PHILADELPHIA – Migraine patients fared as well when managed for a year by telemedicine as when managed by a 12-month series of routine office visits in a single-center, randomized trial with 40 patients, the first reported randomized study of the impact of true telemedicine on mid-term migraine management.

“Telemedicine was viable and produced similar outcomes at 1 year in a highly disabled cohort,” Deborah I. Friedman, MD, said at the annual meeting of the American Headache Society. Many patients expressed high satisfaction with the approach. In addition to resulting in predictably shorter travel times for patients, it also linked with a cut in the consultation length by about a quarter, reported Dr. Friedman, a professor of neurology and chief of the division of headache medicine at UT Southwestern Medical Center in Dallas.

“There is a lot of opportunity for telemedicine, particularly in headache medicine because usually after the first visit we mostly just talk with patients with no further examinations, so it lends itself to telemedicine. It extends your reach.” Dr. Friedman said in a video interview. It is particularly attractive to patients who live a substantial distance from the clinic or find it hard to fit an office visit into their schedule, but some participants said they preferred the direct interaction of an office visit, she noted.

In addition to showing the efficacy of telemedicine in this setting, Dr. Friedman said that she hoped the findings may help pave the way for easier insurance payment for telemedicine consultations with migraineurs.

“One of the main reasons I did this study was to provide evidence to use for compensation for telemedicine visits. It will be good to have evidence in the medical literature that the outcomes are similar and that nothing is lost in patient care with telemedicine,” she said.

The study randomized 40 patients scheduled to see Dr. Friedman for the first time for a migraine consultation and to start treatment. After all patients had their initial office visit and examination, 22 of the patients entered the telemedicine arm and had follow-up consultations after 4-6 weeks, and after 3, 6, 9, and 12 months. The remaining 18 patients were randomized to receive these consultations in the office. Eighteen of the telemedicine patients and 12 of the in-office patients returned for a 12-month assessment. Patients averaged about 40 years old, they had actual or potential travel distances for in-office visits that in some cases exceeded 300 miles one way, and their Migraine Disability Assessment score averaged just above 40.

The telmedicine patients completed 93% of their visits compared with 88% of the in-office patients, a difference that was not statistically different. Migraine Disability Assessment scores improved by an average of 24 points in the telemedicine patients and by an average 19 points among the in-office controls, a difference that was not significant. The two groups also showed similar levels of treatment response for reductions in number of headache days and headache severity improvement. Average session length was 25 minutes with telemedicine and 34 minutes in office, a statistically significant difference that Dr. Friedman attributed to the interest by patients who have traveled long distances to see her to “get their money’s worth” from their visit.


Dr. Friedman highlighted the importance of having the visual aspect of a telemedicine consultation in addition to the conversation. For the trial the audio-visual link was via a standard laptop connection. Some patients assigned to telemedicine voiced regret over not being able to be examined, immediately start a new treatment, or receive drug samples. Dr. Friedman said that she couldn’t think of any migraine patients to whom she wouldn’t offer the option of telemedicine visits following an initial, in-person visit. But her use of telemedicine in routine practice is on hold right now as her institution, UT Southwestern, is still working out its consent and billing system, she said.

The study received partial funding from Merck. Dr. Friedman had no relevant disclosures.

mzoler@mdedge.com

On Twitter @mitchelzoler

SOURCE: Friedman DI. Headache. 2019 June;59[S1]:1-208, LBOR01.

PHILADELPHIA – Migraine patients fared as well when managed for a year by telemedicine as when managed by a 12-month series of routine office visits in a single-center, randomized trial with 40 patients, the first reported randomized study of the impact of true telemedicine on mid-term migraine management.

“Telemedicine was viable and produced similar outcomes at 1 year in a highly disabled cohort,” Deborah I. Friedman, MD, said at the annual meeting of the American Headache Society. Many patients expressed high satisfaction with the approach. In addition to resulting in predictably shorter travel times for patients, it also linked with a cut in the consultation length by about a quarter, reported Dr. Friedman, a professor of neurology and chief of the division of headache medicine at UT Southwestern Medical Center in Dallas.

“There is a lot of opportunity for telemedicine, particularly in headache medicine because usually after the first visit we mostly just talk with patients with no further examinations, so it lends itself to telemedicine. It extends your reach.” Dr. Friedman said in a video interview. It is particularly attractive to patients who live a substantial distance from the clinic or find it hard to fit an office visit into their schedule, but some participants said they preferred the direct interaction of an office visit, she noted.

In addition to showing the efficacy of telemedicine in this setting, Dr. Friedman said that she hoped the findings may help pave the way for easier insurance payment for telemedicine consultations with migraineurs.

“One of the main reasons I did this study was to provide evidence to use for compensation for telemedicine visits. It will be good to have evidence in the medical literature that the outcomes are similar and that nothing is lost in patient care with telemedicine,” she said.

The study randomized 40 patients scheduled to see Dr. Friedman for the first time for a migraine consultation and to start treatment. After all patients had their initial office visit and examination, 22 of the patients entered the telemedicine arm and had follow-up consultations after 4-6 weeks, and after 3, 6, 9, and 12 months. The remaining 18 patients were randomized to receive these consultations in the office. Eighteen of the telemedicine patients and 12 of the in-office patients returned for a 12-month assessment. Patients averaged about 40 years old, they had actual or potential travel distances for in-office visits that in some cases exceeded 300 miles one way, and their Migraine Disability Assessment score averaged just above 40.

The telmedicine patients completed 93% of their visits compared with 88% of the in-office patients, a difference that was not statistically different. Migraine Disability Assessment scores improved by an average of 24 points in the telemedicine patients and by an average 19 points among the in-office controls, a difference that was not significant. The two groups also showed similar levels of treatment response for reductions in number of headache days and headache severity improvement. Average session length was 25 minutes with telemedicine and 34 minutes in office, a statistically significant difference that Dr. Friedman attributed to the interest by patients who have traveled long distances to see her to “get their money’s worth” from their visit.


Dr. Friedman highlighted the importance of having the visual aspect of a telemedicine consultation in addition to the conversation. For the trial the audio-visual link was via a standard laptop connection. Some patients assigned to telemedicine voiced regret over not being able to be examined, immediately start a new treatment, or receive drug samples. Dr. Friedman said that she couldn’t think of any migraine patients to whom she wouldn’t offer the option of telemedicine visits following an initial, in-person visit. But her use of telemedicine in routine practice is on hold right now as her institution, UT Southwestern, is still working out its consent and billing system, she said.

The study received partial funding from Merck. Dr. Friedman had no relevant disclosures.

mzoler@mdedge.com

On Twitter @mitchelzoler

SOURCE: Friedman DI. Headache. 2019 June;59[S1]:1-208, LBOR01.

PHILADELPHIA – Migraine patients fared as well when managed for a year by telemedicine as when managed by a 12-month series of routine office visits in a single-center, randomized trial with 40 patients, the first reported randomized study of the impact of true telemedicine on mid-term migraine management.

“Telemedicine was viable and produced similar outcomes at 1 year in a highly disabled cohort,” Deborah I. Friedman, MD, said at the annual meeting of the American Headache Society. Many patients expressed high satisfaction with the approach. In addition to resulting in predictably shorter travel times for patients, it also linked with a cut in the consultation length by about a quarter, reported Dr. Friedman, a professor of neurology and chief of the division of headache medicine at UT Southwestern Medical Center in Dallas.

“There is a lot of opportunity for telemedicine, particularly in headache medicine because usually after the first visit we mostly just talk with patients with no further examinations, so it lends itself to telemedicine. It extends your reach.” Dr. Friedman said in a video interview. It is particularly attractive to patients who live a substantial distance from the clinic or find it hard to fit an office visit into their schedule, but some participants said they preferred the direct interaction of an office visit, she noted.

In addition to showing the efficacy of telemedicine in this setting, Dr. Friedman said that she hoped the findings may help pave the way for easier insurance payment for telemedicine consultations with migraineurs.

“One of the main reasons I did this study was to provide evidence to use for compensation for telemedicine visits. It will be good to have evidence in the medical literature that the outcomes are similar and that nothing is lost in patient care with telemedicine,” she said.

The study randomized 40 patients scheduled to see Dr. Friedman for the first time for a migraine consultation and to start treatment. After all patients had their initial office visit and examination, 22 of the patients entered the telemedicine arm and had follow-up consultations after 4-6 weeks, and after 3, 6, 9, and 12 months. The remaining 18 patients were randomized to receive these consultations in the office. Eighteen of the telemedicine patients and 12 of the in-office patients returned for a 12-month assessment. Patients averaged about 40 years old, they had actual or potential travel distances for in-office visits that in some cases exceeded 300 miles one way, and their Migraine Disability Assessment score averaged just above 40.

The telmedicine patients completed 93% of their visits compared with 88% of the in-office patients, a difference that was not statistically different. Migraine Disability Assessment scores improved by an average of 24 points in the telemedicine patients and by an average 19 points among the in-office controls, a difference that was not significant. The two groups also showed similar levels of treatment response for reductions in number of headache days and headache severity improvement. Average session length was 25 minutes with telemedicine and 34 minutes in office, a statistically significant difference that Dr. Friedman attributed to the interest by patients who have traveled long distances to see her to “get their money’s worth” from their visit.


Dr. Friedman highlighted the importance of having the visual aspect of a telemedicine consultation in addition to the conversation. For the trial the audio-visual link was via a standard laptop connection. Some patients assigned to telemedicine voiced regret over not being able to be examined, immediately start a new treatment, or receive drug samples. Dr. Friedman said that she couldn’t think of any migraine patients to whom she wouldn’t offer the option of telemedicine visits following an initial, in-person visit. But her use of telemedicine in routine practice is on hold right now as her institution, UT Southwestern, is still working out its consent and billing system, she said.

The study received partial funding from Merck. Dr. Friedman had no relevant disclosures.

mzoler@mdedge.com

On Twitter @mitchelzoler

SOURCE: Friedman DI. Headache. 2019 June;59[S1]:1-208, LBOR01.

Among patients with osteoporosis who have diminished long-term response to bisphosphonate therapy, the addition of eldecalcitol may reduce bone turnover markers and increase bone mineral density, according a study in Osteoporosis and Sarcopenia.

Bisphosphonates may increase bone mineral density, but their efficacy “can diminish over longer treatment periods, and bone mineral density plateaus and even decreases have been encountered regardless of the bisphosphonate usage,” said lead study author Mikio Kamimura, MD, PhD, a researcher at the Kamimura Orthopedic Clinic’s Center of Osteoporosis and Spinal Disorders in Matsumoto, Japan, and colleagues.

