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Assessing adverse events tied to outpatient opioid use in children
Nearly three-quarters of opioid-related adverse events seen in children were related to therapeutic opioid use, based on data from more than a million prescriptions.
Prescription of opioids to children for outpatient conditions may have risen along with the increased opioid prescriptions for adults, but most of the literature focuses on opioid toxicity in children, and “the incidence of adverse opioid effects for children during appropriate medical use for relatively minor conditions is unknown,” wrote Cecilia P. Chung, MD, of Vanderbilt University in Nashville, Tenn., and her colleagues.
In a retrospective study published in Pediatrics, the researchers reviewed data from 401,972 children and adolescents aged 2-17 years with no chronic or severe conditions. The patients filled a total of 1,362,503 prescriptions for opioids, with a mean 15% filling one or more opioid prescriptions a year, and 1 in every 2,611 prescriptions was followed by an emergency department visit, hospitalization, or death related to an adverse event associated with opioid use.
Approximately 20% of the prescriptions were for children aged 2-5 years, 28% for ages 6-11 years, and 52% for ages 12-17 years. The patients were enrolled in Medicaid between Jan. 1, 1999, and Dec. 31, 2014, in Tennessee, and were seen at outpatient centers. Dental procedures were the most common reasons for opioid prescriptions in the study population (31%), followed by outpatient procedures or surgeries (25%), trauma (18%), and infections (16%).
Overall, 437 cases of opioid-related adverse events were confirmed by medical record review; 89% of these were deemed related to the prescription, and 71% were related to proper therapeutic use, the researchers said. The remainder were considered to be related to unintentional overdose, abuse, self-harm, or the circumstances were not indicated.
The opioid-related symptoms most frequently were gastrointestinal, neuropsychiatric, dermatologic, and central nervous system depression.
“The incidence of opioid-related adverse events increased for children and adolescents 12-17 years of age, during current opioid use, and with higher opioid doses,” the researchers said.
The study findings were limited by several factors including the use of Medicaid patients only, the lack of clinical details such as patient weight, and the potential for incomplete medical records, Dr. Chung and her associates noted. However, the results support the need for more comprehensive guidelines in treating acute, self-limited conditions in children to reduce unnecessary opioid exposure, they said.
The researchers had no relevant financial conflicts to disclose. The study was supported by the Eunice Kennedy Shriver National Institute for Child Health and Human Development and funded by the National Institutes of Health. Dr. Chung received grant support from the National Institutes of Health and the Rheumatology Research Foundation Career Development Research K-supplement.
SOURCE: Chung C et al. Pediatrics. 2018 Jul 16. doi: 10.1542/peds.2017-2156.
“We know that opioids are associated with many untoward side effects and are potentially lethal. But we believe there is a reason why opioids have been used to treat pain since the Sumerians 5,000 years ago,” Elliot J. Krane, MD, Steven J. Weisman, MD, and Gary A. Walco, PhD, wrote in an accompanying editorial.
The editorialists noted that they are not blanket advocates of opioid prescriptions for children, but they do believe in the importance of pain management for conditions including postsurgical pain, burns, physical trauma, and medical illnesses. In many cases, opioids are the most effective treatment option.
In addition, data on opioid-related deaths in the United States have been shown inaccurate for various reasons including the coding of deaths as opioid related if opioids were present among a number of other drugs, even if the cause of death was another substance or an act such as suicide, the writers noted. Even the Centers for Disease Control and Prevention has admitted overestimating the prevalence of opioid-related deaths by as much as 100%. Consequently, the opioid epidemic portrayed in the media, “pales in comparison with other public health hazards and causes of deaths in America such as tobacco-related deaths, alcoholic hepatic disease, and even hospital-acquired infections,” Dr. Krane, Dr. Weisman, and Dr. Walco said.
“The data as presented cannot be considered causal for associating opioid prescribing with severe morbidity, more hospital emergency department visits, and even death,” the editorialists concluded. They emphasized the need for good judgment on the part of clinicians when prescribing opioids to children and advocated always making good use of nonopioid alternatives, but Dr. Krane, Dr. Weisman, and Dr. Walco added that the findings of this study should not deter doctors from prescribing an opioid when they think it is the most effective and appropriate option for moderately to severely painful conditions.
“Too often, consideration of the need to prevent and treat pain can be lost in the national discussion,” they said.
Dr. Krane is affiliated with Stanford University in Palo Alto, Calif., Dr. Weisman is affiliated with the Medical College of Milwaukee, Wisc., and Dr. Walco is affiliated with the University of Washington, Seattle. Dr. Krane disclosed consulting for Collegium Pharmaceuticals and honoraria for lecturing on pain and analgesia. Dr. Weisman disclosed consulting for Grünenthal Pharmaceuticals and Pfizer Pharmaceuticals and has conducted clinical trials for Grünenthal Pharmaceuticals, Cadence Pharmaceuticals, and The Medicines Company. Their editorial accompanying the article by Chung et al. appeared in Pediatrics (2018 Jul 16. doi: 10.1542/peds.2018-1623).
“We know that opioids are associated with many untoward side effects and are potentially lethal. But we believe there is a reason why opioids have been used to treat pain since the Sumerians 5,000 years ago,” Elliot J. Krane, MD, Steven J. Weisman, MD, and Gary A. Walco, PhD, wrote in an accompanying editorial.
The editorialists noted that they are not blanket advocates of opioid prescriptions for children, but they do believe in the importance of pain management for conditions including postsurgical pain, burns, physical trauma, and medical illnesses. In many cases, opioids are the most effective treatment option.
In addition, data on opioid-related deaths in the United States have been shown inaccurate for various reasons including the coding of deaths as opioid related if opioids were present among a number of other drugs, even if the cause of death was another substance or an act such as suicide, the writers noted. Even the Centers for Disease Control and Prevention has admitted overestimating the prevalence of opioid-related deaths by as much as 100%. Consequently, the opioid epidemic portrayed in the media, “pales in comparison with other public health hazards and causes of deaths in America such as tobacco-related deaths, alcoholic hepatic disease, and even hospital-acquired infections,” Dr. Krane, Dr. Weisman, and Dr. Walco said.
“The data as presented cannot be considered causal for associating opioid prescribing with severe morbidity, more hospital emergency department visits, and even death,” the editorialists concluded. They emphasized the need for good judgment on the part of clinicians when prescribing opioids to children and advocated always making good use of nonopioid alternatives, but Dr. Krane, Dr. Weisman, and Dr. Walco added that the findings of this study should not deter doctors from prescribing an opioid when they think it is the most effective and appropriate option for moderately to severely painful conditions.
“Too often, consideration of the need to prevent and treat pain can be lost in the national discussion,” they said.
Dr. Krane is affiliated with Stanford University in Palo Alto, Calif., Dr. Weisman is affiliated with the Medical College of Milwaukee, Wisc., and Dr. Walco is affiliated with the University of Washington, Seattle. Dr. Krane disclosed consulting for Collegium Pharmaceuticals and honoraria for lecturing on pain and analgesia. Dr. Weisman disclosed consulting for Grünenthal Pharmaceuticals and Pfizer Pharmaceuticals and has conducted clinical trials for Grünenthal Pharmaceuticals, Cadence Pharmaceuticals, and The Medicines Company. Their editorial accompanying the article by Chung et al. appeared in Pediatrics (2018 Jul 16. doi: 10.1542/peds.2018-1623).
“We know that opioids are associated with many untoward side effects and are potentially lethal. But we believe there is a reason why opioids have been used to treat pain since the Sumerians 5,000 years ago,” Elliot J. Krane, MD, Steven J. Weisman, MD, and Gary A. Walco, PhD, wrote in an accompanying editorial.
The editorialists noted that they are not blanket advocates of opioid prescriptions for children, but they do believe in the importance of pain management for conditions including postsurgical pain, burns, physical trauma, and medical illnesses. In many cases, opioids are the most effective treatment option.
In addition, data on opioid-related deaths in the United States have been shown inaccurate for various reasons including the coding of deaths as opioid related if opioids were present among a number of other drugs, even if the cause of death was another substance or an act such as suicide, the writers noted. Even the Centers for Disease Control and Prevention has admitted overestimating the prevalence of opioid-related deaths by as much as 100%. Consequently, the opioid epidemic portrayed in the media, “pales in comparison with other public health hazards and causes of deaths in America such as tobacco-related deaths, alcoholic hepatic disease, and even hospital-acquired infections,” Dr. Krane, Dr. Weisman, and Dr. Walco said.
“The data as presented cannot be considered causal for associating opioid prescribing with severe morbidity, more hospital emergency department visits, and even death,” the editorialists concluded. They emphasized the need for good judgment on the part of clinicians when prescribing opioids to children and advocated always making good use of nonopioid alternatives, but Dr. Krane, Dr. Weisman, and Dr. Walco added that the findings of this study should not deter doctors from prescribing an opioid when they think it is the most effective and appropriate option for moderately to severely painful conditions.
“Too often, consideration of the need to prevent and treat pain can be lost in the national discussion,” they said.
Dr. Krane is affiliated with Stanford University in Palo Alto, Calif., Dr. Weisman is affiliated with the Medical College of Milwaukee, Wisc., and Dr. Walco is affiliated with the University of Washington, Seattle. Dr. Krane disclosed consulting for Collegium Pharmaceuticals and honoraria for lecturing on pain and analgesia. Dr. Weisman disclosed consulting for Grünenthal Pharmaceuticals and Pfizer Pharmaceuticals and has conducted clinical trials for Grünenthal Pharmaceuticals, Cadence Pharmaceuticals, and The Medicines Company. Their editorial accompanying the article by Chung et al. appeared in Pediatrics (2018 Jul 16. doi: 10.1542/peds.2018-1623).
Nearly three-quarters of opioid-related adverse events seen in children were related to therapeutic opioid use, based on data from more than a million prescriptions.
Prescription of opioids to children for outpatient conditions may have risen along with the increased opioid prescriptions for adults, but most of the literature focuses on opioid toxicity in children, and “the incidence of adverse opioid effects for children during appropriate medical use for relatively minor conditions is unknown,” wrote Cecilia P. Chung, MD, of Vanderbilt University in Nashville, Tenn., and her colleagues.
In a retrospective study published in Pediatrics, the researchers reviewed data from 401,972 children and adolescents aged 2-17 years with no chronic or severe conditions. The patients filled a total of 1,362,503 prescriptions for opioids, with a mean 15% filling one or more opioid prescriptions a year, and 1 in every 2,611 prescriptions was followed by an emergency department visit, hospitalization, or death related to an adverse event associated with opioid use.
Approximately 20% of the prescriptions were for children aged 2-5 years, 28% for ages 6-11 years, and 52% for ages 12-17 years. The patients were enrolled in Medicaid between Jan. 1, 1999, and Dec. 31, 2014, in Tennessee, and were seen at outpatient centers. Dental procedures were the most common reasons for opioid prescriptions in the study population (31%), followed by outpatient procedures or surgeries (25%), trauma (18%), and infections (16%).
