Naseem S. Miller

AMSTERDAM – Obese women with no metabolic disorders had the same cardiovascular disease risk as their normal-weight counterparts, according to a 5-year follow-up of more than 260,000 Danish women in their early 30s.

Meanwhile, during the same follow-up period, women with metabolic disorders had a fourfold increase in cardiovascular disease risk, regardless of their body mass index, according to Dr. Michelle D. Schmiegelow, who presented her findings at the annual congress of the European Society of Cardiology.

The absolute risks were still low in this young population, but given the findings, Dr. Schmiegelow said that physicians should have an "increased awareness of these young metabolically healthy overweight and obese women, because there might be a window of opportunity in which they could change their lifestyle and thereby reduce their risk of metabolic disorders and possibly reduce the risk of cardiovascular disease substantially."

The study was one of several presented at the meeting addressing the ongoing discussions about the obesity paradox.

"If you want to rely on the question on what is my future CVD risk, it’s not as easy to just measure your body weight,’ said Dr. Diethelm Tschöpe of Ruhr University, Bochum, Germany, in a video interview. "It’s a complex situation, which consists of body weight, risk factors, comorbidities, and the genetic background, which at the moment is hard to measure."

Dr. Schmiegelow of Gentofte Hospital, Hellerup, Denmark, and her colleagues examined the risk of myocardial infarctions, ischemic stroke, and all-cause mortality in more than 260,000 women who had given birth between 2004 and 2010, at a mean age of 31 years old. These women were identified in a nationwide registry of birth records. The median follow-up was 5.5 years after childbirth.

The women were considered metabolically unhealthy is they had a hypertensive disorder such as gestational hypertension, preeclampsia, or hypertension; an abnormal glucose metabolism such as diabetes or gestational diabetes; or dyslipidemia.

They were separated to four groups based on metabolic health status and prepregnancy body mass index (BMI): Metabolically healthy with a BMI less than 25 kg/m²; metabolically health with a BMI greater than or equal to 25; metabolically unhealthy with a BMI less than 25; and metabolically unhealthy with a BMI of greater than or equal to 25.

Data were adjusted for age and calendar year. The combined primary endpoints were the risks of MI, ischemic stroke, and all-cause mortality, using the metabolically healthy women with a BMI of less than 25 as reference.

The incidence rate (IR) of the combined endpoints for the normal weight, metabolically healthy women was 0.41 (number of events equaled 375); obese but metabolically healthy women had an IR of .45 (n = 51), and rate ratio (RR) of 1.16; normal weight but metabolically unhealthy women had an IR of .91 (n = 175), RR of 2.11; and obese and metabolically unhealthy women had an IR of 1.25 (n = 86), with an RR of 2.81.

"When you have an obese individual in front of you, that should be the first step, figuring out what their risk profile is," said Dr. Schmiegelow. "If they have metabolic disorders, that means they’re at an increased risk. If they do not have metabolic disorders, that means they’re at an increased risk of developing that, and you should really try and motivate them to change their lifestyle."

Dr. Schmiegelow and Dr. Tschöpe had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – Obese women with no metabolic disorders had the same cardiovascular disease risk as their normal-weight counterparts, according to a 5-year follow-up of more than 260,000 Danish women in their early 30s.

Meanwhile, during the same follow-up period, women with metabolic disorders had a fourfold increase in cardiovascular disease risk, regardless of their body mass index, according to Dr. Michelle D. Schmiegelow, who presented her findings at the annual congress of the European Society of Cardiology.

The absolute risks were still low in this young population, but given the findings, Dr. Schmiegelow said that physicians should have an "increased awareness of these young metabolically healthy overweight and obese women, because there might be a window of opportunity in which they could change their lifestyle and thereby reduce their risk of metabolic disorders and possibly reduce the risk of cardiovascular disease substantially."

The study was one of several presented at the meeting addressing the ongoing discussions about the obesity paradox.

"If you want to rely on the question on what is my future CVD risk, it’s not as easy to just measure your body weight,’ said Dr. Diethelm Tschöpe of Ruhr University, Bochum, Germany, in a video interview. "It’s a complex situation, which consists of body weight, risk factors, comorbidities, and the genetic background, which at the moment is hard to measure."

Dr. Schmiegelow of Gentofte Hospital, Hellerup, Denmark, and her colleagues examined the risk of myocardial infarctions, ischemic stroke, and all-cause mortality in more than 260,000 women who had given birth between 2004 and 2010, at a mean age of 31 years old. These women were identified in a nationwide registry of birth records. The median follow-up was 5.5 years after childbirth.

The women were considered metabolically unhealthy is they had a hypertensive disorder such as gestational hypertension, preeclampsia, or hypertension; an abnormal glucose metabolism such as diabetes or gestational diabetes; or dyslipidemia.

They were separated to four groups based on metabolic health status and prepregnancy body mass index (BMI): Metabolically healthy with a BMI less than 25 kg/m²; metabolically health with a BMI greater than or equal to 25; metabolically unhealthy with a BMI less than 25; and metabolically unhealthy with a BMI of greater than or equal to 25.

Data were adjusted for age and calendar year. The combined primary endpoints were the risks of MI, ischemic stroke, and all-cause mortality, using the metabolically healthy women with a BMI of less than 25 as reference.

The incidence rate (IR) of the combined endpoints for the normal weight, metabolically healthy women was 0.41 (number of events equaled 375); obese but metabolically healthy women had an IR of .45 (n = 51), and rate ratio (RR) of 1.16; normal weight but metabolically unhealthy women had an IR of .91 (n = 175), RR of 2.11; and obese and metabolically unhealthy women had an IR of 1.25 (n = 86), with an RR of 2.81.

"When you have an obese individual in front of you, that should be the first step, figuring out what their risk profile is," said Dr. Schmiegelow. "If they have metabolic disorders, that means they’re at an increased risk. If they do not have metabolic disorders, that means they’re at an increased risk of developing that, and you should really try and motivate them to change their lifestyle."

Dr. Schmiegelow and Dr. Tschöpe had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – Obese women with no metabolic disorders had the same cardiovascular disease risk as their normal-weight counterparts, according to a 5-year follow-up of more than 260,000 Danish women in their early 30s.

Meanwhile, during the same follow-up period, women with metabolic disorders had a fourfold increase in cardiovascular disease risk, regardless of their body mass index, according to Dr. Michelle D. Schmiegelow, who presented her findings at the annual congress of the European Society of Cardiology.

The absolute risks were still low in this young population, but given the findings, Dr. Schmiegelow said that physicians should have an "increased awareness of these young metabolically healthy overweight and obese women, because there might be a window of opportunity in which they could change their lifestyle and thereby reduce their risk of metabolic disorders and possibly reduce the risk of cardiovascular disease substantially."

The study was one of several presented at the meeting addressing the ongoing discussions about the obesity paradox.

"If you want to rely on the question on what is my future CVD risk, it’s not as easy to just measure your body weight,’ said Dr. Diethelm Tschöpe of Ruhr University, Bochum, Germany, in a video interview. "It’s a complex situation, which consists of body weight, risk factors, comorbidities, and the genetic background, which at the moment is hard to measure."

Dr. Schmiegelow of Gentofte Hospital, Hellerup, Denmark, and her colleagues examined the risk of myocardial infarctions, ischemic stroke, and all-cause mortality in more than 260,000 women who had given birth between 2004 and 2010, at a mean age of 31 years old. These women were identified in a nationwide registry of birth records. The median follow-up was 5.5 years after childbirth.

The women were considered metabolically unhealthy is they had a hypertensive disorder such as gestational hypertension, preeclampsia, or hypertension; an abnormal glucose metabolism such as diabetes or gestational diabetes; or dyslipidemia.

They were separated to four groups based on metabolic health status and prepregnancy body mass index (BMI): Metabolically healthy with a BMI less than 25 kg/m²; metabolically health with a BMI greater than or equal to 25; metabolically unhealthy with a BMI less than 25; and metabolically unhealthy with a BMI of greater than or equal to 25.

Data were adjusted for age and calendar year. The combined primary endpoints were the risks of MI, ischemic stroke, and all-cause mortality, using the metabolically healthy women with a BMI of less than 25 as reference.

The incidence rate (IR) of the combined endpoints for the normal weight, metabolically healthy women was 0.41 (number of events equaled 375); obese but metabolically healthy women had an IR of .45 (n = 51), and rate ratio (RR) of 1.16; normal weight but metabolically unhealthy women had an IR of .91 (n = 175), RR of 2.11; and obese and metabolically unhealthy women had an IR of 1.25 (n = 86), with an RR of 2.81.

"When you have an obese individual in front of you, that should be the first step, figuring out what their risk profile is," said Dr. Schmiegelow. "If they have metabolic disorders, that means they’re at an increased risk. If they do not have metabolic disorders, that means they’re at an increased risk of developing that, and you should really try and motivate them to change their lifestyle."

Dr. Schmiegelow and Dr. Tschöpe had no disclosures.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

Taking statins was associated with a higher incidence of cataract diagnosis in a propensity score–matched cohort and in other analyses of a military health care database in Texas. The report was published online Sept. 19 in JAMA Ophthalmology.

This is yet another observational study to show a possible association between statin use and cataracts – this time a negative one – continuing the ongoing controversy in this area of research.

Investigators said that their propensity score–matched analysis was the first study of its kind, and also one of the largest, including 45,000 patients who were followed up longitudinally within the same health care system, with similar health care coverage and access to care and medication.

The study was extremely well done, Dr. Kim Allan Williams Sr., chair of cardiology at Wayne State University, Detroit, said in an interview. "This is one of the larger studies, and the thing that distinguishes this one is how well the propensity matching was done. Dr. Williams, who was not involved in the study, added that the study wasn’t a definite and final answer to the question, and didn’t negate other studies that showed a protective or no association between statins and cataracts.

Researchers conducted the analysis on all adult patients who were enrolled in the San Antonio Military Multi-Market Area as Tricare Prime or Plus, analyzing the data from October 1, 2003, to March 1, 2010. All patients were enrolled in the system throughout the study.

With a computer model, they selected a group of statin users and nonusers who looked very comparable to each other.

"One of the biggest caveats in observational studies is that, patients’ baseline characteristics may be different," Dr. Ishak Mansi, the study’s principal investigator, said in an interview." And when you look after 6 or 7 years, you may have higher incidence of cataract in some, not because of the statins, but because some of the patients who were given statins were sicker from the very beginning. So we have to make sure we’re comparing apples to apples."

They divided the participants according to statin use, using their pharmacy records: There were 13,626 statin users, who had received at least one 90-day supply of a statin; and 32,623 nonusers, who had never received a statin throughout the study.

To conduct a propensity score–matched cohort analysis, researchers used 44 variables that were expected to increase the likelihood of receiving a statin prescription, as well as increasing the risk for cataract. Those variables included age, sex, 17 comorbid conditions, obesity, alcohol dependence/abuse, use of 14 medication groups, and more.

