Mary Ann Moon

Patients with rosacea are more likely than others to have dyslipidemia and hypertension, and they are at increased risk for coronary artery disease independently of cardiovascular risk factors, according to a report published in the Journal of the American Academy of Dermatology.

Rosacea, characterized by central facial erythema, visible blood vessels, papules, and pustules, is considered to be a chronic inflammatory disease even though its precise pathophysiology is not yet understood. A recent small study suggested that patients with rosacea might be at higher than average risk for cardiovascular diseases. To investigate this possibility, researchers in Taiwan performed a nationwide population-based case-control study using information from a health insurance database covering virtually 100% of the country’s population.

The investigators identified all 33,553 adults in Taiwan diagnosed as having rosacea in 1997-2010, and matched them for age and gender with 67,106 control subjects who did not have the disease. Patients were significantly more likely than controls to have dyslipidemia (OR, 1.41) and hypertension (OR, 1.17). After the data were adjusted to control for these and other cardiovascular risk factors, rosacea patients still were at significantly increased risk for CAD (OR, 1.20), said Dr. Tuan-Chun Hua, of the department of dermatology, National Taiwan University Hospital, National Yang-Ming University, and Taipei Medical University, all in Taipei, and associates.

Men with rosacea also were at significantly increased risk for diabetes, peripheral artery occlusive disease, and cerebral infarction, but women were not, Dr. Hua and associates said (J. Amer. Acad. Dermatol. 2015; [http://dx.doi.org/10.1016/j.jaad.2015.04.028]).

“The inflammatory nature of rosacea may be the reason for these associations, they wrote. “Clinicians should be alert to cardiovascular comorbidities in patients with rosacea.”

This study was supported by the Taipei Veterans General Hospital. Dr. Hua and associates reported having no financial conflicts of interest.

Patients with rosacea are more likely than others to have dyslipidemia and hypertension, and they are at increased risk for coronary artery disease independently of cardiovascular risk factors, according to a report published in the Journal of the American Academy of Dermatology.

Rosacea, characterized by central facial erythema, visible blood vessels, papules, and pustules, is considered to be a chronic inflammatory disease even though its precise pathophysiology is not yet understood. A recent small study suggested that patients with rosacea might be at higher than average risk for cardiovascular diseases. To investigate this possibility, researchers in Taiwan performed a nationwide population-based case-control study using information from a health insurance database covering virtually 100% of the country’s population.

The investigators identified all 33,553 adults in Taiwan diagnosed as having rosacea in 1997-2010, and matched them for age and gender with 67,106 control subjects who did not have the disease. Patients were significantly more likely than controls to have dyslipidemia (OR, 1.41) and hypertension (OR, 1.17). After the data were adjusted to control for these and other cardiovascular risk factors, rosacea patients still were at significantly increased risk for CAD (OR, 1.20), said Dr. Tuan-Chun Hua, of the department of dermatology, National Taiwan University Hospital, National Yang-Ming University, and Taipei Medical University, all in Taipei, and associates.

Men with rosacea also were at significantly increased risk for diabetes, peripheral artery occlusive disease, and cerebral infarction, but women were not, Dr. Hua and associates said (J. Amer. Acad. Dermatol. 2015; [http://dx.doi.org/10.1016/j.jaad.2015.04.028]).

“The inflammatory nature of rosacea may be the reason for these associations, they wrote. “Clinicians should be alert to cardiovascular comorbidities in patients with rosacea.”

This study was supported by the Taipei Veterans General Hospital. Dr. Hua and associates reported having no financial conflicts of interest.

Patients with rosacea are more likely than others to have dyslipidemia and hypertension, and they are at increased risk for coronary artery disease independently of cardiovascular risk factors, according to a report published in the Journal of the American Academy of Dermatology.

Rosacea, characterized by central facial erythema, visible blood vessels, papules, and pustules, is considered to be a chronic inflammatory disease even though its precise pathophysiology is not yet understood. A recent small study suggested that patients with rosacea might be at higher than average risk for cardiovascular diseases. To investigate this possibility, researchers in Taiwan performed a nationwide population-based case-control study using information from a health insurance database covering virtually 100% of the country’s population.

The investigators identified all 33,553 adults in Taiwan diagnosed as having rosacea in 1997-2010, and matched them for age and gender with 67,106 control subjects who did not have the disease. Patients were significantly more likely than controls to have dyslipidemia (OR, 1.41) and hypertension (OR, 1.17). After the data were adjusted to control for these and other cardiovascular risk factors, rosacea patients still were at significantly increased risk for CAD (OR, 1.20), said Dr. Tuan-Chun Hua, of the department of dermatology, National Taiwan University Hospital, National Yang-Ming University, and Taipei Medical University, all in Taipei, and associates.

Men with rosacea also were at significantly increased risk for diabetes, peripheral artery occlusive disease, and cerebral infarction, but women were not, Dr. Hua and associates said (J. Amer. Acad. Dermatol. 2015; [http://dx.doi.org/10.1016/j.jaad.2015.04.028]).

“The inflammatory nature of rosacea may be the reason for these associations, they wrote. “Clinicians should be alert to cardiovascular comorbidities in patients with rosacea.”

This study was supported by the Taipei Veterans General Hospital. Dr. Hua and associates reported having no financial conflicts of interest.

Patients with rosacea are more likely than others to have dyslipidemia and hypertension, and they are at increased risk for coronary artery disease independently of cardiovascular risk factors, according to a report published in the Journal of the American Academy of Dermatology.

Rosacea, characterized by central facial erythema, visible blood vessels, papules, and pustules, is considered to be a chronic inflammatory disease even though its precise pathophysiology is not yet understood. A recent small study suggested that patients with rosacea might be at higher than average risk for cardiovascular diseases. To investigate this possibility, researchers in Taiwan performed a nationwide population-based case-control study using information from a health insurance database covering virtually 100% of the country’s population.

The investigators identified all 33,553 adults in Taiwan diagnosed as having rosacea in 1997-2010, and matched them for age and gender with 67,106 control subjects who did not have the disease. Patients were significantly more likely than controls to have dyslipidemia (OR, 1.41) and hypertension (OR, 1.17). After the data were adjusted to control for these and other cardiovascular risk factors, rosacea patients still were at significantly increased risk for CAD (OR, 1.20), said Dr. Tuan-Chun Hua, of the department of dermatology, National Taiwan University Hospital, National Yang-Ming University, and Taipei Medical University, all in Taipei, and associates.

Men with rosacea also were at significantly increased risk for diabetes, peripheral artery occlusive disease, and cerebral infarction, but women were not, Dr. Hua and associates said (J. Amer. Acad. Dermatol. 2015; [http://dx.doi.org/10.1016/j.jaad.2015.04.028]).