Overall, 437 cases of opioid-related adverse events were confirmed by medical record review; 89% of these were deemed related to the prescription, and 71% were related to proper therapeutic use, the researchers said. The remainder were considered to be related to unintentional overdose, abuse, self-harm, or the circumstances were not indicated.
The opioid-related symptoms most frequently were gastrointestinal, neuropsychiatric, dermatologic, and central nervous system depression.
“The incidence of opioid-related adverse events increased for children and adolescents 12-17 years of age, during current opioid use, and with higher opioid doses,” the researchers said.
The study findings were limited by several factors including the use of Medicaid patients only, the lack of clinical details such as patient weight, and the potential for incomplete medical records, Dr. Chung and her associates noted. However, the results support the need for more comprehensive guidelines in treating acute, self-limited conditions in children to reduce unnecessary opioid exposure, they said.
The researchers had no relevant financial conflicts to disclose. The study was supported by the Eunice Kennedy Shriver National Institute for Child Health and Human Development and funded by the National Institutes of Health. Dr. Chung received grant support from the National Institutes of Health and the Rheumatology Research Foundation Career Development Research K-supplement.
SOURCE: Chung C et al. Pediatrics. 2018 Jul 16. doi: 10.1542/peds.2017-2156.
Nearly three-quarters of opioid-related adverse events seen in children were related to therapeutic opioid use, based on data from more than a million prescriptions.
Prescription of opioids to children for outpatient conditions may have risen along with the increased opioid prescriptions for adults, but most of the literature focuses on opioid toxicity in children, and “the incidence of adverse opioid effects for children during appropriate medical use for relatively minor conditions is unknown,” wrote Cecilia P. Chung, MD, of Vanderbilt University in Nashville, Tenn., and her colleagues.
In a retrospective study published in Pediatrics, the researchers reviewed data from 401,972 children and adolescents aged 2-17 years with no chronic or severe conditions. The patients filled a total of 1,362,503 prescriptions for opioids, with a mean 15% filling one or more opioid prescriptions a year, and 1 in every 2,611 prescriptions was followed by an emergency department visit, hospitalization, or death related to an adverse event associated with opioid use.
Approximately 20% of the prescriptions were for children aged 2-5 years, 28% for ages 6-11 years, and 52% for ages 12-17 years. The patients were enrolled in Medicaid between Jan. 1, 1999, and Dec. 31, 2014, in Tennessee, and were seen at outpatient centers. Dental procedures were the most common reasons for opioid prescriptions in the study population (31%), followed by outpatient procedures or surgeries (25%), trauma (18%), and infections (16%).
Overall, 437 cases of opioid-related adverse events were confirmed by medical record review; 89% of these were deemed related to the prescription, and 71% were related to proper therapeutic use, the researchers said. The remainder were considered to be related to unintentional overdose, abuse, self-harm, or the circumstances were not indicated.
The opioid-related symptoms most frequently were gastrointestinal, neuropsychiatric, dermatologic, and central nervous system depression.
“The incidence of opioid-related adverse events increased for children and adolescents 12-17 years of age, during current opioid use, and with higher opioid doses,” the researchers said.
The study findings were limited by several factors including the use of Medicaid patients only, the lack of clinical details such as patient weight, and the potential for incomplete medical records, Dr. Chung and her associates noted. However, the results support the need for more comprehensive guidelines in treating acute, self-limited conditions in children to reduce unnecessary opioid exposure, they said.
The researchers had no relevant financial conflicts to disclose. The study was supported by the Eunice Kennedy Shriver National Institute for Child Health and Human Development and funded by the National Institutes of Health. Dr. Chung received grant support from the National Institutes of Health and the Rheumatology Research Foundation Career Development Research K-supplement.
SOURCE: Chung C et al. Pediatrics. 2018 Jul 16. doi: 10.1542/peds.2017-2156.
FROM PEDIATRICS
Key clinical point: One in every 2,611 opioid prescriptions in children and teens was followed by an ED visit, hospitalization, or death related to an adverse event associated with opioid use.
Major finding: A total of 437 cases of opioid-related adverse events were confirmed; most were associated with therapeutic medication use.
Study details: The data come from a retrospective cohort study of 401,972 children aged 2-17 years enrolled in Medicaid between Jan. 1, 1999, and Dec. 31, 2014.
Disclosures: The researchers had no relevant financial conflicts to disclose. The study was supported by the Eunice Kennedy Shriver National Institute for Child Health and Human Development, and funded by the National Institutes of Health. Dr. Chung received grant support from the National Institutes of Health and the Rheumatology Research Foundation Career Development Research K-supplement.
Source: Chung C et al. Pediatrics. 2018 Jul 16. doi: 10.1542/peds.2017-2156
Depression screening rates remain low for undiagnosed adults
Depression screening among U.S. adults was 1.4% for the period from 2005 to 2015 despite a 2009 recommendation for routine screening from the U.S. Preventive Services Task Force, data from a cross-sectional study show.
In a brief report published online in Psychiatric Services, the researchers reviewed data from the National Ambulatory Medical Care Survey for the years 2005-2015. The study population included adults aged 18 and older without a previous history of depression. Overall, 105 million ambulatory care visits to nonpsychiatrists during the study period included depression screening. About two-thirds of the study population fell into the 18- to 64-year-old age range, 60% were women, 73% were white, and 89% lived in cities.
A multivariate analysis showed a significant increase in the likelihood of depression screening each year (odds ratio, 1.12), the researchers noted, and screening rates increased significantly in the years after 2009 in a piecewise regression analysis, Dr. Bhattacharjee and his associates reported.
The investigators also found links between the amount of time patients spent in physicians’ offices and higher screening rates. “Since increasing the length of time of the actual visit to the physician may be difficult, it is recommended that other health care providers in these settings be trained to provide screening,” they wrote.
The study was conducted before an updated USPSTF recommendation for screening regardless of the presence of enhanced services, the researchers noted, and “the low screening rate observed likely reflects the earlier recommendation,” they said. The findings were limited by several factors, including the cross-sectional study design that prevents causal inferences and the variation in depression screening methods, the researchers noted.
However, the results suggest that depression screening in primary care remains low – even in the years since the 2009 recommendation, they said.
Dr. Bhattacharjee disclosed no financial conflicts.
SOURCE: Bhattacharjee S et al. Psychiatr Serv. 2018 Jul 9. doi: 10.1176/appi.ps.201700439.
Depression screening among U.S. adults was 1.4% for the period from 2005 to 2015 despite a 2009 recommendation for routine screening from the U.S. Preventive Services Task Force, data from a cross-sectional study show.
In a brief report published online in Psychiatric Services, the researchers reviewed data from the National Ambulatory Medical Care Survey for the years 2005-2015. The study population included adults aged 18 and older without a previous history of depression. Overall, 105 million ambulatory care visits to nonpsychiatrists during the study period included depression screening. About two-thirds of the study population fell into the 18- to 64-year-old age range, 60% were women, 73% were white, and 89% lived in cities.
A multivariate analysis showed a significant increase in the likelihood of depression screening each year (odds ratio, 1.12), the researchers noted, and screening rates increased significantly in the years after 2009 in a piecewise regression analysis, Dr. Bhattacharjee and his associates reported.
The investigators also found links between the amount of time patients spent in physicians’ offices and higher screening rates. “Since increasing the length of time of the actual visit to the physician may be difficult, it is recommended that other health care providers in these settings be trained to provide screening,” they wrote.
The study was conducted before an updated USPSTF recommendation for screening regardless of the presence of enhanced services, the researchers noted, and “the low screening rate observed likely reflects the earlier recommendation,” they said. The findings were limited by several factors, including the cross-sectional study design that prevents causal inferences and the variation in depression screening methods, the researchers noted.
However, the results suggest that depression screening in primary care remains low – even in the years since the 2009 recommendation, they said.
Dr. Bhattacharjee disclosed no financial conflicts.
SOURCE: Bhattacharjee S et al. Psychiatr Serv. 2018 Jul 9. doi: 10.1176/appi.ps.201700439.
Depression screening among U.S. adults was 1.4% for the period from 2005 to 2015 despite a 2009 recommendation for routine screening from the U.S. Preventive Services Task Force, data from a cross-sectional study show.
In a brief report published online in Psychiatric Services, the researchers reviewed data from the National Ambulatory Medical Care Survey for the years 2005-2015. The study population included adults aged 18 and older without a previous history of depression. Overall, 105 million ambulatory care visits to nonpsychiatrists during the study period included depression screening. About two-thirds of the study population fell into the 18- to 64-year-old age range, 60% were women, 73% were white, and 89% lived in cities.
A multivariate analysis showed a significant increase in the likelihood of depression screening each year (odds ratio, 1.12), the researchers noted, and screening rates increased significantly in the years after 2009 in a piecewise regression analysis, Dr. Bhattacharjee and his associates reported.
The investigators also found links between the amount of time patients spent in physicians’ offices and higher screening rates. “Since increasing the length of time of the actual visit to the physician may be difficult, it is recommended that other health care providers in these settings be trained to provide screening,” they wrote.
The study was conducted before an updated USPSTF recommendation for screening regardless of the presence of enhanced services, the researchers noted, and “the low screening rate observed likely reflects the earlier recommendation,” they said. The findings were limited by several factors, including the cross-sectional study design that prevents causal inferences and the variation in depression screening methods, the researchers noted.
However, the results suggest that depression screening in primary care remains low – even in the years since the 2009 recommendation, they said.
Dr. Bhattacharjee disclosed no financial conflicts.
SOURCE: Bhattacharjee S et al. Psychiatr Serv. 2018 Jul 9. doi: 10.1176/appi.ps.201700439.
FROM PSYCHIATRIC SERVICES
Cutavirus shows no association with primary cutaneous lymphoma
The parvovirus known as cutavirus appears unlikely to play a pathogenic role in primary cutaneous B- and T-cell lymphoma, based on data from 189 biopsies.
Although researchers have long suspected viruses of a role in primary cutaneous lymphomas, “all of the so-far-suspected viruses including retroviruses, herpesviruses, and polyomaviruses have failed to reveal a consistent association with both cutaneous B-cell lymphoma [CBCL] and cutaneous T-cell lymphoma [CTCL],” wrote Alexander Kreuter, MD, of the department of dermatology, venereology, and allergology at Helios St. Elisabeth Hospital Oberhausen, Germany, and his colleagues.
In a research letter published in JAMA Dermatology, the researchers analyzed 189 paraffin-embedded biopsy specimens from 130 adults with CBCL or CTCL.
Overall, cutavirus DNA was identified in 6 (3.2%) of the 189 lymphoma biopsies and in 6 (4.6%) of 130 patients. Cutavirus was identified only in male patients with mycosis fungoides, and no cutavirus was identified in patients or biopsies without mycosis fungoides, the researchers noted. Viral DNA loads in the cutavirus-positive biopsies ranged from 1.3 to 85.0 cutavirus DNA copies per beta globin gene copy.
The findings were limited by several factors, such as the lack of biopsy samples for some lymphoma subtypes and the availability of a single specimen from most patients, the researchers noted. However, the analysis of a large number of samples suggested that cutavirus is not associated with the development of most primary cutaneous lymphomas, they said.
