Deepak Chitnis

The Food and Drug Administration has approved a topical formulation of ivermectin for the once-daily topical treatment of inflammatory lesions related to rosacea. The drug will be marketed as Soolantra by Galderma Laboratories.

Ivermectin 1% cream was found to be safe and effective for patients in with moderate to severe papulopustular rosacea in two identical phase III, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group studies led by Dr. Linda Stein Gold, director of dermatology clinical research and a division head of dermatology at the Henry Ford Hospital in Detroit.

In both studies, a total of 910 patients were randomized 2:1 to receive ivermectin 1% cream or a control cream once daily. The two coprimary endpoints were the percentage of patients who achieved a “clear” or “almost clear” score on the Investigator’s Global Assessment (IGA) scale at week 12, and the change in inflammatory lesion counts from baseline to week 12. The secondary efficacy endpoint assessment was the percentage change in inflammatory lesion count from baseline to week 12. The researchers also assessed safety endpoints by examining adverse events.

The mean age of patients was 50 years, 96% were white, and 67% were women. Patients had about 30 lesions each; 76%-82% were classified as having moderate rosacea based on IGA score, and the rest had severe disease. More than 90% of patients in each arm completed the study through week 12.

At week 12 in both studies, a significantly higher percentage of patients in the treatment group achieved treatment success, compared with those in the control group (38%-40% vs. 12%-19%, respectively; P less than .001). That difference was seen as early as week 4. Fewer treatment-related adverse events were reported in the ivermectin group, compared with the control group (3.4% vs. 7.2%, respectively)

In a separate head-to-head study comparing ivermectin 1% cream with metronidazole 0.75% topical cream, investigators also found that the former was more effective at treating rosacea.

“Rosacea is a common and challenging condition to manage as it tends to vary from patient to patient, often requiring a tailored approach. For that reason, we are always looking for innovative new treatments,” Dr. Stein Gold said in a statement. “While some rosacea treatments for the common bumps and pimples of the condition may take more than 4 weeks to show effect, Soolantra Cream may provide initial results as early as week 2.”

Dr. Stein Gold is a consultant for Galderma.

[email protected]

Doug Brunk contributed to this report.

The Food and Drug Administration has approved a topical formulation of ivermectin for the once-daily topical treatment of inflammatory lesions related to rosacea. The drug will be marketed as Soolantra by Galderma Laboratories.

Ivermectin 1% cream was found to be safe and effective for patients in with moderate to severe papulopustular rosacea in two identical phase III, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group studies led by Dr. Linda Stein Gold, director of dermatology clinical research and a division head of dermatology at the Henry Ford Hospital in Detroit.

In both studies, a total of 910 patients were randomized 2:1 to receive ivermectin 1% cream or a control cream once daily. The two coprimary endpoints were the percentage of patients who achieved a “clear” or “almost clear” score on the Investigator’s Global Assessment (IGA) scale at week 12, and the change in inflammatory lesion counts from baseline to week 12. The secondary efficacy endpoint assessment was the percentage change in inflammatory lesion count from baseline to week 12. The researchers also assessed safety endpoints by examining adverse events.

The mean age of patients was 50 years, 96% were white, and 67% were women. Patients had about 30 lesions each; 76%-82% were classified as having moderate rosacea based on IGA score, and the rest had severe disease. More than 90% of patients in each arm completed the study through week 12.

At week 12 in both studies, a significantly higher percentage of patients in the treatment group achieved treatment success, compared with those in the control group (38%-40% vs. 12%-19%, respectively; P less than .001). That difference was seen as early as week 4. Fewer treatment-related adverse events were reported in the ivermectin group, compared with the control group (3.4% vs. 7.2%, respectively)

In a separate head-to-head study comparing ivermectin 1% cream with metronidazole 0.75% topical cream, investigators also found that the former was more effective at treating rosacea.

“Rosacea is a common and challenging condition to manage as it tends to vary from patient to patient, often requiring a tailored approach. For that reason, we are always looking for innovative new treatments,” Dr. Stein Gold said in a statement. “While some rosacea treatments for the common bumps and pimples of the condition may take more than 4 weeks to show effect, Soolantra Cream may provide initial results as early as week 2.”

Dr. Stein Gold is a consultant for Galderma.

[email protected]

Doug Brunk contributed to this report.

The Food and Drug Administration has approved a topical formulation of ivermectin for the once-daily topical treatment of inflammatory lesions related to rosacea. The drug will be marketed as Soolantra by Galderma Laboratories.

Ivermectin 1% cream was found to be safe and effective for patients in with moderate to severe papulopustular rosacea in two identical phase III, multicenter, randomized, double-blind, 12-week, vehicle-controlled, parallel-group studies led by Dr. Linda Stein Gold, director of dermatology clinical research and a division head of dermatology at the Henry Ford Hospital in Detroit.

In both studies, a total of 910 patients were randomized 2:1 to receive ivermectin 1% cream or a control cream once daily. The two coprimary endpoints were the percentage of patients who achieved a “clear” or “almost clear” score on the Investigator’s Global Assessment (IGA) scale at week 12, and the change in inflammatory lesion counts from baseline to week 12. The secondary efficacy endpoint assessment was the percentage change in inflammatory lesion count from baseline to week 12. The researchers also assessed safety endpoints by examining adverse events.

The mean age of patients was 50 years, 96% were white, and 67% were women. Patients had about 30 lesions each; 76%-82% were classified as having moderate rosacea based on IGA score, and the rest had severe disease. More than 90% of patients in each arm completed the study through week 12.

At week 12 in both studies, a significantly higher percentage of patients in the treatment group achieved treatment success, compared with those in the control group (38%-40% vs. 12%-19%, respectively; P less than .001). That difference was seen as early as week 4. Fewer treatment-related adverse events were reported in the ivermectin group, compared with the control group (3.4% vs. 7.2%, respectively)

In a separate head-to-head study comparing ivermectin 1% cream with metronidazole 0.75% topical cream, investigators also found that the former was more effective at treating rosacea.

“Rosacea is a common and challenging condition to manage as it tends to vary from patient to patient, often requiring a tailored approach. For that reason, we are always looking for innovative new treatments,” Dr. Stein Gold said in a statement. “While some rosacea treatments for the common bumps and pimples of the condition may take more than 4 weeks to show effect, Soolantra Cream may provide initial results as early as week 2.”

Dr. Stein Gold is a consultant for Galderma.

[email protected]

Doug Brunk contributed to this report.

The American Diabetes Association has issued a new recommendation stating that all Asian American adults who present with a body mass index of at least 23 kg/m² should be tested for type 2 diabetes.

In its latest position statement, the ADA cites increasing evidence that body mass index (BMI) is more indicative than just body weight for determining a patient’s likelihood of developing type 2 diabetes, along with data on the higher predisposition for diabetes among Asian Americans, as the main reasons for lowering the cut point from 25 kg/m², which is the established BMI at which all adults should be tested for diabetes (Diabetes Care 2015;38:1-9 [doi:10.2337/dc14-2391]).

“Given that established BMI cut points indicating elevated diabetes risk are inappropriate for Asian Americans, establishing a specific BMI cut point to identify Asian Americans with or at risk for future diabetes would be beneficial to the potential health of millions of Asian American individuals,” the ADA said in the statement.

© Tashatuvango/Thinkstockphotos.com

According to the ADA, Asian Americans – who currently make up the fastest-growing ethnic group in the United States – are prone to developing diabetes at a lower BMI because, instead of gathering in the thighs, their weight gains tend to accumulate around the waist, an area that is known for being the most harmful from the standpoint of adiposity and disease. The ADA also highlights lifestyle and dietary habits inherent to Asian cultures as reasons for why Asian Americans are more predisposed to the disease.

“Clinicians have known this intuitively for quite some time,” said Dr. William C. Hsu, lead author of the position statement. “They can see that Asian Americans are being diagnosed with diabetes when they do not appear to be overweight or obese according to general standards. But if you use the previous association standard for diabetes screening of being age 45 or older with a BMI of 25 kg/m² or above, you will miss many Asian Americans who are at risk,” said Dr. Hsu of Harvard Medical School in Boston, who is vice president of international programs at Joslin Diabetes Center.

According to the ADA, most studies tend to group Asian Americans along with Native Hawaiian and Pacific Islander demographics, although the groups differ significantly in terms of physiology and body composition. By focusing more on Asian American populations specifically, the ADA aims to have more reliable data that can lead to earlier and more accurate diagnosis of type 2 diabetes within the demographic.

“This paper is a significant step in the right direction of widely recognizing the diabetes disparity that exists in our populations and communities,” said Dr. Ho Luong Tran, president of the National Council of Asian Pacific Islander Physicians and lead coordinator of the Asian American Native Hawaiian and Pacific Islanders Diabetes Coalition. “The next steps are to increase the amount of clinical research and data on this diverse population, while simultaneously pushing for policy change that will positively impact health outcomes.”

[email protected]

The American Diabetes Association has issued a new recommendation stating that all Asian American adults who present with a body mass index of at least 23 kg/m² should be tested for type 2 diabetes.

In its latest position statement, the ADA cites increasing evidence that body mass index (BMI) is more indicative than just body weight for determining a patient’s likelihood of developing type 2 diabetes, along with data on the higher predisposition for diabetes among Asian Americans, as the main reasons for lowering the cut point from 25 kg/m², which is the established BMI at which all adults should be tested for diabetes (Diabetes Care 2015;38:1-9 [doi:10.2337/dc14-2391]).

“Given that established BMI cut points indicating elevated diabetes risk are inappropriate for Asian Americans, establishing a specific BMI cut point to identify Asian Americans with or at risk for future diabetes would be beneficial to the potential health of millions of Asian American individuals,” the ADA said in the statement.

