletal and Skin Diseases funded the studies, and Bristol-Myers Squibb, which markets abatacept, provided the drug. Dr. Langford disclosed receiving research grants from Bristol-Myers Squibb, Genentech, and GlaxoSmithKline.
FROM ARTHRITIS & RHEUMATOLOGY
Key clinical point:
Major finding: At 12 months, 48% of GCA patients who took abatacept survived without relapse, compared with 31% of those who took placebo (P = .049), and the median remission period was longer for abatacept (9.9 months) than placebo (3.9 months; P = .023) For TAK patients, the relapse-free rates were 22% for the abatacept group and 40% for the placebo group (P = .853). The median duration of remission was similar for the groups at 5.5 months for abatacept and 5.7 months for placebo (P = .125).
Data source: Two randomized, double-blinded, placebo-controlled, multicenter trials with identical protocols of prednisone plus abatacept 10 mg/kg IV on days 1, 15, 29, and week 8, then randomization to placebo or monthly abatacept until patients met criteria for early termination or 12 months passed after the last patient was enrolled.
Disclosures: The National Institute of Arthritis and Musculoskeletal and Skin Diseases funded the studies, and Bristol-Myers Squibb, which markets abatacept, provided the drug. Dr. Langford disclosed receiving research grants from Bristol-Myers Squibb, Genentech, and GlaxoSmithKline.
Immune-suppressing drugs in IBD linked to higher skin cancer rates
In another sign that immune-suppressing drugs may cause skin cancer, a new Irish study links immunomodulator use in younger patients with inflammatory bowel disease (IBD) to higher rates of nonmelanoma skin cancer (NMSC).
The 19-year study lacks information about medication doses or duration, and it doesn’t confirm a cause-and-effect link. Still, researchers recommend that all patients with IBD be urged to comply with skin cancer prevention guidelines.
As the study notes, previous research has linked immunosuppression – such as that in transplant patients and those with AIDS and lymphoma – to higher rates of NMSC.
Studies have also linked IBD to higher rates of NMSC even before the age of 50, possibly as the result of immune system dysfunction and exposure to immunomodulators, especially thiopurines. The risk of tumor necrosis factor–alpha (TNF-alpha) inhibitors, the study says, is less clear.
To better understand the risk of immunomodulators, researchers led by Julianne Clowry, MBBCh, of St Vincent’s University Hospital in Dublin tracked 2,053 IBD patients at a tertiary adult hospital from 1994 to 2013.
The median age at IBD diagnosis was 31 with a median of 19.6 years of illness, and the patients had both Crohn’s disease (41%) and ulcerative colitis (59%). Fifty-seven percent of patients had taken immunomodulating medication, although the database used didn’t disclose details about dose or duration, and 43% had not.
The study findings appeared Jan. 3 in the Journal of the European Academy of Dermatology and Venereology (doi: 10.1111/jdv.14105).
NMSC was diagnosed in 1.7% of the entire cohort, 1.4% of patients who’d taken immunosuppressants, and 1.9% of those who had not.
Older ages may explain the higher rate in those who didn’t take the medications. The researchers found that the standardized incidence ratio for the patients who took immunomodulators overall was 1.76 [confidence interval, 1.0-2.7], compared with a matched general population cohort, while the ratio was not considered significant among the nonimmunosuppressed [1.07; CI, 0.6-1.6].
The study links use of thiopurines alone and use of both thiopurines and TNF-alpha inhibitors to higher rates of NMSC [odds ratio, 5.26; 95% CI, 2.15-12.93; P less than .001, and OR: 6.45; 95% CI, 2.69-15.95; P less than .001, respectively].
The researchers note that 82% of those who had taken a TNF-alpha inhibitor also took a thiopurine at some point.
The study says the “relatively high” standardized incident ratios are worrisome amid more use of dual immunomodulators and higher IBD rates in kids and younger adults. But the medications are “vital,” the study says, and the researchers suggest “targeted dermatology referrals for IBD patients, particularly those exposed to dual immunomodulatory therapy from an early age.”
The study authors disclose no source of funding and report no relevant disclosures.
In another sign that immune-suppressing drugs may cause skin cancer, a new Irish study links immunomodulator use in younger patients with inflammatory bowel disease (IBD) to higher rates of nonmelanoma skin cancer (NMSC).
The 19-year study lacks information about medication doses or duration, and it doesn’t confirm a cause-and-effect link. Still, researchers recommend that all patients with IBD be urged to comply with skin cancer prevention guidelines.
As the study notes, previous research has linked immunosuppression – such as that in transplant patients and those with AIDS and lymphoma – to higher rates of NMSC.
Studies have also linked IBD to higher rates of NMSC even before the age of 50, possibly as the result of immune system dysfunction and exposure to immunomodulators, especially thiopurines. The risk of tumor necrosis factor–alpha (TNF-alpha) inhibitors, the study says, is less clear.
To better understand the risk of immunomodulators, researchers led by Julianne Clowry, MBBCh, of St Vincent’s University Hospital in Dublin tracked 2,053 IBD patients at a tertiary adult hospital from 1994 to 2013.
The median age at IBD diagnosis was 31 with a median of 19.6 years of illness, and the patients had both Crohn’s disease (41%) and ulcerative colitis (59%). Fifty-seven percent of patients had taken immunomodulating medication, although the database used didn’t disclose details about dose or duration, and 43% had not.
The study findings appeared Jan. 3 in the Journal of the European Academy of Dermatology and Venereology (doi: 10.1111/jdv.14105).
NMSC was diagnosed in 1.7% of the entire cohort, 1.4% of patients who’d taken immunosuppressants, and 1.9% of those who had not.
Older ages may explain the higher rate in those who didn’t take the medications. The researchers found that the standardized incidence ratio for the patients who took immunomodulators overall was 1.76 [confidence interval, 1.0-2.7], compared with a matched general population cohort, while the ratio was not considered significant among the nonimmunosuppressed [1.07; CI, 0.6-1.6].
The study links use of thiopurines alone and use of both thiopurines and TNF-alpha inhibitors to higher rates of NMSC [odds ratio, 5.26; 95% CI, 2.15-12.93; P less than .001, and OR: 6.45; 95% CI, 2.69-15.95; P less than .001, respectively].
The researchers note that 82% of those who had taken a TNF-alpha inhibitor also took a thiopurine at some point.
The study says the “relatively high” standardized incident ratios are worrisome amid more use of dual immunomodulators and higher IBD rates in kids and younger adults. But the medications are “vital,” the study says, and the researchers suggest “targeted dermatology referrals for IBD patients, particularly those exposed to dual immunomodulatory therapy from an early age.”
The study authors disclose no source of funding and report no relevant disclosures.
In another sign that immune-suppressing drugs may cause skin cancer, a new Irish study links immunomodulator use in younger patients with inflammatory bowel disease (IBD) to higher rates of nonmelanoma skin cancer (NMSC).
The 19-year study lacks information about medication doses or duration, and it doesn’t confirm a cause-and-effect link. Still, researchers recommend that all patients with IBD be urged to comply with skin cancer prevention guidelines.
As the study notes, previous research has linked immunosuppression – such as that in transplant patients and those with AIDS and lymphoma – to higher rates of NMSC.
Studies have also linked IBD to higher rates of NMSC even before the age of 50, possibly as the result of immune system dysfunction and exposure to immunomodulators, especially thiopurines. The risk of tumor necrosis factor–alpha (TNF-alpha) inhibitors, the study says, is less clear.
To better understand the risk of immunomodulators, researchers led by Julianne Clowry, MBBCh, of St Vincent’s University Hospital in Dublin tracked 2,053 IBD patients at a tertiary adult hospital from 1994 to 2013.
The median age at IBD diagnosis was 31 with a median of 19.6 years of illness, and the patients had both Crohn’s disease (41%) and ulcerative colitis (59%). Fifty-seven percent of patients had taken immunomodulating medication, although the database used didn’t disclose details about dose or duration, and 43% had not.
The study findings appeared Jan. 3 in the Journal of the European Academy of Dermatology and Venereology (doi: 10.1111/jdv.14105).
NMSC was diagnosed in 1.7% of the entire cohort, 1.4% of patients who’d taken immunosuppressants, and 1.9% of those who had not.
Older ages may explain the higher rate in those who didn’t take the medications. The researchers found that the standardized incidence ratio for the patients who took immunomodulators overall was 1.76 [confidence interval, 1.0-2.7], compared with a matched general population cohort, while the ratio was not considered significant among the nonimmunosuppressed [1.07; CI, 0.6-1.6].
The study links use of thiopurines alone and use of both thiopurines and TNF-alpha inhibitors to higher rates of NMSC [odds ratio, 5.26; 95% CI, 2.15-12.93; P less than .001, and OR: 6.45; 95% CI, 2.69-15.95; P less than .001, respectively].
The researchers note that 82% of those who had taken a TNF-alpha inhibitor also took a thiopurine at some point.
The study says the “relatively high” standardized incident ratios are worrisome amid more use of dual immunomodulators and higher IBD rates in kids and younger adults. But the medications are “vital,” the study says, and the researchers suggest “targeted dermatology referrals for IBD patients, particularly those exposed to dual immunomodulatory therapy from an early age.”
The study authors disclose no source of funding and report no relevant disclosures.
Key clinical point: Younger inflammatory bowel disease (IBD) patients who’ve taken immunomodulating drugs have higher rates of nonmelanoma skin cancer (NMSC).
Major finding: IBD patients who took thiopurines alone and both thiopurines and TNF-alpha inhibitors had higher rates of NMSC [OR, 5.26; 95% CI, 2.15-12.93; P less than .001, and OR, 6.45; 95% CI, 2.69-15.95; P less than .001, respectively], compared with an age-matched general population cohort.
Data source: Retrospective single-center cohort study over 19 years of 2,053 IBD patients with Crohn’s disease (41%) and ulcerative colitis (59%); 57% had taken immunomodulating medications.
Disclosures: The study authors disclose no source of funding and report no relevant disclosures.
Unique microbiota mix found in guts of T1D patients
potentially offering early insight into possible links between the disease and gut germs.
The findings by an Italian team don’t confirm any connection between bacteria in the digestive system and diabetes. Still, “this study is probably the best example to date in the literature of inflammatory events happening in the gut that are correlated with type 1 diabetes,” said Aleksandar Kostic, PhD, of the department of microbiology and immunobiology at Harvard Medical School, Boston, who conducts similar research.
At issue: What role, if any, does the gut play in the development of type 1 diabetes (T1D)? Scientists already believe that the gut microbiome directly affects metabolism and the development of type 2 diabetes, according to Dr. Kostic. But T1D is an autoimmune disease, not a metabolic one, he said, “and the mechanisms are very different. For type 1, we don’t know a whole lot. We’re in the very early days.”