“The inflammatory nature of rosacea may be the reason for these associations, they wrote. “Clinicians should be alert to cardiovascular comorbidities in patients with rosacea.”

This study was supported by the Taipei Veterans General Hospital. Dr. Hua and associates reported having no financial conflicts of interest.

Patients with rosacea are more likely than others to have dyslipidemia and hypertension, and they are at increased risk for coronary artery disease independently of cardiovascular risk factors, according to a report published in the Journal of the American Academy of Dermatology.

Rosacea, characterized by central facial erythema, visible blood vessels, papules, and pustules, is considered to be a chronic inflammatory disease even though its precise pathophysiology is not yet understood. A recent small study suggested that patients with rosacea might be at higher than average risk for cardiovascular diseases. To investigate this possibility, researchers in Taiwan performed a nationwide population-based case-control study using information from a health insurance database covering virtually 100% of the country’s population.

The investigators identified all 33,553 adults in Taiwan diagnosed as having rosacea in 1997-2010, and matched them for age and gender with 67,106 control subjects who did not have the disease. Patients were significantly more likely than controls to have dyslipidemia (OR, 1.41) and hypertension (OR, 1.17). After the data were adjusted to control for these and other cardiovascular risk factors, rosacea patients still were at significantly increased risk for CAD (OR, 1.20), said Dr. Tuan-Chun Hua, of the department of dermatology, National Taiwan University Hospital, National Yang-Ming University, and Taipei Medical University, all in Taipei, and associates.

Men with rosacea also were at significantly increased risk for diabetes, peripheral artery occlusive disease, and cerebral infarction, but women were not, Dr. Hua and associates said (J. Amer. Acad. Dermatol. 2015; [http://dx.doi.org/10.1016/j.jaad.2015.04.028]).

“The inflammatory nature of rosacea may be the reason for these associations, they wrote. “Clinicians should be alert to cardiovascular comorbidities in patients with rosacea.”

This study was supported by the Taipei Veterans General Hospital. Dr. Hua and associates reported having no financial conflicts of interest.

Patients with rosacea are more likely than others to have dyslipidemia and hypertension, and they are at increased risk for coronary artery disease independently of cardiovascular risk factors, according to a report published in the Journal of the American Academy of Dermatology.

Rosacea, characterized by central facial erythema, visible blood vessels, papules, and pustules, is considered to be a chronic inflammatory disease even though its precise pathophysiology is not yet understood. A recent small study suggested that patients with rosacea might be at higher than average risk for cardiovascular diseases. To investigate this possibility, researchers in Taiwan performed a nationwide population-based case-control study using information from a health insurance database covering virtually 100% of the country’s population.

The investigators identified all 33,553 adults in Taiwan diagnosed as having rosacea in 1997-2010, and matched them for age and gender with 67,106 control subjects who did not have the disease. Patients were significantly more likely than controls to have dyslipidemia (OR, 1.41) and hypertension (OR, 1.17). After the data were adjusted to control for these and other cardiovascular risk factors, rosacea patients still were at significantly increased risk for CAD (OR, 1.20), said Dr. Tuan-Chun Hua, of the department of dermatology, National Taiwan University Hospital, National Yang-Ming University, and Taipei Medical University, all in Taipei, and associates.

Men with rosacea also were at significantly increased risk for diabetes, peripheral artery occlusive disease, and cerebral infarction, but women were not, Dr. Hua and associates said (J. Amer. Acad. Dermatol. 2015; [http://dx.doi.org/10.1016/j.jaad.2015.04.028]).

“The inflammatory nature of rosacea may be the reason for these associations, they wrote. “Clinicians should be alert to cardiovascular comorbidities in patients with rosacea.”

This study was supported by the Taipei Veterans General Hospital. Dr. Hua and associates reported having no financial conflicts of interest.

The erectile dysfunction agents sildenafil, vardenafil, and tadalafil showed a modest but significant association with increased risk of malignant melanoma in a large Swedish cohort study, but the pattern of the association suggests that the association is not causal, a report published online June 23 in JAMA shows.

These phosphodiesterase type 5 (PDE5) inhibitors target a part of the signaling pathway that has been implicated in the development of malignant melanoma, and the findings of a small cohort study (14 cases) suggested that the drugs might raise the risk of the malignancy. “It has been suggested that PDE5 inhibitors represent an important part of the medical history for dermatologists, and that melanoma screening could be performed by the physician when a sildenafil prescription is written for an older man with a history of sunburns,” said Dr. Stacy Loeb, of the department of urology and population health, and the Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, and her associates.

To examine this possible association, the investigators performed a case-control study using information from nationwide Swedish drug and cancer registries. They focused on 4,065 previously cancer-free men who developed malignant melanoma during the 6-year study period and 20,325 control subjects who did not develop melanoma.

Eleven percent of the men with melanoma had filled prescriptions for PDE5 inhibitors, compared with only 8% of the control subjects, for a crude odds ratio of 1.31. Further multivariable analysis showed a persistently increased risk of melanoma among users of ED drugs (OR, 1.21). This translates to 7 additional cases of melanoma for every 100,000 ED drug users in Sweden, Dr. Loeb and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6604]).

However, no dose-response relationship was found when the data were analyzed according to the number of prescriptions filled or the different exposure levels of the three PDE5 inhibitors. Men who filled the highest number of prescriptions did not have a higher risk of melanoma, and neither did men who took vardenafil or tadalafil, which have a longer half-life and thus a greater exposure time than sildenafil. This “raises questions about whether this association is causal. Rather, [it] may reflect confounding by lifestyle factors associated with both PDE5 inhibitor use and melanoma,” the researchers said.

Men who used ED agents were younger, and had fewer comorbidities, higher education levels, and higher incomes than those who did not. Malignant melanoma is known to be associated with higher SES and lower comorbidity burden. So it is possible that the association found in this study reflects residual confounding from “differences in lifestyle factors (such as leisure travel with ensuing sunburns) and health care seeking behavior,” they added.

This study was supported by several entities, including the Swedish Research Council, the Swedish Cancer Foundation, and the Laura and Isaac Perlmutter Cancer Center at the NYU Langone Medical Center. Dr. Loeb reported receiving personal fees from Bayer and Sanofi-Aventis, and her associates reported ties to Pfizer, Ferring, and AstraZeneca.

The erectile dysfunction agents sildenafil, vardenafil, and tadalafil showed a modest but significant association with increased risk of malignant melanoma in a large Swedish cohort study, but the pattern of the association suggests that the association is not causal, a report published online June 23 in JAMA shows.