Eldecalcitol is an active vitamin D₃ derivative approved in Japan for the treatment of osteoporosis. A prior study suggested that bisphosphonate therapy combined with eldecalcitol is more effective than bisphosphonate therapy combined with alfacalcidol, another vitamin D analog, for the treatment of osteoporosis (Tohoku J Exp Med. 2015 Dec;237[4]:339-43.). Investigators had not studied the additive effects of eldecalcitol in patients who are poor responders to long-term bisphosphonate therapy, however.

To examine this question, researchers in Japan conducted a prospective cohort study. Dr. Kamimura and colleagues analyzed data from 42 postmenopausal Japanese women with primary osteoporosis who were poor responders to bisphosphonates – that is, their low lumbar bone mineral density or bilateral total hip bone mineral density did not apparently increase with chronic bisphosphonate treatment over 2 years. The patients had an average age of about 73 years. They received bisphosphonate therapy with alendronate, risedronate, or minodronate. During the study, participants added daily oral eldecalcitol 0.75 mcg/day after breakfast.

The researchers measured markers of bone formation and bone resorption before bisphosphonate therapy, before adding eldecalcitol, and 4 months after starting eldecalcitol. They also assessed measures of bone mineral density.

Serum bone alkaline phosphatase, a bone formation marker, and urinary N-terminal telopeptide of type I collagen, a bone resorption marker, significantly decreased with bisphosphonate therapy. Added eldecalcitol decreased both bone turnover markers further.

Average low lumbar bone mineral density increase rate was 0.2% from 2 to 1 years before eldecalcitol administration, −0.7% during the year before eldecalcitol administration, and 2.9% during 1 year of eldecalcitol therapy. Similarly, mean increase rates of bilateral total hip bone mineral density were 0.2%, −0.7%, and 1.2%, respectively. Mean femoral neck bone mineral density increase rate was 1.1% after eldecalcitol administration, whereas the cohort had no gains with bisphosphonate therapy alone.

In osteoporotic patients exhibiting a poor response to long-term bisphosphonate therapy, the addition of eldecalcitol may represent “a good treatment option,” the authors concluded.

The small sample size, short follow-up period, and lack of evaluation of fracture prevention are limitations of the study, and further studies are needed to confirm these results, the researchers acknowledged.

The authors reported no relevant conflicts of interest.
jremaly@mdedge.com

SOURCE: Kamimura M et al. Osteoporos Sarcopenia. 2019 Jun 28. doi: 10.1016/j.afos.2019.06.001.

Among patients with osteoporosis who have diminished long-term response to bisphosphonate therapy, the addition of eldecalcitol may reduce bone turnover markers and increase bone mineral density, according a study in Osteoporosis and Sarcopenia.

Bisphosphonates may increase bone mineral density, but their efficacy “can diminish over longer treatment periods, and bone mineral density plateaus and even decreases have been encountered regardless of the bisphosphonate usage,” said lead study author Mikio Kamimura, MD, PhD, a researcher at the Kamimura Orthopedic Clinic’s Center of Osteoporosis and Spinal Disorders in Matsumoto, Japan, and colleagues.

Eldecalcitol is an active vitamin D₃ derivative approved in Japan for the treatment of osteoporosis. A prior study suggested that bisphosphonate therapy combined with eldecalcitol is more effective than bisphosphonate therapy combined with alfacalcidol, another vitamin D analog, for the treatment of osteoporosis (Tohoku J Exp Med. 2015 Dec;237[4]:339-43.). Investigators had not studied the additive effects of eldecalcitol in patients who are poor responders to long-term bisphosphonate therapy, however.

To examine this question, researchers in Japan conducted a prospective cohort study. Dr. Kamimura and colleagues analyzed data from 42 postmenopausal Japanese women with primary osteoporosis who were poor responders to bisphosphonates – that is, their low lumbar bone mineral density or bilateral total hip bone mineral density did not apparently increase with chronic bisphosphonate treatment over 2 years. The patients had an average age of about 73 years. They received bisphosphonate therapy with alendronate, risedronate, or minodronate. During the study, participants added daily oral eldecalcitol 0.75 mcg/day after breakfast.

The researchers measured markers of bone formation and bone resorption before bisphosphonate therapy, before adding eldecalcitol, and 4 months after starting eldecalcitol. They also assessed measures of bone mineral density.

Serum bone alkaline phosphatase, a bone formation marker, and urinary N-terminal telopeptide of type I collagen, a bone resorption marker, significantly decreased with bisphosphonate therapy. Added eldecalcitol decreased both bone turnover markers further.

Average low lumbar bone mineral density increase rate was 0.2% from 2 to 1 years before eldecalcitol administration, −0.7% during the year before eldecalcitol administration, and 2.9% during 1 year of eldecalcitol therapy. Similarly, mean increase rates of bilateral total hip bone mineral density were 0.2%, −0.7%, and 1.2%, respectively. Mean femoral neck bone mineral density increase rate was 1.1% after eldecalcitol administration, whereas the cohort had no gains with bisphosphonate therapy alone.

In osteoporotic patients exhibiting a poor response to long-term bisphosphonate therapy, the addition of eldecalcitol may represent “a good treatment option,” the authors concluded.

The small sample size, short follow-up period, and lack of evaluation of fracture prevention are limitations of the study, and further studies are needed to confirm these results, the researchers acknowledged.

The authors reported no relevant conflicts of interest.
jremaly@mdedge.com

SOURCE: Kamimura M et al. Osteoporos Sarcopenia. 2019 Jun 28. doi: 10.1016/j.afos.2019.06.001.

Among patients with osteoporosis who have diminished long-term response to bisphosphonate therapy, the addition of eldecalcitol may reduce bone turnover markers and increase bone mineral density, according a study in Osteoporosis and Sarcopenia.

Bisphosphonates may increase bone mineral density, but their efficacy “can diminish over longer treatment periods, and bone mineral density plateaus and even decreases have been encountered regardless of the bisphosphonate usage,” said lead study author Mikio Kamimura, MD, PhD, a researcher at the Kamimura Orthopedic Clinic’s Center of Osteoporosis and Spinal Disorders in Matsumoto, Japan, and colleagues.

Eldecalcitol is an active vitamin D₃ derivative approved in Japan for the treatment of osteoporosis. A prior study suggested that bisphosphonate therapy combined with eldecalcitol is more effective than bisphosphonate therapy combined with alfacalcidol, another vitamin D analog, for the treatment of osteoporosis (Tohoku J Exp Med. 2015 Dec;237[4]:339-43.). Investigators had not studied the additive effects of eldecalcitol in patients who are poor responders to long-term bisphosphonate therapy, however.

To examine this question, researchers in Japan conducted a prospective cohort study. Dr. Kamimura and colleagues analyzed data from 42 postmenopausal Japanese women with primary osteoporosis who were poor responders to bisphosphonates – that is, their low lumbar bone mineral density or bilateral total hip bone mineral density did not apparently increase with chronic bisphosphonate treatment over 2 years. The patients had an average age of about 73 years. They received bisphosphonate therapy with alendronate, risedronate, or minodronate. During the study, participants added daily oral eldecalcitol 0.75 mcg/day after breakfast.

The researchers measured markers of bone formation and bone resorption before bisphosphonate therapy, before adding eldecalcitol, and 4 months after starting eldecalcitol. They also assessed measures of bone mineral density.

Serum bone alkaline phosphatase, a bone formation marker, and urinary N-terminal telopeptide of type I collagen, a bone resorption marker, significantly decreased with bisphosphonate therapy. Added eldecalcitol decreased both bone turnover markers further.

Average low lumbar bone mineral density increase rate was 0.2% from 2 to 1 years before eldecalcitol administration, −0.7% during the year before eldecalcitol administration, and 2.9% during 1 year of eldecalcitol therapy. Similarly, mean increase rates of bilateral total hip bone mineral density were 0.2%, −0.7%, and 1.2%, respectively. Mean femoral neck bone mineral density increase rate was 1.1% after eldecalcitol administration, whereas the cohort had no gains with bisphosphonate therapy alone.

In osteoporotic patients exhibiting a poor response to long-term bisphosphonate therapy, the addition of eldecalcitol may represent “a good treatment option,” the authors concluded.

The small sample size, short follow-up period, and lack of evaluation of fracture prevention are limitations of the study, and further studies are needed to confirm these results, the researchers acknowledged.

The authors reported no relevant conflicts of interest.
jremaly@mdedge.com

SOURCE: Kamimura M et al. Osteoporos Sarcopenia. 2019 Jun 28. doi: 10.1016/j.afos.2019.06.001.

PHILADELPHIA – The headache field is not free of the gender bias that affects medicine in general, said Elizabeth W. Loder, MD, chief of the Division of Headache and Pain at Brigham and Women’s Hospital in Boston, at the annual meeting of the American Headache Society. Women accrue credentials and are accorded respect as headache experts more slowly than men, she said. They are underrepresented among the speakers at headache conferences and are less likely than men to be invited to write editorials for peer-reviewed publications. Furthermore, a significant proportion of female headache specialists experiences sexual harassment in their professional environments.

Bias also affects interactions between patients and headache specialists, said Dr. Loder. Regardless of their gender, patients expect female care providers to be sympathetic and understanding. If they perceive that a female physician does not sufficiently display these attributes, they often write critical reviews of them on the Internet. In contrast, male physicians are not expected to be particularly caring, and patients praise them highly when they are.

Recognition of these biases is increasing, however. Representation of women in professional societies and on conference programs will improve, and emerging codes of conduct will reduce sexual harassment, said Dr. Loder. Headache specialists can take various steps, such as offering recognition and encouragement, to make the field more welcoming to women and to other disadvantaged groups.

egreb@mdedge.com

PHILADELPHIA – The headache field is not free of the gender bias that affects medicine in general, said Elizabeth W. Loder, MD, chief of the Division of Headache and Pain at Brigham and Women’s Hospital in Boston, at the annual meeting of the American Headache Society. Women accrue credentials and are accorded respect as headache experts more slowly than men, she said. They are underrepresented among the speakers at headache conferences and are less likely than men to be invited to write editorials for peer-reviewed publications. Furthermore, a significant proportion of female headache specialists experiences sexual harassment in their professional environments.

