Clinical Endocrinology News

PHILADELPHIA – Incorporation of cardiac biomarkers into current guideline-based decision-making regarding initiation of antihypertensive medication in patients with previously untreated mild or moderate high blood pressure leads to more appropriate and selective matching of intensive blood pressure control with true patient risk, Ambarish Pandey, MD, reported at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News

That’s because the 2017 American College of Cardiology/AHA blood pressure guidelines recommend incorporating the ACC/AHA 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator into decision making as to whether to start antihypertensive drug therapy in patients with stage 1 hypertension (130-139/80-89 mm Hg), but the risk calculator doesn’t account for the risk of heart failure.

Yet by far the greatest benefit of intensive BP lowering is in reducing the risk of developing heart failure, as demonstrated in the landmark SPRINT trial, which showed that intensive BP lowering achieved much greater risk reduction in new-onset heart failure than in atherosclerotic cardiovascular events.

Thus, there’s a need for better strategies to guide antihypertensive therapy. And therein lies the rationale for incorporating into the risk assessment an individual’s values for N-terminal pro–brain natriuretic peptide (NT-proBNP), which reflects chronic myocardial stress, and high-sensitivity cardiac troponin T (hs-cTnT), which when elevated signals myocardial injury.

“Cardiac biomarkers are intermediate phenotypes from hypertension to future cardiovascular events. They can identify individuals at increased risk for atherosclerotic events, and at even higher risk for heart failure events,” explained Dr. Pandey, a cardiologist at the University of Texas Southwestern Medical Center, Dallas.

He presented a study of 12,987 participants in three major U.S. cohort studies: the Atherosclerosis Risk In Communities (ARIC) study, the Multi-Ethnic Study of Atherosclerosis (MESA), and the Dallas Heart Study. At baseline, none of the participants were on antihypertensive therapy or had known cardiovascular disease. During 10 years of prospective follow-up, 825 of them experienced a first cardiovascular disease event: 251 developed heart failure and 574 had an MI, stroke, or cardiovascular death. Dr. Pandey and his coworkers calculated the cardiovascular event incidence rate and number-needed-to-treat with intensive antihypertensive drug therapy to prevent a first cardiovascular disease event on the basis of whether patients in the various BP categories were positive or negative for one or more biomarkers.
 

The results

Fifty-four percent of subjects had normal BP, defined in the guidelines as less than 120/80 mm Hg. Another 3% had BP in excess of 160/100 mm Hg. No controversy exists regarding pharmacotherapy in either of these groups: It’s not warranted in the former, essential in the latter.

Another 3,000 individuals had what the ACC/AHA guidelines define as elevated BP, meaning 120-129/<80 mm Hg, or low-risk stage 1 hypertension of 130-139/80-89 mm Hg and a 10-year ASCVD risk score of less than 10%. Initiation of antihypertensive medication in these groups is not recommended in the guidelines. Yet 36% of these individuals had at least one positive cardiac biomarker. And here’s the eye-opening finding: Notably, the 10-year cardiovascular event incidence rate in this biomarker group not currently recommended for antihypertensive pharmacotherapy was 11%, more than double the 4.6% rate in the biomarker-negative group, which in turn was comparable to the 3.8% in the normal BP participants.

Antihypertensive therapy was recommended according to the guidelines in 20% of the total study population, comprising patients with stage 1 hypertension who had an ASCVD risk score of 10% or more as well as those with stage 2 hypertension, defined as BP greater than 140/90 mm Hg but less than 160/100 mm Hg. Forty-eight percent of these subjects were positive for at least one biomarker. Their cardiovascular incidence rate was 15.1%, compared to the 7.9% rate in biomarker-negative individuals.

The estimated number-needed-to-treat (NNT) with intensive blood pressure–lowering therapy to a target systolic BP of less than 120 mm Hg, as in SPRINT, to prevent one cardiovascular event in individuals not currently guideline-recommended for antihypertensive medications was 86 in those who were biomarker-negative. The NNT dropped to 36 in the biomarker-positive subgroup, a far more attractive figure that suggests a reasonable likelihood of benefit from intensive blood pressure control, in Dr. Pandey’s view.

Similarly, among individuals currently recommended for pharmacotherapy initiation, the NNTs were 49 if biomarker-negative, improving to 26 in those positive for one or both biomarkers, which was comparable to the NNT of 22 in the group with blood pressures greater than 160/100 mm Hg. The NNT of 49 in the biomarker-negative subgroup is in a borderline gray zone warranting individualized shared decision-making regarding pharmacotherapy, Dr. Pandey said.

In this study, an elevated hs-cTnT was defined as 6 ng/L or more, while an elevated NT-proBNP was considered to be at least 100 pg/mL.

“It’s noteworthy that the degree of elevation in hs-cTnT and NT-proBNP which were observed in our study were pretty subtle and much below the threshold used for diagnosis of ischemic events or heart failure. Thus, these elevations were largely representative of subtle chronic injury and not acute events,” according to the cardiologist.

One audience member asked if the elevated biomarkers could simply be a surrogate for longer duration of exposure of the heart to high BP. Sure, Dr. Pandey replied, pointing to the 6-year greater average age of the biomarker-positive participants.

“It is likely that biomarker-positive status is capturing the culmination of longstanding exposure. But the thing about hypertension is there are no symptoms that can signal to the patient or the doctor that they have this disease, so testing for the biomarkers can actually capture the high-risk group that may have had hypertension for a long duration but now needs to be treated in order to prevent the advance of downstream adverse events,” he said.

Dr. Pandey reported having no financial conflicts of interest regarding his study, conducted free of commercial support.
 

bjancin@mdedge.com

SOURCE: Pandey A. AHA 2019 Abstract EP.AOS.521.141

PHILADELPHIA – Incorporation of cardiac biomarkers into current guideline-based decision-making regarding initiation of antihypertensive medication in patients with previously untreated mild or moderate high blood pressure leads to more appropriate and selective matching of intensive blood pressure control with true patient risk, Ambarish Pandey, MD, reported at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News

That’s because the 2017 American College of Cardiology/AHA blood pressure guidelines recommend incorporating the ACC/AHA 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator into decision making as to whether to start antihypertensive drug therapy in patients with stage 1 hypertension (130-139/80-89 mm Hg), but the risk calculator doesn’t account for the risk of heart failure.

Yet by far the greatest benefit of intensive BP lowering is in reducing the risk of developing heart failure, as demonstrated in the landmark SPRINT trial, which showed that intensive BP lowering achieved much greater risk reduction in new-onset heart failure than in atherosclerotic cardiovascular events.

Thus, there’s a need for better strategies to guide antihypertensive therapy. And therein lies the rationale for incorporating into the risk assessment an individual’s values for N-terminal pro–brain natriuretic peptide (NT-proBNP), which reflects chronic myocardial stress, and high-sensitivity cardiac troponin T (hs-cTnT), which when elevated signals myocardial injury.

“Cardiac biomarkers are intermediate phenotypes from hypertension to future cardiovascular events. They can identify individuals at increased risk for atherosclerotic events, and at even higher risk for heart failure events,” explained Dr. Pandey, a cardiologist at the University of Texas Southwestern Medical Center, Dallas.

He presented a study of 12,987 participants in three major U.S. cohort studies: the Atherosclerosis Risk In Communities (ARIC) study, the Multi-Ethnic Study of Atherosclerosis (MESA), and the Dallas Heart Study. At baseline, none of the participants were on antihypertensive therapy or had known cardiovascular disease. During 10 years of prospective follow-up, 825 of them experienced a first cardiovascular disease event: 251 developed heart failure and 574 had an MI, stroke, or cardiovascular death. Dr. Pandey and his coworkers calculated the cardiovascular event incidence rate and number-needed-to-treat with intensive antihypertensive drug therapy to prevent a first cardiovascular disease event on the basis of whether patients in the various BP categories were positive or negative for one or more biomarkers.
 

The results

Fifty-four percent of subjects had normal BP, defined in the guidelines as less than 120/80 mm Hg. Another 3% had BP in excess of 160/100 mm Hg. No controversy exists regarding pharmacotherapy in either of these groups: It’s not warranted in the former, essential in the latter.

Another 3,000 individuals had what the ACC/AHA guidelines define as elevated BP, meaning 120-129/<80 mm Hg, or low-risk stage 1 hypertension of 130-139/80-89 mm Hg and a 10-year ASCVD risk score of less than 10%. Initiation of antihypertensive medication in these groups is not recommended in the guidelines. Yet 36% of these individuals had at least one positive cardiac biomarker. And here’s the eye-opening finding: Notably, the 10-year cardiovascular event incidence rate in this biomarker group not currently recommended for antihypertensive pharmacotherapy was 11%, more than double the 4.6% rate in the biomarker-negative group, which in turn was comparable to the 3.8% in the normal BP participants.

Antihypertensive therapy was recommended according to the guidelines in 20% of the total study population, comprising patients with stage 1 hypertension who had an ASCVD risk score of 10% or more as well as those with stage 2 hypertension, defined as BP greater than 140/90 mm Hg but less than 160/100 mm Hg. Forty-eight percent of these subjects were positive for at least one biomarker. Their cardiovascular incidence rate was 15.1%, compared to the 7.9% rate in biomarker-negative individuals.

The estimated number-needed-to-treat (NNT) with intensive blood pressure–lowering therapy to a target systolic BP of less than 120 mm Hg, as in SPRINT, to prevent one cardiovascular event in individuals not currently guideline-recommended for antihypertensive medications was 86 in those who were biomarker-negative. The NNT dropped to 36 in the biomarker-positive subgroup, a far more attractive figure that suggests a reasonable likelihood of benefit from intensive blood pressure control, in Dr. Pandey’s view.

Similarly, among individuals currently recommended for pharmacotherapy initiation, the NNTs were 49 if biomarker-negative, improving to 26 in those positive for one or both biomarkers, which was comparable to the NNT of 22 in the group with blood pressures greater than 160/100 mm Hg. The NNT of 49 in the biomarker-negative subgroup is in a borderline gray zone warranting individualized shared decision-making regarding pharmacotherapy, Dr. Pandey said.

In this study, an elevated hs-cTnT was defined as 6 ng/L or more, while an elevated NT-proBNP was considered to be at least 100 pg/mL.

“It’s noteworthy that the degree of elevation in hs-cTnT and NT-proBNP which were observed in our study were pretty subtle and much below the threshold used for diagnosis of ischemic events or heart failure. Thus, these elevations were largely representative of subtle chronic injury and not acute events,” according to the cardiologist.

One audience member asked if the elevated biomarkers could simply be a surrogate for longer duration of exposure of the heart to high BP. Sure, Dr. Pandey replied, pointing to the 6-year greater average age of the biomarker-positive participants.

“It is likely that biomarker-positive status is capturing the culmination of longstanding exposure. But the thing about hypertension is there are no symptoms that can signal to the patient or the doctor that they have this disease, so testing for the biomarkers can actually capture the high-risk group that may have had hypertension for a long duration but now needs to be treated in order to prevent the advance of downstream adverse events,” he said.

Dr. Pandey reported having no financial conflicts of interest regarding his study, conducted free of commercial support.
 

bjancin@mdedge.com

SOURCE: Pandey A. AHA 2019 Abstract EP.AOS.521.141

PHILADELPHIA – Incorporation of cardiac biomarkers into current guideline-based decision-making regarding initiation of antihypertensive medication in patients with previously untreated mild or moderate high blood pressure leads to more appropriate and selective matching of intensive blood pressure control with true patient risk, Ambarish Pandey, MD, reported at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News

That’s because the 2017 American College of Cardiology/AHA blood pressure guidelines recommend incorporating the ACC/AHA 10-Year Atherosclerotic Cardiovascular Disease (ASCVD) Risk Calculator into decision making as to whether to start antihypertensive drug therapy in patients with stage 1 hypertension (130-139/80-89 mm Hg), but the risk calculator doesn’t account for the risk of heart failure.

Yet by far the greatest benefit of intensive BP lowering is in reducing the risk of developing heart failure, as demonstrated in the landmark SPRINT trial, which showed that intensive BP lowering achieved much greater risk reduction in new-onset heart failure than in atherosclerotic cardiovascular events.

Thus, there’s a need for better strategies to guide antihypertensive therapy. And therein lies the rationale for incorporating into the risk assessment an individual’s values for N-terminal pro–brain natriuretic peptide (NT-proBNP), which reflects chronic myocardial stress, and high-sensitivity cardiac troponin T (hs-cTnT), which when elevated signals myocardial injury.

“Cardiac biomarkers are intermediate phenotypes from hypertension to future cardiovascular events. They can identify individuals at increased risk for atherosclerotic events, and at even higher risk for heart failure events,” explained Dr. Pandey, a cardiologist at the University of Texas Southwestern Medical Center, Dallas.

He presented a study of 12,987 participants in three major U.S. cohort studies: the Atherosclerosis Risk In Communities (ARIC) study, the Multi-Ethnic Study of Atherosclerosis (MESA), and the Dallas Heart Study. At baseline, none of the participants were on antihypertensive therapy or had known cardiovascular disease. During 10 years of prospective follow-up, 825 of them experienced a first cardiovascular disease event: 251 developed heart failure and 574 had an MI, stroke, or cardiovascular death. Dr. Pandey and his coworkers calculated the cardiovascular event incidence rate and number-needed-to-treat with intensive antihypertensive drug therapy to prevent a first cardiovascular disease event on the basis of whether patients in the various BP categories were positive or negative for one or more biomarkers.
 

The results

Fifty-four percent of subjects had normal BP, defined in the guidelines as less than 120/80 mm Hg. Another 3% had BP in excess of 160/100 mm Hg. No controversy exists regarding pharmacotherapy in either of these groups: It’s not warranted in the former, essential in the latter.