The study was funded by the German National Reference Center for Papilloma- and Polyomaviruses. The researchers had no financial conflicts to disclose.
SOURCE: Kreuter A et al. JAMA Dermatol. 2018 Jun 27. doi:10.1001/jamadermatol.2018.1628.
The parvovirus known as cutavirus appears unlikely to play a pathogenic role in primary cutaneous B- and T-cell lymphoma, based on data from 189 biopsies.
Although researchers have long suspected viruses of a role in primary cutaneous lymphomas, “all of the so-far-suspected viruses including retroviruses, herpesviruses, and polyomaviruses have failed to reveal a consistent association with both cutaneous B-cell lymphoma [CBCL] and cutaneous T-cell lymphoma [CTCL],” wrote Alexander Kreuter, MD, of the department of dermatology, venereology, and allergology at Helios St. Elisabeth Hospital Oberhausen, Germany, and his colleagues.
In a research letter published in JAMA Dermatology, the researchers analyzed 189 paraffin-embedded biopsy specimens from 130 adults with CBCL or CTCL.
Overall, cutavirus DNA was identified in 6 (3.2%) of the 189 lymphoma biopsies and in 6 (4.6%) of 130 patients. Cutavirus was identified only in male patients with mycosis fungoides, and no cutavirus was identified in patients or biopsies without mycosis fungoides, the researchers noted. Viral DNA loads in the cutavirus-positive biopsies ranged from 1.3 to 85.0 cutavirus DNA copies per beta globin gene copy.
The findings were limited by several factors, such as the lack of biopsy samples for some lymphoma subtypes and the availability of a single specimen from most patients, the researchers noted. However, the analysis of a large number of samples suggested that cutavirus is not associated with the development of most primary cutaneous lymphomas, they said.
The study was funded by the German National Reference Center for Papilloma- and Polyomaviruses. The researchers had no financial conflicts to disclose.
SOURCE: Kreuter A et al. JAMA Dermatol. 2018 Jun 27. doi:10.1001/jamadermatol.2018.1628.
The parvovirus known as cutavirus appears unlikely to play a pathogenic role in primary cutaneous B- and T-cell lymphoma, based on data from 189 biopsies.
Although researchers have long suspected viruses of a role in primary cutaneous lymphomas, “all of the so-far-suspected viruses including retroviruses, herpesviruses, and polyomaviruses have failed to reveal a consistent association with both cutaneous B-cell lymphoma [CBCL] and cutaneous T-cell lymphoma [CTCL],” wrote Alexander Kreuter, MD, of the department of dermatology, venereology, and allergology at Helios St. Elisabeth Hospital Oberhausen, Germany, and his colleagues.
In a research letter published in JAMA Dermatology, the researchers analyzed 189 paraffin-embedded biopsy specimens from 130 adults with CBCL or CTCL.
Overall, cutavirus DNA was identified in 6 (3.2%) of the 189 lymphoma biopsies and in 6 (4.6%) of 130 patients. Cutavirus was identified only in male patients with mycosis fungoides, and no cutavirus was identified in patients or biopsies without mycosis fungoides, the researchers noted. Viral DNA loads in the cutavirus-positive biopsies ranged from 1.3 to 85.0 cutavirus DNA copies per beta globin gene copy.
The findings were limited by several factors, such as the lack of biopsy samples for some lymphoma subtypes and the availability of a single specimen from most patients, the researchers noted. However, the analysis of a large number of samples suggested that cutavirus is not associated with the development of most primary cutaneous lymphomas, they said.
The study was funded by the German National Reference Center for Papilloma- and Polyomaviruses. The researchers had no financial conflicts to disclose.
SOURCE: Kreuter A et al. JAMA Dermatol. 2018 Jun 27. doi:10.1001/jamadermatol.2018.1628.
FROM JAMA DERMATOLOGY
Key clinical point: Cutavirus may not have a primary role in cutaneous lymphomas.
Major finding: Cutavirus was identified in 6 (3.2%) of 189 lymphoma biopsies.
Study details: The data come from 130 patients with cutaneous B-cell lymphoma or cutaneous T-cell lymphoma and a total of 189 biopsy specimens.
Disclosures: The study was funded by the German National Reference Center for Papilloma- and Polyomaviruses. The researchers had no financial conflicts to disclose.
Source: Kreuter A et al. JAMA Dermatol. 2018 Jun 27. doi:10.1001/jamadermatol.2018.1628.
Clomiphene citrate improves pregnancy outcomes for PCOS patients
Clomiphene citrate significantly improved markers of polycystic ovarian syndrome (PCOS) and improved ovulation and pregnancy outcomes in women with PCOS, according to data from 72 women.
Nitric oxide (NO), interleukin-10 (IL-10), and matrix metalloproteinase–9 (MMP-9) “are known to be involved in the pathogenesis as well as the complications of PCOS,” wrote Angel Mercy Sylus, MD, of the Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India, and colleagues.
Clomiphene citrate is used to treat infertility, including infertile women with PCOS, but its mechanism of action remains unclear, the researchers wrote.
In a study published in the European Journal of Obstetrics & Gynecology and Reproductive Biology, the researchers enrolled 72 women with PCOS. The women received 50 mg of oral clomiphene citrate daily on days 3-7 of their cycles to induce ovulation. Levels of NO, IL-10, and MMP-9 were measured at baseline and after 3 weeks. The average age of the women was 25 years, and the average body mass index was 26.4 kg/m2.
After the participants took clomiphene citrate, their levels of NO and IL-10 were significantly higher, compared with baseline (P = .03 and P less than .001, respectively), and MMP-9 levels were significantly lower, compared with baseline (P less than .001).
The ovulation rate in the study population was 52.8%, and the clinical pregnancy rate was 19.4%. Levels of MMP-9 were significantly reduced (P less than .001) in the ovulatory group, compared with the nonovulatory group, the researchers noted. “Although the mechanism through which CC [clomiphene citrate] reduces MMP-9 and increases IL-10 is not clear, our findings indicate that CC therapy improves ovulation by reducing inflammation and reducing MMP-9 levels,” they wrote.
The findings were limited by several factors, mainly by the timing of the 4-week assessment of NO, IL-10, and MPP-9 for ethical reasons, the researchers wrote. They did not get study approval to conduct a separate blood collection. In addition, the study did not measure the effect of increasing doses of clomiphene citrate.
However, the results have suggested that clomiphene citrate can help promote ovulation and pregnancy for infertile women with PCOS, and further studies are needed to assess the mechanism of action and the effect of higher doses on NO, IL-10, and MPP-9, the researchers wrote.
The study was supported by a grant from the Jawaharlal Institute of Postgraduate Medical Education and Research intramural fund. The researchers had no financial conflicts to disclose.
SOURCE: Sylus AM et al. Eur J Obstet Gynecol Reprod Biol. 2018 Sept; 228:27-31.
Clomiphene citrate significantly improved markers of polycystic ovarian syndrome (PCOS) and improved ovulation and pregnancy outcomes in women with PCOS, according to data from 72 women.
Nitric oxide (NO), interleukin-10 (IL-10), and matrix metalloproteinase–9 (MMP-9) “are known to be involved in the pathogenesis as well as the complications of PCOS,” wrote Angel Mercy Sylus, MD, of the Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India, and colleagues.
Clomiphene citrate is used to treat infertility, including infertile women with PCOS, but its mechanism of action remains unclear, the researchers wrote.
In a study published in the European Journal of Obstetrics & Gynecology and Reproductive Biology, the researchers enrolled 72 women with PCOS. The women received 50 mg of oral clomiphene citrate daily on days 3-7 of their cycles to induce ovulation. Levels of NO, IL-10, and MMP-9 were measured at baseline and after 3 weeks. The average age of the women was 25 years, and the average body mass index was 26.4 kg/m2.
After the participants took clomiphene citrate, their levels of NO and IL-10 were significantly higher, compared with baseline (P = .03 and P less than .001, respectively), and MMP-9 levels were significantly lower, compared with baseline (P less than .001).
The ovulation rate in the study population was 52.8%, and the clinical pregnancy rate was 19.4%. Levels of MMP-9 were significantly reduced (P less than .001) in the ovulatory group, compared with the nonovulatory group, the researchers noted. “Although the mechanism through which CC [clomiphene citrate] reduces MMP-9 and increases IL-10 is not clear, our findings indicate that CC therapy improves ovulation by reducing inflammation and reducing MMP-9 levels,” they wrote.
The findings were limited by several factors, mainly by the timing of the 4-week assessment of NO, IL-10, and MPP-9 for ethical reasons, the researchers wrote. They did not get study approval to conduct a separate blood collection. In addition, the study did not measure the effect of increasing doses of clomiphene citrate.
However, the results have suggested that clomiphene citrate can help promote ovulation and pregnancy for infertile women with PCOS, and further studies are needed to assess the mechanism of action and the effect of higher doses on NO, IL-10, and MPP-9, the researchers wrote.
The study was supported by a grant from the Jawaharlal Institute of Postgraduate Medical Education and Research intramural fund. The researchers had no financial conflicts to disclose.
SOURCE: Sylus AM et al. Eur J Obstet Gynecol Reprod Biol. 2018 Sept; 228:27-31.
Clomiphene citrate significantly improved markers of polycystic ovarian syndrome (PCOS) and improved ovulation and pregnancy outcomes in women with PCOS, according to data from 72 women.
Nitric oxide (NO), interleukin-10 (IL-10), and matrix metalloproteinase–9 (MMP-9) “are known to be involved in the pathogenesis as well as the complications of PCOS,” wrote Angel Mercy Sylus, MD, of the Jawaharlal Institute of Postgraduate Medical Education & Research, Puducherry, India, and colleagues.
Clomiphene citrate is used to treat infertility, including infertile women with PCOS, but its mechanism of action remains unclear, the researchers wrote.
In a study published in the European Journal of Obstetrics & Gynecology and Reproductive Biology, the researchers enrolled 72 women with PCOS. The women received 50 mg of oral clomiphene citrate daily on days 3-7 of their cycles to induce ovulation. Levels of NO, IL-10, and MMP-9 were measured at baseline and after 3 weeks. The average age of the women was 25 years, and the average body mass index was 26.4 kg/m2.
After the participants took clomiphene citrate, their levels of NO and IL-10 were significantly higher, compared with baseline (P = .03 and P less than .001, respectively), and MMP-9 levels were significantly lower, compared with baseline (P less than .001).
The ovulation rate in the study population was 52.8%, and the clinical pregnancy rate was 19.4%. Levels of MMP-9 were significantly reduced (P less than .001) in the ovulatory group, compared with the nonovulatory group, the researchers noted. “Although the mechanism through which CC [clomiphene citrate] reduces MMP-9 and increases IL-10 is not clear, our findings indicate that CC therapy improves ovulation by reducing inflammation and reducing MMP-9 levels,” they wrote.
The findings were limited by several factors, mainly by the timing of the 4-week assessment of NO, IL-10, and MPP-9 for ethical reasons, the researchers wrote. They did not get study approval to conduct a separate blood collection. In addition, the study did not measure the effect of increasing doses of clomiphene citrate.