Bias also affects interactions between patients and headache specialists, said Dr. Loder. Regardless of their gender, patients expect female care providers to be sympathetic and understanding. If they perceive that a female physician does not sufficiently display these attributes, they often write critical reviews of them on the Internet. In contrast, male physicians are not expected to be particularly caring, and patients praise them highly when they are.

Recognition of these biases is increasing, however. Representation of women in professional societies and on conference programs will improve, and emerging codes of conduct will reduce sexual harassment, said Dr. Loder. Headache specialists can take various steps, such as offering recognition and encouragement, to make the field more welcoming to women and to other disadvantaged groups.

egreb@mdedge.com

PHILADELPHIA – The headache field is not free of the gender bias that affects medicine in general, said Elizabeth W. Loder, MD, chief of the Division of Headache and Pain at Brigham and Women’s Hospital in Boston, at the annual meeting of the American Headache Society. Women accrue credentials and are accorded respect as headache experts more slowly than men, she said. They are underrepresented among the speakers at headache conferences and are less likely than men to be invited to write editorials for peer-reviewed publications. Furthermore, a significant proportion of female headache specialists experiences sexual harassment in their professional environments.

Bias also affects interactions between patients and headache specialists, said Dr. Loder. Regardless of their gender, patients expect female care providers to be sympathetic and understanding. If they perceive that a female physician does not sufficiently display these attributes, they often write critical reviews of them on the Internet. In contrast, male physicians are not expected to be particularly caring, and patients praise them highly when they are.

Recognition of these biases is increasing, however. Representation of women in professional societies and on conference programs will improve, and emerging codes of conduct will reduce sexual harassment, said Dr. Loder. Headache specialists can take various steps, such as offering recognition and encouragement, to make the field more welcoming to women and to other disadvantaged groups.

egreb@mdedge.com

PHILADELPHIA – More than one-third of patients with migraine who take prescription medications use opioids, although guidelines recommend against it, according to a study presented at the annual meeting of the American Headache Society. Opioid use among migraineurs is associated with indicators of poor health, such as high body mass index (BMI), high pain scores, and cardiovascular comorbidities. Some variables associated with opioid use are modifiable.

Mitchel L. Zoler/MDedge News

Medical associations do not recommend opioid use for migraine because it may increase the risks of dependence, suboptimal outcomes, and new-onset chronic migraine. Richard B. Lipton, MD, Edwin S. Lowe Chair in neurology at Albert Einstein College of Medicine in Bronx, New York, and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study to identify variables associated with opioid use among patients who treat their headaches with acute prescription medications.

Using a web panel that was demographically similar to the U.S. population, CaMEO identified people with migraine, based on the criteria of the International Classification of Headache Disorders, 3rd Edition. Dr. Lipton and colleagues examined participants who reported currently using or having on hand acute prescription pain medication to treat headaches. The researchers compared the features (e.g., demographics, attack frequency, treatment choices, headache-related disability, and comorbidity) of self-reported opioid users with those of nonusers. They created nested, multivariable, binary logistic regression models to evaluate opioid use or nonuse as the outcome. Dr. Lipton and colleagues entered covariates in blocks (i.e., sociodemographics, headache and respondent characteristics, psychiatric comorbidities, emergency facility use for headache in the preceding 6 months, and one or more cardiovascular [CV] comorbidity) and removed nonsignificant sociodemographic variables from the model.

The researchers identified 2,388 respondents with migraine who currently used acute prescription medications for headache. Of this group, 867 (36.3%) used opioids. Compared with opioid nonusers, opioid users had significant increases in monthly headache days; frequency of emergency care use for headache within the past 6 months; medication overuse frequency; presence of allodynia, depression, anxiety, and CV comorbidity; Total Pain Index (TPI) scores; and diabetes diagnoses.

Factors significantly associated with opioid use included male sex (odds ratio [OR], 1.74); increasing body mass index BMI (OR, 1.02); allodynia (OR, 1.39); increasing monthly headache day frequency; increasing TPI scores excluding the head, face, and neck (1.32); anxiety (OR, 1.37); depression (OR, 1.50); one or more CV comorbidity (OR, 1.56); and emergency facility use for headache in the past 6 months (OR, 1.73). The OR of opioid use was 1.37 in patients with a monthly headache frequency of 10-14 days and 1.62 in patients with a frequency of 15 or more days, compared with patients with a monthly headache frequency of 0-4 days.

Receiving a diagnosis of migraine or chronic migraine was associated with a significantly lower likelihood of opioid use (OR, 0.38).

Allergan funded the CaMEO study and paid Dr. Lipton for consulting services.

egreb@mdedge.com

SOURCE: Lipton R et al. AHS 2019. Abstract 629332.

PHILADELPHIA – More than one-third of patients with migraine who take prescription medications use opioids, although guidelines recommend against it, according to a study presented at the annual meeting of the American Headache Society. Opioid use among migraineurs is associated with indicators of poor health, such as high body mass index (BMI), high pain scores, and cardiovascular comorbidities. Some variables associated with opioid use are modifiable.

Mitchel L. Zoler/MDedge News

Medical associations do not recommend opioid use for migraine because it may increase the risks of dependence, suboptimal outcomes, and new-onset chronic migraine. Richard B. Lipton, MD, Edwin S. Lowe Chair in neurology at Albert Einstein College of Medicine in Bronx, New York, and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study to identify variables associated with opioid use among patients who treat their headaches with acute prescription medications.

Using a web panel that was demographically similar to the U.S. population, CaMEO identified people with migraine, based on the criteria of the International Classification of Headache Disorders, 3rd Edition. Dr. Lipton and colleagues examined participants who reported currently using or having on hand acute prescription pain medication to treat headaches. The researchers compared the features (e.g., demographics, attack frequency, treatment choices, headache-related disability, and comorbidity) of self-reported opioid users with those of nonusers. They created nested, multivariable, binary logistic regression models to evaluate opioid use or nonuse as the outcome. Dr. Lipton and colleagues entered covariates in blocks (i.e., sociodemographics, headache and respondent characteristics, psychiatric comorbidities, emergency facility use for headache in the preceding 6 months, and one or more cardiovascular [CV] comorbidity) and removed nonsignificant sociodemographic variables from the model.

The researchers identified 2,388 respondents with migraine who currently used acute prescription medications for headache. Of this group, 867 (36.3%) used opioids. Compared with opioid nonusers, opioid users had significant increases in monthly headache days; frequency of emergency care use for headache within the past 6 months; medication overuse frequency; presence of allodynia, depression, anxiety, and CV comorbidity; Total Pain Index (TPI) scores; and diabetes diagnoses.

Factors significantly associated with opioid use included male sex (odds ratio [OR], 1.74); increasing body mass index BMI (OR, 1.02); allodynia (OR, 1.39); increasing monthly headache day frequency; increasing TPI scores excluding the head, face, and neck (1.32); anxiety (OR, 1.37); depression (OR, 1.50); one or more CV comorbidity (OR, 1.56); and emergency facility use for headache in the past 6 months (OR, 1.73). The OR of opioid use was 1.37 in patients with a monthly headache frequency of 10-14 days and 1.62 in patients with a frequency of 15 or more days, compared with patients with a monthly headache frequency of 0-4 days.

Receiving a diagnosis of migraine or chronic migraine was associated with a significantly lower likelihood of opioid use (OR, 0.38).

Allergan funded the CaMEO study and paid Dr. Lipton for consulting services.

egreb@mdedge.com

SOURCE: Lipton R et al. AHS 2019. Abstract 629332.

PHILADELPHIA – More than one-third of patients with migraine who take prescription medications use opioids, although guidelines recommend against it, according to a study presented at the annual meeting of the American Headache Society. Opioid use among migraineurs is associated with indicators of poor health, such as high body mass index (BMI), high pain scores, and cardiovascular comorbidities. Some variables associated with opioid use are modifiable.

Mitchel L. Zoler/MDedge News

Medical associations do not recommend opioid use for migraine because it may increase the risks of dependence, suboptimal outcomes, and new-onset chronic migraine. Richard B. Lipton, MD, Edwin S. Lowe Chair in neurology at Albert Einstein College of Medicine in Bronx, New York, and colleagues analyzed data from the Chronic Migraine Epidemiology and Outcomes (CaMEO) study to identify variables associated with opioid use among patients who treat their headaches with acute prescription medications.

Using a web panel that was demographically similar to the U.S. population, CaMEO identified people with migraine, based on the criteria of the International Classification of Headache Disorders, 3rd Edition. Dr. Lipton and colleagues examined participants who reported currently using or having on hand acute prescription pain medication to treat headaches. The researchers compared the features (e.g., demographics, attack frequency, treatment choices, headache-related disability, and comorbidity) of self-reported opioid users with those of nonusers. They created nested, multivariable, binary logistic regression models to evaluate opioid use or nonuse as the outcome. Dr. Lipton and colleagues entered covariates in blocks (i.e., sociodemographics, headache and respondent characteristics, psychiatric comorbidities, emergency facility use for headache in the preceding 6 months, and one or more cardiovascular [CV] comorbidity) and removed nonsignificant sociodemographic variables from the model.

The researchers identified 2,388 respondents with migraine who currently used acute prescription medications for headache. Of this group, 867 (36.3%) used opioids. Compared with opioid nonusers, opioid users had significant increases in monthly headache days; frequency of emergency care use for headache within the past 6 months; medication overuse frequency; presence of allodynia, depression, anxiety, and CV comorbidity; Total Pain Index (TPI) scores; and diabetes diagnoses.

Factors significantly associated with opioid use included male sex (odds ratio [OR], 1.74); increasing body mass index BMI (OR, 1.02); allodynia (OR, 1.39); increasing monthly headache day frequency; increasing TPI scores excluding the head, face, and neck (1.32); anxiety (OR, 1.37); depression (OR, 1.50); one or more CV comorbidity (OR, 1.56); and emergency facility use for headache in the past 6 months (OR, 1.73). The OR of opioid use was 1.37 in patients with a monthly headache frequency of 10-14 days and 1.62 in patients with a frequency of 15 or more days, compared with patients with a monthly headache frequency of 0-4 days.

Receiving a diagnosis of migraine or chronic migraine was associated with a significantly lower likelihood of opioid use (OR, 0.38).

Allergan funded the CaMEO study and paid Dr. Lipton for consulting services.

egreb@mdedge.com

SOURCE: Lipton R et al. AHS 2019. Abstract 629332.