Another 3,000 individuals had what the ACC/AHA guidelines define as elevated BP, meaning 120-129/<80 mm Hg, or low-risk stage 1 hypertension of 130-139/80-89 mm Hg and a 10-year ASCVD risk score of less than 10%. Initiation of antihypertensive medication in these groups is not recommended in the guidelines. Yet 36% of these individuals had at least one positive cardiac biomarker. And here’s the eye-opening finding: Notably, the 10-year cardiovascular event incidence rate in this biomarker group not currently recommended for antihypertensive pharmacotherapy was 11%, more than double the 4.6% rate in the biomarker-negative group, which in turn was comparable to the 3.8% in the normal BP participants.

Antihypertensive therapy was recommended according to the guidelines in 20% of the total study population, comprising patients with stage 1 hypertension who had an ASCVD risk score of 10% or more as well as those with stage 2 hypertension, defined as BP greater than 140/90 mm Hg but less than 160/100 mm Hg. Forty-eight percent of these subjects were positive for at least one biomarker. Their cardiovascular incidence rate was 15.1%, compared to the 7.9% rate in biomarker-negative individuals.

The estimated number-needed-to-treat (NNT) with intensive blood pressure–lowering therapy to a target systolic BP of less than 120 mm Hg, as in SPRINT, to prevent one cardiovascular event in individuals not currently guideline-recommended for antihypertensive medications was 86 in those who were biomarker-negative. The NNT dropped to 36 in the biomarker-positive subgroup, a far more attractive figure that suggests a reasonable likelihood of benefit from intensive blood pressure control, in Dr. Pandey’s view.

Similarly, among individuals currently recommended for pharmacotherapy initiation, the NNTs were 49 if biomarker-negative, improving to 26 in those positive for one or both biomarkers, which was comparable to the NNT of 22 in the group with blood pressures greater than 160/100 mm Hg. The NNT of 49 in the biomarker-negative subgroup is in a borderline gray zone warranting individualized shared decision-making regarding pharmacotherapy, Dr. Pandey said.

In this study, an elevated hs-cTnT was defined as 6 ng/L or more, while an elevated NT-proBNP was considered to be at least 100 pg/mL.

“It’s noteworthy that the degree of elevation in hs-cTnT and NT-proBNP which were observed in our study were pretty subtle and much below the threshold used for diagnosis of ischemic events or heart failure. Thus, these elevations were largely representative of subtle chronic injury and not acute events,” according to the cardiologist.

One audience member asked if the elevated biomarkers could simply be a surrogate for longer duration of exposure of the heart to high BP. Sure, Dr. Pandey replied, pointing to the 6-year greater average age of the biomarker-positive participants.

“It is likely that biomarker-positive status is capturing the culmination of longstanding exposure. But the thing about hypertension is there are no symptoms that can signal to the patient or the doctor that they have this disease, so testing for the biomarkers can actually capture the high-risk group that may have had hypertension for a long duration but now needs to be treated in order to prevent the advance of downstream adverse events,” he said.

Dr. Pandey reported having no financial conflicts of interest regarding his study, conducted free of commercial support.
 

bjancin@mdedge.com

SOURCE: Pandey A. AHA 2019 Abstract EP.AOS.521.141

The Food and Drug Administration has approved teprotumumab-trbw (Tepezza) as the first drug for treating thyroid eye disease, according to a press release.

Olivier Le Moal/Getty Images

Thyroid eye disease is a rare, progressive, autoimmune condition that causes the eyes to bulge (proptosis) and can lead to blindness. Until now, treatment has focused on managing its symptoms – which can include eye pain, double vision, or sensitivity to light – with steroids, and in some cases, multiple invasive surgeries.

The human monoclonal antibody and a targeted inhibitor of the insulinlike growth factor-1 receptor is administered to patients once every 3 weeks, for a total of eight infusions, according to a statement from Horizon Therapeutics, which manufactures the drug.

The approval was based on the findings from two similarly designed, parallel-group studies (Studies 1 and 2) involving 170 patients with thyroid eye disease who were randomized to receive either teprotumumab or placebo. Of those receiving the study drug, 71% in Study 1 and 83% in Study 2 had a reduction of more than 2 mm in eye protrusion, compared with 20% and 10%, respectively, among the placebo participants.

The most common adverse reactions in patients receiving teprotumumab were muscle spasm, nausea, alopecia, diarrhea, fatigue, and hyperglycemia. The treatment is contraindicated for pregnancy.

The Food and Drug Administration has approved teprotumumab-trbw (Tepezza) as the first drug for treating thyroid eye disease, according to a press release.

Olivier Le Moal/Getty Images

Thyroid eye disease is a rare, progressive, autoimmune condition that causes the eyes to bulge (proptosis) and can lead to blindness. Until now, treatment has focused on managing its symptoms – which can include eye pain, double vision, or sensitivity to light – with steroids, and in some cases, multiple invasive surgeries.

The human monoclonal antibody and a targeted inhibitor of the insulinlike growth factor-1 receptor is administered to patients once every 3 weeks, for a total of eight infusions, according to a statement from Horizon Therapeutics, which manufactures the drug.

The approval was based on the findings from two similarly designed, parallel-group studies (Studies 1 and 2) involving 170 patients with thyroid eye disease who were randomized to receive either teprotumumab or placebo. Of those receiving the study drug, 71% in Study 1 and 83% in Study 2 had a reduction of more than 2 mm in eye protrusion, compared with 20% and 10%, respectively, among the placebo participants.

The most common adverse reactions in patients receiving teprotumumab were muscle spasm, nausea, alopecia, diarrhea, fatigue, and hyperglycemia. The treatment is contraindicated for pregnancy.

The Food and Drug Administration has approved teprotumumab-trbw (Tepezza) as the first drug for treating thyroid eye disease, according to a press release.

Olivier Le Moal/Getty Images

Thyroid eye disease is a rare, progressive, autoimmune condition that causes the eyes to bulge (proptosis) and can lead to blindness. Until now, treatment has focused on managing its symptoms – which can include eye pain, double vision, or sensitivity to light – with steroids, and in some cases, multiple invasive surgeries.

The human monoclonal antibody and a targeted inhibitor of the insulinlike growth factor-1 receptor is administered to patients once every 3 weeks, for a total of eight infusions, according to a statement from Horizon Therapeutics, which manufactures the drug.

The approval was based on the findings from two similarly designed, parallel-group studies (Studies 1 and 2) involving 170 patients with thyroid eye disease who were randomized to receive either teprotumumab or placebo. Of those receiving the study drug, 71% in Study 1 and 83% in Study 2 had a reduction of more than 2 mm in eye protrusion, compared with 20% and 10%, respectively, among the placebo participants.

The most common adverse reactions in patients receiving teprotumumab were muscle spasm, nausea, alopecia, diarrhea, fatigue, and hyperglycemia. The treatment is contraindicated for pregnancy.

The first case of the novel coronavirus, named 2019-nCoV, in the United States has been diagnosed in a traveler from China who came through Seattle-Tacoma International Airport on Jan 15, the Centers for Disease Control and Prevention announced today at a press briefing.

CDC/John Hierholzer, MD

The outbreak began at a animal and meat market in China and now has spread to at least three other countries, including Thailand, Japan and South Korea. While originally thought to be spreading from animal to person, it appears that limited person-to-person transmission is occurring, although it is currently unknown how easily this virus spreads between people.

More than 300 cases have been reported and six deaths have occurred. Fourteen health care workers have been infected.

Scott Lindquist, MD, MPH, Washington state epidemiologist, said at the briefing that the patient, a man who had been in Wuhan, arrived at Sea-Tac on Jan. 15, 2 days before airport screening had been initiated. He was symptom free at the time of his arrival and probably would not have been identified as infected with 2019-nCoV. The patient had been aware of the public health and news media coverage of 2019-nCoV and, after developing symptoms, contacted his health care provider on Jan. 19. The patient did not fly directly from Wuhan, but Dr. Lindquist said that he has been fully cooperative and has been helpful to authorities in tracing his route and contacts. The man is being treated at Providence Regional Medical Center, Everett, Wash.

The CDC obtained a specimen from the patient immediately and identified the 2019-nCoV within 24 hours.

Screening at airports is part of a multipart strategy to address this type of infection that includes public health information dissemination, patient education, as well as hospital preparation and training exercises. Currently, a strategy referred to as “funneling” is being implemented wherein travelers from China are rerouted and reticketed to one of the five airports conducting screening. At present, JFK in New York, San Francisco International, Los Angeles International, Hartsfield-Jackson Atlanta International Airport, and Chicago O’Hare International Airport are conducting inbound traveler screening.

The CDC is working in close cooperation with the Department of Homeland Security and the Federal Aviation Administration to coordinate travel screenings and reroutings. In addition, the CDC is working with the World Health Organization and the international global health community to share information about this outbreak. The CDC also has staff on site in Wuhan and is communicating with local health authorities. The CDC has activated its Emergency Operations Center to better provide ongoing support to the 2019-nCoV response. Currently, the focus is on tracing contacts and the means of transmission of this virus.

Updates on the outbreak will be posted on the CDC coronavirus website.
 

tborden@mdedge.com

CORRECTION: 1/21/2020: The name of the medical center where the 2019-nCoV patient is being treated was corrected.

The first case of the novel coronavirus, named 2019-nCoV, in the United States has been diagnosed in a traveler from China who came through Seattle-Tacoma International Airport on Jan 15, the Centers for Disease Control and Prevention announced today at a press briefing.

CDC/John Hierholzer, MD

The outbreak began at a animal and meat market in China and now has spread to at least three other countries, including Thailand, Japan and South Korea. While originally thought to be spreading from animal to person, it appears that limited person-to-person transmission is occurring, although it is currently unknown how easily this virus spreads between people.

More than 300 cases have been reported and six deaths have occurred. Fourteen health care workers have been infected.

Scott Lindquist, MD, MPH, Washington state epidemiologist, said at the briefing that the patient, a man who had been in Wuhan, arrived at Sea-Tac on Jan. 15, 2 days before airport screening had been initiated. He was symptom free at the time of his arrival and probably would not have been identified as infected with 2019-nCoV. The patient had been aware of the public health and news media coverage of 2019-nCoV and, after developing symptoms, contacted his health care provider on Jan. 19. The patient did not fly directly from Wuhan, but Dr. Lindquist said that he has been fully cooperative and has been helpful to authorities in tracing his route and contacts. The man is being treated at Providence Regional Medical Center, Everett, Wash.

The CDC obtained a specimen from the patient immediately and identified the 2019-nCoV within 24 hours.

Screening at airports is part of a multipart strategy to address this type of infection that includes public health information dissemination, patient education, as well as hospital preparation and training exercises. Currently, a strategy referred to as “funneling” is being implemented wherein travelers from China are rerouted and reticketed to one of the five airports conducting screening. At present, JFK in New York, San Francisco International, Los Angeles International, Hartsfield-Jackson Atlanta International Airport, and Chicago O’Hare International Airport are conducting inbound traveler screening.

The CDC is working in close cooperation with the Department of Homeland Security and the Federal Aviation Administration to coordinate travel screenings and reroutings. In addition, the CDC is working with the World Health Organization and the international global health community to share information about this outbreak. The CDC also has staff on site in Wuhan and is communicating with local health authorities. The CDC has activated its Emergency Operations Center to better provide ongoing support to the 2019-nCoV response. Currently, the focus is on tracing contacts and the means of transmission of this virus.

Updates on the outbreak will be posted on the CDC coronavirus website.
 

tborden@mdedge.com

CORRECTION: 1/21/2020: The name of the medical center where the 2019-nCoV patient is being treated was corrected.

The first case of the novel coronavirus, named 2019-nCoV, in the United States has been diagnosed in a traveler from China who came through Seattle-Tacoma International Airport on Jan 15, the Centers for Disease Control and Prevention announced today at a press briefing.

CDC/John Hierholzer, MD

The outbreak began at a animal and meat market in China and now has spread to at least three other countries, including Thailand, Japan and South Korea. While originally thought to be spreading from animal to person, it appears that limited person-to-person transmission is occurring, although it is currently unknown how easily this virus spreads between people.

More than 300 cases have been reported and six deaths have occurred. Fourteen health care workers have been infected.

Scott Lindquist, MD, MPH, Washington state epidemiologist, said at the briefing that the patient, a man who had been in Wuhan, arrived at Sea-Tac on Jan. 15, 2 days before airport screening had been initiated. He was symptom free at the time of his arrival and probably would not have been identified as infected with 2019-nCoV. The patient had been aware of the public health and news media coverage of 2019-nCoV and, after developing symptoms, contacted his health care provider on Jan. 19. The patient did not fly directly from Wuhan, but Dr. Lindquist said that he has been fully cooperative and has been helpful to authorities in tracing his route and contacts. The man is being treated at Providence Regional Medical Center, Everett, Wash.

The CDC obtained a specimen from the patient immediately and identified the 2019-nCoV within 24 hours.

Screening at airports is part of a multipart strategy to address this type of infection that includes public health information dissemination, patient education, as well as hospital preparation and training exercises. Currently, a strategy referred to as “funneling” is being implemented wherein travelers from China are rerouted and reticketed to one of the five airports conducting screening. At present, JFK in New York, San Francisco International, Los Angeles International, Hartsfield-Jackson Atlanta International Airport, and Chicago O’Hare International Airport are conducting inbound traveler screening.

The CDC is working in close cooperation with the Department of Homeland Security and the Federal Aviation Administration to coordinate travel screenings and reroutings. In addition, the CDC is working with the World Health Organization and the international global health community to share information about this outbreak. The CDC also has staff on site in Wuhan and is communicating with local health authorities. The CDC has activated its Emergency Operations Center to better provide ongoing support to the 2019-nCoV response. Currently, the focus is on tracing contacts and the means of transmission of this virus.

Updates on the outbreak will be posted on the CDC coronavirus website.
 

tborden@mdedge.com

CORRECTION: 1/21/2020: The name of the medical center where the 2019-nCoV patient is being treated was corrected.

PHILADELPHIA – Enthusiasm for catheter-based renal denervation as a potential nondrug treatment for hypertension is once again on the rise, Michael Bohm, MD, observed at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News

The field experienced “a big depression” in 2014 with the publication of the unexpectedly negative results of the Symplicity HTN-3 trial (N Engl J Med. 2014;370:1393-401), he said. But post hoc analysis of the trial revealed significant shortcomings in design and execution.