© Tashatuvango/Thinkstockphotos.com

According to the ADA, Asian Americans – who currently make up the fastest-growing ethnic group in the United States – are prone to developing diabetes at a lower BMI because, instead of gathering in the thighs, their weight gains tend to accumulate around the waist, an area that is known for being the most harmful from the standpoint of adiposity and disease. The ADA also highlights lifestyle and dietary habits inherent to Asian cultures as reasons for why Asian Americans are more predisposed to the disease.

“Clinicians have known this intuitively for quite some time,” said Dr. William C. Hsu, lead author of the position statement. “They can see that Asian Americans are being diagnosed with diabetes when they do not appear to be overweight or obese according to general standards. But if you use the previous association standard for diabetes screening of being age 45 or older with a BMI of 25 kg/m² or above, you will miss many Asian Americans who are at risk,” said Dr. Hsu of Harvard Medical School in Boston, who is vice president of international programs at Joslin Diabetes Center.

According to the ADA, most studies tend to group Asian Americans along with Native Hawaiian and Pacific Islander demographics, although the groups differ significantly in terms of physiology and body composition. By focusing more on Asian American populations specifically, the ADA aims to have more reliable data that can lead to earlier and more accurate diagnosis of type 2 diabetes within the demographic.

“This paper is a significant step in the right direction of widely recognizing the diabetes disparity that exists in our populations and communities,” said Dr. Ho Luong Tran, president of the National Council of Asian Pacific Islander Physicians and lead coordinator of the Asian American Native Hawaiian and Pacific Islanders Diabetes Coalition. “The next steps are to increase the amount of clinical research and data on this diverse population, while simultaneously pushing for policy change that will positively impact health outcomes.”

[email protected]

The American Diabetes Association has issued a new recommendation stating that all Asian American adults who present with a body mass index of at least 23 kg/m² should be tested for type 2 diabetes.

In its latest position statement, the ADA cites increasing evidence that body mass index (BMI) is more indicative than just body weight for determining a patient’s likelihood of developing type 2 diabetes, along with data on the higher predisposition for diabetes among Asian Americans, as the main reasons for lowering the cut point from 25 kg/m², which is the established BMI at which all adults should be tested for diabetes (Diabetes Care 2015;38:1-9 [doi:10.2337/dc14-2391]).

“Given that established BMI cut points indicating elevated diabetes risk are inappropriate for Asian Americans, establishing a specific BMI cut point to identify Asian Americans with or at risk for future diabetes would be beneficial to the potential health of millions of Asian American individuals,” the ADA said in the statement.

© Tashatuvango/Thinkstockphotos.com

According to the ADA, Asian Americans – who currently make up the fastest-growing ethnic group in the United States – are prone to developing diabetes at a lower BMI because, instead of gathering in the thighs, their weight gains tend to accumulate around the waist, an area that is known for being the most harmful from the standpoint of adiposity and disease. The ADA also highlights lifestyle and dietary habits inherent to Asian cultures as reasons for why Asian Americans are more predisposed to the disease.

“Clinicians have known this intuitively for quite some time,” said Dr. William C. Hsu, lead author of the position statement. “They can see that Asian Americans are being diagnosed with diabetes when they do not appear to be overweight or obese according to general standards. But if you use the previous association standard for diabetes screening of being age 45 or older with a BMI of 25 kg/m² or above, you will miss many Asian Americans who are at risk,” said Dr. Hsu of Harvard Medical School in Boston, who is vice president of international programs at Joslin Diabetes Center.

According to the ADA, most studies tend to group Asian Americans along with Native Hawaiian and Pacific Islander demographics, although the groups differ significantly in terms of physiology and body composition. By focusing more on Asian American populations specifically, the ADA aims to have more reliable data that can lead to earlier and more accurate diagnosis of type 2 diabetes within the demographic.

“This paper is a significant step in the right direction of widely recognizing the diabetes disparity that exists in our populations and communities,” said Dr. Ho Luong Tran, president of the National Council of Asian Pacific Islander Physicians and lead coordinator of the Asian American Native Hawaiian and Pacific Islanders Diabetes Coalition. “The next steps are to increase the amount of clinical research and data on this diverse population, while simultaneously pushing for policy change that will positively impact health outcomes.”

[email protected]

The Food and Drug Administration has approved the 40-mcg dose of QNASL for use in the treatment of nasal symptoms associated with allergic rhinitis in children aged 4-11 years, making it the first waterless nasal allergy spray approved for use in children as young as 4 years old.

“Through the availability of QNASL [beclomethasone dipropionate] 40 mcg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies,” said Dr. Tushar Shah, senior vice president of Teva Global Respiratory Research and Development.

The FDA approved beclomethasone dipropionate 40 mcg based on data from three double-blind, placebo-controlled studies of children aged 4-11 years. In those studies, once-daily beclomethasone dipropionate 40 mcg alleviated allergy symptoms in children with both seasonal and perennial allergic rhinitis with a minimum of adverse effects. The most common side effects were nosebleed and ulcers, which was “consistent with those seen in previous clinical studies of QNASL Nasal Aerosol,” according to a statement from the manufacturer.

QNASL40 mcg is expected to become available in February 2015.

The Food and Drug Administration has approved the 40-mcg dose of QNASL for use in the treatment of nasal symptoms associated with allergic rhinitis in children aged 4-11 years, making it the first waterless nasal allergy spray approved for use in children as young as 4 years old.

“Through the availability of QNASL [beclomethasone dipropionate] 40 mcg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies,” said Dr. Tushar Shah, senior vice president of Teva Global Respiratory Research and Development.

The FDA approved beclomethasone dipropionate 40 mcg based on data from three double-blind, placebo-controlled studies of children aged 4-11 years. In those studies, once-daily beclomethasone dipropionate 40 mcg alleviated allergy symptoms in children with both seasonal and perennial allergic rhinitis with a minimum of adverse effects. The most common side effects were nosebleed and ulcers, which was “consistent with those seen in previous clinical studies of QNASL Nasal Aerosol,” according to a statement from the manufacturer.

QNASL40 mcg is expected to become available in February 2015.

The Food and Drug Administration has approved the 40-mcg dose of QNASL for use in the treatment of nasal symptoms associated with allergic rhinitis in children aged 4-11 years, making it the first waterless nasal allergy spray approved for use in children as young as 4 years old.

“Through the availability of QNASL [beclomethasone dipropionate] 40 mcg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies,” said Dr. Tushar Shah, senior vice president of Teva Global Respiratory Research and Development.

The FDA approved beclomethasone dipropionate 40 mcg based on data from three double-blind, placebo-controlled studies of children aged 4-11 years. In those studies, once-daily beclomethasone dipropionate 40 mcg alleviated allergy symptoms in children with both seasonal and perennial allergic rhinitis with a minimum of adverse effects. The most common side effects were nosebleed and ulcers, which was “consistent with those seen in previous clinical studies of QNASL Nasal Aerosol,” according to a statement from the manufacturer.

QNASL40 mcg is expected to become available in February 2015.

The Food and Drug Administration has approved the 40-mcg dose of QNASL for use in the treatment of nasal symptoms associated with allergic rhinitis in children aged 4-11 years, making it the first waterless nasal allergy spray approved for use in children as young as 4 years old.

“Through the availability of QNASL [beclomethasone dipropionate] 40 mcg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies,” said Dr. Tushar Shah, senior vice president of Teva Global Respiratory Research and Development.

The FDA approved beclomethasone dipropionate 40 mcg based on data from three double-blind, placebo-controlled studies of children aged 4-11 years. In those studies, once-daily beclomethasone dipropionate 40 mcg alleviated allergy symptoms in children with both seasonal and perennial allergic rhinitis with a minimum of adverse effects. The most common side effects were nosebleed and ulcers, which was “consistent with those seen in previous clinical studies of QNASL Nasal Aerosol,” according to a statement from the manufacturer.

QNASL40 mcg is expected to become available in February 2015.

[email protected]

The Food and Drug Administration has approved the 40-mcg dose of QNASL for use in the treatment of nasal symptoms associated with allergic rhinitis in children aged 4-11 years, making it the first waterless nasal allergy spray approved for use in children as young as 4 years old.

“Through the availability of QNASL [beclomethasone dipropionate] 40 mcg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies,” said Dr. Tushar Shah, senior vice president of Teva Global Respiratory Research and Development.

The FDA approved beclomethasone dipropionate 40 mcg based on data from three double-blind, placebo-controlled studies of children aged 4-11 years. In those studies, once-daily beclomethasone dipropionate 40 mcg alleviated allergy symptoms in children with both seasonal and perennial allergic rhinitis with a minimum of adverse effects. The most common side effects were nosebleed and ulcers, which was “consistent with those seen in previous clinical studies of QNASL Nasal Aerosol,” according to a statement from the manufacturer.

QNASL40 mcg is expected to become available in February 2015.

[email protected]

The Food and Drug Administration has approved the 40-mcg dose of QNASL for use in the treatment of nasal symptoms associated with allergic rhinitis in children aged 4-11 years, making it the first waterless nasal allergy spray approved for use in children as young as 4 years old.

“Through the availability of QNASL [beclomethasone dipropionate] 40 mcg, we are aiming to aid children and their caregivers in better managing the burdensome symptoms associated with nasal allergies,” said Dr. Tushar Shah, senior vice president of Teva Global Respiratory Research and Development.

The FDA approved beclomethasone dipropionate 40 mcg based on data from three double-blind, placebo-controlled studies of children aged 4-11 years. In those studies, once-daily beclomethasone dipropionate 40 mcg alleviated allergy symptoms in children with both seasonal and perennial allergic rhinitis with a minimum of adverse effects. The most common side effects were nosebleed and ulcers, which was “consistent with those seen in previous clinical studies of QNASL Nasal Aerosol,” according to a statement from the manufacturer.

QNASL40 mcg is expected to become available in February 2015.