PHILADELPHIA – Monthly or quarterly treatment with fremanezumab provides significant and clinically meaningful reductions in migraine days at 4 weeks, compared with placebo, in patients with inadequate responses to as many as four classes of preventive medications for migraine, according to research presented at the annual meeting of the American Headache Society. Fremanezumab may be an effective treatment for a population that otherwise is difficult to treat, said the researchers.

Fremanezumab is a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP). Previous trials have supported the treatment’s efficacy for the preventive treatment of episodic and chronic migraine in adults. Egilius L. H. Spierings, MD, PhD, a clinical professor of neurology at Tufts Medical Center in Boston and the founder, medical director, and principal investigator at MedVadis Research in Watertown, Massachusetts, and colleagues conducted the phase 3 FOCUS study to examine fremanezumab’s efficacy at preventing migraine in adults with chronic or episodic migraine and inadequate response to two to four classes of migraine preventive medications.

The investigators randomized patients in this multinational, double-blind study to one of three treatment arms. In the first arm, participants received monthly subcutaneous doses of fremanezumab. Patients with chronic migraine in this arm received 675 mg during month 1 and 225 mg during months 2 and 3. Patients with episodic migraine received 225 mg each month. In the second arm, participants received quarterly treatment with fremanezumab (i.e., 675 mg during month 1, followed by placebo during months 2 and 3). In the third arm, participants received matched monthly placebo. The treatment period lasted for 12 weeks.

Dr. Spierings and colleagues created logistic regression models to compare the proportions of responders, defined as patients who achieved 50% or greater and 75% or greater reduction in mean monthly migraine days, during the 4- and 12-week periods after the first dose of study drug. They used a logistic regression model to analyze the proportions of patients who achieved 50% or greater reduction in mean monthly migraine days during the first 4 weeks and sustained this level of response throughout the 12-week period. The study’s secondary endpoints were 50% or greater reductions in migraine days at weeks 4 and 12.

The investigators randomized 837 patients. In all, 278 participants received placebo, 283 received monthly fremanezumab, and 276 received quarterly fremanezumab. At baseline, the mean number of migraine days was 14.3 in the placebo arm, 14.1 in the monthly fremanezumab arm, and 14.1 in the quarterly fremanezumab arm. The proportions of patients who failed to respond to 2, 3, and 4 classes of preventive medications, respectively, were 51%, 29%, and 19% in the placebo group; 47%, 35%, and 18% in the monthly fremanezumab group; and 51%, 31%, and 18% in the quarterly fremanezumab group.

Overall, approximately 37% of patients receiving fremanezumab achieved 50% or greater reductions in migraine days within 4 weeks of the first dose, compared with 10% of patients who received placebo. Approximately 20% of patients receiving fremanezumab had sustained 50% or greater reductions in migraine days from 4 weeks throughout the 12-week treatment period, compared with 3% of controls. Higher proportions of patients also achieved 75% or greater reductions at 4 weeks and during 12 weeks after the first dose with fremanezumab, compared with placebo.

Dr. Spierings is a member of the Teva Pharmaceuticals speakers bureau and has received research grants from the company. His coinvestigators are all employees of Teva, which manufactures fremanezumab.

egreb@mdedge.com

SOURCE: Spierings ELH et al. AHS 2019. Abstract 631663.

PHILADELPHIA – Monthly or quarterly treatment with fremanezumab provides significant and clinically meaningful reductions in migraine days at 4 weeks, compared with placebo, in patients with inadequate responses to as many as four classes of preventive medications for migraine, according to research presented at the annual meeting of the American Headache Society. Fremanezumab may be an effective treatment for a population that otherwise is difficult to treat, said the researchers.

Fremanezumab is a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP). Previous trials have supported the treatment’s efficacy for the preventive treatment of episodic and chronic migraine in adults. Egilius L. H. Spierings, MD, PhD, a clinical professor of neurology at Tufts Medical Center in Boston and the founder, medical director, and principal investigator at MedVadis Research in Watertown, Massachusetts, and colleagues conducted the phase 3 FOCUS study to examine fremanezumab’s efficacy at preventing migraine in adults with chronic or episodic migraine and inadequate response to two to four classes of migraine preventive medications.

The investigators randomized patients in this multinational, double-blind study to one of three treatment arms. In the first arm, participants received monthly subcutaneous doses of fremanezumab. Patients with chronic migraine in this arm received 675 mg during month 1 and 225 mg during months 2 and 3. Patients with episodic migraine received 225 mg each month. In the second arm, participants received quarterly treatment with fremanezumab (i.e., 675 mg during month 1, followed by placebo during months 2 and 3). In the third arm, participants received matched monthly placebo. The treatment period lasted for 12 weeks.

Dr. Spierings and colleagues created logistic regression models to compare the proportions of responders, defined as patients who achieved 50% or greater and 75% or greater reduction in mean monthly migraine days, during the 4- and 12-week periods after the first dose of study drug. They used a logistic regression model to analyze the proportions of patients who achieved 50% or greater reduction in mean monthly migraine days during the first 4 weeks and sustained this level of response throughout the 12-week period. The study’s secondary endpoints were 50% or greater reductions in migraine days at weeks 4 and 12.

The investigators randomized 837 patients. In all, 278 participants received placebo, 283 received monthly fremanezumab, and 276 received quarterly fremanezumab. At baseline, the mean number of migraine days was 14.3 in the placebo arm, 14.1 in the monthly fremanezumab arm, and 14.1 in the quarterly fremanezumab arm. The proportions of patients who failed to respond to 2, 3, and 4 classes of preventive medications, respectively, were 51%, 29%, and 19% in the placebo group; 47%, 35%, and 18% in the monthly fremanezumab group; and 51%, 31%, and 18% in the quarterly fremanezumab group.

Overall, approximately 37% of patients receiving fremanezumab achieved 50% or greater reductions in migraine days within 4 weeks of the first dose, compared with 10% of patients who received placebo. Approximately 20% of patients receiving fremanezumab had sustained 50% or greater reductions in migraine days from 4 weeks throughout the 12-week treatment period, compared with 3% of controls. Higher proportions of patients also achieved 75% or greater reductions at 4 weeks and during 12 weeks after the first dose with fremanezumab, compared with placebo.

Dr. Spierings is a member of the Teva Pharmaceuticals speakers bureau and has received research grants from the company. His coinvestigators are all employees of Teva, which manufactures fremanezumab.

egreb@mdedge.com

SOURCE: Spierings ELH et al. AHS 2019. Abstract 631663.

PHILADELPHIA – Monthly or quarterly treatment with fremanezumab provides significant and clinically meaningful reductions in migraine days at 4 weeks, compared with placebo, in patients with inadequate responses to as many as four classes of preventive medications for migraine, according to research presented at the annual meeting of the American Headache Society. Fremanezumab may be an effective treatment for a population that otherwise is difficult to treat, said the researchers.

Fremanezumab is a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP). Previous trials have supported the treatment’s efficacy for the preventive treatment of episodic and chronic migraine in adults. Egilius L. H. Spierings, MD, PhD, a clinical professor of neurology at Tufts Medical Center in Boston and the founder, medical director, and principal investigator at MedVadis Research in Watertown, Massachusetts, and colleagues conducted the phase 3 FOCUS study to examine fremanezumab’s efficacy at preventing migraine in adults with chronic or episodic migraine and inadequate response to two to four classes of migraine preventive medications.

The investigators randomized patients in this multinational, double-blind study to one of three treatment arms. In the first arm, participants received monthly subcutaneous doses of fremanezumab. Patients with chronic migraine in this arm received 675 mg during month 1 and 225 mg during months 2 and 3. Patients with episodic migraine received 225 mg each month. In the second arm, participants received quarterly treatment with fremanezumab (i.e., 675 mg during month 1, followed by placebo during months 2 and 3). In the third arm, participants received matched monthly placebo. The treatment period lasted for 12 weeks.

Dr. Spierings and colleagues created logistic regression models to compare the proportions of responders, defined as patients who achieved 50% or greater and 75% or greater reduction in mean monthly migraine days, during the 4- and 12-week periods after the first dose of study drug. They used a logistic regression model to analyze the proportions of patients who achieved 50% or greater reduction in mean monthly migraine days during the first 4 weeks and sustained this level of response throughout the 12-week period. The study’s secondary endpoints were 50% or greater reductions in migraine days at weeks 4 and 12.

The investigators randomized 837 patients. In all, 278 participants received placebo, 283 received monthly fremanezumab, and 276 received quarterly fremanezumab. At baseline, the mean number of migraine days was 14.3 in the placebo arm, 14.1 in the monthly fremanezumab arm, and 14.1 in the quarterly fremanezumab arm. The proportions of patients who failed to respond to 2, 3, and 4 classes of preventive medications, respectively, were 51%, 29%, and 19% in the placebo group; 47%, 35%, and 18% in the monthly fremanezumab group; and 51%, 31%, and 18% in the quarterly fremanezumab group.

Overall, approximately 37% of patients receiving fremanezumab achieved 50% or greater reductions in migraine days within 4 weeks of the first dose, compared with 10% of patients who received placebo. Approximately 20% of patients receiving fremanezumab had sustained 50% or greater reductions in migraine days from 4 weeks throughout the 12-week treatment period, compared with 3% of controls. Higher proportions of patients also achieved 75% or greater reductions at 4 weeks and during 12 weeks after the first dose with fremanezumab, compared with placebo.

Dr. Spierings is a member of the Teva Pharmaceuticals speakers bureau and has received research grants from the company. His coinvestigators are all employees of Teva, which manufactures fremanezumab.

egreb@mdedge.com

SOURCE: Spierings ELH et al. AHS 2019. Abstract 631663.

AUSTIN, TEX. – Topical calcineurin inhibitors (TCIs) are an effective therapeutic option for pediatric patients with periorificial dermatitis (POD), as monotherapy or as part of a combination regimen, results from a retrospective cohort study showed.

The mainstays of treatment for POD include topical and oral antibiotics. In an interview prior to the annual meeting of the Society for Pediatric Dermatology, Ayelet Ollech, MD, said that the most common systemic agents used include erythromycin, azithromycin, and, in patients older than 8-10 years of age, minocycline or doxycycline. Topical agents, which are often used as monotherapy in mild disease, include metronidazole, clindamycin, erythromycin, sodium sulfacetamide, and, less often, azelaic acid, topical retinoids, and ivermectin. “TCIs (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment) are a good steroid sparing option for POD,” said Dr. Ollech, a pediatric dermatology fellow at Ann & Robert H. Lurie Children’s Hospital of Chicago. “In the adult population, two randomized controlled studies of pimecrolimus 1% cream showed good results. In the pediatric population, there are only a few case series and case reports of TCIs for the treatment of POD.”