“All of the flaws of this trial have been eliminated and now there is a very tightly controlled program to show whether renal denervation will work or not,” according to Dr. Bohm, director of the department of internal medicine and professor of cardiology at Saarland University in Homburg, Germany.

Indeed, three randomized, double-blind, sham-controlled, proof-of-concept clinical trials – all with strongly positive results – were published in Lancet in 2017 and 2018: SPYRAL HTN-OFF (2017 Nov 11;390:2160-70), RADIANCE SOLO (2018 Jun 9;391:2335-45), and SPYRAL HTN-ON (2018 May 23;391:2346-55). Based on the encouraging findings, four large pivotal trials of renal denervation (RDN) for hypertension are ongoing: RADIANCE HTN, REQUIRE, RADIANCE II, and SPYRAL HTN-ON MED. In addition, the SPYRAL HTN-OFF MED pivotal trial has been completed and will be presented soon, Dr. Bohm said.
 

Defining who’s most likely to benefit

Treatment response has been quite variable within the various RDN trials. A reliable predictor of response would be an important advance because it would enable physicians to select the best candidates for treatment while sparing others from an invasive procedure – albeit a relatively safe one – that they may not benefit from. On this front, Dr. Bohm and colleagues have recently reported that a baseline 24-hour heart rate above the median value of 73.5 bpm in the SPYRAL HTN-OFF MED trial – a marker for sympathetic overdrive – was associated with a 10.7/7.5 mm Hg greater reduction in average ambulatory blood pressures post-RDN than with a sham procedure. In contrast, blood pressure changes in RDN recipients with a below-median baseline 24-hour heart rate weren’t significant (Eur Heart J. 2019 Mar 1;40:743-51).

“Although this is a little bit rough, there is no other really true and reliable marker,” the cardiologist observed.

A pressing need exists for a reliable intraprocedural indicator of success. Dr. Bohm noted that Australian investigators are pursuing a promising approach in animal studies: intraprocedural transvascular high-frequency pacing of the aorticorenal ganglia. Abolition of the pacing-induced increase in blood pressure may be an indicator of complete RDN (JACC Cardiovasc Interv. 2019 Jun 24;12:1109-20).

Applications other than hypertension

Renal denervation is under early-stage investigation for a range of other cardiovascular diseases in which sympathetic overdrive figures prominently.

“The truly interesting things in renal denervation are what happens beyond hypertension. There are a lot of potential applications,” according to Dr. Bohm.

For example, when RDN was performed alongside pulmonary vein isolation for treatment of paroxysmal atrial fibrillation in hypertensive patients, the arrhythmia recurrence rate was significantly reduced during 1 year of follow-up, compared with AF ablation alone, in the randomized, multicenter, 302-patient ERADICATE-AF trial, presented at the most recent meeting of the Heart Rhythm Society.

Also, a small, uncontrolled registry study of RDN in patients with cardiomyopathy and electrical storm suggests the procedure may have an immediate anti–ventricular arrhythmia effect.

Meanwhile, Dr. Bohm is pressing the German government to sponsor an independent randomized controlled trial of RDN for heart failure. He and others have shown in small pilot studies a promising signal that the treatment may improve myocardial function and the signs and symptoms of heart failure in both patients with reduced and preserved left ventricular ejection fraction – and without reducing their blood pressure, which is often already low.

Dr. Bohm and others have also been exploring the impact of RDN in patients with metabolic syndrome. The treatment has a sound pathophysiologic rationale because insulin resistance is dependent upon sympathetic nervous system activation. Preliminary reports show improved insulin sensitivity in response to RDN. Patients also report better quality of life, presumably because of the reduction in sympathetic overactivity.

A couple of small Chinese studies suggest denervating the pulmonary vein in patients with pulmonary hypertension leads to a salutary reduction in pulmonary blood pressures.

“We haven’t done that yet. There is no properly designed catheter. They’ve used a Spyra unipolar catheter. It could work, but it hasn’t been rigorously investigated,” the cardiologist said.

Dr. Bohm reported serving as a scientific adviser to Abbott, AstraZeneca, BMS, Boehringer Ingelheim, and Servier.

bjancin@mdedge.com

PHILADELPHIA – Enthusiasm for catheter-based renal denervation as a potential nondrug treatment for hypertension is once again on the rise, Michael Bohm, MD, observed at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News

The field experienced “a big depression” in 2014 with the publication of the unexpectedly negative results of the Symplicity HTN-3 trial (N Engl J Med. 2014;370:1393-401), he said. But post hoc analysis of the trial revealed significant shortcomings in design and execution.

“All of the flaws of this trial have been eliminated and now there is a very tightly controlled program to show whether renal denervation will work or not,” according to Dr. Bohm, director of the department of internal medicine and professor of cardiology at Saarland University in Homburg, Germany.

Indeed, three randomized, double-blind, sham-controlled, proof-of-concept clinical trials – all with strongly positive results – were published in Lancet in 2017 and 2018: SPYRAL HTN-OFF (2017 Nov 11;390:2160-70), RADIANCE SOLO (2018 Jun 9;391:2335-45), and SPYRAL HTN-ON (2018 May 23;391:2346-55). Based on the encouraging findings, four large pivotal trials of renal denervation (RDN) for hypertension are ongoing: RADIANCE HTN, REQUIRE, RADIANCE II, and SPYRAL HTN-ON MED. In addition, the SPYRAL HTN-OFF MED pivotal trial has been completed and will be presented soon, Dr. Bohm said.
 

Defining who’s most likely to benefit

Treatment response has been quite variable within the various RDN trials. A reliable predictor of response would be an important advance because it would enable physicians to select the best candidates for treatment while sparing others from an invasive procedure – albeit a relatively safe one – that they may not benefit from. On this front, Dr. Bohm and colleagues have recently reported that a baseline 24-hour heart rate above the median value of 73.5 bpm in the SPYRAL HTN-OFF MED trial – a marker for sympathetic overdrive – was associated with a 10.7/7.5 mm Hg greater reduction in average ambulatory blood pressures post-RDN than with a sham procedure. In contrast, blood pressure changes in RDN recipients with a below-median baseline 24-hour heart rate weren’t significant (Eur Heart J. 2019 Mar 1;40:743-51).

“Although this is a little bit rough, there is no other really true and reliable marker,” the cardiologist observed.

A pressing need exists for a reliable intraprocedural indicator of success. Dr. Bohm noted that Australian investigators are pursuing a promising approach in animal studies: intraprocedural transvascular high-frequency pacing of the aorticorenal ganglia. Abolition of the pacing-induced increase in blood pressure may be an indicator of complete RDN (JACC Cardiovasc Interv. 2019 Jun 24;12:1109-20).

Applications other than hypertension

Renal denervation is under early-stage investigation for a range of other cardiovascular diseases in which sympathetic overdrive figures prominently.

“The truly interesting things in renal denervation are what happens beyond hypertension. There are a lot of potential applications,” according to Dr. Bohm.

For example, when RDN was performed alongside pulmonary vein isolation for treatment of paroxysmal atrial fibrillation in hypertensive patients, the arrhythmia recurrence rate was significantly reduced during 1 year of follow-up, compared with AF ablation alone, in the randomized, multicenter, 302-patient ERADICATE-AF trial, presented at the most recent meeting of the Heart Rhythm Society.

Also, a small, uncontrolled registry study of RDN in patients with cardiomyopathy and electrical storm suggests the procedure may have an immediate anti–ventricular arrhythmia effect.

Meanwhile, Dr. Bohm is pressing the German government to sponsor an independent randomized controlled trial of RDN for heart failure. He and others have shown in small pilot studies a promising signal that the treatment may improve myocardial function and the signs and symptoms of heart failure in both patients with reduced and preserved left ventricular ejection fraction – and without reducing their blood pressure, which is often already low.

Dr. Bohm and others have also been exploring the impact of RDN in patients with metabolic syndrome. The treatment has a sound pathophysiologic rationale because insulin resistance is dependent upon sympathetic nervous system activation. Preliminary reports show improved insulin sensitivity in response to RDN. Patients also report better quality of life, presumably because of the reduction in sympathetic overactivity.

A couple of small Chinese studies suggest denervating the pulmonary vein in patients with pulmonary hypertension leads to a salutary reduction in pulmonary blood pressures.

“We haven’t done that yet. There is no properly designed catheter. They’ve used a Spyra unipolar catheter. It could work, but it hasn’t been rigorously investigated,” the cardiologist said.

Dr. Bohm reported serving as a scientific adviser to Abbott, AstraZeneca, BMS, Boehringer Ingelheim, and Servier.

bjancin@mdedge.com

PHILADELPHIA – Enthusiasm for catheter-based renal denervation as a potential nondrug treatment for hypertension is once again on the rise, Michael Bohm, MD, observed at the American Heart Association scientific sessions.

Bruce Jancin/MDedge News

The field experienced “a big depression” in 2014 with the publication of the unexpectedly negative results of the Symplicity HTN-3 trial (N Engl J Med. 2014;370:1393-401), he said. But post hoc analysis of the trial revealed significant shortcomings in design and execution.

“All of the flaws of this trial have been eliminated and now there is a very tightly controlled program to show whether renal denervation will work or not,” according to Dr. Bohm, director of the department of internal medicine and professor of cardiology at Saarland University in Homburg, Germany.

Indeed, three randomized, double-blind, sham-controlled, proof-of-concept clinical trials – all with strongly positive results – were published in Lancet in 2017 and 2018: SPYRAL HTN-OFF (2017 Nov 11;390:2160-70), RADIANCE SOLO (2018 Jun 9;391:2335-45), and SPYRAL HTN-ON (2018 May 23;391:2346-55). Based on the encouraging findings, four large pivotal trials of renal denervation (RDN) for hypertension are ongoing: RADIANCE HTN, REQUIRE, RADIANCE II, and SPYRAL HTN-ON MED. In addition, the SPYRAL HTN-OFF MED pivotal trial has been completed and will be presented soon, Dr. Bohm said.
 

Defining who’s most likely to benefit

Treatment response has been quite variable within the various RDN trials. A reliable predictor of response would be an important advance because it would enable physicians to select the best candidates for treatment while sparing others from an invasive procedure – albeit a relatively safe one – that they may not benefit from. On this front, Dr. Bohm and colleagues have recently reported that a baseline 24-hour heart rate above the median value of 73.5 bpm in the SPYRAL HTN-OFF MED trial – a marker for sympathetic overdrive – was associated with a 10.7/7.5 mm Hg greater reduction in average ambulatory blood pressures post-RDN than with a sham procedure. In contrast, blood pressure changes in RDN recipients with a below-median baseline 24-hour heart rate weren’t significant (Eur Heart J. 2019 Mar 1;40:743-51).

“Although this is a little bit rough, there is no other really true and reliable marker,” the cardiologist observed.

A pressing need exists for a reliable intraprocedural indicator of success. Dr. Bohm noted that Australian investigators are pursuing a promising approach in animal studies: intraprocedural transvascular high-frequency pacing of the aorticorenal ganglia. Abolition of the pacing-induced increase in blood pressure may be an indicator of complete RDN (JACC Cardiovasc Interv. 2019 Jun 24;12:1109-20).

Applications other than hypertension

Renal denervation is under early-stage investigation for a range of other cardiovascular diseases in which sympathetic overdrive figures prominently.

“The truly interesting things in renal denervation are what happens beyond hypertension. There are a lot of potential applications,” according to Dr. Bohm.

For example, when RDN was performed alongside pulmonary vein isolation for treatment of paroxysmal atrial fibrillation in hypertensive patients, the arrhythmia recurrence rate was significantly reduced during 1 year of follow-up, compared with AF ablation alone, in the randomized, multicenter, 302-patient ERADICATE-AF trial, presented at the most recent meeting of the Heart Rhythm Society.

Also, a small, uncontrolled registry study of RDN in patients with cardiomyopathy and electrical storm suggests the procedure may have an immediate anti–ventricular arrhythmia effect.

Meanwhile, Dr. Bohm is pressing the German government to sponsor an independent randomized controlled trial of RDN for heart failure. He and others have shown in small pilot studies a promising signal that the treatment may improve myocardial function and the signs and symptoms of heart failure in both patients with reduced and preserved left ventricular ejection fraction – and without reducing their blood pressure, which is often already low.

Dr. Bohm and others have also been exploring the impact of RDN in patients with metabolic syndrome. The treatment has a sound pathophysiologic rationale because insulin resistance is dependent upon sympathetic nervous system activation. Preliminary reports show improved insulin sensitivity in response to RDN. Patients also report better quality of life, presumably because of the reduction in sympathetic overactivity.

A couple of small Chinese studies suggest denervating the pulmonary vein in patients with pulmonary hypertension leads to a salutary reduction in pulmonary blood pressures.

“We haven’t done that yet. There is no properly designed catheter. They’ve used a Spyra unipolar catheter. It could work, but it hasn’t been rigorously investigated,” the cardiologist said.

Dr. Bohm reported serving as a scientific adviser to Abbott, AstraZeneca, BMS, Boehringer Ingelheim, and Servier.

bjancin@mdedge.com

The American College of Physicians is recommending either a single-payer system or a public option within a regulated private insurance system to help deliver universal and affordable access to health care for all Americans.

“We came to the conclusion that two directions or approaches could get us to where we need to be,” ACP President Robert McLean, MD, said in an interview. “We need ... a system that provides universal, affordable access to care.”

After examining the evidence, ACP discarded one option: a direct market-based approach.

“Direct market-based approaches won’t work,” Dr. McLean explained. “If you look at where direct marketplace approaches ... have been implemented, they just will not get you to a place where you are going to get universal coverage, portability, essential benefits, and preexisting condition protection and administrative simplification.”

Dr. McLean highlighted two paths that could achieve universal coverage and better access to health care: a single-payer–financed system, or a publicly financed coverage option within a system of regulated private insurance.