As for statins, simvastatin made up 73% of the prescriptions, atorvastatin 17.4%, pravastatin 7%, rosuvastatin 1.7%, and fluvastatin or lovastatin 0.24% of the prescription. Nearly 34% of the statin users received maximal doses of statins.

For the primary analysis, researchers matched 6,972 pairs of statin users and nonusers, with no significant differences in their baseline characteristics. Among the statin users, cataracts occurred in 2,477 (35.5%), compared with 2,337 (33.5%) of the nonusers, yielding a statistically significant odds ratio of 1.09 (JAMA Ophthalmol. 2013 Sept. 19 [doi:10.1001/jamaophthalmol.2013.4575]).

"Then we said, let us assume that the computer model may not have been good in selecting patients, and let’s see if we can get the same result by slicing the data differently," said Dr. Mansi, professor of medicine at UT Southwestern, Dallas.

The secondary analysis included 6,113 statin users and 27,400 nonusers with no prespecified comorbidities. Among them, 33.7% of statin users and 9.4% of nonusers developed cataracts, a significant 20% increased risk, the researchers reported.

Further analysis showed that statin use was an independent predictor of cataract (adjusted OR, 1.43), and statin use continued to be an independent predictor of cataract, when researchers repeated the analysis using backward stepwise elimination (adjusted OR, 1.42).

They also examined the relationship between cataract and LDL cholesterol and HDL cholesterol, and found that the mean LDL cholesterol level was inversely related to risk for cataract (adjusted OR, 0.997; P = .009), but mean HDL cholesterol was not (adjusted OR, 1.002; P = .16).

They also analyzed the data according to years of statin use (2, 4, and 6 years). "Whatever approach we used, the result was consistent," said Dr. Mansi, a staff internist at VA North Texas, Dallas.

Dr. Williams, vice president of the American College of Cardiology, said that the study puts the issue "into real question again, and we find ourselves wanting a randomized controlled prospective trial, which would be very difficult to do. These are drugs that you just don’t randomize people to. If we’re stuck with observational trials, no matter how large or how well done they are, there will always be questions."

In September, at the annual congress of the European Society of Cardiology, Dr. John B. Kostis of Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J., presented an unpublished meta-analysis of 13 studies, showing that statins had a protective effect on cataracts, especially when they were prescribed to younger people for a longer period of time.

"The bottom line is that statins prevent cataracts," Dr. Kostis said during his presentation at ESC. "But the bottom bottom line is, don’t be scared of cataracts when prescribing statins." (Dr. Kostis said he was submitting a letter to the JAMA editors regarding Dr. Mansi’s study, raising a few questions about the methods and findings.)

Dr. Mansi and colleagues listed several limitations for the study, including its retrospective observational design. They added that there may be other unidentified baseline confounders, and that successful propensity score matching of individual baseline characteristics doesn’t guarantee that the combined effect of individual difference would have no impact on the outcome of interest. Also, using pharmacy data to identify statin use does not capture statin intake, although most users received the prescription for a mean cumulative duration of 4.5 years, which suggests compliance, they noted.

"The most important message for doctors is that we don’t really know yet the full spectrum of side effects of this very effective group of medications," Dr. Mansi said. "They should prescribe this medication in accordance with the current guidelines, not extrapolate, and not prescribe it lightly. Rather, they should consider the benefit-risk ratio for each individual."

Based on the findings, Dr. Williams said, "Look for statin use in diabetes patients, because it can be associated with faster development of cataract. The other thing is, try and make sure within the patients’ care group, whether it’s in a patient-centered home, in primary care, or even in cardiology, that attention is paid to vision and cataract screening, which can become a routine part of physical exam. Unfortunately, that sounds like that we’re convinced by this study. But I think it’s convincing enough to bring our threshold for screening people with cataracts down a little bit."

The authors suggested that future studies should include regular ophthalmologic examinations and objective assessment tools rather than relying on patient surveys or administrative data.

With the growing elderly population, incidence of cataracts, which comes with a whopping cost of $5 billion annually, is likely to increase, and "understanding and optimizing the modifiable risk factors for developing lens opacities must be a public health priority," Dr. Mansi and colleagues wrote.

Dr. Mansi and Dr. Kostis had no disclosures. Dr. Williams has received consultant fees/honoraria from Astellas Healthcare.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

Taking statins was associated with a higher incidence of cataract diagnosis in a propensity score–matched cohort and in other analyses of a military health care database in Texas. The report was published online Sept. 19 in JAMA Ophthalmology.

This is yet another observational study to show a possible association between statin use and cataracts – this time a negative one – continuing the ongoing controversy in this area of research.

Investigators said that their propensity score–matched analysis was the first study of its kind, and also one of the largest, including 45,000 patients who were followed up longitudinally within the same health care system, with similar health care coverage and access to care and medication.

The study was extremely well done, Dr. Kim Allan Williams Sr., chair of cardiology at Wayne State University, Detroit, said in an interview. "This is one of the larger studies, and the thing that distinguishes this one is how well the propensity matching was done. Dr. Williams, who was not involved in the study, added that the study wasn’t a definite and final answer to the question, and didn’t negate other studies that showed a protective or no association between statins and cataracts.

Researchers conducted the analysis on all adult patients who were enrolled in the San Antonio Military Multi-Market Area as Tricare Prime or Plus, analyzing the data from October 1, 2003, to March 1, 2010. All patients were enrolled in the system throughout the study.

With a computer model, they selected a group of statin users and nonusers who looked very comparable to each other.

"One of the biggest caveats in observational studies is that, patients’ baseline characteristics may be different," Dr. Ishak Mansi, the study’s principal investigator, said in an interview." And when you look after 6 or 7 years, you may have higher incidence of cataract in some, not because of the statins, but because some of the patients who were given statins were sicker from the very beginning. So we have to make sure we’re comparing apples to apples."

They divided the participants according to statin use, using their pharmacy records: There were 13,626 statin users, who had received at least one 90-day supply of a statin; and 32,623 nonusers, who had never received a statin throughout the study.

To conduct a propensity score–matched cohort analysis, researchers used 44 variables that were expected to increase the likelihood of receiving a statin prescription, as well as increasing the risk for cataract. Those variables included age, sex, 17 comorbid conditions, obesity, alcohol dependence/abuse, use of 14 medication groups, and more.

As for statins, simvastatin made up 73% of the prescriptions, atorvastatin 17.4%, pravastatin 7%, rosuvastatin 1.7%, and fluvastatin or lovastatin 0.24% of the prescription. Nearly 34% of the statin users received maximal doses of statins.

For the primary analysis, researchers matched 6,972 pairs of statin users and nonusers, with no significant differences in their baseline characteristics. Among the statin users, cataracts occurred in 2,477 (35.5%), compared with 2,337 (33.5%) of the nonusers, yielding a statistically significant odds ratio of 1.09 (JAMA Ophthalmol. 2013 Sept. 19 [doi:10.1001/jamaophthalmol.2013.4575]).

"Then we said, let us assume that the computer model may not have been good in selecting patients, and let’s see if we can get the same result by slicing the data differently," said Dr. Mansi, professor of medicine at UT Southwestern, Dallas.

The secondary analysis included 6,113 statin users and 27,400 nonusers with no prespecified comorbidities. Among them, 33.7% of statin users and 9.4% of nonusers developed cataracts, a significant 20% increased risk, the researchers reported.

Further analysis showed that statin use was an independent predictor of cataract (adjusted OR, 1.43), and statin use continued to be an independent predictor of cataract, when researchers repeated the analysis using backward stepwise elimination (adjusted OR, 1.42).

They also examined the relationship between cataract and LDL cholesterol and HDL cholesterol, and found that the mean LDL cholesterol level was inversely related to risk for cataract (adjusted OR, 0.997; P = .009), but mean HDL cholesterol was not (adjusted OR, 1.002; P = .16).

They also analyzed the data according to years of statin use (2, 4, and 6 years). "Whatever approach we used, the result was consistent," said Dr. Mansi, a staff internist at VA North Texas, Dallas.

Dr. Williams, vice president of the American College of Cardiology, said that the study puts the issue "into real question again, and we find ourselves wanting a randomized controlled prospective trial, which would be very difficult to do. These are drugs that you just don’t randomize people to. If we’re stuck with observational trials, no matter how large or how well done they are, there will always be questions."

In September, at the annual congress of the European Society of Cardiology, Dr. John B. Kostis of Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J., presented an unpublished meta-analysis of 13 studies, showing that statins had a protective effect on cataracts, especially when they were prescribed to younger people for a longer period of time.

"The bottom line is that statins prevent cataracts," Dr. Kostis said during his presentation at ESC. "But the bottom bottom line is, don’t be scared of cataracts when prescribing statins." (Dr. Kostis said he was submitting a letter to the JAMA editors regarding Dr. Mansi’s study, raising a few questions about the methods and findings.)

Dr. Mansi and colleagues listed several limitations for the study, including its retrospective observational design. They added that there may be other unidentified baseline confounders, and that successful propensity score matching of individual baseline characteristics doesn’t guarantee that the combined effect of individual difference would have no impact on the outcome of interest. Also, using pharmacy data to identify statin use does not capture statin intake, although most users received the prescription for a mean cumulative duration of 4.5 years, which suggests compliance, they noted.

"The most important message for doctors is that we don’t really know yet the full spectrum of side effects of this very effective group of medications," Dr. Mansi said. "They should prescribe this medication in accordance with the current guidelines, not extrapolate, and not prescribe it lightly. Rather, they should consider the benefit-risk ratio for each individual."

Based on the findings, Dr. Williams said, "Look for statin use in diabetes patients, because it can be associated with faster development of cataract. The other thing is, try and make sure within the patients’ care group, whether it’s in a patient-centered home, in primary care, or even in cardiology, that attention is paid to vision and cataract screening, which can become a routine part of physical exam. Unfortunately, that sounds like that we’re convinced by this study. But I think it’s convincing enough to bring our threshold for screening people with cataracts down a little bit."

The authors suggested that future studies should include regular ophthalmologic examinations and objective assessment tools rather than relying on patient surveys or administrative data.

With the growing elderly population, incidence of cataracts, which comes with a whopping cost of $5 billion annually, is likely to increase, and "understanding and optimizing the modifiable risk factors for developing lens opacities must be a public health priority," Dr. Mansi and colleagues wrote.

Dr. Mansi and Dr. Kostis had no disclosures. Dr. Williams has received consultant fees/honoraria from Astellas Healthcare.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

Taking statins was associated with a higher incidence of cataract diagnosis in a propensity score–matched cohort and in other analyses of a military health care database in Texas. The report was published online Sept. 19 in JAMA Ophthalmology.

This is yet another observational study to show a possible association between statin use and cataracts – this time a negative one – continuing the ongoing controversy in this area of research.

Investigators said that their propensity score–matched analysis was the first study of its kind, and also one of the largest, including 45,000 patients who were followed up longitudinally within the same health care system, with similar health care coverage and access to care and medication.

The study was extremely well done, Dr. Kim Allan Williams Sr., chair of cardiology at Wayne State University, Detroit, said in an interview. "This is one of the larger studies, and the thing that distinguishes this one is how well the propensity matching was done. Dr. Williams, who was not involved in the study, added that the study wasn’t a definite and final answer to the question, and didn’t negate other studies that showed a protective or no association between statins and cataracts.