[email protected]

By mapping the testing and care of patients with the hepatitis C virus on a continuum, health care providers can get a better picture of the stages at which the disease is being managed effectively and where along the spectrum there may be room for greater improvement, according to a study published in Hepatology.

“This continuum provides a ‘real-life’ snapshot of how this disease is being managed in a major U.S. urban center,” according to the investigators, led by Kendra Viner, Ph.D., of the Philadelphia Department of Public Health (PDPH). “Many patients are lost at each stage, highlighting the need to raise awareness among health care professionals and at-risk populations about appropriate hepatitis testing, referral, support, and care.”

In a retrospective, population-based study, Dr. Viner and her coinvestigators – all of whom are also with PDPH – examined reports of hepatitis filed in the city between January 2010 and December 2013. During this time, 70% of hepatitis reports were from electronic laboratory reporting (ELR), 25% were from fax or phone reports, and the remaining 5% came from “active case findings.” Investigators also used enhanced surveillance data to find hepatitis cases reported during the study period (Hepatology 2014 ([doi:10.1002/hep.27584]).

Using population estimates from the 2010 United States Census, the American Community Survey (ACS), and the National Health and Nutrition Examination Survey (NHANES), the authors were also able to estimate hepatitis C (HCV) seroprevalence in certain demographics. The HCV care continuum (HCV-CoC) was defined as follows: stage 1: HCV Ab screening; stage 2: HCV Ab and RNA testing; stage 3: RNA-confirmation and continuing care; stage 4: RNA-confirmation, care, and HCV treatment.

Based on their estimates, Dr. Viner and her associates postulated that of approximately 1,584,848 Philadelphia residents, 47,207 (2.9%) would have HCV, with test results anticipated for 28,990 (61%) of those individuals. Positive HCV results were received for 13,596 individuals, of whom 6,383 (47%) had a positive HCV RNA test. Of these, 1,745 (27%) were in care, and 956 (15%) had received or were currently receiving treatment.

“These findings elucidate how few HCV-infected residents are successfully mobilized from screening through confirmatory testing and into care and treatment,” wrote Dr. Viner and her coauthors. “Understanding and addressing the specific reasons why patients are lost at each stage is critical if public health and clinical care practitioners hope to affect the outcomes of chronic HCV infection.”

Continue for more >>

In each category of testing and treatment, men presented nearly twice as often as women: 61% vs. 39%, Ab only; 64% vs. 36%, Ab plus RNA; 64% vs. 36%, Ab plus RNA with no antiviral treatment; and 71% vs. 29%, Ab plus RNA with antiviral treatment, respectively (P < .001). Patients aged 45-64 years presented the most often for both genders (P < .001), and blacks and whites were most common in the study population (P < .001).

The investigators noted that their findings were consistent with national estimates, which say that fewer than half of a city’s population would have HCV infections, and that 3%-5% of cases would be underreported, thus possibly explaining some missing cases in their own data.

“To promote movement through the continuum of HCV care, state and local health departments need to devise ways to improve surveillance and enhance screening and linkage and retention in HCV care services,” concluded the authors. “However, none of this can happen effectively without strong federal support and greater efforts to promote an implementation science agenda that pulls on surveillance data to execute the CDC’s recommendation for routine baby boomer and risk-based screening, and enhance the HCV care continuum,” they added.

The authors reported no financial conflicts of interest.

By mapping the testing and care of patients with the hepatitis C virus on a continuum, health care providers can get a better picture of the stages at which the disease is being managed effectively and where along the spectrum there may be room for greater improvement, according to a study published in Hepatology.

“This continuum provides a ‘real-life’ snapshot of how this disease is being managed in a major U.S. urban center,” according to the investigators, led by Kendra Viner, Ph.D., of the Philadelphia Department of Public Health (PDPH). “Many patients are lost at each stage, highlighting the need to raise awareness among health care professionals and at-risk populations about appropriate hepatitis testing, referral, support, and care.”

In a retrospective, population-based study, Dr. Viner and her coinvestigators – all of whom are also with PDPH – examined reports of hepatitis filed in the city between January 2010 and December 2013. During this time, 70% of hepatitis reports were from electronic laboratory reporting (ELR), 25% were from fax or phone reports, and the remaining 5% came from “active case findings.” Investigators also used enhanced surveillance data to find hepatitis cases reported during the study period (Hepatology 2014 ([doi:10.1002/hep.27584]).

Using population estimates from the 2010 United States Census, the American Community Survey (ACS), and the National Health and Nutrition Examination Survey (NHANES), the authors were also able to estimate hepatitis C (HCV) seroprevalence in certain demographics. The HCV care continuum (HCV-CoC) was defined as follows: stage 1: HCV Ab screening; stage 2: HCV Ab and RNA testing; stage 3: RNA-confirmation and continuing care; stage 4: RNA-confirmation, care, and HCV treatment.

Based on their estimates, Dr. Viner and her associates postulated that of approximately 1,584,848 Philadelphia residents, 47,207 (2.9%) would have HCV, with test results anticipated for 28,990 (61%) of those individuals. Positive HCV results were received for 13,596 individuals, of whom 6,383 (47%) had a positive HCV RNA test. Of these, 1,745 (27%) were in care, and 956 (15%) had received or were currently receiving treatment.

“These findings elucidate how few HCV-infected residents are successfully mobilized from screening through confirmatory testing and into care and treatment,” wrote Dr. Viner and her coauthors. “Understanding and addressing the specific reasons why patients are lost at each stage is critical if public health and clinical care practitioners hope to affect the outcomes of chronic HCV infection.”

Continue for more >>

In each category of testing and treatment, men presented nearly twice as often as women: 61% vs. 39%, Ab only; 64% vs. 36%, Ab plus RNA; 64% vs. 36%, Ab plus RNA with no antiviral treatment; and 71% vs. 29%, Ab plus RNA with antiviral treatment, respectively (P < .001). Patients aged 45-64 years presented the most often for both genders (P < .001), and blacks and whites were most common in the study population (P < .001).

The investigators noted that their findings were consistent with national estimates, which say that fewer than half of a city’s population would have HCV infections, and that 3%-5% of cases would be underreported, thus possibly explaining some missing cases in their own data.

“To promote movement through the continuum of HCV care, state and local health departments need to devise ways to improve surveillance and enhance screening and linkage and retention in HCV care services,” concluded the authors. “However, none of this can happen effectively without strong federal support and greater efforts to promote an implementation science agenda that pulls on surveillance data to execute the CDC’s recommendation for routine baby boomer and risk-based screening, and enhance the HCV care continuum,” they added.

The authors reported no financial conflicts of interest.

By mapping the testing and care of patients with the hepatitis C virus on a continuum, health care providers can get a better picture of the stages at which the disease is being managed effectively and where along the spectrum there may be room for greater improvement, according to a study published in Hepatology.

“This continuum provides a ‘real-life’ snapshot of how this disease is being managed in a major U.S. urban center,” according to the investigators, led by Kendra Viner, Ph.D., of the Philadelphia Department of Public Health (PDPH). “Many patients are lost at each stage, highlighting the need to raise awareness among health care professionals and at-risk populations about appropriate hepatitis testing, referral, support, and care.”

In a retrospective, population-based study, Dr. Viner and her coinvestigators – all of whom are also with PDPH – examined reports of hepatitis filed in the city between January 2010 and December 2013. During this time, 70% of hepatitis reports were from electronic laboratory reporting (ELR), 25% were from fax or phone reports, and the remaining 5% came from “active case findings.” Investigators also used enhanced surveillance data to find hepatitis cases reported during the study period (Hepatology 2014 ([doi:10.1002/hep.27584]).

Using population estimates from the 2010 United States Census, the American Community Survey (ACS), and the National Health and Nutrition Examination Survey (NHANES), the authors were also able to estimate hepatitis C (HCV) seroprevalence in certain demographics. The HCV care continuum (HCV-CoC) was defined as follows: stage 1: HCV Ab screening; stage 2: HCV Ab and RNA testing; stage 3: RNA-confirmation and continuing care; stage 4: RNA-confirmation, care, and HCV treatment.

Based on their estimates, Dr. Viner and her associates postulated that of approximately 1,584,848 Philadelphia residents, 47,207 (2.9%) would have HCV, with test results anticipated for 28,990 (61%) of those individuals. Positive HCV results were received for 13,596 individuals, of whom 6,383 (47%) had a positive HCV RNA test. Of these, 1,745 (27%) were in care, and 956 (15%) had received or were currently receiving treatment.

“These findings elucidate how few HCV-infected residents are successfully mobilized from screening through confirmatory testing and into care and treatment,” wrote Dr. Viner and her coauthors. “Understanding and addressing the specific reasons why patients are lost at each stage is critical if public health and clinical care practitioners hope to affect the outcomes of chronic HCV infection.”

Continue for more >>

In each category of testing and treatment, men presented nearly twice as often as women: 61% vs. 39%, Ab only; 64% vs. 36%, Ab plus RNA; 64% vs. 36%, Ab plus RNA with no antiviral treatment; and 71% vs. 29%, Ab plus RNA with antiviral treatment, respectively (P < .001). Patients aged 45-64 years presented the most often for both genders (P < .001), and blacks and whites were most common in the study population (P < .001).

The investigators noted that their findings were consistent with national estimates, which say that fewer than half of a city’s population would have HCV infections, and that 3%-5% of cases would be underreported, thus possibly explaining some missing cases in their own data.

“To promote movement through the continuum of HCV care, state and local health departments need to devise ways to improve surveillance and enhance screening and linkage and retention in HCV care services,” concluded the authors. “However, none of this can happen effectively without strong federal support and greater efforts to promote an implementation science agenda that pulls on surveillance data to execute the CDC’s recommendation for routine baby boomer and risk-based screening, and enhance the HCV care continuum,” they added.

The authors reported no financial conflicts of interest.

By mapping the testing and care of patients with the hepatitis C virus on a continuum, health care providers can get a better picture of the stages at which the disease is being managed effectively and where along the spectrum there may be room for greater improvement, according to a study published in Hepatology.