However, the results have suggested that clomiphene citrate can help promote ovulation and pregnancy for infertile women with PCOS, and further studies are needed to assess the mechanism of action and the effect of higher doses on NO, IL-10, and MPP-9, the researchers wrote.
The study was supported by a grant from the Jawaharlal Institute of Postgraduate Medical Education and Research intramural fund. The researchers had no financial conflicts to disclose.
SOURCE: Sylus AM et al. Eur J Obstet Gynecol Reprod Biol. 2018 Sept; 228:27-31.
FROM THE EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY
Key clinical point: Clomiphene citrate increased the levels of both nitric oxide and interleukin-10 and reduced levels of matrix metalloproteinase–9.
Major finding: The ovulation rate was 53%, and the clinical pregnancy rate was 19% in PCOS women given clomiphene citrate.
Study details: The data come from 72 women with PCOS.
Disclosures: The study was supported by a grant from the Jawaharlal Institute of Postgraduate Medical Education and Research intramural fund. The researchers had no financial conflicts to disclose.
Source: Sylus A et al. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:27-31.
Urge expectant parents to have prenatal pediatrician visit
All parents-to-be, especially first-time parents, should visit a pediatrician during the third trimester of pregnancy to establish a relationship, according to an updated clinical report on the prenatal visit issued by the American Academy of Pediatrics. The report was published online June 25 and in the July issue of Pediatrics.
“It’s a chance to talk about how to keep a baby safe and thriving physically, but also ways to build strong parent-child bonds that promote resilience and help a child stay emotionally healthy,” Michael Yogman, MD, of Harvard Medical School, Boston, said in a statement. Dr. Yogman was the lead author of the report and chair of the AAP Committee on Psychosocial Aspects of Child and Family Health.
A comprehensive prenatal visit gives pediatricians the opportunity to meet four objectives: build a trusting relationship with parents, gather information about family history, provide advice and guidance on infant care and safety, and identify risk factors for psychosocial issues such as perinatal depression, according to the report in Pediatrics.
The prenatal visit allows families and clinicians to learn whether their philosophies align to start a relationship that may last for many years and this visit can include extended family members such as grandparents. In addition, pediatricians can use the prenatal visit as an opportunity to learn more about family history including past pregnancies, failed and successful, as well as pregnancy complications, chronic medical conditions in family members that may affect the home environment, and plans for child care if parents will be working outside the home.
The report also emphasizes “positive parenting” and the role of pediatricians at a prenatal visit in offering support and guidance to help prepare parents for infant care. This guidance may include advice on feeding, sleeping, diapering, and bathing, as well as acknowledging cultural practices.
The authors noted that a prime opporunity to schedule the prenatal visit is when an expectant parent seeking information about insurance, practice hours, and whether the practice is taking new patients.
The AAP advises clinicians to encourage same sex parents, parents expecting via surrogate, and parents who are adopting to schedule a prenatal visit to identify particular concerns they may have.
“This is the only routine child wellness visit recommended by the American Academy of Pediatrics that doesn’t actually require a child in the room,” coauthor Arthur Lavin, MD, also of Harvard Medical School, said in a statement.
The prenatal visit “gives parents an opportunity to really focus on any questions and concerns they may have. They can talk with a pediatrician before the fatigue of new parenthood sets in and there’s an adorably distracting little human in their arms who may be crying, spitting up, or in immediate need of feeding or a diaper change,” Dr. Lavin said.
“At its heart and soul,” Dr. Lavin noted, “this visit is about laying a foundation for a trusting, supportive relationship between the family and their pediatrician, who will work together to keep the child healthy for the next 18 or 20 years.”
The report recommends the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Fourth Edition, as a resource for clinicians. The researchers had no financial conflicts to disclose.
SOURCE: Yogman M et al. Pediatrics. 2018; doi: 10.1542/peds. 2018-1218
All parents-to-be, especially first-time parents, should visit a pediatrician during the third trimester of pregnancy to establish a relationship, according to an updated clinical report on the prenatal visit issued by the American Academy of Pediatrics. The report was published online June 25 and in the July issue of Pediatrics.
“It’s a chance to talk about how to keep a baby safe and thriving physically, but also ways to build strong parent-child bonds that promote resilience and help a child stay emotionally healthy,” Michael Yogman, MD, of Harvard Medical School, Boston, said in a statement. Dr. Yogman was the lead author of the report and chair of the AAP Committee on Psychosocial Aspects of Child and Family Health.
A comprehensive prenatal visit gives pediatricians the opportunity to meet four objectives: build a trusting relationship with parents, gather information about family history, provide advice and guidance on infant care and safety, and identify risk factors for psychosocial issues such as perinatal depression, according to the report in Pediatrics.
The prenatal visit allows families and clinicians to learn whether their philosophies align to start a relationship that may last for many years and this visit can include extended family members such as grandparents. In addition, pediatricians can use the prenatal visit as an opportunity to learn more about family history including past pregnancies, failed and successful, as well as pregnancy complications, chronic medical conditions in family members that may affect the home environment, and plans for child care if parents will be working outside the home.
The report also emphasizes “positive parenting” and the role of pediatricians at a prenatal visit in offering support and guidance to help prepare parents for infant care. This guidance may include advice on feeding, sleeping, diapering, and bathing, as well as acknowledging cultural practices.
The authors noted that a prime opporunity to schedule the prenatal visit is when an expectant parent seeking information about insurance, practice hours, and whether the practice is taking new patients.
The AAP advises clinicians to encourage same sex parents, parents expecting via surrogate, and parents who are adopting to schedule a prenatal visit to identify particular concerns they may have.
“This is the only routine child wellness visit recommended by the American Academy of Pediatrics that doesn’t actually require a child in the room,” coauthor Arthur Lavin, MD, also of Harvard Medical School, said in a statement.
The prenatal visit “gives parents an opportunity to really focus on any questions and concerns they may have. They can talk with a pediatrician before the fatigue of new parenthood sets in and there’s an adorably distracting little human in their arms who may be crying, spitting up, or in immediate need of feeding or a diaper change,” Dr. Lavin said.
“At its heart and soul,” Dr. Lavin noted, “this visit is about laying a foundation for a trusting, supportive relationship between the family and their pediatrician, who will work together to keep the child healthy for the next 18 or 20 years.”
The report recommends the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Fourth Edition, as a resource for clinicians. The researchers had no financial conflicts to disclose.
SOURCE: Yogman M et al. Pediatrics. 2018; doi: 10.1542/peds. 2018-1218
All parents-to-be, especially first-time parents, should visit a pediatrician during the third trimester of pregnancy to establish a relationship, according to an updated clinical report on the prenatal visit issued by the American Academy of Pediatrics. The report was published online June 25 and in the July issue of Pediatrics.
“It’s a chance to talk about how to keep a baby safe and thriving physically, but also ways to build strong parent-child bonds that promote resilience and help a child stay emotionally healthy,” Michael Yogman, MD, of Harvard Medical School, Boston, said in a statement. Dr. Yogman was the lead author of the report and chair of the AAP Committee on Psychosocial Aspects of Child and Family Health.
A comprehensive prenatal visit gives pediatricians the opportunity to meet four objectives: build a trusting relationship with parents, gather information about family history, provide advice and guidance on infant care and safety, and identify risk factors for psychosocial issues such as perinatal depression, according to the report in Pediatrics.
The prenatal visit allows families and clinicians to learn whether their philosophies align to start a relationship that may last for many years and this visit can include extended family members such as grandparents. In addition, pediatricians can use the prenatal visit as an opportunity to learn more about family history including past pregnancies, failed and successful, as well as pregnancy complications, chronic medical conditions in family members that may affect the home environment, and plans for child care if parents will be working outside the home.
The report also emphasizes “positive parenting” and the role of pediatricians at a prenatal visit in offering support and guidance to help prepare parents for infant care. This guidance may include advice on feeding, sleeping, diapering, and bathing, as well as acknowledging cultural practices.
The authors noted that a prime opporunity to schedule the prenatal visit is when an expectant parent seeking information about insurance, practice hours, and whether the practice is taking new patients.
The AAP advises clinicians to encourage same sex parents, parents expecting via surrogate, and parents who are adopting to schedule a prenatal visit to identify particular concerns they may have.
“This is the only routine child wellness visit recommended by the American Academy of Pediatrics that doesn’t actually require a child in the room,” coauthor Arthur Lavin, MD, also of Harvard Medical School, said in a statement.
The prenatal visit “gives parents an opportunity to really focus on any questions and concerns they may have. They can talk with a pediatrician before the fatigue of new parenthood sets in and there’s an adorably distracting little human in their arms who may be crying, spitting up, or in immediate need of feeding or a diaper change,” Dr. Lavin said.
“At its heart and soul,” Dr. Lavin noted, “this visit is about laying a foundation for a trusting, supportive relationship between the family and their pediatrician, who will work together to keep the child healthy for the next 18 or 20 years.”
The report recommends the Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, Fourth Edition, as a resource for clinicians. The researchers had no financial conflicts to disclose.
SOURCE: Yogman M et al. Pediatrics. 2018; doi: 10.1542/peds. 2018-1218
FROM PEDIATRICS
Monoclonal antibody reduced alpha-synuclein levels in Parkinson’s patients
Adults with mild to moderate Parkinson’s disease showed reductions in free serum alpha-synuclein levels without notable side effects after intravenous treatment with a monoclonal antibody known as PRX002.
“Pathologically, PD [Parkinson’s disease] is typically associated with an accumulation of aggregated alpha-synuclein protein in the central nervous system and the peripheral nervous system,” making alpha-synuclein a target for treatment in preclinical studies, wrote Joseph Jankovic, MD, of Baylor College of Medicine, Houston, and his colleagues.
“Notably, rapid and robust reductions in free serum alpha-synuclein levels were achieved without seriously affecting safety,” the researchers said. Overall, reductions in free serum alpha-synuclein occurred quickly and were similar throughout the study period, and treatment with PRX002 was safe, well tolerated, and effective at doses up to 60 mg/kg.
The most relevant adverse events were mild to moderate infusion-related reactions in four patients in the highest-dose group; two of these patients discontinued the study. No anti-PRX002 antibodies were seen, and no serious adverse events or deaths occurred during the study period.
Statistically significant reductions from baseline were noted at 1 and 4 hours after the first and third infusion in all dose groups, compared with placebo, and these reductions lasted longer after the higher doses.
Over the longer term, statistically significant reductions after the third infusion were noted at day 64 for the 1.0-mg/kg through 60-mg/kg dose groups, day 71 for the 1.0-mg/kg through 60-mg/kg dose groups, and at day 85 for the 3-mg/kg through 60-mg/kg dose groups.
The study findings were limited by several factors, including the relatively small sample size, short period of exposure to the treatment, homogeneous population, and lack of imaging to monitor brain pathology, the researchers noted. However, the results support the safety of PRX002 and the progression of the follow-up phase 2 study known as PASADENA.