Researchers conducted the analysis on all adult patients who were enrolled in the San Antonio Military Multi-Market Area as Tricare Prime or Plus, analyzing the data from October 1, 2003, to March 1, 2010. All patients were enrolled in the system throughout the study.

With a computer model, they selected a group of statin users and nonusers who looked very comparable to each other.

"One of the biggest caveats in observational studies is that, patients’ baseline characteristics may be different," Dr. Ishak Mansi, the study’s principal investigator, said in an interview." And when you look after 6 or 7 years, you may have higher incidence of cataract in some, not because of the statins, but because some of the patients who were given statins were sicker from the very beginning. So we have to make sure we’re comparing apples to apples."

They divided the participants according to statin use, using their pharmacy records: There were 13,626 statin users, who had received at least one 90-day supply of a statin; and 32,623 nonusers, who had never received a statin throughout the study.

To conduct a propensity score–matched cohort analysis, researchers used 44 variables that were expected to increase the likelihood of receiving a statin prescription, as well as increasing the risk for cataract. Those variables included age, sex, 17 comorbid conditions, obesity, alcohol dependence/abuse, use of 14 medication groups, and more.

As for statins, simvastatin made up 73% of the prescriptions, atorvastatin 17.4%, pravastatin 7%, rosuvastatin 1.7%, and fluvastatin or lovastatin 0.24% of the prescription. Nearly 34% of the statin users received maximal doses of statins.

For the primary analysis, researchers matched 6,972 pairs of statin users and nonusers, with no significant differences in their baseline characteristics. Among the statin users, cataracts occurred in 2,477 (35.5%), compared with 2,337 (33.5%) of the nonusers, yielding a statistically significant odds ratio of 1.09 (JAMA Ophthalmol. 2013 Sept. 19 [doi:10.1001/jamaophthalmol.2013.4575]).

"Then we said, let us assume that the computer model may not have been good in selecting patients, and let’s see if we can get the same result by slicing the data differently," said Dr. Mansi, professor of medicine at UT Southwestern, Dallas.

The secondary analysis included 6,113 statin users and 27,400 nonusers with no prespecified comorbidities. Among them, 33.7% of statin users and 9.4% of nonusers developed cataracts, a significant 20% increased risk, the researchers reported.

Further analysis showed that statin use was an independent predictor of cataract (adjusted OR, 1.43), and statin use continued to be an independent predictor of cataract, when researchers repeated the analysis using backward stepwise elimination (adjusted OR, 1.42).

They also examined the relationship between cataract and LDL cholesterol and HDL cholesterol, and found that the mean LDL cholesterol level was inversely related to risk for cataract (adjusted OR, 0.997; P = .009), but mean HDL cholesterol was not (adjusted OR, 1.002; P = .16).

They also analyzed the data according to years of statin use (2, 4, and 6 years). "Whatever approach we used, the result was consistent," said Dr. Mansi, a staff internist at VA North Texas, Dallas.

Dr. Williams, vice president of the American College of Cardiology, said that the study puts the issue "into real question again, and we find ourselves wanting a randomized controlled prospective trial, which would be very difficult to do. These are drugs that you just don’t randomize people to. If we’re stuck with observational trials, no matter how large or how well done they are, there will always be questions."

In September, at the annual congress of the European Society of Cardiology, Dr. John B. Kostis of Rutgers Robert Wood Johnson Medical School, New Brunswick, N.J., presented an unpublished meta-analysis of 13 studies, showing that statins had a protective effect on cataracts, especially when they were prescribed to younger people for a longer period of time.

"The bottom line is that statins prevent cataracts," Dr. Kostis said during his presentation at ESC. "But the bottom bottom line is, don’t be scared of cataracts when prescribing statins." (Dr. Kostis said he was submitting a letter to the JAMA editors regarding Dr. Mansi’s study, raising a few questions about the methods and findings.)

Dr. Mansi and colleagues listed several limitations for the study, including its retrospective observational design. They added that there may be other unidentified baseline confounders, and that successful propensity score matching of individual baseline characteristics doesn’t guarantee that the combined effect of individual difference would have no impact on the outcome of interest. Also, using pharmacy data to identify statin use does not capture statin intake, although most users received the prescription for a mean cumulative duration of 4.5 years, which suggests compliance, they noted.

"The most important message for doctors is that we don’t really know yet the full spectrum of side effects of this very effective group of medications," Dr. Mansi said. "They should prescribe this medication in accordance with the current guidelines, not extrapolate, and not prescribe it lightly. Rather, they should consider the benefit-risk ratio for each individual."

Based on the findings, Dr. Williams said, "Look for statin use in diabetes patients, because it can be associated with faster development of cataract. The other thing is, try and make sure within the patients’ care group, whether it’s in a patient-centered home, in primary care, or even in cardiology, that attention is paid to vision and cataract screening, which can become a routine part of physical exam. Unfortunately, that sounds like that we’re convinced by this study. But I think it’s convincing enough to bring our threshold for screening people with cataracts down a little bit."

The authors suggested that future studies should include regular ophthalmologic examinations and objective assessment tools rather than relying on patient surveys or administrative data.

With the growing elderly population, incidence of cataracts, which comes with a whopping cost of $5 billion annually, is likely to increase, and "understanding and optimizing the modifiable risk factors for developing lens opacities must be a public health priority," Dr. Mansi and colleagues wrote.

Dr. Mansi and Dr. Kostis had no disclosures. Dr. Williams has received consultant fees/honoraria from Astellas Healthcare.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

In 2011, nearly 23,000 of 2.5 million drug-related emergency department visits were linked to a group of synthetic drugs called "bath salts," according to a report by the Substance Abuse and Mental Health Services Administration. The agency said this is the first national study to track such data.

The numbers are "worrisome, because these are relatively new drugs that we haven’t seen until the last few years," Dr. Elinore F. McCance-Katz, SAMHSA’s chief medical officer, said in an interview.

"These are drugs that are mainly abused by young people, and because of that, as physicians, we need to be attuned to the potential for misuse of these substance by younger people," Dr. McCance-Katz said. "And physicians need to be aware that we don’t have treatments that are specific to toxicities related to these drugs, so it’s going to be symptomatic treatment. And for individuals who do develop abuse or addiction to these drugs, there’s not a treatment that’s shown to be effective, so prevention is going to be important.

"Provide information to these young folks, and help keep them from starting the use of these drugs," she said.

The drugs’ adverse effects include heart and blood vessel problems, depression, suicidal thoughts, psychosis, and death.

The toxicities are similar to those of other stimulants seen in the ED, Dr. McCance-Katz said. "Treat the patients symptomatically. If they have severe hypertension, give medication to reduce blood pressure. If the person presents with severe agitation and anxiety, we might give them benzodiazepines. If that’s not helpful, and/or if they also have psychosis, we might give them an antipsychotic.

"But we need to be careful about the antipsychotic selection, because antipsychotics themselves can reduce the seizure threshold, as can happen with amphetamine abuse, so we don’t want to risk seizure. But in a patient who is severely agitated and psychotic, that may be the emergency treatment that is necessary."

Dr. McCance-Katz added that it’s important for psychiatrists to know that there are also adverse mental health symptoms, as seen with other amphetamines.

"Someone might present with toxicity from using this type of a drug with agitation, psychosis, a rapid heartbeat, possibly even chest pain, and severe anxiety, and that person would need a good bit of medical and psychiatric care," she said.

The report, based on the 2011 Drug Abuse Warning Network, or DAWN report, also showed that two-thirds (67%) of bath salt–related ED visits involved the use of another drug: 15% involved combined use of marijuana or synthetic forms of marijuana, and 52% involved the use of other drugs. Only 33% of the cases involved exposure to bath salts only.

Dr. McCance-Katz said the combined use means that these synthetic drugs could be even more dangerous to the users.

Synthetic drugs, including bath salts, were first detected in the United States in 2008 by the Drug Enforcement Administration (DEA).

Bath salts began to gain national attention in 2011, when poison centers reported a sudden jump to more than 6,000 cases of exposure to the drug, up from a mere 300 in 2010.

Since then, however, there has been a 10-fold drop in the number of calls to poison centers, in part because of increased local awareness, education, and federal actions.

In April of this year, the DEA put one of the main chemicals in bath salts in the Schedule I category, the most restrictive category created by the Controlled Substance Act. Several large national drug busts also have taken place in connection with the substance.

Bath salts come in the form of white or brown powder and contain one or more chemicals related to cathinone, an amphetamine-like stimulant. They are sold in packages that are labeled as household products, such as bath salts, or jewelry cleaner, and labeled as "legal high" or "not for human consumption." They can be taken by mouth, inhaled, or injected.

Dr. McCance-Katz stressed that patient education and prevention are key.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

In 2011, nearly 23,000 of 2.5 million drug-related emergency department visits were linked to a group of synthetic drugs called "bath salts," according to a report by the Substance Abuse and Mental Health Services Administration. The agency said this is the first national study to track such data.

The numbers are "worrisome, because these are relatively new drugs that we haven’t seen until the last few years," Dr. Elinore F. McCance-Katz, SAMHSA’s chief medical officer, said in an interview.

"These are drugs that are mainly abused by young people, and because of that, as physicians, we need to be attuned to the potential for misuse of these substance by younger people," Dr. McCance-Katz said. "And physicians need to be aware that we don’t have treatments that are specific to toxicities related to these drugs, so it’s going to be symptomatic treatment. And for individuals who do develop abuse or addiction to these drugs, there’s not a treatment that’s shown to be effective, so prevention is going to be important.

"Provide information to these young folks, and help keep them from starting the use of these drugs," she said.

The drugs’ adverse effects include heart and blood vessel problems, depression, suicidal thoughts, psychosis, and death.

The toxicities are similar to those of other stimulants seen in the ED, Dr. McCance-Katz said. "Treat the patients symptomatically. If they have severe hypertension, give medication to reduce blood pressure. If the person presents with severe agitation and anxiety, we might give them benzodiazepines. If that’s not helpful, and/or if they also have psychosis, we might give them an antipsychotic.

"But we need to be careful about the antipsychotic selection, because antipsychotics themselves can reduce the seizure threshold, as can happen with amphetamine abuse, so we don’t want to risk seizure. But in a patient who is severely agitated and psychotic, that may be the emergency treatment that is necessary."

Dr. McCance-Katz added that it’s important for psychiatrists to know that there are also adverse mental health symptoms, as seen with other amphetamines.

"Someone might present with toxicity from using this type of a drug with agitation, psychosis, a rapid heartbeat, possibly even chest pain, and severe anxiety, and that person would need a good bit of medical and psychiatric care," she said.

The report, based on the 2011 Drug Abuse Warning Network, or DAWN report, also showed that two-thirds (67%) of bath salt–related ED visits involved the use of another drug: 15% involved combined use of marijuana or synthetic forms of marijuana, and 52% involved the use of other drugs. Only 33% of the cases involved exposure to bath salts only.