Still, “there’s a theory that inflammatory stimulus in the gut that is somehow partially responsible for causing T1D. The idea is that the microbiome is less diverse, which means that it loses its integrity in some way and loses the ability to crowd out inflammatory organisms,” he said in an interview.
For the new study, researchers led by scientists at Milan’s IRCCS San Raffaele Scientific Institute measured inflammation and the microbiome in the duodenal mucosa of 19 patients with T1D, 19 with celiac disease, and 16 healthy controls. They reported their findings online Jan. 19 (J Clin Endocrinol Metab. 2017. doi: 10.1210/jc.2016-3222).
The researchers found a unique inflammation profile through an analysis of gene expression in the patients with T1D. They called it a “peculiar signature” that’s notable for increased numbers of infiltration from the monocyte/macrophage lineage.
“In T1D patients, we didn’t observe any correlation between gene expression and [hemoglobin A1c] level, duration of diabetes, presence of secondary complications or the reason that led to endoscopy, indicating that gene expression was not influenced by these variables,” the researchers write.
They also found a “specific microbiota composition” featuring a reduction in the role of Proteobacteria and an increase in Firmicutes; this was unique to the T1D patients. Bacteroidetes “showed a trend to reduction” in both T1D and celiac patients compared to the controls.
“The expression of genes specific for T1D inflammation was associated with the abundance of specific bacteria in duodenum,” the researchers added.
Elena Barengolts, MD, of the division of endocrinology, diabetes, and metabolism at the University of Illinois, Chicago, who’s familiar with the study, said it appears to be valid. However, the methods used have limited powers to define specific types of bacteria, making it difficult to know if the germs in question are “bad” or “good,” she said in an interview.
For his part, Dr. Kostic said the findings are “really neat” and consistent with previous findings regarding the role of the gut microbiome and T1D. He pointed to a study he led that found less-diverse microbiomes in the guts of Finnish infants with T1D (Cell Host Microbe. 2015 Feb 11;17[2]:260-73).
As a result, the gut microbiome is “functionally capable of doing fewer things, and the community gets overrun by certain pathogens,” he said. “We saw that a lot of organisms were capable of promoting inflammation in the gut.”
Dr. Kostic, Dr. Barengolts, and the study authors report no relevant disclosures.
potentially offering early insight into possible links between the disease and gut germs.
The findings by an Italian team don’t confirm any connection between bacteria in the digestive system and diabetes. Still, “this study is probably the best example to date in the literature of inflammatory events happening in the gut that are correlated with type 1 diabetes,” said Aleksandar Kostic, PhD, of the department of microbiology and immunobiology at Harvard Medical School, Boston, who conducts similar research.
At issue: What role, if any, does the gut play in the development of type 1 diabetes (T1D)? Scientists already believe that the gut microbiome directly affects metabolism and the development of type 2 diabetes, according to Dr. Kostic. But T1D is an autoimmune disease, not a metabolic one, he said, “and the mechanisms are very different. For type 1, we don’t know a whole lot. We’re in the very early days.”
Still, “there’s a theory that inflammatory stimulus in the gut that is somehow partially responsible for causing T1D. The idea is that the microbiome is less diverse, which means that it loses its integrity in some way and loses the ability to crowd out inflammatory organisms,” he said in an interview.
For the new study, researchers led by scientists at Milan’s IRCCS San Raffaele Scientific Institute measured inflammation and the microbiome in the duodenal mucosa of 19 patients with T1D, 19 with celiac disease, and 16 healthy controls. They reported their findings online Jan. 19 (J Clin Endocrinol Metab. 2017. doi: 10.1210/jc.2016-3222).
The researchers found a unique inflammation profile through an analysis of gene expression in the patients with T1D. They called it a “peculiar signature” that’s notable for increased numbers of infiltration from the monocyte/macrophage lineage.
“In T1D patients, we didn’t observe any correlation between gene expression and [hemoglobin A1c] level, duration of diabetes, presence of secondary complications or the reason that led to endoscopy, indicating that gene expression was not influenced by these variables,” the researchers write.
They also found a “specific microbiota composition” featuring a reduction in the role of Proteobacteria and an increase in Firmicutes; this was unique to the T1D patients. Bacteroidetes “showed a trend to reduction” in both T1D and celiac patients compared to the controls.
“The expression of genes specific for T1D inflammation was associated with the abundance of specific bacteria in duodenum,” the researchers added.
Elena Barengolts, MD, of the division of endocrinology, diabetes, and metabolism at the University of Illinois, Chicago, who’s familiar with the study, said it appears to be valid. However, the methods used have limited powers to define specific types of bacteria, making it difficult to know if the germs in question are “bad” or “good,” she said in an interview.
For his part, Dr. Kostic said the findings are “really neat” and consistent with previous findings regarding the role of the gut microbiome and T1D. He pointed to a study he led that found less-diverse microbiomes in the guts of Finnish infants with T1D (Cell Host Microbe. 2015 Feb 11;17[2]:260-73).
As a result, the gut microbiome is “functionally capable of doing fewer things, and the community gets overrun by certain pathogens,” he said. “We saw that a lot of organisms were capable of promoting inflammation in the gut.”
Dr. Kostic, Dr. Barengolts, and the study authors report no relevant disclosures.
potentially offering early insight into possible links between the disease and gut germs.
The findings by an Italian team don’t confirm any connection between bacteria in the digestive system and diabetes. Still, “this study is probably the best example to date in the literature of inflammatory events happening in the gut that are correlated with type 1 diabetes,” said Aleksandar Kostic, PhD, of the department of microbiology and immunobiology at Harvard Medical School, Boston, who conducts similar research.
At issue: What role, if any, does the gut play in the development of type 1 diabetes (T1D)? Scientists already believe that the gut microbiome directly affects metabolism and the development of type 2 diabetes, according to Dr. Kostic. But T1D is an autoimmune disease, not a metabolic one, he said, “and the mechanisms are very different. For type 1, we don’t know a whole lot. We’re in the very early days.”
Still, “there’s a theory that inflammatory stimulus in the gut that is somehow partially responsible for causing T1D. The idea is that the microbiome is less diverse, which means that it loses its integrity in some way and loses the ability to crowd out inflammatory organisms,” he said in an interview.
For the new study, researchers led by scientists at Milan’s IRCCS San Raffaele Scientific Institute measured inflammation and the microbiome in the duodenal mucosa of 19 patients with T1D, 19 with celiac disease, and 16 healthy controls. They reported their findings online Jan. 19 (J Clin Endocrinol Metab. 2017. doi: 10.1210/jc.2016-3222).
The researchers found a unique inflammation profile through an analysis of gene expression in the patients with T1D. They called it a “peculiar signature” that’s notable for increased numbers of infiltration from the monocyte/macrophage lineage.
“In T1D patients, we didn’t observe any correlation between gene expression and [hemoglobin A1c] level, duration of diabetes, presence of secondary complications or the reason that led to endoscopy, indicating that gene expression was not influenced by these variables,” the researchers write.
They also found a “specific microbiota composition” featuring a reduction in the role of Proteobacteria and an increase in Firmicutes; this was unique to the T1D patients. Bacteroidetes “showed a trend to reduction” in both T1D and celiac patients compared to the controls.
“The expression of genes specific for T1D inflammation was associated with the abundance of specific bacteria in duodenum,” the researchers added.
Elena Barengolts, MD, of the division of endocrinology, diabetes, and metabolism at the University of Illinois, Chicago, who’s familiar with the study, said it appears to be valid. However, the methods used have limited powers to define specific types of bacteria, making it difficult to know if the germs in question are “bad” or “good,” she said in an interview.
For his part, Dr. Kostic said the findings are “really neat” and consistent with previous findings regarding the role of the gut microbiome and T1D. He pointed to a study he led that found less-diverse microbiomes in the guts of Finnish infants with T1D (Cell Host Microbe. 2015 Feb 11;17[2]:260-73).
As a result, the gut microbiome is “functionally capable of doing fewer things, and the community gets overrun by certain pathogens,” he said. “We saw that a lot of organisms were capable of promoting inflammation in the gut.”
Dr. Kostic, Dr. Barengolts, and the study authors report no relevant disclosures.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Key clinical point: Patients with type 1 diabetes (T1D) show signs of unique inflammation and microbiota in the duodenal mucosa, compared with controls and celiac patients.
Major finding: T1D patients had a “peculiar” inflammation signature and a unique microbiota composition, and there’s a sign of a link between inflammation and bacteria levels.
Data source: An analysis of 19 patients with T1D, 19 with celiac disease, and 16 healthy controls.
Disclosures: The study was supported by institutional funds, and the authors report no relevant disclosures.
Symptoms don’t worsen during pregnancy in most PsA patients
Psoriatic arthritis disease activity tended to improve or stabilize during pregnancy and the first year after giving birth, even outpacing controls, in a small retrospective cohort study.
“The outcome of pregnancy in PsA [psoriatic arthritis] patients is excellent,” investigators from the University of Toronto Psoriatic Arthritis Program reported. They found that “arthritis activity has a favorable course during pregnancy in almost 60% of the pregnancies, while the skin disease shows a favorable course in close to 90% of the pregnancies.”
According to the researchers, led by Ari Polachek, MD, of the Centre for Prognosis Studies in the Rheumatic Diseases at Toronto Western Hospital, previous research has found that rheumatoid arthritis improves in most pregnant women with the condition but then worsens in the year after birth, while most patients with ankylosing spondylitis don’t get better or worse. Limited research suggests psoriasis tends to improve during pregnancy and then flares afterward.
For the new study, researchers tracked 29 pregnant PsA patients with 42 total pregnancies who had a mean age of about 34 years at the beginning of pregnancy and matched them with 67 control patients with PsA who were not pregnant and had an average age of about 35 years. They had all visited the University of Toronto Psoriatic Arthritis Clinic during 1990-2015 (Semin Arthritis Rheum. 2017 Jan 16. doi: 10.1016/j.semarthrit.2017.01.002).
Among the 41 pregnancies in women who began follow-up prior to pregnancy, 13 (32%) had an unfavorable course of disease activity marked by worsening during 8 (20%) of the pregnancies or stable high disease activity during 5 (12%). The course of disease activity was more favorable for 24 (59%) pregnancies, in which it improved in 11 (27%) and stayed stable at a low disease level in 13 (32%). Four pregnancies (10%) had a mixed pattern of improvement followed by worsening.
The 1-year postpartum period during 40 pregnancies showed that stable or worsening symptoms were most common: 8 (20%) had improvement and 13 (32.5%) had stable low disease activity, while another 16 (4%) worsened and 3 (8%) had a mixed course of improvement followed by worsening.
After they controlled the results to account for various factors, the researchers found that pregnancy appeared to be especially beneficial for skin-related PsA symptoms. The likelihood of improved skin activity during pregnancy rose significantly (odds ratio, 7.7; 95% confidence interval, 1.8-23.5; P = .004) when compared with a matched period among controls, but this was no longer the case during the year after birth (OR, 0.4; 95% CI, 0.2-1.4; P = .60).