The study was funded by Prothena Biosciences and F. Hoffmann-LaRoche. Lead author Dr. Jankovich disclosed relationships with both of those companies and has received funding from the Parkinson’s Foundation. Many of the other authors are employees of Prothena Biosciences or F. Hoffmann-LaRoche or a subsidiary.
SOURCE: Jankovic J et al. JAMA Neurol. 2018 June 18. doi: 10.1001/jamaneurol.2018.1487.
The study results met the endpoints for safety and tolerance; however, “the question remains: To what extent does this process reflect the role of alpha-synuclein in the causal mechanisms of Parkinson disease?” wrote Fredric P. Manfredsson, PhD; Malú G. Tansey, PhD; and Todd E. Golde, PhD, in an accompanying editorial (JAMA Neurol. 2018 June 18. doi: 10.1001/jamaneurol.2018.0346).
The trio noted that the potential of alpha-synuclein for cell-to-cell transmission and disease propagation and progression remains unknown and the research behind the passive immunization technique remains limited and controversial at the preclinical level. In addition, they emphasized the need to consider the potential for neurotoxicity with the removal of soluble alpha-synuclein from neurons.
“Thus, the potential negative consequences following sustained treatment with PRX002 must also be heavily scrutinized before it can be said to be safe for long-term use in elderly individuals,” they wrote.
The study also lacked data on whether the antibody directly engaged its target in the CNS, they said.
“Although the PRX002 trial met its primary goals and is now poised to move forward into efficacy trials, it is clear that progress within the synuclein basic science field needs to follow suit,” they concluded.
Dr. Manfredsson is affiliated with Michigan State University in Grand Rapids. Dr. Tansey is affiliated with Emory University in Atlanta. Dr. Golde is affiliated with the University of Florida, Gainesville. Dr. Tansey disclosed relationships with INmune Bio, Above and Beyond, Hygieia Sciences, UCB, and the Michael J. Fox Foundation for Parkinson’s Research.
The study results met the endpoints for safety and tolerance; however, “the question remains: To what extent does this process reflect the role of alpha-synuclein in the causal mechanisms of Parkinson disease?” wrote Fredric P. Manfredsson, PhD; Malú G. Tansey, PhD; and Todd E. Golde, PhD, in an accompanying editorial (JAMA Neurol. 2018 June 18. doi: 10.1001/jamaneurol.2018.0346).
The trio noted that the potential of alpha-synuclein for cell-to-cell transmission and disease propagation and progression remains unknown and the research behind the passive immunization technique remains limited and controversial at the preclinical level. In addition, they emphasized the need to consider the potential for neurotoxicity with the removal of soluble alpha-synuclein from neurons.
“Thus, the potential negative consequences following sustained treatment with PRX002 must also be heavily scrutinized before it can be said to be safe for long-term use in elderly individuals,” they wrote.
The study also lacked data on whether the antibody directly engaged its target in the CNS, they said.
“Although the PRX002 trial met its primary goals and is now poised to move forward into efficacy trials, it is clear that progress within the synuclein basic science field needs to follow suit,” they concluded.
Dr. Manfredsson is affiliated with Michigan State University in Grand Rapids. Dr. Tansey is affiliated with Emory University in Atlanta. Dr. Golde is affiliated with the University of Florida, Gainesville. Dr. Tansey disclosed relationships with INmune Bio, Above and Beyond, Hygieia Sciences, UCB, and the Michael J. Fox Foundation for Parkinson’s Research.
The study results met the endpoints for safety and tolerance; however, “the question remains: To what extent does this process reflect the role of alpha-synuclein in the causal mechanisms of Parkinson disease?” wrote Fredric P. Manfredsson, PhD; Malú G. Tansey, PhD; and Todd E. Golde, PhD, in an accompanying editorial (JAMA Neurol. 2018 June 18. doi: 10.1001/jamaneurol.2018.0346).
The trio noted that the potential of alpha-synuclein for cell-to-cell transmission and disease propagation and progression remains unknown and the research behind the passive immunization technique remains limited and controversial at the preclinical level. In addition, they emphasized the need to consider the potential for neurotoxicity with the removal of soluble alpha-synuclein from neurons.
“Thus, the potential negative consequences following sustained treatment with PRX002 must also be heavily scrutinized before it can be said to be safe for long-term use in elderly individuals,” they wrote.
The study also lacked data on whether the antibody directly engaged its target in the CNS, they said.
“Although the PRX002 trial met its primary goals and is now poised to move forward into efficacy trials, it is clear that progress within the synuclein basic science field needs to follow suit,” they concluded.
Dr. Manfredsson is affiliated with Michigan State University in Grand Rapids. Dr. Tansey is affiliated with Emory University in Atlanta. Dr. Golde is affiliated with the University of Florida, Gainesville. Dr. Tansey disclosed relationships with INmune Bio, Above and Beyond, Hygieia Sciences, UCB, and the Michael J. Fox Foundation for Parkinson’s Research.
Adults with mild to moderate Parkinson’s disease showed reductions in free serum alpha-synuclein levels without notable side effects after intravenous treatment with a monoclonal antibody known as PRX002.
“Pathologically, PD [Parkinson’s disease] is typically associated with an accumulation of aggregated alpha-synuclein protein in the central nervous system and the peripheral nervous system,” making alpha-synuclein a target for treatment in preclinical studies, wrote Joseph Jankovic, MD, of Baylor College of Medicine, Houston, and his colleagues.
“Notably, rapid and robust reductions in free serum alpha-synuclein levels were achieved without seriously affecting safety,” the researchers said. Overall, reductions in free serum alpha-synuclein occurred quickly and were similar throughout the study period, and treatment with PRX002 was safe, well tolerated, and effective at doses up to 60 mg/kg.
The most relevant adverse events were mild to moderate infusion-related reactions in four patients in the highest-dose group; two of these patients discontinued the study. No anti-PRX002 antibodies were seen, and no serious adverse events or deaths occurred during the study period.
Statistically significant reductions from baseline were noted at 1 and 4 hours after the first and third infusion in all dose groups, compared with placebo, and these reductions lasted longer after the higher doses.
Over the longer term, statistically significant reductions after the third infusion were noted at day 64 for the 1.0-mg/kg through 60-mg/kg dose groups, day 71 for the 1.0-mg/kg through 60-mg/kg dose groups, and at day 85 for the 3-mg/kg through 60-mg/kg dose groups.
The study findings were limited by several factors, including the relatively small sample size, short period of exposure to the treatment, homogeneous population, and lack of imaging to monitor brain pathology, the researchers noted. However, the results support the safety of PRX002 and the progression of the follow-up phase 2 study known as PASADENA.
The study was funded by Prothena Biosciences and F. Hoffmann-LaRoche. Lead author Dr. Jankovich disclosed relationships with both of those companies and has received funding from the Parkinson’s Foundation. Many of the other authors are employees of Prothena Biosciences or F. Hoffmann-LaRoche or a subsidiary.
SOURCE: Jankovic J et al. JAMA Neurol. 2018 June 18. doi: 10.1001/jamaneurol.2018.1487.
Adults with mild to moderate Parkinson’s disease showed reductions in free serum alpha-synuclein levels without notable side effects after intravenous treatment with a monoclonal antibody known as PRX002.
“Pathologically, PD [Parkinson’s disease] is typically associated with an accumulation of aggregated alpha-synuclein protein in the central nervous system and the peripheral nervous system,” making alpha-synuclein a target for treatment in preclinical studies, wrote Joseph Jankovic, MD, of Baylor College of Medicine, Houston, and his colleagues.
“Notably, rapid and robust reductions in free serum alpha-synuclein levels were achieved without seriously affecting safety,” the researchers said. Overall, reductions in free serum alpha-synuclein occurred quickly and were similar throughout the study period, and treatment with PRX002 was safe, well tolerated, and effective at doses up to 60 mg/kg.
The most relevant adverse events were mild to moderate infusion-related reactions in four patients in the highest-dose group; two of these patients discontinued the study. No anti-PRX002 antibodies were seen, and no serious adverse events or deaths occurred during the study period.
Statistically significant reductions from baseline were noted at 1 and 4 hours after the first and third infusion in all dose groups, compared with placebo, and these reductions lasted longer after the higher doses.
Over the longer term, statistically significant reductions after the third infusion were noted at day 64 for the 1.0-mg/kg through 60-mg/kg dose groups, day 71 for the 1.0-mg/kg through 60-mg/kg dose groups, and at day 85 for the 3-mg/kg through 60-mg/kg dose groups.
The study findings were limited by several factors, including the relatively small sample size, short period of exposure to the treatment, homogeneous population, and lack of imaging to monitor brain pathology, the researchers noted. However, the results support the safety of PRX002 and the progression of the follow-up phase 2 study known as PASADENA.
The study was funded by Prothena Biosciences and F. Hoffmann-LaRoche. Lead author Dr. Jankovich disclosed relationships with both of those companies and has received funding from the Parkinson’s Foundation. Many of the other authors are employees of Prothena Biosciences or F. Hoffmann-LaRoche or a subsidiary.
SOURCE: Jankovic J et al. JAMA Neurol. 2018 June 18. doi: 10.1001/jamaneurol.2018.1487.
FROM JAMA NEUROLOGY
Key clinical point: Treatment with a monoclonal antibody for alpha-synuclein known as PRX002 was safe and effective in a preliminary study of Parkinson’s disease patients.
Major finding: Significant reductions in free serum alpha-synuclein levels persisted at 85 days after the third infusion in the 3-mg/kg through 60-mg/kg dose groups.
Study details: The data come from a randomized, phase 1b trial of 80 adults aged 40-80 years with Parkinson’s disease.
Disclosures: The study was funded by Prothena Biosciences and F. Hoffmann-LaRoche. Lead author Dr. Jankovich disclosed relationships with both of those companies and has received funding from the Parkinson’s Foundation. Many of the other authors are employees of Prothena Biosciences or F. Hoffmann-LaRoche or a subsidiary.
Source: Jankovic J et al. JAMA Neurol. 2018 June 18. doi: 10.1001/jamaneurol.2018.1487.
Axial SpA diagnostic strategies need not be sex-specific
AMSTERDAM – Imaging and a positive HLA-B27 test are effective tools for early diagnosis of axial spondyloarthritis in both men and women, according to data from a study of 719 patients with chronic back pain reported at the European Congress of Rheumatology.
Data from previous studies have shown greater severity of axial spondyloarthritis (axSpA) in men, but gender differences at first presentation of the disease have not been well studied, noted Dr. Augusta Ortolan of the University of Padova (Italy) and her colleagues.
The researchers analyzed baseline data from 444 women and 275 men in the Spondyloarthritis Caught Early (SPACE) cohort, which included patients with chronic back pain that had lasted 3 months to 2 years. The patients were younger than 45 years at the onset of symptoms.
Overall, 53% of men and 35% of women were diagnosed with axSpA. The duration of symptoms was similar between genders, but the average age at diagnosis was significantly younger for men, compared with women (27 years vs. 30 years; P = .021). A positive HLA-B27 test was more common among men with axSpA than among women with axSpA (80% vs. 60%; P less than .001).
Similarly, the presence of axial spondyloarthritis features on imaging was greater among men with axSpA than women with axSpA (78% vs. 64%; P = .007).