Dr. McCance-Katz said the combined use means that these synthetic drugs could be even more dangerous to the users.

Synthetic drugs, including bath salts, were first detected in the United States in 2008 by the Drug Enforcement Administration (DEA).

Bath salts began to gain national attention in 2011, when poison centers reported a sudden jump to more than 6,000 cases of exposure to the drug, up from a mere 300 in 2010.

Since then, however, there has been a 10-fold drop in the number of calls to poison centers, in part because of increased local awareness, education, and federal actions.

In April of this year, the DEA put one of the main chemicals in bath salts in the Schedule I category, the most restrictive category created by the Controlled Substance Act. Several large national drug busts also have taken place in connection with the substance.

Bath salts come in the form of white or brown powder and contain one or more chemicals related to cathinone, an amphetamine-like stimulant. They are sold in packages that are labeled as household products, such as bath salts, or jewelry cleaner, and labeled as "legal high" or "not for human consumption." They can be taken by mouth, inhaled, or injected.

Dr. McCance-Katz stressed that patient education and prevention are key.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

In 2011, nearly 23,000 of 2.5 million drug-related emergency department visits were linked to a group of synthetic drugs called "bath salts," according to a report by the Substance Abuse and Mental Health Services Administration. The agency said this is the first national study to track such data.

The numbers are "worrisome, because these are relatively new drugs that we haven’t seen until the last few years," Dr. Elinore F. McCance-Katz, SAMHSA’s chief medical officer, said in an interview.

"These are drugs that are mainly abused by young people, and because of that, as physicians, we need to be attuned to the potential for misuse of these substance by younger people," Dr. McCance-Katz said. "And physicians need to be aware that we don’t have treatments that are specific to toxicities related to these drugs, so it’s going to be symptomatic treatment. And for individuals who do develop abuse or addiction to these drugs, there’s not a treatment that’s shown to be effective, so prevention is going to be important.

"Provide information to these young folks, and help keep them from starting the use of these drugs," she said.

The drugs’ adverse effects include heart and blood vessel problems, depression, suicidal thoughts, psychosis, and death.

The toxicities are similar to those of other stimulants seen in the ED, Dr. McCance-Katz said. "Treat the patients symptomatically. If they have severe hypertension, give medication to reduce blood pressure. If the person presents with severe agitation and anxiety, we might give them benzodiazepines. If that’s not helpful, and/or if they also have psychosis, we might give them an antipsychotic.

"But we need to be careful about the antipsychotic selection, because antipsychotics themselves can reduce the seizure threshold, as can happen with amphetamine abuse, so we don’t want to risk seizure. But in a patient who is severely agitated and psychotic, that may be the emergency treatment that is necessary."

Dr. McCance-Katz added that it’s important for psychiatrists to know that there are also adverse mental health symptoms, as seen with other amphetamines.

"Someone might present with toxicity from using this type of a drug with agitation, psychosis, a rapid heartbeat, possibly even chest pain, and severe anxiety, and that person would need a good bit of medical and psychiatric care," she said.

The report, based on the 2011 Drug Abuse Warning Network, or DAWN report, also showed that two-thirds (67%) of bath salt–related ED visits involved the use of another drug: 15% involved combined use of marijuana or synthetic forms of marijuana, and 52% involved the use of other drugs. Only 33% of the cases involved exposure to bath salts only.

Dr. McCance-Katz said the combined use means that these synthetic drugs could be even more dangerous to the users.

Synthetic drugs, including bath salts, were first detected in the United States in 2008 by the Drug Enforcement Administration (DEA).

Bath salts began to gain national attention in 2011, when poison centers reported a sudden jump to more than 6,000 cases of exposure to the drug, up from a mere 300 in 2010.

Since then, however, there has been a 10-fold drop in the number of calls to poison centers, in part because of increased local awareness, education, and federal actions.

In April of this year, the DEA put one of the main chemicals in bath salts in the Schedule I category, the most restrictive category created by the Controlled Substance Act. Several large national drug busts also have taken place in connection with the substance.

Bath salts come in the form of white or brown powder and contain one or more chemicals related to cathinone, an amphetamine-like stimulant. They are sold in packages that are labeled as household products, such as bath salts, or jewelry cleaner, and labeled as "legal high" or "not for human consumption." They can be taken by mouth, inhaled, or injected.

Dr. McCance-Katz stressed that patient education and prevention are key.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

NEW YORK – To frustrated parents of children with severe atopic dermatitis, Dr. Sheilagh Maguiness offers a fast and effective remedy: a 2-week intensive treatment she calls Boot Camp. Instead of push-ups, however, this Boot Camp involves bleach baths, wet wraps, steroids, moisturizers, and sometimes oral antibiotics or antihistamines.

During the 2-week period, the treatment plan attempts to address all aspects of the disease – dry skin, itching, inflammation, and infection or colonization – simultaneously.

Dr. Maguiness’ instructions for the severe atopic dermatitis Boot Camp are as follows:

• For 2 weeks, bathe the child nightly in a dilute bleach bath of lukewarm water for 10 minutes. (No soap is needed, or use unscented Dove or Cetaphil for armpits, groin, hands, and feet.) After 2 weeks, use lukewarm water alone.

Data have shown that the baths are safe, said Dr. Maguiness of Harvard University, Boston, and Boston Children’s Hospital. In a recent randomized trial of 31 children, those who underwent regular, dilute bleach baths showed improvement in their atopic dermatitis with no increased susceptibility to infection (Pediatrics 2009;123:e808-14). The recipe for the bleach baths is ¼ to ½ cup of plain Clorox bleach in a full tub of bath water. (With more concentrated forms of Clorox, use 1/3 cup per full tub.) Comfort the worried parents by letting them know that the concentration is similar to that found in a swimming pool, and is safe for head and neck areas, she said in a presentation at the American Academy of Dermatology summer meeting.

• After bathing, pat the skin dry, and within 3 minutes apply triamcinolone (0.1% ointment) to affected areas on the body, and hydrocortisone (2.5% ointment) to the face.

• Follow the bath with a thick moisturizer (Vaseline, Aquaphor, or Hydrolatum ointment). Use the moisturizer on top of the medication twice daily, even if no bath is taken. Avoid lotions.

• Add wet pajama wraps nightly for 1-2 weeks as part of the Boot Camp and/or for acute flares, Dr. Maguiness noted. Studies have shown that wet wraps plus topical corticosteroids are effective, and can promote rapid improvement in the majority of patients, with very few side effects. In a recent retrospective study of 216 pediatric patients who underwent this combination, all of them showed at least 25% improvement, and 45% had 75-100% improvement (J. Am. Acad. Dermatol. 2012;67:100-6).

Advise parents to use long-sleeve cotton pajamas or Onesies for wet wraps, Dr. Maguiness added. Parents should soak the garment in warm water, wring it out until it’s slightly damp, then dress the child, and put on a dry outfit on top of the wet one. They should make sure the room is warm so the child can go to sleep.

In cases of obvious superinfection, prescribe an appropriate oral antibiotic such as cephalexin.

For itching at night, sedating antihistamines such as hydroxyzine 10 mg/5 mL, 30 minutes before bedtime can be helpful, Dr. Maguiness noted. For daytime itching, she suggested fexofenadine or cetirizine in the morning. Have a few "go-to" agents, she advised. For infants, consider fluocinolone oil or triamcinalone 0.025% ointment. For children, consider triamcinalone 0.1% ointment. For teenagers (or for use in more localized areas with younger children), consider stronger agents such as mometasone or fluocinonide ointment.

Limited studies support some systemic therapies for use in pediatric atopic dermatitis, including narrow-band ultraviolet B (nb UVB); cyclosporine and mycophenolate mofetil; and methotrexate and azathioprine, Dr. Maguiness said. Perhaps in the future, biologics such as tocilizumab may emerge as additional treatment options, she added. While cyclosporine can help with the rapid clearance of the disease, methotrexate and mycophenolate mofetil may represent longer-term options, she said.

Meanwhile, don’t be surprised if families resist the Boot Camp at first, Dr. Maguiness said.

"You have to get the families on your side," she said. "They’re terrified of bleach baths, wet pajamas, and topical steroids. Let them know there’s no faster or safer way to improve their child’s condition in 2 weeks or less."

So invest time in the first visit, educate your patients and parents about the treatment plan, and give them printed instructions and handouts, Dr. Maguiness said.

Finally, don’t forget to obtain cultures to rule out possible superinfection, as well as schedule a prompt follow-up visit in about 2 weeks.

At this visit, after following the Boot Camp regimen, the eczematous areas should be mostly cleared, with possible residual hot spots, she said. Begin to taper the topical steroids, bleach baths, and wet wraps at night.

Despite the challenges of treating severe atopic dermatitis in children, she told her audience that treating these young patients has been one of the most rewarding parts of her practice.

Dr. Maguiness had no relevant disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

NEW YORK – To frustrated parents of children with severe atopic dermatitis, Dr. Sheilagh Maguiness offers a fast and effective remedy: a 2-week intensive treatment she calls Boot Camp. Instead of push-ups, however, this Boot Camp involves bleach baths, wet wraps, steroids, moisturizers, and sometimes oral antibiotics or antihistamines.

During the 2-week period, the treatment plan attempts to address all aspects of the disease – dry skin, itching, inflammation, and infection or colonization – simultaneously.

Dr. Maguiness’ instructions for the severe atopic dermatitis Boot Camp are as follows:

• For 2 weeks, bathe the child nightly in a dilute bleach bath of lukewarm water for 10 minutes. (No soap is needed, or use unscented Dove or Cetaphil for armpits, groin, hands, and feet.) After 2 weeks, use lukewarm water alone.

Data have shown that the baths are safe, said Dr. Maguiness of Harvard University, Boston, and Boston Children’s Hospital. In a recent randomized trial of 31 children, those who underwent regular, dilute bleach baths showed improvement in their atopic dermatitis with no increased susceptibility to infection (Pediatrics 2009;123:e808-14). The recipe for the bleach baths is ¼ to ½ cup of plain Clorox bleach in a full tub of bath water. (With more concentrated forms of Clorox, use 1/3 cup per full tub.) Comfort the worried parents by letting them know that the concentration is similar to that found in a swimming pool, and is safe for head and neck areas, she said in a presentation at the American Academy of Dermatology summer meeting.

• After bathing, pat the skin dry, and within 3 minutes apply triamcinolone (0.1% ointment) to affected areas on the body, and hydrocortisone (2.5% ointment) to the face.

• Follow the bath with a thick moisturizer (Vaseline, Aquaphor, or Hydrolatum ointment). Use the moisturizer on top of the medication twice daily, even if no bath is taken. Avoid lotions.

• Add wet pajama wraps nightly for 1-2 weeks as part of the Boot Camp and/or for acute flares, Dr. Maguiness noted. Studies have shown that wet wraps plus topical corticosteroids are effective, and can promote rapid improvement in the majority of patients, with very few side effects. In a recent retrospective study of 216 pediatric patients who underwent this combination, all of them showed at least 25% improvement, and 45% had 75-100% improvement (J. Am. Acad. Dermatol. 2012;67:100-6).