These phosphodiesterase type 5 (PDE5) inhibitors target a part of the signaling pathway that has been implicated in the development of malignant melanoma, and the findings of a small cohort study (14 cases) suggested that the drugs might raise the risk of the malignancy. “It has been suggested that PDE5 inhibitors represent an important part of the medical history for dermatologists, and that melanoma screening could be performed by the physician when a sildenafil prescription is written for an older man with a history of sunburns,” said Dr. Stacy Loeb, of the department of urology and population health, and the Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, and her associates.

To examine this possible association, the investigators performed a case-control study using information from nationwide Swedish drug and cancer registries. They focused on 4,065 previously cancer-free men who developed malignant melanoma during the 6-year study period and 20,325 control subjects who did not develop melanoma.

Eleven percent of the men with melanoma had filled prescriptions for PDE5 inhibitors, compared with only 8% of the control subjects, for a crude odds ratio of 1.31. Further multivariable analysis showed a persistently increased risk of melanoma among users of ED drugs (OR, 1.21). This translates to 7 additional cases of melanoma for every 100,000 ED drug users in Sweden, Dr. Loeb and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6604]).

However, no dose-response relationship was found when the data were analyzed according to the number of prescriptions filled or the different exposure levels of the three PDE5 inhibitors. Men who filled the highest number of prescriptions did not have a higher risk of melanoma, and neither did men who took vardenafil or tadalafil, which have a longer half-life and thus a greater exposure time than sildenafil. This “raises questions about whether this association is causal. Rather, [it] may reflect confounding by lifestyle factors associated with both PDE5 inhibitor use and melanoma,” the researchers said.

Men who used ED agents were younger, and had fewer comorbidities, higher education levels, and higher incomes than those who did not. Malignant melanoma is known to be associated with higher SES and lower comorbidity burden. So it is possible that the association found in this study reflects residual confounding from “differences in lifestyle factors (such as leisure travel with ensuing sunburns) and health care seeking behavior,” they added.

This study was supported by several entities, including the Swedish Research Council, the Swedish Cancer Foundation, and the Laura and Isaac Perlmutter Cancer Center at the NYU Langone Medical Center. Dr. Loeb reported receiving personal fees from Bayer and Sanofi-Aventis, and her associates reported ties to Pfizer, Ferring, and AstraZeneca.

The erectile dysfunction agents sildenafil, vardenafil, and tadalafil showed a modest but significant association with increased risk of malignant melanoma in a large Swedish cohort study, but the pattern of the association suggests that the association is not causal, a report published online June 23 in JAMA shows.

These phosphodiesterase type 5 (PDE5) inhibitors target a part of the signaling pathway that has been implicated in the development of malignant melanoma, and the findings of a small cohort study (14 cases) suggested that the drugs might raise the risk of the malignancy. “It has been suggested that PDE5 inhibitors represent an important part of the medical history for dermatologists, and that melanoma screening could be performed by the physician when a sildenafil prescription is written for an older man with a history of sunburns,” said Dr. Stacy Loeb, of the department of urology and population health, and the Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, and her associates.

To examine this possible association, the investigators performed a case-control study using information from nationwide Swedish drug and cancer registries. They focused on 4,065 previously cancer-free men who developed malignant melanoma during the 6-year study period and 20,325 control subjects who did not develop melanoma.

Eleven percent of the men with melanoma had filled prescriptions for PDE5 inhibitors, compared with only 8% of the control subjects, for a crude odds ratio of 1.31. Further multivariable analysis showed a persistently increased risk of melanoma among users of ED drugs (OR, 1.21). This translates to 7 additional cases of melanoma for every 100,000 ED drug users in Sweden, Dr. Loeb and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6604]).

However, no dose-response relationship was found when the data were analyzed according to the number of prescriptions filled or the different exposure levels of the three PDE5 inhibitors. Men who filled the highest number of prescriptions did not have a higher risk of melanoma, and neither did men who took vardenafil or tadalafil, which have a longer half-life and thus a greater exposure time than sildenafil. This “raises questions about whether this association is causal. Rather, [it] may reflect confounding by lifestyle factors associated with both PDE5 inhibitor use and melanoma,” the researchers said.

Men who used ED agents were younger, and had fewer comorbidities, higher education levels, and higher incomes than those who did not. Malignant melanoma is known to be associated with higher SES and lower comorbidity burden. So it is possible that the association found in this study reflects residual confounding from “differences in lifestyle factors (such as leisure travel with ensuing sunburns) and health care seeking behavior,” they added.

This study was supported by several entities, including the Swedish Research Council, the Swedish Cancer Foundation, and the Laura and Isaac Perlmutter Cancer Center at the NYU Langone Medical Center. Dr. Loeb reported receiving personal fees from Bayer and Sanofi-Aventis, and her associates reported ties to Pfizer, Ferring, and AstraZeneca.

The erectile dysfunction agents sildenafil, vardenafil, and tadalafil showed a modest but significant association with increased risk of malignant melanoma in a large Swedish cohort study, but the pattern of the association suggests that the association is not causal, a report published online June 23 in JAMA shows.

These phosphodiesterase type 5 (PDE5) inhibitors target a part of the signaling pathway that has been implicated in the development of malignant melanoma, and the findings of a small cohort study (14 cases) suggested that the drugs might raise the risk of the malignancy. “It has been suggested that PDE5 inhibitors represent an important part of the medical history for dermatologists, and that melanoma screening could be performed by the physician when a sildenafil prescription is written for an older man with a history of sunburns,” said Dr. Stacy Loeb, of the department of urology and population health, and the Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, and her associates.

To examine this possible association, the investigators performed a case-control study using information from nationwide Swedish drug and cancer registries. They focused on 4,065 previously cancer-free men who developed malignant melanoma during the 6-year study period and 20,325 control subjects who did not develop melanoma.

Eleven percent of the men with melanoma had filled prescriptions for PDE5 inhibitors, compared with only 8% of the control subjects, for a crude odds ratio of 1.31. Further multivariable analysis showed a persistently increased risk of melanoma among users of ED drugs (OR, 1.21). This translates to 7 additional cases of melanoma for every 100,000 ED drug users in Sweden, Dr. Loeb and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6604]).

However, no dose-response relationship was found when the data were analyzed according to the number of prescriptions filled or the different exposure levels of the three PDE5 inhibitors. Men who filled the highest number of prescriptions did not have a higher risk of melanoma, and neither did men who took vardenafil or tadalafil, which have a longer half-life and thus a greater exposure time than sildenafil. This “raises questions about whether this association is causal. Rather, [it] may reflect confounding by lifestyle factors associated with both PDE5 inhibitor use and melanoma,” the researchers said.

