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Vitamin D and Kids: What Dermatologists Should Know
Vitamin D insufficiency is thought to play a role in a range of diseases, including bone and autoimmune disease, cancer, infection, and life-threatening conditions such as heart attack and stroke.
"Vitamin D synthesis in the skin from UVB exposure cannot be dissociated from acute and chronic photodamage, including photocarcinogenesis," said Dr. Ki-Young Suh. "Because it is has a relatively long half-life in the serum, 25(OH)D is the metabolite we use to measure the amount of vitamin D status."
The amount of vitamin D needed for good health remains controversial, noted Dr. Suh of the University of California, Los Angeles. The accepted level that has been shown to prevent rickets is 50 nmol/L, and any serum vitamin D level below that is considered deficient. Serum vitamin D levels of at least 75 nmol/L have been associated with preventing osteoporosis.
Recent studies have shown that the prevalence of vitamin D deficiency in the U.S. population is on the rise. Potential factors that impact serum vitamin D levels include sun exposure, diet, obesity, and the use of certain medications, Dr. Suh said at the seminar on women's and pediatric dermatology, which was sponsored by Skin Disease Education Foundation.
It has been questioned whether or not dermatologists contribute to the increased prevalence of vitamin D deficiency because of sun protection recommendations, Dr. Suh said. However, studies have shown that most Americans probably do not use sun protection properly or adequately enough to cause vitamin D deficiency.
Although in vitro studies of human skin show inhibition of vitamin D production with sunscreen use, real-life studies show that seasonal increases in serum vitamin D levels persist even when people use sunscreen, she said.
One key factor that may drive vitamin D deficiency is the increased amount of time children spend indoors, both at school and during leisure time. Adolescent girls in particular have been found to have the lowest amount of dietary vitamin D consumption, Dr. Suh said.
The American Academy of Pediatrics' latest recommendations on vitamin D were issued in 2008. The recommendations stated that serum vitamin D levels in children should be greater than 50 nmol/L to maintain good bone health. The AAP recommends a supplement of 400 IU of vitamin D for breastfed infants, for infants and children who consume less than 1 L/day of vitamin D–fortified milk or formula, and for adolescents whose diets are low in vitamin D.
Dr. Suh noted that these recommendations may not apply equally to all ethnic groups, and that children who are at increased risk of vitamin D deficiency may need additional supplementation.
Disclosures: Dr. Suh did not report having any conflicts of interest. SDEF and this news organization are owned by Elsevier.
Vitamin D insufficiency is thought to play a role in a range of diseases, including bone and autoimmune disease, cancer, infection, and life-threatening conditions such as heart attack and stroke.
"Vitamin D synthesis in the skin from UVB exposure cannot be dissociated from acute and chronic photodamage, including photocarcinogenesis," said Dr. Ki-Young Suh. "Because it is has a relatively long half-life in the serum, 25(OH)D is the metabolite we use to measure the amount of vitamin D status."
The amount of vitamin D needed for good health remains controversial, noted Dr. Suh of the University of California, Los Angeles. The accepted level that has been shown to prevent rickets is 50 nmol/L, and any serum vitamin D level below that is considered deficient. Serum vitamin D levels of at least 75 nmol/L have been associated with preventing osteoporosis.
Recent studies have shown that the prevalence of vitamin D deficiency in the U.S. population is on the rise. Potential factors that impact serum vitamin D levels include sun exposure, diet, obesity, and the use of certain medications, Dr. Suh said at the seminar on women's and pediatric dermatology, which was sponsored by Skin Disease Education Foundation.
It has been questioned whether or not dermatologists contribute to the increased prevalence of vitamin D deficiency because of sun protection recommendations, Dr. Suh said. However, studies have shown that most Americans probably do not use sun protection properly or adequately enough to cause vitamin D deficiency.
Although in vitro studies of human skin show inhibition of vitamin D production with sunscreen use, real-life studies show that seasonal increases in serum vitamin D levels persist even when people use sunscreen, she said.
One key factor that may drive vitamin D deficiency is the increased amount of time children spend indoors, both at school and during leisure time. Adolescent girls in particular have been found to have the lowest amount of dietary vitamin D consumption, Dr. Suh said.
The American Academy of Pediatrics' latest recommendations on vitamin D were issued in 2008. The recommendations stated that serum vitamin D levels in children should be greater than 50 nmol/L to maintain good bone health. The AAP recommends a supplement of 400 IU of vitamin D for breastfed infants, for infants and children who consume less than 1 L/day of vitamin D–fortified milk or formula, and for adolescents whose diets are low in vitamin D.
Dr. Suh noted that these recommendations may not apply equally to all ethnic groups, and that children who are at increased risk of vitamin D deficiency may need additional supplementation.
Disclosures: Dr. Suh did not report having any conflicts of interest. SDEF and this news organization are owned by Elsevier.
Vitamin D insufficiency is thought to play a role in a range of diseases, including bone and autoimmune disease, cancer, infection, and life-threatening conditions such as heart attack and stroke.
"Vitamin D synthesis in the skin from UVB exposure cannot be dissociated from acute and chronic photodamage, including photocarcinogenesis," said Dr. Ki-Young Suh. "Because it is has a relatively long half-life in the serum, 25(OH)D is the metabolite we use to measure the amount of vitamin D status."
The amount of vitamin D needed for good health remains controversial, noted Dr. Suh of the University of California, Los Angeles. The accepted level that has been shown to prevent rickets is 50 nmol/L, and any serum vitamin D level below that is considered deficient. Serum vitamin D levels of at least 75 nmol/L have been associated with preventing osteoporosis.
Recent studies have shown that the prevalence of vitamin D deficiency in the U.S. population is on the rise. Potential factors that impact serum vitamin D levels include sun exposure, diet, obesity, and the use of certain medications, Dr. Suh said at the seminar on women's and pediatric dermatology, which was sponsored by Skin Disease Education Foundation.
It has been questioned whether or not dermatologists contribute to the increased prevalence of vitamin D deficiency because of sun protection recommendations, Dr. Suh said. However, studies have shown that most Americans probably do not use sun protection properly or adequately enough to cause vitamin D deficiency.
Although in vitro studies of human skin show inhibition of vitamin D production with sunscreen use, real-life studies show that seasonal increases in serum vitamin D levels persist even when people use sunscreen, she said.
One key factor that may drive vitamin D deficiency is the increased amount of time children spend indoors, both at school and during leisure time. Adolescent girls in particular have been found to have the lowest amount of dietary vitamin D consumption, Dr. Suh said.
The American Academy of Pediatrics' latest recommendations on vitamin D were issued in 2008. The recommendations stated that serum vitamin D levels in children should be greater than 50 nmol/L to maintain good bone health. The AAP recommends a supplement of 400 IU of vitamin D for breastfed infants, for infants and children who consume less than 1 L/day of vitamin D–fortified milk or formula, and for adolescents whose diets are low in vitamin D.
Dr. Suh noted that these recommendations may not apply equally to all ethnic groups, and that children who are at increased risk of vitamin D deficiency may need additional supplementation.
Disclosures: Dr. Suh did not report having any conflicts of interest. SDEF and this news organization are owned by Elsevier.
EXPERT ANALYSIS FROM A SEMINAR ON WOMEN'S AND PEDIATRIC DERMATOLOGY
Screening Mammography Accounts for 10% of Reduction in Breast Cancer Deaths
The availability of screening mammography accounted for a 10% relative reduction in deaths from breast cancer from 1996 through 2005, based on data from more than 40,000 women with breast cancer, according to findings published online on Sept. 22 in the New England Journal of Medicine.
“The use of screening mammography is still debated, chiefly because of concern regarding methodologic limitations in some of the randomized trials,” wrote Dr. Mette Kalager of the Cancer Registry of Norway, Oslo, and the Harvard School of Public Health in Boston, and colleagues. Norway implemented a nationwide breast cancer screening program in 1996. To avoid some of the limitations of previous studies, the researchers divided 40,075 women with breast cancer into four groups: those in counties of Norway with and without breast cancer screening programs between 1996 and 2005, and two historical comparison groups of women living in these same areas between 1986 and 1995. The researchers obtained information on breast cancer as the cause of death through links between the Cancer Registry of Norway and the Cause of Death Registry at Statistics Norway (N. Engl. J. Med. 2010;363:1203-10).
Women who were aged 50-69 years beginning in 1996 were eligible for screening mammography. The maximum follow-up time was 8.9 years. Overall, 4,791 (12%) of the women with a breast cancer diagnosis died, and 423 of these women (9%) were diagnosed after the introduction of the screening program.
The rate of death in the screened group of women aged 50-69 years was 18 per 100,000 person-years, compared with 25 per 100,000 person-years in their historical counterparts. The rate of death in the unscreened group was 21 per 100,000 person-years, compared with 26 per 100,000 person-years in their historical counterparts.
These numbers translate to a 28% drop in breast cancer mortality in the screened group and an 18% drop in the unscreened group, compared with their historical counterparts, suggesting a 10% relative reduction in mortality from breast cancer screening alone, Dr. Kalager and associates noted.
Part of the reduction in both screened and unscreened groups was “presumably a result of increased breast cancer awareness, improved therapy, and more sensitive diagnostic tools,” they said.
When mortality rates were broken down by stage, women in the screened group with stage I tumors had a 16% relative reduction in mortality, compared with their historical counterparts. Women in the unscreened group had a 13% relative reduction in mortality, compared with their historical counterparts.
Women in the screened group with stage II tumors had a 29% reduction in mortality, compared with their historical counterparts. The reduction in mortality in the unscreened group was 7%. Women with stage III or IV tumors showed equally reduced mortality from cancer in both the screened and unscreened groups (rate ratio for death in both groups, 0.70), compared with their historical counterparts.
Women who were younger than 50 years or older than 69 years and therefore not eligible for screening during the study period also showed fewer deaths from breast cancer per 100,000 person-years, compared with their historical counterparts. Women in these age groups likely benefited from the presence of multidisciplinary cancer care teams, although they were not screened for breast cancer, the researchers noted.
“To our surprise, the reduction in breast cancer mortality among women [aged 70-84] was largely the same as that in the screening group,” they added.
The study was limited by a relatively short follow-up period and by the possibility that some women in the unscreened group may have in fact been screened. The results suggest that screening mammography does reduce the rates of death from breast cancer, but the benefits may occur only in the context of “a well-functioning health care system that is available to the entire population,” the investigators said.
The study was funded by the Cancer Registry of Norway and the Research Council of Norway. Dr. Kalager and associates had no financial conflicts to disclose. Dr. Welch had no relevant financial disclosures.