Advise parents to use long-sleeve cotton pajamas or Onesies for wet wraps, Dr. Maguiness added. Parents should soak the garment in warm water, wring it out until it’s slightly damp, then dress the child, and put on a dry outfit on top of the wet one. They should make sure the room is warm so the child can go to sleep.

In cases of obvious superinfection, prescribe an appropriate oral antibiotic such as cephalexin.

For itching at night, sedating antihistamines such as hydroxyzine 10 mg/5 mL, 30 minutes before bedtime can be helpful, Dr. Maguiness noted. For daytime itching, she suggested fexofenadine or cetirizine in the morning. Have a few "go-to" agents, she advised. For infants, consider fluocinolone oil or triamcinalone 0.025% ointment. For children, consider triamcinalone 0.1% ointment. For teenagers (or for use in more localized areas with younger children), consider stronger agents such as mometasone or fluocinonide ointment.

Limited studies support some systemic therapies for use in pediatric atopic dermatitis, including narrow-band ultraviolet B (nb UVB); cyclosporine and mycophenolate mofetil; and methotrexate and azathioprine, Dr. Maguiness said. Perhaps in the future, biologics such as tocilizumab may emerge as additional treatment options, she added. While cyclosporine can help with the rapid clearance of the disease, methotrexate and mycophenolate mofetil may represent longer-term options, she said.

Meanwhile, don’t be surprised if families resist the Boot Camp at first, Dr. Maguiness said.

"You have to get the families on your side," she said. "They’re terrified of bleach baths, wet pajamas, and topical steroids. Let them know there’s no faster or safer way to improve their child’s condition in 2 weeks or less."

So invest time in the first visit, educate your patients and parents about the treatment plan, and give them printed instructions and handouts, Dr. Maguiness said.

Finally, don’t forget to obtain cultures to rule out possible superinfection, as well as schedule a prompt follow-up visit in about 2 weeks.

At this visit, after following the Boot Camp regimen, the eczematous areas should be mostly cleared, with possible residual hot spots, she said. Begin to taper the topical steroids, bleach baths, and wet wraps at night.

Despite the challenges of treating severe atopic dermatitis in children, she told her audience that treating these young patients has been one of the most rewarding parts of her practice.

Dr. Maguiness had no relevant disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

NEW YORK – To frustrated parents of children with severe atopic dermatitis, Dr. Sheilagh Maguiness offers a fast and effective remedy: a 2-week intensive treatment she calls Boot Camp. Instead of push-ups, however, this Boot Camp involves bleach baths, wet wraps, steroids, moisturizers, and sometimes oral antibiotics or antihistamines.

During the 2-week period, the treatment plan attempts to address all aspects of the disease – dry skin, itching, inflammation, and infection or colonization – simultaneously.

Dr. Maguiness’ instructions for the severe atopic dermatitis Boot Camp are as follows:

• For 2 weeks, bathe the child nightly in a dilute bleach bath of lukewarm water for 10 minutes. (No soap is needed, or use unscented Dove or Cetaphil for armpits, groin, hands, and feet.) After 2 weeks, use lukewarm water alone.

Data have shown that the baths are safe, said Dr. Maguiness of Harvard University, Boston, and Boston Children’s Hospital. In a recent randomized trial of 31 children, those who underwent regular, dilute bleach baths showed improvement in their atopic dermatitis with no increased susceptibility to infection (Pediatrics 2009;123:e808-14). The recipe for the bleach baths is ¼ to ½ cup of plain Clorox bleach in a full tub of bath water. (With more concentrated forms of Clorox, use 1/3 cup per full tub.) Comfort the worried parents by letting them know that the concentration is similar to that found in a swimming pool, and is safe for head and neck areas, she said in a presentation at the American Academy of Dermatology summer meeting.

• After bathing, pat the skin dry, and within 3 minutes apply triamcinolone (0.1% ointment) to affected areas on the body, and hydrocortisone (2.5% ointment) to the face.

• Follow the bath with a thick moisturizer (Vaseline, Aquaphor, or Hydrolatum ointment). Use the moisturizer on top of the medication twice daily, even if no bath is taken. Avoid lotions.

• Add wet pajama wraps nightly for 1-2 weeks as part of the Boot Camp and/or for acute flares, Dr. Maguiness noted. Studies have shown that wet wraps plus topical corticosteroids are effective, and can promote rapid improvement in the majority of patients, with very few side effects. In a recent retrospective study of 216 pediatric patients who underwent this combination, all of them showed at least 25% improvement, and 45% had 75-100% improvement (J. Am. Acad. Dermatol. 2012;67:100-6).

Advise parents to use long-sleeve cotton pajamas or Onesies for wet wraps, Dr. Maguiness added. Parents should soak the garment in warm water, wring it out until it’s slightly damp, then dress the child, and put on a dry outfit on top of the wet one. They should make sure the room is warm so the child can go to sleep.

In cases of obvious superinfection, prescribe an appropriate oral antibiotic such as cephalexin.

For itching at night, sedating antihistamines such as hydroxyzine 10 mg/5 mL, 30 minutes before bedtime can be helpful, Dr. Maguiness noted. For daytime itching, she suggested fexofenadine or cetirizine in the morning. Have a few "go-to" agents, she advised. For infants, consider fluocinolone oil or triamcinalone 0.025% ointment. For children, consider triamcinalone 0.1% ointment. For teenagers (or for use in more localized areas with younger children), consider stronger agents such as mometasone or fluocinonide ointment.

Limited studies support some systemic therapies for use in pediatric atopic dermatitis, including narrow-band ultraviolet B (nb UVB); cyclosporine and mycophenolate mofetil; and methotrexate and azathioprine, Dr. Maguiness said. Perhaps in the future, biologics such as tocilizumab may emerge as additional treatment options, she added. While cyclosporine can help with the rapid clearance of the disease, methotrexate and mycophenolate mofetil may represent longer-term options, she said.

Meanwhile, don’t be surprised if families resist the Boot Camp at first, Dr. Maguiness said.

"You have to get the families on your side," she said. "They’re terrified of bleach baths, wet pajamas, and topical steroids. Let them know there’s no faster or safer way to improve their child’s condition in 2 weeks or less."

So invest time in the first visit, educate your patients and parents about the treatment plan, and give them printed instructions and handouts, Dr. Maguiness said.

Finally, don’t forget to obtain cultures to rule out possible superinfection, as well as schedule a prompt follow-up visit in about 2 weeks.

At this visit, after following the Boot Camp regimen, the eczematous areas should be mostly cleared, with possible residual hot spots, she said. Begin to taper the topical steroids, bleach baths, and wet wraps at night.

Despite the challenges of treating severe atopic dermatitis in children, she told her audience that treating these young patients has been one of the most rewarding parts of her practice.

Dr. Maguiness had no relevant disclosures.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

AMSTERDAM – Four studies presented at the European Society of Cardiology further highlighted the fact that there’s still much to be learned about the connection between obesity and its health risks. Data on the "obesity paradox" is building, and the usefulness of the body mass index continues to draw controversy.

A study by Danish researchers showed that obesity might not be all that bad if the overweight woman is metabolically healthy. "But because obesity markedly increases the risk of developing these metabolic disorders, these women most likely have a window of opportunity to lose weight and change their prognosis," said Dr. Michelle Schmiegelow of Gentofte Hospital, Hellerup, Denmark, in a statement.

Japanese researchers found that as the BMI increased, the risk of cardiovascular disease decreased among Japanese patients who had hypertension and were glucose intolerant. Still, the authors wrote, "Hypertensive patients with glucose intolerance and a high BMI should lose weight and restore their BMI to normal range."

Also, Dr. Aziza Azimi of Gentofte Hospital showed that weight maintenance or weight loss seemed to increase the risk of death in underweight women with coronary artery disease. "These data appear to be against the common sense that obesity is a risk factor for cardiovascular mortality, as underweight has been even more strongly related to worse clinical outcomes than overweight," she said in a statement. "Future investigations will be necessary to prove this new concept."

Meanwhile, long-term data from the French FAST-MI 2005 registry showed that both lean patients (BMI less than 22 kg/m²) and very obese patients (BMI of at least 35 kg/m²) had an increased risk of death at 5 years. "It is not good to be too lean or too fat, but it is worse still when you have a big belly," said Prof. Tabassome Simon of Hospital St. Antoine, Paris, France, in a statement. 

To put the findings into perspective, we spoke with Prof. Diethelm Tschoepe of Germany, who moderated the session. 

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – Four studies presented at the European Society of Cardiology further highlighted the fact that there’s still much to be learned about the connection between obesity and its health risks. Data on the "obesity paradox" is building, and the usefulness of the body mass index continues to draw controversy.

A study by Danish researchers showed that obesity might not be all that bad if the overweight woman is metabolically healthy. "But because obesity markedly increases the risk of developing these metabolic disorders, these women most likely have a window of opportunity to lose weight and change their prognosis," said Dr. Michelle Schmiegelow of Gentofte Hospital, Hellerup, Denmark, in a statement.

Japanese researchers found that as the BMI increased, the risk of cardiovascular disease decreased among Japanese patients who had hypertension and were glucose intolerant. Still, the authors wrote, "Hypertensive patients with glucose intolerance and a high BMI should lose weight and restore their BMI to normal range."

Also, Dr. Aziza Azimi of Gentofte Hospital showed that weight maintenance or weight loss seemed to increase the risk of death in underweight women with coronary artery disease. "These data appear to be against the common sense that obesity is a risk factor for cardiovascular mortality, as underweight has been even more strongly related to worse clinical outcomes than overweight," she said in a statement. "Future investigations will be necessary to prove this new concept."

Meanwhile, long-term data from the French FAST-MI 2005 registry showed that both lean patients (BMI less than 22 kg/m²) and very obese patients (BMI of at least 35 kg/m²) had an increased risk of death at 5 years. "It is not good to be too lean or too fat, but it is worse still when you have a big belly," said Prof. Tabassome Simon of Hospital St. Antoine, Paris, France, in a statement. 

To put the findings into perspective, we spoke with Prof. Diethelm Tschoepe of Germany, who moderated the session. 

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – Four studies presented at the European Society of Cardiology further highlighted the fact that there’s still much to be learned about the connection between obesity and its health risks. Data on the "obesity paradox" is building, and the usefulness of the body mass index continues to draw controversy.

A study by Danish researchers showed that obesity might not be all that bad if the overweight woman is metabolically healthy. "But because obesity markedly increases the risk of developing these metabolic disorders, these women most likely have a window of opportunity to lose weight and change their prognosis," said Dr. Michelle Schmiegelow of Gentofte Hospital, Hellerup, Denmark, in a statement.

Japanese researchers found that as the BMI increased, the risk of cardiovascular disease decreased among Japanese patients who had hypertension and were glucose intolerant. Still, the authors wrote, "Hypertensive patients with glucose intolerance and a high BMI should lose weight and restore their BMI to normal range."