In what is believed to be the largest study of its kind, Dr. Ollech, Anthony J. Mancini, MD, and colleagues assessed the clinical utility of TCI in 132 pediatric patients with POD who were treated in the division of dermatology at Children’s Hospital of Chicago between 2008 and 2018. The researchers made note of epidemiologic variables, personal and family medical histories, possible triggers, duration of illness, previous treatments, distribution (periocular, perinasal, perioral, extra facial regions), severity of POD, treatment(s) prescribed, duration of therapy, clinical response, recurrences, and side effects. In an effort to capture missing data, the researchers performed follow-up via telephone for all patients who lacked appropriate follow-up documentation in the medical record.

Of the 132 patients, the female: male ratio was 1.2:1 and the median age at diagnosis was 4.2 years. About one-third of patients (33%) had involvement of one region, 38% had involvement of two regions, 26% had involvement of three regions, and 3% patients had involvement of all regions. The most common disorders on medical history were atopic dermatitis and asthma (in 29% and 17% of patients, respectively).


Dr. Ollech reported that 72 of the 132 patients (55%) had evaluable follow up data via either medical record documentation or the phone questionnaire. Of these, 67% were treated with TCI alone, 19% were treated with a combination of TCI and topical metronidazole, and 10% were treated with a combination of TCI and a systemic antibiotic. The median duration of treatment was 60 days. The researchers observed complete response in 65% of patients treated with TCI alone, in 64% of those treated with TCI and metronidazole, and in 70% of those treated with TCI and a systemic antibiotic. Adverse events attributed to TCI were rare and mild in severity.

“We were surprised that there were almost no reported side effects from the usage of TCIs as it is known that these agents can cause a burning or stinging sensation,” Dr. Ollech said. “Only one case described this side effect. We found 30% of the patients to have associated atopic dermatitis (AD) as well as a few patients with irritant dermatitis. We were also surprised how convenient the TCI treatment was for a patient who had POD and concomitant facial AD or even irritant dermatitis as an agent that can treat both. This can be very helpful for the parents that apply the medication to have a single solution to more than one rash.”

The researchers noted recurrence of POD in 14% of patients overall, including 6% of patients treated with TCI alone, 29% of patients treated with TCI and metronidazole, and 30% of patients treated with TCI and a systemic antibiotic.

Dr. Ollech acknowledged certain limitations of the study, including its retrospective design and lack of a control group. She and her colleagues reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Ollech A et al. SPD 2019, poster 23.

AUSTIN, TEX. – Topical calcineurin inhibitors (TCIs) are an effective therapeutic option for pediatric patients with periorificial dermatitis (POD), as monotherapy or as part of a combination regimen, results from a retrospective cohort study showed.

The mainstays of treatment for POD include topical and oral antibiotics. In an interview prior to the annual meeting of the Society for Pediatric Dermatology, Ayelet Ollech, MD, said that the most common systemic agents used include erythromycin, azithromycin, and, in patients older than 8-10 years of age, minocycline or doxycycline. Topical agents, which are often used as monotherapy in mild disease, include metronidazole, clindamycin, erythromycin, sodium sulfacetamide, and, less often, azelaic acid, topical retinoids, and ivermectin. “TCIs (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment) are a good steroid sparing option for POD,” said Dr. Ollech, a pediatric dermatology fellow at Ann & Robert H. Lurie Children’s Hospital of Chicago. “In the adult population, two randomized controlled studies of pimecrolimus 1% cream showed good results. In the pediatric population, there are only a few case series and case reports of TCIs for the treatment of POD.”

In what is believed to be the largest study of its kind, Dr. Ollech, Anthony J. Mancini, MD, and colleagues assessed the clinical utility of TCI in 132 pediatric patients with POD who were treated in the division of dermatology at Children’s Hospital of Chicago between 2008 and 2018. The researchers made note of epidemiologic variables, personal and family medical histories, possible triggers, duration of illness, previous treatments, distribution (periocular, perinasal, perioral, extra facial regions), severity of POD, treatment(s) prescribed, duration of therapy, clinical response, recurrences, and side effects. In an effort to capture missing data, the researchers performed follow-up via telephone for all patients who lacked appropriate follow-up documentation in the medical record.

Of the 132 patients, the female: male ratio was 1.2:1 and the median age at diagnosis was 4.2 years. About one-third of patients (33%) had involvement of one region, 38% had involvement of two regions, 26% had involvement of three regions, and 3% patients had involvement of all regions. The most common disorders on medical history were atopic dermatitis and asthma (in 29% and 17% of patients, respectively).


Dr. Ollech reported that 72 of the 132 patients (55%) had evaluable follow up data via either medical record documentation or the phone questionnaire. Of these, 67% were treated with TCI alone, 19% were treated with a combination of TCI and topical metronidazole, and 10% were treated with a combination of TCI and a systemic antibiotic. The median duration of treatment was 60 days. The researchers observed complete response in 65% of patients treated with TCI alone, in 64% of those treated with TCI and metronidazole, and in 70% of those treated with TCI and a systemic antibiotic. Adverse events attributed to TCI were rare and mild in severity.

“We were surprised that there were almost no reported side effects from the usage of TCIs as it is known that these agents can cause a burning or stinging sensation,” Dr. Ollech said. “Only one case described this side effect. We found 30% of the patients to have associated atopic dermatitis (AD) as well as a few patients with irritant dermatitis. We were also surprised how convenient the TCI treatment was for a patient who had POD and concomitant facial AD or even irritant dermatitis as an agent that can treat both. This can be very helpful for the parents that apply the medication to have a single solution to more than one rash.”

The researchers noted recurrence of POD in 14% of patients overall, including 6% of patients treated with TCI alone, 29% of patients treated with TCI and metronidazole, and 30% of patients treated with TCI and a systemic antibiotic.

Dr. Ollech acknowledged certain limitations of the study, including its retrospective design and lack of a control group. She and her colleagues reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Ollech A et al. SPD 2019, poster 23.

AUSTIN, TEX. – Topical calcineurin inhibitors (TCIs) are an effective therapeutic option for pediatric patients with periorificial dermatitis (POD), as monotherapy or as part of a combination regimen, results from a retrospective cohort study showed.

The mainstays of treatment for POD include topical and oral antibiotics. In an interview prior to the annual meeting of the Society for Pediatric Dermatology, Ayelet Ollech, MD, said that the most common systemic agents used include erythromycin, azithromycin, and, in patients older than 8-10 years of age, minocycline or doxycycline. Topical agents, which are often used as monotherapy in mild disease, include metronidazole, clindamycin, erythromycin, sodium sulfacetamide, and, less often, azelaic acid, topical retinoids, and ivermectin. “TCIs (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment) are a good steroid sparing option for POD,” said Dr. Ollech, a pediatric dermatology fellow at Ann & Robert H. Lurie Children’s Hospital of Chicago. “In the adult population, two randomized controlled studies of pimecrolimus 1% cream showed good results. In the pediatric population, there are only a few case series and case reports of TCIs for the treatment of POD.”

In what is believed to be the largest study of its kind, Dr. Ollech, Anthony J. Mancini, MD, and colleagues assessed the clinical utility of TCI in 132 pediatric patients with POD who were treated in the division of dermatology at Children’s Hospital of Chicago between 2008 and 2018. The researchers made note of epidemiologic variables, personal and family medical histories, possible triggers, duration of illness, previous treatments, distribution (periocular, perinasal, perioral, extra facial regions), severity of POD, treatment(s) prescribed, duration of therapy, clinical response, recurrences, and side effects. In an effort to capture missing data, the researchers performed follow-up via telephone for all patients who lacked appropriate follow-up documentation in the medical record.

Of the 132 patients, the female: male ratio was 1.2:1 and the median age at diagnosis was 4.2 years. About one-third of patients (33%) had involvement of one region, 38% had involvement of two regions, 26% had involvement of three regions, and 3% patients had involvement of all regions. The most common disorders on medical history were atopic dermatitis and asthma (in 29% and 17% of patients, respectively).


Dr. Ollech reported that 72 of the 132 patients (55%) had evaluable follow up data via either medical record documentation or the phone questionnaire. Of these, 67% were treated with TCI alone, 19% were treated with a combination of TCI and topical metronidazole, and 10% were treated with a combination of TCI and a systemic antibiotic. The median duration of treatment was 60 days. The researchers observed complete response in 65% of patients treated with TCI alone, in 64% of those treated with TCI and metronidazole, and in 70% of those treated with TCI and a systemic antibiotic. Adverse events attributed to TCI were rare and mild in severity.

“We were surprised that there were almost no reported side effects from the usage of TCIs as it is known that these agents can cause a burning or stinging sensation,” Dr. Ollech said. “Only one case described this side effect. We found 30% of the patients to have associated atopic dermatitis (AD) as well as a few patients with irritant dermatitis. We were also surprised how convenient the TCI treatment was for a patient who had POD and concomitant facial AD or even irritant dermatitis as an agent that can treat both. This can be very helpful for the parents that apply the medication to have a single solution to more than one rash.”

The researchers noted recurrence of POD in 14% of patients overall, including 6% of patients treated with TCI alone, 29% of patients treated with TCI and metronidazole, and 30% of patients treated with TCI and a systemic antibiotic.

Dr. Ollech acknowledged certain limitations of the study, including its retrospective design and lack of a control group. She and her colleagues reported having no financial disclosures.

dbrunk@mdedge.com

SOURCE: Ollech A et al. SPD 2019, poster 23.

Radiation oncologists are applauding the Centers for Medicare & Medicaid Services’ introduction of a test radiation oncology alternative payment model (APM) to help encourage the move to value-based care, but concerns, particularly about its mandatory participation, have been raised.

TheaDesign/Thinkstock

The proposed radiation oncology APM, posted online as part of a larger notice of proposed rulemaking on July 10 and scheduled for publication in the Federal Register on July 18, will be tested over a 5-year period to determine if a prospective, site-neutral, episode-based payment for radiation therapy will improve the quality of care and lower costs for Medicare. Comments on the proposal are due 60 days from Federal Register publication.

According to the CMS website, the agency would make “prospective, episode-based (i.e. bundled) payments, based on a patient’s cancer diagnosis, that would cover radiotherapy services furnished in a 90-day episode for the 17 cancer types meeting the included cancer type criteria.”

