SGLT2 inhibitors cut cardiovascular outcomes regardless of region

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– Cardiovascular outcomes were significantly more favorable with sodium glucose cotransporter-2 inhibitors compared with other glucose-lowering drugs, according to data from more than 400,000 type 2 diabetes patients in the Middle East, Asia Pacific, and North America.

Data on cardiovascular outcomes from diabetes treatments in patients outside the United States and Europe are limited, said Mikhail Kosiborod, MD, of Saint Luke’s Mid-America Heart Institute and University of Missouri–Kansas City.

In fact, most patients with type 2 diabetes reside in the Asia-Pacific and the Middle East, he said in a presentation at the annual meeting of the American College of Cardiology.

Dr. Kosiborod was involved in a previous large pharmaco-epidemiologic study known as the Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors (CVD-REAL), that showed SGLT2 inhibitor effects in a broad population of type 2 diabetes patients, but that study included only patients from Europe and North America, and focused on just two outcomes: all-cause mortality and hospitalization for heart failure.

In this study, CVD-REAL 2, Dr. Kosiborod and his colleagues compared multiple outcomes data for patients treated with other glucose lowering drugs (GLDs) and those treated with SGLT2 inhibitors in three world regions: the Middle East, Asia-Pacific, and North America.

 

 


The study population included adults aged 18 years and older diagnosed with type 2 diabetes; a total of 235,064 treated with SGLT2 inhibitors and 235,064 treated with other GLDs. The participants were selected from national databases in Australia, Canada, Israel, Japan, Singapore, and South Korea. Individuals with type 1 diabetes or gestational diabetes were excluded from the study.

Outcomes comparing SGLT2 inhibitors and other GLDs included all-cause death, all-cause death or hospitalization for heart failure, hospitalization for heart failure, myocardial infarction, and stroke. Baseline patient characteristics were similar between the two treatment groups. Exposure time for patients in the SGLT2-inhibitor group was highest by far for dapagliflozin (75%), followed by empagliflozin, ipragliflozin, canagliflozin, tofogliflozin, and luseogliflozin at 9%, 8%, 4%, 3%, and 1%, respectively. (Ipragliflozin, tofogliflozin, and luseogliflozin are approved only in Japan.)

The researchers identified 5,216 deaths from any cause. Overall, treatment with an SGLT2 inhibitor was associated with significantly lower risks of death (hazard ratio, 0.51), hospitalization for heart failure (HR, 0.64), death or hospitalization for heart failure (HR, 0.60), myocardial infarction (HR, 0.81), and stroke (HR, 0.68).

The findings remained consistent across countries and patient subgroups, and in patients with and without cardiovascular disease, Dr. Kosiborod noted.
 

 


The results were limited by several factors, including the observational nature of the study and incomplete mortality data, Dr. Kosiborod said. However, the results suggest that the SGLT2 inhibitors’ impacts on cardiovascular outcomes persist across categories of ethnicity, geography, and cardiovascular disease.

AstraZeneca supported the study. Dr. Kosiborod disclosed relationships with multiple companies including AstraZeneca, Boehringer Ingelheim, Janssen, Merck, Novartis, Novo Nordisk, Glytec, and ZS Pharma. The findings were simultaneously published online (J Am Coll Cardiol. 2018 Mar 11. doi: 10.1016/j.jacc.2018.03.009).

SOURCE: Kosiborod M. ACC 2018.

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– Cardiovascular outcomes were significantly more favorable with sodium glucose cotransporter-2 inhibitors compared with other glucose-lowering drugs, according to data from more than 400,000 type 2 diabetes patients in the Middle East, Asia Pacific, and North America.

Data on cardiovascular outcomes from diabetes treatments in patients outside the United States and Europe are limited, said Mikhail Kosiborod, MD, of Saint Luke’s Mid-America Heart Institute and University of Missouri–Kansas City.

In fact, most patients with type 2 diabetes reside in the Asia-Pacific and the Middle East, he said in a presentation at the annual meeting of the American College of Cardiology.

Dr. Kosiborod was involved in a previous large pharmaco-epidemiologic study known as the Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors (CVD-REAL), that showed SGLT2 inhibitor effects in a broad population of type 2 diabetes patients, but that study included only patients from Europe and North America, and focused on just two outcomes: all-cause mortality and hospitalization for heart failure.

In this study, CVD-REAL 2, Dr. Kosiborod and his colleagues compared multiple outcomes data for patients treated with other glucose lowering drugs (GLDs) and those treated with SGLT2 inhibitors in three world regions: the Middle East, Asia-Pacific, and North America.

 

 


The study population included adults aged 18 years and older diagnosed with type 2 diabetes; a total of 235,064 treated with SGLT2 inhibitors and 235,064 treated with other GLDs. The participants were selected from national databases in Australia, Canada, Israel, Japan, Singapore, and South Korea. Individuals with type 1 diabetes or gestational diabetes were excluded from the study.

Outcomes comparing SGLT2 inhibitors and other GLDs included all-cause death, all-cause death or hospitalization for heart failure, hospitalization for heart failure, myocardial infarction, and stroke. Baseline patient characteristics were similar between the two treatment groups. Exposure time for patients in the SGLT2-inhibitor group was highest by far for dapagliflozin (75%), followed by empagliflozin, ipragliflozin, canagliflozin, tofogliflozin, and luseogliflozin at 9%, 8%, 4%, 3%, and 1%, respectively. (Ipragliflozin, tofogliflozin, and luseogliflozin are approved only in Japan.)

The researchers identified 5,216 deaths from any cause. Overall, treatment with an SGLT2 inhibitor was associated with significantly lower risks of death (hazard ratio, 0.51), hospitalization for heart failure (HR, 0.64), death or hospitalization for heart failure (HR, 0.60), myocardial infarction (HR, 0.81), and stroke (HR, 0.68).

The findings remained consistent across countries and patient subgroups, and in patients with and without cardiovascular disease, Dr. Kosiborod noted.
 

 


The results were limited by several factors, including the observational nature of the study and incomplete mortality data, Dr. Kosiborod said. However, the results suggest that the SGLT2 inhibitors’ impacts on cardiovascular outcomes persist across categories of ethnicity, geography, and cardiovascular disease.

AstraZeneca supported the study. Dr. Kosiborod disclosed relationships with multiple companies including AstraZeneca, Boehringer Ingelheim, Janssen, Merck, Novartis, Novo Nordisk, Glytec, and ZS Pharma. The findings were simultaneously published online (J Am Coll Cardiol. 2018 Mar 11. doi: 10.1016/j.jacc.2018.03.009).

SOURCE: Kosiborod M. ACC 2018.

 

– Cardiovascular outcomes were significantly more favorable with sodium glucose cotransporter-2 inhibitors compared with other glucose-lowering drugs, according to data from more than 400,000 type 2 diabetes patients in the Middle East, Asia Pacific, and North America.

Data on cardiovascular outcomes from diabetes treatments in patients outside the United States and Europe are limited, said Mikhail Kosiborod, MD, of Saint Luke’s Mid-America Heart Institute and University of Missouri–Kansas City.

In fact, most patients with type 2 diabetes reside in the Asia-Pacific and the Middle East, he said in a presentation at the annual meeting of the American College of Cardiology.

Dr. Kosiborod was involved in a previous large pharmaco-epidemiologic study known as the Comparative Effectiveness of Cardiovascular Outcomes in New Users of Sodium-Glucose Cotransporter-2 Inhibitors (CVD-REAL), that showed SGLT2 inhibitor effects in a broad population of type 2 diabetes patients, but that study included only patients from Europe and North America, and focused on just two outcomes: all-cause mortality and hospitalization for heart failure.

In this study, CVD-REAL 2, Dr. Kosiborod and his colleagues compared multiple outcomes data for patients treated with other glucose lowering drugs (GLDs) and those treated with SGLT2 inhibitors in three world regions: the Middle East, Asia-Pacific, and North America.

 

 


The study population included adults aged 18 years and older diagnosed with type 2 diabetes; a total of 235,064 treated with SGLT2 inhibitors and 235,064 treated with other GLDs. The participants were selected from national databases in Australia, Canada, Israel, Japan, Singapore, and South Korea. Individuals with type 1 diabetes or gestational diabetes were excluded from the study.

Outcomes comparing SGLT2 inhibitors and other GLDs included all-cause death, all-cause death or hospitalization for heart failure, hospitalization for heart failure, myocardial infarction, and stroke. Baseline patient characteristics were similar between the two treatment groups. Exposure time for patients in the SGLT2-inhibitor group was highest by far for dapagliflozin (75%), followed by empagliflozin, ipragliflozin, canagliflozin, tofogliflozin, and luseogliflozin at 9%, 8%, 4%, 3%, and 1%, respectively. (Ipragliflozin, tofogliflozin, and luseogliflozin are approved only in Japan.)

The researchers identified 5,216 deaths from any cause. Overall, treatment with an SGLT2 inhibitor was associated with significantly lower risks of death (hazard ratio, 0.51), hospitalization for heart failure (HR, 0.64), death or hospitalization for heart failure (HR, 0.60), myocardial infarction (HR, 0.81), and stroke (HR, 0.68).

The findings remained consistent across countries and patient subgroups, and in patients with and without cardiovascular disease, Dr. Kosiborod noted.
 

 


The results were limited by several factors, including the observational nature of the study and incomplete mortality data, Dr. Kosiborod said. However, the results suggest that the SGLT2 inhibitors’ impacts on cardiovascular outcomes persist across categories of ethnicity, geography, and cardiovascular disease.

AstraZeneca supported the study. Dr. Kosiborod disclosed relationships with multiple companies including AstraZeneca, Boehringer Ingelheim, Janssen, Merck, Novartis, Novo Nordisk, Glytec, and ZS Pharma. The findings were simultaneously published online (J Am Coll Cardiol. 2018 Mar 11. doi: 10.1016/j.jacc.2018.03.009).

SOURCE: Kosiborod M. ACC 2018.

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Key clinical point: SGLT2 inhibitor use was linked to a lower risk of all-cause death, hospitalization for heart failure, myocardial infarction, and stroke in a large, multinational study of adults with type 2 diabetes.

Major finding: All-cause mortality was significantly lower in patients treated with an SGLT2 inhibitor compared with other glucose lowering drugs (HR 0.51).

Study details: The data come from more than 400,000 adults with type 2 diabetes via databases in the Middle East, Asia Pacific, and North America.

Disclosures: AstraZeneca supported the study. Dr. Kosiborod disclosed relationships with AstraZeneca, Boehringer Ingelheim, Janssen, Merck, Novartis, Novo Nordisk, Glytec, and ZS Pharma.

Source: Kosiborod M. ACC 2018.

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Popular vaginal dryness products don’t beat placebos

For vaginal dryness relief, less may be more
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Estrogen tablets and a popular vaginal gel failed to top placebo for relieving vulvovaginal symptoms in postmenopausal women, based on data from a randomized trial of more than 300 patients suffering from genitourinary syndrome of menopause (GSM), a constellation of symptoms including pain on vaginal penetration and vaginal dryness.

“Surveys of postmenopausal women demonstrate a preference for effective, nonhormonal therapies, often due to safety concerns,” wrote Caroline M. Mitchell, MD, of Massachusetts General Hospital, Boston, and her colleagues. The report was published in JAMA Internal Medicine. The researchers randomized 302 postmenopausal women with GSM 1:1:1 to a Vagifem 10-microgram estradiol tablet and placebo gel, a placebo tablet and Replens gel, or a placebo tablet and a placebo gel.

The average age of the women was 61 years, 88% were white, and 81% were sexually active.