Also, Dr. Aziza Azimi of Gentofte Hospital showed that weight maintenance or weight loss seemed to increase the risk of death in underweight women with coronary artery disease. "These data appear to be against the common sense that obesity is a risk factor for cardiovascular mortality, as underweight has been even more strongly related to worse clinical outcomes than overweight," she said in a statement. "Future investigations will be necessary to prove this new concept."

Meanwhile, long-term data from the French FAST-MI 2005 registry showed that both lean patients (BMI less than 22 kg/m²) and very obese patients (BMI of at least 35 kg/m²) had an increased risk of death at 5 years. "It is not good to be too lean or too fat, but it is worse still when you have a big belly," said Prof. Tabassome Simon of Hospital St. Antoine, Paris, France, in a statement. 

To put the findings into perspective, we spoke with Prof. Diethelm Tschoepe of Germany, who moderated the session. 

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – Elderly patients who received the highest total equivalent doses of high-potency statins, such as atorvastatin or rosuvastatin, had a threefold decrease in the risk of developing dementia, according to a retrospective, observational study in Taiwan.

Dr. Tin-Tse Lin, who presented the study at the annual congress of the European Society of Cardiology, said that the mechanism might be due to the statins’ effect on cholesterol reduction, antithrombotic activity, and their anti-inflammatory effect. The study, however, showed that lesser-prescribed lovastatin at a higher dose was positively associated with dementia development. 

The findings add another piece to the statin-dementia puzzle and may alleviate some of the concerns with the so-called "brain fog" effect of statins, experts said.

Dr. Kim Williams Sr., chair of cardiology at Wayne State University, Detroit, said that the study "was very reassuring in that there was no real evidence of dementia with the statins that we tend to use, which are the more powerful ones." Older statins like lovastatin, however, are still of concern, said Dr. Williams, vice president of the American College of Cardiology, who was not involved in the study.

In 2012, the Food and Drug Administration added a warning to the statins’ label that the drugs could cause temporary memory loss and confusion.  Meanwhile, several studies, including a 2012 review, have found no causality or conclusive relationship between statins and cognitive impairment. 

For the Taiwanese study, researchers used a random sample of 1,000,000 people covered by the country’s National Health Insurance. They identified nearly 58,000 patients who were older than 65 years of age and without a history of dementia in 1997 and 1998. The patients were followed up for an average of 4.5 years. 

The study was divided into tertiles – low, medium, and high dosage – according to mean daily equivalent or total (across the entire follow-up period) equivalent dosage. 

The primary endpoint was new diagnosis of presenile and senile dementia. Patients with vascular dementia were excluded. 

More than 5,500 developed dementia. The remaining 52,000 patient served as controls. 

Results showed that the adjusted hazard ratios for dementia were significantly inversely associated with increased total or daily equivalent statin dosage among the tertiles. For total equivalent statin dosage, the hazard ratios for dementia were 0.77 (low dosage), 0.63 (medium), and 0.33 (high), compared with controls, all significant differences. For mean equivalent daily dosage, HRs for dementia were 0.62, 0.70, 0.42, respectively, compared with controls, also significant differences. 

The authors said that the protective effect of statins remained robust in different age, gender, and cardiovascular risk subgroups, with strong statistical trends. 

Dr. Lin of the National Taiwan University Hospital, Hsin-Chu, Taiwan, said he did not know whether the findings would apply to other ethnicities. 

He hypothesized that because disorders of cholesterol metabolism could lead to an increased incidence of cerebrovascular disease, and elevation of the cholesterol level may result in a high inflammatory status associated with neurodegeneration, "I think it is reasonable to say that statins may facilitate lowering the risk of dementia."

Prof. Terje R. Pedersen of the University of Oslo (Norway), who commented on the study, said that "It is implausible that statins have any impact on progression of Alzheimer’s disease, but it might be plausible to think that when you prevent extensive atherosclerosis, then you also prevent dementia."

The bottom line, said Dr. Williams, is that the study "adds another dimension to the idea that the stronger statins that are used in the highest doses have the best benefit. That’s certainly true for the cardiovascular risk and now with dementia prevention."

Dr. Lin and Dr. Williams had no relevant disclosures. Prof. Pedersen has received research grants from Merck and Pfizer; consultation fees from Merck, AstraZeneca, Pfizer, and Amgen; speaker honoraria from Merck, Pfizer, AstraZeneca, Roche, Novartis, Amgen, and GlaxoSmithKline.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – Elderly patients who received the highest total equivalent doses of high-potency statins, such as atorvastatin or rosuvastatin, had a threefold decrease in the risk of developing dementia, according to a retrospective, observational study in Taiwan.

Dr. Tin-Tse Lin, who presented the study at the annual congress of the European Society of Cardiology, said that the mechanism might be due to the statins’ effect on cholesterol reduction, antithrombotic activity, and their anti-inflammatory effect. The study, however, showed that lesser-prescribed lovastatin at a higher dose was positively associated with dementia development. 

The findings add another piece to the statin-dementia puzzle and may alleviate some of the concerns with the so-called "brain fog" effect of statins, experts said.

Dr. Kim Williams Sr., chair of cardiology at Wayne State University, Detroit, said that the study "was very reassuring in that there was no real evidence of dementia with the statins that we tend to use, which are the more powerful ones." Older statins like lovastatin, however, are still of concern, said Dr. Williams, vice president of the American College of Cardiology, who was not involved in the study.

In 2012, the Food and Drug Administration added a warning to the statins’ label that the drugs could cause temporary memory loss and confusion.  Meanwhile, several studies, including a 2012 review, have found no causality or conclusive relationship between statins and cognitive impairment. 

For the Taiwanese study, researchers used a random sample of 1,000,000 people covered by the country’s National Health Insurance. They identified nearly 58,000 patients who were older than 65 years of age and without a history of dementia in 1997 and 1998. The patients were followed up for an average of 4.5 years. 

The study was divided into tertiles – low, medium, and high dosage – according to mean daily equivalent or total (across the entire follow-up period) equivalent dosage. 

The primary endpoint was new diagnosis of presenile and senile dementia. Patients with vascular dementia were excluded. 

More than 5,500 developed dementia. The remaining 52,000 patient served as controls. 

Results showed that the adjusted hazard ratios for dementia were significantly inversely associated with increased total or daily equivalent statin dosage among the tertiles. For total equivalent statin dosage, the hazard ratios for dementia were 0.77 (low dosage), 0.63 (medium), and 0.33 (high), compared with controls, all significant differences. For mean equivalent daily dosage, HRs for dementia were 0.62, 0.70, 0.42, respectively, compared with controls, also significant differences. 

The authors said that the protective effect of statins remained robust in different age, gender, and cardiovascular risk subgroups, with strong statistical trends. 

Dr. Lin of the National Taiwan University Hospital, Hsin-Chu, Taiwan, said he did not know whether the findings would apply to other ethnicities. 

He hypothesized that because disorders of cholesterol metabolism could lead to an increased incidence of cerebrovascular disease, and elevation of the cholesterol level may result in a high inflammatory status associated with neurodegeneration, "I think it is reasonable to say that statins may facilitate lowering the risk of dementia."

Prof. Terje R. Pedersen of the University of Oslo (Norway), who commented on the study, said that "It is implausible that statins have any impact on progression of Alzheimer’s disease, but it might be plausible to think that when you prevent extensive atherosclerosis, then you also prevent dementia."

The bottom line, said Dr. Williams, is that the study "adds another dimension to the idea that the stronger statins that are used in the highest doses have the best benefit. That’s certainly true for the cardiovascular risk and now with dementia prevention."

Dr. Lin and Dr. Williams had no relevant disclosures. Prof. Pedersen has received research grants from Merck and Pfizer; consultation fees from Merck, AstraZeneca, Pfizer, and Amgen; speaker honoraria from Merck, Pfizer, AstraZeneca, Roche, Novartis, Amgen, and GlaxoSmithKline.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

AMSTERDAM – Elderly patients who received the highest total equivalent doses of high-potency statins, such as atorvastatin or rosuvastatin, had a threefold decrease in the risk of developing dementia, according to a retrospective, observational study in Taiwan.

Dr. Tin-Tse Lin, who presented the study at the annual congress of the European Society of Cardiology, said that the mechanism might be due to the statins’ effect on cholesterol reduction, antithrombotic activity, and their anti-inflammatory effect. The study, however, showed that lesser-prescribed lovastatin at a higher dose was positively associated with dementia development. 

The findings add another piece to the statin-dementia puzzle and may alleviate some of the concerns with the so-called "brain fog" effect of statins, experts said.

Dr. Kim Williams Sr., chair of cardiology at Wayne State University, Detroit, said that the study "was very reassuring in that there was no real evidence of dementia with the statins that we tend to use, which are the more powerful ones." Older statins like lovastatin, however, are still of concern, said Dr. Williams, vice president of the American College of Cardiology, who was not involved in the study.

In 2012, the Food and Drug Administration added a warning to the statins’ label that the drugs could cause temporary memory loss and confusion.  Meanwhile, several studies, including a 2012 review, have found no causality or conclusive relationship between statins and cognitive impairment. 

For the Taiwanese study, researchers used a random sample of 1,000,000 people covered by the country’s National Health Insurance. They identified nearly 58,000 patients who were older than 65 years of age and without a history of dementia in 1997 and 1998. The patients were followed up for an average of 4.5 years. 

The study was divided into tertiles – low, medium, and high dosage – according to mean daily equivalent or total (across the entire follow-up period) equivalent dosage. 

The primary endpoint was new diagnosis of presenile and senile dementia. Patients with vascular dementia were excluded. 

More than 5,500 developed dementia. The remaining 52,000 patient served as controls. 

Results showed that the adjusted hazard ratios for dementia were significantly inversely associated with increased total or daily equivalent statin dosage among the tertiles. For total equivalent statin dosage, the hazard ratios for dementia were 0.77 (low dosage), 0.63 (medium), and 0.33 (high), compared with controls, all significant differences. For mean equivalent daily dosage, HRs for dementia were 0.62, 0.70, 0.42, respectively, compared with controls, also significant differences. 

The authors said that the protective effect of statins remained robust in different age, gender, and cardiovascular risk subgroups, with strong statistical trends. 

Dr. Lin of the National Taiwan University Hospital, Hsin-Chu, Taiwan, said he did not know whether the findings would apply to other ethnicities. 

He hypothesized that because disorders of cholesterol metabolism could lead to an increased incidence of cerebrovascular disease, and elevation of the cholesterol level may result in a high inflammatory status associated with neurodegeneration, "I think it is reasonable to say that statins may facilitate lowering the risk of dementia."

Prof. Terje R. Pedersen of the University of Oslo (Norway), who commented on the study, said that "It is implausible that statins have any impact on progression of Alzheimer’s disease, but it might be plausible to think that when you prevent extensive atherosclerosis, then you also prevent dementia."

The bottom line, said Dr. Williams, is that the study "adds another dimension to the idea that the stronger statins that are used in the highest doses have the best benefit. That’s certainly true for the cardiovascular risk and now with dementia prevention."