Men who used ED agents were younger, and had fewer comorbidities, higher education levels, and higher incomes than those who did not. Malignant melanoma is known to be associated with higher SES and lower comorbidity burden. So it is possible that the association found in this study reflects residual confounding from “differences in lifestyle factors (such as leisure travel with ensuing sunburns) and health care seeking behavior,” they added.

This study was supported by several entities, including the Swedish Research Council, the Swedish Cancer Foundation, and the Laura and Isaac Perlmutter Cancer Center at the NYU Langone Medical Center. Dr. Loeb reported receiving personal fees from Bayer and Sanofi-Aventis, and her associates reported ties to Pfizer, Ferring, and AstraZeneca.

The erectile dysfunction agents sildenafil, vardenafil, and tadalafil showed a modest but significant association with increased risk of malignant melanoma in a large Swedish cohort study, but the pattern of the association suggests that the association is not causal, a report published online June 23 in JAMA shows.

These phosphodiesterase type 5 (PDE5) inhibitors target a part of the signaling pathway that has been implicated in the development of malignant melanoma, and the findings of a small cohort study (14 cases) suggested that the drugs might raise the risk of the malignancy. “It has been suggested that PDE5 inhibitors represent an important part of the medical history for dermatologists, and that melanoma screening could be performed by the physician when a sildenafil prescription is written for an older man with a history of sunburns,” said Dr. Stacy Loeb, of the department of urology and population health, and the Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, and her associates.

To examine this possible association, the investigators performed a case-control study using information from nationwide Swedish drug and cancer registries. They focused on 4,065 previously cancer-free men who developed malignant melanoma during the 6-year study period and 20,325 control subjects who did not develop melanoma.

Eleven percent of the men with melanoma had filled prescriptions for PDE5 inhibitors, compared with only 8% of the control subjects, for a crude odds ratio of 1.31. Further multivariable analysis showed a persistently increased risk of melanoma among users of ED drugs (OR, 1.21). This translates to 7 additional cases of melanoma for every 100,000 ED drug users in Sweden, Dr. Loeb and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6604]).

However, no dose-response relationship was found when the data were analyzed according to the number of prescriptions filled or the different exposure levels of the three PDE5 inhibitors. Men who filled the highest number of prescriptions did not have a higher risk of melanoma, and neither did men who took vardenafil or tadalafil, which have a longer half-life and thus a greater exposure time than sildenafil. This “raises questions about whether this association is causal. Rather, [it] may reflect confounding by lifestyle factors associated with both PDE5 inhibitor use and melanoma,” the researchers said.

Men who used ED agents were younger, and had fewer comorbidities, higher education levels, and higher incomes than those who did not. Malignant melanoma is known to be associated with higher SES and lower comorbidity burden. So it is possible that the association found in this study reflects residual confounding from “differences in lifestyle factors (such as leisure travel with ensuing sunburns) and health care seeking behavior,” they added.

This study was supported by several entities, including the Swedish Research Council, the Swedish Cancer Foundation, and the Laura and Isaac Perlmutter Cancer Center at the NYU Langone Medical Center. Dr. Loeb reported receiving personal fees from Bayer and Sanofi-Aventis, and her associates reported ties to Pfizer, Ferring, and AstraZeneca.

The erectile dysfunction agents sildenafil, vardenafil, and tadalafil showed a modest but significant association with increased risk of malignant melanoma in a large Swedish cohort study, but the pattern of the association suggests that the association is not causal, a report published online June 23 in JAMA shows.

These phosphodiesterase type 5 (PDE5) inhibitors target a part of the signaling pathway that has been implicated in the development of malignant melanoma, and the findings of a small cohort study (14 cases) suggested that the drugs might raise the risk of the malignancy. “It has been suggested that PDE5 inhibitors represent an important part of the medical history for dermatologists, and that melanoma screening could be performed by the physician when a sildenafil prescription is written for an older man with a history of sunburns,” said Dr. Stacy Loeb, of the department of urology and population health, and the Laura and Isaac Perlmutter Cancer Center, NYU Langone Medical Center, New York, and her associates.

To examine this possible association, the investigators performed a case-control study using information from nationwide Swedish drug and cancer registries. They focused on 4,065 previously cancer-free men who developed malignant melanoma during the 6-year study period and 20,325 control subjects who did not develop melanoma.

Eleven percent of the men with melanoma had filled prescriptions for PDE5 inhibitors, compared with only 8% of the control subjects, for a crude odds ratio of 1.31. Further multivariable analysis showed a persistently increased risk of melanoma among users of ED drugs (OR, 1.21). This translates to 7 additional cases of melanoma for every 100,000 ED drug users in Sweden, Dr. Loeb and her associates said (JAMA 2015 June 23 [doi:10.1001/jama.2015.6604]).

However, no dose-response relationship was found when the data were analyzed according to the number of prescriptions filled or the different exposure levels of the three PDE5 inhibitors. Men who filled the highest number of prescriptions did not have a higher risk of melanoma, and neither did men who took vardenafil or tadalafil, which have a longer half-life and thus a greater exposure time than sildenafil. This “raises questions about whether this association is causal. Rather, [it] may reflect confounding by lifestyle factors associated with both PDE5 inhibitor use and melanoma,” the researchers said.

Men who used ED agents were younger, and had fewer comorbidities, higher education levels, and higher incomes than those who did not. Malignant melanoma is known to be associated with higher SES and lower comorbidity burden. So it is possible that the association found in this study reflects residual confounding from “differences in lifestyle factors (such as leisure travel with ensuing sunburns) and health care seeking behavior,” they added.

This study was supported by several entities, including the Swedish Research Council, the Swedish Cancer Foundation, and the Laura and Isaac Perlmutter Cancer Center at the NYU Langone Medical Center. Dr. Loeb reported receiving personal fees from Bayer and Sanofi-Aventis, and her associates reported ties to Pfizer, Ferring, and AstraZeneca.

Half of the Latinos living in the United States who had high cholesterol were unaware that they had the condition, and fewer than one-third who knew about it were being treated, according to a large epidemiologic study reported online June 24 in Journal of the American Heart Association.

To examine cholesterol awareness among Mexicans, Puerto Ricans, Cubans, Central Americans, Dominicans, and South Americans residing in the United States, researchers analyzed data from the Hispanic Community Health Study/Study of Latinos, a study of Latino adults assessed during a 3-year period at four medical centers affiliated with San Diego State University, Northwestern University, Chicago, Albert Einstein College of Medicine, New York, and the University of Miami. They focused on 9,835 female and 6,580 male participants. High cholesterol was extremely common, affecting 45% of them, said Dr. Carlos J. Rodriguez of the department of medicine and public health sciences, Wake Forest University, Winston-Salem, N.C., and his associates.