The primary outcome was a decrease in the most bothersome symptoms reported by the women after 12 weeks of treatment. The most common of these were pain on penetration (60%) and vulvovaginal dryness (21%).

 

 


After 12 weeks, the women reported no significant difference in most bothersome symptoms between estradiol or moisturizing gel, compared with placebo products (P = .25 and P = .31, respectively). The average improvement in symptom scores was similar between the estradiol tablet and placebo tablet (P = .64) and between the moisturizer and placebo gels (P = .17).

The study was limited by several factors including the homogenous population and the absence of a head-to-head comparison of treatments, the researchers noted. However, the results suggest that more research is needed about genitourinary syndrome of menopause, but that a nonprescription lubricating gel may be an appropriate estrogen-free choice, and that “treatment choice should be based on individual patient preferences regarding cost and formulation,” they said.

The study was funded by the National Institutes of Health/National Institute on Aging. Dr. Mitchell is a consultant for Symbiomix Therapeutics, and coauthors reported grant support from Bayer and having served on a scientific advisory board for Sermonix.

SOURCE: Mitchell C et al. JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0116.

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The double-negative finding of the study suggests a potential change in clinical practice as to the value of estrogen for postmenopausal women, Alison J. Huang, MD, and Deborah Grady, MD, wrote in an editorial.

“Based on the results of this study, women and their physicians may want to take this one step further and conclude that postmenopausal women experiencing vulvovaginal symptoms should choose the cheapest moisturizer or lubricant available over the counter – at least until new evidence arises to suggest that there is any benefit to doing otherwise,” they said. The study compared popular active treatments – an estradiol tablet and a nonhormonal moisturizing gel – with placebo and not with each other, which could be considered a limitation, they said. However, the similar effectiveness of the treatments to placebo support a choice of treatments for vulvovaginal symptoms based on cost and patient preference for a particular formulation, they noted (JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0094).
 

Dr. Huang and Dr. Grady are affiliated with the University of California, San Francisco, and the San Francisco Veterans Affairs Health Care System. Dr. Huang disclosed research grants from Pfizer and Astellas Pharma. Dr. Grady has served as a consultant to MenoGeniX.

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The double-negative finding of the study suggests a potential change in clinical practice as to the value of estrogen for postmenopausal women, Alison J. Huang, MD, and Deborah Grady, MD, wrote in an editorial.

“Based on the results of this study, women and their physicians may want to take this one step further and conclude that postmenopausal women experiencing vulvovaginal symptoms should choose the cheapest moisturizer or lubricant available over the counter – at least until new evidence arises to suggest that there is any benefit to doing otherwise,” they said. The study compared popular active treatments – an estradiol tablet and a nonhormonal moisturizing gel – with placebo and not with each other, which could be considered a limitation, they said. However, the similar effectiveness of the treatments to placebo support a choice of treatments for vulvovaginal symptoms based on cost and patient preference for a particular formulation, they noted (JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0094).
 

Dr. Huang and Dr. Grady are affiliated with the University of California, San Francisco, and the San Francisco Veterans Affairs Health Care System. Dr. Huang disclosed research grants from Pfizer and Astellas Pharma. Dr. Grady has served as a consultant to MenoGeniX.

Body

 

The double-negative finding of the study suggests a potential change in clinical practice as to the value of estrogen for postmenopausal women, Alison J. Huang, MD, and Deborah Grady, MD, wrote in an editorial.

“Based on the results of this study, women and their physicians may want to take this one step further and conclude that postmenopausal women experiencing vulvovaginal symptoms should choose the cheapest moisturizer or lubricant available over the counter – at least until new evidence arises to suggest that there is any benefit to doing otherwise,” they said. The study compared popular active treatments – an estradiol tablet and a nonhormonal moisturizing gel – with placebo and not with each other, which could be considered a limitation, they said. However, the similar effectiveness of the treatments to placebo support a choice of treatments for vulvovaginal symptoms based on cost and patient preference for a particular formulation, they noted (JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0094).
 

Dr. Huang and Dr. Grady are affiliated with the University of California, San Francisco, and the San Francisco Veterans Affairs Health Care System. Dr. Huang disclosed research grants from Pfizer and Astellas Pharma. Dr. Grady has served as a consultant to MenoGeniX.

Title
For vaginal dryness relief, less may be more
For vaginal dryness relief, less may be more

 

Estrogen tablets and a popular vaginal gel failed to top placebo for relieving vulvovaginal symptoms in postmenopausal women, based on data from a randomized trial of more than 300 patients suffering from genitourinary syndrome of menopause (GSM), a constellation of symptoms including pain on vaginal penetration and vaginal dryness.

“Surveys of postmenopausal women demonstrate a preference for effective, nonhormonal therapies, often due to safety concerns,” wrote Caroline M. Mitchell, MD, of Massachusetts General Hospital, Boston, and her colleagues. The report was published in JAMA Internal Medicine. The researchers randomized 302 postmenopausal women with GSM 1:1:1 to a Vagifem 10-microgram estradiol tablet and placebo gel, a placebo tablet and Replens gel, or a placebo tablet and a placebo gel.

The average age of the women was 61 years, 88% were white, and 81% were sexually active.

The primary outcome was a decrease in the most bothersome symptoms reported by the women after 12 weeks of treatment. The most common of these were pain on penetration (60%) and vulvovaginal dryness (21%).

 

 


After 12 weeks, the women reported no significant difference in most bothersome symptoms between estradiol or moisturizing gel, compared with placebo products (P = .25 and P = .31, respectively). The average improvement in symptom scores was similar between the estradiol tablet and placebo tablet (P = .64) and between the moisturizer and placebo gels (P = .17).

The study was limited by several factors including the homogenous population and the absence of a head-to-head comparison of treatments, the researchers noted. However, the results suggest that more research is needed about genitourinary syndrome of menopause, but that a nonprescription lubricating gel may be an appropriate estrogen-free choice, and that “treatment choice should be based on individual patient preferences regarding cost and formulation,” they said.

The study was funded by the National Institutes of Health/National Institute on Aging. Dr. Mitchell is a consultant for Symbiomix Therapeutics, and coauthors reported grant support from Bayer and having served on a scientific advisory board for Sermonix.

SOURCE: Mitchell C et al. JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0116.

 

Estrogen tablets and a popular vaginal gel failed to top placebo for relieving vulvovaginal symptoms in postmenopausal women, based on data from a randomized trial of more than 300 patients suffering from genitourinary syndrome of menopause (GSM), a constellation of symptoms including pain on vaginal penetration and vaginal dryness.

“Surveys of postmenopausal women demonstrate a preference for effective, nonhormonal therapies, often due to safety concerns,” wrote Caroline M. Mitchell, MD, of Massachusetts General Hospital, Boston, and her colleagues. The report was published in JAMA Internal Medicine. The researchers randomized 302 postmenopausal women with GSM 1:1:1 to a Vagifem 10-microgram estradiol tablet and placebo gel, a placebo tablet and Replens gel, or a placebo tablet and a placebo gel.

The average age of the women was 61 years, 88% were white, and 81% were sexually active.

The primary outcome was a decrease in the most bothersome symptoms reported by the women after 12 weeks of treatment. The most common of these were pain on penetration (60%) and vulvovaginal dryness (21%).

 

 


After 12 weeks, the women reported no significant difference in most bothersome symptoms between estradiol or moisturizing gel, compared with placebo products (P = .25 and P = .31, respectively). The average improvement in symptom scores was similar between the estradiol tablet and placebo tablet (P = .64) and between the moisturizer and placebo gels (P = .17).

The study was limited by several factors including the homogenous population and the absence of a head-to-head comparison of treatments, the researchers noted. However, the results suggest that more research is needed about genitourinary syndrome of menopause, but that a nonprescription lubricating gel may be an appropriate estrogen-free choice, and that “treatment choice should be based on individual patient preferences regarding cost and formulation,” they said.

The study was funded by the National Institutes of Health/National Institute on Aging. Dr. Mitchell is a consultant for Symbiomix Therapeutics, and coauthors reported grant support from Bayer and having served on a scientific advisory board for Sermonix.

SOURCE: Mitchell C et al. JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0116.

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Key clinical point: Estradiol tablets had no increased benefit, compared with placebo, for relieving postmenopausal vulvovaginal symptoms.

Major finding: The improvement in vaginal discomfort after 12 weeks was not significantly different between an estradiol tablet and placebo (P = .64) or between a popular vaginal moisturizer and placebo (P = .17).

Study details: The data come from a randomized, clinical trial of 302 postmenopausal women.

Disclosures: The study was funded by the National Institutes of Health/National Institute on Aging. Dr. Mitchell is a consultant for Symbiomix Therapeutics, and coauthors reported grant support from Bayer and having served on a scientific advisory board for Sermonix.

Source: Mitchell C et al. JAMA Intern Med. 2018 Mar. doi: 10.1001/jamainternmed.2018.0116.

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VIDEO: Patient vouchers prompt physicians to prescribe top antiplatelet drugs

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– Patients who received vouchers to cover copayments were more likely to receive prescriptions for more effective antiplatelet medication, according to data from a multicenter, randomized trial.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

“We know that guidelines are very clear; we need to treat patients with antiplatelet therapy for 12 months,” and that the most potent drug, ticagrelor, should be used, Tracy Wang, MD, of Duke University, Durham, N.C., said in a video interview at the annual meeting of the American College of Cardiology. However, in the United States, clopidogrel, though less effective, is prescribed much more often, and many patients discontinue their P2Y12 inhibitor therapy within the first year because of cost, she added.

“We hypothesized that, by reducing the out of pocket costs, treatment would be more evidence driven, rather than driven by what patients could afford,” she said.

The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) included 11,001 MI patients at 301 hospitals across the United States. Patients in the treatment hospital group received a voucher to use at a pharmacy or through a mail-order pharmacy to reduce out of pocket costs. Randomization occurred at the hospital level, and hospital characteristics were similar between the groups.

 

 


Overall, patients in the treatment group were significantly more likely to receive a prescription for ticagrelor than clopidogrel (60% vs. 36%); 55% and 32% of patients in the usual care group were prescribed ticagrelor and clopidogrel, respectively. Nonpersistence, defined as a gap in P2Y12-inhibitor use of at least 30 days within 1 year, was significantly lower in the treatment group than it was in the usual care group based on patient reported analysis (13% vs. 16%).

However, the incidence of major adverse cardiac events was roughly 10% in both groups. The similar outcomes may stem from the fact that 28% of patients with vouchers did not fill their prescriptions for reasons that the study did not explore, said Dr. Wang.



All patients had health insurance: 64% private, 42% Medicare, 9% Medicaid. The average age of the patients was 62 years, and 31% were women. Patient demographics and clinical characteristics were similar between the groups.

The vouchers affected choice of treatment but didn’t help clinical outcomes, which suggests that copayment reduction should be part of a broader strategy to help patients with adherence over time, said Dr. Wang.

 

 


Next steps for research include taking a subset of patients who are more likely to be nonadherent and at high risk for adverse events and targeting them for additional intervention, she noted.

Discussant Craig J. Beavers, PharmD, of the University of Kentucky College of Pharmacy, Lexington, agreed that a multipronged approach is needed to get patients to take their medicines. “We have to figure out what other barriers there are,” he said. “The real trick is, even if you lead a horse to water, how to get them to drink it,” he said.

The study was funded by AstraZeneca. Dr. Wang disclosed relationships with companies including Gilead Sciences, Merck, and Sanofi Pasteur. Dr. Beavers had no financial conflicts to disclose.

SOURCE: Wang T. ACC 18.