“This continuum provides a ‘real-life’ snapshot of how this disease is being managed in a major U.S. urban center,” according to the investigators, led by Kendra Viner, Ph.D., of the Philadelphia Department of Public Health (PDPH). “Many patients are lost at each stage, highlighting the need to raise awareness among health care professionals and at-risk populations about appropriate hepatitis testing, referral, support, and care.”

Courtesy NIH

In a retrospective, population-based study, Dr. Viner and her coinvestigators – all of whom are also with PDPH – examined reports of hepatitis filed in the city between January 2010 and December 2013. During this time, 70% of hepatitis reports were from electronic laboratory reporting (ELR), 25% were from fax or phone reports, and the remaining 5% came from “active case findings.” Investigators also used enhanced surveillance data to find hepatitis cases reported during the study period (Hepatology 2014 ([doi:10.1002/hep.27584]).

Using population estimates from the 2010 United States Census, the American Community Survey (ACS), and the National Health and Nutrition Examination Survey (NHANES), the authors were also able to estimate hepatitis C (HCV) seroprevalence in certain demographics. The HCV care continuum (HCV-CoC) was defined as follows: stage 1: HCV Ab screening; stage 2: HCV Ab and RNA testing; stage 3: RNA-confirmation and continuing care; stage 4: RNA-confirmation, care, and HCV treatment.

Based on their estimates, Dr. Viner and her associates postulated that of approximately 1,584,848 Philadelphia residents, 47,207 (2.9%) would have HCV, with test results anticipated for 28,990 (61%) of those individuals. Positive HCV results were received for 13,596 individuals, of whom 6,383 (47%) had a positive HCV RNA test. Of these, 1,745 (27%) were in care, and 956 (15%) had received or were currently receiving treatment.

“These findings elucidate how few HCV-infected residents are successfully mobilized from screening through confirmatory testing and into care and treatment,” wrote Dr. Viner and her coauthors. “Understanding and addressing the specific reasons why patients are lost at each stage is critical if public health and clinical care practitioners hope to affect the outcomes of chronic HCV infection.”

In each category of testing and treatment, men presented nearly twice as often as women: 61% vs. 39%, Ab only; 64% vs. 36%, Ab plus RNA; 64% vs. 36%, Ab plus RNA with no antiviral treatment; and 71% vs. 29%, Ab plus RNA with antiviral treatment, respectively (P < .001). Patients aged 45-64 years presented the most often for both genders (P < .001), and blacks and whites were most common in the study population (P < .001).

The investigators noted that their findings were consistent with national estimates, which say that fewer than half of a city’s population would have HCV infections, and that 3%-5% of cases would be underreported, thus possibly explaining some missing cases in their own data.

“To promote movement through the continuum of HCV care, state and local health departments need to devise ways to improve surveillance and enhance screening and linkage and retention in HCV care services,” concluded the authors. “However, none of this can happen effectively without strong federal support and greater efforts to promote an implementation science agenda that pulls on surveillance data to execute the CDC’s recommendation for routine baby boomer and risk-based screening, and enhance the HCV care continuum,” they added.

The authors reported no financial conflicts of interest.

[email protected]

By mapping the testing and care of patients with the hepatitis C virus on a continuum, health care providers can get a better picture of the stages at which the disease is being managed effectively and where along the spectrum there may be room for greater improvement, according to a study published in Hepatology.

“This continuum provides a ‘real-life’ snapshot of how this disease is being managed in a major U.S. urban center,” according to the investigators, led by Kendra Viner, Ph.D., of the Philadelphia Department of Public Health (PDPH). “Many patients are lost at each stage, highlighting the need to raise awareness among health care professionals and at-risk populations about appropriate hepatitis testing, referral, support, and care.”

Courtesy NIH

In a retrospective, population-based study, Dr. Viner and her coinvestigators – all of whom are also with PDPH – examined reports of hepatitis filed in the city between January 2010 and December 2013. During this time, 70% of hepatitis reports were from electronic laboratory reporting (ELR), 25% were from fax or phone reports, and the remaining 5% came from “active case findings.” Investigators also used enhanced surveillance data to find hepatitis cases reported during the study period (Hepatology 2014 ([doi:10.1002/hep.27584]).

Using population estimates from the 2010 United States Census, the American Community Survey (ACS), and the National Health and Nutrition Examination Survey (NHANES), the authors were also able to estimate hepatitis C (HCV) seroprevalence in certain demographics. The HCV care continuum (HCV-CoC) was defined as follows: stage 1: HCV Ab screening; stage 2: HCV Ab and RNA testing; stage 3: RNA-confirmation and continuing care; stage 4: RNA-confirmation, care, and HCV treatment.

Based on their estimates, Dr. Viner and her associates postulated that of approximately 1,584,848 Philadelphia residents, 47,207 (2.9%) would have HCV, with test results anticipated for 28,990 (61%) of those individuals. Positive HCV results were received for 13,596 individuals, of whom 6,383 (47%) had a positive HCV RNA test. Of these, 1,745 (27%) were in care, and 956 (15%) had received or were currently receiving treatment.

“These findings elucidate how few HCV-infected residents are successfully mobilized from screening through confirmatory testing and into care and treatment,” wrote Dr. Viner and her coauthors. “Understanding and addressing the specific reasons why patients are lost at each stage is critical if public health and clinical care practitioners hope to affect the outcomes of chronic HCV infection.”

In each category of testing and treatment, men presented nearly twice as often as women: 61% vs. 39%, Ab only; 64% vs. 36%, Ab plus RNA; 64% vs. 36%, Ab plus RNA with no antiviral treatment; and 71% vs. 29%, Ab plus RNA with antiviral treatment, respectively (P < .001). Patients aged 45-64 years presented the most often for both genders (P < .001), and blacks and whites were most common in the study population (P < .001).

The investigators noted that their findings were consistent with national estimates, which say that fewer than half of a city’s population would have HCV infections, and that 3%-5% of cases would be underreported, thus possibly explaining some missing cases in their own data.

“To promote movement through the continuum of HCV care, state and local health departments need to devise ways to improve surveillance and enhance screening and linkage and retention in HCV care services,” concluded the authors. “However, none of this can happen effectively without strong federal support and greater efforts to promote an implementation science agenda that pulls on surveillance data to execute the CDC’s recommendation for routine baby boomer and risk-based screening, and enhance the HCV care continuum,” they added.

The authors reported no financial conflicts of interest.

[email protected]

By mapping the testing and care of patients with the hepatitis C virus on a continuum, health care providers can get a better picture of the stages at which the disease is being managed effectively and where along the spectrum there may be room for greater improvement, according to a study published in Hepatology.

“This continuum provides a ‘real-life’ snapshot of how this disease is being managed in a major U.S. urban center,” according to the investigators, led by Kendra Viner, Ph.D., of the Philadelphia Department of Public Health (PDPH). “Many patients are lost at each stage, highlighting the need to raise awareness among health care professionals and at-risk populations about appropriate hepatitis testing, referral, support, and care.”

Courtesy NIH

In a retrospective, population-based study, Dr. Viner and her coinvestigators – all of whom are also with PDPH – examined reports of hepatitis filed in the city between January 2010 and December 2013. During this time, 70% of hepatitis reports were from electronic laboratory reporting (ELR), 25% were from fax or phone reports, and the remaining 5% came from “active case findings.” Investigators also used enhanced surveillance data to find hepatitis cases reported during the study period (Hepatology 2014 ([doi:10.1002/hep.27584]).

Using population estimates from the 2010 United States Census, the American Community Survey (ACS), and the National Health and Nutrition Examination Survey (NHANES), the authors were also able to estimate hepatitis C (HCV) seroprevalence in certain demographics. The HCV care continuum (HCV-CoC) was defined as follows: stage 1: HCV Ab screening; stage 2: HCV Ab and RNA testing; stage 3: RNA-confirmation and continuing care; stage 4: RNA-confirmation, care, and HCV treatment.

Based on their estimates, Dr. Viner and her associates postulated that of approximately 1,584,848 Philadelphia residents, 47,207 (2.9%) would have HCV, with test results anticipated for 28,990 (61%) of those individuals. Positive HCV results were received for 13,596 individuals, of whom 6,383 (47%) had a positive HCV RNA test. Of these, 1,745 (27%) were in care, and 956 (15%) had received or were currently receiving treatment.

“These findings elucidate how few HCV-infected residents are successfully mobilized from screening through confirmatory testing and into care and treatment,” wrote Dr. Viner and her coauthors. “Understanding and addressing the specific reasons why patients are lost at each stage is critical if public health and clinical care practitioners hope to affect the outcomes of chronic HCV infection.”

In each category of testing and treatment, men presented nearly twice as often as women: 61% vs. 39%, Ab only; 64% vs. 36%, Ab plus RNA; 64% vs. 36%, Ab plus RNA with no antiviral treatment; and 71% vs. 29%, Ab plus RNA with antiviral treatment, respectively (P < .001). Patients aged 45-64 years presented the most often for both genders (P < .001), and blacks and whites were most common in the study population (P < .001).

The investigators noted that their findings were consistent with national estimates, which say that fewer than half of a city’s population would have HCV infections, and that 3%-5% of cases would be underreported, thus possibly explaining some missing cases in their own data.

“To promote movement through the continuum of HCV care, state and local health departments need to devise ways to improve surveillance and enhance screening and linkage and retention in HCV care services,” concluded the authors. “However, none of this can happen effectively without strong federal support and greater efforts to promote an implementation science agenda that pulls on surveillance data to execute the CDC’s recommendation for routine baby boomer and risk-based screening, and enhance the HCV care continuum,” they added.

The authors reported no financial conflicts of interest.