Dr. Ortolan said in an interview that she was somewhat surprised by the findings. “I probably expected to see more differences between male and female patients,” she said. “Although it has been demonstrated that the proportion of men to women is more balanced in axial spondyloarthritis in general [nearly 1:1] as compared to the more advanced stages of the disease [known as ankylosing spondylitis or radiographic axial spondyloarthritis, where the male-to-female ratio is around 3:1], there is a tendency to believe that spondyloarthritis in females is rarer or at least more difficult to detect,” she said. “In fact, the study does not completely contradict this belief as we found that from our chronic back pain population, males are twice as likely to be diagnosed. However, all in all, they do not present so much differently than women,” she noted.
The take home message is for clinicians to examine all features that may lead to a diagnosis of axSpA in patients regardless of gender, Dr. Ortolan said. The study results showing that HLA-B27 and imaging are strongly associated with axSpA diagnosis in both genders in a multivariate analysis, which suggests that clinicians do not need to adopt different diagnostic strategies, she said.
The study findings were the result of a cross-sectional approach that was based on an examination of baseline data, Dr. Ortolan noted. “However, it would be really interesting to see what happens in the long term: Do these gender differences tend to increase? Does the disease have a different long-term impact in men and women? Should we treat them differently? These are open questions that need to be addressed in the future,” she said.
Dr. Ortolan and her colleagues had no relevant disclosures.
Mitchel L. Zoler contributed to this story.
SOURCE: Ortolan A et al. Ann Rheum Dis. 2018;77(Suppl 2):207-8. Abstract OP0323.
AMSTERDAM – Imaging and a positive HLA-B27 test are effective tools for early diagnosis of axial spondyloarthritis in both men and women, according to data from a study of 719 patients with chronic back pain reported at the European Congress of Rheumatology.
Data from previous studies have shown greater severity of axial spondyloarthritis (axSpA) in men, but gender differences at first presentation of the disease have not been well studied, noted Dr. Augusta Ortolan of the University of Padova (Italy) and her colleagues.
The researchers analyzed baseline data from 444 women and 275 men in the Spondyloarthritis Caught Early (SPACE) cohort, which included patients with chronic back pain that had lasted 3 months to 2 years. The patients were younger than 45 years at the onset of symptoms.
Overall, 53% of men and 35% of women were diagnosed with axSpA. The duration of symptoms was similar between genders, but the average age at diagnosis was significantly younger for men, compared with women (27 years vs. 30 years; P = .021). A positive HLA-B27 test was more common among men with axSpA than among women with axSpA (80% vs. 60%; P less than .001).
Similarly, the presence of axial spondyloarthritis features on imaging was greater among men with axSpA than women with axSpA (78% vs. 64%; P = .007).
Dr. Ortolan said in an interview that she was somewhat surprised by the findings. “I probably expected to see more differences between male and female patients,” she said. “Although it has been demonstrated that the proportion of men to women is more balanced in axial spondyloarthritis in general [nearly 1:1] as compared to the more advanced stages of the disease [known as ankylosing spondylitis or radiographic axial spondyloarthritis, where the male-to-female ratio is around 3:1], there is a tendency to believe that spondyloarthritis in females is rarer or at least more difficult to detect,” she said. “In fact, the study does not completely contradict this belief as we found that from our chronic back pain population, males are twice as likely to be diagnosed. However, all in all, they do not present so much differently than women,” she noted.
The take home message is for clinicians to examine all features that may lead to a diagnosis of axSpA in patients regardless of gender, Dr. Ortolan said. The study results showing that HLA-B27 and imaging are strongly associated with axSpA diagnosis in both genders in a multivariate analysis, which suggests that clinicians do not need to adopt different diagnostic strategies, she said.
The study findings were the result of a cross-sectional approach that was based on an examination of baseline data, Dr. Ortolan noted. “However, it would be really interesting to see what happens in the long term: Do these gender differences tend to increase? Does the disease have a different long-term impact in men and women? Should we treat them differently? These are open questions that need to be addressed in the future,” she said.
Dr. Ortolan and her colleagues had no relevant disclosures.
Mitchel L. Zoler contributed to this story.
SOURCE: Ortolan A et al. Ann Rheum Dis. 2018;77(Suppl 2):207-8. Abstract OP0323.
AMSTERDAM – Imaging and a positive HLA-B27 test are effective tools for early diagnosis of axial spondyloarthritis in both men and women, according to data from a study of 719 patients with chronic back pain reported at the European Congress of Rheumatology.
Data from previous studies have shown greater severity of axial spondyloarthritis (axSpA) in men, but gender differences at first presentation of the disease have not been well studied, noted Dr. Augusta Ortolan of the University of Padova (Italy) and her colleagues.
The researchers analyzed baseline data from 444 women and 275 men in the Spondyloarthritis Caught Early (SPACE) cohort, which included patients with chronic back pain that had lasted 3 months to 2 years. The patients were younger than 45 years at the onset of symptoms.
Overall, 53% of men and 35% of women were diagnosed with axSpA. The duration of symptoms was similar between genders, but the average age at diagnosis was significantly younger for men, compared with women (27 years vs. 30 years; P = .021). A positive HLA-B27 test was more common among men with axSpA than among women with axSpA (80% vs. 60%; P less than .001).
Similarly, the presence of axial spondyloarthritis features on imaging was greater among men with axSpA than women with axSpA (78% vs. 64%; P = .007).
Dr. Ortolan said in an interview that she was somewhat surprised by the findings. “I probably expected to see more differences between male and female patients,” she said. “Although it has been demonstrated that the proportion of men to women is more balanced in axial spondyloarthritis in general [nearly 1:1] as compared to the more advanced stages of the disease [known as ankylosing spondylitis or radiographic axial spondyloarthritis, where the male-to-female ratio is around 3:1], there is a tendency to believe that spondyloarthritis in females is rarer or at least more difficult to detect,” she said. “In fact, the study does not completely contradict this belief as we found that from our chronic back pain population, males are twice as likely to be diagnosed. However, all in all, they do not present so much differently than women,” she noted.
The take home message is for clinicians to examine all features that may lead to a diagnosis of axSpA in patients regardless of gender, Dr. Ortolan said. The study results showing that HLA-B27 and imaging are strongly associated with axSpA diagnosis in both genders in a multivariate analysis, which suggests that clinicians do not need to adopt different diagnostic strategies, she said.
The study findings were the result of a cross-sectional approach that was based on an examination of baseline data, Dr. Ortolan noted. “However, it would be really interesting to see what happens in the long term: Do these gender differences tend to increase? Does the disease have a different long-term impact in men and women? Should we treat them differently? These are open questions that need to be addressed in the future,” she said.
Dr. Ortolan and her colleagues had no relevant disclosures.
Mitchel L. Zoler contributed to this story.
SOURCE: Ortolan A et al. Ann Rheum Dis. 2018;77(Suppl 2):207-8. Abstract OP0323.
REPORTING FROM THE EULAR 2018 CONGRESS
Key clinical point: Although there are clear sex differences in early axSpA, HLA-B27 and imaging are key elements for a diagnosis of axSpA in both sexes.
Major finding: The presence of axSpA features on imaging was greater among men with axSpA than women with axSpA (78% vs. 64%; P = .007).
Study details: A cross-sectional study of baseline data from 444 women and 275 men in the Spondyloarthritis Caught Early (SPACE) cohort.
Disclosures: Dr. Ortolan and her colleagues had no relevant disclosures.
Source: Ortolan A et al. Ann Rheum Dis. 2018;77(Suppl 2):207-8. Abstract OP0323.
E-cigarette flavorings foster cardiovascular dysfunction
Flavored tobacco products are popular among current smokers, including youth, and the flavorings have been deemed ingestible, but their impact on heart health has not been studied, wrote Jennifer Fetterman, PhD, of Boston University, and her colleagues. The report was published in Arteriosclerosis, Thrombosis, and Vascular Biology.
The researchers studied nine types of flavorings used in alternative tobacco products to assess their impact on cardiovascular health.
The first part of the study comprised a population of nine nonsmokers, six nonmenthol cigarette smokers, and six menthol cigarette smokers without cardiovascular disease. The researchers isolated venous endothelial cells from each participant.
Overall, cells from both nonmenthol and menthol cigarette smokers had significantly lower nitric oxide production compared with nonsmokers (P = .003 and P = .012, respectively). In addition, the flavoring compounds menthol and eugenol impaired nitric oxide production in the cells of healthy individuals.
“Increased inflammation and a loss of nitric oxide are some of the first changes to occur leading up to cardiovascular disease and events like heart attacks and stroke, so they are considered early predictors of heart disease,” Dr. Fetterman said in a statement, adding that the “findings suggest that these flavoring additives may have serious health consequences.”
All nine flavorings induced cell death at the highest concentration tested, ranging from 10 to 100 mmol/L).
The study findings were limited by several factors, primarily a lack of data on how heating the flavorings in the in vitro part of the study might have affected toxicity in the body, the researchers noted.
“Future studies will focus on how the toxicity of the flavorings is altered with heating and characterization of the levels obtained in the circulation after use of an e-cigarette,” they said.
However, data support the need for regulation and limits on the level of flavorings used in e-cigarettes and other tobacco products, they emphasized.
“These findings suggest that flavoring compounds induce endothelial cell dysfunction in human cells similarly to the abnormal function in active cigarette smokers,” the researchers noted.
The study was funded by the National Heart, Lung, and Blood Institute; Food and Drug Administration Center for Tobacco Products; and the American Heart Association. The researchers had no financial conflicts to disclose.
SOURCE: Fetterman J et al. Arterioscler Thromb Vasc Biol. 2018. doi: 10.1161/ATVBAHA.118.311156.
Flavored tobacco products are popular among current smokers, including youth, and the flavorings have been deemed ingestible, but their impact on heart health has not been studied, wrote Jennifer Fetterman, PhD, of Boston University, and her colleagues. The report was published in Arteriosclerosis, Thrombosis, and Vascular Biology.
The researchers studied nine types of flavorings used in alternative tobacco products to assess their impact on cardiovascular health.
The first part of the study comprised a population of nine nonsmokers, six nonmenthol cigarette smokers, and six menthol cigarette smokers without cardiovascular disease. The researchers isolated venous endothelial cells from each participant.
Overall, cells from both nonmenthol and menthol cigarette smokers had significantly lower nitric oxide production compared with nonsmokers (P = .003 and P = .012, respectively). In addition, the flavoring compounds menthol and eugenol impaired nitric oxide production in the cells of healthy individuals.
“Increased inflammation and a loss of nitric oxide are some of the first changes to occur leading up to cardiovascular disease and events like heart attacks and stroke, so they are considered early predictors of heart disease,” Dr. Fetterman said in a statement, adding that the “findings suggest that these flavoring additives may have serious health consequences.”
All nine flavorings induced cell death at the highest concentration tested, ranging from 10 to 100 mmol/L).
The study findings were limited by several factors, primarily a lack of data on how heating the flavorings in the in vitro part of the study might have affected toxicity in the body, the researchers noted.