Dr. H. Gilbert Welch noted that the 10% reduction in death rates in the study by Dr. Kalager and colleagues is below the 15%-23% reduction estimated by the U.S. Preventive Services Task Force in a study published in 2009 (Ann. Intern. Med. 2009;151:738-42). Dr. Welch commented that, based on the historical comparisons used in the study, “it is quite plausible that screening mammography was more effective in the past than it is now.” He suggested that increased awareness of breast cancer and of the need to seek care for overt breast abnormalities have made screening less of a factor in reducing breast cancer deaths.
He also emphasized that the reduction in mortality in this study appeared to be due to a combination of both screening and the multidisciplinary teams that provided better breast cancer treatment. Indeed, the study provides data that the treatment may be most important, since women over age 70 years who were not offered screening mammography had an 8% reduction in breast cancer mortality. “Thus, the relative reduction in mortality due to screening mammography alone could be as low as 2%,” he said.
Dr. Welch also raised the issue of the false alarm. “Up to 1,000 women will have at least one ‘false alarm,’ about half of whom will undergo biopsy.”
He added that screening mammography has become a measure of health care performance, but “the time has come for it to stop being used as an indicator of the quality of our health care system.” Instead, the study findings by Dr. Kalager and colleagues “help confirm that the decision to undergo screening mammography is, in fact, a close call.”
H. Gilbert Welch, M.D., M.P.H., is a professor of medicine and community and family medicine at the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, N.H. Dr. Welch made his comments in an editorial accompanying the study (N. Engl. J. Med. 2010;363:1276-8). He had no relevant financial disclosures
Dr. H. Gilbert Welch noted that the 10% reduction in death rates in the study by Dr. Kalager and colleagues is below the 15%-23% reduction estimated by the U.S. Preventive Services Task Force in a study published in 2009 (Ann. Intern. Med. 2009;151:738-42). Dr. Welch commented that, based on the historical comparisons used in the study, “it is quite plausible that screening mammography was more effective in the past than it is now.” He suggested that increased awareness of breast cancer and of the need to seek care for overt breast abnormalities have made screening less of a factor in reducing breast cancer deaths.
He also emphasized that the reduction in mortality in this study appeared to be due to a combination of both screening and the multidisciplinary teams that provided better breast cancer treatment. Indeed, the study provides data that the treatment may be most important, since women over age 70 years who were not offered screening mammography had an 8% reduction in breast cancer mortality. “Thus, the relative reduction in mortality due to screening mammography alone could be as low as 2%,” he said.
Dr. Welch also raised the issue of the false alarm. “Up to 1,000 women will have at least one ‘false alarm,’ about half of whom will undergo biopsy.”
He added that screening mammography has become a measure of health care performance, but “the time has come for it to stop being used as an indicator of the quality of our health care system.” Instead, the study findings by Dr. Kalager and colleagues “help confirm that the decision to undergo screening mammography is, in fact, a close call.”
H. Gilbert Welch, M.D., M.P.H., is a professor of medicine and community and family medicine at the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, N.H. Dr. Welch made his comments in an editorial accompanying the study (N. Engl. J. Med. 2010;363:1276-8). He had no relevant financial disclosures
Dr. H. Gilbert Welch noted that the 10% reduction in death rates in the study by Dr. Kalager and colleagues is below the 15%-23% reduction estimated by the U.S. Preventive Services Task Force in a study published in 2009 (Ann. Intern. Med. 2009;151:738-42). Dr. Welch commented that, based on the historical comparisons used in the study, “it is quite plausible that screening mammography was more effective in the past than it is now.” He suggested that increased awareness of breast cancer and of the need to seek care for overt breast abnormalities have made screening less of a factor in reducing breast cancer deaths.
He also emphasized that the reduction in mortality in this study appeared to be due to a combination of both screening and the multidisciplinary teams that provided better breast cancer treatment. Indeed, the study provides data that the treatment may be most important, since women over age 70 years who were not offered screening mammography had an 8% reduction in breast cancer mortality. “Thus, the relative reduction in mortality due to screening mammography alone could be as low as 2%,” he said.
Dr. Welch also raised the issue of the false alarm. “Up to 1,000 women will have at least one ‘false alarm,’ about half of whom will undergo biopsy.”
He added that screening mammography has become a measure of health care performance, but “the time has come for it to stop being used as an indicator of the quality of our health care system.” Instead, the study findings by Dr. Kalager and colleagues “help confirm that the decision to undergo screening mammography is, in fact, a close call.”
H. Gilbert Welch, M.D., M.P.H., is a professor of medicine and community and family medicine at the Dartmouth Institute for Health Policy & Clinical Practice in Lebanon, N.H. Dr. Welch made his comments in an editorial accompanying the study (N. Engl. J. Med. 2010;363:1276-8). He had no relevant financial disclosures
The availability of screening mammography accounted for a 10% relative reduction in deaths from breast cancer from 1996 through 2005, based on data from more than 40,000 women with breast cancer, according to findings published online on Sept. 22 in the New England Journal of Medicine.
“The use of screening mammography is still debated, chiefly because of concern regarding methodologic limitations in some of the randomized trials,” wrote Dr. Mette Kalager of the Cancer Registry of Norway, Oslo, and the Harvard School of Public Health in Boston, and colleagues. Norway implemented a nationwide breast cancer screening program in 1996. To avoid some of the limitations of previous studies, the researchers divided 40,075 women with breast cancer into four groups: those in counties of Norway with and without breast cancer screening programs between 1996 and 2005, and two historical comparison groups of women living in these same areas between 1986 and 1995. The researchers obtained information on breast cancer as the cause of death through links between the Cancer Registry of Norway and the Cause of Death Registry at Statistics Norway (N. Engl. J. Med. 2010;363:1203-10).
Women who were aged 50-69 years beginning in 1996 were eligible for screening mammography. The maximum follow-up time was 8.9 years. Overall, 4,791 (12%) of the women with a breast cancer diagnosis died, and 423 of these women (9%) were diagnosed after the introduction of the screening program.
The rate of death in the screened group of women aged 50-69 years was 18 per 100,000 person-years, compared with 25 per 100,000 person-years in their historical counterparts. The rate of death in the unscreened group was 21 per 100,000 person-years, compared with 26 per 100,000 person-years in their historical counterparts.
These numbers translate to a 28% drop in breast cancer mortality in the screened group and an 18% drop in the unscreened group, compared with their historical counterparts, suggesting a 10% relative reduction in mortality from breast cancer screening alone, Dr. Kalager and associates noted.
Part of the reduction in both screened and unscreened groups was “presumably a result of increased breast cancer awareness, improved therapy, and more sensitive diagnostic tools,” they said.
When mortality rates were broken down by stage, women in the screened group with stage I tumors had a 16% relative reduction in mortality, compared with their historical counterparts. Women in the unscreened group had a 13% relative reduction in mortality, compared with their historical counterparts.
Women in the screened group with stage II tumors had a 29% reduction in mortality, compared with their historical counterparts. The reduction in mortality in the unscreened group was 7%. Women with stage III or IV tumors showed equally reduced mortality from cancer in both the screened and unscreened groups (rate ratio for death in both groups, 0.70), compared with their historical counterparts.
Women who were younger than 50 years or older than 69 years and therefore not eligible for screening during the study period also showed fewer deaths from breast cancer per 100,000 person-years, compared with their historical counterparts. Women in these age groups likely benefited from the presence of multidisciplinary cancer care teams, although they were not screened for breast cancer, the researchers noted.
“To our surprise, the reduction in breast cancer mortality among women [aged 70-84] was largely the same as that in the screening group,” they added.
The study was limited by a relatively short follow-up period and by the possibility that some women in the unscreened group may have in fact been screened. The results suggest that screening mammography does reduce the rates of death from breast cancer, but the benefits may occur only in the context of “a well-functioning health care system that is available to the entire population,” the investigators said.
The study was funded by the Cancer Registry of Norway and the Research Council of Norway. Dr. Kalager and associates had no financial conflicts to disclose. Dr. Welch had no relevant financial disclosures.
The availability of screening mammography accounted for a 10% relative reduction in deaths from breast cancer from 1996 through 2005, based on data from more than 40,000 women with breast cancer, according to findings published online on Sept. 22 in the New England Journal of Medicine.
“The use of screening mammography is still debated, chiefly because of concern regarding methodologic limitations in some of the randomized trials,” wrote Dr. Mette Kalager of the Cancer Registry of Norway, Oslo, and the Harvard School of Public Health in Boston, and colleagues. Norway implemented a nationwide breast cancer screening program in 1996. To avoid some of the limitations of previous studies, the researchers divided 40,075 women with breast cancer into four groups: those in counties of Norway with and without breast cancer screening programs between 1996 and 2005, and two historical comparison groups of women living in these same areas between 1986 and 1995. The researchers obtained information on breast cancer as the cause of death through links between the Cancer Registry of Norway and the Cause of Death Registry at Statistics Norway (N. Engl. J. Med. 2010;363:1203-10).
Women who were aged 50-69 years beginning in 1996 were eligible for screening mammography. The maximum follow-up time was 8.9 years. Overall, 4,791 (12%) of the women with a breast cancer diagnosis died, and 423 of these women (9%) were diagnosed after the introduction of the screening program.
The rate of death in the screened group of women aged 50-69 years was 18 per 100,000 person-years, compared with 25 per 100,000 person-years in their historical counterparts. The rate of death in the unscreened group was 21 per 100,000 person-years, compared with 26 per 100,000 person-years in their historical counterparts.
These numbers translate to a 28% drop in breast cancer mortality in the screened group and an 18% drop in the unscreened group, compared with their historical counterparts, suggesting a 10% relative reduction in mortality from breast cancer screening alone, Dr. Kalager and associates noted.
Part of the reduction in both screened and unscreened groups was “presumably a result of increased breast cancer awareness, improved therapy, and more sensitive diagnostic tools,” they said.
When mortality rates were broken down by stage, women in the screened group with stage I tumors had a 16% relative reduction in mortality, compared with their historical counterparts. Women in the unscreened group had a 13% relative reduction in mortality, compared with their historical counterparts.
Women in the screened group with stage II tumors had a 29% reduction in mortality, compared with their historical counterparts. The reduction in mortality in the unscreened group was 7%. Women with stage III or IV tumors showed equally reduced mortality from cancer in both the screened and unscreened groups (rate ratio for death in both groups, 0.70), compared with their historical counterparts.