The likelihood of improved joint symptoms during pregnancy also rose, but not to a significant extent (OR, 2.1; 95% CI, 0.8-5.1; P = .10), and the effect on joints was not significant in the year after pregnancy (OR, 1.4; 95% CI, 0.5-3.4; P = .50).
There was a declining use of medications among the patients during pregnancy, particularly in the second and third trimesters, but two-thirds of the patients were treated with medications for PsA during this time, including NSAIDs (41%), disease-modifying antirheumatic drugs (35%), and biologic agents (26%).
The researchers speculated that hormonal changes during pregnancy may explain the improvement in skin activity. However, they noted that women with PsA who have multiple pregnancies don’t tend to have the same experiences each time: “Most of the women with more than one pregnancy had different joint disease course during their own different pregnancies and postpartum periods. Accordingly, this suggests that each woman needs specific evaluation and treatment adjustment during each pregnancy.”
The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation. Dr. Polachek is supported by an educational grant from Janssen Canada.
Psoriatic arthritis disease activity tended to improve or stabilize during pregnancy and the first year after giving birth, even outpacing controls, in a small retrospective cohort study.
“The outcome of pregnancy in PsA [psoriatic arthritis] patients is excellent,” investigators from the University of Toronto Psoriatic Arthritis Program reported. They found that “arthritis activity has a favorable course during pregnancy in almost 60% of the pregnancies, while the skin disease shows a favorable course in close to 90% of the pregnancies.”
According to the researchers, led by Ari Polachek, MD, of the Centre for Prognosis Studies in the Rheumatic Diseases at Toronto Western Hospital, previous research has found that rheumatoid arthritis improves in most pregnant women with the condition but then worsens in the year after birth, while most patients with ankylosing spondylitis don’t get better or worse. Limited research suggests psoriasis tends to improve during pregnancy and then flares afterward.
For the new study, researchers tracked 29 pregnant PsA patients with 42 total pregnancies who had a mean age of about 34 years at the beginning of pregnancy and matched them with 67 control patients with PsA who were not pregnant and had an average age of about 35 years. They had all visited the University of Toronto Psoriatic Arthritis Clinic during 1990-2015 (Semin Arthritis Rheum. 2017 Jan 16. doi: 10.1016/j.semarthrit.2017.01.002).
Among the 41 pregnancies in women who began follow-up prior to pregnancy, 13 (32%) had an unfavorable course of disease activity marked by worsening during 8 (20%) of the pregnancies or stable high disease activity during 5 (12%). The course of disease activity was more favorable for 24 (59%) pregnancies, in which it improved in 11 (27%) and stayed stable at a low disease level in 13 (32%). Four pregnancies (10%) had a mixed pattern of improvement followed by worsening.
The 1-year postpartum period during 40 pregnancies showed that stable or worsening symptoms were most common: 8 (20%) had improvement and 13 (32.5%) had stable low disease activity, while another 16 (4%) worsened and 3 (8%) had a mixed course of improvement followed by worsening.
After they controlled the results to account for various factors, the researchers found that pregnancy appeared to be especially beneficial for skin-related PsA symptoms. The likelihood of improved skin activity during pregnancy rose significantly (odds ratio, 7.7; 95% confidence interval, 1.8-23.5; P = .004) when compared with a matched period among controls, but this was no longer the case during the year after birth (OR, 0.4; 95% CI, 0.2-1.4; P = .60).
The likelihood of improved joint symptoms during pregnancy also rose, but not to a significant extent (OR, 2.1; 95% CI, 0.8-5.1; P = .10), and the effect on joints was not significant in the year after pregnancy (OR, 1.4; 95% CI, 0.5-3.4; P = .50).
There was a declining use of medications among the patients during pregnancy, particularly in the second and third trimesters, but two-thirds of the patients were treated with medications for PsA during this time, including NSAIDs (41%), disease-modifying antirheumatic drugs (35%), and biologic agents (26%).
The researchers speculated that hormonal changes during pregnancy may explain the improvement in skin activity. However, they noted that women with PsA who have multiple pregnancies don’t tend to have the same experiences each time: “Most of the women with more than one pregnancy had different joint disease course during their own different pregnancies and postpartum periods. Accordingly, this suggests that each woman needs specific evaluation and treatment adjustment during each pregnancy.”
The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation. Dr. Polachek is supported by an educational grant from Janssen Canada.
Psoriatic arthritis disease activity tended to improve or stabilize during pregnancy and the first year after giving birth, even outpacing controls, in a small retrospective cohort study.
“The outcome of pregnancy in PsA [psoriatic arthritis] patients is excellent,” investigators from the University of Toronto Psoriatic Arthritis Program reported. They found that “arthritis activity has a favorable course during pregnancy in almost 60% of the pregnancies, while the skin disease shows a favorable course in close to 90% of the pregnancies.”
According to the researchers, led by Ari Polachek, MD, of the Centre for Prognosis Studies in the Rheumatic Diseases at Toronto Western Hospital, previous research has found that rheumatoid arthritis improves in most pregnant women with the condition but then worsens in the year after birth, while most patients with ankylosing spondylitis don’t get better or worse. Limited research suggests psoriasis tends to improve during pregnancy and then flares afterward.
For the new study, researchers tracked 29 pregnant PsA patients with 42 total pregnancies who had a mean age of about 34 years at the beginning of pregnancy and matched them with 67 control patients with PsA who were not pregnant and had an average age of about 35 years. They had all visited the University of Toronto Psoriatic Arthritis Clinic during 1990-2015 (Semin Arthritis Rheum. 2017 Jan 16. doi: 10.1016/j.semarthrit.2017.01.002).
Among the 41 pregnancies in women who began follow-up prior to pregnancy, 13 (32%) had an unfavorable course of disease activity marked by worsening during 8 (20%) of the pregnancies or stable high disease activity during 5 (12%). The course of disease activity was more favorable for 24 (59%) pregnancies, in which it improved in 11 (27%) and stayed stable at a low disease level in 13 (32%). Four pregnancies (10%) had a mixed pattern of improvement followed by worsening.
The 1-year postpartum period during 40 pregnancies showed that stable or worsening symptoms were most common: 8 (20%) had improvement and 13 (32.5%) had stable low disease activity, while another 16 (4%) worsened and 3 (8%) had a mixed course of improvement followed by worsening.
After they controlled the results to account for various factors, the researchers found that pregnancy appeared to be especially beneficial for skin-related PsA symptoms. The likelihood of improved skin activity during pregnancy rose significantly (odds ratio, 7.7; 95% confidence interval, 1.8-23.5; P = .004) when compared with a matched period among controls, but this was no longer the case during the year after birth (OR, 0.4; 95% CI, 0.2-1.4; P = .60).
The likelihood of improved joint symptoms during pregnancy also rose, but not to a significant extent (OR, 2.1; 95% CI, 0.8-5.1; P = .10), and the effect on joints was not significant in the year after pregnancy (OR, 1.4; 95% CI, 0.5-3.4; P = .50).
There was a declining use of medications among the patients during pregnancy, particularly in the second and third trimesters, but two-thirds of the patients were treated with medications for PsA during this time, including NSAIDs (41%), disease-modifying antirheumatic drugs (35%), and biologic agents (26%).
The researchers speculated that hormonal changes during pregnancy may explain the improvement in skin activity. However, they noted that women with PsA who have multiple pregnancies don’t tend to have the same experiences each time: “Most of the women with more than one pregnancy had different joint disease course during their own different pregnancies and postpartum periods. Accordingly, this suggests that each woman needs specific evaluation and treatment adjustment during each pregnancy.”
The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation. Dr. Polachek is supported by an educational grant from Janssen Canada.
Key clinical point:
Major finding: PsA symptoms improved in 27% of pregnancies, stabilized at a low level in 32%, and worsened in 20%.
Data source: 29 pregnant PsA patients with 42 total pregnancies and 67 non-pregnant PsA patients.
Disclosures: The University of Toronto Psoriatic Arthritis Program is supported by a grant from the Krembil Foundation. Dr. Polachek is supported by an educational grant from Janssen Canada.
Childhood PCV program produces overall protection
Childhood pneumococcal conjugate vaccines continue to indirectly produce widespread societal protection against invasive pneumococcal disease, a review and meta-analysis showed.
In fact, the reviewed studies suggest that the use of these vaccines in children can lead to an overall 90% drop in invasive pneumococcal disease within fewer than 10 years.
Herd immunity appears to be at work, the review authors said. The effect is so powerful that the findings raise questions about “the merit of offering [the 13-valent pneumococcal vaccine] in older groups” in places that have a children’s pneumococcal conjugate vaccine (PCV) program, the investigators said.
U.S. guidelines recommend vaccinations for older people, although the recommendations are up for review in 2018.
According to the review, childhood PCVs have had a tremendous impact since a seven-valent version (PCV7) was first released in 2000. “In vaccinated young children, disease due to serotypes included in the vaccines has been reduced to negligible levels,” the authors wrote.
But unvaccinated people, especially the elderly, remain susceptible.
The review authors, led by Tinevimbo Shiri, PhD, of the University of Warwick, Coventry, England, updated a 2013 systemic review (Vaccine. 2013 Dec 17;32[1]:133-45). They focused on studies from 1994 to 2016 that examined the effects of introducing PCV in children.
A total of 242 studies were included in the meta-analysis, published in the January issue of Lancet Global Health (2017 Jan;5[1]:e51-e9), including 70 from the previous review. Of these, only 9 (4%) were performed in poor or middle-income countries, with most of the rest having been done in North America (42%) and Europe (38%).
The researchers found that “[herd] immunity effects continued to accumulate over time and reduced disease due to PCV7 serotypes, for which follow-up data have generally been available for the longest period, with a 90% average reduction after about 9 years.”
Specifically, the review estimated it would take 8.9 years for a 90% reduction in invasive pneumococcal disease for grouped serotypes in the PCV7 and 9.5 years for the extra six grouped serotypes in the 13-valent PCV. The latter vaccine was introduced in 2010.
The researchers found evidence of a similar annual reduction in disease linked to grouped serotypes in the 23-valent pneumococcal polysaccharide vaccine in adults aged 19 and up. They noted that the 11 serotypes contained in PPV23 but not in PCV13 “did not change invasive pneumococcal disease at any age.”
The investigators added: “In countries with mature pediatric PCV programmes such as Canada, Germany, the Netherlands, the U.K., and the U.S.A., invasive pneumococcal disease due to PCV7 serotypes has been nearly eliminated through indirect protection - i.e., the average incidence of PCV7-invasive pneumococcal disease after nearly a decade of PCV7 use is less than 10 per 100,000 people. In these countries, consistent decreases in vaccine-type adult community-acquired pneumonia (CAP) or meningitis, and nonbacteraemic CAP, have been observed, indicating substantial indirect protection effects against noninvasive disease from childhood vaccination.”