[email protected]

WASHINGTON– Despite improved surgical procedures aimed at repairing severe genitourinary injuries sustained in the line of duty, such injuries still can have profound long-term psychological effects on military service members, according to a pair of experts who spoke Dec. 11 at the Bob Woodruff Foundation: Intimacy After Injury meeting.

Sherrie L. Wilcox, Ph.D., a professor in the School of Social Work at the University of Southern California, Los Angeles, and head of the school’s Sex & the Military program, said “sexual health” can be defined broadly as sexually related physical, emotional, mental, and social well-being, emphasizing both the absence of dysfunction and disease. Calling sexual health a “vital component of overall quality of life,” Dr. Wilcox cautioned that failure to adequately address those psychological issues can lead to long-term ramifications in service members’ civilian lives. Failure to address these issues predisposes the service members to sexual and marital problems, as well as to illnesses such as depression and posttraumatic stress disorder (PTSD).

Dr. Wilcox was one of two presenters who spoke during a session highlighting the steps necessary to mitigate long-term sexual dysfunction by focusing attention on physical and psychological health. The other presenter was Jean L. Orman, Sc.D., chief of statistics and epidemiology at the U.S. Army Institute of Surgical Research and the Joint Trauma System.

“The wars in Iraq and Afghanistan are distinctive for having the highest rate of survival of wounded combatants in any major military conflict,” Dr. Orman said. “But with that distinction comes an important price: larger numbers of service members surviving with multiple, complex, and often very severe injuries – including genital injuries.”

Citing a review of data from the U.S. Department of Defense Trauma Registry, Dr. Orman explained that 1,291 American male service members have survived genitourinary (GU) injuries sustained in combat; nearly 75% of these men were injured by contact with an improvised explosive device, and the average age of the population was 25 years.

A total of 965 men had injuries to their urinary tracts or genitals, of which 65 sustained severe damage to the penis or penile area. Three service members ultimately lost either their penis, testicles, or scrotum, while others sustained injuries of several other kinds, including bilateral lower extremity amputation and traumatic brain injury (TBI), which occurred in more than 40% of service members with GU injury.

“Injuries this extreme no doubt have a very strong impact on the person who experiences them,” Dr. Orman said. “Unfortunately, if you look for copious literature on any long-term effects [or] outcomes, there really isn’t very much” regarding the urinary, sexual, fertility, social, and psychological aspects of living with severe GU injuries.

Sharing statistics comparing psychological disorders in military service members before and after deployment, Dr. Wilcox showed that 16% of personnel reported psychological injuries predeployment, but that number nearly doubled to 30% of personnel after returning from their tours. Furthermore, 22.4% of male and female service members surveyed who joined the military after Sept.11, 2001, reported having sexual issues upon returning from active duty. More than 30% of male military personnel surveyed reported symptoms of erectile dysfunction (ED), with the probability of PTSD increasing by a factor of 30 in soldiers with ED.

Dr. Orman and her coinvestigators identified 301 service members with GU injury and more than 650,000 without in a study conducted jointly by the Department of Defense and the South Texas branch of the Department of Veterans Affairs (VA) that examined a database of information on all patients seen between 2001 and 2011 who were deployed as part of Operation Enduring Freedom or Operation Iraqi Freedom. TBI and PTSD were reported nearly twice as often by veterans with GU injuries than did those without: 21.9% vs. 9.7% reported having TBI; 40.1% vs 22.6% reported PTSD alone; 9.3% vs. 5% experienced TBI and PTSD, respectively.

Service members who sustained GU injuries more often had several physical afflictions than service members who did not: 46% vs. 27% reported experiencing chronic pain; 12% vs. 2% reported urinary symptoms; 15% vs. 6% reported sexual dysfunction; and 2% vs. 0.4% reported infertility, respectively. Psychological conditions also presented more in GU patients vs. non-GU patients: 19.3% vs. 7.1% reported suffering “major depression”; 19.6% vs. 9.3% reported substance abuse after returning from active service; 3.3% vs. 1.0% reported having a panic disorder; and 77.6% vs. 1.9% said that they had seriously contemplated suicide, respectively.

“We must put these results in perspective,” Dr. Orman stated. “As important as these results might be, they give us just an initial glimpse of the effects of GU injuries, [meaning] our results reflect perhaps just the tip of the iceberg.” Both Dr. Orman and Dr. Wilcox called for more study, particularly since only about 40% of military veterans seek help from the VA, and even within that population, not all who have GU injuries or related psychological conditions would be willing to come forward for help.

“We need to reduce the barriers to care and treatment; we need to close gaps; and we all have to work together to create new best practices in this area,” said Dr. Wilcox in her concluding remarks.

Dr. Wilcox disclosed that funding for the “Sex & the Military” project comes from the California Community Foundation’s Iraq Afghanistan Deployment Impact Fund. Neither presenter reported any other potential financial conflicts of interest.

[email protected]

WASHINGTON– Despite improved surgical procedures aimed at repairing severe genitourinary injuries sustained in the line of duty, such injuries still can have profound long-term psychological effects on military service members, according to a pair of experts who spoke Dec. 11 at the Bob Woodruff Foundation: Intimacy After Injury meeting.

Sherrie L. Wilcox, Ph.D., a professor in the School of Social Work at the University of Southern California, Los Angeles, and head of the school’s Sex & the Military program, said “sexual health” can be defined broadly as sexually related physical, emotional, mental, and social well-being, emphasizing both the absence of dysfunction and disease. Calling sexual health a “vital component of overall quality of life,” Dr. Wilcox cautioned that failure to adequately address those psychological issues can lead to long-term ramifications in service members’ civilian lives. Failure to address these issues predisposes the service members to sexual and marital problems, as well as to illnesses such as depression and posttraumatic stress disorder (PTSD).

Dr. Wilcox was one of two presenters who spoke during a session highlighting the steps necessary to mitigate long-term sexual dysfunction by focusing attention on physical and psychological health. The other presenter was Jean L. Orman, Sc.D., chief of statistics and epidemiology at the U.S. Army Institute of Surgical Research and the Joint Trauma System.

“The wars in Iraq and Afghanistan are distinctive for having the highest rate of survival of wounded combatants in any major military conflict,” Dr. Orman said. “But with that distinction comes an important price: larger numbers of service members surviving with multiple, complex, and often very severe injuries – including genital injuries.”

Citing a review of data from the U.S. Department of Defense Trauma Registry, Dr. Orman explained that 1,291 American male service members have survived genitourinary (GU) injuries sustained in combat; nearly 75% of these men were injured by contact with an improvised explosive device, and the average age of the population was 25 years.

A total of 965 men had injuries to their urinary tracts or genitals, of which 65 sustained severe damage to the penis or penile area. Three service members ultimately lost either their penis, testicles, or scrotum, while others sustained injuries of several other kinds, including bilateral lower extremity amputation and traumatic brain injury (TBI), which occurred in more than 40% of service members with GU injury.

“Injuries this extreme no doubt have a very strong impact on the person who experiences them,” Dr. Orman said. “Unfortunately, if you look for copious literature on any long-term effects [or] outcomes, there really isn’t very much” regarding the urinary, sexual, fertility, social, and psychological aspects of living with severe GU injuries.

Sharing statistics comparing psychological disorders in military service members before and after deployment, Dr. Wilcox showed that 16% of personnel reported psychological injuries predeployment, but that number nearly doubled to 30% of personnel after returning from their tours. Furthermore, 22.4% of male and female service members surveyed who joined the military after Sept.11, 2001, reported having sexual issues upon returning from active duty. More than 30% of male military personnel surveyed reported symptoms of erectile dysfunction (ED), with the probability of PTSD increasing by a factor of 30 in soldiers with ED.

Dr. Orman and her coinvestigators identified 301 service members with GU injury and more than 650,000 without in a study conducted jointly by the Department of Defense and the South Texas branch of the Department of Veterans Affairs (VA) that examined a database of information on all patients seen between 2001 and 2011 who were deployed as part of Operation Enduring Freedom or Operation Iraqi Freedom. TBI and PTSD were reported nearly twice as often by veterans with GU injuries than did those without: 21.9% vs. 9.7% reported having TBI; 40.1% vs 22.6% reported PTSD alone; 9.3% vs. 5% experienced TBI and PTSD, respectively.

Service members who sustained GU injuries more often had several physical afflictions than service members who did not: 46% vs. 27% reported experiencing chronic pain; 12% vs. 2% reported urinary symptoms; 15% vs. 6% reported sexual dysfunction; and 2% vs. 0.4% reported infertility, respectively. Psychological conditions also presented more in GU patients vs. non-GU patients: 19.3% vs. 7.1% reported suffering “major depression”; 19.6% vs. 9.3% reported substance abuse after returning from active service; 3.3% vs. 1.0% reported having a panic disorder; and 77.6% vs. 1.9% said that they had seriously contemplated suicide, respectively.

“We must put these results in perspective,” Dr. Orman stated. “As important as these results might be, they give us just an initial glimpse of the effects of GU injuries, [meaning] our results reflect perhaps just the tip of the iceberg.” Both Dr. Orman and Dr. Wilcox called for more study, particularly since only about 40% of military veterans seek help from the VA, and even within that population, not all who have GU injuries or related psychological conditions would be willing to come forward for help.

“We need to reduce the barriers to care and treatment; we need to close gaps; and we all have to work together to create new best practices in this area,” said Dr. Wilcox in her concluding remarks.

Dr. Wilcox disclosed that funding for the “Sex & the Military” project comes from the California Community Foundation’s Iraq Afghanistan Deployment Impact Fund. Neither presenter reported any other potential financial conflicts of interest.

[email protected]

WASHINGTON– Despite improved surgical procedures aimed at repairing severe genitourinary injuries sustained in the line of duty, such injuries still can have profound long-term psychological effects on military service members, according to a pair of experts who spoke Dec. 11 at the Bob Woodruff Foundation: Intimacy After Injury meeting.