Dr. Lin and Dr. Williams had no relevant disclosures. Prof. Pedersen has received research grants from Merck and Pfizer; consultation fees from Merck, AstraZeneca, Pfizer, and Amgen; speaker honoraria from Merck, Pfizer, AstraZeneca, Roche, Novartis, Amgen, and GlaxoSmithKline.

nmiller@frontlinemedcom.com

On Twitter @NaseemSMiller

Despite advancements in therapies for psoriasis, a large proportion of patients are not treated or are receiving suboptimal treatment, according to analysis of a series of comprehensive patient surveys.

The analysis showed that nearly half of the patients with mild psoriasis were receiving no treatments at all in 2011, while 42% of them were treated only with topical agents. In other words, they were undertreated.

On a positive note, the proportion of patients with severe psoriasis who reported receiving no treatment dropped from 30% in the early 2000s to 9% in 2011. Still, 22% of them were undertreated and were prescribed topical medications alone (JAMA Dermatol. 2013 Aug. 14 [doi: 10.1001/jamadermatol.2013.5264]).

The study also revealed that many of the patients were dissatisfied with their treatment, highlighting "a call to action for [dermatologists] to actively seek feedback from psoriasis patients, and find out how their condition is being treated from their perspective," said Dr. April W. Armstrong, lead author of the study and associate professor of dermatology at the University of California, Davis.

"And since many new medications are coming up as well, we should be up to date on the data and literature, and be comfortable with using all sorts of different treatment modalities so that we can offer patients a wide range of treatment options and be able to individualize the treatments," Dr. Armstrong said in an interview.

Meanwhile, the type of health insurance can limit treatment options. In two of the surveys, patients were asked why they discontinued using biological agents. Lack of health insurance was among the top reasons.

"Hopefully, payers will pay attention and find a way to work with providers to make therapies more accessible," Dr. Armstrong said. "Many of our patients need systemic treatments, and I hope payers will pay attention and understand consequences."

Some estimates show that the cost of psoriasis is nearly $11 billion in the United States. But there’s a dearth of studies on patients’ perspectives and the extent to which patients are treated, the authors noted.

One source that has captured such data is the National Psoriasis Foundation’s (NPF’s) biannual surveys of its members. A 2007 study of the survey data was the first to show that as many as 40% of patients with moderate to severe psoriasis didn’t receive treatment (J. Am. Acad. Dermatol. 2007;57:957-62).

For their analysis, Dr. Armstrong and her colleagues examined 13 NPF surveys conducted during 2003-2011. More than 5,600 patients with psoriasis and/or psoriatic arthritis completed the surveys. They had a mean age of 50 years, and most were white.

The analysis showed that the proportion of patients with mild psoriasis who didn’t receive any treatment rose from 42% in the 2003-2005 period to 49% in 2011. The percentage of untreated patients with moderate psoriasis dropped from 36% to 24% during that period, and from 30% to 9% for patients with severe psoriasis.

Dr. Armstrong said there are several explanations for why patients go untreated. Psoriasis is chronic, and after going to one, two, or three doctors and not getting satisfactory results, the patients may give up, she said. "Some of the untreated patients might have sought help before and decided that nothing could be done, and resolved [themselves] to their situation."

Meanwhile, she expressed her concern with the proportion of patients who were undertreated. Close to 30% of patients with moderate psoriasis and 22% of those with severe psoriasis were treated only with topical agents, and the proportions were higher in 2011 than in the 2003-2005 period.

Patients said the top three reasons they used topical agents alone were because they had fewer adverse effects than other treatments, their disease wasn’t serious enough for other kinds of treatments, and their physician wouldn’t prescribe any other treatments. 

"There is still much to be learned about exactly why psoriasis patients are undertreated," Dr. Junko Takeshita of the University of Pennsylvania said via e-mail.

But, "it is essential that patients be properly educated about the risks and benefits of various therapies so that they can make informed treatment choices. It is also important for physicians to be aware of and inform their psoriasis patients about the overall health implications of psoriasis itself (i.e., associations with cardiovascular and metabolic diseases as well as emerging associations with other comorbid diseases)," said Dr. Takeshita, who was not involved in the study.

The study also showed the most common forms of various treatment modalities, with ultraviolet B as the most common form of phototherapy, methotrexate as the top oral agent, and etanercept and adalimumab as the most common biological agents.

The authors said that the study had some limitations. The results may have underestimated the data in the general population, because NPF members are more involved in their health care. Also, severity of the disease at the time of the survey may not have been representative of the patients’ disease course, they noted.

"Going forward, it will be important for us to better understand why psoriasis patients are being undertreated and their reasons for treatment dissatisfaction and discontinuation so that, as physicians, we can provide better care to our psoriasis patients," Dr. Takeshita said.

Dr. Armstrong has received research grants or consultant honoraria from Abbott, Amgen, and Janssen. Dr. Takeshita is a former recipient of the National Psoriasis Foundation’s research fellowship in 2011-2012 and 2012-2013.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

Despite advancements in therapies for psoriasis, a large proportion of patients are not treated or are receiving suboptimal treatment, according to analysis of a series of comprehensive patient surveys.

The analysis showed that nearly half of the patients with mild psoriasis were receiving no treatments at all in 2011, while 42% of them were treated only with topical agents. In other words, they were undertreated.

On a positive note, the proportion of patients with severe psoriasis who reported receiving no treatment dropped from 30% in the early 2000s to 9% in 2011. Still, 22% of them were undertreated and were prescribed topical medications alone (JAMA Dermatol. 2013 Aug. 14 [doi: 10.1001/jamadermatol.2013.5264]).

The study also revealed that many of the patients were dissatisfied with their treatment, highlighting "a call to action for [dermatologists] to actively seek feedback from psoriasis patients, and find out how their condition is being treated from their perspective," said Dr. April W. Armstrong, lead author of the study and associate professor of dermatology at the University of California, Davis.

"And since many new medications are coming up as well, we should be up to date on the data and literature, and be comfortable with using all sorts of different treatment modalities so that we can offer patients a wide range of treatment options and be able to individualize the treatments," Dr. Armstrong said in an interview.

Meanwhile, the type of health insurance can limit treatment options. In two of the surveys, patients were asked why they discontinued using biological agents. Lack of health insurance was among the top reasons.

"Hopefully, payers will pay attention and find a way to work with providers to make therapies more accessible," Dr. Armstrong said. "Many of our patients need systemic treatments, and I hope payers will pay attention and understand consequences."

Some estimates show that the cost of psoriasis is nearly $11 billion in the United States. But there’s a dearth of studies on patients’ perspectives and the extent to which patients are treated, the authors noted.

One source that has captured such data is the National Psoriasis Foundation’s (NPF’s) biannual surveys of its members. A 2007 study of the survey data was the first to show that as many as 40% of patients with moderate to severe psoriasis didn’t receive treatment (J. Am. Acad. Dermatol. 2007;57:957-62).

For their analysis, Dr. Armstrong and her colleagues examined 13 NPF surveys conducted during 2003-2011. More than 5,600 patients with psoriasis and/or psoriatic arthritis completed the surveys. They had a mean age of 50 years, and most were white.

The analysis showed that the proportion of patients with mild psoriasis who didn’t receive any treatment rose from 42% in the 2003-2005 period to 49% in 2011. The percentage of untreated patients with moderate psoriasis dropped from 36% to 24% during that period, and from 30% to 9% for patients with severe psoriasis.

Dr. Armstrong said there are several explanations for why patients go untreated. Psoriasis is chronic, and after going to one, two, or three doctors and not getting satisfactory results, the patients may give up, she said. "Some of the untreated patients might have sought help before and decided that nothing could be done, and resolved [themselves] to their situation."

Meanwhile, she expressed her concern with the proportion of patients who were undertreated. Close to 30% of patients with moderate psoriasis and 22% of those with severe psoriasis were treated only with topical agents, and the proportions were higher in 2011 than in the 2003-2005 period.

Patients said the top three reasons they used topical agents alone were because they had fewer adverse effects than other treatments, their disease wasn’t serious enough for other kinds of treatments, and their physician wouldn’t prescribe any other treatments. 

"There is still much to be learned about exactly why psoriasis patients are undertreated," Dr. Junko Takeshita of the University of Pennsylvania said via e-mail.

But, "it is essential that patients be properly educated about the risks and benefits of various therapies so that they can make informed treatment choices. It is also important for physicians to be aware of and inform their psoriasis patients about the overall health implications of psoriasis itself (i.e., associations with cardiovascular and metabolic diseases as well as emerging associations with other comorbid diseases)," said Dr. Takeshita, who was not involved in the study.

The study also showed the most common forms of various treatment modalities, with ultraviolet B as the most common form of phototherapy, methotrexate as the top oral agent, and etanercept and adalimumab as the most common biological agents.

The authors said that the study had some limitations. The results may have underestimated the data in the general population, because NPF members are more involved in their health care. Also, severity of the disease at the time of the survey may not have been representative of the patients’ disease course, they noted.

"Going forward, it will be important for us to better understand why psoriasis patients are being undertreated and their reasons for treatment dissatisfaction and discontinuation so that, as physicians, we can provide better care to our psoriasis patients," Dr. Takeshita said.

Dr. Armstrong has received research grants or consultant honoraria from Abbott, Amgen, and Janssen. Dr. Takeshita is a former recipient of the National Psoriasis Foundation’s research fellowship in 2011-2012 and 2012-2013.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

Despite advancements in therapies for psoriasis, a large proportion of patients are not treated or are receiving suboptimal treatment, according to analysis of a series of comprehensive patient surveys.

The analysis showed that nearly half of the patients with mild psoriasis were receiving no treatments at all in 2011, while 42% of them were treated only with topical agents. In other words, they were undertreated.

On a positive note, the proportion of patients with severe psoriasis who reported receiving no treatment dropped from 30% in the early 2000s to 9% in 2011. Still, 22% of them were undertreated and were prescribed topical medications alone (JAMA Dermatol. 2013 Aug. 14 [doi: 10.1001/jamadermatol.2013.5264]).

The study also revealed that many of the patients were dissatisfied with their treatment, highlighting "a call to action for [dermatologists] to actively seek feedback from psoriasis patients, and find out how their condition is being treated from their perspective," said Dr. April W. Armstrong, lead author of the study and associate professor of dermatology at the University of California, Davis.

"And since many new medications are coming up as well, we should be up to date on the data and literature, and be comfortable with using all sorts of different treatment modalities so that we can offer patients a wide range of treatment options and be able to individualize the treatments," Dr. Armstrong said in an interview.

Meanwhile, the type of health insurance can limit treatment options. In two of the surveys, patients were asked why they discontinued using biological agents. Lack of health insurance was among the top reasons.

"Hopefully, payers will pay attention and find a way to work with providers to make therapies more accessible," Dr. Armstrong said. "Many of our patients need systemic treatments, and I hope payers will pay attention and understand consequences."

Some estimates show that the cost of psoriasis is nearly $11 billion in the United States. But there’s a dearth of studies on patients’ perspectives and the extent to which patients are treated, the authors noted.