The review authors noted that a major “evidence gap” in the effectiveness of childhood PCV programs in low-income countries exists. “Because these countries are increasingly undertaking childhood vaccination programs, research to assess the indirect effects in these settings is particularly relevant,” they wrote.
The review’s limitations include the possibility that the results could be thrown off by variations across nations in areas like diagnostic protocols, surveillance, and outcome measures.
The authors of the review, funded by the Policy Research Program of England’s Department of Health, reported no relevant financial disclosures.
The impact of pneumococcal conjugate vaccines has been hampered by serotypes that they don’t address, said David Goldblatt, PhD, MBChB, of the Great Ormond Street Institute of Child Health and University College London, in a commentary accompanying this review and meta-analysis (Lancet Glob Health. 2017 Jan;5[1]:e6-e7).
“Data from this meta-analysis have shown an overall reduction of invasive pneumococcal disease in all unvaccinated age groups of just 1%. … New extended-valency vaccines will be required to halt this erosion of PCV impact,” he wrote.
Dr. Goldblatt reported receiving grants and personal fees from GlaxoSmithKline, Merck, Sharpe, and Dohme and a publication with Pfizer.
The impact of pneumococcal conjugate vaccines has been hampered by serotypes that they don’t address, said David Goldblatt, PhD, MBChB, of the Great Ormond Street Institute of Child Health and University College London, in a commentary accompanying this review and meta-analysis (Lancet Glob Health. 2017 Jan;5[1]:e6-e7).
“Data from this meta-analysis have shown an overall reduction of invasive pneumococcal disease in all unvaccinated age groups of just 1%. … New extended-valency vaccines will be required to halt this erosion of PCV impact,” he wrote.
Dr. Goldblatt reported receiving grants and personal fees from GlaxoSmithKline, Merck, Sharpe, and Dohme and a publication with Pfizer.
The impact of pneumococcal conjugate vaccines has been hampered by serotypes that they don’t address, said David Goldblatt, PhD, MBChB, of the Great Ormond Street Institute of Child Health and University College London, in a commentary accompanying this review and meta-analysis (Lancet Glob Health. 2017 Jan;5[1]:e6-e7).
“Data from this meta-analysis have shown an overall reduction of invasive pneumococcal disease in all unvaccinated age groups of just 1%. … New extended-valency vaccines will be required to halt this erosion of PCV impact,” he wrote.
Dr. Goldblatt reported receiving grants and personal fees from GlaxoSmithKline, Merck, Sharpe, and Dohme and a publication with Pfizer.
Childhood pneumococcal conjugate vaccines continue to indirectly produce widespread societal protection against invasive pneumococcal disease, a review and meta-analysis showed.
In fact, the reviewed studies suggest that the use of these vaccines in children can lead to an overall 90% drop in invasive pneumococcal disease within fewer than 10 years.
Herd immunity appears to be at work, the review authors said. The effect is so powerful that the findings raise questions about “the merit of offering [the 13-valent pneumococcal vaccine] in older groups” in places that have a children’s pneumococcal conjugate vaccine (PCV) program, the investigators said.
U.S. guidelines recommend vaccinations for older people, although the recommendations are up for review in 2018.
According to the review, childhood PCVs have had a tremendous impact since a seven-valent version (PCV7) was first released in 2000. “In vaccinated young children, disease due to serotypes included in the vaccines has been reduced to negligible levels,” the authors wrote.
But unvaccinated people, especially the elderly, remain susceptible.
The review authors, led by Tinevimbo Shiri, PhD, of the University of Warwick, Coventry, England, updated a 2013 systemic review (Vaccine. 2013 Dec 17;32[1]:133-45). They focused on studies from 1994 to 2016 that examined the effects of introducing PCV in children.
A total of 242 studies were included in the meta-analysis, published in the January issue of Lancet Global Health (2017 Jan;5[1]:e51-e9), including 70 from the previous review. Of these, only 9 (4%) were performed in poor or middle-income countries, with most of the rest having been done in North America (42%) and Europe (38%).
The researchers found that “[herd] immunity effects continued to accumulate over time and reduced disease due to PCV7 serotypes, for which follow-up data have generally been available for the longest period, with a 90% average reduction after about 9 years.”
Specifically, the review estimated it would take 8.9 years for a 90% reduction in invasive pneumococcal disease for grouped serotypes in the PCV7 and 9.5 years for the extra six grouped serotypes in the 13-valent PCV. The latter vaccine was introduced in 2010.
The researchers found evidence of a similar annual reduction in disease linked to grouped serotypes in the 23-valent pneumococcal polysaccharide vaccine in adults aged 19 and up. They noted that the 11 serotypes contained in PPV23 but not in PCV13 “did not change invasive pneumococcal disease at any age.”
The investigators added: “In countries with mature pediatric PCV programmes such as Canada, Germany, the Netherlands, the U.K., and the U.S.A., invasive pneumococcal disease due to PCV7 serotypes has been nearly eliminated through indirect protection - i.e., the average incidence of PCV7-invasive pneumococcal disease after nearly a decade of PCV7 use is less than 10 per 100,000 people. In these countries, consistent decreases in vaccine-type adult community-acquired pneumonia (CAP) or meningitis, and nonbacteraemic CAP, have been observed, indicating substantial indirect protection effects against noninvasive disease from childhood vaccination.”
The review authors noted that a major “evidence gap” in the effectiveness of childhood PCV programs in low-income countries exists. “Because these countries are increasingly undertaking childhood vaccination programs, research to assess the indirect effects in these settings is particularly relevant,” they wrote.
The review’s limitations include the possibility that the results could be thrown off by variations across nations in areas like diagnostic protocols, surveillance, and outcome measures.
The authors of the review, funded by the Policy Research Program of England’s Department of Health, reported no relevant financial disclosures.
Childhood pneumococcal conjugate vaccines continue to indirectly produce widespread societal protection against invasive pneumococcal disease, a review and meta-analysis showed.
In fact, the reviewed studies suggest that the use of these vaccines in children can lead to an overall 90% drop in invasive pneumococcal disease within fewer than 10 years.
Herd immunity appears to be at work, the review authors said. The effect is so powerful that the findings raise questions about “the merit of offering [the 13-valent pneumococcal vaccine] in older groups” in places that have a children’s pneumococcal conjugate vaccine (PCV) program, the investigators said.
U.S. guidelines recommend vaccinations for older people, although the recommendations are up for review in 2018.
According to the review, childhood PCVs have had a tremendous impact since a seven-valent version (PCV7) was first released in 2000. “In vaccinated young children, disease due to serotypes included in the vaccines has been reduced to negligible levels,” the authors wrote.
But unvaccinated people, especially the elderly, remain susceptible.
The review authors, led by Tinevimbo Shiri, PhD, of the University of Warwick, Coventry, England, updated a 2013 systemic review (Vaccine. 2013 Dec 17;32[1]:133-45). They focused on studies from 1994 to 2016 that examined the effects of introducing PCV in children.
A total of 242 studies were included in the meta-analysis, published in the January issue of Lancet Global Health (2017 Jan;5[1]:e51-e9), including 70 from the previous review. Of these, only 9 (4%) were performed in poor or middle-income countries, with most of the rest having been done in North America (42%) and Europe (38%).
The researchers found that “[herd] immunity effects continued to accumulate over time and reduced disease due to PCV7 serotypes, for which follow-up data have generally been available for the longest period, with a 90% average reduction after about 9 years.”
Specifically, the review estimated it would take 8.9 years for a 90% reduction in invasive pneumococcal disease for grouped serotypes in the PCV7 and 9.5 years for the extra six grouped serotypes in the 13-valent PCV. The latter vaccine was introduced in 2010.
The researchers found evidence of a similar annual reduction in disease linked to grouped serotypes in the 23-valent pneumococcal polysaccharide vaccine in adults aged 19 and up. They noted that the 11 serotypes contained in PPV23 but not in PCV13 “did not change invasive pneumococcal disease at any age.”
The investigators added: “In countries with mature pediatric PCV programmes such as Canada, Germany, the Netherlands, the U.K., and the U.S.A., invasive pneumococcal disease due to PCV7 serotypes has been nearly eliminated through indirect protection - i.e., the average incidence of PCV7-invasive pneumococcal disease after nearly a decade of PCV7 use is less than 10 per 100,000 people. In these countries, consistent decreases in vaccine-type adult community-acquired pneumonia (CAP) or meningitis, and nonbacteraemic CAP, have been observed, indicating substantial indirect protection effects against noninvasive disease from childhood vaccination.”
The review authors noted that a major “evidence gap” in the effectiveness of childhood PCV programs in low-income countries exists. “Because these countries are increasingly undertaking childhood vaccination programs, research to assess the indirect effects in these settings is particularly relevant,” they wrote.
The review’s limitations include the possibility that the results could be thrown off by variations across nations in areas like diagnostic protocols, surveillance, and outcome measures.
The authors of the review, funded by the Policy Research Program of England’s Department of Health, reported no relevant financial disclosures.
FROM THE LANCET GLOBAL HEALTH
Key clinical point: Through apparent herd immunity, childhood pneumococcal conjugate vaccines produce societywide reductions in invasive pneumococcal disease in less than a decade.
Major finding: When a seven-valent PCV is given to children, it would take an estimated 8.9 years for a 90% reduction in invasive pneumococcal disease to be seen among the grouped serotypes. It would take an estimated 9.5 years for an identical reduction in the extra six grouped serotypes in the 13-valent PCV.
Data source: A review and meta-analysis of 242 studies from 1994 to 2016 that examined the effects of introducing PCVs in children.
Disclosures: The review authors reported no relevant financial disclosures.
Macitentan boosts quality of life in PAH patients
Macitentan, a recent addition to the drugs that treat pulmonary arterial hypertension (PAH), improves and stabilizes quality of life for patients with the condition, according to an industry-funded study.
Macitentan (Opsumit) remains tremendously expensive, costing as much as $100,000 per year in the United States, and the study provides little in the way of direct comparison to other drugs in its class. Still, the drug’s effects on quality of life are dramatic, said study lead author Sanjay Mehta, MD, FRCPC, FCCP, professor of medicine at the University of Western Ontario and director of the Southwest Ontario Pulmonary Hypertension Clinic at the London Health Sciences Center in London, Ont.
Researchers found that those who took the 10-mg dose, versus placebo, reported significant improvement in seven of eight quality-of-life domains, and in physical and mental components scores, as measured by the 36-item Short Form Health Survey (SF-36). In addition, the study linked 10-mg doses, versus placebo, to a lower risk of a decline of three points or more in the physical component score (hazard ratio [HR], 0.60; 95% CI, 0.47-0.76; P less than .0001] and the mental component scores (HR, 0.76; 95% CI, 0.61-0.95; P = .0173) until end of treatment.