A total of 49% of the adults who had high cholesterol were not aware that they had it. Only 30% were receiving treatment, and hypercholesterolemia was adequately controlled in only two-thirds of those who were treated, the investigators said (J. Am. Heart Assoc. 2015 June 24 [doi:10.1161/JAHA.115.001867]).

This lack of cholesterol awareness and treatment “bodes poorly for the public health of this large and growing segment of the U.S. population.” Public health programs to raise awareness, increase treatment rates, and ultimately control hypercholesterolemia among Latinos would not only improve health care disparities but would also significantly reduce the overall burden of heart disease in this country, the investigators noted.

This study was funded by the National Heart, Lung, and Blood Institute. Dr. Rodriguez reported receiving support from Alnylam, Amgen, and the American Heart Association.

Half of the Latinos living in the United States who had high cholesterol were unaware that they had the condition, and fewer than one-third who knew about it were being treated, according to a large epidemiologic study reported online June 24 in Journal of the American Heart Association.

To examine cholesterol awareness among Mexicans, Puerto Ricans, Cubans, Central Americans, Dominicans, and South Americans residing in the United States, researchers analyzed data from the Hispanic Community Health Study/Study of Latinos, a study of Latino adults assessed during a 3-year period at four medical centers affiliated with San Diego State University, Northwestern University, Chicago, Albert Einstein College of Medicine, New York, and the University of Miami. They focused on 9,835 female and 6,580 male participants. High cholesterol was extremely common, affecting 45% of them, said Dr. Carlos J. Rodriguez of the department of medicine and public health sciences, Wake Forest University, Winston-Salem, N.C., and his associates.

A total of 49% of the adults who had high cholesterol were not aware that they had it. Only 30% were receiving treatment, and hypercholesterolemia was adequately controlled in only two-thirds of those who were treated, the investigators said (J. Am. Heart Assoc. 2015 June 24 [doi:10.1161/JAHA.115.001867]).

This lack of cholesterol awareness and treatment “bodes poorly for the public health of this large and growing segment of the U.S. population.” Public health programs to raise awareness, increase treatment rates, and ultimately control hypercholesterolemia among Latinos would not only improve health care disparities but would also significantly reduce the overall burden of heart disease in this country, the investigators noted.

This study was funded by the National Heart, Lung, and Blood Institute. Dr. Rodriguez reported receiving support from Alnylam, Amgen, and the American Heart Association.

Half of the Latinos living in the United States who had high cholesterol were unaware that they had the condition, and fewer than one-third who knew about it were being treated, according to a large epidemiologic study reported online June 24 in Journal of the American Heart Association.

To examine cholesterol awareness among Mexicans, Puerto Ricans, Cubans, Central Americans, Dominicans, and South Americans residing in the United States, researchers analyzed data from the Hispanic Community Health Study/Study of Latinos, a study of Latino adults assessed during a 3-year period at four medical centers affiliated with San Diego State University, Northwestern University, Chicago, Albert Einstein College of Medicine, New York, and the University of Miami. They focused on 9,835 female and 6,580 male participants. High cholesterol was extremely common, affecting 45% of them, said Dr. Carlos J. Rodriguez of the department of medicine and public health sciences, Wake Forest University, Winston-Salem, N.C., and his associates.

A total of 49% of the adults who had high cholesterol were not aware that they had it. Only 30% were receiving treatment, and hypercholesterolemia was adequately controlled in only two-thirds of those who were treated, the investigators said (J. Am. Heart Assoc. 2015 June 24 [doi:10.1161/JAHA.115.001867]).

This lack of cholesterol awareness and treatment “bodes poorly for the public health of this large and growing segment of the U.S. population.” Public health programs to raise awareness, increase treatment rates, and ultimately control hypercholesterolemia among Latinos would not only improve health care disparities but would also significantly reduce the overall burden of heart disease in this country, the investigators noted.

This study was funded by the National Heart, Lung, and Blood Institute. Dr. Rodriguez reported receiving support from Alnylam, Amgen, and the American Heart Association.

Half of the Latinos living in the United States who had high cholesterol were unaware that they had the condition, and fewer than one-third who knew about it were being treated, according to a large epidemiologic study reported online June 24 in Journal of the American Heart Association.

To examine cholesterol awareness among Mexicans, Puerto Ricans, Cubans, Central Americans, Dominicans, and South Americans residing in the United States, researchers analyzed data from the Hispanic Community Health Study/Study of Latinos, a study of Latino adults assessed during a 3-year period at four medical centers affiliated with San Diego State University, Northwestern University, Chicago, Albert Einstein College of Medicine, New York, and the University of Miami. They focused on 9,835 female and 6,580 male participants. High cholesterol was extremely common, affecting 45% of them, said Dr. Carlos J. Rodriguez of the department of medicine and public health sciences, Wake Forest University, Winston-Salem, N.C., and his associates.

A total of 49% of the adults who had high cholesterol were not aware that they had it. Only 30% were receiving treatment, and hypercholesterolemia was adequately controlled in only two-thirds of those who were treated, the investigators said (J. Am. Heart Assoc. 2015 June 24 [doi:10.1161/JAHA.115.001867]).

This lack of cholesterol awareness and treatment “bodes poorly for the public health of this large and growing segment of the U.S. population.” Public health programs to raise awareness, increase treatment rates, and ultimately control hypercholesterolemia among Latinos would not only improve health care disparities but would also significantly reduce the overall burden of heart disease in this country, the investigators noted.

This study was funded by the National Heart, Lung, and Blood Institute. Dr. Rodriguez reported receiving support from Alnylam, Amgen, and the American Heart Association.

Half of the Latinos living in the United States who had high cholesterol were unaware that they had the condition, and fewer than one-third who knew about it were being treated, according to a large epidemiologic study reported online June 24 in Journal of the American Heart Association.

To examine cholesterol awareness among Mexicans, Puerto Ricans, Cubans, Central Americans, Dominicans, and South Americans residing in the United States, researchers analyzed data from the Hispanic Community Health Study/Study of Latinos, a study of Latino adults assessed during a 3-year period at four medical centers affiliated with San Diego State University, Northwestern University, Chicago, Albert Einstein College of Medicine, New York, and the University of Miami. They focused on 9,835 female and 6,580 male participants. High cholesterol was extremely common, affecting 45% of them, said Dr. Carlos J. Rodriguez of the department of medicine and public health sciences, Wake Forest University, Winston-Salem, N.C., and his associates.