Women who were younger than 50 years or older than 69 years and therefore not eligible for screening during the study period also showed fewer deaths from breast cancer per 100,000 person-years, compared with their historical counterparts. Women in these age groups likely benefited from the presence of multidisciplinary cancer care teams, although they were not screened for breast cancer, the researchers noted.
“To our surprise, the reduction in breast cancer mortality among women [aged 70-84] was largely the same as that in the screening group,” they added.
The study was limited by a relatively short follow-up period and by the possibility that some women in the unscreened group may have in fact been screened. The results suggest that screening mammography does reduce the rates of death from breast cancer, but the benefits may occur only in the context of “a well-functioning health care system that is available to the entire population,” the investigators said.
The study was funded by the Cancer Registry of Norway and the Research Council of Norway. Dr. Kalager and associates had no financial conflicts to disclose. Dr. Welch had no relevant financial disclosures.
Major Finding: Breast cancer screening was associated with a 10% relative reduction in mortality.
Data Source: A review of data from 40,075 women with breast cancer.
Disclosures: The study was funded by the Cancer Registry of Norway and the Research Council of Norway. Dr. Kalager and associates had no financial conflicts to disclose.
Metabolic Syndrome Threatens Heart Health Regardless of Diabetes Status
The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis published online Sept. 20 in the Journal of the American College of Cardiology.
“The value of the metabolic syndrome as a predictor of cardiovascular risk has been met with much debate,” wrote Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues.
The researchers reviewed data on 951,083 patients from 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.
The five factors in the NCEP definition are waist circumference (greater than 88 cm for women and greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women and less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.
Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.
Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease mortality approximately doubled (relative risk, 2.40), as did the risk for cardiovascular disease (relative risk, 2.35), stroke (relative risk, 2.27), and myocardial infarction (1.99).
Metabolic syndrome remained significantly associated with an increased risk of cardiovascular disease (CVD) mortality in patients without type 2 diabetes, the researchers noted. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113-32).
“We therefore suggest that the metabolic syndrome does not require type 2 diabetes mellitus in its definition in order to be closely associated with cardiovascular risk,” the researchers wrote.
The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.
Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “in order to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said. Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” they said.
Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for Merck & Co. and AstraZeneca.
The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis published online Sept. 20 in the Journal of the American College of Cardiology.
“The value of the metabolic syndrome as a predictor of cardiovascular risk has been met with much debate,” wrote Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues.
The researchers reviewed data on 951,083 patients from 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.
The five factors in the NCEP definition are waist circumference (greater than 88 cm for women and greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women and less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.
Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.
Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease mortality approximately doubled (relative risk, 2.40), as did the risk for cardiovascular disease (relative risk, 2.35), stroke (relative risk, 2.27), and myocardial infarction (1.99).
Metabolic syndrome remained significantly associated with an increased risk of cardiovascular disease (CVD) mortality in patients without type 2 diabetes, the researchers noted. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113-32).
“We therefore suggest that the metabolic syndrome does not require type 2 diabetes mellitus in its definition in order to be closely associated with cardiovascular risk,” the researchers wrote.
The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.
Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “in order to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said. Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” they said.
Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for Merck & Co. and AstraZeneca.
The constellation of risk factors known as the metabolic syndrome was associated with a 1.5-fold increase in all-cause mortality and a 2-fold increase in cardiovascular outcomes, in a meta-analysis published online Sept. 20 in the Journal of the American College of Cardiology.
“The value of the metabolic syndrome as a predictor of cardiovascular risk has been met with much debate,” wrote Salvatore Mottillo of the Jewish General Hospital and McGill University, Montreal, and his colleagues.
The researchers reviewed data on 951,083 patients from 87 prospective, observational studies of cardiovascular risk and metabolic syndrome based on either the National Cholesterol Education Program (NCEP) definition of three or more of five cardiovascular risk factors, or the revised NCEP (rNCEP) issued in 2004.
The five factors in the NCEP definition are waist circumference (greater than 88 cm for women and greater than 102 cm for men), triglycerides (150 mg/dL or higher for men and women), systemic hypertension (130/85 mm Hg or higher), HDL cholesterol level (less than 50 mg/dL for women and less than 40 for men), and fasting glucose of 110 mg/dL or higher. The revised version dropped the fasting glucose to 100 mg/dL or higher and modified the central obesity measurements to be greater than or equal to 102 cm for men and greater than or equal to 88 cm for women.
Some of the studies involved more than one cardiovascular risk factor and more than one definition of metabolic syndrome.
Overall, metabolic syndrome was associated with an increase in all-cause mortality, with a relative risk of 1.54 based on the NCEP definition and 1.63 based on the rNCEP definition. In a pooled analysis, the risk of cardiovascular disease mortality approximately doubled (relative risk, 2.40), as did the risk for cardiovascular disease (relative risk, 2.35), stroke (relative risk, 2.27), and myocardial infarction (1.99).
Metabolic syndrome remained significantly associated with an increased risk of cardiovascular disease (CVD) mortality in patients without type 2 diabetes, the researchers noted. The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke (J. Am. Coll. Cardiol. 2010;56:1113-32).
“We therefore suggest that the metabolic syndrome does not require type 2 diabetes mellitus in its definition in order to be closely associated with cardiovascular risk,” the researchers wrote.
The results were limited by the use of observational studies and the variation in follow-up times. However, in a sensitivity analysis, the risk for CVD mortality associated with metabolic syndrome was similar in studies with follow-up times both longer and shorter than the median time.
Prospective studies of cardiovascular risk associated with metabolic syndrome itself, rather than the different components, are needed, “in order to establish whether or not the metabolic syndrome adds any prognostic significance,” the researchers said. Meanwhile, “we recommend that health care workers use the metabolic syndrome to identify patients who are at particularly high risk for cardiovascular complications,” they said.
Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for Merck & Co. and AstraZeneca.
Major Finding: The relative risks of cardiovascular outcomes in individuals without type 2 diabetes were 1.62 for MI, 1.75 for CVD mortality, and 1.86 for stroke.
Data Source: A meta-analysis of 87 studies involving 951,083 adults.
Disclosures: Mr. Mottillo was supported by a Canadian Institutes of Health Research grant in cardiovascular outcomes research. Study coauthor Dr. Jacques Genest is on the speakers bureau for Merck and AstraZeneca.
Combination Therapies Equal For Reducing Acne Lesions
Major Finding: After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant.
Data Source: A randomized trial of 46 patients aged 18-31 years with mild to moderate acne and an average lesion count of 67.
Disclosures: The researchers had no financial conflicts to disclose.
Combination topical tretinoin and clindamycin was as effective as salicylic acid/clindamycin for reducing lesions in patients with mild to moderate acne, based on data from a 12-week randomized trial.
The findings were published online July 28 in the Journal of the European Academy of Dermatology and Venereology. Several types of combination treatments allow clinicians to target different causes of acne vulgaris, but the safety and efficacy of tretinoin/clindamycin phosphate and salicylic acid/clindamycin phosphate have not previously been compared, according to Dr. A. Babayeva of Dokuz Eylül University in Izmir, Turkey, and colleagues.
Researchers randomized 46 acne patients aged 18-31 years to one of the two therapies: 3% salicylic acid plus clindamycin phosphate 1% lotion (SA/CDP) or all-trans retinoic acid 0.05% cream plus clindamycin phosphate 1% lotion (all-TRA/CDP). The average lesion count at baseline was 67 in both groups, and the proportion of inflammatory and noninflammatory lesions was similar between the groups (J. Eur. Acad. Dermatol. Venerol. 2010 July 28 [doi:10.1111/j.1468-3083.2010.03793.x]).
After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant. The average inflammatory and noninflammatory lesion counts were not significantly different between the two groups (5 vs. 4 and 8 vs. 6, respectively).
After 2 weeks of treatment, significantly more patients in the all-TRA/CDP group showed a 50% reduction in total lesion counts, compared with the SA/CDP group, but there were no significant differences in lesion counts between the groups when patients were assessed after 4, 8, and 12 weeks of treatment, according to the investigators.
All reported side effects were mild to moderate; most occurred during the first 2 weeks. The most common reported side effects were dryness, peeling, erythema, burning, and itching. The proportion of patients reporting at least one side effect was similar between the SA/CDP and all-TRA/CDP groups (83% vs. 74%).
Major Finding: After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant.
Data Source: A randomized trial of 46 patients aged 18-31 years with mild to moderate acne and an average lesion count of 67.
Disclosures: The researchers had no financial conflicts to disclose.
Combination topical tretinoin and clindamycin was as effective as salicylic acid/clindamycin for reducing lesions in patients with mild to moderate acne, based on data from a 12-week randomized trial.
The findings were published online July 28 in the Journal of the European Academy of Dermatology and Venereology. Several types of combination treatments allow clinicians to target different causes of acne vulgaris, but the safety and efficacy of tretinoin/clindamycin phosphate and salicylic acid/clindamycin phosphate have not previously been compared, according to Dr. A. Babayeva of Dokuz Eylül University in Izmir, Turkey, and colleagues.
Researchers randomized 46 acne patients aged 18-31 years to one of the two therapies: 3% salicylic acid plus clindamycin phosphate 1% lotion (SA/CDP) or all-trans retinoic acid 0.05% cream plus clindamycin phosphate 1% lotion (all-TRA/CDP). The average lesion count at baseline was 67 in both groups, and the proportion of inflammatory and noninflammatory lesions was similar between the groups (J. Eur. Acad. Dermatol. Venerol. 2010 July 28 [doi:10.1111/j.1468-3083.2010.03793.x]).
After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant. The average inflammatory and noninflammatory lesion counts were not significantly different between the two groups (5 vs. 4 and 8 vs. 6, respectively).
After 2 weeks of treatment, significantly more patients in the all-TRA/CDP group showed a 50% reduction in total lesion counts, compared with the SA/CDP group, but there were no significant differences in lesion counts between the groups when patients were assessed after 4, 8, and 12 weeks of treatment, according to the investigators.
All reported side effects were mild to moderate; most occurred during the first 2 weeks. The most common reported side effects were dryness, peeling, erythema, burning, and itching. The proportion of patients reporting at least one side effect was similar between the SA/CDP and all-TRA/CDP groups (83% vs. 74%).
Major Finding: After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant.
Data Source: A randomized trial of 46 patients aged 18-31 years with mild to moderate acne and an average lesion count of 67.
Disclosures: The researchers had no financial conflicts to disclose.
Combination topical tretinoin and clindamycin was as effective as salicylic acid/clindamycin for reducing lesions in patients with mild to moderate acne, based on data from a 12-week randomized trial.