“The drug has shown stability in patients’ quality of life over 6 months and 12 months,” Dr. Mehta said in an interview. “I can’t cure anybody, and they’ll get worse at some point, but I can improve them. They physically feel better, they’re less short of breath with less body pain, and they feel better psychologically.”
Macitentan, an endothelin receptor antagonist, received Food and Drug Administration approval in 2013 following a study that year (N Engl J Med. 2013 Aug 29;369[9]:809-18) that linked 10-mg doses to a significantly lower risk of death and various complications, compared with placebo and the 3-mg dose. The new study (Chest. 2017 Jan;151[1]:106-18), is an analysis of data from the 2013 study.
The PAH patients were randomly assigned to one of three groups: macitentan 10 mg once daily (234), macitentan 3 mg (237), and placebo (239). The study examined responses from 710 patients (76.9% were female, 55.2% were white, mean age was 45.5) to the SF-36 at baseline, 6 months, 12 months, and end of treatment.
Dr. Mehta noted that macitentan has not been clinically compared to the other drugs. The study, however, notes that it is the first PAH treatment to show improvement in seven of eight domains in the quality-of-life survey.
The new study was funded by Actelion Pharmaceuticals, maker of macitentan. Dr. Mehta has received consulting and speaking fees and institutional support for clinical trials from Actelion, among other drug companies. The other authors report various disclosures, including relationships with Actelion.
Macitentan, a recent addition to the drugs that treat pulmonary arterial hypertension (PAH), improves and stabilizes quality of life for patients with the condition, according to an industry-funded study.
Macitentan (Opsumit) remains tremendously expensive, costing as much as $100,000 per year in the United States, and the study provides little in the way of direct comparison to other drugs in its class. Still, the drug’s effects on quality of life are dramatic, said study lead author Sanjay Mehta, MD, FRCPC, FCCP, professor of medicine at the University of Western Ontario and director of the Southwest Ontario Pulmonary Hypertension Clinic at the London Health Sciences Center in London, Ont.
Researchers found that those who took the 10-mg dose, versus placebo, reported significant improvement in seven of eight quality-of-life domains, and in physical and mental components scores, as measured by the 36-item Short Form Health Survey (SF-36). In addition, the study linked 10-mg doses, versus placebo, to a lower risk of a decline of three points or more in the physical component score (hazard ratio [HR], 0.60; 95% CI, 0.47-0.76; P less than .0001] and the mental component scores (HR, 0.76; 95% CI, 0.61-0.95; P = .0173) until end of treatment.
“The drug has shown stability in patients’ quality of life over 6 months and 12 months,” Dr. Mehta said in an interview. “I can’t cure anybody, and they’ll get worse at some point, but I can improve them. They physically feel better, they’re less short of breath with less body pain, and they feel better psychologically.”
Macitentan, an endothelin receptor antagonist, received Food and Drug Administration approval in 2013 following a study that year (N Engl J Med. 2013 Aug 29;369[9]:809-18) that linked 10-mg doses to a significantly lower risk of death and various complications, compared with placebo and the 3-mg dose. The new study (Chest. 2017 Jan;151[1]:106-18), is an analysis of data from the 2013 study.
The PAH patients were randomly assigned to one of three groups: macitentan 10 mg once daily (234), macitentan 3 mg (237), and placebo (239). The study examined responses from 710 patients (76.9% were female, 55.2% were white, mean age was 45.5) to the SF-36 at baseline, 6 months, 12 months, and end of treatment.
Dr. Mehta noted that macitentan has not been clinically compared to the other drugs. The study, however, notes that it is the first PAH treatment to show improvement in seven of eight domains in the quality-of-life survey.
The new study was funded by Actelion Pharmaceuticals, maker of macitentan. Dr. Mehta has received consulting and speaking fees and institutional support for clinical trials from Actelion, among other drug companies. The other authors report various disclosures, including relationships with Actelion.
Macitentan, a recent addition to the drugs that treat pulmonary arterial hypertension (PAH), improves and stabilizes quality of life for patients with the condition, according to an industry-funded study.
Macitentan (Opsumit) remains tremendously expensive, costing as much as $100,000 per year in the United States, and the study provides little in the way of direct comparison to other drugs in its class. Still, the drug’s effects on quality of life are dramatic, said study lead author Sanjay Mehta, MD, FRCPC, FCCP, professor of medicine at the University of Western Ontario and director of the Southwest Ontario Pulmonary Hypertension Clinic at the London Health Sciences Center in London, Ont.
Researchers found that those who took the 10-mg dose, versus placebo, reported significant improvement in seven of eight quality-of-life domains, and in physical and mental components scores, as measured by the 36-item Short Form Health Survey (SF-36). In addition, the study linked 10-mg doses, versus placebo, to a lower risk of a decline of three points or more in the physical component score (hazard ratio [HR], 0.60; 95% CI, 0.47-0.76; P less than .0001] and the mental component scores (HR, 0.76; 95% CI, 0.61-0.95; P = .0173) until end of treatment.
“The drug has shown stability in patients’ quality of life over 6 months and 12 months,” Dr. Mehta said in an interview. “I can’t cure anybody, and they’ll get worse at some point, but I can improve them. They physically feel better, they’re less short of breath with less body pain, and they feel better psychologically.”
Macitentan, an endothelin receptor antagonist, received Food and Drug Administration approval in 2013 following a study that year (N Engl J Med. 2013 Aug 29;369[9]:809-18) that linked 10-mg doses to a significantly lower risk of death and various complications, compared with placebo and the 3-mg dose. The new study (Chest. 2017 Jan;151[1]:106-18), is an analysis of data from the 2013 study.
The PAH patients were randomly assigned to one of three groups: macitentan 10 mg once daily (234), macitentan 3 mg (237), and placebo (239). The study examined responses from 710 patients (76.9% were female, 55.2% were white, mean age was 45.5) to the SF-36 at baseline, 6 months, 12 months, and end of treatment.
Dr. Mehta noted that macitentan has not been clinically compared to the other drugs. The study, however, notes that it is the first PAH treatment to show improvement in seven of eight domains in the quality-of-life survey.
The new study was funded by Actelion Pharmaceuticals, maker of macitentan. Dr. Mehta has received consulting and speaking fees and institutional support for clinical trials from Actelion, among other drug companies. The other authors report various disclosures, including relationships with Actelion.
FROM CHEST
Key clinical point: Macitentan improves and stabilizes quality of life in patients with pulmonary arterial hypertension.
Major finding: Patients who took 10 mg daily macitentan improved in seven of eight quality-of-life domains and in combined physical and mental health measures.
Data source: Multicenter, double-blind, placebo-controlled, randomized phase III study of 710 patients (76.9% female, 55.2% white, mean age 45.5) assigned to placebo, macitentan 3 mg, or macitentan 10 mg once daily.
Disclosures: Actelion Pharmaceuticals, maker of macitentan, funded the study. The authors disclosed ties with Actelion.
Endocrinologists report little training in transgender care
Although endocrinologists are often the go-to specialists for hormone therapy, more than 80% of those surveyed had no training in how to treat transgender patients, a study showed.
Meanwhile, more than a quarter of endocrinology fellowship directors surveyed said their programs don’t offer education in transgender care.
According to a June 2016 report by the Williams Institute at the University of California, Los Angeles, an estimated 0.58% of adults in the United States identify as transgender, with numbers reaching as high as 2.77% in Washington, D.C., 0.78% in Hawaii, 0.76% in California, and 0.75% in New Mexico and Georgia.
Endocrinologists are especially likely to see transgender patients in order to assist with hormone therapy. Of course, they also see them for general endocrinology needs, said lead study author Caroline Davidge-Pitts, MBBCh, of the Mayo Clinic’s department of endocrinology in Rochester, Minn.
For the current study of transgender care, “we wanted to assess what the current knowledge and practice is among practicing physicians as well as the state of education for our endocrinology fellows,” she said in an interview.
Dr. Davidge-Pitts and her colleagues sent an anonymous Internet survey to 104 endocrinology fellowship program directors (PDs) and 6,992 physician members of the Endocrine Society in the United States. Fifty-four of the program directors responded (51.9%), as did 411 of the clinicians (5.9%) (J Clin Endocrinol Metab. 2017 Jan 10. doi: 10.1210/jc.2016-3007).
The program directors represent 54 programs, of which 35 (72.2%) provide instruction regarding transgender care. All offer instruction about hormone therapy in this context.
Almost 94% of the program directors described education about transgender care as important. Forty-two respondents said challenges to better education regarding transgender care include lack of faculty interest or experience (59.5%), lack of resources for training (47.6%), and lack of money (40.5%).
Of 46 respondents, 91% said online training modules for students would be helpful; 71.7% pointed to modules for professors, and 71.7% mentioned lectures from visiting faculty.
Among clinicians, 79.8% said they had ever treated a transgender patient, and 55% reported treating more than five transgender patients a year. But 80.6% of 382 responders said they’d never had training in the treatment of these patients.
Most of the responding endocrinologists said they felt confident regarding definitions, taking a history, and prescribing hormones, but 42.4% or less felt that way about sex change operations, organ-specific screening guidelines, and psychosocial/legal issues.
Dr. Davidge-Pitts said the study indicates more education in transgender care is needed in fellowship programs: “We envision a more structured approach ... with an introductory curriculum in the first year of fellowship aligned to specific competencies, followed by a more advanced curriculum in the second or third year.”
Overall, “we need to allocate resources to develop online training modules to help our endocrine fellows and practitioners too, to give them the ability to get education in their office,” Dr. Davidge-Pitts said.
As for the clinical setting, the study supports changes to make transgender patients more comfortable, such as gender-neutral restrooms and training for staff about how to treat transgender patients with respect, she said.
Dr. Safer, medical director of the center for transgender medicine and surgery at Boston University and Boston Medical Center, said things have changed since he graduated from medical school in 1990. “I didn’t even hear the word transgender in medical school, residency, or fellowship,” he said, “and I don’t think much changed in the next 10-20 years.”
Now, there’s more focus on treating these patients sensitively, but “they still don’t still teach the underlying medicine, so the physicians are still not equipped with the basic knowledge they need to take care of the patients,” Dr. Safer said.
He suggested that endocrinologists who are interested in learning more about transgender care get in touch with the World Professional Association for Transgender Health at wpath.org.
Although endocrinologists are often the go-to specialists for hormone therapy, more than 80% of those surveyed had no training in how to treat transgender patients, a study showed.
Meanwhile, more than a quarter of endocrinology fellowship directors surveyed said their programs don’t offer education in transgender care.
According to a June 2016 report by the Williams Institute at the University of California, Los Angeles, an estimated 0.58% of adults in the United States identify as transgender, with numbers reaching as high as 2.77% in Washington, D.C., 0.78% in Hawaii, 0.76% in California, and 0.75% in New Mexico and Georgia.