It’s the first time ACP has endorsed a single-payer approach. The college supported the public option that wasn’t included as part of the Affordable Care Act. But ACP’s latest publicly financed proposal offers a deeper level of detail on how to make that option work in the context of a private insurance system.

While the health reform conversation may be a political, ACP doesn’t want to make it a partisan one. ACP’s policy recommendations represent a carefully researched series of ideas backed by evidence-based research, Dr. McLean said.

“There is a lot of nuance behind” the two recommendations, he noted, and those nuances are explored in a series of articles and editorials published Jan. 21 in Annals of Internal Medicine.

Sizing up single payer

The ACP acknowledges that for its single-payer system, the transition could be “politically difficult and strain the federal budget,” according to Ryan A. Crowley, senior analyst at ACP, and colleagues in an article outlining the organization’s vision. “Taxes would probably replace premiums, and private insurance would have a reduced role or be eliminated altogether.”

However, the authors note that a single-payer system could be designed to address concerns from a generally skeptical public, such as providing bulk funding or setting minimum standards to guide state operations. It also could include private insurance to provide supplemental coverage.

Even so, “adopting a single-payer system would be highly disruptive and could lead to price controls that would perpetuate flaws in the current Medicare payment system, including the undervaluation of primary care,” Mr. Crowley and colleagues wrote. “If prices are set too low, it could lead to shortages and longer wait times for services. Without sufficient cost controls, however, the cost of a single-payer system could be too high to be feasible.”

Pondering the public option

Given a single-payer plan’s potential challenges, ACP also is endorsing a public option model, which provides the choice of a government-sponsored health insurance plan to compete with existing private insurance options.

“Depending on its structure and implementation, a public choice (or public option) model available to all could help to achieve universal coverage, better access, and improved outcomes without the disruption of a single-payer approach,” the ACP authors noted.

The public option has its own drawbacks, they acknowledge. Those include an inability to achieve better savings on prescription drugs, compared with a single-payer system. The public option approach also doesn’t do away with the current administrative burden, and access issues related to narrow provider networks would persist.

Dr. McLean noted that a more highly regulated insurance market would be needed to help make the public option model work.

“Insurance companies don’t have regulation in a lot of things that they do,” Dr. McLean said. “We see that as quite problematic. They are kind of running amok at this point.”

Expanding the role of primary care

In either reform scenario, primary care would play a much greater role.

“We need to promote primary care,” Dr. McLean said. That includes better incentives to draw physicians to it. “We have to pay them enough,” he added.

The health care models will need to move away from higher pay to specialties for high-cost, high-volume procedural reimbursement. And they’ll need to recognize the need for placing a higher value on the cognitive services provided at the primary care level.

Also in need of change: physicians’ administrative burdens. Reforms need to address the burden created by value-based care and the poor application and misapplication of quality measures.

Migration to a single-payer environment could would make reducing the administrative burden a lot easier, Dr. McLean said. But it also could be done with a public option approach.

That’s where regulators can play a big role in working with insurers to help address administrative burden – streamlining prior authorization of procedures, the types of forms used, and other policies, Dr. McLean explained.

“The number of insurers and their ability to have their own rules and regulations [make it] incredibly complex for patients as well as physicians trying to figure out how to deliver the care that they need,” he noted.

Dr. McLean hopes that the ACP’s papers will spark conversation, particularly among legislators and regulators.

“The bottom line is we cannot afford to not do something bold,” he cautioned. “It is just not working. Our patients deserve better, and we can do better.”

gtwachtman@mdedge.com

The American College of Physicians is recommending either a single-payer system or a public option within a regulated private insurance system to help deliver universal and affordable access to health care for all Americans.

“We came to the conclusion that two directions or approaches could get us to where we need to be,” ACP President Robert McLean, MD, said in an interview. “We need ... a system that provides universal, affordable access to care.”

After examining the evidence, ACP discarded one option: a direct market-based approach.

“Direct market-based approaches won’t work,” Dr. McLean explained. “If you look at where direct marketplace approaches ... have been implemented, they just will not get you to a place where you are going to get universal coverage, portability, essential benefits, and preexisting condition protection and administrative simplification.”

Dr. McLean highlighted two paths that could achieve universal coverage and better access to health care: a single-payer–financed system, or a publicly financed coverage option within a system of regulated private insurance.

It’s the first time ACP has endorsed a single-payer approach. The college supported the public option that wasn’t included as part of the Affordable Care Act. But ACP’s latest publicly financed proposal offers a deeper level of detail on how to make that option work in the context of a private insurance system.

While the health reform conversation may be a political, ACP doesn’t want to make it a partisan one. ACP’s policy recommendations represent a carefully researched series of ideas backed by evidence-based research, Dr. McLean said.

“There is a lot of nuance behind” the two recommendations, he noted, and those nuances are explored in a series of articles and editorials published Jan. 21 in Annals of Internal Medicine.

Sizing up single payer

The ACP acknowledges that for its single-payer system, the transition could be “politically difficult and strain the federal budget,” according to Ryan A. Crowley, senior analyst at ACP, and colleagues in an article outlining the organization’s vision. “Taxes would probably replace premiums, and private insurance would have a reduced role or be eliminated altogether.”

However, the authors note that a single-payer system could be designed to address concerns from a generally skeptical public, such as providing bulk funding or setting minimum standards to guide state operations. It also could include private insurance to provide supplemental coverage.

Even so, “adopting a single-payer system would be highly disruptive and could lead to price controls that would perpetuate flaws in the current Medicare payment system, including the undervaluation of primary care,” Mr. Crowley and colleagues wrote. “If prices are set too low, it could lead to shortages and longer wait times for services. Without sufficient cost controls, however, the cost of a single-payer system could be too high to be feasible.”

Pondering the public option

Given a single-payer plan’s potential challenges, ACP also is endorsing a public option model, which provides the choice of a government-sponsored health insurance plan to compete with existing private insurance options.

“Depending on its structure and implementation, a public choice (or public option) model available to all could help to achieve universal coverage, better access, and improved outcomes without the disruption of a single-payer approach,” the ACP authors noted.

The public option has its own drawbacks, they acknowledge. Those include an inability to achieve better savings on prescription drugs, compared with a single-payer system. The public option approach also doesn’t do away with the current administrative burden, and access issues related to narrow provider networks would persist.

Dr. McLean noted that a more highly regulated insurance market would be needed to help make the public option model work.

“Insurance companies don’t have regulation in a lot of things that they do,” Dr. McLean said. “We see that as quite problematic. They are kind of running amok at this point.”

Expanding the role of primary care

In either reform scenario, primary care would play a much greater role.

“We need to promote primary care,” Dr. McLean said. That includes better incentives to draw physicians to it. “We have to pay them enough,” he added.

The health care models will need to move away from higher pay to specialties for high-cost, high-volume procedural reimbursement. And they’ll need to recognize the need for placing a higher value on the cognitive services provided at the primary care level.

Also in need of change: physicians’ administrative burdens. Reforms need to address the burden created by value-based care and the poor application and misapplication of quality measures.

Migration to a single-payer environment could would make reducing the administrative burden a lot easier, Dr. McLean said. But it also could be done with a public option approach.

That’s where regulators can play a big role in working with insurers to help address administrative burden – streamlining prior authorization of procedures, the types of forms used, and other policies, Dr. McLean explained.

“The number of insurers and their ability to have their own rules and regulations [make it] incredibly complex for patients as well as physicians trying to figure out how to deliver the care that they need,” he noted.

Dr. McLean hopes that the ACP’s papers will spark conversation, particularly among legislators and regulators.

“The bottom line is we cannot afford to not do something bold,” he cautioned. “It is just not working. Our patients deserve better, and we can do better.”

gtwachtman@mdedge.com

The American College of Physicians is recommending either a single-payer system or a public option within a regulated private insurance system to help deliver universal and affordable access to health care for all Americans.

“We came to the conclusion that two directions or approaches could get us to where we need to be,” ACP President Robert McLean, MD, said in an interview. “We need ... a system that provides universal, affordable access to care.”

After examining the evidence, ACP discarded one option: a direct market-based approach.

“Direct market-based approaches won’t work,” Dr. McLean explained. “If you look at where direct marketplace approaches ... have been implemented, they just will not get you to a place where you are going to get universal coverage, portability, essential benefits, and preexisting condition protection and administrative simplification.”

Dr. McLean highlighted two paths that could achieve universal coverage and better access to health care: a single-payer–financed system, or a publicly financed coverage option within a system of regulated private insurance.

It’s the first time ACP has endorsed a single-payer approach. The college supported the public option that wasn’t included as part of the Affordable Care Act. But ACP’s latest publicly financed proposal offers a deeper level of detail on how to make that option work in the context of a private insurance system.

While the health reform conversation may be a political, ACP doesn’t want to make it a partisan one. ACP’s policy recommendations represent a carefully researched series of ideas backed by evidence-based research, Dr. McLean said.

“There is a lot of nuance behind” the two recommendations, he noted, and those nuances are explored in a series of articles and editorials published Jan. 21 in Annals of Internal Medicine.

Sizing up single payer

The ACP acknowledges that for its single-payer system, the transition could be “politically difficult and strain the federal budget,” according to Ryan A. Crowley, senior analyst at ACP, and colleagues in an article outlining the organization’s vision. “Taxes would probably replace premiums, and private insurance would have a reduced role or be eliminated altogether.”

However, the authors note that a single-payer system could be designed to address concerns from a generally skeptical public, such as providing bulk funding or setting minimum standards to guide state operations. It also could include private insurance to provide supplemental coverage.

Even so, “adopting a single-payer system would be highly disruptive and could lead to price controls that would perpetuate flaws in the current Medicare payment system, including the undervaluation of primary care,” Mr. Crowley and colleagues wrote. “If prices are set too low, it could lead to shortages and longer wait times for services. Without sufficient cost controls, however, the cost of a single-payer system could be too high to be feasible.”

Pondering the public option

Given a single-payer plan’s potential challenges, ACP also is endorsing a public option model, which provides the choice of a government-sponsored health insurance plan to compete with existing private insurance options.

“Depending on its structure and implementation, a public choice (or public option) model available to all could help to achieve universal coverage, better access, and improved outcomes without the disruption of a single-payer approach,” the ACP authors noted.

The public option has its own drawbacks, they acknowledge. Those include an inability to achieve better savings on prescription drugs, compared with a single-payer system. The public option approach also doesn’t do away with the current administrative burden, and access issues related to narrow provider networks would persist.

Dr. McLean noted that a more highly regulated insurance market would be needed to help make the public option model work.

“Insurance companies don’t have regulation in a lot of things that they do,” Dr. McLean said. “We see that as quite problematic. They are kind of running amok at this point.”

Expanding the role of primary care

In either reform scenario, primary care would play a much greater role.

“We need to promote primary care,” Dr. McLean said. That includes better incentives to draw physicians to it. “We have to pay them enough,” he added.

The health care models will need to move away from higher pay to specialties for high-cost, high-volume procedural reimbursement. And they’ll need to recognize the need for placing a higher value on the cognitive services provided at the primary care level.

Also in need of change: physicians’ administrative burdens. Reforms need to address the burden created by value-based care and the poor application and misapplication of quality measures.

Migration to a single-payer environment could would make reducing the administrative burden a lot easier, Dr. McLean said. But it also could be done with a public option approach.

That’s where regulators can play a big role in working with insurers to help address administrative burden – streamlining prior authorization of procedures, the types of forms used, and other policies, Dr. McLean explained.

“The number of insurers and their ability to have their own rules and regulations [make it] incredibly complex for patients as well as physicians trying to figure out how to deliver the care that they need,” he noted.

Dr. McLean hopes that the ACP’s papers will spark conversation, particularly among legislators and regulators.

“The bottom line is we cannot afford to not do something bold,” he cautioned. “It is just not working. Our patients deserve better, and we can do better.”

gtwachtman@mdedge.com

Burnout among physicians appears to have decreased slightly in the past few years, but remains a significant problem for the medical profession, according to the Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide.

olm26250/Thinkstock

A survey of more than 15,000 physicians revealed that 42% reported being burned out, down from 46% who responded to the survey 5 years ago. However, there are variations in the rates based on certain demographic factors such as specialty, age, and gender.

Urology sits at the top of the list as the specialty that is experiencing the highest rate of burnout, with 54% of urologists responding to the survey reporting burnout. Neurology and nephrology followed with rates of burnout at 50% and 49%, respectively. The next five specialties on the list all reported burnout rates of 46%: diabetes and endocrinology, family medicine, radiology, ob.gyn., and rheumatology. Pulmonology specialists reported a burnout rate of 41%. Gastroenterologists reported burnout rates of 37%.

The survey divided participants into three age categories – Millennial (ages 25-39 years), Generation X (ages 40-54 years), and Baby Boomer (ages 55-73 years). Both Millennials and Baby Boomers reported similar rates of burnout (38% and 39%, respectively) and those in Generation X reported a higher rate of burnout (48%).

This higher rate is not unexpected. The survey results cite Carol Bernstein, MD, of the Albert Einstein College of Medicine, New York, as noting that midcareer “is typically the time of highest burnout, which is where Gen Xers are in their career trajectory, suggesting a number of factors outside of work such as caring for children and elderly parents, planning for retirement, can play a role in contributing to burnout.”

Women also reported a higher rate of burnout, although the rate has dropped from the survey conducted 5 years ago. The rate of burnout among women reported for the 2020 survey was 48%, down from 51% reported 5 years ago. By comparison, the rate of burnout for men was 37% in 2020, down from 43% in 2015.

In terms of what is causing burnout, the biggest contributor is the bureaucratic tasks (charting and paperwork, for example) that physicians must complete, which 55% of respondents to the survey said was the leading cause of burnout. Next was spending too many hours at work (33%); lack of respect from administrators, employers, colleagues, and staff (32%); and the increased computerization of the practice, including the use of electronic health records (30%).