Sherrie L. Wilcox, Ph.D., a professor in the School of Social Work at the University of Southern California, Los Angeles, and head of the school’s Sex & the Military program, said “sexual health” can be defined broadly as sexually related physical, emotional, mental, and social well-being, emphasizing both the absence of dysfunction and disease. Calling sexual health a “vital component of overall quality of life,” Dr. Wilcox cautioned that failure to adequately address those psychological issues can lead to long-term ramifications in service members’ civilian lives. Failure to address these issues predisposes the service members to sexual and marital problems, as well as to illnesses such as depression and posttraumatic stress disorder (PTSD).

Dr. Wilcox was one of two presenters who spoke during a session highlighting the steps necessary to mitigate long-term sexual dysfunction by focusing attention on physical and psychological health. The other presenter was Jean L. Orman, Sc.D., chief of statistics and epidemiology at the U.S. Army Institute of Surgical Research and the Joint Trauma System.

“The wars in Iraq and Afghanistan are distinctive for having the highest rate of survival of wounded combatants in any major military conflict,” Dr. Orman said. “But with that distinction comes an important price: larger numbers of service members surviving with multiple, complex, and often very severe injuries – including genital injuries.”

Citing a review of data from the U.S. Department of Defense Trauma Registry, Dr. Orman explained that 1,291 American male service members have survived genitourinary (GU) injuries sustained in combat; nearly 75% of these men were injured by contact with an improvised explosive device, and the average age of the population was 25 years.

A total of 965 men had injuries to their urinary tracts or genitals, of which 65 sustained severe damage to the penis or penile area. Three service members ultimately lost either their penis, testicles, or scrotum, while others sustained injuries of several other kinds, including bilateral lower extremity amputation and traumatic brain injury (TBI), which occurred in more than 40% of service members with GU injury.

“Injuries this extreme no doubt have a very strong impact on the person who experiences them,” Dr. Orman said. “Unfortunately, if you look for copious literature on any long-term effects [or] outcomes, there really isn’t very much” regarding the urinary, sexual, fertility, social, and psychological aspects of living with severe GU injuries.

Sharing statistics comparing psychological disorders in military service members before and after deployment, Dr. Wilcox showed that 16% of personnel reported psychological injuries predeployment, but that number nearly doubled to 30% of personnel after returning from their tours. Furthermore, 22.4% of male and female service members surveyed who joined the military after Sept.11, 2001, reported having sexual issues upon returning from active duty. More than 30% of male military personnel surveyed reported symptoms of erectile dysfunction (ED), with the probability of PTSD increasing by a factor of 30 in soldiers with ED.

Dr. Orman and her coinvestigators identified 301 service members with GU injury and more than 650,000 without in a study conducted jointly by the Department of Defense and the South Texas branch of the Department of Veterans Affairs (VA) that examined a database of information on all patients seen between 2001 and 2011 who were deployed as part of Operation Enduring Freedom or Operation Iraqi Freedom. TBI and PTSD were reported nearly twice as often by veterans with GU injuries than did those without: 21.9% vs. 9.7% reported having TBI; 40.1% vs 22.6% reported PTSD alone; 9.3% vs. 5% experienced TBI and PTSD, respectively.

Service members who sustained GU injuries more often had several physical afflictions than service members who did not: 46% vs. 27% reported experiencing chronic pain; 12% vs. 2% reported urinary symptoms; 15% vs. 6% reported sexual dysfunction; and 2% vs. 0.4% reported infertility, respectively. Psychological conditions also presented more in GU patients vs. non-GU patients: 19.3% vs. 7.1% reported suffering “major depression”; 19.6% vs. 9.3% reported substance abuse after returning from active service; 3.3% vs. 1.0% reported having a panic disorder; and 77.6% vs. 1.9% said that they had seriously contemplated suicide, respectively.

“We must put these results in perspective,” Dr. Orman stated. “As important as these results might be, they give us just an initial glimpse of the effects of GU injuries, [meaning] our results reflect perhaps just the tip of the iceberg.” Both Dr. Orman and Dr. Wilcox called for more study, particularly since only about 40% of military veterans seek help from the VA, and even within that population, not all who have GU injuries or related psychological conditions would be willing to come forward for help.

“We need to reduce the barriers to care and treatment; we need to close gaps; and we all have to work together to create new best practices in this area,” said Dr. Wilcox in her concluding remarks.

Dr. Wilcox disclosed that funding for the “Sex & the Military” project comes from the California Community Foundation’s Iraq Afghanistan Deployment Impact Fund. Neither presenter reported any other potential financial conflicts of interest.

[email protected]

Two new studies published by the New England Journal of Medicine show that progesterone has little-to-no clinical benefit when administered to patients after severe traumatic brain injury, contradicting the findings of several previous studies that were optimistic about the drug’s efficacy in treating this particular progressive disorder (doi:10.1056/NEJMoal1411090 and doi:10.1056/NEJMoa1404304).

“Progesterone has been shown to have broad neuroprotective properties in multiple animal species and in a variety of models of neurologic injury,” said Dr. Brett E. Skolnick of North Shore University Hospital, Manhasset, N.Y., who led the analysis of the Severe Traumatic Brain Injury (SYNAPSE) trial.

“A total of 20 research groups working with four species and 22 different models have found neuroprotective effects of progesterone in more than 180 experimental pharmacologic studies [and] two phase II randomized, controlled clinical trials with progesterone showed a clinical benefit,” he said.

For SYNAPSE – a multinational, placebo-controlled, prospective, randomized phase III clinical trial – investigators looked at 10,519 male and female patients, aged 16-70 years, admitted to level 1 or equivalent centers in 21 countries around the world. All individuals had nonpenetrating traumatic brain injury (TBI), Glasgow Coma Scale (GCS) scores of 8 or less, a Marshall classification score of II or higher, at least one reactive pupil, body weight of 99-298 pounds, and clinical indication for monitoring intracranial pressure. All subjects also underwent treatment within 8 hours of injury, and dosing continued for 120 hours.

Recruitment lasted from July 2010 to September 2013, with the final 6-month follow-up occurring in March 2014. Of the subjects who were randomized and went through full treatment and procedure, 591 received intravenous administration of progesterone, and 588 received a placebo. The primary outcome measure was GOS score at 6 months after initial injury, and secondary outcome measure was defined as GOS score at 3 months, mortality at 1 month and 6 months, and the GOS-E (Extended GOS) score.

Between the progesterone and placebo cohorts, there was no significant difference in the primary outcome: 189 subjects (32%) vs. 1,883 (31.1%) were in “good recovery,” 109 (18.4%) vs. 114 (19.4%) had “moderate disability,” 162 (27.4%) vs. 160 (27.2%) had “severe disability,” and 131 (22.2%) vs. 131 (22.3%) were in a “dead or vegetative state” 6 months after injury, respectively. Both adjusted and unadjusted data showed statistical insignificance (adjusted OR, 0.96).

Furthermore, mortality rates between both groups were similar, and the difference in proportion of subjects who received favorable GOS – with “good recovery” or “moderate disability,” as defined by the investigators – between the progesterone and placebo cohorts was negligible: 50.4% for progesterone vs. 50.5% for placebo.

“TBI is a complex, heterogeneous disorder, in which the primary injury initiates a variety of secondary injury cascades,” the authors noted. “These cascades involve various processes that may not be responsive to monotherapy [and] suggest that a successful therapeutic agent should influence rather than a single cascade. On the basis of the experimental data, progesterone would appear to be an appropriate candidate for this pluripotential role.”

The second study, “Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment” (PROTECT III), was a double-blind, multicenter clinical trial with 882 patients randomized into cohorts receiving either progesterone or a placebo.

Subjects were randomized from April 2010 to October 2013, and were included on the basis of adults who had either severe, moderate to severe, or moderate TBI caused by a blunt mechanism, and a GOS of 4-12. Subjects were enrolled if they could begin treatment within 4 hours of initial injury. The median age of the patients was 35 years; 73.7% of subjects were men, 15.2% were black, and the mean Injury Severity Score was 24.4 on a scale of 0-75, with higher scores indicating greater severity of symptoms. The most common cause of TBI in subjects was motor vehicle accident.

Primary outcome measure was defined as the GOS-E score at 6 months after injury (1 = death, 2 = vegetative state, 3 or 4 = severe disability, 5 or 6 = moderate disability, and 7 or 8 = good recovery), while secondary outcomes measure “included mortality, the Disability Rating Scale score, the rates of nine prespecified adverse events that were considered to be potentially associated with treatment, and the rates of all reported adverse events and serious adverse events.” Efficacy was defined as an increase of 10 percentage points in the proportion of patients with a favorable outcome at 6 months after injury.

The progesterone cohort comprised 442 subjects, while the remaining 440 received placebos. Investigators found that 213 (48.2%) of the progesterone subjects had favorable outcomes at 6 months after injury, and 232 (52.7%) were favorable in the placebo group; therefore, a total of 445 patients (50.5% of total population) had optimal response to treatment, and no significant difference between the two treatment options.

“Despite extensive preclinical data and two promising single-center trials, progesterone was not associated with any benefit over placebo, as measured by the GOS-E score at 6 months, in this large, multicenter clinical trial,” wrote lead author Dr. David W. Wright of Emory University, Atlanta, and his associates.

“The PROTECT III trial joins a growing list of negative or inconclusive trials in the arduous search for a treatment for TBI. To date, no treatment has succeeded at the confirmatory trial stage,” the researchers noted.

The SYNAPSE trial was funded by BHR Pharma, a division of Besins Healthcare. PROTECT III was funded by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke and the National Center for Advancing Translational Sciences; the Emory Emergency Neurosciences Laboratory at Emory University, Atlanta; and Grady Memorial Hospital, Atlanta. Several coauthors for each study had their own disclosures, as well.