The findings were published online July 28 in the Journal of the European Academy of Dermatology and Venereology. Several types of combination treatments allow clinicians to target different causes of acne vulgaris, but the safety and efficacy of tretinoin/clindamycin phosphate and salicylic acid/clindamycin phosphate have not previously been compared, according to Dr. A. Babayeva of Dokuz Eylül University in Izmir, Turkey, and colleagues.
Researchers randomized 46 acne patients aged 18-31 years to one of the two therapies: 3% salicylic acid plus clindamycin phosphate 1% lotion (SA/CDP) or all-trans retinoic acid 0.05% cream plus clindamycin phosphate 1% lotion (all-TRA/CDP). The average lesion count at baseline was 67 in both groups, and the proportion of inflammatory and noninflammatory lesions was similar between the groups (J. Eur. Acad. Dermatol. Venerol. 2010 July 28 [doi:10.1111/j.1468-3083.2010.03793.x]).
After 12 weeks, the average total lesion count was 13 in the SA/CDP group and 10 in the all-TRA/CDP group; the difference was not statistically significant. The average inflammatory and noninflammatory lesion counts were not significantly different between the two groups (5 vs. 4 and 8 vs. 6, respectively).
After 2 weeks of treatment, significantly more patients in the all-TRA/CDP group showed a 50% reduction in total lesion counts, compared with the SA/CDP group, but there were no significant differences in lesion counts between the groups when patients were assessed after 4, 8, and 12 weeks of treatment, according to the investigators.
All reported side effects were mild to moderate; most occurred during the first 2 weeks. The most common reported side effects were dryness, peeling, erythema, burning, and itching. The proportion of patients reporting at least one side effect was similar between the SA/CDP and all-TRA/CDP groups (83% vs. 74%).
Nebivolol Reduced High Blood Pressure in Hispanic Adults
Major Finding: A single dose of nebivolol of up to 40 mg/day significantly improved blood pressure in Hispanic adults with stage I or II hypertension.
Data Source: A post hoc analysis of 277 patients from a phase IV randomized, double-blind placebo-controlled trial.
Disclosures: The study was funded by Forest Laboratories. Dr. Punzi had no financial conflicts to disclose, but one of his study collaborators is employed by the Forest Research Institute.
CRYSTAL CITY, VA. — Nebivolol monotherapy significantly reduced high blood pressure in obese and nonobese Hispanic adults with stage I and II hypertension, based on data from 277 patients.
Prevalence of hypertension is similar in Hispanic and non-Hispanic adults in the United States, but studies have shown that Hispanics are less likely to be aware of their hypertension, or to have it under control, said Dr. Henry Punzi of Trinity Hypertension and Metabolic Research Institute in Carrollton, Tex.
In a post hoc analysis of data from a phase IV, double-blind placebo-controlled trial, Dr. Punzi and his colleagues reviewed the safety and efficacy of nebivolol as a monotherapy for Hispanics with stage I or stage II hypertension. They also stratified the study participants based on obesity status. Obesity was defined as a body mass index of 30 kg/m
The mean baseline blood pressure was 157/101 mm Hg in the obese participants and 155/100 mm Hg in the nonobese participants. After 8 weeks, the mean blood pressure in the nebivolol-treated obese and nonobese participants was 142/90 mm Hg and 141/88 mm Hg. The improvement in blood pressure was significant compared with the placebo groups of both obese and nonobese participants.
The starting dose of nebivolol was 5 mg/day, with titration up to 10 mg/day after week 2, 20 mg/day after week 4, and 40 kg/day after week 6.
Nebivolol had no significant effect on fasting plasma glucose levels, regardless of obesity status, which is important given the high rates of diabetes in Hispanics in the United States, compared with non-Hispanics, Dr. Punzi noted in a poster at the meeting. After 8 weeks of treatment, the average fasting plasma glucose levels in the obese participants who took nebivolol and placebo were 5.86 and 6.13. In nonobese participants, the average fasting plasma glucose levels for nebivolol and placebo were 6.10 and 5.61. None of these numbers changed significantly from the baseline measures.
Adverse events were mild, and were reported by 23% of the nebivolol group and 24% of the placebo group, Dr. Punzi reported.
Major Finding: A single dose of nebivolol of up to 40 mg/day significantly improved blood pressure in Hispanic adults with stage I or II hypertension.
Data Source: A post hoc analysis of 277 patients from a phase IV randomized, double-blind placebo-controlled trial.
Disclosures: The study was funded by Forest Laboratories. Dr. Punzi had no financial conflicts to disclose, but one of his study collaborators is employed by the Forest Research Institute.
CRYSTAL CITY, VA. — Nebivolol monotherapy significantly reduced high blood pressure in obese and nonobese Hispanic adults with stage I and II hypertension, based on data from 277 patients.
Prevalence of hypertension is similar in Hispanic and non-Hispanic adults in the United States, but studies have shown that Hispanics are less likely to be aware of their hypertension, or to have it under control, said Dr. Henry Punzi of Trinity Hypertension and Metabolic Research Institute in Carrollton, Tex.
In a post hoc analysis of data from a phase IV, double-blind placebo-controlled trial, Dr. Punzi and his colleagues reviewed the safety and efficacy of nebivolol as a monotherapy for Hispanics with stage I or stage II hypertension. They also stratified the study participants based on obesity status. Obesity was defined as a body mass index of 30 kg/m
The mean baseline blood pressure was 157/101 mm Hg in the obese participants and 155/100 mm Hg in the nonobese participants. After 8 weeks, the mean blood pressure in the nebivolol-treated obese and nonobese participants was 142/90 mm Hg and 141/88 mm Hg. The improvement in blood pressure was significant compared with the placebo groups of both obese and nonobese participants.
The starting dose of nebivolol was 5 mg/day, with titration up to 10 mg/day after week 2, 20 mg/day after week 4, and 40 kg/day after week 6.
Nebivolol had no significant effect on fasting plasma glucose levels, regardless of obesity status, which is important given the high rates of diabetes in Hispanics in the United States, compared with non-Hispanics, Dr. Punzi noted in a poster at the meeting. After 8 weeks of treatment, the average fasting plasma glucose levels in the obese participants who took nebivolol and placebo were 5.86 and 6.13. In nonobese participants, the average fasting plasma glucose levels for nebivolol and placebo were 6.10 and 5.61. None of these numbers changed significantly from the baseline measures.
Adverse events were mild, and were reported by 23% of the nebivolol group and 24% of the placebo group, Dr. Punzi reported.
Major Finding: A single dose of nebivolol of up to 40 mg/day significantly improved blood pressure in Hispanic adults with stage I or II hypertension.
Data Source: A post hoc analysis of 277 patients from a phase IV randomized, double-blind placebo-controlled trial.
Disclosures: The study was funded by Forest Laboratories. Dr. Punzi had no financial conflicts to disclose, but one of his study collaborators is employed by the Forest Research Institute.
CRYSTAL CITY, VA. — Nebivolol monotherapy significantly reduced high blood pressure in obese and nonobese Hispanic adults with stage I and II hypertension, based on data from 277 patients.
Prevalence of hypertension is similar in Hispanic and non-Hispanic adults in the United States, but studies have shown that Hispanics are less likely to be aware of their hypertension, or to have it under control, said Dr. Henry Punzi of Trinity Hypertension and Metabolic Research Institute in Carrollton, Tex.
In a post hoc analysis of data from a phase IV, double-blind placebo-controlled trial, Dr. Punzi and his colleagues reviewed the safety and efficacy of nebivolol as a monotherapy for Hispanics with stage I or stage II hypertension. They also stratified the study participants based on obesity status. Obesity was defined as a body mass index of 30 kg/m
The mean baseline blood pressure was 157/101 mm Hg in the obese participants and 155/100 mm Hg in the nonobese participants. After 8 weeks, the mean blood pressure in the nebivolol-treated obese and nonobese participants was 142/90 mm Hg and 141/88 mm Hg. The improvement in blood pressure was significant compared with the placebo groups of both obese and nonobese participants.
The starting dose of nebivolol was 5 mg/day, with titration up to 10 mg/day after week 2, 20 mg/day after week 4, and 40 kg/day after week 6.
Nebivolol had no significant effect on fasting plasma glucose levels, regardless of obesity status, which is important given the high rates of diabetes in Hispanics in the United States, compared with non-Hispanics, Dr. Punzi noted in a poster at the meeting. After 8 weeks of treatment, the average fasting plasma glucose levels in the obese participants who took nebivolol and placebo were 5.86 and 6.13. In nonobese participants, the average fasting plasma glucose levels for nebivolol and placebo were 6.10 and 5.61. None of these numbers changed significantly from the baseline measures.
Adverse events were mild, and were reported by 23% of the nebivolol group and 24% of the placebo group, Dr. Punzi reported.
Stent Thrombosis Occurs More Often in Blacks
Major Finding: Black patients receiving drug-eluting stents were significantly more likely than nonblack patients to develop stent thrombosis.
Data Source: Retrospective study of 7,236 adults who underwent PCI between 2003 and 2008.
Disclosures: The researchers said they had no financial conflicts to disclose.
Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis than were nonblack patients, based on data from more than 7,000 adults.
To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008. The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).
For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.
The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1, 2, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.
In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.
“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.
Black patients were more likely to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.
In a univariate analysis, black patients were significantly more likely than were nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.
The results support data from studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.
“Further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.
Major Finding: Black patients receiving drug-eluting stents were significantly more likely than nonblack patients to develop stent thrombosis.
Data Source: Retrospective study of 7,236 adults who underwent PCI between 2003 and 2008.
Disclosures: The researchers said they had no financial conflicts to disclose.
Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis than were nonblack patients, based on data from more than 7,000 adults.
To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008. The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).
For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.
The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1, 2, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.
In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.
“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.
Black patients were more likely to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.
In a univariate analysis, black patients were significantly more likely than were nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.
The results support data from studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.
“Further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.
Major Finding: Black patients receiving drug-eluting stents were significantly more likely than nonblack patients to develop stent thrombosis.
Data Source: Retrospective study of 7,236 adults who underwent PCI between 2003 and 2008.
Disclosures: The researchers said they had no financial conflicts to disclose.
Black patients who received drug-eluting stents were significantly more likely to develop stent thrombosis than were nonblack patients, based on data from more than 7,000 adults.
To determine the incidence of early, late, and very late stent thrombosis (ST) in black patients compared with nonblack patients, Dr. Sara D. Collins and her colleagues at the Washington (D.C.) Hospital Center reviewed data from 7,236 adults who underwent percutaneous coronary intervention at a single hospital from April 2003 through December 2008. The study group included 1,594 black patients and 5,642 nonblack patients (Circulation 2010 Aug. 30 [doi:10.1161/CIRCULATIONAHA.109.907998]).