When broken down by age category, the bureaucratic tasks was tops in all three groups (57% for Millennials, 56% for Generation X, and 54% for Baby Boomers), but what ranks next differs slightly by age group. For Millennials, the next two factors were too many hours at work (38%) and lack of respect (35%). Generation X respondents cited the same two factors, both at 33%. Baby Boomers cited computerization as their second-highest factor (41%) and spending too many hours at work as the third-highest factor (31%).

The generations had different approaches to coping with burnout. Millennials (56%) reported sleep as their top-ranked coping strategy, while Gen Xers and Baby Boomers ranked exercise and personal isolation as their top choice. For these two older groups, sleep was ranked last, after other activities such as talking with family and friends.

The survey also asked about depression, and respondents reported a similar rate across all age groups (15%, 18%, and 16%, respectively). Among those who said they were depressed, the three age groups had similar rates of suicidal thoughts (21%, 24%, and 22%).

Perhaps the most striking finding of the survey is the number of physicians who would take a pay cut to achieve a better work-life balance. Among Millennials, 52% would accept a pay cut, compared with 48% of Generation X and 49% of Baby Boomers. A surprising number (36%, 34%, and 31%, respectively, reported that they would accept a $10,000-$20,000 pay cut to have a 20% reduction in work hours. gtwachtman@mdedge.com

*This story was updated on 1/22/2020.

SOURCE: Kane L et al. Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide. Medscape. 2020 Jan 15.

Burnout among physicians appears to have decreased slightly in the past few years, but remains a significant problem for the medical profession, according to the Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide.

olm26250/Thinkstock

A survey of more than 15,000 physicians revealed that 42% reported being burned out, down from 46% who responded to the survey 5 years ago. However, there are variations in the rates based on certain demographic factors such as specialty, age, and gender.

Urology sits at the top of the list as the specialty that is experiencing the highest rate of burnout, with 54% of urologists responding to the survey reporting burnout. Neurology and nephrology followed with rates of burnout at 50% and 49%, respectively. The next five specialties on the list all reported burnout rates of 46%: diabetes and endocrinology, family medicine, radiology, ob.gyn., and rheumatology. Pulmonology specialists reported a burnout rate of 41%. Gastroenterologists reported burnout rates of 37%.

The survey divided participants into three age categories – Millennial (ages 25-39 years), Generation X (ages 40-54 years), and Baby Boomer (ages 55-73 years). Both Millennials and Baby Boomers reported similar rates of burnout (38% and 39%, respectively) and those in Generation X reported a higher rate of burnout (48%).

This higher rate is not unexpected. The survey results cite Carol Bernstein, MD, of the Albert Einstein College of Medicine, New York, as noting that midcareer “is typically the time of highest burnout, which is where Gen Xers are in their career trajectory, suggesting a number of factors outside of work such as caring for children and elderly parents, planning for retirement, can play a role in contributing to burnout.”

Women also reported a higher rate of burnout, although the rate has dropped from the survey conducted 5 years ago. The rate of burnout among women reported for the 2020 survey was 48%, down from 51% reported 5 years ago. By comparison, the rate of burnout for men was 37% in 2020, down from 43% in 2015.

In terms of what is causing burnout, the biggest contributor is the bureaucratic tasks (charting and paperwork, for example) that physicians must complete, which 55% of respondents to the survey said was the leading cause of burnout. Next was spending too many hours at work (33%); lack of respect from administrators, employers, colleagues, and staff (32%); and the increased computerization of the practice, including the use of electronic health records (30%).

When broken down by age category, the bureaucratic tasks was tops in all three groups (57% for Millennials, 56% for Generation X, and 54% for Baby Boomers), but what ranks next differs slightly by age group. For Millennials, the next two factors were too many hours at work (38%) and lack of respect (35%). Generation X respondents cited the same two factors, both at 33%. Baby Boomers cited computerization as their second-highest factor (41%) and spending too many hours at work as the third-highest factor (31%).

The generations had different approaches to coping with burnout. Millennials (56%) reported sleep as their top-ranked coping strategy, while Gen Xers and Baby Boomers ranked exercise and personal isolation as their top choice. For these two older groups, sleep was ranked last, after other activities such as talking with family and friends.

The survey also asked about depression, and respondents reported a similar rate across all age groups (15%, 18%, and 16%, respectively). Among those who said they were depressed, the three age groups had similar rates of suicidal thoughts (21%, 24%, and 22%).

Perhaps the most striking finding of the survey is the number of physicians who would take a pay cut to achieve a better work-life balance. Among Millennials, 52% would accept a pay cut, compared with 48% of Generation X and 49% of Baby Boomers. A surprising number (36%, 34%, and 31%, respectively, reported that they would accept a $10,000-$20,000 pay cut to have a 20% reduction in work hours. gtwachtman@mdedge.com

*This story was updated on 1/22/2020.

SOURCE: Kane L et al. Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide. Medscape. 2020 Jan 15.

Burnout among physicians appears to have decreased slightly in the past few years, but remains a significant problem for the medical profession, according to the Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide.

olm26250/Thinkstock

A survey of more than 15,000 physicians revealed that 42% reported being burned out, down from 46% who responded to the survey 5 years ago. However, there are variations in the rates based on certain demographic factors such as specialty, age, and gender.

Urology sits at the top of the list as the specialty that is experiencing the highest rate of burnout, with 54% of urologists responding to the survey reporting burnout. Neurology and nephrology followed with rates of burnout at 50% and 49%, respectively. The next five specialties on the list all reported burnout rates of 46%: diabetes and endocrinology, family medicine, radiology, ob.gyn., and rheumatology. Pulmonology specialists reported a burnout rate of 41%. Gastroenterologists reported burnout rates of 37%.

The survey divided participants into three age categories – Millennial (ages 25-39 years), Generation X (ages 40-54 years), and Baby Boomer (ages 55-73 years). Both Millennials and Baby Boomers reported similar rates of burnout (38% and 39%, respectively) and those in Generation X reported a higher rate of burnout (48%).

This higher rate is not unexpected. The survey results cite Carol Bernstein, MD, of the Albert Einstein College of Medicine, New York, as noting that midcareer “is typically the time of highest burnout, which is where Gen Xers are in their career trajectory, suggesting a number of factors outside of work such as caring for children and elderly parents, planning for retirement, can play a role in contributing to burnout.”

Women also reported a higher rate of burnout, although the rate has dropped from the survey conducted 5 years ago. The rate of burnout among women reported for the 2020 survey was 48%, down from 51% reported 5 years ago. By comparison, the rate of burnout for men was 37% in 2020, down from 43% in 2015.

In terms of what is causing burnout, the biggest contributor is the bureaucratic tasks (charting and paperwork, for example) that physicians must complete, which 55% of respondents to the survey said was the leading cause of burnout. Next was spending too many hours at work (33%); lack of respect from administrators, employers, colleagues, and staff (32%); and the increased computerization of the practice, including the use of electronic health records (30%).

When broken down by age category, the bureaucratic tasks was tops in all three groups (57% for Millennials, 56% for Generation X, and 54% for Baby Boomers), but what ranks next differs slightly by age group. For Millennials, the next two factors were too many hours at work (38%) and lack of respect (35%). Generation X respondents cited the same two factors, both at 33%. Baby Boomers cited computerization as their second-highest factor (41%) and spending too many hours at work as the third-highest factor (31%).

The generations had different approaches to coping with burnout. Millennials (56%) reported sleep as their top-ranked coping strategy, while Gen Xers and Baby Boomers ranked exercise and personal isolation as their top choice. For these two older groups, sleep was ranked last, after other activities such as talking with family and friends.

The survey also asked about depression, and respondents reported a similar rate across all age groups (15%, 18%, and 16%, respectively). Among those who said they were depressed, the three age groups had similar rates of suicidal thoughts (21%, 24%, and 22%).

Perhaps the most striking finding of the survey is the number of physicians who would take a pay cut to achieve a better work-life balance. Among Millennials, 52% would accept a pay cut, compared with 48% of Generation X and 49% of Baby Boomers. A surprising number (36%, 34%, and 31%, respectively, reported that they would accept a $10,000-$20,000 pay cut to have a 20% reduction in work hours. gtwachtman@mdedge.com

*This story was updated on 1/22/2020.

SOURCE: Kane L et al. Medscape National Physician Burnout & Suicide Report 2020: The Generational Divide. Medscape. 2020 Jan 15.

LA JOLLA, CALIF. – The first time that legendary actor Alan Alda conducted an interview for “Scientific American Frontiers” on PBS, an award-winning series that ran for more than a decade, he remembers learning a lesson in humility.

Doug Brunk/MDedge News

“I wasn’t as smart as I thought I was,” he told a crowd of largely scientists and medical professionals who gathered in a small auditorium on the campus of Scripps Research on Jan. 16, 2020. “I didn’t realize the value of ignorance. I have a natural supply of it. I began to use it and say [to interviewees]: ‘I don’t understand what that means.’ Sometimes it would be basic physics and they’d look at me like I was a school child. I am a very curious person. What I discovered was, I was bringing out their humanity by my own curiosity, by the way I related to them, which I developed through studying improvisation as an actor, and relating as an actor to other actors.”

Mr. Alda, 83, appeared on the research campus to announce that Scripps Research is the new West Coast home of Alda Communication Training, which will work in tandem with the Alan Alda Center for Communicating Science at the State University of New York at Stony Brook, a nonprofit organization that Mr. Alda helped found in 2009.
 

Immersive training experience

“This will be a center where people can come to get training in effective communication,” said Mr. Alda, who is the winner of six Emmy Awards and six Golden Globe awards. “It’s an experiential kind of training. We don’t give tips. We don’t give lectures. We put you through exercises that are fun and actually make you laugh, but turn you into a better communicator, so you’re better able to connect to the people you’re talking to.”

To date, the Alan Alda Center for Communicating Science has trained more than 15,000 scientific leaders in the United States and other countries. The location at Scripps Research makes it more convenient for West Coast–based researchers and industry leaders to participate. “One of the things we wished, for years, we had was a place where we could train scientists and researchers and medical professionals all up and down the West Coast,” he said.

Recently, more than 30 of Scripps Research scientists participated in Mr. Alda’s training program, an immersive and engaging experience that helps participants learn to empathize with an audience and present their work in a way that connects with different stakeholders. The skills and strategies can help participants relate to prospective investors and philanthropists, government officials, members of the media, peers across scientific disciplines, and the general public.

Earlier in the day that he spoke on the Scripps campus, Mr. Alda encountered some of the Scripps researchers who had participated in that training. “One group of scientists came in and we shook hands,” he said. “They introduced themselves and said: ‘We’re working on infectious diseases.’ I said: ‘Oh my God; I just shook hands with you!’ No matter what I asked them, they had a clear way to express what they did. Then I realized they had studied with Alda Communications.”
 

Why communication matters

During the early stages of forming what became the Alan Alda Center for Communicating Science, one Nobel Prize winner at a major university dismissed the importance of improving the communication skills of young scientists. “He said to me: ‘We don’t have time for that; we have too much science to teach,’ ” said Mr. Alda, who played Army surgeon “Hawkeye” Pierce on the TV series “M*A*S*H”. “But communication is the essence of science. How can you do science unless you communicate with other scientists? There’s a stereotype that scientists are not as good at communicating as other people are. It’s true that they often speak a language that a lot of us don’t understand, but we all speak a language that is hard for other people to understand if we know something in great depth. We want to tell all the details; we want to speak in our special language because it makes us feel good.”

He underscored the importance of scientists being able to effectively communicate with the general public, “because the public needs to understand how important science is to their lives. It matters because at a place like [Scripps Research], understanding how nature works is put to work to keep our health secure.” Members of the public, he continued, “are busy living their lives; they’re busy working and bringing up their children. They haven’t spent 20, 30, 40 years devoted to a single aspect of nature the way scientists have. We can’t expect them to know as much as professional scientists, so we have to help them understand it. I hope we find ways to increase curiosity. I don’t know how to do that. I wish somebody would do a study on it, how you can take someone with a modicum of curiosity and help them enlarge it so it gives them the pleasure of discovering things about nature or understanding things about nature that other people don’t discover. Curiosity is the key to staying alive. That would bring us to a point of more people understanding science.”

Cultivating a sense of responsibility is another key to effective communication. “It’s the job of the person leading the discussion to make clear to the person listening,” Mr. Alda said. “You get the impression that ‘this person is my responsibility. I have to take care of them, so they understand what’s going on.’ ”
 

Parkinson’s disease diagnosis

During a question-and-answer session, Mr. Alda opened up about his Parkinson’s disease, which he said was diagnosed about 5 years ago. In 2018, he decided to speak publicly about his diagnosis for the first time.

“The reason was that I wanted to communicate to people who had recently been diagnosed not to believe or give into the stereotype that when you get a diagnosis, your life is over,” said Mr. Alda, who received the Public Welfare Medal from the National Academy of Sciences in 2016. “Under the burden of that belief, some people won’t tell their family or workplace colleagues. There are exercises you can do and medications you can take to prolong the time it takes before Parkinson’s gets much more serious. It’s not to diminish the fact that it can get really bad; but to think that your life is over as soon as you get a diagnosis is wrong.”

He added: “I’ve gone 5 years and I’m almost busier than I’ve ever been. I’m getting a lot accomplished and I look forward to I don’t know how many years. As long as I have them, I’m going to be grateful. It’s amazing how great it feels not to keep the diagnosis a secret.”

The first 2-day training session at Scripps Research will be held in June 2020. Additional sessions are scheduled to take place in October and December. Registration is available at aldacommunicationtraining.com/workshops.

dbrunk@mdedge.com

LA JOLLA, CALIF. – The first time that legendary actor Alan Alda conducted an interview for “Scientific American Frontiers” on PBS, an award-winning series that ran for more than a decade, he remembers learning a lesson in humility.

Doug Brunk/MDedge News

“I wasn’t as smart as I thought I was,” he told a crowd of largely scientists and medical professionals who gathered in a small auditorium on the campus of Scripps Research on Jan. 16, 2020. “I didn’t realize the value of ignorance. I have a natural supply of it. I began to use it and say [to interviewees]: ‘I don’t understand what that means.’ Sometimes it would be basic physics and they’d look at me like I was a school child. I am a very curious person. What I discovered was, I was bringing out their humanity by my own curiosity, by the way I related to them, which I developed through studying improvisation as an actor, and relating as an actor to other actors.”