“Future studies will focus on how the toxicity of the flavorings is altered with heating and characterization of the levels obtained in the circulation after use of an e-cigarette,” they said.
However, data support the need for regulation and limits on the level of flavorings used in e-cigarettes and other tobacco products, they emphasized.
“These findings suggest that flavoring compounds induce endothelial cell dysfunction in human cells similarly to the abnormal function in active cigarette smokers,” the researchers noted.
The study was funded by the National Heart, Lung, and Blood Institute; Food and Drug Administration Center for Tobacco Products; and the American Heart Association. The researchers had no financial conflicts to disclose.
SOURCE: Fetterman J et al. Arterioscler Thromb Vasc Biol. 2018. doi: 10.1161/ATVBAHA.118.311156.
Flavored tobacco products are popular among current smokers, including youth, and the flavorings have been deemed ingestible, but their impact on heart health has not been studied, wrote Jennifer Fetterman, PhD, of Boston University, and her colleagues. The report was published in Arteriosclerosis, Thrombosis, and Vascular Biology.
The researchers studied nine types of flavorings used in alternative tobacco products to assess their impact on cardiovascular health.
The first part of the study comprised a population of nine nonsmokers, six nonmenthol cigarette smokers, and six menthol cigarette smokers without cardiovascular disease. The researchers isolated venous endothelial cells from each participant.
Overall, cells from both nonmenthol and menthol cigarette smokers had significantly lower nitric oxide production compared with nonsmokers (P = .003 and P = .012, respectively). In addition, the flavoring compounds menthol and eugenol impaired nitric oxide production in the cells of healthy individuals.
“Increased inflammation and a loss of nitric oxide are some of the first changes to occur leading up to cardiovascular disease and events like heart attacks and stroke, so they are considered early predictors of heart disease,” Dr. Fetterman said in a statement, adding that the “findings suggest that these flavoring additives may have serious health consequences.”
All nine flavorings induced cell death at the highest concentration tested, ranging from 10 to 100 mmol/L).
The study findings were limited by several factors, primarily a lack of data on how heating the flavorings in the in vitro part of the study might have affected toxicity in the body, the researchers noted.
“Future studies will focus on how the toxicity of the flavorings is altered with heating and characterization of the levels obtained in the circulation after use of an e-cigarette,” they said.
However, data support the need for regulation and limits on the level of flavorings used in e-cigarettes and other tobacco products, they emphasized.
“These findings suggest that flavoring compounds induce endothelial cell dysfunction in human cells similarly to the abnormal function in active cigarette smokers,” the researchers noted.
The study was funded by the National Heart, Lung, and Blood Institute; Food and Drug Administration Center for Tobacco Products; and the American Heart Association. The researchers had no financial conflicts to disclose.
SOURCE: Fetterman J et al. Arterioscler Thromb Vasc Biol. 2018. doi: 10.1161/ATVBAHA.118.311156.
FROM ARTERIOSCLEROSIS, THROMBOSIS, AND VASCULAR BIOLOGY
Key clinical point: Nitric oxide production was impaired in cells exposed to compounds used in alternative tobacco products.
Major finding: Nitric oxide products were significantly lower in nonmenthol and menthol cigarette smokers compared with nonsmokers (P = .003 and P = .012, respectively).
Study details: The data come from nine nonsmokers, six menthol cigarette smokers, and six nonmenthol cigarette smokers, plus in vitro cells.
Disclosures: The study was funded by the National Heart, Lung, and Blood Institute; Food and Drug Administration Center for Tobacco Products; and the American Heart Association. The researchers had no financial conflicts to disclose.
Source: Fetterman J et al. Arterioscler Thromb Vasc Biol. 2018. doi: 10.1161/ATVBAHA.118.311156.
USPSTF: Don’t add ECG for cardio risk assessment
Adding electrocardiography screening to standard cardiovascular disease assessment is not necessary for asymptomatic, low-risk adults, according to final recommendations from the U.S. Preventive Services Task Force.
In the statement published June 12 in JAMA, the USPSTF gave a D recommendation against using ECG screening to evaluate cardiovascular disease risk in asymptomatic, low-risk individuals and issued a statement that current evidence is inadequate (I statement) to evaluate the harms versus benefits of additional ECG for asymptomatic individuals who may be at medium to high risk for future cardiovascular events.
The Task Force concluded that the potential harms of screening ECG outweigh or equal potential benefits in the asymptomatic low-risk population. However, they noted clinical considerations for screening in moderate to high-risk individuals including the potential for more intensive medical management in those identified as higher risk after an ECG, balanced by the potential for harms from medication side effects or follow-up procedures.
Treatment for asymptomatic adults at increased risk for CVD may include lipid-lowering medications, tobacco cessation, and lifestyle modifications regarding diet and exercise, according to the Task Force, and guidelines already exist for many of these factors.
ECG screening could reclassify individuals as higher or lower risk, which could potentially improve health outcomes, wrote Daniel E. Jonas, MD, of the University of North Carolina, Chapel Hill, and his colleagues in the evidence report accompanying the recommendations. The researchers reviewed data from 16 studies including 77,140 individuals. However, the strength of evidence was low for the value of ECG to reclassify individuals, and no improvements in health outcomes were noted, even in high-risk populations such as diabetes patients, the researchers said.
In particular, no significant improvement from additional exercise ECG occurred in a pair of randomized controlled trials including 1,151 individuals, they noted.
The final recommendation reflects the 2017 draft statement and the 2012 final recommendation statement. The full recommendation statement is available online in JAMA and on the Task Force website.
The research was funded by the Agency for Healthcare Research and Quality under a grant from the U.S. Department of Health and Human Services. The researchers had no financial conflicts to disclose.
SOURCES: Jonas D et al. JAMA. 2018 Jun 12;319(22):2315-28; Curry S et al. JAMA. 2018 Jun 12;319(22):2308-14.
The conclusions reached by the USPSTF were warranted, based on the latest research, but may be modified by future information as the science evolves.
In contrast to the 2004 and 2012 task force statements, which were focused on coronary heart disease events, the current analysis used a measure of cardiovascular events, defined as the composite of coronary heart disease, cerebrovascular disease, and peripheral artery disease. Given that ECG parameters usually reflect the presence of coronary heart disease, their value as a predictor of cardiovascular disease in asymptomatic adults may be limited.
The evidence reviewed by the USPSTF shows that ECG screening of low-risk individuals is unlikely to prevent CVD; however, the assessment of risk remains a challenge and puts the decision on physicians based on individual risk factors. It would be an overstatement of current knowledge to conclude that patients at the higher end of the intermediate to high-risk classification would benefit from routine ECG testing with repeated measures over time,” he said.
However, risk factors aside, one special population to be considered for ECG screening is competitive athletes. Screening athletes is common in many countries, though somewhat controversial in the United States, despite its increasing use by professional and college sports team. More research is needed on the value of resting and exercise ECG as markers of CVD risk, and new data may lead researchers to reassess the value of ECG procedures and use them for improved risk classification.
Robert J. Myerburg, MD, an electrophysiologist at the University of Miami, made these comments in an editorial accompanying the article (JAMA. 2018 June 12;319[2]:2277-9). He had no financial conflicts to disclose.
The conclusions reached by the USPSTF were warranted, based on the latest research, but may be modified by future information as the science evolves.
In contrast to the 2004 and 2012 task force statements, which were focused on coronary heart disease events, the current analysis used a measure of cardiovascular events, defined as the composite of coronary heart disease, cerebrovascular disease, and peripheral artery disease. Given that ECG parameters usually reflect the presence of coronary heart disease, their value as a predictor of cardiovascular disease in asymptomatic adults may be limited.
The evidence reviewed by the USPSTF shows that ECG screening of low-risk individuals is unlikely to prevent CVD; however, the assessment of risk remains a challenge and puts the decision on physicians based on individual risk factors. It would be an overstatement of current knowledge to conclude that patients at the higher end of the intermediate to high-risk classification would benefit from routine ECG testing with repeated measures over time,” he said.
However, risk factors aside, one special population to be considered for ECG screening is competitive athletes. Screening athletes is common in many countries, though somewhat controversial in the United States, despite its increasing use by professional and college sports team. More research is needed on the value of resting and exercise ECG as markers of CVD risk, and new data may lead researchers to reassess the value of ECG procedures and use them for improved risk classification.
Robert J. Myerburg, MD, an electrophysiologist at the University of Miami, made these comments in an editorial accompanying the article (JAMA. 2018 June 12;319[2]:2277-9). He had no financial conflicts to disclose.
The conclusions reached by the USPSTF were warranted, based on the latest research, but may be modified by future information as the science evolves.
In contrast to the 2004 and 2012 task force statements, which were focused on coronary heart disease events, the current analysis used a measure of cardiovascular events, defined as the composite of coronary heart disease, cerebrovascular disease, and peripheral artery disease. Given that ECG parameters usually reflect the presence of coronary heart disease, their value as a predictor of cardiovascular disease in asymptomatic adults may be limited.
The evidence reviewed by the USPSTF shows that ECG screening of low-risk individuals is unlikely to prevent CVD; however, the assessment of risk remains a challenge and puts the decision on physicians based on individual risk factors. It would be an overstatement of current knowledge to conclude that patients at the higher end of the intermediate to high-risk classification would benefit from routine ECG testing with repeated measures over time,” he said.
However, risk factors aside, one special population to be considered for ECG screening is competitive athletes. Screening athletes is common in many countries, though somewhat controversial in the United States, despite its increasing use by professional and college sports team. More research is needed on the value of resting and exercise ECG as markers of CVD risk, and new data may lead researchers to reassess the value of ECG procedures and use them for improved risk classification.
Robert J. Myerburg, MD, an electrophysiologist at the University of Miami, made these comments in an editorial accompanying the article (JAMA. 2018 June 12;319[2]:2277-9). He had no financial conflicts to disclose.
Adding electrocardiography screening to standard cardiovascular disease assessment is not necessary for asymptomatic, low-risk adults, according to final recommendations from the U.S. Preventive Services Task Force.
In the statement published June 12 in JAMA, the USPSTF gave a D recommendation against using ECG screening to evaluate cardiovascular disease risk in asymptomatic, low-risk individuals and issued a statement that current evidence is inadequate (I statement) to evaluate the harms versus benefits of additional ECG for asymptomatic individuals who may be at medium to high risk for future cardiovascular events.
The Task Force concluded that the potential harms of screening ECG outweigh or equal potential benefits in the asymptomatic low-risk population. However, they noted clinical considerations for screening in moderate to high-risk individuals including the potential for more intensive medical management in those identified as higher risk after an ECG, balanced by the potential for harms from medication side effects or follow-up procedures.
Treatment for asymptomatic adults at increased risk for CVD may include lipid-lowering medications, tobacco cessation, and lifestyle modifications regarding diet and exercise, according to the Task Force, and guidelines already exist for many of these factors.
ECG screening could reclassify individuals as higher or lower risk, which could potentially improve health outcomes, wrote Daniel E. Jonas, MD, of the University of North Carolina, Chapel Hill, and his colleagues in the evidence report accompanying the recommendations. The researchers reviewed data from 16 studies including 77,140 individuals. However, the strength of evidence was low for the value of ECG to reclassify individuals, and no improvements in health outcomes were noted, even in high-risk populations such as diabetes patients, the researchers said.