[email protected]

Two new studies published by the New England Journal of Medicine show that progesterone has little-to-no clinical benefit when administered to patients after severe traumatic brain injury, contradicting the findings of several previous studies that were optimistic about the drug’s efficacy in treating this particular progressive disorder (doi:10.1056/NEJMoal1411090 and doi:10.1056/NEJMoa1404304).

“Progesterone has been shown to have broad neuroprotective properties in multiple animal species and in a variety of models of neurologic injury,” said Dr. Brett E. Skolnick of North Shore University Hospital, Manhasset, N.Y., who led the analysis of the Severe Traumatic Brain Injury (SYNAPSE) trial.

“A total of 20 research groups working with four species and 22 different models have found neuroprotective effects of progesterone in more than 180 experimental pharmacologic studies [and] two phase II randomized, controlled clinical trials with progesterone showed a clinical benefit,” he said.

For SYNAPSE – a multinational, placebo-controlled, prospective, randomized phase III clinical trial – investigators looked at 10,519 male and female patients, aged 16-70 years, admitted to level 1 or equivalent centers in 21 countries around the world. All individuals had nonpenetrating traumatic brain injury (TBI), Glasgow Coma Scale (GCS) scores of 8 or less, a Marshall classification score of II or higher, at least one reactive pupil, body weight of 99-298 pounds, and clinical indication for monitoring intracranial pressure. All subjects also underwent treatment within 8 hours of injury, and dosing continued for 120 hours.

Recruitment lasted from July 2010 to September 2013, with the final 6-month follow-up occurring in March 2014. Of the subjects who were randomized and went through full treatment and procedure, 591 received intravenous administration of progesterone, and 588 received a placebo. The primary outcome measure was GOS score at 6 months after initial injury, and secondary outcome measure was defined as GOS score at 3 months, mortality at 1 month and 6 months, and the GOS-E (Extended GOS) score.

Between the progesterone and placebo cohorts, there was no significant difference in the primary outcome: 189 subjects (32%) vs. 1,883 (31.1%) were in “good recovery,” 109 (18.4%) vs. 114 (19.4%) had “moderate disability,” 162 (27.4%) vs. 160 (27.2%) had “severe disability,” and 131 (22.2%) vs. 131 (22.3%) were in a “dead or vegetative state” 6 months after injury, respectively. Both adjusted and unadjusted data showed statistical insignificance (adjusted OR, 0.96).

Furthermore, mortality rates between both groups were similar, and the difference in proportion of subjects who received favorable GOS – with “good recovery” or “moderate disability,” as defined by the investigators – between the progesterone and placebo cohorts was negligible: 50.4% for progesterone vs. 50.5% for placebo.

“TBI is a complex, heterogeneous disorder, in which the primary injury initiates a variety of secondary injury cascades,” the authors noted. “These cascades involve various processes that may not be responsive to monotherapy [and] suggest that a successful therapeutic agent should influence rather than a single cascade. On the basis of the experimental data, progesterone would appear to be an appropriate candidate for this pluripotential role.”

The second study, “Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment” (PROTECT III), was a double-blind, multicenter clinical trial with 882 patients randomized into cohorts receiving either progesterone or a placebo.

Subjects were randomized from April 2010 to October 2013, and were included on the basis of adults who had either severe, moderate to severe, or moderate TBI caused by a blunt mechanism, and a GOS of 4-12. Subjects were enrolled if they could begin treatment within 4 hours of initial injury. The median age of the patients was 35 years; 73.7% of subjects were men, 15.2% were black, and the mean Injury Severity Score was 24.4 on a scale of 0-75, with higher scores indicating greater severity of symptoms. The most common cause of TBI in subjects was motor vehicle accident.

Primary outcome measure was defined as the GOS-E score at 6 months after injury (1 = death, 2 = vegetative state, 3 or 4 = severe disability, 5 or 6 = moderate disability, and 7 or 8 = good recovery), while secondary outcomes measure “included mortality, the Disability Rating Scale score, the rates of nine prespecified adverse events that were considered to be potentially associated with treatment, and the rates of all reported adverse events and serious adverse events.” Efficacy was defined as an increase of 10 percentage points in the proportion of patients with a favorable outcome at 6 months after injury.

The progesterone cohort comprised 442 subjects, while the remaining 440 received placebos. Investigators found that 213 (48.2%) of the progesterone subjects had favorable outcomes at 6 months after injury, and 232 (52.7%) were favorable in the placebo group; therefore, a total of 445 patients (50.5% of total population) had optimal response to treatment, and no significant difference between the two treatment options.

“Despite extensive preclinical data and two promising single-center trials, progesterone was not associated with any benefit over placebo, as measured by the GOS-E score at 6 months, in this large, multicenter clinical trial,” wrote lead author Dr. David W. Wright of Emory University, Atlanta, and his associates.

“The PROTECT III trial joins a growing list of negative or inconclusive trials in the arduous search for a treatment for TBI. To date, no treatment has succeeded at the confirmatory trial stage,” the researchers noted.

The SYNAPSE trial was funded by BHR Pharma, a division of Besins Healthcare. PROTECT III was funded by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke and the National Center for Advancing Translational Sciences; the Emory Emergency Neurosciences Laboratory at Emory University, Atlanta; and Grady Memorial Hospital, Atlanta. Several coauthors for each study had their own disclosures, as well.

[email protected]

Two new studies published by the New England Journal of Medicine show that progesterone has little-to-no clinical benefit when administered to patients after severe traumatic brain injury, contradicting the findings of several previous studies that were optimistic about the drug’s efficacy in treating this particular progressive disorder (doi:10.1056/NEJMoal1411090 and doi:10.1056/NEJMoa1404304).

“Progesterone has been shown to have broad neuroprotective properties in multiple animal species and in a variety of models of neurologic injury,” said Dr. Brett E. Skolnick of North Shore University Hospital, Manhasset, N.Y., who led the analysis of the Severe Traumatic Brain Injury (SYNAPSE) trial.

“A total of 20 research groups working with four species and 22 different models have found neuroprotective effects of progesterone in more than 180 experimental pharmacologic studies [and] two phase II randomized, controlled clinical trials with progesterone showed a clinical benefit,” he said.

For SYNAPSE – a multinational, placebo-controlled, prospective, randomized phase III clinical trial – investigators looked at 10,519 male and female patients, aged 16-70 years, admitted to level 1 or equivalent centers in 21 countries around the world. All individuals had nonpenetrating traumatic brain injury (TBI), Glasgow Coma Scale (GCS) scores of 8 or less, a Marshall classification score of II or higher, at least one reactive pupil, body weight of 99-298 pounds, and clinical indication for monitoring intracranial pressure. All subjects also underwent treatment within 8 hours of injury, and dosing continued for 120 hours.

Recruitment lasted from July 2010 to September 2013, with the final 6-month follow-up occurring in March 2014. Of the subjects who were randomized and went through full treatment and procedure, 591 received intravenous administration of progesterone, and 588 received a placebo. The primary outcome measure was GOS score at 6 months after initial injury, and secondary outcome measure was defined as GOS score at 3 months, mortality at 1 month and 6 months, and the GOS-E (Extended GOS) score.

Between the progesterone and placebo cohorts, there was no significant difference in the primary outcome: 189 subjects (32%) vs. 1,883 (31.1%) were in “good recovery,” 109 (18.4%) vs. 114 (19.4%) had “moderate disability,” 162 (27.4%) vs. 160 (27.2%) had “severe disability,” and 131 (22.2%) vs. 131 (22.3%) were in a “dead or vegetative state” 6 months after injury, respectively. Both adjusted and unadjusted data showed statistical insignificance (adjusted OR, 0.96).

Furthermore, mortality rates between both groups were similar, and the difference in proportion of subjects who received favorable GOS – with “good recovery” or “moderate disability,” as defined by the investigators – between the progesterone and placebo cohorts was negligible: 50.4% for progesterone vs. 50.5% for placebo.

“TBI is a complex, heterogeneous disorder, in which the primary injury initiates a variety of secondary injury cascades,” the authors noted. “These cascades involve various processes that may not be responsive to monotherapy [and] suggest that a successful therapeutic agent should influence rather than a single cascade. On the basis of the experimental data, progesterone would appear to be an appropriate candidate for this pluripotential role.”

The second study, “Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment” (PROTECT III), was a double-blind, multicenter clinical trial with 882 patients randomized into cohorts receiving either progesterone or a placebo.

Subjects were randomized from April 2010 to October 2013, and were included on the basis of adults who had either severe, moderate to severe, or moderate TBI caused by a blunt mechanism, and a GOS of 4-12. Subjects were enrolled if they could begin treatment within 4 hours of initial injury. The median age of the patients was 35 years; 73.7% of subjects were men, 15.2% were black, and the mean Injury Severity Score was 24.4 on a scale of 0-75, with higher scores indicating greater severity of symptoms. The most common cause of TBI in subjects was motor vehicle accident.

Primary outcome measure was defined as the GOS-E score at 6 months after injury (1 = death, 2 = vegetative state, 3 or 4 = severe disability, 5 or 6 = moderate disability, and 7 or 8 = good recovery), while secondary outcomes measure “included mortality, the Disability Rating Scale score, the rates of nine prespecified adverse events that were considered to be potentially associated with treatment, and the rates of all reported adverse events and serious adverse events.” Efficacy was defined as an increase of 10 percentage points in the proportion of patients with a favorable outcome at 6 months after injury.

The progesterone cohort comprised 442 subjects, while the remaining 440 received placebos. Investigators found that 213 (48.2%) of the progesterone subjects had favorable outcomes at 6 months after injury, and 232 (52.7%) were favorable in the placebo group; therefore, a total of 445 patients (50.5% of total population) had optimal response to treatment, and no significant difference between the two treatment options.

“Despite extensive preclinical data and two promising single-center trials, progesterone was not associated with any benefit over placebo, as measured by the GOS-E score at 6 months, in this large, multicenter clinical trial,” wrote lead author Dr. David W. Wright of Emory University, Atlanta, and his associates.