A total of 49% of the adults who had high cholesterol were not aware that they had it. Only 30% were receiving treatment, and hypercholesterolemia was adequately controlled in only two-thirds of those who were treated, the investigators said (J. Am. Heart Assoc. 2015 June 24 [doi:10.1161/JAHA.115.001867]).

This lack of cholesterol awareness and treatment “bodes poorly for the public health of this large and growing segment of the U.S. population.” Public health programs to raise awareness, increase treatment rates, and ultimately control hypercholesterolemia among Latinos would not only improve health care disparities but would also significantly reduce the overall burden of heart disease in this country, the investigators noted.

This study was funded by the National Heart, Lung, and Blood Institute. Dr. Rodriguez reported receiving support from Alnylam, Amgen, and the American Heart Association.

Half of the Latinos living in the United States who had high cholesterol were unaware that they had the condition, and fewer than one-third who knew about it were being treated, according to a large epidemiologic study reported online June 24 in Journal of the American Heart Association.

To examine cholesterol awareness among Mexicans, Puerto Ricans, Cubans, Central Americans, Dominicans, and South Americans residing in the United States, researchers analyzed data from the Hispanic Community Health Study/Study of Latinos, a study of Latino adults assessed during a 3-year period at four medical centers affiliated with San Diego State University, Northwestern University, Chicago, Albert Einstein College of Medicine, New York, and the University of Miami. They focused on 9,835 female and 6,580 male participants. High cholesterol was extremely common, affecting 45% of them, said Dr. Carlos J. Rodriguez of the department of medicine and public health sciences, Wake Forest University, Winston-Salem, N.C., and his associates.

A total of 49% of the adults who had high cholesterol were not aware that they had it. Only 30% were receiving treatment, and hypercholesterolemia was adequately controlled in only two-thirds of those who were treated, the investigators said (J. Am. Heart Assoc. 2015 June 24 [doi:10.1161/JAHA.115.001867]).

This lack of cholesterol awareness and treatment “bodes poorly for the public health of this large and growing segment of the U.S. population.” Public health programs to raise awareness, increase treatment rates, and ultimately control hypercholesterolemia among Latinos would not only improve health care disparities but would also significantly reduce the overall burden of heart disease in this country, the investigators noted.

This study was funded by the National Heart, Lung, and Blood Institute. Dr. Rodriguez reported receiving support from Alnylam, Amgen, and the American Heart Association.

A new clinical practice guideline for managing dyslipidemia to reduce adults’ CVD risk will likely draw criticism for the simple reason that it calls for change, according to the co-chairs of the panel that compiled the guideline’s 26 recommendations.

Like the existing American College of Cardiology/American Heart Association guideline, this guideline issued jointly by the U.S. Department of Veterans Affairs and the U.S. Department of Defense in January 2015 calls for eliminating the use of cholesterol levels as treatment targets. But the VA/DOD guideline differs in its more conservative approach: It recommends against the routine use of extensive testing to estimate CVD risk, calls for a more nuanced and “shared” approach to weighing the risks and benefits of statin therapy, advocates initiating such therapy at a lower dose, and recommends against routine laboratory monitoring using liver function panels and lipid testing.

These new recommendations are based on strong and recent evidence, but they challenge previous, firmly embedded beliefs and so “will undoubtedly provoke criticism,” said panel co-chairs Dr. John R. Downs of South Texas Veterans Health Care System, San Antonio, and Dr. Patrick G. O’Malley of the Uniformed Services University of the Health Sciences, Bethesda, Md.

“We hope we have brought some order to the chaos of clinical guidelines by providing a rigorous, simple, transparent, and high-quality guideline that providers can use to efficiently care for their patients,” they noted (Ann. Intern. Med. 2015 June 22 [doi:10.736/M15-0840]).

The recommendations include:

• No longer using LDL or non-HDL cholesterol levels as treatment targets, because the only data to suggest that this is beneficial are both indirect and questionable.

• No routine use of new genetic, serologic, physiologic, anatomical, or psychosocial risk markers to improve CVD risk prediction. In particular, high-sensitivity C-reactive protein testing and coronary artery calcium testing add only a little information to conventional risk calculations, do not improve CVD outcomes, and are costly; the latter test also exposes patients to potentially harmful radiation.

There is no evidence that primary prevention benefits low-risk patients (those with less than a 6% 10-year risk of CVD events) and only limited evidence that it benefits intermediate-risk patients (those at 6%-12% 10-year risk), so any decision to initiate statin therapy in this patient population must be “nuanced” and must include patient input.

For secondary prevention, statins should be initiated at a moderate dose and titrated to a higher dose only when medically indicated, such as when acute coronary syndrome or recurrent CVD events develop. Higher doses are not consistently beneficial and are associated with side effects that may lead to decreased adherence.

Patients no longer need to fast before lipid testing because fasting makes only a small difference in test results that is unlikely to affect risk classification or therapeutic decisions. Moreover, fasting is a burden for patients, who may avoid lipid testing altogether if they have to fast for 9-12 hours, and a burden for laboratories because of the large number of patients who present for testing early in the morning.

Routine lipid testing to monitor treatment effect is now unnecessary because lipid levels are no longer to be used as treatment targets.

Routine liver-function tests are unnecessary because evidence doesn’t show this improves detection of statin-associated liver damage (except at the highest doses), and serious liver damage is extremely rare. Moreover, frequent testing is a burden for both the patient and the clinician.

The full guideline is available at www.healthquality.va.gov/guidelines/CD/lipids

A new clinical practice guideline for managing dyslipidemia to reduce adults’ CVD risk will likely draw criticism for the simple reason that it calls for change, according to the co-chairs of the panel that compiled the guideline’s 26 recommendations.

Like the existing American College of Cardiology/American Heart Association guideline, this guideline issued jointly by the U.S. Department of Veterans Affairs and the U.S. Department of Defense in January 2015 calls for eliminating the use of cholesterol levels as treatment targets. But the VA/DOD guideline differs in its more conservative approach: It recommends against the routine use of extensive testing to estimate CVD risk, calls for a more nuanced and “shared” approach to weighing the risks and benefits of statin therapy, advocates initiating such therapy at a lower dose, and recommends against routine laboratory monitoring using liver function panels and lipid testing.

These new recommendations are based on strong and recent evidence, but they challenge previous, firmly embedded beliefs and so “will undoubtedly provoke criticism,” said panel co-chairs Dr. John R. Downs of South Texas Veterans Health Care System, San Antonio, and Dr. Patrick G. O’Malley of the Uniformed Services University of the Health Sciences, Bethesda, Md.

“We hope we have brought some order to the chaos of clinical guidelines by providing a rigorous, simple, transparent, and high-quality guideline that providers can use to efficiently care for their patients,” they noted (Ann. Intern. Med. 2015 June 22 [doi:10.736/M15-0840]).