In particular, no significant improvement from additional exercise ECG occurred in a pair of randomized controlled trials including 1,151 individuals, they noted.
The final recommendation reflects the 2017 draft statement and the 2012 final recommendation statement. The full recommendation statement is available online in JAMA and on the Task Force website.
The research was funded by the Agency for Healthcare Research and Quality under a grant from the U.S. Department of Health and Human Services. The researchers had no financial conflicts to disclose.
SOURCES: Jonas D et al. JAMA. 2018 Jun 12;319(22):2315-28; Curry S et al. JAMA. 2018 Jun 12;319(22):2308-14.
Adding electrocardiography screening to standard cardiovascular disease assessment is not necessary for asymptomatic, low-risk adults, according to final recommendations from the U.S. Preventive Services Task Force.
In the statement published June 12 in JAMA, the USPSTF gave a D recommendation against using ECG screening to evaluate cardiovascular disease risk in asymptomatic, low-risk individuals and issued a statement that current evidence is inadequate (I statement) to evaluate the harms versus benefits of additional ECG for asymptomatic individuals who may be at medium to high risk for future cardiovascular events.
The Task Force concluded that the potential harms of screening ECG outweigh or equal potential benefits in the asymptomatic low-risk population. However, they noted clinical considerations for screening in moderate to high-risk individuals including the potential for more intensive medical management in those identified as higher risk after an ECG, balanced by the potential for harms from medication side effects or follow-up procedures.
Treatment for asymptomatic adults at increased risk for CVD may include lipid-lowering medications, tobacco cessation, and lifestyle modifications regarding diet and exercise, according to the Task Force, and guidelines already exist for many of these factors.
ECG screening could reclassify individuals as higher or lower risk, which could potentially improve health outcomes, wrote Daniel E. Jonas, MD, of the University of North Carolina, Chapel Hill, and his colleagues in the evidence report accompanying the recommendations. The researchers reviewed data from 16 studies including 77,140 individuals. However, the strength of evidence was low for the value of ECG to reclassify individuals, and no improvements in health outcomes were noted, even in high-risk populations such as diabetes patients, the researchers said.
In particular, no significant improvement from additional exercise ECG occurred in a pair of randomized controlled trials including 1,151 individuals, they noted.
The final recommendation reflects the 2017 draft statement and the 2012 final recommendation statement. The full recommendation statement is available online in JAMA and on the Task Force website.
The research was funded by the Agency for Healthcare Research and Quality under a grant from the U.S. Department of Health and Human Services. The researchers had no financial conflicts to disclose.
SOURCES: Jonas D et al. JAMA. 2018 Jun 12;319(22):2315-28; Curry S et al. JAMA. 2018 Jun 12;319(22):2308-14.
FROM JAMA
Key clinical point:
Major finding: Two randomized controlled trials including 1,151 individuals found no significant improvement from additional exercise ECG.
Study details: Researchers reviewed data from 16 studies including 77,140 individuals.
Disclosures: The research was funded by the Agency for Healthcare Research and Quality under a grant from the U.S. Department of Health & Human Services. The researchers had no financial conflicts to disclose.
Sources: Jonas D et al. JAMA.2018;319[22]:2315-28; Curry S et al. JAMA.2018;319[22]:2308-14.
Suicides up 30%; risk factors go beyond diagnosed disorders
About 45,000 individuals in the United States took their own lives in 2016, and about half of them had no known mental health diagnosis at the time of death, based on data from the Centers for Disease Control and Prevention. Suicide rates rose by approximately 30% across all age groups up to age 75 years.
“Suicide is preventable; that’s why it is important to understand all the factors,” Anne Schuchat, MD, principal deputy director of the Centers for Disease Control and Prevention, said in a June 7 teleconference announcing the findings. Although mental health conditions often are seen as the cause of suicide, the results highlight the need to address other factors, including relationship problems, substance abuse, trouble with life transitions, and financial difficulties.
In a Vital Signs report published June 7, a team of CDC researchers led by Deborah M. Stone, ScD, reviewed data from suicide rates by state from 1999-2016. To examine the circumstances of suicide among individuals with and without mental health conditions, the researchers also reviewed data from the CDC’s National Violent Death Reporting System for 2015, which included 27 states.
Although rates increased among all age groups,.
Overall, 54% of the suicides in 2016 had no mental health diagnosis. Compared with those with a mental health diagnosis, those without a diagnosis were more likely to be male, part of an ethnic minority, and to have a history of homicide. In addition, those without known mental health conditions were more likely to have served in the military.
The most common causes of suicide were firearms, hanging/suffocation/strangulation, and poisoning.
Individuals without known mental health conditions were significantly more likely than those with mental health con-ditions to have used firearms (55% vs. 41%) and significantly less likely to die from hanging/suffocation/strangulation (27% vs. 31%) or poisoning (10% vs. 20%) in adjusted models, the researchers noted.
“If we only look at this as a mental health issue, we won’t make the progress that we need,” Dr. Schuchat said. She urged health professionals, community organizations, government organizations, and the public at large to learn to rec-ognize warning signs and factors that can lead to suicide.
To help achieve the national goal of a 20% reduction in the annual suicide rate by 2025, the CDC has developed a technical package of recommendations for policies, prevention strategies, and resources aimed at communities and states.
In addition, “Health care providers have an important role to play” to prevent those at risk for suicide from falling through the cracks, Dr. Schuchat said. She noted the importance of protocols for patient safety and support, and she stressed that health providers should be especially vigilant during times of life transition such as changes in relationship stages, leaving for college, retirement, financial insecurity, or the loss of a loved one.
“We don’t think we can just leave this to the mental health discipline,” Dr. Schuchat noted. “Preventing suicide takes everyone; everyone in the community can help by learning the warning signs,” she said.
[email protected]
SOURCE: Stone D et al. MMWR. 2018 Jun 7; 67(22):617-24
About 45,000 individuals in the United States took their own lives in 2016, and about half of them had no known mental health diagnosis at the time of death, based on data from the Centers for Disease Control and Prevention. Suicide rates rose by approximately 30% across all age groups up to age 75 years.
“Suicide is preventable; that’s why it is important to understand all the factors,” Anne Schuchat, MD, principal deputy director of the Centers for Disease Control and Prevention, said in a June 7 teleconference announcing the findings. Although mental health conditions often are seen as the cause of suicide, the results highlight the need to address other factors, including relationship problems, substance abuse, trouble with life transitions, and financial difficulties.
In a Vital Signs report published June 7, a team of CDC researchers led by Deborah M. Stone, ScD, reviewed data from suicide rates by state from 1999-2016. To examine the circumstances of suicide among individuals with and without mental health conditions, the researchers also reviewed data from the CDC’s National Violent Death Reporting System for 2015, which included 27 states.
Although rates increased among all age groups,.
Overall, 54% of the suicides in 2016 had no mental health diagnosis. Compared with those with a mental health diagnosis, those without a diagnosis were more likely to be male, part of an ethnic minority, and to have a history of homicide. In addition, those without known mental health conditions were more likely to have served in the military.
The most common causes of suicide were firearms, hanging/suffocation/strangulation, and poisoning.
Individuals without known mental health conditions were significantly more likely than those with mental health con-ditions to have used firearms (55% vs. 41%) and significantly less likely to die from hanging/suffocation/strangulation (27% vs. 31%) or poisoning (10% vs. 20%) in adjusted models, the researchers noted.
“If we only look at this as a mental health issue, we won’t make the progress that we need,” Dr. Schuchat said. She urged health professionals, community organizations, government organizations, and the public at large to learn to rec-ognize warning signs and factors that can lead to suicide.
To help achieve the national goal of a 20% reduction in the annual suicide rate by 2025, the CDC has developed a technical package of recommendations for policies, prevention strategies, and resources aimed at communities and states.
In addition, “Health care providers have an important role to play” to prevent those at risk for suicide from falling through the cracks, Dr. Schuchat said. She noted the importance of protocols for patient safety and support, and she stressed that health providers should be especially vigilant during times of life transition such as changes in relationship stages, leaving for college, retirement, financial insecurity, or the loss of a loved one.
“We don’t think we can just leave this to the mental health discipline,” Dr. Schuchat noted. “Preventing suicide takes everyone; everyone in the community can help by learning the warning signs,” she said.
[email protected]
SOURCE: Stone D et al. MMWR. 2018 Jun 7; 67(22):617-24
About 45,000 individuals in the United States took their own lives in 2016, and about half of them had no known mental health diagnosis at the time of death, based on data from the Centers for Disease Control and Prevention. Suicide rates rose by approximately 30% across all age groups up to age 75 years.
“Suicide is preventable; that’s why it is important to understand all the factors,” Anne Schuchat, MD, principal deputy director of the Centers for Disease Control and Prevention, said in a June 7 teleconference announcing the findings. Although mental health conditions often are seen as the cause of suicide, the results highlight the need to address other factors, including relationship problems, substance abuse, trouble with life transitions, and financial difficulties.
In a Vital Signs report published June 7, a team of CDC researchers led by Deborah M. Stone, ScD, reviewed data from suicide rates by state from 1999-2016. To examine the circumstances of suicide among individuals with and without mental health conditions, the researchers also reviewed data from the CDC’s National Violent Death Reporting System for 2015, which included 27 states.
Although rates increased among all age groups,.
Overall, 54% of the suicides in 2016 had no mental health diagnosis. Compared with those with a mental health diagnosis, those without a diagnosis were more likely to be male, part of an ethnic minority, and to have a history of homicide. In addition, those without known mental health conditions were more likely to have served in the military.
The most common causes of suicide were firearms, hanging/suffocation/strangulation, and poisoning.
Individuals without known mental health conditions were significantly more likely than those with mental health con-ditions to have used firearms (55% vs. 41%) and significantly less likely to die from hanging/suffocation/strangulation (27% vs. 31%) or poisoning (10% vs. 20%) in adjusted models, the researchers noted.
“If we only look at this as a mental health issue, we won’t make the progress that we need,” Dr. Schuchat said. She urged health professionals, community organizations, government organizations, and the public at large to learn to rec-ognize warning signs and factors that can lead to suicide.
To help achieve the national goal of a 20% reduction in the annual suicide rate by 2025, the CDC has developed a technical package of recommendations for policies, prevention strategies, and resources aimed at communities and states.
In addition, “Health care providers have an important role to play” to prevent those at risk for suicide from falling through the cracks, Dr. Schuchat said. She noted the importance of protocols for patient safety and support, and she stressed that health providers should be especially vigilant during times of life transition such as changes in relationship stages, leaving for college, retirement, financial insecurity, or the loss of a loved one.
“We don’t think we can just leave this to the mental health discipline,” Dr. Schuchat noted. “Preventing suicide takes everyone; everyone in the community can help by learning the warning signs,” she said.
[email protected]
SOURCE: Stone D et al. MMWR. 2018 Jun 7; 67(22):617-24