The site-neutral payments would be based on a “common, adjusted national base payment amount” and would contain two components (professional and technical) “to allow for use of current claims systems for PFS [physician fee schedule] and OPPS [outpatient prospective payment system] to be used to adjudicate RO (radiation oncology) Model claims and be consistent with existing business relationships.”

Payments would be linked to quality “using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to participants.” The radiation oncology model qualifies as an advanced alternative payment model under the Quality Payment Program.

In addition to measuring whether the model improves quality and lowers costs, CMS will be studying whether it results in shorter courses of radiation therapy, more efficient care delivery, and higher-value care for Medicare beneficiaries.

The biggest detail about this proposed alternative payment model that is raising some red flags within the community is that it has a mandatory participation requirement, with participation determined by a random selection of providers in selected geographic areas.

The Community Oncology Alliance said in a statement that it has “deep reservations and fundamental opposition to a proposed mandatory or ‘required’ Center for Medicare & Medicaid Innovation model. Radiation therapy is a powerful, complex part of cancer care for patients. While the proposed CMMI model does include a much-needed policy proposal to implement site-neutral payments, COA absolutely does not support mandatory CMMI models,” adding that if models are “reasonable and would advance value-based care, then voluntary provider participation would be robust.”

Dave Adler, vice president of advocacy at the American Society for Radiation Oncology, also expressed concern regarding the requirement for participation.

“At least at the outset, having a voluntary model is the right way to start,” he said in an interview. “This is something that has not been tested before. I think it’s really important to its long-term success that we understand its impact on providers and patients before it’s required for anybody.”

He offered a little flexibility on that stance, noting that if CMS would not budge on the mandatory aspect, he suggested that it lower the amount of participation that will be required from the proposed 40% of radiation oncologists to something smaller, coupled with a mechanism for voluntary participation, which does not exist in the current proposal.

Outside of that immediate concern, Mr. Adler said it was really too early to tell whether the proposal is in fact adequate to meet the needs of practicing radiation oncologists, including the payment rates, and the patients they treat. He said ASTRO will be doing a deeper analysis in the coming weeks and will provide the necessary feedback to CMS on the proposal.

gtwatchtman@mdedge.com

Radiation oncologists are applauding the Centers for Medicare & Medicaid Services’ introduction of a test radiation oncology alternative payment model (APM) to help encourage the move to value-based care, but concerns, particularly about its mandatory participation, have been raised.

TheaDesign/Thinkstock

The proposed radiation oncology APM, posted online as part of a larger notice of proposed rulemaking on July 10 and scheduled for publication in the Federal Register on July 18, will be tested over a 5-year period to determine if a prospective, site-neutral, episode-based payment for radiation therapy will improve the quality of care and lower costs for Medicare. Comments on the proposal are due 60 days from Federal Register publication.

According to the CMS website, the agency would make “prospective, episode-based (i.e. bundled) payments, based on a patient’s cancer diagnosis, that would cover radiotherapy services furnished in a 90-day episode for the 17 cancer types meeting the included cancer type criteria.”

The site-neutral payments would be based on a “common, adjusted national base payment amount” and would contain two components (professional and technical) “to allow for use of current claims systems for PFS [physician fee schedule] and OPPS [outpatient prospective payment system] to be used to adjudicate RO (radiation oncology) Model claims and be consistent with existing business relationships.”

Payments would be linked to quality “using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to participants.” The radiation oncology model qualifies as an advanced alternative payment model under the Quality Payment Program.

In addition to measuring whether the model improves quality and lowers costs, CMS will be studying whether it results in shorter courses of radiation therapy, more efficient care delivery, and higher-value care for Medicare beneficiaries.

The biggest detail about this proposed alternative payment model that is raising some red flags within the community is that it has a mandatory participation requirement, with participation determined by a random selection of providers in selected geographic areas.

The Community Oncology Alliance said in a statement that it has “deep reservations and fundamental opposition to a proposed mandatory or ‘required’ Center for Medicare & Medicaid Innovation model. Radiation therapy is a powerful, complex part of cancer care for patients. While the proposed CMMI model does include a much-needed policy proposal to implement site-neutral payments, COA absolutely does not support mandatory CMMI models,” adding that if models are “reasonable and would advance value-based care, then voluntary provider participation would be robust.”

Dave Adler, vice president of advocacy at the American Society for Radiation Oncology, also expressed concern regarding the requirement for participation.

“At least at the outset, having a voluntary model is the right way to start,” he said in an interview. “This is something that has not been tested before. I think it’s really important to its long-term success that we understand its impact on providers and patients before it’s required for anybody.”

He offered a little flexibility on that stance, noting that if CMS would not budge on the mandatory aspect, he suggested that it lower the amount of participation that will be required from the proposed 40% of radiation oncologists to something smaller, coupled with a mechanism for voluntary participation, which does not exist in the current proposal.

Outside of that immediate concern, Mr. Adler said it was really too early to tell whether the proposal is in fact adequate to meet the needs of practicing radiation oncologists, including the payment rates, and the patients they treat. He said ASTRO will be doing a deeper analysis in the coming weeks and will provide the necessary feedback to CMS on the proposal.

gtwatchtman@mdedge.com

Radiation oncologists are applauding the Centers for Medicare & Medicaid Services’ introduction of a test radiation oncology alternative payment model (APM) to help encourage the move to value-based care, but concerns, particularly about its mandatory participation, have been raised.

TheaDesign/Thinkstock

The proposed radiation oncology APM, posted online as part of a larger notice of proposed rulemaking on July 10 and scheduled for publication in the Federal Register on July 18, will be tested over a 5-year period to determine if a prospective, site-neutral, episode-based payment for radiation therapy will improve the quality of care and lower costs for Medicare. Comments on the proposal are due 60 days from Federal Register publication.

According to the CMS website, the agency would make “prospective, episode-based (i.e. bundled) payments, based on a patient’s cancer diagnosis, that would cover radiotherapy services furnished in a 90-day episode for the 17 cancer types meeting the included cancer type criteria.”

The site-neutral payments would be based on a “common, adjusted national base payment amount” and would contain two components (professional and technical) “to allow for use of current claims systems for PFS [physician fee schedule] and OPPS [outpatient prospective payment system] to be used to adjudicate RO (radiation oncology) Model claims and be consistent with existing business relationships.”

Payments would be linked to quality “using reporting and performance on quality measures, clinical data reporting, and patient experience as factors when determining payment to participants.” The radiation oncology model qualifies as an advanced alternative payment model under the Quality Payment Program.

In addition to measuring whether the model improves quality and lowers costs, CMS will be studying whether it results in shorter courses of radiation therapy, more efficient care delivery, and higher-value care for Medicare beneficiaries.

The biggest detail about this proposed alternative payment model that is raising some red flags within the community is that it has a mandatory participation requirement, with participation determined by a random selection of providers in selected geographic areas.

The Community Oncology Alliance said in a statement that it has “deep reservations and fundamental opposition to a proposed mandatory or ‘required’ Center for Medicare & Medicaid Innovation model. Radiation therapy is a powerful, complex part of cancer care for patients. While the proposed CMMI model does include a much-needed policy proposal to implement site-neutral payments, COA absolutely does not support mandatory CMMI models,” adding that if models are “reasonable and would advance value-based care, then voluntary provider participation would be robust.”

Dave Adler, vice president of advocacy at the American Society for Radiation Oncology, also expressed concern regarding the requirement for participation.

“At least at the outset, having a voluntary model is the right way to start,” he said in an interview. “This is something that has not been tested before. I think it’s really important to its long-term success that we understand its impact on providers and patients before it’s required for anybody.”

He offered a little flexibility on that stance, noting that if CMS would not budge on the mandatory aspect, he suggested that it lower the amount of participation that will be required from the proposed 40% of radiation oncologists to something smaller, coupled with a mechanism for voluntary participation, which does not exist in the current proposal.

Outside of that immediate concern, Mr. Adler said it was really too early to tell whether the proposal is in fact adequate to meet the needs of practicing radiation oncologists, including the payment rates, and the patients they treat. He said ASTRO will be doing a deeper analysis in the coming weeks and will provide the necessary feedback to CMS on the proposal.

gtwatchtman@mdedge.com

MADRID – Tocilizumab was associated with improved vision in about half of 22 enrolled children with juvenile idiopathic arthritis (JIA) and uveitis refractory to tumor necrosis factor inhibitor (TNFi) therapy, based on results from an investigator-initiated phase 2 trial presented at the European Congress of Rheumatology.

At 12 weeks of treatment, 11 children in the study had some improvement in uveitis and 7 of them had achieved the primary study outcome, which was a two-step decrease in the level of inflammation as measured by the Standard of the Uveitis Nomenclature (SUN) criteria, Athimalaipet V. Ramanan, MBBS, of the department of paediatric rheumatology at the University Hospitals Bristol (England) NHS Foundation Trust, said. Ten of the 21 evaluable patients had no apparent response to tocilizumab. One study participant could not be included in the final analysis because of a violation in study protocol that involved use of disallowed concomitant medications.

“Although this study did not meet the prespecified criterion for efficacy (for most of those treated) ... almost half of those enrolled achieved some benefit,” reported Dr. Ramanan.

The multicenter investigator-initiated phase 2 trial conducted in the United Kingdom enrolled children with JIA and uveitis that was refractory to methotrexate and TNFi therapy. The study participants received methotrexate as well as 162 mg of tocilizumab administered subcutaneously every 2 weeks (those weighing less than 30 kg received tocilizumab treatment every 3 weeks).

Seven of 21 evaluable patients achieved the two-step reduction in inflammation that was the prespecified criterion for a response. For the study population overall, this fell short of statistical significance (P = .11).

However, Dr. Ramanan emphasized that another three patients achieved a one-step improvement, which he believes merits consideration as a sign of efficacy in a “very refractory group.” Moreover, three of four patients with macular edema at baseline had total resolution of this complication.

Other outcomes of interest monitored during the study included the safety and tolerability of tocilizumab and change in use of topical corticosteroids. There were no serious adverse events associated with tocilizumab in this study, according to Dr. Ramanan.
 

SOURCE: Ann Rheum Dis. Jun 2019;78(Suppl2)265, Abstract LB0011.

MADRID – Tocilizumab was associated with improved vision in about half of 22 enrolled children with juvenile idiopathic arthritis (JIA) and uveitis refractory to tumor necrosis factor inhibitor (TNFi) therapy, based on results from an investigator-initiated phase 2 trial presented at the European Congress of Rheumatology.