Endocrinologists are especially likely to see transgender patients in order to assist with hormone therapy. Of course, they also see them for general endocrinology needs, said lead study author Caroline Davidge-Pitts, MBBCh, of the Mayo Clinic’s department of endocrinology in Rochester, Minn.
For the current study of transgender care, “we wanted to assess what the current knowledge and practice is among practicing physicians as well as the state of education for our endocrinology fellows,” she said in an interview.
Dr. Davidge-Pitts and her colleagues sent an anonymous Internet survey to 104 endocrinology fellowship program directors (PDs) and 6,992 physician members of the Endocrine Society in the United States. Fifty-four of the program directors responded (51.9%), as did 411 of the clinicians (5.9%) (J Clin Endocrinol Metab. 2017 Jan 10. doi: 10.1210/jc.2016-3007).
The program directors represent 54 programs, of which 35 (72.2%) provide instruction regarding transgender care. All offer instruction about hormone therapy in this context.
Almost 94% of the program directors described education about transgender care as important. Forty-two respondents said challenges to better education regarding transgender care include lack of faculty interest or experience (59.5%), lack of resources for training (47.6%), and lack of money (40.5%).
Of 46 respondents, 91% said online training modules for students would be helpful; 71.7% pointed to modules for professors, and 71.7% mentioned lectures from visiting faculty.
Among clinicians, 79.8% said they had ever treated a transgender patient, and 55% reported treating more than five transgender patients a year. But 80.6% of 382 responders said they’d never had training in the treatment of these patients.
Most of the responding endocrinologists said they felt confident regarding definitions, taking a history, and prescribing hormones, but 42.4% or less felt that way about sex change operations, organ-specific screening guidelines, and psychosocial/legal issues.
Dr. Davidge-Pitts said the study indicates more education in transgender care is needed in fellowship programs: “We envision a more structured approach ... with an introductory curriculum in the first year of fellowship aligned to specific competencies, followed by a more advanced curriculum in the second or third year.”
Overall, “we need to allocate resources to develop online training modules to help our endocrine fellows and practitioners too, to give them the ability to get education in their office,” Dr. Davidge-Pitts said.
As for the clinical setting, the study supports changes to make transgender patients more comfortable, such as gender-neutral restrooms and training for staff about how to treat transgender patients with respect, she said.
Dr. Safer, medical director of the center for transgender medicine and surgery at Boston University and Boston Medical Center, said things have changed since he graduated from medical school in 1990. “I didn’t even hear the word transgender in medical school, residency, or fellowship,” he said, “and I don’t think much changed in the next 10-20 years.”
Now, there’s more focus on treating these patients sensitively, but “they still don’t still teach the underlying medicine, so the physicians are still not equipped with the basic knowledge they need to take care of the patients,” Dr. Safer said.
He suggested that endocrinologists who are interested in learning more about transgender care get in touch with the World Professional Association for Transgender Health at wpath.org.
Although endocrinologists are often the go-to specialists for hormone therapy, more than 80% of those surveyed had no training in how to treat transgender patients, a study showed.
Meanwhile, more than a quarter of endocrinology fellowship directors surveyed said their programs don’t offer education in transgender care.
According to a June 2016 report by the Williams Institute at the University of California, Los Angeles, an estimated 0.58% of adults in the United States identify as transgender, with numbers reaching as high as 2.77% in Washington, D.C., 0.78% in Hawaii, 0.76% in California, and 0.75% in New Mexico and Georgia.
Endocrinologists are especially likely to see transgender patients in order to assist with hormone therapy. Of course, they also see them for general endocrinology needs, said lead study author Caroline Davidge-Pitts, MBBCh, of the Mayo Clinic’s department of endocrinology in Rochester, Minn.
For the current study of transgender care, “we wanted to assess what the current knowledge and practice is among practicing physicians as well as the state of education for our endocrinology fellows,” she said in an interview.
Dr. Davidge-Pitts and her colleagues sent an anonymous Internet survey to 104 endocrinology fellowship program directors (PDs) and 6,992 physician members of the Endocrine Society in the United States. Fifty-four of the program directors responded (51.9%), as did 411 of the clinicians (5.9%) (J Clin Endocrinol Metab. 2017 Jan 10. doi: 10.1210/jc.2016-3007).
The program directors represent 54 programs, of which 35 (72.2%) provide instruction regarding transgender care. All offer instruction about hormone therapy in this context.
Almost 94% of the program directors described education about transgender care as important. Forty-two respondents said challenges to better education regarding transgender care include lack of faculty interest or experience (59.5%), lack of resources for training (47.6%), and lack of money (40.5%).
Of 46 respondents, 91% said online training modules for students would be helpful; 71.7% pointed to modules for professors, and 71.7% mentioned lectures from visiting faculty.
Among clinicians, 79.8% said they had ever treated a transgender patient, and 55% reported treating more than five transgender patients a year. But 80.6% of 382 responders said they’d never had training in the treatment of these patients.
Most of the responding endocrinologists said they felt confident regarding definitions, taking a history, and prescribing hormones, but 42.4% or less felt that way about sex change operations, organ-specific screening guidelines, and psychosocial/legal issues.
Dr. Davidge-Pitts said the study indicates more education in transgender care is needed in fellowship programs: “We envision a more structured approach ... with an introductory curriculum in the first year of fellowship aligned to specific competencies, followed by a more advanced curriculum in the second or third year.”
Overall, “we need to allocate resources to develop online training modules to help our endocrine fellows and practitioners too, to give them the ability to get education in their office,” Dr. Davidge-Pitts said.
As for the clinical setting, the study supports changes to make transgender patients more comfortable, such as gender-neutral restrooms and training for staff about how to treat transgender patients with respect, she said.
Dr. Safer, medical director of the center for transgender medicine and surgery at Boston University and Boston Medical Center, said things have changed since he graduated from medical school in 1990. “I didn’t even hear the word transgender in medical school, residency, or fellowship,” he said, “and I don’t think much changed in the next 10-20 years.”
Now, there’s more focus on treating these patients sensitively, but “they still don’t still teach the underlying medicine, so the physicians are still not equipped with the basic knowledge they need to take care of the patients,” Dr. Safer said.
He suggested that endocrinologists who are interested in learning more about transgender care get in touch with the World Professional Association for Transgender Health at wpath.org.
FROM THE JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM
Key clinical point:
Major finding: Of endocrinologists surveyed, 80.6% said they’d never received training in transgender care, while 72.2% of fellowship program directors reported offering instruction in how to treat these patients.
Data source: Responses to surveys from 54 endocrinology fellowship program directors and 411 clinical endocrinologists.
Disclosures: The study authors reported no relevant financial disclosures.
Four-part ‘safety bundle’ targets gynecologic surgery infections
In a new consensus safety bundle designed to reduce the frequency of infections related to gynecologic surgery, an expert panel is calling for preoperative evaluation of infection risk in every patient and surgical timeouts in every case.
The bundle, from the Council on Patient Safety in Women & Mother’s Health Care, seeks to compile existing guidelines and evidence-based recommendations in a way that can be easily implemented with whatever resources an individual institution has available.
The safety bundle covers four domains:
1. Readiness (every facility). The statement calls for standardized preoperative and postoperative care instructions and clearly defined roles for each surgical team member.
Standards should also be established regarding skin preparation, use of prophylactic antibiotics (terminate them within 24 hours after surgery completion unless medical indications are present), and temperature, such as ambient operating room temperature.
“Although the effect of temperature maintenance on surgical site infection is not definitive,” the consensus statement says, “there is no denying other benefits of normothermia; foremost among these is overall patient satisfaction and comfort.”
2. Recognition and prevention (every patient). Every patient should undergo a preoperative evaluation of infection risk based on blood glucose level, body mass index, immunodeficiency, methicillin-resistant Staphylococcus aureus (MRSA) status, nutritional status, and smoking status.
3. Response (every case). Develop “timeouts” during operations, as mandated by the Joint Commission, to address antibiotic dosage and timing, and reassess risk for infection following the procedure based on the length of surgery and blood loss.
4. Reporting and systems learning (every facility). Develop “huddles” – brief team meetings of less than 15 minutes – for high-risk patients. Surgeons and hospital officials should also create a system to report and analyze data about surgical site infections and share physician-specific infection data with all surgeons as part of ongoing professional practice evaluation.
The statement appeared in Obstetrics & Gynecology (2017;129:50-61) and was published concurrently in Anesthesia & Analgesia, the Journal of Obstetric, Gynecologic & Neonatal Nursing, and the AANA Journal.
The authors reported having no potential conflicts of interest.
In a new consensus safety bundle designed to reduce the frequency of infections related to gynecologic surgery, an expert panel is calling for preoperative evaluation of infection risk in every patient and surgical timeouts in every case.
The bundle, from the Council on Patient Safety in Women & Mother’s Health Care, seeks to compile existing guidelines and evidence-based recommendations in a way that can be easily implemented with whatever resources an individual institution has available.
The safety bundle covers four domains:
1. Readiness (every facility). The statement calls for standardized preoperative and postoperative care instructions and clearly defined roles for each surgical team member.
Standards should also be established regarding skin preparation, use of prophylactic antibiotics (terminate them within 24 hours after surgery completion unless medical indications are present), and temperature, such as ambient operating room temperature.
“Although the effect of temperature maintenance on surgical site infection is not definitive,” the consensus statement says, “there is no denying other benefits of normothermia; foremost among these is overall patient satisfaction and comfort.”
2. Recognition and prevention (every patient). Every patient should undergo a preoperative evaluation of infection risk based on blood glucose level, body mass index, immunodeficiency, methicillin-resistant Staphylococcus aureus (MRSA) status, nutritional status, and smoking status.
3. Response (every case). Develop “timeouts” during operations, as mandated by the Joint Commission, to address antibiotic dosage and timing, and reassess risk for infection following the procedure based on the length of surgery and blood loss.
4. Reporting and systems learning (every facility). Develop “huddles” – brief team meetings of less than 15 minutes – for high-risk patients. Surgeons and hospital officials should also create a system to report and analyze data about surgical site infections and share physician-specific infection data with all surgeons as part of ongoing professional practice evaluation.
The statement appeared in Obstetrics & Gynecology (2017;129:50-61) and was published concurrently in Anesthesia & Analgesia, the Journal of Obstetric, Gynecologic & Neonatal Nursing, and the AANA Journal.
The authors reported having no potential conflicts of interest.
In a new consensus safety bundle designed to reduce the frequency of infections related to gynecologic surgery, an expert panel is calling for preoperative evaluation of infection risk in every patient and surgical timeouts in every case.
The bundle, from the Council on Patient Safety in Women & Mother’s Health Care, seeks to compile existing guidelines and evidence-based recommendations in a way that can be easily implemented with whatever resources an individual institution has available.