“The PROTECT III trial joins a growing list of negative or inconclusive trials in the arduous search for a treatment for TBI. To date, no treatment has succeeded at the confirmatory trial stage,” the researchers noted.

The SYNAPSE trial was funded by BHR Pharma, a division of Besins Healthcare. PROTECT III was funded by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke and the National Center for Advancing Translational Sciences; the Emory Emergency Neurosciences Laboratory at Emory University, Atlanta; and Grady Memorial Hospital, Atlanta. Several coauthors for each study had their own disclosures, as well.

[email protected]

Consuming an increased number of beverages from cans and plastic bottles, which use the chemical product bisphenol A, can lead to a noticeable increase in blood pressure and, consequently, may predispose individuals to hypertension and related cardiovascular complications, a study showed.

“We had previously reported that increased urinary BPA [bisphenol A] concentration was associated with higher blood pressure and decreased heart rate variability in a panel study with elderly participants,” wrote Dr. Sanghyuk Bae and Dr. Yun-Chul Hong of Seoul (South Korea) National University, adding that, “previous epidemiological studies have reported the associations between BPA exposure and adverse health effects on the reproductive and endocrine systems. BPA exposure had also been associated with cardiovascular disorders.”

In a randomized, crossover intervention study, the investigators recruited 60 subjects aged at least 60 years because of the predisposition of elderly patients to environmental exposure. Individuals with heart diseases, cancer, liver diseases, and endocrine diseases in their medical histories were excluded from the study population (Hypertension 2015 [doi:10.1161/HYPERTENSIONAHA.114.04261]).

Each of these participants visited the study site a total of three times, with at least 1-week intervals in between visits, and were randomly assigned to consume two 195-mg servings of soy milk from two cans (CC), two glass bottles (GG), or one of each (CG); all subjects drank the same soy milk, manufactured by a single Korean company. Urine samples from each subject were then collected 2 hours after consumption of soy milk – during which time subjects were instructed not to eat or drink any other food – and were subsequently analyzed for BPA content within 90 minutes of collection.

©American Heart Association

The average urinary concentration of BPA was significantly higher in the CC and CG groups than in the GG group. Average urinary BPA was found to be 16.91 mcg/L for CC and 7.93 mcg/L (SD, 6.01) for CG (both P < .0001). For the GG group, however, mean urinary BPA concentration was just 1.13 mcg/L. The authors added that the average concentration of BPA in the canned beverages measured 8.22 mcg/L.

“Unlike previous trials, the present study examined only one time of exposure,” Dr. Bae and Dr. Hong noted. “However, this was sufficient to increase urinary BPA concentration by [more than] 1,600%.”

BPA found in canned beverages also had an effect on systolic blood pressure, which the investigators measured during the study. The results indicated that average systolic blood pressure in the CC group increased by around 4.5 mm Hg more than that of the GG group, with similar results being found when the analysis was adjusted for subjects who had no previous history of hypertension or diabetes mellitus.

“Hypertension is a risk factor of cardiovascular diseases, and the 20–mm Hg increase of systolic BP [blood pressure] doubles the risk of cardiovascular disease,” wrote the investigators. “In light of this, the 5–mm Hg increase observed in the present trial may cause a clinically significant increase of risk of cardiovascular disorders, such as heart diseases and peripheral arterial diseases, which were associated with increased BPA concentration in the previous epidemiological studies. However, the increase of BP followed by BPA exposure does not necessarily lead to chronic elevation of BP. The present study only accounted for the acute effect of BPA exposure.” Further study is needed, the investigators said.

The authors reported no relevant financial disclosures. This study was supported by a grant of the Korean Health Technology R&D Project, Ministry of Health & Welfare.

[email protected]

Consuming an increased number of beverages from cans and plastic bottles, which use the chemical product bisphenol A, can lead to a noticeable increase in blood pressure and, consequently, may predispose individuals to hypertension and related cardiovascular complications, a study showed.

“We had previously reported that increased urinary BPA [bisphenol A] concentration was associated with higher blood pressure and decreased heart rate variability in a panel study with elderly participants,” wrote Dr. Sanghyuk Bae and Dr. Yun-Chul Hong of Seoul (South Korea) National University, adding that, “previous epidemiological studies have reported the associations between BPA exposure and adverse health effects on the reproductive and endocrine systems. BPA exposure had also been associated with cardiovascular disorders.”

In a randomized, crossover intervention study, the investigators recruited 60 subjects aged at least 60 years because of the predisposition of elderly patients to environmental exposure. Individuals with heart diseases, cancer, liver diseases, and endocrine diseases in their medical histories were excluded from the study population (Hypertension 2015 [doi:10.1161/HYPERTENSIONAHA.114.04261]).

Each of these participants visited the study site a total of three times, with at least 1-week intervals in between visits, and were randomly assigned to consume two 195-mg servings of soy milk from two cans (CC), two glass bottles (GG), or one of each (CG); all subjects drank the same soy milk, manufactured by a single Korean company. Urine samples from each subject were then collected 2 hours after consumption of soy milk – during which time subjects were instructed not to eat or drink any other food – and were subsequently analyzed for BPA content within 90 minutes of collection.

©American Heart Association

The average urinary concentration of BPA was significantly higher in the CC and CG groups than in the GG group. Average urinary BPA was found to be 16.91 mcg/L for CC and 7.93 mcg/L (SD, 6.01) for CG (both P < .0001). For the GG group, however, mean urinary BPA concentration was just 1.13 mcg/L. The authors added that the average concentration of BPA in the canned beverages measured 8.22 mcg/L.

“Unlike previous trials, the present study examined only one time of exposure,” Dr. Bae and Dr. Hong noted. “However, this was sufficient to increase urinary BPA concentration by [more than] 1,600%.”

BPA found in canned beverages also had an effect on systolic blood pressure, which the investigators measured during the study. The results indicated that average systolic blood pressure in the CC group increased by around 4.5 mm Hg more than that of the GG group, with similar results being found when the analysis was adjusted for subjects who had no previous history of hypertension or diabetes mellitus.

“Hypertension is a risk factor of cardiovascular diseases, and the 20–mm Hg increase of systolic BP [blood pressure] doubles the risk of cardiovascular disease,” wrote the investigators. “In light of this, the 5–mm Hg increase observed in the present trial may cause a clinically significant increase of risk of cardiovascular disorders, such as heart diseases and peripheral arterial diseases, which were associated with increased BPA concentration in the previous epidemiological studies. However, the increase of BP followed by BPA exposure does not necessarily lead to chronic elevation of BP. The present study only accounted for the acute effect of BPA exposure.” Further study is needed, the investigators said.

The authors reported no relevant financial disclosures. This study was supported by a grant of the Korean Health Technology R&D Project, Ministry of Health & Welfare.

[email protected]

Consuming an increased number of beverages from cans and plastic bottles, which use the chemical product bisphenol A, can lead to a noticeable increase in blood pressure and, consequently, may predispose individuals to hypertension and related cardiovascular complications, a study showed.

“We had previously reported that increased urinary BPA [bisphenol A] concentration was associated with higher blood pressure and decreased heart rate variability in a panel study with elderly participants,” wrote Dr. Sanghyuk Bae and Dr. Yun-Chul Hong of Seoul (South Korea) National University, adding that, “previous epidemiological studies have reported the associations between BPA exposure and adverse health effects on the reproductive and endocrine systems. BPA exposure had also been associated with cardiovascular disorders.”

In a randomized, crossover intervention study, the investigators recruited 60 subjects aged at least 60 years because of the predisposition of elderly patients to environmental exposure. Individuals with heart diseases, cancer, liver diseases, and endocrine diseases in their medical histories were excluded from the study population (Hypertension 2015 [doi:10.1161/HYPERTENSIONAHA.114.04261]).

Each of these participants visited the study site a total of three times, with at least 1-week intervals in between visits, and were randomly assigned to consume two 195-mg servings of soy milk from two cans (CC), two glass bottles (GG), or one of each (CG); all subjects drank the same soy milk, manufactured by a single Korean company. Urine samples from each subject were then collected 2 hours after consumption of soy milk – during which time subjects were instructed not to eat or drink any other food – and were subsequently analyzed for BPA content within 90 minutes of collection.

©American Heart Association

The average urinary concentration of BPA was significantly higher in the CC and CG groups than in the GG group. Average urinary BPA was found to be 16.91 mcg/L for CC and 7.93 mcg/L (SD, 6.01) for CG (both P < .0001). For the GG group, however, mean urinary BPA concentration was just 1.13 mcg/L. The authors added that the average concentration of BPA in the canned beverages measured 8.22 mcg/L.

“Unlike previous trials, the present study examined only one time of exposure,” Dr. Bae and Dr. Hong noted. “However, this was sufficient to increase urinary BPA concentration by [more than] 1,600%.”

BPA found in canned beverages also had an effect on systolic blood pressure, which the investigators measured during the study. The results indicated that average systolic blood pressure in the CC group increased by around 4.5 mm Hg more than that of the GG group, with similar results being found when the analysis was adjusted for subjects who had no previous history of hypertension or diabetes mellitus.

“Hypertension is a risk factor of cardiovascular diseases, and the 20–mm Hg increase of systolic BP [blood pressure] doubles the risk of cardiovascular disease,” wrote the investigators. “In light of this, the 5–mm Hg increase observed in the present trial may cause a clinically significant increase of risk of cardiovascular disorders, such as heart diseases and peripheral arterial diseases, which were associated with increased BPA concentration in the previous epidemiological studies. However, the increase of BP followed by BPA exposure does not necessarily lead to chronic elevation of BP. The present study only accounted for the acute effect of BPA exposure.” Further study is needed, the investigators said.

The authors reported no relevant financial disclosures. This study was supported by a grant of the Korean Health Technology R&D Project, Ministry of Health & Welfare.

[email protected]