Mr. Alda, 83, appeared on the research campus to announce that Scripps Research is the new West Coast home of Alda Communication Training, which will work in tandem with the Alan Alda Center for Communicating Science at the State University of New York at Stony Brook, a nonprofit organization that Mr. Alda helped found in 2009.
 

Immersive training experience

“This will be a center where people can come to get training in effective communication,” said Mr. Alda, who is the winner of six Emmy Awards and six Golden Globe awards. “It’s an experiential kind of training. We don’t give tips. We don’t give lectures. We put you through exercises that are fun and actually make you laugh, but turn you into a better communicator, so you’re better able to connect to the people you’re talking to.”

To date, the Alan Alda Center for Communicating Science has trained more than 15,000 scientific leaders in the United States and other countries. The location at Scripps Research makes it more convenient for West Coast–based researchers and industry leaders to participate. “One of the things we wished, for years, we had was a place where we could train scientists and researchers and medical professionals all up and down the West Coast,” he said.

Recently, more than 30 of Scripps Research scientists participated in Mr. Alda’s training program, an immersive and engaging experience that helps participants learn to empathize with an audience and present their work in a way that connects with different stakeholders. The skills and strategies can help participants relate to prospective investors and philanthropists, government officials, members of the media, peers across scientific disciplines, and the general public.

Earlier in the day that he spoke on the Scripps campus, Mr. Alda encountered some of the Scripps researchers who had participated in that training. “One group of scientists came in and we shook hands,” he said. “They introduced themselves and said: ‘We’re working on infectious diseases.’ I said: ‘Oh my God; I just shook hands with you!’ No matter what I asked them, they had a clear way to express what they did. Then I realized they had studied with Alda Communications.”
 

Why communication matters

During the early stages of forming what became the Alan Alda Center for Communicating Science, one Nobel Prize winner at a major university dismissed the importance of improving the communication skills of young scientists. “He said to me: ‘We don’t have time for that; we have too much science to teach,’ ” said Mr. Alda, who played Army surgeon “Hawkeye” Pierce on the TV series “M*A*S*H”. “But communication is the essence of science. How can you do science unless you communicate with other scientists? There’s a stereotype that scientists are not as good at communicating as other people are. It’s true that they often speak a language that a lot of us don’t understand, but we all speak a language that is hard for other people to understand if we know something in great depth. We want to tell all the details; we want to speak in our special language because it makes us feel good.”

He underscored the importance of scientists being able to effectively communicate with the general public, “because the public needs to understand how important science is to their lives. It matters because at a place like [Scripps Research], understanding how nature works is put to work to keep our health secure.” Members of the public, he continued, “are busy living their lives; they’re busy working and bringing up their children. They haven’t spent 20, 30, 40 years devoted to a single aspect of nature the way scientists have. We can’t expect them to know as much as professional scientists, so we have to help them understand it. I hope we find ways to increase curiosity. I don’t know how to do that. I wish somebody would do a study on it, how you can take someone with a modicum of curiosity and help them enlarge it so it gives them the pleasure of discovering things about nature or understanding things about nature that other people don’t discover. Curiosity is the key to staying alive. That would bring us to a point of more people understanding science.”

Cultivating a sense of responsibility is another key to effective communication. “It’s the job of the person leading the discussion to make clear to the person listening,” Mr. Alda said. “You get the impression that ‘this person is my responsibility. I have to take care of them, so they understand what’s going on.’ ”
 

Parkinson’s disease diagnosis

During a question-and-answer session, Mr. Alda opened up about his Parkinson’s disease, which he said was diagnosed about 5 years ago. In 2018, he decided to speak publicly about his diagnosis for the first time.

“The reason was that I wanted to communicate to people who had recently been diagnosed not to believe or give into the stereotype that when you get a diagnosis, your life is over,” said Mr. Alda, who received the Public Welfare Medal from the National Academy of Sciences in 2016. “Under the burden of that belief, some people won’t tell their family or workplace colleagues. There are exercises you can do and medications you can take to prolong the time it takes before Parkinson’s gets much more serious. It’s not to diminish the fact that it can get really bad; but to think that your life is over as soon as you get a diagnosis is wrong.”

He added: “I’ve gone 5 years and I’m almost busier than I’ve ever been. I’m getting a lot accomplished and I look forward to I don’t know how many years. As long as I have them, I’m going to be grateful. It’s amazing how great it feels not to keep the diagnosis a secret.”

The first 2-day training session at Scripps Research will be held in June 2020. Additional sessions are scheduled to take place in October and December. Registration is available at aldacommunicationtraining.com/workshops.

dbrunk@mdedge.com

LA JOLLA, CALIF. – The first time that legendary actor Alan Alda conducted an interview for “Scientific American Frontiers” on PBS, an award-winning series that ran for more than a decade, he remembers learning a lesson in humility.

Doug Brunk/MDedge News

“I wasn’t as smart as I thought I was,” he told a crowd of largely scientists and medical professionals who gathered in a small auditorium on the campus of Scripps Research on Jan. 16, 2020. “I didn’t realize the value of ignorance. I have a natural supply of it. I began to use it and say [to interviewees]: ‘I don’t understand what that means.’ Sometimes it would be basic physics and they’d look at me like I was a school child. I am a very curious person. What I discovered was, I was bringing out their humanity by my own curiosity, by the way I related to them, which I developed through studying improvisation as an actor, and relating as an actor to other actors.”

Mr. Alda, 83, appeared on the research campus to announce that Scripps Research is the new West Coast home of Alda Communication Training, which will work in tandem with the Alan Alda Center for Communicating Science at the State University of New York at Stony Brook, a nonprofit organization that Mr. Alda helped found in 2009.
 

Immersive training experience

“This will be a center where people can come to get training in effective communication,” said Mr. Alda, who is the winner of six Emmy Awards and six Golden Globe awards. “It’s an experiential kind of training. We don’t give tips. We don’t give lectures. We put you through exercises that are fun and actually make you laugh, but turn you into a better communicator, so you’re better able to connect to the people you’re talking to.”

To date, the Alan Alda Center for Communicating Science has trained more than 15,000 scientific leaders in the United States and other countries. The location at Scripps Research makes it more convenient for West Coast–based researchers and industry leaders to participate. “One of the things we wished, for years, we had was a place where we could train scientists and researchers and medical professionals all up and down the West Coast,” he said.

Recently, more than 30 of Scripps Research scientists participated in Mr. Alda’s training program, an immersive and engaging experience that helps participants learn to empathize with an audience and present their work in a way that connects with different stakeholders. The skills and strategies can help participants relate to prospective investors and philanthropists, government officials, members of the media, peers across scientific disciplines, and the general public.

Earlier in the day that he spoke on the Scripps campus, Mr. Alda encountered some of the Scripps researchers who had participated in that training. “One group of scientists came in and we shook hands,” he said. “They introduced themselves and said: ‘We’re working on infectious diseases.’ I said: ‘Oh my God; I just shook hands with you!’ No matter what I asked them, they had a clear way to express what they did. Then I realized they had studied with Alda Communications.”
 

Why communication matters

During the early stages of forming what became the Alan Alda Center for Communicating Science, one Nobel Prize winner at a major university dismissed the importance of improving the communication skills of young scientists. “He said to me: ‘We don’t have time for that; we have too much science to teach,’ ” said Mr. Alda, who played Army surgeon “Hawkeye” Pierce on the TV series “M*A*S*H”. “But communication is the essence of science. How can you do science unless you communicate with other scientists? There’s a stereotype that scientists are not as good at communicating as other people are. It’s true that they often speak a language that a lot of us don’t understand, but we all speak a language that is hard for other people to understand if we know something in great depth. We want to tell all the details; we want to speak in our special language because it makes us feel good.”

He underscored the importance of scientists being able to effectively communicate with the general public, “because the public needs to understand how important science is to their lives. It matters because at a place like [Scripps Research], understanding how nature works is put to work to keep our health secure.” Members of the public, he continued, “are busy living their lives; they’re busy working and bringing up their children. They haven’t spent 20, 30, 40 years devoted to a single aspect of nature the way scientists have. We can’t expect them to know as much as professional scientists, so we have to help them understand it. I hope we find ways to increase curiosity. I don’t know how to do that. I wish somebody would do a study on it, how you can take someone with a modicum of curiosity and help them enlarge it so it gives them the pleasure of discovering things about nature or understanding things about nature that other people don’t discover. Curiosity is the key to staying alive. That would bring us to a point of more people understanding science.”

Cultivating a sense of responsibility is another key to effective communication. “It’s the job of the person leading the discussion to make clear to the person listening,” Mr. Alda said. “You get the impression that ‘this person is my responsibility. I have to take care of them, so they understand what’s going on.’ ”
 

Parkinson’s disease diagnosis

During a question-and-answer session, Mr. Alda opened up about his Parkinson’s disease, which he said was diagnosed about 5 years ago. In 2018, he decided to speak publicly about his diagnosis for the first time.

“The reason was that I wanted to communicate to people who had recently been diagnosed not to believe or give into the stereotype that when you get a diagnosis, your life is over,” said Mr. Alda, who received the Public Welfare Medal from the National Academy of Sciences in 2016. “Under the burden of that belief, some people won’t tell their family or workplace colleagues. There are exercises you can do and medications you can take to prolong the time it takes before Parkinson’s gets much more serious. It’s not to diminish the fact that it can get really bad; but to think that your life is over as soon as you get a diagnosis is wrong.”

He added: “I’ve gone 5 years and I’m almost busier than I’ve ever been. I’m getting a lot accomplished and I look forward to I don’t know how many years. As long as I have them, I’m going to be grateful. It’s amazing how great it feels not to keep the diagnosis a secret.”

The first 2-day training session at Scripps Research will be held in June 2020. Additional sessions are scheduled to take place in October and December. Registration is available at aldacommunicationtraining.com/workshops.

dbrunk@mdedge.com

Cognitive screening of 141 clinicians 70 years or older at Yale New Haven (Conn.) Hospital identified 18 with cognitive deficits likely to impair their ability to practice medicine. Six retired and 12 agreed to limit their practice to closely proctored environments, according to a report in JAMA.

It was part of a program to screen all practitioners 70 years or older who apply for reappointment to the medical staff, and every 2 years thereafter, due to “concerns about the potentially compromised ability of older clinicians,” said the authors, Yale rheumatologist and geriatrician Leo M. Cooney Jr., MD, and Thomas Balcezak, MD, Yale New Haven’s chief medical officer.

Yale is not alone. Intermountain Healthcare, Stanford Hospitals and Clinics, Scripps Health Care, Penn Medicine, and the University of California, San Diego, are among the institutions with similar programs.

The move is being driven by the aging of the medical community. About 15% of U.S. physicians are over 65 years old, a tripling from 23,000 in 1980 to 73,000 in 2012-2016, and the number is growing, according to an editorial by Jeffrey L. Saver, MD, professor of neurology and senior associate vice president of neurology at the University of California, Los Angeles.

Mitchel L. Zoler/MDedge News

Photographee.eu

aotto@mdedge.com

SOURCE: Cooney L et al. JAMA. 2020 Jan 14;323(2):179-80.

Cognitive screening of 141 clinicians 70 years or older at Yale New Haven (Conn.) Hospital identified 18 with cognitive deficits likely to impair their ability to practice medicine. Six retired and 12 agreed to limit their practice to closely proctored environments, according to a report in JAMA.

It was part of a program to screen all practitioners 70 years or older who apply for reappointment to the medical staff, and every 2 years thereafter, due to “concerns about the potentially compromised ability of older clinicians,” said the authors, Yale rheumatologist and geriatrician Leo M. Cooney Jr., MD, and Thomas Balcezak, MD, Yale New Haven’s chief medical officer.

Yale is not alone. Intermountain Healthcare, Stanford Hospitals and Clinics, Scripps Health Care, Penn Medicine, and the University of California, San Diego, are among the institutions with similar programs.

The move is being driven by the aging of the medical community. About 15% of U.S. physicians are over 65 years old, a tripling from 23,000 in 1980 to 73,000 in 2012-2016, and the number is growing, according to an editorial by Jeffrey L. Saver, MD, professor of neurology and senior associate vice president of neurology at the University of California, Los Angeles.

Mitchel L. Zoler/MDedge News

Photographee.eu

aotto@mdedge.com

SOURCE: Cooney L et al. JAMA. 2020 Jan 14;323(2):179-80.

Cognitive screening of 141 clinicians 70 years or older at Yale New Haven (Conn.) Hospital identified 18 with cognitive deficits likely to impair their ability to practice medicine. Six retired and 12 agreed to limit their practice to closely proctored environments, according to a report in JAMA.

It was part of a program to screen all practitioners 70 years or older who apply for reappointment to the medical staff, and every 2 years thereafter, due to “concerns about the potentially compromised ability of older clinicians,” said the authors, Yale rheumatologist and geriatrician Leo M. Cooney Jr., MD, and Thomas Balcezak, MD, Yale New Haven’s chief medical officer.

Yale is not alone. Intermountain Healthcare, Stanford Hospitals and Clinics, Scripps Health Care, Penn Medicine, and the University of California, San Diego, are among the institutions with similar programs.

The move is being driven by the aging of the medical community. About 15% of U.S. physicians are over 65 years old, a tripling from 23,000 in 1980 to 73,000 in 2012-2016, and the number is growing, according to an editorial by Jeffrey L. Saver, MD, professor of neurology and senior associate vice president of neurology at the University of California, Los Angeles.

Mitchel L. Zoler/MDedge News

Photographee.eu

aotto@mdedge.com

SOURCE: Cooney L et al. JAMA. 2020 Jan 14;323(2):179-80.