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– Patients who received vouchers to cover copayments were more likely to receive prescriptions for more effective antiplatelet medication, according to data from a multicenter, randomized trial.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

“We know that guidelines are very clear; we need to treat patients with antiplatelet therapy for 12 months,” and that the most potent drug, ticagrelor, should be used, Tracy Wang, MD, of Duke University, Durham, N.C., said in a video interview at the annual meeting of the American College of Cardiology. However, in the United States, clopidogrel, though less effective, is prescribed much more often, and many patients discontinue their P2Y12 inhibitor therapy within the first year because of cost, she added.

“We hypothesized that, by reducing the out of pocket costs, treatment would be more evidence driven, rather than driven by what patients could afford,” she said.

The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) included 11,001 MI patients at 301 hospitals across the United States. Patients in the treatment hospital group received a voucher to use at a pharmacy or through a mail-order pharmacy to reduce out of pocket costs. Randomization occurred at the hospital level, and hospital characteristics were similar between the groups.

 

 


Overall, patients in the treatment group were significantly more likely to receive a prescription for ticagrelor than clopidogrel (60% vs. 36%); 55% and 32% of patients in the usual care group were prescribed ticagrelor and clopidogrel, respectively. Nonpersistence, defined as a gap in P2Y12-inhibitor use of at least 30 days within 1 year, was significantly lower in the treatment group than it was in the usual care group based on patient reported analysis (13% vs. 16%).

However, the incidence of major adverse cardiac events was roughly 10% in both groups. The similar outcomes may stem from the fact that 28% of patients with vouchers did not fill their prescriptions for reasons that the study did not explore, said Dr. Wang.



All patients had health insurance: 64% private, 42% Medicare, 9% Medicaid. The average age of the patients was 62 years, and 31% were women. Patient demographics and clinical characteristics were similar between the groups.

The vouchers affected choice of treatment but didn’t help clinical outcomes, which suggests that copayment reduction should be part of a broader strategy to help patients with adherence over time, said Dr. Wang.

 

 


Next steps for research include taking a subset of patients who are more likely to be nonadherent and at high risk for adverse events and targeting them for additional intervention, she noted.

Discussant Craig J. Beavers, PharmD, of the University of Kentucky College of Pharmacy, Lexington, agreed that a multipronged approach is needed to get patients to take their medicines. “We have to figure out what other barriers there are,” he said. “The real trick is, even if you lead a horse to water, how to get them to drink it,” he said.

The study was funded by AstraZeneca. Dr. Wang disclosed relationships with companies including Gilead Sciences, Merck, and Sanofi Pasteur. Dr. Beavers had no financial conflicts to disclose.

SOURCE: Wang T. ACC 18.

 

– Patients who received vouchers to cover copayments were more likely to receive prescriptions for more effective antiplatelet medication, according to data from a multicenter, randomized trial.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel

“We know that guidelines are very clear; we need to treat patients with antiplatelet therapy for 12 months,” and that the most potent drug, ticagrelor, should be used, Tracy Wang, MD, of Duke University, Durham, N.C., said in a video interview at the annual meeting of the American College of Cardiology. However, in the United States, clopidogrel, though less effective, is prescribed much more often, and many patients discontinue their P2Y12 inhibitor therapy within the first year because of cost, she added.

“We hypothesized that, by reducing the out of pocket costs, treatment would be more evidence driven, rather than driven by what patients could afford,” she said.

The Affordability and Real-World Antiplatelet Treatment Effectiveness After Myocardial Infarction Study (ARTEMIS) included 11,001 MI patients at 301 hospitals across the United States. Patients in the treatment hospital group received a voucher to use at a pharmacy or through a mail-order pharmacy to reduce out of pocket costs. Randomization occurred at the hospital level, and hospital characteristics were similar between the groups.

 

 


Overall, patients in the treatment group were significantly more likely to receive a prescription for ticagrelor than clopidogrel (60% vs. 36%); 55% and 32% of patients in the usual care group were prescribed ticagrelor and clopidogrel, respectively. Nonpersistence, defined as a gap in P2Y12-inhibitor use of at least 30 days within 1 year, was significantly lower in the treatment group than it was in the usual care group based on patient reported analysis (13% vs. 16%).

However, the incidence of major adverse cardiac events was roughly 10% in both groups. The similar outcomes may stem from the fact that 28% of patients with vouchers did not fill their prescriptions for reasons that the study did not explore, said Dr. Wang.



All patients had health insurance: 64% private, 42% Medicare, 9% Medicaid. The average age of the patients was 62 years, and 31% were women. Patient demographics and clinical characteristics were similar between the groups.

The vouchers affected choice of treatment but didn’t help clinical outcomes, which suggests that copayment reduction should be part of a broader strategy to help patients with adherence over time, said Dr. Wang.

 

 


Next steps for research include taking a subset of patients who are more likely to be nonadherent and at high risk for adverse events and targeting them for additional intervention, she noted.

Discussant Craig J. Beavers, PharmD, of the University of Kentucky College of Pharmacy, Lexington, agreed that a multipronged approach is needed to get patients to take their medicines. “We have to figure out what other barriers there are,” he said. “The real trick is, even if you lead a horse to water, how to get them to drink it,” he said.

The study was funded by AstraZeneca. Dr. Wang disclosed relationships with companies including Gilead Sciences, Merck, and Sanofi Pasteur. Dr. Beavers had no financial conflicts to disclose.

SOURCE: Wang T. ACC 18.

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Key clinical point: Physicians were more likely to prescribe ticagrelor after an MI when patients received vouchers.

Major finding: Patients with vouchers received prescriptions for ticagrelor significantly more than clopidogrel (60% vs. 36%).

Study details: The data come from a randomized trial of 301 hospitals in the United States and included 11,001 MI patients.

Disclosures: ARTEMIS was funded by AstraZeneca. Dr. Wang disclosed relationships with companies including Gilead Sciences, Merck, and Sanofi Pasteur. Dr. Beavers had no financial conflicts to disclose.

Source: Wang T. ACC 2018.

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Barbershop intervention cuts blood pressure in black men

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– Black men who received a pharmacist-led intervention in their local barbershops showed significantly improved blood pressure after 6 months, compared with controls, in a randomized trial of 319 individuals.

“Non-Hispanic black men still have the highest hypertension death rate of any group in the country. Something like 60% of black men have blood pressure of 140/90 or higher,” but they have relatively low rates of physician interaction for blood pressure management, compared with other groups, Ronald G. Victor, MD, of Cedars-Sinai Medical Center, Los Angeles, said in a video interview at the annual meeting of the American College of Cardiology.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


“Health outreach to barbershops has been well established in the lay press, but they only scratch the surface in terms of a scientific evaluation, and that’s what we did,” he noted.

The primary outcome was a change in systolic blood pressure at 6 months. The average decrease was 27.0 mm Hg in the intervention group, compared with 9.3 mm Hg in the control group.

 

 

Dr. Victor and colleagues identified a study population of non-Hispanic black men aged 35-79 years with a baseline blood pressure of at least 140 mm Hg who were regular patrons of their local barbershops. Of these, 139 were randomized to a pharmacist-led intervention in 28 barbershops, and 180 served as controls in 24 barbershops.

The intervention included monthly checkups with a pharmacist in the barbershop setting, along with blood pressure readings, medication management, electrolyte monitoring, and progress notes sent to each man’s primary care provider. In addition, the barbers encouraged blood pressure management and a healthy lifestyle during the men’s regular haircut visits, occurring about every 2 weeks. The control group received encouragement from their barbers and usual care from their primary care providers.

The average baseline systolic blood pressure was 152.8 mm Hg in the intervention group, which dropped to 125.8 mm Hg at 6 months. The controls’ average systolic blood pressure was 154.6 mm Hg at baseline and 145.4 at 6 months.

Dr. Victor said he was thrilled with the results, and that the intervention group’s improvement was roughly three times that seen in many blood pressure intervention studies. “We lost very few men to follow-up,” Dr. Victor said. “I can’t underestimate how important the buy-in of the barbers was,” he emphasized. The primary analysis included 132 intervention men and 171 controls with complete 6 months data.
 

 

The between-group difference for the primary outcome was 21.6 mm Hg in favor of the intervention,” Dr. Victor said. As a secondary outcome, the between-group difference in diastolic blood pressure was 14.9 mm Hg in favor of the intervention.

In addition, 64% and 12% of the intervention and control groups, respectively, achieved the blood pressure target of 130/80.

“We think the intervention effect is multifaceted,” said Dr. Victor. The pharmacists were doctorate level with specialty training, and prescribed more intense therapy than did a community clinic. In addition, the convenience and comfort of the community barbershop setting, and the endorsement by the barbers, who are significant figures in the community, contributed to the success of the study, he said.

“We think the whole package was important,” he emphasized.
 

 

The intervention was safe and well tolerated, with no adverse events. A total of three cases of reversible acute kidney injury occurred in the intervention group that were related to indapamide and resolved when it was discontinued.

“This [study] is a home run,” discussant Eileen Handberg, MD, said in a press conference, “This is taking care where patients live; this is ‘high-touch’ medicine,” she said. Also, the 9-mm Hg improvement in the control group was comparable with improvements in many previous blood pressure control trials, she noted.

Dr. Victor said he plans to expand the study by establishing similar protocols in other communities. Additional next steps for research include extending the current study for another 6 months, expanding the research criteria to include men with mild hypertension, and conducting a cost analysis, he said.

The study was funded by the National Heart, Lung, and Blood Institute and others. Dr. Victor had no financial conflicts to disclose. Dr. Handberg disclosed relationships with multiple companies including Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Ionis, and Relypsa.
 

 

The findings were published online simultaneously with Dr. Victor’s report (N Engl J Med. 2018 Mar 11; doi: 10.1056/NEJMoa1717250).

SOURCE: Victor R et al. ACC 2018.

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– Black men who received a pharmacist-led intervention in their local barbershops showed significantly improved blood pressure after 6 months, compared with controls, in a randomized trial of 319 individuals.

“Non-Hispanic black men still have the highest hypertension death rate of any group in the country. Something like 60% of black men have blood pressure of 140/90 or higher,” but they have relatively low rates of physician interaction for blood pressure management, compared with other groups, Ronald G. Victor, MD, of Cedars-Sinai Medical Center, Los Angeles, said in a video interview at the annual meeting of the American College of Cardiology.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


“Health outreach to barbershops has been well established in the lay press, but they only scratch the surface in terms of a scientific evaluation, and that’s what we did,” he noted.

The primary outcome was a change in systolic blood pressure at 6 months. The average decrease was 27.0 mm Hg in the intervention group, compared with 9.3 mm Hg in the control group.

 

 

Dr. Victor and colleagues identified a study population of non-Hispanic black men aged 35-79 years with a baseline blood pressure of at least 140 mm Hg who were regular patrons of their local barbershops. Of these, 139 were randomized to a pharmacist-led intervention in 28 barbershops, and 180 served as controls in 24 barbershops.

The intervention included monthly checkups with a pharmacist in the barbershop setting, along with blood pressure readings, medication management, electrolyte monitoring, and progress notes sent to each man’s primary care provider. In addition, the barbers encouraged blood pressure management and a healthy lifestyle during the men’s regular haircut visits, occurring about every 2 weeks. The control group received encouragement from their barbers and usual care from their primary care providers.

The average baseline systolic blood pressure was 152.8 mm Hg in the intervention group, which dropped to 125.8 mm Hg at 6 months. The controls’ average systolic blood pressure was 154.6 mm Hg at baseline and 145.4 at 6 months.

Dr. Victor said he was thrilled with the results, and that the intervention group’s improvement was roughly three times that seen in many blood pressure intervention studies. “We lost very few men to follow-up,” Dr. Victor said. “I can’t underestimate how important the buy-in of the barbers was,” he emphasized. The primary analysis included 132 intervention men and 171 controls with complete 6 months data.
 