The safety bundle covers four domains:
1. Readiness (every facility). The statement calls for standardized preoperative and postoperative care instructions and clearly defined roles for each surgical team member.
Standards should also be established regarding skin preparation, use of prophylactic antibiotics (terminate them within 24 hours after surgery completion unless medical indications are present), and temperature, such as ambient operating room temperature.
“Although the effect of temperature maintenance on surgical site infection is not definitive,” the consensus statement says, “there is no denying other benefits of normothermia; foremost among these is overall patient satisfaction and comfort.”
2. Recognition and prevention (every patient). Every patient should undergo a preoperative evaluation of infection risk based on blood glucose level, body mass index, immunodeficiency, methicillin-resistant Staphylococcus aureus (MRSA) status, nutritional status, and smoking status.
3. Response (every case). Develop “timeouts” during operations, as mandated by the Joint Commission, to address antibiotic dosage and timing, and reassess risk for infection following the procedure based on the length of surgery and blood loss.
4. Reporting and systems learning (every facility). Develop “huddles” – brief team meetings of less than 15 minutes – for high-risk patients. Surgeons and hospital officials should also create a system to report and analyze data about surgical site infections and share physician-specific infection data with all surgeons as part of ongoing professional practice evaluation.
The statement appeared in Obstetrics & Gynecology (2017;129:50-61) and was published concurrently in Anesthesia & Analgesia, the Journal of Obstetric, Gynecologic & Neonatal Nursing, and the AANA Journal.
The authors reported having no potential conflicts of interest.
FROM OBSTETRICS & GYNECOLOGY
Prescribing the landmark hemangioma drug: The challenges and the benefits
For Beth Drolet, MD, a pediatric dermatologist in Wisconsin, the tremendous impact oral propranolol has had on the treatment of severe infantile hemangioma is written on the faces of children diagnosed with the condition in recent years.
“You can tell which drugs the kids were on by their age,” said Dr. Drolet, professor of dermatology and pediatrics at the Medical College of Wisconsin, Milwaukee. “If they were born before 2008, before we used this medication, those kids have had multiple surgeries and are still not looking that good. But we rarely see that in the kids born after.”
Still, it is possible for dermatologists to successfully treat their smallest patients with oral propranolol, according to Dr. Drolet and Ilona J. Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco.
In interviews, the two pediatric dermatologists spoke about the challenges and benefits of treating hemangioma patients with oral propranolol solution, which was approved by the Food and Drug Administration in 2014 for “proliferating infantile hemangioma requiring systemic therapy.” It is the only FDA-approved systemic treatment for this indication.
The oral form of the drug was used off label to treat patients with hemangioma after a French dermatologist discovered in 2007 that it could effectively treat the condition. A topical form of propranolol is also used for hemangiomas that do not require systemic treatment.
Prior to about a decade ago, Dr. Drolet said, steroids were used to treat severe hemangiomas with limited success.
In general, infantile hemangiomas “have a natural course of gradually involuting even without treatment,” Dr. Frieden noted. But the most severe cases can produce functional impairment, scarring, and anatomic distortion.
Dr. Drolet said she considers treatment if hemangioma threatens a vital function (hearing, sight, breathing) or can lead to pain, infection, or scarring.
One challenge for dermatologists is that standard of care treatment with oral propranolol requires in-office cardiac monitoring, especially as the dose is increased over the first week or two of treatment.
“I don’t think most dermatologists are comfortable taking a heart rate and blood pressure in an infant,” said Dr. Drolet, who is director of the birthmarks and vascular anomalies section at Children’s Hospital of Wisconsin, Milwaukee. Instead, they tend to refer patients to a pediatrician or pediatric cardiologist.
Her clinic hired a cardiac nurse to train the staff in how to take heart rate and blood pressure in babies. “Partnering with cardiology was really important for us,” she commented. “We worked really closely with our pediatric cardiology team to gain that expertise for our staff to assess that. You have to be pretty comfortable with it. If you’re not, you’re going to have to find someone else.”
Another option for dermatologists, Dr. Frieden said, is to focus on heart rate alone since blood pressure in infants is difficult to measure. “It’s not FDA sanctioned, but many people seem to do that and it’s OK,” she said.
Dr. Frieden and Dr. Drolet provided the following recommendations about treating babies with oral propranolol:
• Caution parents about side effects. Cardiac side effects have been “extraordinarily rare,” Dr. Drolet said. “We have seen problems with wheezing and, very rarely, severe hypoglycemia,” which can be prevented by educating the family. While it’s uncommon for the medication alone to produce wheezing, this may occur when a respiratory infection and propranolol combine to stress the body, she noted.
In some cases, physicians prescribe albuterol for wheezing without realizing that it will interact with propranolol, she added. “One is a beta-blocker, and the other is a beta-antagonist. They completely cancel each other out.”
To prevent hypoglycemia, Dr. Frieden said she recommends that children be fed every 6 hours if they’re under 6 months old or every 8 hours if they’re over 6 months of age. And Dr. Drolet said she advises parents to stop propranolol when their infants are sick.
A major focus of an educational video provided by Dr. Drolet’s clinic is advising parents “to stop the medication if the infant is not eating regularly, vomiting, or has diarrhea. It interferes with how you respond to low blood sugar if you’re not eating,” she said. “That surprised us. Now that we’ve been teaching parents about when to call us, that’s been pretty preventable.”
Minor side effects include cold hands and feet and sleep disturbances such as sleepiness and apparent nightmares, Dr. Frieden pointed out.
• Monitor guidelines regarding safety and protocols. “Over time, we’re getting more and more expertise,” Dr. Drolet said. For example, her clinic no longer performs ECGs on babies who take the medication because research has suggested they are not needed.
• Spend time developing an education program for parents. Dr. Drolet’s clinic provides the educational video to teach parents about how oral propranolol is used. “We haven’t done that for any other drugs,” she said. “But we want to make sure we aren’t overdosing it. We’ve been very careful about our parent education to prevent that.”
Guidelines on the diagnosis and management of infantile hemangioma were published in 2015 in Pediatrics (2015 Oct;136[4]:e1060-104).
Dr. Frieden has consulted for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product, marketed as Hemangeol. Dr. Drolet has received an investigator-initiated grant from the company.
For Beth Drolet, MD, a pediatric dermatologist in Wisconsin, the tremendous impact oral propranolol has had on the treatment of severe infantile hemangioma is written on the faces of children diagnosed with the condition in recent years.
“You can tell which drugs the kids were on by their age,” said Dr. Drolet, professor of dermatology and pediatrics at the Medical College of Wisconsin, Milwaukee. “If they were born before 2008, before we used this medication, those kids have had multiple surgeries and are still not looking that good. But we rarely see that in the kids born after.”
Still, it is possible for dermatologists to successfully treat their smallest patients with oral propranolol, according to Dr. Drolet and Ilona J. Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco.
In interviews, the two pediatric dermatologists spoke about the challenges and benefits of treating hemangioma patients with oral propranolol solution, which was approved by the Food and Drug Administration in 2014 for “proliferating infantile hemangioma requiring systemic therapy.” It is the only FDA-approved systemic treatment for this indication.
The oral form of the drug was used off label to treat patients with hemangioma after a French dermatologist discovered in 2007 that it could effectively treat the condition. A topical form of propranolol is also used for hemangiomas that do not require systemic treatment.
Prior to about a decade ago, Dr. Drolet said, steroids were used to treat severe hemangiomas with limited success.
In general, infantile hemangiomas “have a natural course of gradually involuting even without treatment,” Dr. Frieden noted. But the most severe cases can produce functional impairment, scarring, and anatomic distortion.
Dr. Drolet said she considers treatment if hemangioma threatens a vital function (hearing, sight, breathing) or can lead to pain, infection, or scarring.
One challenge for dermatologists is that standard of care treatment with oral propranolol requires in-office cardiac monitoring, especially as the dose is increased over the first week or two of treatment.
“I don’t think most dermatologists are comfortable taking a heart rate and blood pressure in an infant,” said Dr. Drolet, who is director of the birthmarks and vascular anomalies section at Children’s Hospital of Wisconsin, Milwaukee. Instead, they tend to refer patients to a pediatrician or pediatric cardiologist.
Her clinic hired a cardiac nurse to train the staff in how to take heart rate and blood pressure in babies. “Partnering with cardiology was really important for us,” she commented. “We worked really closely with our pediatric cardiology team to gain that expertise for our staff to assess that. You have to be pretty comfortable with it. If you’re not, you’re going to have to find someone else.”
Another option for dermatologists, Dr. Frieden said, is to focus on heart rate alone since blood pressure in infants is difficult to measure. “It’s not FDA sanctioned, but many people seem to do that and it’s OK,” she said.
Dr. Frieden and Dr. Drolet provided the following recommendations about treating babies with oral propranolol:
• Caution parents about side effects. Cardiac side effects have been “extraordinarily rare,” Dr. Drolet said. “We have seen problems with wheezing and, very rarely, severe hypoglycemia,” which can be prevented by educating the family. While it’s uncommon for the medication alone to produce wheezing, this may occur when a respiratory infection and propranolol combine to stress the body, she noted.
In some cases, physicians prescribe albuterol for wheezing without realizing that it will interact with propranolol, she added. “One is a beta-blocker, and the other is a beta-antagonist. They completely cancel each other out.”
To prevent hypoglycemia, Dr. Frieden said she recommends that children be fed every 6 hours if they’re under 6 months old or every 8 hours if they’re over 6 months of age. And Dr. Drolet said she advises parents to stop propranolol when their infants are sick.
A major focus of an educational video provided by Dr. Drolet’s clinic is advising parents “to stop the medication if the infant is not eating regularly, vomiting, or has diarrhea. It interferes with how you respond to low blood sugar if you’re not eating,” she said. “That surprised us. Now that we’ve been teaching parents about when to call us, that’s been pretty preventable.”
Minor side effects include cold hands and feet and sleep disturbances such as sleepiness and apparent nightmares, Dr. Frieden pointed out.
• Monitor guidelines regarding safety and protocols. “Over time, we’re getting more and more expertise,” Dr. Drolet said. For example, her clinic no longer performs ECGs on babies who take the medication because research has suggested they are not needed.
• Spend time developing an education program for parents. Dr. Drolet’s clinic provides the educational video to teach parents about how oral propranolol is used. “We haven’t done that for any other drugs,” she said. “But we want to make sure we aren’t overdosing it. We’ve been very careful about our parent education to prevent that.”
Guidelines on the diagnosis and management of infantile hemangioma were published in 2015 in Pediatrics (2015 Oct;136[4]:e1060-104).
Dr. Frieden has consulted for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product, marketed as Hemangeol. Dr. Drolet has received an investigator-initiated grant from the company.