For all patients, the incidence of early ST at 30 days was 0.83%. The cumulative incidence of late ST was 0.24% per year between 30 days and 1 year, which rose to 0.36% per year between 1 and 2 years.
The rates of ST were more than twice as high in blacks vs. nonblacks across all time points. At 30 days, the rate of ST in blacks vs. nonblacks was 1.71% vs. 0.59%. At 1, 2, and 3 years, the ST rates in blacks were 2.25%, 2.78%, and 3.67%, respectively. In nonblacks, the ST rates were 0.79%, 1.09%, and 1.25%, respectively.
In a multivariate analysis, black race was the strongest significant independent predictor of ST more than 30 days after PCI, and it was a significant predictor of early ST at 30 days.
“Black race is an independent predictor of ST even when accounting for potential confounders such as socioeconomic status and comorbidities,” the researchers said.
Black patients were more likely to be taking clopidogrel at the time of the ST (88% vs. 78%), although the difference was not significant.
In a univariate analysis, black patients were significantly more likely than were nonblack patients to have a history of hypertension, chronic renal insufficiency, diabetes, and heart failure. Black patients were significantly younger (average age, 63 years vs. 65 years), and the median household income was significantly lower for black patients, the researchers noted.
The results support data from studies suggesting that black patients are more likely to experience ST, but this study is the first to control for variables typically associated with racial disparities in health care, the investigators noted.
“Further mechanisms such as genetic polymorphisms and responsiveness to antiplatelet therapy must be pursued,” they said.
Arthroscopic Rotator Cuff Surgery Improves Function; Gabapentin Manages Pain
Arthroscopic rotator cuff repair is a safe and effective option for adults, including those older than 70 years, based on data from two studies published in the journal Arthroscopy.
In one prospective, randomized, double-blind study, a single 300-mg dose of gabapentin before arthroscopic rotator cuff surgery significantly reduced pain during the first 24 hours after surgery, compared with a placebo, with no increase in side effects.
Previous studies have shown that 300- to 1,200-mg doses of gabapentin can reduce postoperative pain, but side effects at higher doses remain a concern because of the older age of many patients who undergo rotator cuff surgery, the researchers noted.
To determine the effect of low-dose gabapentin on postoperative pain, Dr. Si Ra Bang of Sungkyunkwan University in Suwon, South Korea, and colleagues randomized 46 adults to receive either 300-mg gabapentin or a placebo 2 hours before surgery.
The average visual analog scale scores at 2, 6, and 12 hours after surgery were significantly lower in the gabapentin group, compared with the placebo group. The most common side effects were nausea and vomiting. Neither the use of fentanyl nor the occurrence of side effects was significantly different between the two groups. There were no significant demographic differences between the groups, and the average age of the patients was 58 years. (Arthroscopy 2010;26[suppl.]:S106-111).
The results suggest that “preoperative gabapentin may be useful in outpatient-based arthroscopic repair,” the researchers said. But more studies are needed to confirm the findings and the correct dose of gabapentin, they added.
In another study, Dr. Nikhil N. Verma of Rush University in Chicago and colleagues focused on outcomes of arthroscopic rotator cuff repair in 44 consecutive adults aged 70 years and older. After an average of 3 years’ follow-up, complete data were available for 39 patients with an average age of 75 years (Arthroscopy October 2010 [doi:10.1016/j.arthro.2010.01.031]).
Scores on the ASES (American Shoulder and Elbow Surgeons) scale, the SST (Simple Shoulder Test), and a visual analog pain scale improved significantly from baseline to final follow-up.
“Because elderly individuals increasingly desire to remain physically active, their activity expectations often justify surgical treatment of a rotator cuff lesion,” the case series investigators said.
At the final follow-up, the mean active forward flexion on the affected shoulder was 31.4 degrees greater, representing a significant improvement both from baseline (114.8 degrees) and postoperatively (146.2 degrees). The mean ASES score improved from 45.8 to 87.5, and the mean SST score improved from 3.9 to 9.8. The mean VAS pain score dropped from 4.6 to 0.5.
The study group included 18 men and 21 women. None of the patients reported a history of tobacco use, four had diabetes, and two had rheumatoid arthritis. The mean size of the rotator cuff tear was 3.24 cm. The tears were repaired with bioabsorbable or metal suture anchors.
The rehab process for all patients included passive range of motion and keeping the affected arm in a sling for 6 weeks, followed by 6 weeks of active motion, progressing to strengthening exercises after 12 weeks.
A majority of the patients (94%) said that they were satisfied with the results of the surgery and would do it again.
The study was limited by the lack of a control group and the lack of postoperative-imaging data, but it is the largest study of arthroscopic rotator cuff surgery in adults aged 70 years and older. Data on postoperative complications were similar to those from previous studies.
Given that the goal of rotator cuff surgery is improvement in pain and function, the results justify the use of arthroscopic rotator cuff surgery to treat older adults, the researchers said.
Dr. Verma and several colleagues have received research or institutional support from or served as consultants to orthopedic industry companies such as Arthrex, DJ Orthopaedics, Ossur, Smith & Nephew, Miomed, Athletico, and Linvatec. Dr. Bang and colleagues reported no financial conflicts.
Arthroscopic rotator cuff repair is a safe and effective option for adults, including those older than 70 years, based on data from two studies published in the journal Arthroscopy.
In one prospective, randomized, double-blind study, a single 300-mg dose of gabapentin before arthroscopic rotator cuff surgery significantly reduced pain during the first 24 hours after surgery, compared with a placebo, with no increase in side effects.
Previous studies have shown that 300- to 1,200-mg doses of gabapentin can reduce postoperative pain, but side effects at higher doses remain a concern because of the older age of many patients who undergo rotator cuff surgery, the researchers noted.
To determine the effect of low-dose gabapentin on postoperative pain, Dr. Si Ra Bang of Sungkyunkwan University in Suwon, South Korea, and colleagues randomized 46 adults to receive either 300-mg gabapentin or a placebo 2 hours before surgery.
The average visual analog scale scores at 2, 6, and 12 hours after surgery were significantly lower in the gabapentin group, compared with the placebo group. The most common side effects were nausea and vomiting. Neither the use of fentanyl nor the occurrence of side effects was significantly different between the two groups. There were no significant demographic differences between the groups, and the average age of the patients was 58 years. (Arthroscopy 2010;26[suppl.]:S106-111).
The results suggest that “preoperative gabapentin may be useful in outpatient-based arthroscopic repair,” the researchers said. But more studies are needed to confirm the findings and the correct dose of gabapentin, they added.
In another study, Dr. Nikhil N. Verma of Rush University in Chicago and colleagues focused on outcomes of arthroscopic rotator cuff repair in 44 consecutive adults aged 70 years and older. After an average of 3 years’ follow-up, complete data were available for 39 patients with an average age of 75 years (Arthroscopy October 2010 [doi:10.1016/j.arthro.2010.01.031]).
Scores on the ASES (American Shoulder and Elbow Surgeons) scale, the SST (Simple Shoulder Test), and a visual analog pain scale improved significantly from baseline to final follow-up.
“Because elderly individuals increasingly desire to remain physically active, their activity expectations often justify surgical treatment of a rotator cuff lesion,” the case series investigators said.
At the final follow-up, the mean active forward flexion on the affected shoulder was 31.4 degrees greater, representing a significant improvement both from baseline (114.8 degrees) and postoperatively (146.2 degrees). The mean ASES score improved from 45.8 to 87.5, and the mean SST score improved from 3.9 to 9.8. The mean VAS pain score dropped from 4.6 to 0.5.
The study group included 18 men and 21 women. None of the patients reported a history of tobacco use, four had diabetes, and two had rheumatoid arthritis. The mean size of the rotator cuff tear was 3.24 cm. The tears were repaired with bioabsorbable or metal suture anchors.
The rehab process for all patients included passive range of motion and keeping the affected arm in a sling for 6 weeks, followed by 6 weeks of active motion, progressing to strengthening exercises after 12 weeks.
A majority of the patients (94%) said that they were satisfied with the results of the surgery and would do it again.
The study was limited by the lack of a control group and the lack of postoperative-imaging data, but it is the largest study of arthroscopic rotator cuff surgery in adults aged 70 years and older. Data on postoperative complications were similar to those from previous studies.
Given that the goal of rotator cuff surgery is improvement in pain and function, the results justify the use of arthroscopic rotator cuff surgery to treat older adults, the researchers said.
Dr. Verma and several colleagues have received research or institutional support from or served as consultants to orthopedic industry companies such as Arthrex, DJ Orthopaedics, Ossur, Smith & Nephew, Miomed, Athletico, and Linvatec. Dr. Bang and colleagues reported no financial conflicts.
Arthroscopic rotator cuff repair is a safe and effective option for adults, including those older than 70 years, based on data from two studies published in the journal Arthroscopy.
In one prospective, randomized, double-blind study, a single 300-mg dose of gabapentin before arthroscopic rotator cuff surgery significantly reduced pain during the first 24 hours after surgery, compared with a placebo, with no increase in side effects.
Previous studies have shown that 300- to 1,200-mg doses of gabapentin can reduce postoperative pain, but side effects at higher doses remain a concern because of the older age of many patients who undergo rotator cuff surgery, the researchers noted.
To determine the effect of low-dose gabapentin on postoperative pain, Dr. Si Ra Bang of Sungkyunkwan University in Suwon, South Korea, and colleagues randomized 46 adults to receive either 300-mg gabapentin or a placebo 2 hours before surgery.
The average visual analog scale scores at 2, 6, and 12 hours after surgery were significantly lower in the gabapentin group, compared with the placebo group. The most common side effects were nausea and vomiting. Neither the use of fentanyl nor the occurrence of side effects was significantly different between the two groups. There were no significant demographic differences between the groups, and the average age of the patients was 58 years. (Arthroscopy 2010;26[suppl.]:S106-111).
The results suggest that “preoperative gabapentin may be useful in outpatient-based arthroscopic repair,” the researchers said. But more studies are needed to confirm the findings and the correct dose of gabapentin, they added.
In another study, Dr. Nikhil N. Verma of Rush University in Chicago and colleagues focused on outcomes of arthroscopic rotator cuff repair in 44 consecutive adults aged 70 years and older. After an average of 3 years’ follow-up, complete data were available for 39 patients with an average age of 75 years (Arthroscopy October 2010 [doi:10.1016/j.arthro.2010.01.031]).
Scores on the ASES (American Shoulder and Elbow Surgeons) scale, the SST (Simple Shoulder Test), and a visual analog pain scale improved significantly from baseline to final follow-up.