 

The between-group difference for the primary outcome was 21.6 mm Hg in favor of the intervention,” Dr. Victor said. As a secondary outcome, the between-group difference in diastolic blood pressure was 14.9 mm Hg in favor of the intervention.

In addition, 64% and 12% of the intervention and control groups, respectively, achieved the blood pressure target of 130/80.

“We think the intervention effect is multifaceted,” said Dr. Victor. The pharmacists were doctorate level with specialty training, and prescribed more intense therapy than did a community clinic. In addition, the convenience and comfort of the community barbershop setting, and the endorsement by the barbers, who are significant figures in the community, contributed to the success of the study, he said.

“We think the whole package was important,” he emphasized.
 

 

The intervention was safe and well tolerated, with no adverse events. A total of three cases of reversible acute kidney injury occurred in the intervention group that were related to indapamide and resolved when it was discontinued.

“This [study] is a home run,” discussant Eileen Handberg, MD, said in a press conference, “This is taking care where patients live; this is ‘high-touch’ medicine,” she said. Also, the 9-mm Hg improvement in the control group was comparable with improvements in many previous blood pressure control trials, she noted.

Dr. Victor said he plans to expand the study by establishing similar protocols in other communities. Additional next steps for research include extending the current study for another 6 months, expanding the research criteria to include men with mild hypertension, and conducting a cost analysis, he said.

The study was funded by the National Heart, Lung, and Blood Institute and others. Dr. Victor had no financial conflicts to disclose. Dr. Handberg disclosed relationships with multiple companies including Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Ionis, and Relypsa.
 

 

The findings were published online simultaneously with Dr. Victor’s report (N Engl J Med. 2018 Mar 11; doi: 10.1056/NEJMoa1717250).

SOURCE: Victor R et al. ACC 2018.

 

– Black men who received a pharmacist-led intervention in their local barbershops showed significantly improved blood pressure after 6 months, compared with controls, in a randomized trial of 319 individuals.

“Non-Hispanic black men still have the highest hypertension death rate of any group in the country. Something like 60% of black men have blood pressure of 140/90 or higher,” but they have relatively low rates of physician interaction for blood pressure management, compared with other groups, Ronald G. Victor, MD, of Cedars-Sinai Medical Center, Los Angeles, said in a video interview at the annual meeting of the American College of Cardiology.

The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel


“Health outreach to barbershops has been well established in the lay press, but they only scratch the surface in terms of a scientific evaluation, and that’s what we did,” he noted.

The primary outcome was a change in systolic blood pressure at 6 months. The average decrease was 27.0 mm Hg in the intervention group, compared with 9.3 mm Hg in the control group.

 

 

Dr. Victor and colleagues identified a study population of non-Hispanic black men aged 35-79 years with a baseline blood pressure of at least 140 mm Hg who were regular patrons of their local barbershops. Of these, 139 were randomized to a pharmacist-led intervention in 28 barbershops, and 180 served as controls in 24 barbershops.

The intervention included monthly checkups with a pharmacist in the barbershop setting, along with blood pressure readings, medication management, electrolyte monitoring, and progress notes sent to each man’s primary care provider. In addition, the barbers encouraged blood pressure management and a healthy lifestyle during the men’s regular haircut visits, occurring about every 2 weeks. The control group received encouragement from their barbers and usual care from their primary care providers.

The average baseline systolic blood pressure was 152.8 mm Hg in the intervention group, which dropped to 125.8 mm Hg at 6 months. The controls’ average systolic blood pressure was 154.6 mm Hg at baseline and 145.4 at 6 months.

Dr. Victor said he was thrilled with the results, and that the intervention group’s improvement was roughly three times that seen in many blood pressure intervention studies. “We lost very few men to follow-up,” Dr. Victor said. “I can’t underestimate how important the buy-in of the barbers was,” he emphasized. The primary analysis included 132 intervention men and 171 controls with complete 6 months data.
 

 

The between-group difference for the primary outcome was 21.6 mm Hg in favor of the intervention,” Dr. Victor said. As a secondary outcome, the between-group difference in diastolic blood pressure was 14.9 mm Hg in favor of the intervention.

In addition, 64% and 12% of the intervention and control groups, respectively, achieved the blood pressure target of 130/80.

“We think the intervention effect is multifaceted,” said Dr. Victor. The pharmacists were doctorate level with specialty training, and prescribed more intense therapy than did a community clinic. In addition, the convenience and comfort of the community barbershop setting, and the endorsement by the barbers, who are significant figures in the community, contributed to the success of the study, he said.

“We think the whole package was important,” he emphasized.
 

 

The intervention was safe and well tolerated, with no adverse events. A total of three cases of reversible acute kidney injury occurred in the intervention group that were related to indapamide and resolved when it was discontinued.

“This [study] is a home run,” discussant Eileen Handberg, MD, said in a press conference, “This is taking care where patients live; this is ‘high-touch’ medicine,” she said. Also, the 9-mm Hg improvement in the control group was comparable with improvements in many previous blood pressure control trials, she noted.

Dr. Victor said he plans to expand the study by establishing similar protocols in other communities. Additional next steps for research include extending the current study for another 6 months, expanding the research criteria to include men with mild hypertension, and conducting a cost analysis, he said.

The study was funded by the National Heart, Lung, and Blood Institute and others. Dr. Victor had no financial conflicts to disclose. Dr. Handberg disclosed relationships with multiple companies including Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Gilead Sciences, Ionis, and Relypsa.
 

 

The findings were published online simultaneously with Dr. Victor’s report (N Engl J Med. 2018 Mar 11; doi: 10.1056/NEJMoa1717250).

SOURCE: Victor R et al. ACC 2018.

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Key clinical point: Pharmacist-led interventions in barbershops significantly improved blood pressure control in African American men.Major finding: After 6 months, mean systolic blood pressure among men who received intervention dropped an average of 27 mm Hg, compared with 9 mm Hg in controls.

Study details: The data come from a cluster randomized trial including 319 black men who visited 52 barbershops.

Disclosures: The study was funded by the National Heart, Lung, and Blood Institute and others.

Source: Victor R et al. ACC 2018.

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CECCY: Carvedilol didn’t curb cardiotoxicity in breast cancer patients

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– Anthracycline chemotherapy was associated with a cardiotoxicity incidence of roughly 14% of breast cancer patients regardless of treatment with carvedilol, based on data from a randomized trial of 200 patients.

“Cardio-oncology has been neglected,” Monica Samuel Avila, MD, of Hospital das Clínicas da Faculdade de Medicina da Universidade in São Paulo, Brazil, said in a video interview at the annual meeting of the American College of Cardiology. “We have seen improvement of survival in patients with cancer, but with that comes complications related to treatment. I think that the interactions between cardiologists and oncologists are increasing in a more important way,” she said.

In the Carvedilol for Prevention of Chemotherapy-Induced Cardiotoxicity (CECCY) Trial, Dr. Avila and colleagues evaluated primary prevention of cardiotoxicity in women with normal hearts who were undergoing chemotherapy for breast cancer.

 

 


Patients in the treatment group received a median carvedilol dose of 18.4 mg/day. The primary endpoint of cardiotoxicity, defined as a decrease in left ventricular ejection fraction (LVEF) of at least 10% at 6 months, occurred in 15% of carvedilol patients and 14% placebo patients, a nonsignificant difference. No significant differences occurred in diastolic dysfunction or in B-type natriuretic peptide (BNP) levels at 6 weeks, 12 weeks, or 24 weeks between the groups.

However, carvedilol patients showed significantly reduced troponin 1 levels compared with placebo, which suggests protection against myocardial injury, Dr. Avila said.


“In short follow up, we can see cardiotoxicity appearing, and we know we have to treat it promptly to prevent cardiac events,” she said.

Dr. Avila and colleagues identified 200 women older than 18 years with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction. The patients were undergoing chemotherapy with 240 mg/m2 of anthracycline and were randomized to treatment with carvedilol or a placebo. Baseline characteristics were similar between the two groups.
 

 


Adverse effects were not significantly different between the groups, and the most common events in each group included dizziness, dry mouth, symptomatic hypertension, stomachache, and nausea. Although the results suggest that carvedilol can reduce the risk of myocardial injury, more research is needed to address the question of the increase in troponin without change in the LVEF, Dr. Avila noted. The study is ongoing and the research team intends to follow the low-risk patient population for a total of 2 years. “For high-risk patients, I am already giving carvedilol,” she said. “We believe if we find a difference in LVEF or clinical events, we could encourage cardiologists to give carvedilol in a low-risk population,” she said.

“This study highlights that there is no safe dose of anthracycline,” commented Bonnie Ky, MD of the University of Pennsylvania, Philadelphia, at a press briefing. She emphasized the value of carvedilol for a high-risk population, and stressed the importance of following long-term changes in heart injury markers after 1-2 years for low-risk patients.

Dr. Avila had no financial conflicts to disclose. Dr. Ky disclosed relationships with multiple companies including Bioinvent and Bristol Myers.

The findings were published simultaneously in the Journal of the American College of Cardiology.
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– Anthracycline chemotherapy was associated with a cardiotoxicity incidence of roughly 14% of breast cancer patients regardless of treatment with carvedilol, based on data from a randomized trial of 200 patients.

“Cardio-oncology has been neglected,” Monica Samuel Avila, MD, of Hospital das Clínicas da Faculdade de Medicina da Universidade in São Paulo, Brazil, said in a video interview at the annual meeting of the American College of Cardiology. “We have seen improvement of survival in patients with cancer, but with that comes complications related to treatment. I think that the interactions between cardiologists and oncologists are increasing in a more important way,” she said.

In the Carvedilol for Prevention of Chemotherapy-Induced Cardiotoxicity (CECCY) Trial, Dr. Avila and colleagues evaluated primary prevention of cardiotoxicity in women with normal hearts who were undergoing chemotherapy for breast cancer.

 

 


Patients in the treatment group received a median carvedilol dose of 18.4 mg/day. The primary endpoint of cardiotoxicity, defined as a decrease in left ventricular ejection fraction (LVEF) of at least 10% at 6 months, occurred in 15% of carvedilol patients and 14% placebo patients, a nonsignificant difference. No significant differences occurred in diastolic dysfunction or in B-type natriuretic peptide (BNP) levels at 6 weeks, 12 weeks, or 24 weeks between the groups.

However, carvedilol patients showed significantly reduced troponin 1 levels compared with placebo, which suggests protection against myocardial injury, Dr. Avila said.


“In short follow up, we can see cardiotoxicity appearing, and we know we have to treat it promptly to prevent cardiac events,” she said.

Dr. Avila and colleagues identified 200 women older than 18 years with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction. The patients were undergoing chemotherapy with 240 mg/m2 of anthracycline and were randomized to treatment with carvedilol or a placebo. Baseline characteristics were similar between the two groups.
 

 


Adverse effects were not significantly different between the groups, and the most common events in each group included dizziness, dry mouth, symptomatic hypertension, stomachache, and nausea. Although the results suggest that carvedilol can reduce the risk of myocardial injury, more research is needed to address the question of the increase in troponin without change in the LVEF, Dr. Avila noted. The study is ongoing and the research team intends to follow the low-risk patient population for a total of 2 years. “For high-risk patients, I am already giving carvedilol,” she said. “We believe if we find a difference in LVEF or clinical events, we could encourage cardiologists to give carvedilol in a low-risk population,” she said.

“This study highlights that there is no safe dose of anthracycline,” commented Bonnie Ky, MD of the University of Pennsylvania, Philadelphia, at a press briefing. She emphasized the value of carvedilol for a high-risk population, and stressed the importance of following long-term changes in heart injury markers after 1-2 years for low-risk patients.