For Beth Drolet, MD, a pediatric dermatologist in Wisconsin, the tremendous impact oral propranolol has had on the treatment of severe infantile hemangioma is written on the faces of children diagnosed with the condition in recent years.
“You can tell which drugs the kids were on by their age,” said Dr. Drolet, professor of dermatology and pediatrics at the Medical College of Wisconsin, Milwaukee. “If they were born before 2008, before we used this medication, those kids have had multiple surgeries and are still not looking that good. But we rarely see that in the kids born after.”
Still, it is possible for dermatologists to successfully treat their smallest patients with oral propranolol, according to Dr. Drolet and Ilona J. Frieden, MD, professor of dermatology and pediatrics at the University of California, San Francisco.
In interviews, the two pediatric dermatologists spoke about the challenges and benefits of treating hemangioma patients with oral propranolol solution, which was approved by the Food and Drug Administration in 2014 for “proliferating infantile hemangioma requiring systemic therapy.” It is the only FDA-approved systemic treatment for this indication.
The oral form of the drug was used off label to treat patients with hemangioma after a French dermatologist discovered in 2007 that it could effectively treat the condition. A topical form of propranolol is also used for hemangiomas that do not require systemic treatment.
Prior to about a decade ago, Dr. Drolet said, steroids were used to treat severe hemangiomas with limited success.
In general, infantile hemangiomas “have a natural course of gradually involuting even without treatment,” Dr. Frieden noted. But the most severe cases can produce functional impairment, scarring, and anatomic distortion.
Dr. Drolet said she considers treatment if hemangioma threatens a vital function (hearing, sight, breathing) or can lead to pain, infection, or scarring.
One challenge for dermatologists is that standard of care treatment with oral propranolol requires in-office cardiac monitoring, especially as the dose is increased over the first week or two of treatment.
“I don’t think most dermatologists are comfortable taking a heart rate and blood pressure in an infant,” said Dr. Drolet, who is director of the birthmarks and vascular anomalies section at Children’s Hospital of Wisconsin, Milwaukee. Instead, they tend to refer patients to a pediatrician or pediatric cardiologist.
Her clinic hired a cardiac nurse to train the staff in how to take heart rate and blood pressure in babies. “Partnering with cardiology was really important for us,” she commented. “We worked really closely with our pediatric cardiology team to gain that expertise for our staff to assess that. You have to be pretty comfortable with it. If you’re not, you’re going to have to find someone else.”
Another option for dermatologists, Dr. Frieden said, is to focus on heart rate alone since blood pressure in infants is difficult to measure. “It’s not FDA sanctioned, but many people seem to do that and it’s OK,” she said.
Dr. Frieden and Dr. Drolet provided the following recommendations about treating babies with oral propranolol:
• Caution parents about side effects. Cardiac side effects have been “extraordinarily rare,” Dr. Drolet said. “We have seen problems with wheezing and, very rarely, severe hypoglycemia,” which can be prevented by educating the family. While it’s uncommon for the medication alone to produce wheezing, this may occur when a respiratory infection and propranolol combine to stress the body, she noted.
In some cases, physicians prescribe albuterol for wheezing without realizing that it will interact with propranolol, she added. “One is a beta-blocker, and the other is a beta-antagonist. They completely cancel each other out.”
To prevent hypoglycemia, Dr. Frieden said she recommends that children be fed every 6 hours if they’re under 6 months old or every 8 hours if they’re over 6 months of age. And Dr. Drolet said she advises parents to stop propranolol when their infants are sick.
A major focus of an educational video provided by Dr. Drolet’s clinic is advising parents “to stop the medication if the infant is not eating regularly, vomiting, or has diarrhea. It interferes with how you respond to low blood sugar if you’re not eating,” she said. “That surprised us. Now that we’ve been teaching parents about when to call us, that’s been pretty preventable.”
Minor side effects include cold hands and feet and sleep disturbances such as sleepiness and apparent nightmares, Dr. Frieden pointed out.
• Monitor guidelines regarding safety and protocols. “Over time, we’re getting more and more expertise,” Dr. Drolet said. For example, her clinic no longer performs ECGs on babies who take the medication because research has suggested they are not needed.
• Spend time developing an education program for parents. Dr. Drolet’s clinic provides the educational video to teach parents about how oral propranolol is used. “We haven’t done that for any other drugs,” she said. “But we want to make sure we aren’t overdosing it. We’ve been very careful about our parent education to prevent that.”
Guidelines on the diagnosis and management of infantile hemangioma were published in 2015 in Pediatrics (2015 Oct;136[4]:e1060-104).
Dr. Frieden has consulted for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product, marketed as Hemangeol. Dr. Drolet has received an investigator-initiated grant from the company.
Study: Pretreatment ECG not always needed in babies with hemangiomas
Routine ECG screening in infants before they receive propranolol for hemangiomas is “not likely to be an effective screening tool in patients with otherwise normal physical examination and family history” and may even cause harmful delays in treatment, study authors concluded.
“As previously published guidelines suggest, it is likely that an indication-driven ECG strategy is a better approach, because there is a low incidence of ECG abnormalities that would limit propranolol use in children,” wrote Kevin B. Yarbrough, MD, a dermatologist at Phoenix Children’s Hospital, and his associates. The results “support published guidelines for propranolol initiation and are congruent with findings from other investigators” (Pediatr Dermatol. 2016 Nov;33[6]:615-20).
In the retrospective study, Dr. Yarbrough and his associates tracked 162 patients (median age, 5.2 months) who underwent routine ECG screening at several clinics before propranolol treatment for hemangiomas from 2008 to 2013. The ECGs were read as abnormal in 69 cases (43%); the most common abnormality was left ventricular hypertrophy (16 patients), followed by right ventricular hypertrophy (8), sinus bradycardia (6), and sinus tachycardia (5).
Cardiologists cleared all 69 patients for propranolol treatment, which they received. “No patients in our cohort experienced an adverse effect during treatment that could have been predicted or prevented by ECG before initiation of the propranolol,” the authors wrote.
“Routine ECG adds to the cost of treating hemangiomas and leads to unnecessary consultations and testing. Even more importantly, abnormalities detected on ECG can lead to delays in treatment initiation, which in turn can lead to greater patient morbidity, as seen in the case of our patient whose hemangioma ulcerated while awaiting cardiology consultation,” they added.
Still, they noted that ECG tests should still be performed on “infants with bradycardia or cardiac arrhythmia found during initial physical examination, a family history of congenital heart disease or arrhythmias, and a maternal history of connective tissue disease.”
Study funding information was not provided. One of the study authors reported that he was a clinical investigator for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product Hemangeol.
Routine ECG screening in infants before they receive propranolol for hemangiomas is “not likely to be an effective screening tool in patients with otherwise normal physical examination and family history” and may even cause harmful delays in treatment, study authors concluded.
“As previously published guidelines suggest, it is likely that an indication-driven ECG strategy is a better approach, because there is a low incidence of ECG abnormalities that would limit propranolol use in children,” wrote Kevin B. Yarbrough, MD, a dermatologist at Phoenix Children’s Hospital, and his associates. The results “support published guidelines for propranolol initiation and are congruent with findings from other investigators” (Pediatr Dermatol. 2016 Nov;33[6]:615-20).
In the retrospective study, Dr. Yarbrough and his associates tracked 162 patients (median age, 5.2 months) who underwent routine ECG screening at several clinics before propranolol treatment for hemangiomas from 2008 to 2013. The ECGs were read as abnormal in 69 cases (43%); the most common abnormality was left ventricular hypertrophy (16 patients), followed by right ventricular hypertrophy (8), sinus bradycardia (6), and sinus tachycardia (5).
Cardiologists cleared all 69 patients for propranolol treatment, which they received. “No patients in our cohort experienced an adverse effect during treatment that could have been predicted or prevented by ECG before initiation of the propranolol,” the authors wrote.
“Routine ECG adds to the cost of treating hemangiomas and leads to unnecessary consultations and testing. Even more importantly, abnormalities detected on ECG can lead to delays in treatment initiation, which in turn can lead to greater patient morbidity, as seen in the case of our patient whose hemangioma ulcerated while awaiting cardiology consultation,” they added.
Still, they noted that ECG tests should still be performed on “infants with bradycardia or cardiac arrhythmia found during initial physical examination, a family history of congenital heart disease or arrhythmias, and a maternal history of connective tissue disease.”
Study funding information was not provided. One of the study authors reported that he was a clinical investigator for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product Hemangeol.
Routine ECG screening in infants before they receive propranolol for hemangiomas is “not likely to be an effective screening tool in patients with otherwise normal physical examination and family history” and may even cause harmful delays in treatment, study authors concluded.
“As previously published guidelines suggest, it is likely that an indication-driven ECG strategy is a better approach, because there is a low incidence of ECG abnormalities that would limit propranolol use in children,” wrote Kevin B. Yarbrough, MD, a dermatologist at Phoenix Children’s Hospital, and his associates. The results “support published guidelines for propranolol initiation and are congruent with findings from other investigators” (Pediatr Dermatol. 2016 Nov;33[6]:615-20).
In the retrospective study, Dr. Yarbrough and his associates tracked 162 patients (median age, 5.2 months) who underwent routine ECG screening at several clinics before propranolol treatment for hemangiomas from 2008 to 2013. The ECGs were read as abnormal in 69 cases (43%); the most common abnormality was left ventricular hypertrophy (16 patients), followed by right ventricular hypertrophy (8), sinus bradycardia (6), and sinus tachycardia (5).
Cardiologists cleared all 69 patients for propranolol treatment, which they received. “No patients in our cohort experienced an adverse effect during treatment that could have been predicted or prevented by ECG before initiation of the propranolol,” the authors wrote.
“Routine ECG adds to the cost of treating hemangiomas and leads to unnecessary consultations and testing. Even more importantly, abnormalities detected on ECG can lead to delays in treatment initiation, which in turn can lead to greater patient morbidity, as seen in the case of our patient whose hemangioma ulcerated while awaiting cardiology consultation,” they added.
Still, they noted that ECG tests should still be performed on “infants with bradycardia or cardiac arrhythmia found during initial physical examination, a family history of congenital heart disease or arrhythmias, and a maternal history of connective tissue disease.”
Study funding information was not provided. One of the study authors reported that he was a clinical investigator for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product Hemangeol.
FROM PEDIATRIC DERMATOLOGY
Key clinical point: While it’s appropriate in some cases, routine ECG screening appears to be unnecessary before administering propranolol to infants to treat hemangiomas.
Major finding: All 69 infants whose screening ECGs turned up abnormalities were subsequently cleared by cardiologists.
Data source: A retrospective analysis of 162 patients with infantile hemangiomas seen at various clinics from 2008 to 2013.
Disclosures: Study funding information was not provided. One of the study authors, Alfons L. Krol, MD, reported being a clinical investigator for Pierre Fabre Dermatologie, the manufacturer of the oral propranolol product Hemangeol.