At 12 weeks of treatment, 11 children in the study had some improvement in uveitis and 7 of them had achieved the primary study outcome, which was a two-step decrease in the level of inflammation as measured by the Standard of the Uveitis Nomenclature (SUN) criteria, Athimalaipet V. Ramanan, MBBS, of the department of paediatric rheumatology at the University Hospitals Bristol (England) NHS Foundation Trust, said. Ten of the 21 evaluable patients had no apparent response to tocilizumab. One study participant could not be included in the final analysis because of a violation in study protocol that involved use of disallowed concomitant medications.

“Although this study did not meet the prespecified criterion for efficacy (for most of those treated) ... almost half of those enrolled achieved some benefit,” reported Dr. Ramanan.

The multicenter investigator-initiated phase 2 trial conducted in the United Kingdom enrolled children with JIA and uveitis that was refractory to methotrexate and TNFi therapy. The study participants received methotrexate as well as 162 mg of tocilizumab administered subcutaneously every 2 weeks (those weighing less than 30 kg received tocilizumab treatment every 3 weeks).

Seven of 21 evaluable patients achieved the two-step reduction in inflammation that was the prespecified criterion for a response. For the study population overall, this fell short of statistical significance (P = .11).

However, Dr. Ramanan emphasized that another three patients achieved a one-step improvement, which he believes merits consideration as a sign of efficacy in a “very refractory group.” Moreover, three of four patients with macular edema at baseline had total resolution of this complication.

Other outcomes of interest monitored during the study included the safety and tolerability of tocilizumab and change in use of topical corticosteroids. There were no serious adverse events associated with tocilizumab in this study, according to Dr. Ramanan.
 

SOURCE: Ann Rheum Dis. Jun 2019;78(Suppl2)265, Abstract LB0011.

MADRID – Tocilizumab was associated with improved vision in about half of 22 enrolled children with juvenile idiopathic arthritis (JIA) and uveitis refractory to tumor necrosis factor inhibitor (TNFi) therapy, based on results from an investigator-initiated phase 2 trial presented at the European Congress of Rheumatology.

At 12 weeks of treatment, 11 children in the study had some improvement in uveitis and 7 of them had achieved the primary study outcome, which was a two-step decrease in the level of inflammation as measured by the Standard of the Uveitis Nomenclature (SUN) criteria, Athimalaipet V. Ramanan, MBBS, of the department of paediatric rheumatology at the University Hospitals Bristol (England) NHS Foundation Trust, said. Ten of the 21 evaluable patients had no apparent response to tocilizumab. One study participant could not be included in the final analysis because of a violation in study protocol that involved use of disallowed concomitant medications.

“Although this study did not meet the prespecified criterion for efficacy (for most of those treated) ... almost half of those enrolled achieved some benefit,” reported Dr. Ramanan.

The multicenter investigator-initiated phase 2 trial conducted in the United Kingdom enrolled children with JIA and uveitis that was refractory to methotrexate and TNFi therapy. The study participants received methotrexate as well as 162 mg of tocilizumab administered subcutaneously every 2 weeks (those weighing less than 30 kg received tocilizumab treatment every 3 weeks).

Seven of 21 evaluable patients achieved the two-step reduction in inflammation that was the prespecified criterion for a response. For the study population overall, this fell short of statistical significance (P = .11).

However, Dr. Ramanan emphasized that another three patients achieved a one-step improvement, which he believes merits consideration as a sign of efficacy in a “very refractory group.” Moreover, three of four patients with macular edema at baseline had total resolution of this complication.

Other outcomes of interest monitored during the study included the safety and tolerability of tocilizumab and change in use of topical corticosteroids. There were no serious adverse events associated with tocilizumab in this study, according to Dr. Ramanan.
 

SOURCE: Ann Rheum Dis. Jun 2019;78(Suppl2)265, Abstract LB0011.

Depressive symptoms may be linked to poor-quality diets in middle-aged and older men, according to findings from the Longitudinal Aging Study Amsterdam (LASA).

In a longitudinal study of 1,312 Dutch people aged 55 years or older, 52% of whom were women, depressive symptoms were associated with significantly lower diet quality scores on food quality questionnaires among men, Liset E.M. Elstgeest of the Amsterdam Public Health research institute at Vrije Universiteit Amsterdam and coauthors reported in the Journal of Affective Disorders.

Depressive symptoms were defined as a score of at least 16 on the Center for Epidemiologic Studies Depression scale (CES-D). Study participants were assessed in 2014-2015, and for five cycles of three times per year from 2001-2003 to 2015-2016. Diet quality was assessed in 2014 and 2015 using the Mediterranean Diet Score, Alternative Healthy Eating Index, and Dietary Approaches to Stop Hypertension (DASH) score.

The majority (84.8%) had no depressive symptoms in both cycles, while 5.4% experienced emerging, 4.6% remitted, and 5.1% chronic/recurrent depressive symptoms. For the history sample, the numbers with depressive symptoms were 69 (10.0%), 67(9.8%), 59 (8.6%), and 60 (8.7%) in the four regular cycles from 2001-2003 to 2011-2013. In total 144 participants (21.0%) ever had a CES-D of at least 16 from 2001-2003 to 2011-2013, of which 20 had an elevated CES-D score only in 2011-2013.

Compared with participants with CES-D scores less than 16, the 120 (9.7%) study participants with CES-D scores of at least 16 in 2011-2013 and the 130 (10.5%) study participants with elevated CES-D scores in 2015-2016 were more likely to have lower Mediterranean Diet Score and Alternative Healthy Eating Index scores. After adjustment for confounders, however, the association remained statistically significant only for men. Current depressive symptoms were also associated with a lower Alternative Healthy Eating Index score in men, but not in women.

More longitudinal studies are needed to confirm results, the investigators added. “Such studies should preferably include repeated diet measurements and investigate gender differences,” they concluded.

No conflicts of interest were reported.

SOURCE: Elstgeest L et al. 2019. J Affec Disord. doi: 10.1016/j.jad.2019.02.004.

Depressive symptoms may be linked to poor-quality diets in middle-aged and older men, according to findings from the Longitudinal Aging Study Amsterdam (LASA).

In a longitudinal study of 1,312 Dutch people aged 55 years or older, 52% of whom were women, depressive symptoms were associated with significantly lower diet quality scores on food quality questionnaires among men, Liset E.M. Elstgeest of the Amsterdam Public Health research institute at Vrije Universiteit Amsterdam and coauthors reported in the Journal of Affective Disorders.

Depressive symptoms were defined as a score of at least 16 on the Center for Epidemiologic Studies Depression scale (CES-D). Study participants were assessed in 2014-2015, and for five cycles of three times per year from 2001-2003 to 2015-2016. Diet quality was assessed in 2014 and 2015 using the Mediterranean Diet Score, Alternative Healthy Eating Index, and Dietary Approaches to Stop Hypertension (DASH) score.

The majority (84.8%) had no depressive symptoms in both cycles, while 5.4% experienced emerging, 4.6% remitted, and 5.1% chronic/recurrent depressive symptoms. For the history sample, the numbers with depressive symptoms were 69 (10.0%), 67(9.8%), 59 (8.6%), and 60 (8.7%) in the four regular cycles from 2001-2003 to 2011-2013. In total 144 participants (21.0%) ever had a CES-D of at least 16 from 2001-2003 to 2011-2013, of which 20 had an elevated CES-D score only in 2011-2013.

Compared with participants with CES-D scores less than 16, the 120 (9.7%) study participants with CES-D scores of at least 16 in 2011-2013 and the 130 (10.5%) study participants with elevated CES-D scores in 2015-2016 were more likely to have lower Mediterranean Diet Score and Alternative Healthy Eating Index scores. After adjustment for confounders, however, the association remained statistically significant only for men. Current depressive symptoms were also associated with a lower Alternative Healthy Eating Index score in men, but not in women.

More longitudinal studies are needed to confirm results, the investigators added. “Such studies should preferably include repeated diet measurements and investigate gender differences,” they concluded.

No conflicts of interest were reported.

SOURCE: Elstgeest L et al. 2019. J Affec Disord. doi: 10.1016/j.jad.2019.02.004.

Depressive symptoms may be linked to poor-quality diets in middle-aged and older men, according to findings from the Longitudinal Aging Study Amsterdam (LASA).

In a longitudinal study of 1,312 Dutch people aged 55 years or older, 52% of whom were women, depressive symptoms were associated with significantly lower diet quality scores on food quality questionnaires among men, Liset E.M. Elstgeest of the Amsterdam Public Health research institute at Vrije Universiteit Amsterdam and coauthors reported in the Journal of Affective Disorders.

Depressive symptoms were defined as a score of at least 16 on the Center for Epidemiologic Studies Depression scale (CES-D). Study participants were assessed in 2014-2015, and for five cycles of three times per year from 2001-2003 to 2015-2016. Diet quality was assessed in 2014 and 2015 using the Mediterranean Diet Score, Alternative Healthy Eating Index, and Dietary Approaches to Stop Hypertension (DASH) score.

The majority (84.8%) had no depressive symptoms in both cycles, while 5.4% experienced emerging, 4.6% remitted, and 5.1% chronic/recurrent depressive symptoms. For the history sample, the numbers with depressive symptoms were 69 (10.0%), 67(9.8%), 59 (8.6%), and 60 (8.7%) in the four regular cycles from 2001-2003 to 2011-2013. In total 144 participants (21.0%) ever had a CES-D of at least 16 from 2001-2003 to 2011-2013, of which 20 had an elevated CES-D score only in 2011-2013.

Compared with participants with CES-D scores less than 16, the 120 (9.7%) study participants with CES-D scores of at least 16 in 2011-2013 and the 130 (10.5%) study participants with elevated CES-D scores in 2015-2016 were more likely to have lower Mediterranean Diet Score and Alternative Healthy Eating Index scores. After adjustment for confounders, however, the association remained statistically significant only for men. Current depressive symptoms were also associated with a lower Alternative Healthy Eating Index score in men, but not in women.

More longitudinal studies are needed to confirm results, the investigators added. “Such studies should preferably include repeated diet measurements and investigate gender differences,” they concluded.

No conflicts of interest were reported.

SOURCE: Elstgeest L et al. 2019. J Affec Disord. doi: 10.1016/j.jad.2019.02.004.

SAN FRANCISCO – Just a single risk factor for type 2 diabetes warrants screening for the disease in black and Hispanic adults, regardless of their body mass index, according to findings presented at the annual scientific sessions of the American Diabetes Association.