Dr. Avila had no financial conflicts to disclose. Dr. Ky disclosed relationships with multiple companies including Bioinvent and Bristol Myers.

The findings were published simultaneously in the Journal of the American College of Cardiology.

– Anthracycline chemotherapy was associated with a cardiotoxicity incidence of roughly 14% of breast cancer patients regardless of treatment with carvedilol, based on data from a randomized trial of 200 patients.

“Cardio-oncology has been neglected,” Monica Samuel Avila, MD, of Hospital das Clínicas da Faculdade de Medicina da Universidade in São Paulo, Brazil, said in a video interview at the annual meeting of the American College of Cardiology. “We have seen improvement of survival in patients with cancer, but with that comes complications related to treatment. I think that the interactions between cardiologists and oncologists are increasing in a more important way,” she said.

In the Carvedilol for Prevention of Chemotherapy-Induced Cardiotoxicity (CECCY) Trial, Dr. Avila and colleagues evaluated primary prevention of cardiotoxicity in women with normal hearts who were undergoing chemotherapy for breast cancer.

 

 


Patients in the treatment group received a median carvedilol dose of 18.4 mg/day. The primary endpoint of cardiotoxicity, defined as a decrease in left ventricular ejection fraction (LVEF) of at least 10% at 6 months, occurred in 15% of carvedilol patients and 14% placebo patients, a nonsignificant difference. No significant differences occurred in diastolic dysfunction or in B-type natriuretic peptide (BNP) levels at 6 weeks, 12 weeks, or 24 weeks between the groups.

However, carvedilol patients showed significantly reduced troponin 1 levels compared with placebo, which suggests protection against myocardial injury, Dr. Avila said.


“In short follow up, we can see cardiotoxicity appearing, and we know we have to treat it promptly to prevent cardiac events,” she said.

Dr. Avila and colleagues identified 200 women older than 18 years with HER2-negative breast cancer tumor status and normal left ventricular ejection fraction. The patients were undergoing chemotherapy with 240 mg/m2 of anthracycline and were randomized to treatment with carvedilol or a placebo. Baseline characteristics were similar between the two groups.
 

 


Adverse effects were not significantly different between the groups, and the most common events in each group included dizziness, dry mouth, symptomatic hypertension, stomachache, and nausea. Although the results suggest that carvedilol can reduce the risk of myocardial injury, more research is needed to address the question of the increase in troponin without change in the LVEF, Dr. Avila noted. The study is ongoing and the research team intends to follow the low-risk patient population for a total of 2 years. “For high-risk patients, I am already giving carvedilol,” she said. “We believe if we find a difference in LVEF or clinical events, we could encourage cardiologists to give carvedilol in a low-risk population,” she said.

“This study highlights that there is no safe dose of anthracycline,” commented Bonnie Ky, MD of the University of Pennsylvania, Philadelphia, at a press briefing. She emphasized the value of carvedilol for a high-risk population, and stressed the importance of following long-term changes in heart injury markers after 1-2 years for low-risk patients.

Dr. Avila had no financial conflicts to disclose. Dr. Ky disclosed relationships with multiple companies including Bioinvent and Bristol Myers.

The findings were published simultaneously in the Journal of the American College of Cardiology.
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Key clinical point: Carvedilol was associated with a significant improvement in troponin 1 levels compared with placebo, but had no impact on left ventricular ejection fraction.

Major finding: Cardiotoxicity was roughly 14% in breast cancer patients treated with anthracycline whether they received carvedilol or placebo.

Study details: CECCY was a randomized, placebo-controlled trial of 200 patients with HER2-negative breast cancer tumor status.

Disclosures: Dr. Avila had no financial conflicts to disclose.

Source: Avila M. ACC 2018.

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Postmenopausal women: Walk farther and faster to reduce heart failure risk

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Brisk walking for at least 40 minutes two or three times a week reduced the risk of heart failure by approximately 25% in postmenopausal women, according to data from more that 89,000 participants in the Women’s Health Initiative.

The benefits of walking are well understood, said Somwail Rasla, MD, of Saint Vincent Hospital in Worcester, Mass., but he and his colleagues focused for the first time on how the speed, frequency, and duration of walking affected health in older women who may be less likely to visit a gym or engage in a formal exercise program.

iStock/thinkstockphotos
“The more they walk, the higher the speed, and the longer the duration, the less likely they are to have heart failure,” Dr. Rasla said in a press briefing in advance of the annual meeting of the American College of Cardiology.

The researchers followed the women, aged 50-79 years, for approximately 10 years.

 

 

SOURCE: Rasla S et al. ACC 18, Poster 1315M-03.
 

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Brisk walking for at least 40 minutes two or three times a week reduced the risk of heart failure by approximately 25% in postmenopausal women, according to data from more that 89,000 participants in the Women’s Health Initiative.

The benefits of walking are well understood, said Somwail Rasla, MD, of Saint Vincent Hospital in Worcester, Mass., but he and his colleagues focused for the first time on how the speed, frequency, and duration of walking affected health in older women who may be less likely to visit a gym or engage in a formal exercise program.

iStock/thinkstockphotos
“The more they walk, the higher the speed, and the longer the duration, the less likely they are to have heart failure,” Dr. Rasla said in a press briefing in advance of the annual meeting of the American College of Cardiology.

The researchers followed the women, aged 50-79 years, for approximately 10 years.

 

 

SOURCE: Rasla S et al. ACC 18, Poster 1315M-03.
 

 

Brisk walking for at least 40 minutes two or three times a week reduced the risk of heart failure by approximately 25% in postmenopausal women, according to data from more that 89,000 participants in the Women’s Health Initiative.

The benefits of walking are well understood, said Somwail Rasla, MD, of Saint Vincent Hospital in Worcester, Mass., but he and his colleagues focused for the first time on how the speed, frequency, and duration of walking affected health in older women who may be less likely to visit a gym or engage in a formal exercise program.

iStock/thinkstockphotos
“The more they walk, the higher the speed, and the longer the duration, the less likely they are to have heart failure,” Dr. Rasla said in a press briefing in advance of the annual meeting of the American College of Cardiology.

The researchers followed the women, aged 50-79 years, for approximately 10 years.

 

 

SOURCE: Rasla S et al. ACC 18, Poster 1315M-03.
 

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Key clinical point: Urge older female patients to walk briskly at least twice a week.

Major finding: Patients with a fast pace had a 38% lower risk of heart failure.

Study details: A long-term, national observational study of 89,270 women.

Disclosures: The Women’s Health Initiative is sponsored by the National Institutes of Health. The investigators reported no relevant conflicts of interest.

Source: Rasla S et al. ACC 18, Poster 1315M-03.

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Finding a groove helps patients move

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Listening to uptempo music significantly improved patients’ exercise capacity during a stress test, compared with patients who didn’t listen to music, according to data from a randomized trial of 127 patients.

Exercise stress tests are frequently recommended to evaluate patients for heart disease, but many patients don’t work hard enough to reach a useful level of exertion, Waseem Shami, MD, of Texas Tech University in El Paso, said in a web briefing in advance of the annual meeting of the American College of Cardiology.

©Zoonar/hormydesign/Thinkstock
Although many exercisers find motivation in listening to music during workouts, the value of music to improve the quality of treadmill exercise stress testing has not been well studied, said Dr. Shami, who said he was inspired to conduct the study based on his own experience with music providing motivation for his daily runs.

The group of patients that listened to lively music averaged 55 seconds longer exercise time, compared with the no-music control group, Dr. Shami said. The average exercise time was 505.8 seconds in the music group and 455.2 in the control group (P = .045).

Dr. Shami and his colleagues randomized 67 adults scheduled for cardiac stress tests to listen to music during the test and 60 controls to undergo the test without music. The average age of the patients was 53 years, and 61% and 67% of those in the music and control groups, respectively, were women. Demographic characteristics and variables, including resting heart rate and blood pressure, were similar between the music and control groups.

In a clinical setting, the use of music may help reduce unnecessary stress testing, which is deemed unsuccessful if the patient doesn’t exercise hard enough to achieve a target heart rate. “Perhaps this motivational tool can help us make stress testing more valuable,” said Dr. Shami. The results were limited by the relatively small study population and the fact that the researchers, not the patients, chose the music, Dr. Shami said.

More research is needed in a larger trial, and “allowing patients to choose their own music might make an even bigger difference,” he noted. Also, patients’ discomfort with exercising in general and exercising in public may have impacted the results, he said.

Moderator Martha Gulati, MD, of the University of Arizona, Phoenix, noted that an area for future research might be to do a cardiac stress test without and without music on the same person, with the patient serving as his or her own control.

Dr. Shami had no relevant financial conflicts to disclose.

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Listening to uptempo music significantly improved patients’ exercise capacity during a stress test, compared with patients who didn’t listen to music, according to data from a randomized trial of 127 patients.

Exercise stress tests are frequently recommended to evaluate patients for heart disease, but many patients don’t work hard enough to reach a useful level of exertion, Waseem Shami, MD, of Texas Tech University in El Paso, said in a web briefing in advance of the annual meeting of the American College of Cardiology.

©Zoonar/hormydesign/Thinkstock
Although many exercisers find motivation in listening to music during workouts, the value of music to improve the quality of treadmill exercise stress testing has not been well studied, said Dr. Shami, who said he was inspired to conduct the study based on his own experience with music providing motivation for his daily runs.

The group of patients that listened to lively music averaged 55 seconds longer exercise time, compared with the no-music control group, Dr. Shami said. The average exercise time was 505.8 seconds in the music group and 455.2 in the control group (P = .045).

Dr. Shami and his colleagues randomized 67 adults scheduled for cardiac stress tests to listen to music during the test and 60 controls to undergo the test without music. The average age of the patients was 53 years, and 61% and 67% of those in the music and control groups, respectively, were women. Demographic characteristics and variables, including resting heart rate and blood pressure, were similar between the music and control groups.

In a clinical setting, the use of music may help reduce unnecessary stress testing, which is deemed unsuccessful if the patient doesn’t exercise hard enough to achieve a target heart rate. “Perhaps this motivational tool can help us make stress testing more valuable,” said Dr. Shami. The results were limited by the relatively small study population and the fact that the researchers, not the patients, chose the music, Dr. Shami said.

More research is needed in a larger trial, and “allowing patients to choose their own music might make an even bigger difference,” he noted. Also, patients’ discomfort with exercising in general and exercising in public may have impacted the results, he said.

Moderator Martha Gulati, MD, of the University of Arizona, Phoenix, noted that an area for future research might be to do a cardiac stress test without and without music on the same person, with the patient serving as his or her own control.

Dr. Shami had no relevant financial conflicts to disclose.

 

Listening to uptempo music significantly improved patients’ exercise capacity during a stress test, compared with patients who didn’t listen to music, according to data from a randomized trial of 127 patients.

Exercise stress tests are frequently recommended to evaluate patients for heart disease, but many patients don’t work hard enough to reach a useful level of exertion, Waseem Shami, MD, of Texas Tech University in El Paso, said in a web briefing in advance of the annual meeting of the American College of Cardiology.

©Zoonar/hormydesign/Thinkstock
Although many exercisers find motivation in listening to music during workouts, the value of music to improve the quality of treadmill exercise stress testing has not been well studied, said Dr. Shami, who said he was inspired to conduct the study based on his own experience with music providing motivation for his daily runs.

The group of patients that listened to lively music averaged 55 seconds longer exercise time, compared with the no-music control group, Dr. Shami said. The average exercise time was 505.8 seconds in the music group and 455.2 in the control group (P = .045).