The Food and Drug Administration has approved an additional indication – reduction of cardiovascular (CV) disease risk – for the injectable formulation of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) in the treatment of type 2 diabetes and has added new trial data information to the label of the oral version (Rybelsus, Novo Nordisk) pertaining to CV safety.

The agency expanded the once-weekly injectable semaglutide’s label to include an indication for reducing the risk for major adverse cardiovascular events (MACE), including CV death, nonfatal myocardial infarction (MI), or nonfatal stroke, in adults with type 2 diabetes who have established CV disease.

Initially approved for the treatment of type 2 diabetes in adults in December 2017, once-weekly subcutaneously injectable semaglutide comes in 0.5-mg and 1.0-mg doses in a dedicated prefilled pen device.

The approval for the new indication was based on data from the 2-year randomized Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN 6), in which injectable semaglutide or placebo was added to standard of care in 3,297 adults with type 2 diabetes and established CV disease.

As reported by Medscape Medical News in September 2016, patients who underwent treatment with one of the two doses of semaglutide had a significant 26% lower risk for the primary composite outcome of first occurrence of CV death, nonfatal MI, or nonfatal stroke, compared with those who received placebo.

The reduced CV risk was driven primarily by significant reductions in nonfatal stroke and nonfatal MI (39% and 26%, respectively). There was no difference in CV death between drug and placebo groups. Gastrointestinal adverse events were more frequent with semaglutide than placebo, with the majority occurring during the first 30 weeks.

The oral semaglutide formulation, taken daily in 7-mg or 14-mg doses, was approved for the treatment of type 2 diabetes in September 2019, the first orally available GLP-1 agonist.

Now, the FDA has updated the prescribing information in the clinical studies section (section 14) to include results from the randomized, placebo-controlled, 3,183-subject Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6), reported in June 2019, which found a nonsignificant 21% reduction in three-component MACE with oral semaglutide. The addition to the label for Rybelsus is with regard to CV safety, not benefit.
 

SOUL: Large ongoing CV outcomes trial for oral semaglutide

In June 2019, Novo Nordisk initiated a larger CV outcomes trial of oral semaglutide, A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (SOUL). The trial, which includes 9,642 adults with type 2 diabetes and established CV disease, is further investigating the drug’s effects on the incidence of MACE. The estimated completion date is July 2024.

Semaglutide joins a growing list of drugs approved for treating type 2 diabetes that have been granted additional label indications for benefits beyond the lowering of glucose.

These include Novo Nordisk’s other injectable GLP-1 agonist, liraglutide (Victoza), additionally approved for reducing CV events in high-risk patients with type 2 diabetes, and the sodium-glucose transport 2 inhibitors empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), for reducing CV death; canagliflozin (Invokana, Janssen), for reducing major adverse CV events,; kidney disease, CV death, and heart failure hospitalization; and dapagliflozin (Farxiga, AstraZeneca), for reducing heart failure hospitalization.

Recently, in an exclusive Medscape Medical News article, some experts questioned the design of these CV outcomes trials, suggesting that imbalances in glycemic control, blood pressure, and diuretic use between treatment and placebo arms could have biased the CV and renal outcomes of the trials in favor of the study drugs
 

A version of this story originally appeared on Medscape.com.

The Food and Drug Administration has approved an additional indication – reduction of cardiovascular (CV) disease risk – for the injectable formulation of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) in the treatment of type 2 diabetes and has added new trial data information to the label of the oral version (Rybelsus, Novo Nordisk) pertaining to CV safety.

The agency expanded the once-weekly injectable semaglutide’s label to include an indication for reducing the risk for major adverse cardiovascular events (MACE), including CV death, nonfatal myocardial infarction (MI), or nonfatal stroke, in adults with type 2 diabetes who have established CV disease.

Initially approved for the treatment of type 2 diabetes in adults in December 2017, once-weekly subcutaneously injectable semaglutide comes in 0.5-mg and 1.0-mg doses in a dedicated prefilled pen device.

The approval for the new indication was based on data from the 2-year randomized Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN 6), in which injectable semaglutide or placebo was added to standard of care in 3,297 adults with type 2 diabetes and established CV disease.

As reported by Medscape Medical News in September 2016, patients who underwent treatment with one of the two doses of semaglutide had a significant 26% lower risk for the primary composite outcome of first occurrence of CV death, nonfatal MI, or nonfatal stroke, compared with those who received placebo.

The reduced CV risk was driven primarily by significant reductions in nonfatal stroke and nonfatal MI (39% and 26%, respectively). There was no difference in CV death between drug and placebo groups. Gastrointestinal adverse events were more frequent with semaglutide than placebo, with the majority occurring during the first 30 weeks.

The oral semaglutide formulation, taken daily in 7-mg or 14-mg doses, was approved for the treatment of type 2 diabetes in September 2019, the first orally available GLP-1 agonist.

Now, the FDA has updated the prescribing information in the clinical studies section (section 14) to include results from the randomized, placebo-controlled, 3,183-subject Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6), reported in June 2019, which found a nonsignificant 21% reduction in three-component MACE with oral semaglutide. The addition to the label for Rybelsus is with regard to CV safety, not benefit.
 

SOUL: Large ongoing CV outcomes trial for oral semaglutide

In June 2019, Novo Nordisk initiated a larger CV outcomes trial of oral semaglutide, A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (SOUL). The trial, which includes 9,642 adults with type 2 diabetes and established CV disease, is further investigating the drug’s effects on the incidence of MACE. The estimated completion date is July 2024.

Semaglutide joins a growing list of drugs approved for treating type 2 diabetes that have been granted additional label indications for benefits beyond the lowering of glucose.

These include Novo Nordisk’s other injectable GLP-1 agonist, liraglutide (Victoza), additionally approved for reducing CV events in high-risk patients with type 2 diabetes, and the sodium-glucose transport 2 inhibitors empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), for reducing CV death; canagliflozin (Invokana, Janssen), for reducing major adverse CV events,; kidney disease, CV death, and heart failure hospitalization; and dapagliflozin (Farxiga, AstraZeneca), for reducing heart failure hospitalization.

Recently, in an exclusive Medscape Medical News article, some experts questioned the design of these CV outcomes trials, suggesting that imbalances in glycemic control, blood pressure, and diuretic use between treatment and placebo arms could have biased the CV and renal outcomes of the trials in favor of the study drugs
 

A version of this story originally appeared on Medscape.com.

The Food and Drug Administration has approved an additional indication – reduction of cardiovascular (CV) disease risk – for the injectable formulation of the GLP-1 agonist semaglutide (Ozempic, Novo Nordisk) in the treatment of type 2 diabetes and has added new trial data information to the label of the oral version (Rybelsus, Novo Nordisk) pertaining to CV safety.

The agency expanded the once-weekly injectable semaglutide’s label to include an indication for reducing the risk for major adverse cardiovascular events (MACE), including CV death, nonfatal myocardial infarction (MI), or nonfatal stroke, in adults with type 2 diabetes who have established CV disease.

Initially approved for the treatment of type 2 diabetes in adults in December 2017, once-weekly subcutaneously injectable semaglutide comes in 0.5-mg and 1.0-mg doses in a dedicated prefilled pen device.

The approval for the new indication was based on data from the 2-year randomized Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (SUSTAIN 6), in which injectable semaglutide or placebo was added to standard of care in 3,297 adults with type 2 diabetes and established CV disease.

As reported by Medscape Medical News in September 2016, patients who underwent treatment with one of the two doses of semaglutide had a significant 26% lower risk for the primary composite outcome of first occurrence of CV death, nonfatal MI, or nonfatal stroke, compared with those who received placebo.

The reduced CV risk was driven primarily by significant reductions in nonfatal stroke and nonfatal MI (39% and 26%, respectively). There was no difference in CV death between drug and placebo groups. Gastrointestinal adverse events were more frequent with semaglutide than placebo, with the majority occurring during the first 30 weeks.

The oral semaglutide formulation, taken daily in 7-mg or 14-mg doses, was approved for the treatment of type 2 diabetes in September 2019, the first orally available GLP-1 agonist.

Now, the FDA has updated the prescribing information in the clinical studies section (section 14) to include results from the randomized, placebo-controlled, 3,183-subject Trial Investigating the Cardiovascular Safety of Oral Semaglutide in Subjects With Type 2 Diabetes (PIONEER 6), reported in June 2019, which found a nonsignificant 21% reduction in three-component MACE with oral semaglutide. The addition to the label for Rybelsus is with regard to CV safety, not benefit.
 

SOUL: Large ongoing CV outcomes trial for oral semaglutide

In June 2019, Novo Nordisk initiated a larger CV outcomes trial of oral semaglutide, A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (SOUL). The trial, which includes 9,642 adults with type 2 diabetes and established CV disease, is further investigating the drug’s effects on the incidence of MACE. The estimated completion date is July 2024.

Semaglutide joins a growing list of drugs approved for treating type 2 diabetes that have been granted additional label indications for benefits beyond the lowering of glucose.

These include Novo Nordisk’s other injectable GLP-1 agonist, liraglutide (Victoza), additionally approved for reducing CV events in high-risk patients with type 2 diabetes, and the sodium-glucose transport 2 inhibitors empagliflozin (Jardiance, Boehringer Ingelheim/Lilly), for reducing CV death; canagliflozin (Invokana, Janssen), for reducing major adverse CV events,; kidney disease, CV death, and heart failure hospitalization; and dapagliflozin (Farxiga, AstraZeneca), for reducing heart failure hospitalization.

Recently, in an exclusive Medscape Medical News article, some experts questioned the design of these CV outcomes trials, suggesting that imbalances in glycemic control, blood pressure, and diuretic use between treatment and placebo arms could have biased the CV and renal outcomes of the trials in favor of the study drugs
 

A version of this story originally appeared on Medscape.com.

LOS ANGELES – Mounting evidence suggests that decreasing muscle mass with aging is associated with increased cardiometabolic risk.

Doug Brunk/MDedge News

“Loss of lean body mass and function with aging decreases the amount of metabolically active tissue, which can lead to insulin resistance,” Elena Volpi, MD, said at the World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease. “Insulin resistance reduces muscle protein anabolism and accelerates sarcopenia, perpetuating a vicious cycle.”

Sarcopenia, the involuntary loss of muscle mass and function that occurs with aging, is an ICD-10 codable condition that can be diagnosed by measuring muscle strength and quality, said Dr. Volpi, director of the Sealy Center on Aging at the University of Texas Medical Branch at Galveston. In the Health, Aging and Body Composition Study (Health ABC), researchers followed 2,292 relatively healthy adults aged 70-79 years for an average of 4.9 years (J Gerontol A Biol Sci Med. 2006;61[1]:72-7). The researchers used isokinetic dynamometry to measure knee extension strength, isometric dynamometry to measure grip strength, CT scan to measure thigh muscle area, and dual X-ray absorptiometry to determine leg and arm lean soft-tissue mass. “Those individuals who started with the highest levels of muscle strength had the greatest survival, while those who had the lowest levels of muscle strength died earlier,” said Dr. Volpi, who was not affiliated with the study. “That was true for both men and women.”

More recently, researchers conducted a pooled analysis of nine cohort studies involving 34,485 community-dwelling older individuals who were tested with gait speed and followed for 6-21 years (JAMA. 2011;305[1]:50-8). They found that a higher gait speed was associated with higher survival at 5 and 10 years (P less than .001). “Muscle mass also appears to be associated in part with mortality and survival, although the association is not as strong as measures of strength and gait speed,” Dr. Volpi said.

Data from the 2009 Korea National Health and Nutrition Examination Survey of 1,537 participants, aged 65 years and older, found that sarcopenia is independently associated with cardiovascular disease (PLoS One. 2013 Mar 22. doi: 10.1371/journal.pone.0060119). Most of the risk factors for cardiovascular disease – such as age, waist circumference, body mass index, fasting plasma glucose, and total cholesterol – showed significant negative correlations with the ratio between appendicular skeletal muscle mass and body weight. Multiple logistic regression analysis demonstrated that sarcopenia was associated with cardiovascular disease, independent of other well-documented risk factors, renal function, and medications (odds ratio, 1.77; P = .025).

In addition, data from the British Regional Heart Study, which followed 4,252 older men for a mean of 11.3 years, found an association of sarcopenia and adiposity with cardiovascular mortality and all-cause mortality (J Am Geriatr Soc. 2014;62[2]:253-60). Specifically, all-cause mortality risk was significantly greater in men in the sarcopenic and obese groups (HRs, 1.41 and 1.21, respectively), compared with those in the optimal reference group, with the highest risk in sarcopenic obese individuals (HR, 1.72) after adjustment for lifestyle characteristics.

“Diabetes also accelerates loss of lean body mass in older adults,” added Dr. Volpi. “Data from the Health ABC study showed that individuals who did not have diabetes at the beginning of the 6-year observation period ... lost the least amount of muscle, compared with those who had undiagnosed or already diagnosed diabetes.”

The precise way in which sarcopenia is linked to metabolic disease remains elusive, she continued, but current evidence suggests that sarcopenia is characterized by a reduction in the protein synthetic response to metabolic stimulation by amino acids, exercise, and insulin in skeletal muscle. “This reduction in the anabolic response to protein synthesis is called anabolic resistance of aging, and it is mediated by reduced acute activation of mTORC1 [mTOR complex 1] signaling,” Dr. Volpi said. “There’s another step upstream of the mTORC1, in which the amino acids and insulin have to cross the blood-muscle barrier. Amino acids need to be transported into the muscle actively, like glucose. That is an important unexplored area that may contribute to sarcopenia.”

Dr. Volpi went on to note that endothelial dysfunction underlies muscle anabolic resistance and cardiovascular risk and is likely to be a fundamental cause of both problems. Recent studies have shown that increased levels of physical activity improve endothelial function, enhance insulin sensitivity and anabolic sensitivity to nutrients, and reduce cardiovascular risk.