The recommendations include:

• No longer using LDL or non-HDL cholesterol levels as treatment targets, because the only data to suggest that this is beneficial are both indirect and questionable.

• No routine use of new genetic, serologic, physiologic, anatomical, or psychosocial risk markers to improve CVD risk prediction. In particular, high-sensitivity C-reactive protein testing and coronary artery calcium testing add only a little information to conventional risk calculations, do not improve CVD outcomes, and are costly; the latter test also exposes patients to potentially harmful radiation.

There is no evidence that primary prevention benefits low-risk patients (those with less than a 6% 10-year risk of CVD events) and only limited evidence that it benefits intermediate-risk patients (those at 6%-12% 10-year risk), so any decision to initiate statin therapy in this patient population must be “nuanced” and must include patient input.

For secondary prevention, statins should be initiated at a moderate dose and titrated to a higher dose only when medically indicated, such as when acute coronary syndrome or recurrent CVD events develop. Higher doses are not consistently beneficial and are associated with side effects that may lead to decreased adherence.

Patients no longer need to fast before lipid testing because fasting makes only a small difference in test results that is unlikely to affect risk classification or therapeutic decisions. Moreover, fasting is a burden for patients, who may avoid lipid testing altogether if they have to fast for 9-12 hours, and a burden for laboratories because of the large number of patients who present for testing early in the morning.

Routine lipid testing to monitor treatment effect is now unnecessary because lipid levels are no longer to be used as treatment targets.

Routine liver-function tests are unnecessary because evidence doesn’t show this improves detection of statin-associated liver damage (except at the highest doses), and serious liver damage is extremely rare. Moreover, frequent testing is a burden for both the patient and the clinician.

The full guideline is available at www.healthquality.va.gov/guidelines/CD/lipids

A new clinical practice guideline for managing dyslipidemia to reduce adults’ CVD risk will likely draw criticism for the simple reason that it calls for change, according to the co-chairs of the panel that compiled the guideline’s 26 recommendations.

Like the existing American College of Cardiology/American Heart Association guideline, this guideline issued jointly by the U.S. Department of Veterans Affairs and the U.S. Department of Defense in January 2015 calls for eliminating the use of cholesterol levels as treatment targets. But the VA/DOD guideline differs in its more conservative approach: It recommends against the routine use of extensive testing to estimate CVD risk, calls for a more nuanced and “shared” approach to weighing the risks and benefits of statin therapy, advocates initiating such therapy at a lower dose, and recommends against routine laboratory monitoring using liver function panels and lipid testing.

These new recommendations are based on strong and recent evidence, but they challenge previous, firmly embedded beliefs and so “will undoubtedly provoke criticism,” said panel co-chairs Dr. John R. Downs of South Texas Veterans Health Care System, San Antonio, and Dr. Patrick G. O’Malley of the Uniformed Services University of the Health Sciences, Bethesda, Md.

“We hope we have brought some order to the chaos of clinical guidelines by providing a rigorous, simple, transparent, and high-quality guideline that providers can use to efficiently care for their patients,” they noted (Ann. Intern. Med. 2015 June 22 [doi:10.736/M15-0840]).

The recommendations include:

• No longer using LDL or non-HDL cholesterol levels as treatment targets, because the only data to suggest that this is beneficial are both indirect and questionable.

• No routine use of new genetic, serologic, physiologic, anatomical, or psychosocial risk markers to improve CVD risk prediction. In particular, high-sensitivity C-reactive protein testing and coronary artery calcium testing add only a little information to conventional risk calculations, do not improve CVD outcomes, and are costly; the latter test also exposes patients to potentially harmful radiation.

There is no evidence that primary prevention benefits low-risk patients (those with less than a 6% 10-year risk of CVD events) and only limited evidence that it benefits intermediate-risk patients (those at 6%-12% 10-year risk), so any decision to initiate statin therapy in this patient population must be “nuanced” and must include patient input.

For secondary prevention, statins should be initiated at a moderate dose and titrated to a higher dose only when medically indicated, such as when acute coronary syndrome or recurrent CVD events develop. Higher doses are not consistently beneficial and are associated with side effects that may lead to decreased adherence.

Patients no longer need to fast before lipid testing because fasting makes only a small difference in test results that is unlikely to affect risk classification or therapeutic decisions. Moreover, fasting is a burden for patients, who may avoid lipid testing altogether if they have to fast for 9-12 hours, and a burden for laboratories because of the large number of patients who present for testing early in the morning.

Routine lipid testing to monitor treatment effect is now unnecessary because lipid levels are no longer to be used as treatment targets.

Routine liver-function tests are unnecessary because evidence doesn’t show this improves detection of statin-associated liver damage (except at the highest doses), and serious liver damage is extremely rare. Moreover, frequent testing is a burden for both the patient and the clinician.

The full guideline is available at www.healthquality.va.gov/guidelines/CD/lipids

Pregnancy outcomes in women with systemic lupus erythematosus were better than expected in the largest study of the issue to date, according to a report published online June 22 in Annals of Internal Medicine.

Until now, research examining pregnancy outcomes in systemic lupus erythematosus (SLE) has comprised retrospective or single-center studies with few patients. These studies have failed to include women of diverse ethnic backgrounds and have drawn “controversial” conclusions, Dr. Jill P. Buyon of New York University/Langone Medical Center, New York, and her associates wrote in their report.

Dr. Buyon and her colleagues examined pregnancy outcomes in SLE by analyzing data in the prospective PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and SLE) study. They focused on 385 women who conceived singleton pregnancies while their SLE was inactive or mildly to moderately active during the 8-year study period. The women (48% non-Hispanic white, 15% Hispanic white, 20% African American, 11% Asian American, 3% other, and 3% unknown ethnicity) were enrolled after attaining at least 12 weeks’ gestation, and were followed at eight sites in the United States and one in Canada.

The adverse outcomes of interest in this study were fetal or neonatal death; birth before 36 weeks due to placental insufficiency, maternal hypertension, or preeclampsia; and small-for-gestational-age neonates. Overall, 81% of these pregnancies had none of these complications, and 3% of the women experienced severe SLE flares during pregnancy. “In patients with inactive disease or stable mild or moderate activity, pregnancy is safer for mother and child than it was previously believed to be,” the investigators wrote (Ann. Intern, Med. 2015 June 22 [doi:10.7326/M14-2235]).

One or more adverse outcomes occurred in 19% of the pregnancies, including fetal death (4%), neonatal death (1%), preterm delivery due to placental insufficiency or preeclampsia (9%), and small-for-gestational-age neonates (10%). The rate of adverse pregnancy outcomes was highest among both African Americans and Hispanic whites (26% in each), followed by non-Hispanic whites (15%) and Asian Americans (14%).