Dr. Shami and his colleagues randomized 67 adults scheduled for cardiac stress tests to listen to music during the test and 60 controls to undergo the test without music. The average age of the patients was 53 years, and 61% and 67% of those in the music and control groups, respectively, were women. Demographic characteristics and variables, including resting heart rate and blood pressure, were similar between the music and control groups.

In a clinical setting, the use of music may help reduce unnecessary stress testing, which is deemed unsuccessful if the patient doesn’t exercise hard enough to achieve a target heart rate. “Perhaps this motivational tool can help us make stress testing more valuable,” said Dr. Shami. The results were limited by the relatively small study population and the fact that the researchers, not the patients, chose the music, Dr. Shami said.

More research is needed in a larger trial, and “allowing patients to choose their own music might make an even bigger difference,” he noted. Also, patients’ discomfort with exercising in general and exercising in public may have impacted the results, he said.

Moderator Martha Gulati, MD, of the University of Arizona, Phoenix, noted that an area for future research might be to do a cardiac stress test without and without music on the same person, with the patient serving as his or her own control.

Dr. Shami had no relevant financial conflicts to disclose.

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Heart attacks soar in young IBD patients

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Inflammatory bowel disease significantly increases the risk of a heart attack in adults, but especially young adults aged 18-24 years, and in women compared with men across all age groups, according to data from about 200,000 IBD patients.

The odds ratio for heart attack in IBD patients vs. controls remained a significant 1.2 after adjustment for traditional cardiovascular risk factors, Muhammad S. Panhwar, MD, said in a media briefing in advance of the annual meeting of the American College of Cardiology.

“Chronic inflammation has been recognized as having an important role in the development of heart disease,” he noted.

Although other chronic inflammatory conditions are associated with increased heart attack risk, the link between heart attacks and IBD has not been well studied, despite its high prevalence in the United States (about 3 million adults, according to the Centers for Disease Control and Prevention), said Dr. Panhwar, an internal medicine resident at Case Western Reserve University in Cleveland. He and his colleagues reviewed a nationwide medical records database of 17.5 million adults aged 18-65 years for diagnoses of IBD between 2013 and 2017. Overall, 1.2% of the patients (211,870) had IBD, and most of the patients in the IBD group were younger, female, and white, Dr. Panhwar noted.

 

 


The relative risk of myocardial infarction was roughly twice as high in IBD patients as that of controls without IBD (5.9% vs. 3.5%), Dr. Panhwar said. That risk was highest in patients aged 20-25 years, with a relative risk of 20.5, occurring mostly in women, and decreased to 1.8 by age 60-64 (both P less than .001).

In addition, IBD patients tended to have a higher prevalence of common cardiovascular risk factors such as high blood pressure, obesity, and smoking.

The IBD patients’ higher prevalence of smoking – 21%, vs. 12% of the controls – is not a surprise, said Martha Gulati, MD, who moderated the briefing. Many people with IBD smoke, particularly those with Crohn’s disease, because it seems to reduce the number of flares, said Dr. Gulati, chief of cardiology at the University of Arizona, Phoenix.

The findings may be affected by the increased inflammation often observed in younger individuals with IBD and younger women with IBD, who may not present with traditional cardiovascular risk factors, the researchers noted.

“Clinicians who care for patients with traditional cardiovascular risk factors who also have IBD should recognize IBD as an independent risk factor as well, and treat appropriately,” Dr. Panhwar said.

Dr. Panhwar had no relevant financial conflicts to disclose.

SOURCE: Panhwar M. ACC 18.

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Inflammatory bowel disease significantly increases the risk of a heart attack in adults, but especially young adults aged 18-24 years, and in women compared with men across all age groups, according to data from about 200,000 IBD patients.

The odds ratio for heart attack in IBD patients vs. controls remained a significant 1.2 after adjustment for traditional cardiovascular risk factors, Muhammad S. Panhwar, MD, said in a media briefing in advance of the annual meeting of the American College of Cardiology.

“Chronic inflammation has been recognized as having an important role in the development of heart disease,” he noted.

Although other chronic inflammatory conditions are associated with increased heart attack risk, the link between heart attacks and IBD has not been well studied, despite its high prevalence in the United States (about 3 million adults, according to the Centers for Disease Control and Prevention), said Dr. Panhwar, an internal medicine resident at Case Western Reserve University in Cleveland. He and his colleagues reviewed a nationwide medical records database of 17.5 million adults aged 18-65 years for diagnoses of IBD between 2013 and 2017. Overall, 1.2% of the patients (211,870) had IBD, and most of the patients in the IBD group were younger, female, and white, Dr. Panhwar noted.

 

 


The relative risk of myocardial infarction was roughly twice as high in IBD patients as that of controls without IBD (5.9% vs. 3.5%), Dr. Panhwar said. That risk was highest in patients aged 20-25 years, with a relative risk of 20.5, occurring mostly in women, and decreased to 1.8 by age 60-64 (both P less than .001).

In addition, IBD patients tended to have a higher prevalence of common cardiovascular risk factors such as high blood pressure, obesity, and smoking.

The IBD patients’ higher prevalence of smoking – 21%, vs. 12% of the controls – is not a surprise, said Martha Gulati, MD, who moderated the briefing. Many people with IBD smoke, particularly those with Crohn’s disease, because it seems to reduce the number of flares, said Dr. Gulati, chief of cardiology at the University of Arizona, Phoenix.

The findings may be affected by the increased inflammation often observed in younger individuals with IBD and younger women with IBD, who may not present with traditional cardiovascular risk factors, the researchers noted.

“Clinicians who care for patients with traditional cardiovascular risk factors who also have IBD should recognize IBD as an independent risk factor as well, and treat appropriately,” Dr. Panhwar said.

Dr. Panhwar had no relevant financial conflicts to disclose.

SOURCE: Panhwar M. ACC 18.

 

Inflammatory bowel disease significantly increases the risk of a heart attack in adults, but especially young adults aged 18-24 years, and in women compared with men across all age groups, according to data from about 200,000 IBD patients.

The odds ratio for heart attack in IBD patients vs. controls remained a significant 1.2 after adjustment for traditional cardiovascular risk factors, Muhammad S. Panhwar, MD, said in a media briefing in advance of the annual meeting of the American College of Cardiology.

“Chronic inflammation has been recognized as having an important role in the development of heart disease,” he noted.

Although other chronic inflammatory conditions are associated with increased heart attack risk, the link between heart attacks and IBD has not been well studied, despite its high prevalence in the United States (about 3 million adults, according to the Centers for Disease Control and Prevention), said Dr. Panhwar, an internal medicine resident at Case Western Reserve University in Cleveland. He and his colleagues reviewed a nationwide medical records database of 17.5 million adults aged 18-65 years for diagnoses of IBD between 2013 and 2017. Overall, 1.2% of the patients (211,870) had IBD, and most of the patients in the IBD group were younger, female, and white, Dr. Panhwar noted.

 

 


The relative risk of myocardial infarction was roughly twice as high in IBD patients as that of controls without IBD (5.9% vs. 3.5%), Dr. Panhwar said. That risk was highest in patients aged 20-25 years, with a relative risk of 20.5, occurring mostly in women, and decreased to 1.8 by age 60-64 (both P less than .001).

In addition, IBD patients tended to have a higher prevalence of common cardiovascular risk factors such as high blood pressure, obesity, and smoking.

The IBD patients’ higher prevalence of smoking – 21%, vs. 12% of the controls – is not a surprise, said Martha Gulati, MD, who moderated the briefing. Many people with IBD smoke, particularly those with Crohn’s disease, because it seems to reduce the number of flares, said Dr. Gulati, chief of cardiology at the University of Arizona, Phoenix.

The findings may be affected by the increased inflammation often observed in younger individuals with IBD and younger women with IBD, who may not present with traditional cardiovascular risk factors, the researchers noted.

“Clinicians who care for patients with traditional cardiovascular risk factors who also have IBD should recognize IBD as an independent risk factor as well, and treat appropriately,” Dr. Panhwar said.

Dr. Panhwar had no relevant financial conflicts to disclose.

SOURCE: Panhwar M. ACC 18.

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Key clinical point: Inflammatory bowel disease raises the risk of MI, particularly in young women.

Major finding: The relative risk of MI was roughly twice as high in IBD patients compared with controls without IBD (5.9% vs. 3.5%).

Study details: Review of a nationwide medical records database of 17.5 million adults aged 18-65 years.

Disclosures: Dr. Panhwar had no relevant financial conflicts to disclose.

Source: Panhwar M. ACC 18.

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Collaboration, consultation part of AAP teen depression guidelines update

Guidelines will boost primary care clinician confidence
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Primary care providers may be the first to encounter teens with depression; updated guidelines from the American Academy of Pediatrics support their efforts.

The updated information includes recommendations on collaborative care, practice preparation, establishing networks of referrals, and much more.

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“In primary care (PC), as many as two in three youth with depression are not identified by their PC clinicians and fail to receive any kind of care,” wrote Rachel A. Zuckerbrot, MD, of Columbia University Medical Center, New York, and her colleagues.

“These guidelines were developed for PC clinicians who are in a position to identify and assist youth with depression in their practice settings,” they said. The guidelines apply to individuals aged 10-21 years, and support universal depression screening for those aged 12 and older.

 


Known as the Guidelines for Adolescent Depression in Primary Care (GLAD-PC), they consist of two parts: Practice Preparation, Identification, Assessment, and Initial Management, with Dr. Zuckerbrot as the lead author, and Treatment and Ongoing Management, led by Amy H. Cheung, MD, of the University of Toronto. They were published online in Pediatrics.

“It has been over 10 years since the [last] guidelines were published and they are supposed to be updated every 5,” Dr. Zuckerbrot said in an interview. “Given the new evidence on screening, psychopharmacology, and collaborative care, the guidelines needed to be revised. The USPSTF [United States Preventive Services Task Force ] and the AAP had already supported universal adolescent depression screening, and these guidelines are finally aligned with those positions.

“Different parts of the guidelines will be the go-to for different pediatricians, depending on where they are in their delivery of mental health care,” she explained. “Some may need help with practice preparation while others may need advice on screening; others may already be prescribing and may need advice on ongoing treatment and follow-up. I think there is something for everyone.”

Implementation of the guidelines is difficult in a short visit, Dr. Zuckerbrot acknowledged. “In addition, pediatricians may not have been well trained in the management of adolescent depression during their residencies.” However, the guidelines discuss both “real teams to support the pediatricians in their efforts, as well as virtual teams when staffing is limited.

 


“The guidelines advise that pediatricians learn about child psychiatry primary care consultation programs in their state and make use of those free telephone consultation programs.” The guidelines also discuss strategies for collaborative or integrative care, she said.

Part I

Part I of the guidelines, “Practice Preparation, Identification, Assessment, and Initial Management,” includes several recommendations for each topic.

For practice preparation, the guidelines recommend that clinicians seek training in the assessment, diagnosis, and treatment of depression, and that they establish a network of referrals and mental health resources in their communities. This network may include not only health professionals, but also current patients and families who are managing teen depression. If available, state-wide or regional child and adolescent psychiatry consultation programs can be included.

The identification and surveillance section of the guidelines calls for screening all patients aged 12 years and older for depression each year, using a formal screening tool on paper or online. The screening could occur at an annual wellness visit or any other medical visit, such as a sports physical. A second recommendation calls for identifying patients at increased risk for depression because of factors such as personal history, family history, substance use, other psychiatric disorders, frequent somatic complaints, or trauma, and monitoring these individuals regularly for signs of depression using a formal screening tool.

 


The assessment and diagnosis section states that assessment should include interviews with the patients alone as well as with their families or caregivers, and should include screening teens for functional impairment.