“Because elderly individuals increasingly desire to remain physically active, their activity expectations often justify surgical treatment of a rotator cuff lesion,” the case series investigators said.
At the final follow-up, the mean active forward flexion on the affected shoulder was 31.4 degrees greater, representing a significant improvement both from baseline (114.8 degrees) and postoperatively (146.2 degrees). The mean ASES score improved from 45.8 to 87.5, and the mean SST score improved from 3.9 to 9.8. The mean VAS pain score dropped from 4.6 to 0.5.
The study group included 18 men and 21 women. None of the patients reported a history of tobacco use, four had diabetes, and two had rheumatoid arthritis. The mean size of the rotator cuff tear was 3.24 cm. The tears were repaired with bioabsorbable or metal suture anchors.
The rehab process for all patients included passive range of motion and keeping the affected arm in a sling for 6 weeks, followed by 6 weeks of active motion, progressing to strengthening exercises after 12 weeks.
A majority of the patients (94%) said that they were satisfied with the results of the surgery and would do it again.
The study was limited by the lack of a control group and the lack of postoperative-imaging data, but it is the largest study of arthroscopic rotator cuff surgery in adults aged 70 years and older. Data on postoperative complications were similar to those from previous studies.
Given that the goal of rotator cuff surgery is improvement in pain and function, the results justify the use of arthroscopic rotator cuff surgery to treat older adults, the researchers said.
Dr. Verma and several colleagues have received research or institutional support from or served as consultants to orthopedic industry companies such as Arthrex, DJ Orthopaedics, Ossur, Smith & Nephew, Miomed, Athletico, and Linvatec. Dr. Bang and colleagues reported no financial conflicts.
Arthroscopic Rotator Cuff Surgery Improves Function; Gabapentin Manages Pain
Arthroscopic rotator cuff repair is a safe and effective option for adults, including those older than 70 years, based on data from two studies published in the journal Arthroscopy.
In one prospective, randomized, double-blind study, a single 300-mg dose of gabapentin before arthroscopic rotator cuff surgery significantly reduced pain during the first 24 hours after surgery, compared with a placebo, with no increase in side effects.
Previous studies have shown that 300- to 1,200-mg doses of gabapentin can reduce postoperative pain, but side effects at higher doses remain a concern because of the older age of many patients who undergo rotator cuff surgery, the researchers noted.
To determine the effect of low-dose gabapentin on postoperative pain, Dr. Si Ra Bang of Sungkyunkwan University in Suwon, South Korea, and colleagues randomized 46 adults to receive either 300-mg gabapentin or a placebo 2 hours before surgery.
The average visual analog scale scores at 2, 6, and 12 hours after surgery were significantly lower in the gabapentin group, compared with the placebo group. The most common side effects were nausea and vomiting. Neither the use of fentanyl nor the occurrence of side effects was significantly different between the two groups. There were no significant demographic differences between the groups, and the average age of the patients was 58 years. (Arthroscopy 2010;26[suppl.]:S106-111).
The results suggest that “preoperative gabapentin may be useful in outpatient-based arthroscopic repair,” the researchers said. But more studies are needed to confirm the findings and the correct dose of gabapentin, they added.
In another study, Dr. Nikhil N. Verma of Rush University in Chicago and colleagues focused on outcomes of arthroscopic rotator cuff repair in 44 consecutive adults aged 70 years and older. After an average of 3 years’ follow-up, complete data were available for 39 patients with an average age of 75 years (Arthroscopy October 2010 [doi:10.1016/j.arthro.2010.01.031]).
Scores on the ASES (American Shoulder and Elbow Surgeons) scale, the SST (Simple Shoulder Test), and a visual analog pain scale improved significantly from baseline to final follow-up.
“Because elderly individuals increasingly desire to remain physically active, their activity expectations often justify surgical treatment of a rotator cuff lesion,” the case series investigators said.
At the final follow-up, the mean active forward flexion on the affected shoulder was 31.4 degrees greater, representing a significant improvement both from baseline (114.8 degrees) and postoperatively (146.2 degrees). The mean ASES score improved from 45.8 to 87.5, and the mean SST score improved from 3.9 to 9.8. The mean VAS pain score dropped from 4.6 to 0.5.
The study group included 18 men and 21 women. None of the patients reported a history of tobacco use, four had diabetes, and two had rheumatoid arthritis. The mean size of the rotator cuff tear was 3.24 cm. The tears were repaired with bioabsorbable or metal suture anchors.
The rehab process for all patients included passive range of motion and keeping the affected arm in a sling for 6 weeks, followed by 6 weeks of active motion, progressing to strengthening exercises after 12 weeks.
A majority of the patients (94%) said that they were satisfied with the results of the surgery and would do it again.
The study was limited by the lack of a control group and the lack of postoperative-imaging data, but it is the largest study of arthroscopic rotator cuff surgery in adults aged 70 years and older. Data on postoperative complications were similar to those from previous studies.
Given that the goal of rotator cuff surgery is improvement in pain and function, the results justify the use of arthroscopic rotator cuff surgery to treat older adults, the researchers said.
Dr. Verma and several colleagues have received research or institutional support from or served as consultants to orthopedic industry companies such as Arthrex, DJ Orthopaedics, Ossur, Smith & Nephew, Miomed, Athletico, and Linvatec. Dr. Bang and colleagues reported no financial conflicts.
Arthroscopic rotator cuff repair is a safe and effective option for adults, including those older than 70 years, based on data from two studies published in the journal Arthroscopy.
In one prospective, randomized, double-blind study, a single 300-mg dose of gabapentin before arthroscopic rotator cuff surgery significantly reduced pain during the first 24 hours after surgery, compared with a placebo, with no increase in side effects.
Previous studies have shown that 300- to 1,200-mg doses of gabapentin can reduce postoperative pain, but side effects at higher doses remain a concern because of the older age of many patients who undergo rotator cuff surgery, the researchers noted.
To determine the effect of low-dose gabapentin on postoperative pain, Dr. Si Ra Bang of Sungkyunkwan University in Suwon, South Korea, and colleagues randomized 46 adults to receive either 300-mg gabapentin or a placebo 2 hours before surgery.
The average visual analog scale scores at 2, 6, and 12 hours after surgery were significantly lower in the gabapentin group, compared with the placebo group. The most common side effects were nausea and vomiting. Neither the use of fentanyl nor the occurrence of side effects was significantly different between the two groups. There were no significant demographic differences between the groups, and the average age of the patients was 58 years. (Arthroscopy 2010;26[suppl.]:S106-111).
The results suggest that “preoperative gabapentin may be useful in outpatient-based arthroscopic repair,” the researchers said. But more studies are needed to confirm the findings and the correct dose of gabapentin, they added.
In another study, Dr. Nikhil N. Verma of Rush University in Chicago and colleagues focused on outcomes of arthroscopic rotator cuff repair in 44 consecutive adults aged 70 years and older. After an average of 3 years’ follow-up, complete data were available for 39 patients with an average age of 75 years (Arthroscopy October 2010 [doi:10.1016/j.arthro.2010.01.031]).
Scores on the ASES (American Shoulder and Elbow Surgeons) scale, the SST (Simple Shoulder Test), and a visual analog pain scale improved significantly from baseline to final follow-up.
“Because elderly individuals increasingly desire to remain physically active, their activity expectations often justify surgical treatment of a rotator cuff lesion,” the case series investigators said.
At the final follow-up, the mean active forward flexion on the affected shoulder was 31.4 degrees greater, representing a significant improvement both from baseline (114.8 degrees) and postoperatively (146.2 degrees). The mean ASES score improved from 45.8 to 87.5, and the mean SST score improved from 3.9 to 9.8. The mean VAS pain score dropped from 4.6 to 0.5.
The study group included 18 men and 21 women. None of the patients reported a history of tobacco use, four had diabetes, and two had rheumatoid arthritis. The mean size of the rotator cuff tear was 3.24 cm. The tears were repaired with bioabsorbable or metal suture anchors.
The rehab process for all patients included passive range of motion and keeping the affected arm in a sling for 6 weeks, followed by 6 weeks of active motion, progressing to strengthening exercises after 12 weeks.
A majority of the patients (94%) said that they were satisfied with the results of the surgery and would do it again.
The study was limited by the lack of a control group and the lack of postoperative-imaging data, but it is the largest study of arthroscopic rotator cuff surgery in adults aged 70 years and older. Data on postoperative complications were similar to those from previous studies.
Given that the goal of rotator cuff surgery is improvement in pain and function, the results justify the use of arthroscopic rotator cuff surgery to treat older adults, the researchers said.
Dr. Verma and several colleagues have received research or institutional support from or served as consultants to orthopedic industry companies such as Arthrex, DJ Orthopaedics, Ossur, Smith & Nephew, Miomed, Athletico, and Linvatec. Dr. Bang and colleagues reported no financial conflicts.
Arthroscopic rotator cuff repair is a safe and effective option for adults, including those older than 70 years, based on data from two studies published in the journal Arthroscopy.
In one prospective, randomized, double-blind study, a single 300-mg dose of gabapentin before arthroscopic rotator cuff surgery significantly reduced pain during the first 24 hours after surgery, compared with a placebo, with no increase in side effects.
Previous studies have shown that 300- to 1,200-mg doses of gabapentin can reduce postoperative pain, but side effects at higher doses remain a concern because of the older age of many patients who undergo rotator cuff surgery, the researchers noted.
To determine the effect of low-dose gabapentin on postoperative pain, Dr. Si Ra Bang of Sungkyunkwan University in Suwon, South Korea, and colleagues randomized 46 adults to receive either 300-mg gabapentin or a placebo 2 hours before surgery.
The average visual analog scale scores at 2, 6, and 12 hours after surgery were significantly lower in the gabapentin group, compared with the placebo group. The most common side effects were nausea and vomiting. Neither the use of fentanyl nor the occurrence of side effects was significantly different between the two groups. There were no significant demographic differences between the groups, and the average age of the patients was 58 years. (Arthroscopy 2010;26[suppl.]:S106-111).
The results suggest that “preoperative gabapentin may be useful in outpatient-based arthroscopic repair,” the researchers said. But more studies are needed to confirm the findings and the correct dose of gabapentin, they added.
In another study, Dr. Nikhil N. Verma of Rush University in Chicago and colleagues focused on outcomes of arthroscopic rotator cuff repair in 44 consecutive adults aged 70 years and older. After an average of 3 years’ follow-up, complete data were available for 39 patients with an average age of 75 years (Arthroscopy October 2010 [doi:10.1016/j.arthro.2010.01.031]).