For example, in a cohort of 45 nonfrail older adults with a mean age of 72 years, Dr. Volpi and colleagues carried out a phase 1, double-blind, placebo-controlled, randomized clinical trial to determine if chronic essential amino acid supplementation, aerobic exercise training, or a combination of the two interventions could improve muscle mass and function by stimulating muscle protein synthesis over the course of 24 weeks (J Gerontol A Biol Sci Med Sci. 2019;74[10]:1598-604). “We found that exercise supervised three times per week on a treadmill for 6 months improved physical function in both groups randomized to exercise,” Dr. Volpi said. “Disappointingly, there was no change in total lean mass with any of the interventions. There was a decrease in fat mass with exercise alone, and no change with exercise and amino acids. [Of note is that] the individuals who were randomized to the amino acids plus exercise group had a significant increase in leg strength, whereas the others did not.”

Preliminary findings from ongoing work by Dr. Volpi and colleagues suggest that, in diabetes, muscle protein synthesis and blood flow really “are not different in response to insulin in healthy older adults and diabetic older adults because they don’t change at all. However, we did find alterations in amino acid trafficking in diabetes. We found that older individuals with type 2 diabetes had a reduction of amino acid transport and a higher intracellular amino acid concentration, compared with age-matched, healthier individuals. The intracellular amino acid clearance improved in the healthy, nondiabetic older adults with hyperinsulinemia, whereas it did not change in diabetic older adults. As a result, the net muscle protein balance improved a little in the nondiabetic patients, but did not change in the diabetic patients.”

The researchers are evaluating older patients with type 2 diabetes to see whether there are alterations in vascular reactivity and protein synthesis and whether those can be overcome by resistance-exercise training. “Preliminary results show that flow-mediated dilation can actually increase in an older diabetic patient with resistance exercise training three times a week for 3 months,” she said. “Exercise can improve both endothelial dysfunction and sarcopenia and therefore improve physical function and reduce cardiovascular risk.”

Dr. Volpi reported having no relevant disclosures.

dbrunk@mdedge.com

LOS ANGELES – Mounting evidence suggests that decreasing muscle mass with aging is associated with increased cardiometabolic risk.

Doug Brunk/MDedge News

“Loss of lean body mass and function with aging decreases the amount of metabolically active tissue, which can lead to insulin resistance,” Elena Volpi, MD, said at the World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease. “Insulin resistance reduces muscle protein anabolism and accelerates sarcopenia, perpetuating a vicious cycle.”

Sarcopenia, the involuntary loss of muscle mass and function that occurs with aging, is an ICD-10 codable condition that can be diagnosed by measuring muscle strength and quality, said Dr. Volpi, director of the Sealy Center on Aging at the University of Texas Medical Branch at Galveston. In the Health, Aging and Body Composition Study (Health ABC), researchers followed 2,292 relatively healthy adults aged 70-79 years for an average of 4.9 years (J Gerontol A Biol Sci Med. 2006;61[1]:72-7). The researchers used isokinetic dynamometry to measure knee extension strength, isometric dynamometry to measure grip strength, CT scan to measure thigh muscle area, and dual X-ray absorptiometry to determine leg and arm lean soft-tissue mass. “Those individuals who started with the highest levels of muscle strength had the greatest survival, while those who had the lowest levels of muscle strength died earlier,” said Dr. Volpi, who was not affiliated with the study. “That was true for both men and women.”

More recently, researchers conducted a pooled analysis of nine cohort studies involving 34,485 community-dwelling older individuals who were tested with gait speed and followed for 6-21 years (JAMA. 2011;305[1]:50-8). They found that a higher gait speed was associated with higher survival at 5 and 10 years (P less than .001). “Muscle mass also appears to be associated in part with mortality and survival, although the association is not as strong as measures of strength and gait speed,” Dr. Volpi said.

Data from the 2009 Korea National Health and Nutrition Examination Survey of 1,537 participants, aged 65 years and older, found that sarcopenia is independently associated with cardiovascular disease (PLoS One. 2013 Mar 22. doi: 10.1371/journal.pone.0060119). Most of the risk factors for cardiovascular disease – such as age, waist circumference, body mass index, fasting plasma glucose, and total cholesterol – showed significant negative correlations with the ratio between appendicular skeletal muscle mass and body weight. Multiple logistic regression analysis demonstrated that sarcopenia was associated with cardiovascular disease, independent of other well-documented risk factors, renal function, and medications (odds ratio, 1.77; P = .025).

In addition, data from the British Regional Heart Study, which followed 4,252 older men for a mean of 11.3 years, found an association of sarcopenia and adiposity with cardiovascular mortality and all-cause mortality (J Am Geriatr Soc. 2014;62[2]:253-60). Specifically, all-cause mortality risk was significantly greater in men in the sarcopenic and obese groups (HRs, 1.41 and 1.21, respectively), compared with those in the optimal reference group, with the highest risk in sarcopenic obese individuals (HR, 1.72) after adjustment for lifestyle characteristics.

“Diabetes also accelerates loss of lean body mass in older adults,” added Dr. Volpi. “Data from the Health ABC study showed that individuals who did not have diabetes at the beginning of the 6-year observation period ... lost the least amount of muscle, compared with those who had undiagnosed or already diagnosed diabetes.”

The precise way in which sarcopenia is linked to metabolic disease remains elusive, she continued, but current evidence suggests that sarcopenia is characterized by a reduction in the protein synthetic response to metabolic stimulation by amino acids, exercise, and insulin in skeletal muscle. “This reduction in the anabolic response to protein synthesis is called anabolic resistance of aging, and it is mediated by reduced acute activation of mTORC1 [mTOR complex 1] signaling,” Dr. Volpi said. “There’s another step upstream of the mTORC1, in which the amino acids and insulin have to cross the blood-muscle barrier. Amino acids need to be transported into the muscle actively, like glucose. That is an important unexplored area that may contribute to sarcopenia.”

Dr. Volpi went on to note that endothelial dysfunction underlies muscle anabolic resistance and cardiovascular risk and is likely to be a fundamental cause of both problems. Recent studies have shown that increased levels of physical activity improve endothelial function, enhance insulin sensitivity and anabolic sensitivity to nutrients, and reduce cardiovascular risk.

For example, in a cohort of 45 nonfrail older adults with a mean age of 72 years, Dr. Volpi and colleagues carried out a phase 1, double-blind, placebo-controlled, randomized clinical trial to determine if chronic essential amino acid supplementation, aerobic exercise training, or a combination of the two interventions could improve muscle mass and function by stimulating muscle protein synthesis over the course of 24 weeks (J Gerontol A Biol Sci Med Sci. 2019;74[10]:1598-604). “We found that exercise supervised three times per week on a treadmill for 6 months improved physical function in both groups randomized to exercise,” Dr. Volpi said. “Disappointingly, there was no change in total lean mass with any of the interventions. There was a decrease in fat mass with exercise alone, and no change with exercise and amino acids. [Of note is that] the individuals who were randomized to the amino acids plus exercise group had a significant increase in leg strength, whereas the others did not.”

Preliminary findings from ongoing work by Dr. Volpi and colleagues suggest that, in diabetes, muscle protein synthesis and blood flow really “are not different in response to insulin in healthy older adults and diabetic older adults because they don’t change at all. However, we did find alterations in amino acid trafficking in diabetes. We found that older individuals with type 2 diabetes had a reduction of amino acid transport and a higher intracellular amino acid concentration, compared with age-matched, healthier individuals. The intracellular amino acid clearance improved in the healthy, nondiabetic older adults with hyperinsulinemia, whereas it did not change in diabetic older adults. As a result, the net muscle protein balance improved a little in the nondiabetic patients, but did not change in the diabetic patients.”

The researchers are evaluating older patients with type 2 diabetes to see whether there are alterations in vascular reactivity and protein synthesis and whether those can be overcome by resistance-exercise training. “Preliminary results show that flow-mediated dilation can actually increase in an older diabetic patient with resistance exercise training three times a week for 3 months,” she said. “Exercise can improve both endothelial dysfunction and sarcopenia and therefore improve physical function and reduce cardiovascular risk.”

Dr. Volpi reported having no relevant disclosures.

dbrunk@mdedge.com

LOS ANGELES – Mounting evidence suggests that decreasing muscle mass with aging is associated with increased cardiometabolic risk.

Doug Brunk/MDedge News

“Loss of lean body mass and function with aging decreases the amount of metabolically active tissue, which can lead to insulin resistance,” Elena Volpi, MD, said at the World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease. “Insulin resistance reduces muscle protein anabolism and accelerates sarcopenia, perpetuating a vicious cycle.”

Sarcopenia, the involuntary loss of muscle mass and function that occurs with aging, is an ICD-10 codable condition that can be diagnosed by measuring muscle strength and quality, said Dr. Volpi, director of the Sealy Center on Aging at the University of Texas Medical Branch at Galveston. In the Health, Aging and Body Composition Study (Health ABC), researchers followed 2,292 relatively healthy adults aged 70-79 years for an average of 4.9 years (J Gerontol A Biol Sci Med. 2006;61[1]:72-7). The researchers used isokinetic dynamometry to measure knee extension strength, isometric dynamometry to measure grip strength, CT scan to measure thigh muscle area, and dual X-ray absorptiometry to determine leg and arm lean soft-tissue mass. “Those individuals who started with the highest levels of muscle strength had the greatest survival, while those who had the lowest levels of muscle strength died earlier,” said Dr. Volpi, who was not affiliated with the study. “That was true for both men and women.”

More recently, researchers conducted a pooled analysis of nine cohort studies involving 34,485 community-dwelling older individuals who were tested with gait speed and followed for 6-21 years (JAMA. 2011;305[1]:50-8). They found that a higher gait speed was associated with higher survival at 5 and 10 years (P less than .001). “Muscle mass also appears to be associated in part with mortality and survival, although the association is not as strong as measures of strength and gait speed,” Dr. Volpi said.

Data from the 2009 Korea National Health and Nutrition Examination Survey of 1,537 participants, aged 65 years and older, found that sarcopenia is independently associated with cardiovascular disease (PLoS One. 2013 Mar 22. doi: 10.1371/journal.pone.0060119). Most of the risk factors for cardiovascular disease – such as age, waist circumference, body mass index, fasting plasma glucose, and total cholesterol – showed significant negative correlations with the ratio between appendicular skeletal muscle mass and body weight. Multiple logistic regression analysis demonstrated that sarcopenia was associated with cardiovascular disease, independent of other well-documented risk factors, renal function, and medications (odds ratio, 1.77; P = .025).

In addition, data from the British Regional Heart Study, which followed 4,252 older men for a mean of 11.3 years, found an association of sarcopenia and adiposity with cardiovascular mortality and all-cause mortality (J Am Geriatr Soc. 2014;62[2]:253-60). Specifically, all-cause mortality risk was significantly greater in men in the sarcopenic and obese groups (HRs, 1.41 and 1.21, respectively), compared with those in the optimal reference group, with the highest risk in sarcopenic obese individuals (HR, 1.72) after adjustment for lifestyle characteristics.

“Diabetes also accelerates loss of lean body mass in older adults,” added Dr. Volpi. “Data from the Health ABC study showed that individuals who did not have diabetes at the beginning of the 6-year observation period ... lost the least amount of muscle, compared with those who had undiagnosed or already diagnosed diabetes.”

The precise way in which sarcopenia is linked to metabolic disease remains elusive, she continued, but current evidence suggests that sarcopenia is characterized by a reduction in the protein synthetic response to metabolic stimulation by amino acids, exercise, and insulin in skeletal muscle. “This reduction in the anabolic response to protein synthesis is called anabolic resistance of aging, and it is mediated by reduced acute activation of mTORC1 [mTOR complex 1] signaling,” Dr. Volpi said. “There’s another step upstream of the mTORC1, in which the amino acids and insulin have to cross the blood-muscle barrier. Amino acids need to be transported into the muscle actively, like glucose. That is an important unexplored area that may contribute to sarcopenia.”

Dr. Volpi went on to note that endothelial dysfunction underlies muscle anabolic resistance and cardiovascular risk and is likely to be a fundamental cause of both problems. Recent studies have shown that increased levels of physical activity improve endothelial function, enhance insulin sensitivity and anabolic sensitivity to nutrients, and reduce cardiovascular risk.

For example, in a cohort of 45 nonfrail older adults with a mean age of 72 years, Dr. Volpi and colleagues carried out a phase 1, double-blind, placebo-controlled, randomized clinical trial to determine if chronic essential amino acid supplementation, aerobic exercise training, or a combination of the two interventions could improve muscle mass and function by stimulating muscle protein synthesis over the course of 24 weeks (J Gerontol A Biol Sci Med Sci. 2019;74[10]:1598-604). “We found that exercise supervised three times per week on a treadmill for 6 months improved physical function in both groups randomized to exercise,” Dr. Volpi said. “Disappointingly, there was no change in total lean mass with any of the interventions. There was a decrease in fat mass with exercise alone, and no change with exercise and amino acids. [Of note is that] the individuals who were randomized to the amino acids plus exercise group had a significant increase in leg strength, whereas the others did not.”

Preliminary findings from ongoing work by Dr. Volpi and colleagues suggest that, in diabetes, muscle protein synthesis and blood flow really “are not different in response to insulin in healthy older adults and diabetic older adults because they don’t change at all. However, we did find alterations in amino acid trafficking in diabetes. We found that older individuals with type 2 diabetes had a reduction of amino acid transport and a higher intracellular amino acid concentration, compared with age-matched, healthier individuals. The intracellular amino acid clearance improved in the healthy, nondiabetic older adults with hyperinsulinemia, whereas it did not change in diabetic older adults. As a result, the net muscle protein balance improved a little in the nondiabetic patients, but did not change in the diabetic patients.”

The researchers are evaluating older patients with type 2 diabetes to see whether there are alterations in vascular reactivity and protein synthesis and whether those can be overcome by resistance-exercise training. “Preliminary results show that flow-mediated dilation can actually increase in an older diabetic patient with resistance exercise training three times a week for 3 months,” she said. “Exercise can improve both endothelial dysfunction and sarcopenia and therefore improve physical function and reduce cardiovascular risk.”

Dr. Volpi reported having no relevant disclosures.

dbrunk@mdedge.com