Primary care physicians should evaluate for depression not only if an adolescent tests positive on a screening tool, but also in children who present with any emotional problem as the chief complaint, and in those in whom depression is highly suspected even if they test negative on a formal screening tool, the guidelines state.

The three recommendations for initial management of depression in the primary care setting are educating patients and families about depression; developing a treatment plan (if the primary care clinician has had appropriate training) and setting specific treatment goals in areas of functioning such as at home, with peers, and at school; and developing a safety plan that includes restricting access to weapons or other means of self-harm, according to the guidelines.

Part II

Part II of the recommendations, “Treatment and Ongoing Management,” discusses options for managing depression in the primary care setting and utilizing outside resources.

 

The treatment recommendations emphasize the use of integrated models, if possible. “There is a growing recognition that complex chronic conditions, such as depression, are most successfully managed with proactive, multidisciplinary, patient-centered care teams,” Dr. Cheung and her associates said.

The recommendation for cases of mild depression calls for a period of “active support and monitoring” for 6-8 weeks before reassessing if the teen shows no improvement. By contrast, for cases of moderate to severe depression or cases with evidence of substance abuse or other psychoses, the recommendation calls for potential consultation with a mental health specialist and a discussion of the roles primary and specialty care will play in treatment. The guidelines include a flow chart for PC physicians to follow.

The guidelines suggest that PC clinicians recommend “scientifically tested and proven treatments,” such as psychotherapies, cognitive behavioral therapy (CBT) or interpersonal psychotherapy for adolescents, and/or antidepressant treatment, such as SSRIs, whenever possible and appropriate. It is important to monitor teens on antidepressants regularly to identify adverse events.

Recommendations for the ongoing management of teens with depression in the primary care setting include regular tracking of progress, reassessment if the teen shows no improvement in 6-8 weeks, and consultation with a mental health professional for those who show only partial improvement after exhausting primary care diagnostic and treatment options. Assessment of depressive symptoms is not the only thing to track. Functioning at home, school, and among peers also is important.

 

Body

 

“Mental health disorders have become one of the new morbidities in pediatric care,” Karalyn Kinsella, MD, said in an interview. “With one in five patients having depression, it is an illness that must be within our domain to identify and treat. I think the guidelines will make providers feel more confident in making a diagnosis and providing initial treatment. For those that do not feel comfortable, hopefully the guidelines will encourage them to seek training.

Dr. Karalyn Kinsella
“I think many providers may be concerned about the time it takes to identify and treat [depression] as well as a lack of expertise,” she noted. “Ideally, the guidelines will streamline the identification and treatment process to make them more manageable during preventative care visits.”

The take-home message for general pediatricians is that a standardized screening tool makes identifying depression relatively easy. “We have been using the PHQ-9 [Patient Health Questionnaire-9] in my office for several years, and it is very easy to administer and score, and is billable,” said Dr. Kinsella. “It can take some practice to tease out some typical teen behaviors, especially on the sleep and fatigue questions, but it provides an opportunity to open up discussion with the teen.

“Treatment [of depression] can be more complicated and time consuming, but rewarding and invaluable to the patient,” she emphasized. “Many states now have psychiatrists available by phone consultation to aid in management of medication. The key is establishing a list of quality counselors for referrals. With those supports and frequent follow-up, pediatricians can play a key role in the treatment of this prevalent and important illness that affects our patients.”

Dr. Kinsella is a pediatrician in Cheshire, Conn., and a member of the Pediatric News editorial advisory board. She was asked to comment on the new AAP teen depression guidelines.

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“Mental health disorders have become one of the new morbidities in pediatric care,” Karalyn Kinsella, MD, said in an interview. “With one in five patients having depression, it is an illness that must be within our domain to identify and treat. I think the guidelines will make providers feel more confident in making a diagnosis and providing initial treatment. For those that do not feel comfortable, hopefully the guidelines will encourage them to seek training.

Dr. Karalyn Kinsella
“I think many providers may be concerned about the time it takes to identify and treat [depression] as well as a lack of expertise,” she noted. “Ideally, the guidelines will streamline the identification and treatment process to make them more manageable during preventative care visits.”

The take-home message for general pediatricians is that a standardized screening tool makes identifying depression relatively easy. “We have been using the PHQ-9 [Patient Health Questionnaire-9] in my office for several years, and it is very easy to administer and score, and is billable,” said Dr. Kinsella. “It can take some practice to tease out some typical teen behaviors, especially on the sleep and fatigue questions, but it provides an opportunity to open up discussion with the teen.

“Treatment [of depression] can be more complicated and time consuming, but rewarding and invaluable to the patient,” she emphasized. “Many states now have psychiatrists available by phone consultation to aid in management of medication. The key is establishing a list of quality counselors for referrals. With those supports and frequent follow-up, pediatricians can play a key role in the treatment of this prevalent and important illness that affects our patients.”

Dr. Kinsella is a pediatrician in Cheshire, Conn., and a member of the Pediatric News editorial advisory board. She was asked to comment on the new AAP teen depression guidelines.

Body

 

“Mental health disorders have become one of the new morbidities in pediatric care,” Karalyn Kinsella, MD, said in an interview. “With one in five patients having depression, it is an illness that must be within our domain to identify and treat. I think the guidelines will make providers feel more confident in making a diagnosis and providing initial treatment. For those that do not feel comfortable, hopefully the guidelines will encourage them to seek training.

Dr. Karalyn Kinsella
“I think many providers may be concerned about the time it takes to identify and treat [depression] as well as a lack of expertise,” she noted. “Ideally, the guidelines will streamline the identification and treatment process to make them more manageable during preventative care visits.”

The take-home message for general pediatricians is that a standardized screening tool makes identifying depression relatively easy. “We have been using the PHQ-9 [Patient Health Questionnaire-9] in my office for several years, and it is very easy to administer and score, and is billable,” said Dr. Kinsella. “It can take some practice to tease out some typical teen behaviors, especially on the sleep and fatigue questions, but it provides an opportunity to open up discussion with the teen.

“Treatment [of depression] can be more complicated and time consuming, but rewarding and invaluable to the patient,” she emphasized. “Many states now have psychiatrists available by phone consultation to aid in management of medication. The key is establishing a list of quality counselors for referrals. With those supports and frequent follow-up, pediatricians can play a key role in the treatment of this prevalent and important illness that affects our patients.”

Dr. Kinsella is a pediatrician in Cheshire, Conn., and a member of the Pediatric News editorial advisory board. She was asked to comment on the new AAP teen depression guidelines.

Title
Guidelines will boost primary care clinician confidence
Guidelines will boost primary care clinician confidence

 

Primary care providers may be the first to encounter teens with depression; updated guidelines from the American Academy of Pediatrics support their efforts.

The updated information includes recommendations on collaborative care, practice preparation, establishing networks of referrals, and much more.

AlexRaths/Thinkstock
“In primary care (PC), as many as two in three youth with depression are not identified by their PC clinicians and fail to receive any kind of care,” wrote Rachel A. Zuckerbrot, MD, of Columbia University Medical Center, New York, and her colleagues.

“These guidelines were developed for PC clinicians who are in a position to identify and assist youth with depression in their practice settings,” they said. The guidelines apply to individuals aged 10-21 years, and support universal depression screening for those aged 12 and older.

 


Known as the Guidelines for Adolescent Depression in Primary Care (GLAD-PC), they consist of two parts: Practice Preparation, Identification, Assessment, and Initial Management, with Dr. Zuckerbrot as the lead author, and Treatment and Ongoing Management, led by Amy H. Cheung, MD, of the University of Toronto. They were published online in Pediatrics.

“It has been over 10 years since the [last] guidelines were published and they are supposed to be updated every 5,” Dr. Zuckerbrot said in an interview. “Given the new evidence on screening, psychopharmacology, and collaborative care, the guidelines needed to be revised. The USPSTF [United States Preventive Services Task Force ] and the AAP had already supported universal adolescent depression screening, and these guidelines are finally aligned with those positions.

“Different parts of the guidelines will be the go-to for different pediatricians, depending on where they are in their delivery of mental health care,” she explained. “Some may need help with practice preparation while others may need advice on screening; others may already be prescribing and may need advice on ongoing treatment and follow-up. I think there is something for everyone.”

Implementation of the guidelines is difficult in a short visit, Dr. Zuckerbrot acknowledged. “In addition, pediatricians may not have been well trained in the management of adolescent depression during their residencies.” However, the guidelines discuss both “real teams to support the pediatricians in their efforts, as well as virtual teams when staffing is limited.

 


“The guidelines advise that pediatricians learn about child psychiatry primary care consultation programs in their state and make use of those free telephone consultation programs.” The guidelines also discuss strategies for collaborative or integrative care, she said.

Part I

Part I of the guidelines, “Practice Preparation, Identification, Assessment, and Initial Management,” includes several recommendations for each topic.

For practice preparation, the guidelines recommend that clinicians seek training in the assessment, diagnosis, and treatment of depression, and that they establish a network of referrals and mental health resources in their communities. This network may include not only health professionals, but also current patients and families who are managing teen depression. If available, state-wide or regional child and adolescent psychiatry consultation programs can be included.

The identification and surveillance section of the guidelines calls for screening all patients aged 12 years and older for depression each year, using a formal screening tool on paper or online. The screening could occur at an annual wellness visit or any other medical visit, such as a sports physical. A second recommendation calls for identifying patients at increased risk for depression because of factors such as personal history, family history, substance use, other psychiatric disorders, frequent somatic complaints, or trauma, and monitoring these individuals regularly for signs of depression using a formal screening tool.

 


The assessment and diagnosis section states that assessment should include interviews with the patients alone as well as with their families or caregivers, and should include screening teens for functional impairment.

Primary care physicians should evaluate for depression not only if an adolescent tests positive on a screening tool, but also in children who present with any emotional problem as the chief complaint, and in those in whom depression is highly suspected even if they test negative on a formal screening tool, the guidelines state.

The three recommendations for initial management of depression in the primary care setting are educating patients and families about depression; developing a treatment plan (if the primary care clinician has had appropriate training) and setting specific treatment goals in areas of functioning such as at home, with peers, and at school; and developing a safety plan that includes restricting access to weapons or other means of self-harm, according to the guidelines.

Part II

Part II of the recommendations, “Treatment and Ongoing Management,” discusses options for managing depression in the primary care setting and utilizing outside resources.

 

The treatment recommendations emphasize the use of integrated models, if possible. “There is a growing recognition that complex chronic conditions, such as depression, are most successfully managed with proactive, multidisciplinary, patient-centered care teams,” Dr. Cheung and her associates said.

The recommendation for cases of mild depression calls for a period of “active support and monitoring” for 6-8 weeks before reassessing if the teen shows no improvement. By contrast, for cases of moderate to severe depression or cases with evidence of substance abuse or other psychoses, the recommendation calls for potential consultation with a mental health specialist and a discussion of the roles primary and specialty care will play in treatment. The guidelines include a flow chart for PC physicians to follow.

The guidelines suggest that PC clinicians recommend “scientifically tested and proven treatments,” such as psychotherapies, cognitive behavioral therapy (CBT) or interpersonal psychotherapy for adolescents, and/or antidepressant treatment, such as SSRIs, whenever possible and appropriate. It is important to monitor teens on antidepressants regularly to identify adverse events.

Recommendations for the ongoing management of teens with depression in the primary care setting include regular tracking of progress, reassessment if the teen shows no improvement in 6-8 weeks, and consultation with a mental health professional for those who show only partial improvement after exhausting primary care diagnostic and treatment options. Assessment of depressive symptoms is not the only thing to track. Functioning at home, school, and among peers also is important.