Scores on the ASES (American Shoulder and Elbow Surgeons) scale, the SST (Simple Shoulder Test), and a visual analog pain scale improved significantly from baseline to final follow-up.
“Because elderly individuals increasingly desire to remain physically active, their activity expectations often justify surgical treatment of a rotator cuff lesion,” the case series investigators said.
At the final follow-up, the mean active forward flexion on the affected shoulder was 31.4 degrees greater, representing a significant improvement both from baseline (114.8 degrees) and postoperatively (146.2 degrees). The mean ASES score improved from 45.8 to 87.5, and the mean SST score improved from 3.9 to 9.8. The mean VAS pain score dropped from 4.6 to 0.5.
The study group included 18 men and 21 women. None of the patients reported a history of tobacco use, four had diabetes, and two had rheumatoid arthritis. The mean size of the rotator cuff tear was 3.24 cm. The tears were repaired with bioabsorbable or metal suture anchors.
The rehab process for all patients included passive range of motion and keeping the affected arm in a sling for 6 weeks, followed by 6 weeks of active motion, progressing to strengthening exercises after 12 weeks.
A majority of the patients (94%) said that they were satisfied with the results of the surgery and would do it again.
The study was limited by the lack of a control group and the lack of postoperative-imaging data, but it is the largest study of arthroscopic rotator cuff surgery in adults aged 70 years and older. Data on postoperative complications were similar to those from previous studies.
Given that the goal of rotator cuff surgery is improvement in pain and function, the results justify the use of arthroscopic rotator cuff surgery to treat older adults, the researchers said.
Dr. Verma and several colleagues have received research or institutional support from or served as consultants to orthopedic industry companies such as Arthrex, DJ Orthopaedics, Ossur, Smith & Nephew, Miomed, Athletico, and Linvatec. Dr. Bang and colleagues reported no financial conflicts.
Major Finding: Arthroscopic rotator cuff surgery significantly improved pain and function in older adults, and a 300-mg dose of gabapentin significantly reduced pain scores immediately after surgery.
Data Source: Two studies of outcomes after arthroscopic rotator cuff surgery.
Disclosures: Dr. Verma has received research or institutional support and serves as a consultant or employee to Smith & Nephew. Dr. Bang and colleagues reported no financial conflicts.
FDA Cites Five E-Cigarette Distributors for Multiple Violations
The Food and Drug Administration cited five distributors of electronic cigarettes for multiple violations, including those related to health claims and manufacturing methods, Michael M. Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, said in a telebriefing Sept. 9.
The five companies that received warning letters from the FDA are E-CigaretteDirect LLC; Ruyan America Inc.; Gamucci America (also known as Smokey Bayou Inc.); E-Cig Technology Inc.; and Johnson’s Creek Enterprises LLC.
Health violations discussed in the warning letters included marketing drugs in unapproved liquid form, including the erectile dysfunction drug tadalafil and the weight-loss drug rimonabant, which has not been approved for use in the United States.
“These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so the drugs can be vaporized and inhaled,” Mr. Levy said.
Manufacturing violations cited in the warning letters included failure to establish sufficient quality control and testing procedures as required by the Federal Food, Drug, and Cosmetic Act (FDCA).
The FDA considered the smoking cessation claims of the e-cigarette products to be “evidence that these products were intended to be used as drug device combinations,” Mr. Levy said.
The FDA wants doctors in particular to know that e-cigarettes have not been evaluated by the FDA for safety and effectiveness, Mr. Levy emphasized, and that there are FDA-approved smoking cessation aids on the market that are readily available.
“We are interested in finding out whether e-cigarettes can be proven safe and effective. That’s why we sent the letter today to the Electronic Cigarette Association,” he said.
In that letter, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, said that the electronic cigarette products addressed in the warning letters, and similar products, meet the FDCA definitions of a drug, a device, and a combination product. As such, “the FDA intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protection the public health,” she wrote.
Dr. Woodcock’s letter also noted the possible need for companies seeking new drug applications to conduct consumer studies in addition to efficacy studies.
The companies have 15 days to respond to the letters, at which point the FDA will decide what to do next, said Mr. Levy.
The current action concerns only the five companies who received warning letters. “We have not made a decision to remove all e-cigarettes from the market,” Mr. Levy noted.
“We are interested in having firms that market these particular products meet with the agency to see about obtaining drug approval for them,” he noted.
“The agency has had discussions with firms that are interested in obtaining drug approval for e-cigarette products,” he said. Mr. Levy said that he could not discuss the progress of new applications at this time.
For further information, see the FDA’s full analysis of e-cigarettes.
The Food and Drug Administration cited five distributors of electronic cigarettes for multiple violations, including those related to health claims and manufacturing methods, Michael M. Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, said in a telebriefing Sept. 9.
The five companies that received warning letters from the FDA are E-CigaretteDirect LLC; Ruyan America Inc.; Gamucci America (also known as Smokey Bayou Inc.); E-Cig Technology Inc.; and Johnson’s Creek Enterprises LLC.
Health violations discussed in the warning letters included marketing drugs in unapproved liquid form, including the erectile dysfunction drug tadalafil and the weight-loss drug rimonabant, which has not been approved for use in the United States.
“These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so the drugs can be vaporized and inhaled,” Mr. Levy said.
Manufacturing violations cited in the warning letters included failure to establish sufficient quality control and testing procedures as required by the Federal Food, Drug, and Cosmetic Act (FDCA).
The FDA considered the smoking cessation claims of the e-cigarette products to be “evidence that these products were intended to be used as drug device combinations,” Mr. Levy said.
The FDA wants doctors in particular to know that e-cigarettes have not been evaluated by the FDA for safety and effectiveness, Mr. Levy emphasized, and that there are FDA-approved smoking cessation aids on the market that are readily available.
“We are interested in finding out whether e-cigarettes can be proven safe and effective. That’s why we sent the letter today to the Electronic Cigarette Association,” he said.
In that letter, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, said that the electronic cigarette products addressed in the warning letters, and similar products, meet the FDCA definitions of a drug, a device, and a combination product. As such, “the FDA intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protection the public health,” she wrote.
Dr. Woodcock’s letter also noted the possible need for companies seeking new drug applications to conduct consumer studies in addition to efficacy studies.
The companies have 15 days to respond to the letters, at which point the FDA will decide what to do next, said Mr. Levy.
The current action concerns only the five companies who received warning letters. “We have not made a decision to remove all e-cigarettes from the market,” Mr. Levy noted.
“We are interested in having firms that market these particular products meet with the agency to see about obtaining drug approval for them,” he noted.
“The agency has had discussions with firms that are interested in obtaining drug approval for e-cigarette products,” he said. Mr. Levy said that he could not discuss the progress of new applications at this time.
For further information, see the FDA’s full analysis of e-cigarettes.
The Food and Drug Administration cited five distributors of electronic cigarettes for multiple violations, including those related to health claims and manufacturing methods, Michael M. Levy, director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, said in a telebriefing Sept. 9.
The five companies that received warning letters from the FDA are E-CigaretteDirect LLC; Ruyan America Inc.; Gamucci America (also known as Smokey Bayou Inc.); E-Cig Technology Inc.; and Johnson’s Creek Enterprises LLC.
Health violations discussed in the warning letters included marketing drugs in unapproved liquid form, including the erectile dysfunction drug tadalafil and the weight-loss drug rimonabant, which has not been approved for use in the United States.
“These liquid pharmaceuticals are designed to refill cartridges used in e-cigarettes so the drugs can be vaporized and inhaled,” Mr. Levy said.
Manufacturing violations cited in the warning letters included failure to establish sufficient quality control and testing procedures as required by the Federal Food, Drug, and Cosmetic Act (FDCA).
The FDA considered the smoking cessation claims of the e-cigarette products to be “evidence that these products were intended to be used as drug device combinations,” Mr. Levy said.
The FDA wants doctors in particular to know that e-cigarettes have not been evaluated by the FDA for safety and effectiveness, Mr. Levy emphasized, and that there are FDA-approved smoking cessation aids on the market that are readily available.
“We are interested in finding out whether e-cigarettes can be proven safe and effective. That’s why we sent the letter today to the Electronic Cigarette Association,” he said.
In that letter, Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, said that the electronic cigarette products addressed in the warning letters, and similar products, meet the FDCA definitions of a drug, a device, and a combination product. As such, “the FDA intends to regulate electronic cigarettes and related products in a manner consistent with its mission of protection the public health,” she wrote.
Dr. Woodcock’s letter also noted the possible need for companies seeking new drug applications to conduct consumer studies in addition to efficacy studies.
The companies have 15 days to respond to the letters, at which point the FDA will decide what to do next, said Mr. Levy.
The current action concerns only the five companies who received warning letters. “We have not made a decision to remove all e-cigarettes from the market,” Mr. Levy noted.
“We are interested in having firms that market these particular products meet with the agency to see about obtaining drug approval for them,” he noted.
“The agency has had discussions with firms that are interested in obtaining drug approval for e-cigarette products,” he said. Mr. Levy said that he could not discuss the progress of new applications at this time.
For further information, see the FDA’s full analysis of e-cigarettes.
Low Heart Function May Accelerate Brain Aging
Major Finding: Individuals in the highest tertile for cardiac index (indicating healthier heart function) had 0.35% and 0.36% greater total brain volume than did individuals in the middle and lowest tertiles, respectively.
Data Source: A cross-sectional review of brain and heart MRI data from 1,504 adults in the Framingham Offspring Cohort.
Disclosures: None of the investigators had financial conflicts to disclose. The research was supported in part by grants from the National Heart, Lung, and Blood Institute's Framingham Heart Study.
Reduced heart function might be associated with signs of preclinical brain aging, based on a review of data from the observational Framingham Heart Study.
Investigators led by Angela Jefferson, Ph.D., of Boston University, found that cardiac output, adjusted for body size, was significantly associated with the rate of change in brain volume as the study participants aged.
Because initial research studies on the effects of cardiac output on brain aging were conducted on small samples of referred patients with clinical cardiovascular disease and were not systematically adjusted for environmental risk factors known to contribute to both central nervous system and myocardial injury, Dr. Jefferson and her colleagues sought to determine if the relationship existed in patients who were free of clinical dementia or stroke. On the basis of previous findings from animal and clinical studies, they “hypothesized that MRI-assessed cardiac function is associated with cognitive and neuroimaging markers of preclinical Alzheimer's disease and cerebrovascular disease.”