Risk factors that predicted adverse pregnancy outcomes included nonwhite ethnicity, the presence of antiphospholipid antibodies, the presence of lupus anticoagulant, higher scores on the Physician’s Global Assessment (PGA) or Systemic Lupus Erythematosus Pregnancy Disease Activity Index, the use of antihypertensive drugs, a low platelet count, and the development of a severe SLE flare during pregnancy.

The rate of adverse pregnancy outcomes was remarkably low – less than 8% – in the large subgroup of women at lowest risk for adverse pregnancy outcomes, which includes those who were white, negative for lupus anticoagulant, had a PGA score of 1 or lower, were not taking antihypertensive medication, had adequate platelet counts, and did not experience a severe SLE flare during the pregnancy, Dr. Buyon and her associates added.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institutes of Health, the Mary Kirkland Center for Lupus Research, and Rheuminations supported the study. Dr. Buyon and her associates reported having no conflicts of interest.

Pregnancy outcomes in women with systemic lupus erythematosus were better than expected in the largest study of the issue to date, according to a report published online June 22 in Annals of Internal Medicine.

Until now, research examining pregnancy outcomes in systemic lupus erythematosus (SLE) has comprised retrospective or single-center studies with few patients. These studies have failed to include women of diverse ethnic backgrounds and have drawn “controversial” conclusions, Dr. Jill P. Buyon of New York University/Langone Medical Center, New York, and her associates wrote in their report.

Dr. Buyon and her colleagues examined pregnancy outcomes in SLE by analyzing data in the prospective PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and SLE) study. They focused on 385 women who conceived singleton pregnancies while their SLE was inactive or mildly to moderately active during the 8-year study period. The women (48% non-Hispanic white, 15% Hispanic white, 20% African American, 11% Asian American, 3% other, and 3% unknown ethnicity) were enrolled after attaining at least 12 weeks’ gestation, and were followed at eight sites in the United States and one in Canada.

The adverse outcomes of interest in this study were fetal or neonatal death; birth before 36 weeks due to placental insufficiency, maternal hypertension, or preeclampsia; and small-for-gestational-age neonates. Overall, 81% of these pregnancies had none of these complications, and 3% of the women experienced severe SLE flares during pregnancy. “In patients with inactive disease or stable mild or moderate activity, pregnancy is safer for mother and child than it was previously believed to be,” the investigators wrote (Ann. Intern, Med. 2015 June 22 [doi:10.7326/M14-2235]).

One or more adverse outcomes occurred in 19% of the pregnancies, including fetal death (4%), neonatal death (1%), preterm delivery due to placental insufficiency or preeclampsia (9%), and small-for-gestational-age neonates (10%). The rate of adverse pregnancy outcomes was highest among both African Americans and Hispanic whites (26% in each), followed by non-Hispanic whites (15%) and Asian Americans (14%).

Risk factors that predicted adverse pregnancy outcomes included nonwhite ethnicity, the presence of antiphospholipid antibodies, the presence of lupus anticoagulant, higher scores on the Physician’s Global Assessment (PGA) or Systemic Lupus Erythematosus Pregnancy Disease Activity Index, the use of antihypertensive drugs, a low platelet count, and the development of a severe SLE flare during pregnancy.

The rate of adverse pregnancy outcomes was remarkably low – less than 8% – in the large subgroup of women at lowest risk for adverse pregnancy outcomes, which includes those who were white, negative for lupus anticoagulant, had a PGA score of 1 or lower, were not taking antihypertensive medication, had adequate platelet counts, and did not experience a severe SLE flare during the pregnancy, Dr. Buyon and her associates added.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institutes of Health, the Mary Kirkland Center for Lupus Research, and Rheuminations supported the study. Dr. Buyon and her associates reported having no conflicts of interest.

Pregnancy outcomes in women with systemic lupus erythematosus were better than expected in the largest study of the issue to date, according to a report published online June 22 in Annals of Internal Medicine.

Until now, research examining pregnancy outcomes in systemic lupus erythematosus (SLE) has comprised retrospective or single-center studies with few patients. These studies have failed to include women of diverse ethnic backgrounds and have drawn “controversial” conclusions, Dr. Jill P. Buyon of New York University/Langone Medical Center, New York, and her associates wrote in their report.

Dr. Buyon and her colleagues examined pregnancy outcomes in SLE by analyzing data in the prospective PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and SLE) study. They focused on 385 women who conceived singleton pregnancies while their SLE was inactive or mildly to moderately active during the 8-year study period. The women (48% non-Hispanic white, 15% Hispanic white, 20% African American, 11% Asian American, 3% other, and 3% unknown ethnicity) were enrolled after attaining at least 12 weeks’ gestation, and were followed at eight sites in the United States and one in Canada.

The adverse outcomes of interest in this study were fetal or neonatal death; birth before 36 weeks due to placental insufficiency, maternal hypertension, or preeclampsia; and small-for-gestational-age neonates. Overall, 81% of these pregnancies had none of these complications, and 3% of the women experienced severe SLE flares during pregnancy. “In patients with inactive disease or stable mild or moderate activity, pregnancy is safer for mother and child than it was previously believed to be,” the investigators wrote (Ann. Intern, Med. 2015 June 22 [doi:10.7326/M14-2235]).

One or more adverse outcomes occurred in 19% of the pregnancies, including fetal death (4%), neonatal death (1%), preterm delivery due to placental insufficiency or preeclampsia (9%), and small-for-gestational-age neonates (10%). The rate of adverse pregnancy outcomes was highest among both African Americans and Hispanic whites (26% in each), followed by non-Hispanic whites (15%) and Asian Americans (14%).

Risk factors that predicted adverse pregnancy outcomes included nonwhite ethnicity, the presence of antiphospholipid antibodies, the presence of lupus anticoagulant, higher scores on the Physician’s Global Assessment (PGA) or Systemic Lupus Erythematosus Pregnancy Disease Activity Index, the use of antihypertensive drugs, a low platelet count, and the development of a severe SLE flare during pregnancy.

The rate of adverse pregnancy outcomes was remarkably low – less than 8% – in the large subgroup of women at lowest risk for adverse pregnancy outcomes, which includes those who were white, negative for lupus anticoagulant, had a PGA score of 1 or lower, were not taking antihypertensive medication, had adequate platelet counts, and did not experience a severe SLE flare during the pregnancy, Dr. Buyon and her associates added.

The National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institutes of Health, the Mary Kirkland Center for Lupus Research, and Rheuminations supported the study. Dr. Buyon and her associates reported having no conflicts of interest.