M. Alexander Otto/MDedge News

The conclusions come from a review of 5,656 participants aged 45-84 years in the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective cohort study. The participants had no signs of cardiovascular disease at enrollment.

The goal of the study reported at the meeting was to see if current ADA screening guidelines are appropriate across racial groups in an increasingly diverse United States. The guidelines recommend body mass index (BMI) as a trigger for screening for type 2 diabetes. The current advice is to screen any adult who has a BMI at or above 25 kg/m² (23 kg/m² for Asian Americans) and at least one risk factor for type 2 diabetes, such as hypertension, dyslipidemia, or physical inactivity.

Being black, Asian American, Hispanic, Pacific Islander, or American Indian is itself a risk factor, so “someone from a minority group just needs to meet the BMI criteria,” said lead investigator Luis Rodriguez, a PhD candidate in epidemiology at the University of California, San Francisco.

He and his colleagues focused on 2,383 white, 653 Chinese American, 1,459 black, and 1,161 Hispanic participants in MESA who did not have type 2 diabetes at baseline. Participants were in their early 60s at baseline, on average, and just more than half of them were women. They had five medical exams between 2000 and 2012. The investigators calculated the BMI at which each group hit a 10% risk of developing diabetes within the next 10 years.

In general, the lines crossed at a BMI of about 23 kg/m² for Chinese Americans; 25 kg/m² for black and Hispanic participants; and 27 kg/m² for white participants, which is consistent with ADA advice. The guideline cut points are “appropriate for population-based screening where you may not know if the person in front of you has any diabetes risk factors,” Mr. Rodriguez said.

With known risk factors, however, BMI didn’t hold up. Black participants with one or more risk factor hit the 10% mark at a BMI of 24.7 kg/m^2, Hispanics at 23.8 kg/m^2, and Chinese Americans at 21.7 kg/m², all of which are below the recommended cut-points.

“Almost 80%-90% of participants” in minority groups “who had one or more risk factors were above the 10% threshold, so if they have at least one factor, they should pretty much be screened for diabetes, regardless of BMI,” he said.

The 25-kg/m² threshold worked for white participants; the investigators found that with one or more risk factors, white participants crossed the 10% line at a BMI of 26.2 kg/m². In addition, white participants with no diabetes risk factors crossed the 10% mark at around a BMI of 30 kg/m², which the investigators suggested as an appropriate screening trigger.

Participants were in their early 60s at baseline, on average, and just more than half of them were women. In all, 696 cases of type 2 diabetes were diagnosed over a median follow-up of about 9 years, which translated to an incidence rate of 11 cases per 1,000 person-years in white participants, 16 cases for Chinese Americans, 21 for black participants, and 22 for Hispanic participants. Well over half of the participants were overweight or obese at baseline, including about 80% of black and Hispanic participants.

The sample size reported in the abstract was smaller than that in the final presentation because the investigators did not adjust for diet in the final presentation, Mr. Rodriguez explained. Because some study participants did not report diet, by excluding diet from the model adjustment, the number of participants increased, as reflected in this text. Adjusting for diet did not alter the findings.

The National Heart, Lung, and Blood Institute sponsors MESA. Mr. Rodriguez was supported by a grant from the National Institutes of Health/National Institute of Diabetes and Kidney Disease. The other investigators reported having no disclosures.
 

aotto@mdedge.com

SOURCE: Rodriguez L et al. ADA 2019, Abstract 115-OR.

SAN FRANCISCO – Just a single risk factor for type 2 diabetes warrants screening for the disease in black and Hispanic adults, regardless of their body mass index, according to findings presented at the annual scientific sessions of the American Diabetes Association.

M. Alexander Otto/MDedge News

The conclusions come from a review of 5,656 participants aged 45-84 years in the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective cohort study. The participants had no signs of cardiovascular disease at enrollment.

The goal of the study reported at the meeting was to see if current ADA screening guidelines are appropriate across racial groups in an increasingly diverse United States. The guidelines recommend body mass index (BMI) as a trigger for screening for type 2 diabetes. The current advice is to screen any adult who has a BMI at or above 25 kg/m² (23 kg/m² for Asian Americans) and at least one risk factor for type 2 diabetes, such as hypertension, dyslipidemia, or physical inactivity.

Being black, Asian American, Hispanic, Pacific Islander, or American Indian is itself a risk factor, so “someone from a minority group just needs to meet the BMI criteria,” said lead investigator Luis Rodriguez, a PhD candidate in epidemiology at the University of California, San Francisco.

He and his colleagues focused on 2,383 white, 653 Chinese American, 1,459 black, and 1,161 Hispanic participants in MESA who did not have type 2 diabetes at baseline. Participants were in their early 60s at baseline, on average, and just more than half of them were women. They had five medical exams between 2000 and 2012. The investigators calculated the BMI at which each group hit a 10% risk of developing diabetes within the next 10 years.

In general, the lines crossed at a BMI of about 23 kg/m² for Chinese Americans; 25 kg/m² for black and Hispanic participants; and 27 kg/m² for white participants, which is consistent with ADA advice. The guideline cut points are “appropriate for population-based screening where you may not know if the person in front of you has any diabetes risk factors,” Mr. Rodriguez said.

With known risk factors, however, BMI didn’t hold up. Black participants with one or more risk factor hit the 10% mark at a BMI of 24.7 kg/m^2, Hispanics at 23.8 kg/m^2, and Chinese Americans at 21.7 kg/m², all of which are below the recommended cut-points.

“Almost 80%-90% of participants” in minority groups “who had one or more risk factors were above the 10% threshold, so if they have at least one factor, they should pretty much be screened for diabetes, regardless of BMI,” he said.

The 25-kg/m² threshold worked for white participants; the investigators found that with one or more risk factors, white participants crossed the 10% line at a BMI of 26.2 kg/m². In addition, white participants with no diabetes risk factors crossed the 10% mark at around a BMI of 30 kg/m², which the investigators suggested as an appropriate screening trigger.

Participants were in their early 60s at baseline, on average, and just more than half of them were women. In all, 696 cases of type 2 diabetes were diagnosed over a median follow-up of about 9 years, which translated to an incidence rate of 11 cases per 1,000 person-years in white participants, 16 cases for Chinese Americans, 21 for black participants, and 22 for Hispanic participants. Well over half of the participants were overweight or obese at baseline, including about 80% of black and Hispanic participants.

The sample size reported in the abstract was smaller than that in the final presentation because the investigators did not adjust for diet in the final presentation, Mr. Rodriguez explained. Because some study participants did not report diet, by excluding diet from the model adjustment, the number of participants increased, as reflected in this text. Adjusting for diet did not alter the findings.

The National Heart, Lung, and Blood Institute sponsors MESA. Mr. Rodriguez was supported by a grant from the National Institutes of Health/National Institute of Diabetes and Kidney Disease. The other investigators reported having no disclosures.
 

aotto@mdedge.com

SOURCE: Rodriguez L et al. ADA 2019, Abstract 115-OR.

SAN FRANCISCO – Just a single risk factor for type 2 diabetes warrants screening for the disease in black and Hispanic adults, regardless of their body mass index, according to findings presented at the annual scientific sessions of the American Diabetes Association.

M. Alexander Otto/MDedge News

The conclusions come from a review of 5,656 participants aged 45-84 years in the Multi-Ethnic Study of Atherosclerosis (MESA), an ongoing prospective cohort study. The participants had no signs of cardiovascular disease at enrollment.

The goal of the study reported at the meeting was to see if current ADA screening guidelines are appropriate across racial groups in an increasingly diverse United States. The guidelines recommend body mass index (BMI) as a trigger for screening for type 2 diabetes. The current advice is to screen any adult who has a BMI at or above 25 kg/m² (23 kg/m² for Asian Americans) and at least one risk factor for type 2 diabetes, such as hypertension, dyslipidemia, or physical inactivity.

Being black, Asian American, Hispanic, Pacific Islander, or American Indian is itself a risk factor, so “someone from a minority group just needs to meet the BMI criteria,” said lead investigator Luis Rodriguez, a PhD candidate in epidemiology at the University of California, San Francisco.

He and his colleagues focused on 2,383 white, 653 Chinese American, 1,459 black, and 1,161 Hispanic participants in MESA who did not have type 2 diabetes at baseline. Participants were in their early 60s at baseline, on average, and just more than half of them were women. They had five medical exams between 2000 and 2012. The investigators calculated the BMI at which each group hit a 10% risk of developing diabetes within the next 10 years.

In general, the lines crossed at a BMI of about 23 kg/m² for Chinese Americans; 25 kg/m² for black and Hispanic participants; and 27 kg/m² for white participants, which is consistent with ADA advice. The guideline cut points are “appropriate for population-based screening where you may not know if the person in front of you has any diabetes risk factors,” Mr. Rodriguez said.

With known risk factors, however, BMI didn’t hold up. Black participants with one or more risk factor hit the 10% mark at a BMI of 24.7 kg/m^2, Hispanics at 23.8 kg/m^2, and Chinese Americans at 21.7 kg/m², all of which are below the recommended cut-points.

“Almost 80%-90% of participants” in minority groups “who had one or more risk factors were above the 10% threshold, so if they have at least one factor, they should pretty much be screened for diabetes, regardless of BMI,” he said.

The 25-kg/m² threshold worked for white participants; the investigators found that with one or more risk factors, white participants crossed the 10% line at a BMI of 26.2 kg/m². In addition, white participants with no diabetes risk factors crossed the 10% mark at around a BMI of 30 kg/m², which the investigators suggested as an appropriate screening trigger.

Participants were in their early 60s at baseline, on average, and just more than half of them were women. In all, 696 cases of type 2 diabetes were diagnosed over a median follow-up of about 9 years, which translated to an incidence rate of 11 cases per 1,000 person-years in white participants, 16 cases for Chinese Americans, 21 for black participants, and 22 for Hispanic participants. Well over half of the participants were overweight or obese at baseline, including about 80% of black and Hispanic participants.

The sample size reported in the abstract was smaller than that in the final presentation because the investigators did not adjust for diet in the final presentation, Mr. Rodriguez explained. Because some study participants did not report diet, by excluding diet from the model adjustment, the number of participants increased, as reflected in this text. Adjusting for diet did not alter the findings.

The National Heart, Lung, and Blood Institute sponsors MESA. Mr. Rodriguez was supported by a grant from the National Institutes of Health/National Institute of Diabetes and Kidney Disease. The other investigators reported having no disclosures.
 

aotto@mdedge.com

SOURCE: Rodriguez L et al. ADA 2019, Abstract 115-OR.