The investigators reviewed brain and heart MRI data from 1,504 adults aged 34-84 years, excluding individuals with a documented history of clinical stroke, transient ischemic attack, or dementia. The average age was 61 years; 54% were women. In the ongoing study, participants are assessed every 4-8 years (Circulation 2010 Aug. 2 [doi:10.1161/circulationaha.109.905091]).
Low cardiac index (defined as less than 2.5 L/min per m
The researchers found that for every one standard deviation increase in cardiac index, the total brain volume (measured as a percentage of total cranial volume) increased by 0.30%. Cardiac index also increased as lateral ventricular volume decreased, but this relationship was not significant when individuals with cardiovascular disease were excluded.
In a post hoc analysis, the researchers compared cardiac index tertiles and changes in brain volume. They used the highest tertile as the referent, given that higher cardiac index values reflect healthier heart function.
Individuals in the middle tertile for cardiac index had an average total brain volume that was 0.35% less than that of those in the top tertile. Those in the bottom tertile had average total brain volume of 0.36% less than that of those in the top tertile. These changes corresponded to an average difference in brain aging of 1.9 years (a total brain volume decrease of 0.19% per 1-year increase in age).
Cardiac index as a continuous variable was not significantly related to any of the neuropsychological factor scores. But low executive function and information processing nearly reached statistical significance in association with low cardiac index.
The association between cardiac index and brain volume was significantly stronger among adults who were younger than 60 years, compared with older adults, and in men compared with women. However, the association was not significantly modified by apolipoprotein E e4 allele status.
The results were limited by the observational nature of the study, which cannot establish causality.
However, the findings were consistent with the hypothesis that decreasing cardiac function is associated with accelerated brain aging, and suggest that low and low-normal cardiac index values might be related to brain health, as measured by brain volume, the investigators said.
My Take
Study Results Strong, but Not Definitive
Teasing out the role of brain volume in cognitive function is a challenge, as early cognitive changes are often minimal.
In this study by Dr. Jefferson and her associates, the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results.
It is not clear whether a lower cardiac index promotes a reduction in brain volume that in turn accelerates neurodegeneration. Previous data indicate that vascular risk factors can contribute to dementia. More research is needed in “vascular cognitive disorders,” a newly identified term describing conditions “in which vascular damage plays a role, either alone or in combination with a neurodegenerative or other process, in the development of cognitive impairment or dementia,” to explore how addressing vascular risk factors could modify the course of different types of dementias.
CLINTON B. WRIGHT, M.D., and RALPH L. SACCO, M.D., are in the department of neurology at the University of Miami. Their comments are paraphrased from an editorial (Circulation 2010 Aug. 4 [doi:10.1161/circulationaha.110.970301]). They had no financial conflicts to disclose.
Major Finding: Individuals in the highest tertile for cardiac index (indicating healthier heart function) had 0.35% and 0.36% greater total brain volume than did individuals in the middle and lowest tertiles, respectively.
Data Source: A cross-sectional review of brain and heart MRI data from 1,504 adults in the Framingham Offspring Cohort.
Disclosures: None of the investigators had financial conflicts to disclose. The research was supported in part by grants from the National Heart, Lung, and Blood Institute's Framingham Heart Study.
Reduced heart function might be associated with signs of preclinical brain aging, based on a review of data from the observational Framingham Heart Study.
Investigators led by Angela Jefferson, Ph.D., of Boston University, found that cardiac output, adjusted for body size, was significantly associated with the rate of change in brain volume as the study participants aged.
Because initial research studies on the effects of cardiac output on brain aging were conducted on small samples of referred patients with clinical cardiovascular disease and were not systematically adjusted for environmental risk factors known to contribute to both central nervous system and myocardial injury, Dr. Jefferson and her colleagues sought to determine if the relationship existed in patients who were free of clinical dementia or stroke. On the basis of previous findings from animal and clinical studies, they “hypothesized that MRI-assessed cardiac function is associated with cognitive and neuroimaging markers of preclinical Alzheimer's disease and cerebrovascular disease.”
The investigators reviewed brain and heart MRI data from 1,504 adults aged 34-84 years, excluding individuals with a documented history of clinical stroke, transient ischemic attack, or dementia. The average age was 61 years; 54% were women. In the ongoing study, participants are assessed every 4-8 years (Circulation 2010 Aug. 2 [doi:10.1161/circulationaha.109.905091]).
Low cardiac index (defined as less than 2.5 L/min per m
The researchers found that for every one standard deviation increase in cardiac index, the total brain volume (measured as a percentage of total cranial volume) increased by 0.30%. Cardiac index also increased as lateral ventricular volume decreased, but this relationship was not significant when individuals with cardiovascular disease were excluded.
In a post hoc analysis, the researchers compared cardiac index tertiles and changes in brain volume. They used the highest tertile as the referent, given that higher cardiac index values reflect healthier heart function.
Individuals in the middle tertile for cardiac index had an average total brain volume that was 0.35% less than that of those in the top tertile. Those in the bottom tertile had average total brain volume of 0.36% less than that of those in the top tertile. These changes corresponded to an average difference in brain aging of 1.9 years (a total brain volume decrease of 0.19% per 1-year increase in age).
Cardiac index as a continuous variable was not significantly related to any of the neuropsychological factor scores. But low executive function and information processing nearly reached statistical significance in association with low cardiac index.
The association between cardiac index and brain volume was significantly stronger among adults who were younger than 60 years, compared with older adults, and in men compared with women. However, the association was not significantly modified by apolipoprotein E e4 allele status.
The results were limited by the observational nature of the study, which cannot establish causality.
However, the findings were consistent with the hypothesis that decreasing cardiac function is associated with accelerated brain aging, and suggest that low and low-normal cardiac index values might be related to brain health, as measured by brain volume, the investigators said.
My Take
Study Results Strong, but Not Definitive
Teasing out the role of brain volume in cognitive function is a challenge, as early cognitive changes are often minimal.
In this study by Dr. Jefferson and her associates, the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results.
It is not clear whether a lower cardiac index promotes a reduction in brain volume that in turn accelerates neurodegeneration. Previous data indicate that vascular risk factors can contribute to dementia. More research is needed in “vascular cognitive disorders,” a newly identified term describing conditions “in which vascular damage plays a role, either alone or in combination with a neurodegenerative or other process, in the development of cognitive impairment or dementia,” to explore how addressing vascular risk factors could modify the course of different types of dementias.
CLINTON B. WRIGHT, M.D., and RALPH L. SACCO, M.D., are in the department of neurology at the University of Miami. Their comments are paraphrased from an editorial (Circulation 2010 Aug. 4 [doi:10.1161/circulationaha.110.970301]). They had no financial conflicts to disclose.
Major Finding: Individuals in the highest tertile for cardiac index (indicating healthier heart function) had 0.35% and 0.36% greater total brain volume than did individuals in the middle and lowest tertiles, respectively.
Data Source: A cross-sectional review of brain and heart MRI data from 1,504 adults in the Framingham Offspring Cohort.
Disclosures: None of the investigators had financial conflicts to disclose. The research was supported in part by grants from the National Heart, Lung, and Blood Institute's Framingham Heart Study.
Reduced heart function might be associated with signs of preclinical brain aging, based on a review of data from the observational Framingham Heart Study.
Investigators led by Angela Jefferson, Ph.D., of Boston University, found that cardiac output, adjusted for body size, was significantly associated with the rate of change in brain volume as the study participants aged.
Because initial research studies on the effects of cardiac output on brain aging were conducted on small samples of referred patients with clinical cardiovascular disease and were not systematically adjusted for environmental risk factors known to contribute to both central nervous system and myocardial injury, Dr. Jefferson and her colleagues sought to determine if the relationship existed in patients who were free of clinical dementia or stroke. On the basis of previous findings from animal and clinical studies, they “hypothesized that MRI-assessed cardiac function is associated with cognitive and neuroimaging markers of preclinical Alzheimer's disease and cerebrovascular disease.”
The investigators reviewed brain and heart MRI data from 1,504 adults aged 34-84 years, excluding individuals with a documented history of clinical stroke, transient ischemic attack, or dementia. The average age was 61 years; 54% were women. In the ongoing study, participants are assessed every 4-8 years (Circulation 2010 Aug. 2 [doi:10.1161/circulationaha.109.905091]).
Low cardiac index (defined as less than 2.5 L/min per m
The researchers found that for every one standard deviation increase in cardiac index, the total brain volume (measured as a percentage of total cranial volume) increased by 0.30%. Cardiac index also increased as lateral ventricular volume decreased, but this relationship was not significant when individuals with cardiovascular disease were excluded.
In a post hoc analysis, the researchers compared cardiac index tertiles and changes in brain volume. They used the highest tertile as the referent, given that higher cardiac index values reflect healthier heart function.
Individuals in the middle tertile for cardiac index had an average total brain volume that was 0.35% less than that of those in the top tertile. Those in the bottom tertile had average total brain volume of 0.36% less than that of those in the top tertile. These changes corresponded to an average difference in brain aging of 1.9 years (a total brain volume decrease of 0.19% per 1-year increase in age).
Cardiac index as a continuous variable was not significantly related to any of the neuropsychological factor scores. But low executive function and information processing nearly reached statistical significance in association with low cardiac index.
The association between cardiac index and brain volume was significantly stronger among adults who were younger than 60 years, compared with older adults, and in men compared with women. However, the association was not significantly modified by apolipoprotein E e4 allele status.
The results were limited by the observational nature of the study, which cannot establish causality.
However, the findings were consistent with the hypothesis that decreasing cardiac function is associated with accelerated brain aging, and suggest that low and low-normal cardiac index values might be related to brain health, as measured by brain volume, the investigators said.
My Take
Study Results Strong, but Not Definitive
Teasing out the role of brain volume in cognitive function is a challenge, as early cognitive changes are often minimal.
In this study by Dr. Jefferson and her associates, the fact that the relationship between brain volume and cardiac index was modified by younger age and male sex strengthens the results.
It is not clear whether a lower cardiac index promotes a reduction in brain volume that in turn accelerates neurodegeneration. Previous data indicate that vascular risk factors can contribute to dementia. More research is needed in “vascular cognitive disorders,” a newly identified term describing conditions “in which vascular damage plays a role, either alone or in combination with a neurodegenerative or other process, in the development of cognitive impairment or dementia,” to explore how addressing vascular risk factors could modify the course of different types of dementias.
CLINTON B. WRIGHT, M.D., and RALPH L. SACCO, M.D., are in the department of neurology at the University of Miami. Their comments are paraphrased from an editorial (Circulation 2010 Aug. 4 [doi:10.1161/circulationaha.110.970301]). They had no financial conflicts to disclose.