 

 

Primary care providers may be the first to encounter teens with depression; updated guidelines from the American Academy of Pediatrics support their efforts.

The updated information includes recommendations on collaborative care, practice preparation, establishing networks of referrals, and much more.

AlexRaths/Thinkstock
“In primary care (PC), as many as two in three youth with depression are not identified by their PC clinicians and fail to receive any kind of care,” wrote Rachel A. Zuckerbrot, MD, of Columbia University Medical Center, New York, and her colleagues.

“These guidelines were developed for PC clinicians who are in a position to identify and assist youth with depression in their practice settings,” they said. The guidelines apply to individuals aged 10-21 years, and support universal depression screening for those aged 12 and older.

 


Known as the Guidelines for Adolescent Depression in Primary Care (GLAD-PC), they consist of two parts: Practice Preparation, Identification, Assessment, and Initial Management, with Dr. Zuckerbrot as the lead author, and Treatment and Ongoing Management, led by Amy H. Cheung, MD, of the University of Toronto. They were published online in Pediatrics.

“It has been over 10 years since the [last] guidelines were published and they are supposed to be updated every 5,” Dr. Zuckerbrot said in an interview. “Given the new evidence on screening, psychopharmacology, and collaborative care, the guidelines needed to be revised. The USPSTF [United States Preventive Services Task Force ] and the AAP had already supported universal adolescent depression screening, and these guidelines are finally aligned with those positions.

“Different parts of the guidelines will be the go-to for different pediatricians, depending on where they are in their delivery of mental health care,” she explained. “Some may need help with practice preparation while others may need advice on screening; others may already be prescribing and may need advice on ongoing treatment and follow-up. I think there is something for everyone.”

Implementation of the guidelines is difficult in a short visit, Dr. Zuckerbrot acknowledged. “In addition, pediatricians may not have been well trained in the management of adolescent depression during their residencies.” However, the guidelines discuss both “real teams to support the pediatricians in their efforts, as well as virtual teams when staffing is limited.

 


“The guidelines advise that pediatricians learn about child psychiatry primary care consultation programs in their state and make use of those free telephone consultation programs.” The guidelines also discuss strategies for collaborative or integrative care, she said.

Part I

Part I of the guidelines, “Practice Preparation, Identification, Assessment, and Initial Management,” includes several recommendations for each topic.

For practice preparation, the guidelines recommend that clinicians seek training in the assessment, diagnosis, and treatment of depression, and that they establish a network of referrals and mental health resources in their communities. This network may include not only health professionals, but also current patients and families who are managing teen depression. If available, state-wide or regional child and adolescent psychiatry consultation programs can be included.

The identification and surveillance section of the guidelines calls for screening all patients aged 12 years and older for depression each year, using a formal screening tool on paper or online. The screening could occur at an annual wellness visit or any other medical visit, such as a sports physical. A second recommendation calls for identifying patients at increased risk for depression because of factors such as personal history, family history, substance use, other psychiatric disorders, frequent somatic complaints, or trauma, and monitoring these individuals regularly for signs of depression using a formal screening tool.

 


The assessment and diagnosis section states that assessment should include interviews with the patients alone as well as with their families or caregivers, and should include screening teens for functional impairment.

Primary care physicians should evaluate for depression not only if an adolescent tests positive on a screening tool, but also in children who present with any emotional problem as the chief complaint, and in those in whom depression is highly suspected even if they test negative on a formal screening tool, the guidelines state.

The three recommendations for initial management of depression in the primary care setting are educating patients and families about depression; developing a treatment plan (if the primary care clinician has had appropriate training) and setting specific treatment goals in areas of functioning such as at home, with peers, and at school; and developing a safety plan that includes restricting access to weapons or other means of self-harm, according to the guidelines.

Part II

Part II of the recommendations, “Treatment and Ongoing Management,” discusses options for managing depression in the primary care setting and utilizing outside resources.

 

The treatment recommendations emphasize the use of integrated models, if possible. “There is a growing recognition that complex chronic conditions, such as depression, are most successfully managed with proactive, multidisciplinary, patient-centered care teams,” Dr. Cheung and her associates said.

The recommendation for cases of mild depression calls for a period of “active support and monitoring” for 6-8 weeks before reassessing if the teen shows no improvement. By contrast, for cases of moderate to severe depression or cases with evidence of substance abuse or other psychoses, the recommendation calls for potential consultation with a mental health specialist and a discussion of the roles primary and specialty care will play in treatment. The guidelines include a flow chart for PC physicians to follow.

The guidelines suggest that PC clinicians recommend “scientifically tested and proven treatments,” such as psychotherapies, cognitive behavioral therapy (CBT) or interpersonal psychotherapy for adolescents, and/or antidepressant treatment, such as SSRIs, whenever possible and appropriate. It is important to monitor teens on antidepressants regularly to identify adverse events.

Recommendations for the ongoing management of teens with depression in the primary care setting include regular tracking of progress, reassessment if the teen shows no improvement in 6-8 weeks, and consultation with a mental health professional for those who show only partial improvement after exhausting primary care diagnostic and treatment options. Assessment of depressive symptoms is not the only thing to track. Functioning at home, school, and among peers also is important.

 

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Aesthetic procedures becoming more popular in skin of color patients

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Interest in aesthetic procedures among skin of color patients is on the rise, Andrew F. Alexis, MD, said in a presentation at the Caribbean Dermatology Symposium.

In 2015, ethnic minority patients accounted for 25% of aesthetic procedures in the United States, up from 20% in 2010, according to data from the American Society for Aesthetic Plastic Surgery, said Dr. Alexis, chair of dermatology and director of the Skin of Color Center at Mount Sinai St. Luke’s and Mount Sinai West hospitals in New York.

Dr. Andrew Alexis
When considering treatments to improve the appearance of aging skin, keep some functional and structural differences between patients in mind, he said. While lighter-skinned patients are frequently concerned with fine lines and wrinkles, darker-skinned patients often express concern about pigment alterations, benign facial neoplasms, textural irregularities, and intrinsic structural changes, he noted at the symposium, provided by Global Academy for Medical Education.

Chemical peels can be used successfully to treat a range of conditions in skin of color patients, including postinflammatory hyperpigmentation, acne, melasma, textural irregularities, and pseudofolliculitis barbae. They also can be used for skin brightening, said Dr. Alexis, who recommended a chemical peel protocol of salicylic acid, glycolic acid, or Jessner’s every 2-4 weeks. “Consider hydroquinone 4% concurrently to enhance efficacy for treating hyperpigmentation and to prevent postinflammatory hyperpigmentation,” he said. Patients on retinoids should discontinue them for 1 week prior to a chemical peel, he added.
 

 


Dr. Alexis shared several treatment pearls to promote successful peels in skin of color patients:

  • Salicylic acid: Resist the urge to overapply and “titrate according to patient tolerability.” The endpoint of a salicylic acid peel is white precipitate, not frost; cool compresses can be used for patient comfort and for later removal of the white precipitate.
  • Glycolic acid: Stick to a contact time of 2-4 minutes to avoid epidermolysis. “Completely neutralize all areas of application to avoid overpeeling.”
  • Trichloroacetic acid (TCA): TCA carries a greater risk of dyspigmentation, and should be reserved for patients who have not been successfully treated with salicylic or glycolic acid; a 10%-15% concentration of TCA, applied conservatively, is recommended.
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Interest in aesthetic procedures among skin of color patients is on the rise, Andrew F. Alexis, MD, said in a presentation at the Caribbean Dermatology Symposium.

In 2015, ethnic minority patients accounted for 25% of aesthetic procedures in the United States, up from 20% in 2010, according to data from the American Society for Aesthetic Plastic Surgery, said Dr. Alexis, chair of dermatology and director of the Skin of Color Center at Mount Sinai St. Luke’s and Mount Sinai West hospitals in New York.

Dr. Andrew Alexis
When considering treatments to improve the appearance of aging skin, keep some functional and structural differences between patients in mind, he said. While lighter-skinned patients are frequently concerned with fine lines and wrinkles, darker-skinned patients often express concern about pigment alterations, benign facial neoplasms, textural irregularities, and intrinsic structural changes, he noted at the symposium, provided by Global Academy for Medical Education.

Chemical peels can be used successfully to treat a range of conditions in skin of color patients, including postinflammatory hyperpigmentation, acne, melasma, textural irregularities, and pseudofolliculitis barbae. They also can be used for skin brightening, said Dr. Alexis, who recommended a chemical peel protocol of salicylic acid, glycolic acid, or Jessner’s every 2-4 weeks. “Consider hydroquinone 4% concurrently to enhance efficacy for treating hyperpigmentation and to prevent postinflammatory hyperpigmentation,” he said. Patients on retinoids should discontinue them for 1 week prior to a chemical peel, he added.
 

 


Dr. Alexis shared several treatment pearls to promote successful peels in skin of color patients:

  • Salicylic acid: Resist the urge to overapply and “titrate according to patient tolerability.” The endpoint of a salicylic acid peel is white precipitate, not frost; cool compresses can be used for patient comfort and for later removal of the white precipitate.
  • Glycolic acid: Stick to a contact time of 2-4 minutes to avoid epidermolysis. “Completely neutralize all areas of application to avoid overpeeling.”
  • Trichloroacetic acid (TCA): TCA carries a greater risk of dyspigmentation, and should be reserved for patients who have not been successfully treated with salicylic or glycolic acid; a 10%-15% concentration of TCA, applied conservatively, is recommended.

 

Interest in aesthetic procedures among skin of color patients is on the rise, Andrew F. Alexis, MD, said in a presentation at the Caribbean Dermatology Symposium.

In 2015, ethnic minority patients accounted for 25% of aesthetic procedures in the United States, up from 20% in 2010, according to data from the American Society for Aesthetic Plastic Surgery, said Dr. Alexis, chair of dermatology and director of the Skin of Color Center at Mount Sinai St. Luke’s and Mount Sinai West hospitals in New York.

Dr. Andrew Alexis
When considering treatments to improve the appearance of aging skin, keep some functional and structural differences between patients in mind, he said. While lighter-skinned patients are frequently concerned with fine lines and wrinkles, darker-skinned patients often express concern about pigment alterations, benign facial neoplasms, textural irregularities, and intrinsic structural changes, he noted at the symposium, provided by Global Academy for Medical Education.

Chemical peels can be used successfully to treat a range of conditions in skin of color patients, including postinflammatory hyperpigmentation, acne, melasma, textural irregularities, and pseudofolliculitis barbae. They also can be used for skin brightening, said Dr. Alexis, who recommended a chemical peel protocol of salicylic acid, glycolic acid, or Jessner’s every 2-4 weeks. “Consider hydroquinone 4% concurrently to enhance efficacy for treating hyperpigmentation and to prevent postinflammatory hyperpigmentation,” he said. Patients on retinoids should discontinue them for 1 week prior to a chemical peel, he added.
 

 


Dr. Alexis shared several treatment pearls to promote successful peels in skin of color patients:

  • Salicylic acid: Resist the urge to overapply and “titrate according to patient tolerability.” The endpoint of a salicylic acid peel is white precipitate, not frost; cool compresses can be used for patient comfort and for later removal of the white precipitate.
  • Glycolic acid: Stick to a contact time of 2-4 minutes to avoid epidermolysis. “Completely neutralize all areas of application to avoid overpeeling.”
  • Trichloroacetic acid (TCA): TCA carries a greater risk of dyspigmentation, and should be reserved for patients who have not been successfully treated with salicylic or glycolic acid; a 10%-15% concentration of TCA, applied conservatively, is recommended.
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EXPERT ANALYSIS FROM THE CARIBBEAN DERMATOLOGY SYMPOSIUM

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