One source that has captured such data is the National Psoriasis Foundation’s (NPF’s) biannual surveys of its members. A 2007 study of the survey data was the first to show that as many as 40% of patients with moderate to severe psoriasis didn’t receive treatment (J. Am. Acad. Dermatol. 2007;57:957-62).

For their analysis, Dr. Armstrong and her colleagues examined 13 NPF surveys conducted during 2003-2011. More than 5,600 patients with psoriasis and/or psoriatic arthritis completed the surveys. They had a mean age of 50 years, and most were white.

The analysis showed that the proportion of patients with mild psoriasis who didn’t receive any treatment rose from 42% in the 2003-2005 period to 49% in 2011. The percentage of untreated patients with moderate psoriasis dropped from 36% to 24% during that period, and from 30% to 9% for patients with severe psoriasis.

Dr. Armstrong said there are several explanations for why patients go untreated. Psoriasis is chronic, and after going to one, two, or three doctors and not getting satisfactory results, the patients may give up, she said. "Some of the untreated patients might have sought help before and decided that nothing could be done, and resolved [themselves] to their situation."

Meanwhile, she expressed her concern with the proportion of patients who were undertreated. Close to 30% of patients with moderate psoriasis and 22% of those with severe psoriasis were treated only with topical agents, and the proportions were higher in 2011 than in the 2003-2005 period.

Patients said the top three reasons they used topical agents alone were because they had fewer adverse effects than other treatments, their disease wasn’t serious enough for other kinds of treatments, and their physician wouldn’t prescribe any other treatments. 

"There is still much to be learned about exactly why psoriasis patients are undertreated," Dr. Junko Takeshita of the University of Pennsylvania said via e-mail.

But, "it is essential that patients be properly educated about the risks and benefits of various therapies so that they can make informed treatment choices. It is also important for physicians to be aware of and inform their psoriasis patients about the overall health implications of psoriasis itself (i.e., associations with cardiovascular and metabolic diseases as well as emerging associations with other comorbid diseases)," said Dr. Takeshita, who was not involved in the study.

The study also showed the most common forms of various treatment modalities, with ultraviolet B as the most common form of phototherapy, methotrexate as the top oral agent, and etanercept and adalimumab as the most common biological agents.

The authors said that the study had some limitations. The results may have underestimated the data in the general population, because NPF members are more involved in their health care. Also, severity of the disease at the time of the survey may not have been representative of the patients’ disease course, they noted.

"Going forward, it will be important for us to better understand why psoriasis patients are being undertreated and their reasons for treatment dissatisfaction and discontinuation so that, as physicians, we can provide better care to our psoriasis patients," Dr. Takeshita said.

Dr. Armstrong has received research grants or consultant honoraria from Abbott, Amgen, and Janssen. Dr. Takeshita is a former recipient of the National Psoriasis Foundation’s research fellowship in 2011-2012 and 2012-2013.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

Despite advancements in therapies for psoriasis, a large proportion of patients are not treated or are receiving suboptimal treatment, according to analysis of a series of comprehensive patient surveys.

The analysis showed that nearly half of the patients with mild psoriasis were receiving no treatments at all in 2011, while 42% of them were treated only with topical agents. In other words, they were undertreated.

On a positive note, the proportion of patients with severe psoriasis who reported receiving no treatment dropped from 30% in the early 2000s to 9% in 2011. Still, 22% of them were undertreated and were prescribed topical medications alone (JAMA Dermatol. 2013 Aug. 14 [doi: 10.1001/jamadermatol.2013.5264]).

The study also revealed that many of the patients were dissatisfied with their treatment, highlighting "a call to action for [dermatologists] to actively seek feedback from psoriasis patients, and find out how their condition is being treated from their perspective," said Dr. April W. Armstrong, lead author of the study and associate professor of dermatology at the University of California, Davis.

"And since many new medications are coming up as well, we should be up to date on the data and literature, and be comfortable with using all sorts of different treatment modalities so that we can offer patients a wide range of treatment options and be able to individualize the treatments," Dr. Armstrong said in an interview.

Meanwhile, the type of health insurance can limit treatment options. In two of the surveys, patients were asked why they discontinued using biological agents. Lack of health insurance was among the top reasons.

"Hopefully, payers will pay attention and find a way to work with providers to make therapies more accessible," Dr. Armstrong said. "Many of our patients need systemic treatments, and I hope payers will pay attention and understand consequences."

Some estimates show that the cost of psoriasis is nearly $11 billion in the United States. But there’s a dearth of studies on patients’ perspectives and the extent to which patients are treated, the authors noted.

One source that has captured such data is the National Psoriasis Foundation’s (NPF’s) biannual surveys of its members. A 2007 study of the survey data was the first to show that as many as 40% of patients with moderate to severe psoriasis didn’t receive treatment (J. Am. Acad. Dermatol. 2007;57:957-62).

For their analysis, Dr. Armstrong and her colleagues examined 13 NPF surveys conducted during 2003-2011. More than 5,600 patients with psoriasis and/or psoriatic arthritis completed the surveys. They had a mean age of 50 years, and most were white.

The analysis showed that the proportion of patients with mild psoriasis who didn’t receive any treatment rose from 42% in the 2003-2005 period to 49% in 2011. The percentage of untreated patients with moderate psoriasis dropped from 36% to 24% during that period, and from 30% to 9% for patients with severe psoriasis.

Dr. Armstrong said there are several explanations for why patients go untreated. Psoriasis is chronic, and after going to one, two, or three doctors and not getting satisfactory results, the patients may give up, she said. "Some of the untreated patients might have sought help before and decided that nothing could be done, and resolved [themselves] to their situation."

Meanwhile, she expressed her concern with the proportion of patients who were undertreated. Close to 30% of patients with moderate psoriasis and 22% of those with severe psoriasis were treated only with topical agents, and the proportions were higher in 2011 than in the 2003-2005 period.

Patients said the top three reasons they used topical agents alone were because they had fewer adverse effects than other treatments, their disease wasn’t serious enough for other kinds of treatments, and their physician wouldn’t prescribe any other treatments. 

"There is still much to be learned about exactly why psoriasis patients are undertreated," Dr. Junko Takeshita of the University of Pennsylvania said via e-mail.

But, "it is essential that patients be properly educated about the risks and benefits of various therapies so that they can make informed treatment choices. It is also important for physicians to be aware of and inform their psoriasis patients about the overall health implications of psoriasis itself (i.e., associations with cardiovascular and metabolic diseases as well as emerging associations with other comorbid diseases)," said Dr. Takeshita, who was not involved in the study.

The study also showed the most common forms of various treatment modalities, with ultraviolet B as the most common form of phototherapy, methotrexate as the top oral agent, and etanercept and adalimumab as the most common biological agents.

The authors said that the study had some limitations. The results may have underestimated the data in the general population, because NPF members are more involved in their health care. Also, severity of the disease at the time of the survey may not have been representative of the patients’ disease course, they noted.

"Going forward, it will be important for us to better understand why psoriasis patients are being undertreated and their reasons for treatment dissatisfaction and discontinuation so that, as physicians, we can provide better care to our psoriasis patients," Dr. Takeshita said.

Dr. Armstrong has received research grants or consultant honoraria from Abbott, Amgen, and Janssen. Dr. Takeshita is a former recipient of the National Psoriasis Foundation’s research fellowship in 2011-2012 and 2012-2013.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

Despite advancements in therapies for psoriasis, a large proportion of patients are not treated or are receiving suboptimal treatment, according to analysis of a series of comprehensive patient surveys.

The analysis showed that nearly half of the patients with mild psoriasis were receiving no treatments at all in 2011, while 42% of them were treated only with topical agents. In other words, they were undertreated.

On a positive note, the proportion of patients with severe psoriasis who reported receiving no treatment dropped from 30% in the early 2000s to 9% in 2011. Still, 22% of them were undertreated and were prescribed topical medications alone (JAMA Dermatol. 2013 Aug. 14 [doi: 10.1001/jamadermatol.2013.5264]).

The study also revealed that many of the patients were dissatisfied with their treatment, highlighting "a call to action for [dermatologists] to actively seek feedback from psoriasis patients, and find out how their condition is being treated from their perspective," said Dr. April W. Armstrong, lead author of the study and associate professor of dermatology at the University of California, Davis.

"And since many new medications are coming up as well, we should be up to date on the data and literature, and be comfortable with using all sorts of different treatment modalities so that we can offer patients a wide range of treatment options and be able to individualize the treatments," Dr. Armstrong said in an interview.

Meanwhile, the type of health insurance can limit treatment options. In two of the surveys, patients were asked why they discontinued using biological agents. Lack of health insurance was among the top reasons.

"Hopefully, payers will pay attention and find a way to work with providers to make therapies more accessible," Dr. Armstrong said. "Many of our patients need systemic treatments, and I hope payers will pay attention and understand consequences."

Some estimates show that the cost of psoriasis is nearly $11 billion in the United States. But there’s a dearth of studies on patients’ perspectives and the extent to which patients are treated, the authors noted.

One source that has captured such data is the National Psoriasis Foundation’s (NPF’s) biannual surveys of its members. A 2007 study of the survey data was the first to show that as many as 40% of patients with moderate to severe psoriasis didn’t receive treatment (J. Am. Acad. Dermatol. 2007;57:957-62).

For their analysis, Dr. Armstrong and her colleagues examined 13 NPF surveys conducted during 2003-2011. More than 5,600 patients with psoriasis and/or psoriatic arthritis completed the surveys. They had a mean age of 50 years, and most were white.

The analysis showed that the proportion of patients with mild psoriasis who didn’t receive any treatment rose from 42% in the 2003-2005 period to 49% in 2011. The percentage of untreated patients with moderate psoriasis dropped from 36% to 24% during that period, and from 30% to 9% for patients with severe psoriasis.

Dr. Armstrong said there are several explanations for why patients go untreated. Psoriasis is chronic, and after going to one, two, or three doctors and not getting satisfactory results, the patients may give up, she said. "Some of the untreated patients might have sought help before and decided that nothing could be done, and resolved [themselves] to their situation."

Meanwhile, she expressed her concern with the proportion of patients who were undertreated. Close to 30% of patients with moderate psoriasis and 22% of those with severe psoriasis were treated only with topical agents, and the proportions were higher in 2011 than in the 2003-2005 period.

Patients said the top three reasons they used topical agents alone were because they had fewer adverse effects than other treatments, their disease wasn’t serious enough for other kinds of treatments, and their physician wouldn’t prescribe any other treatments. 

"There is still much to be learned about exactly why psoriasis patients are undertreated," Dr. Junko Takeshita of the University of Pennsylvania said via e-mail.

But, "it is essential that patients be properly educated about the risks and benefits of various therapies so that they can make informed treatment choices. It is also important for physicians to be aware of and inform their psoriasis patients about the overall health implications of psoriasis itself (i.e., associations with cardiovascular and metabolic diseases as well as emerging associations with other comorbid diseases)," said Dr. Takeshita, who was not involved in the study.

The study also showed the most common forms of various treatment modalities, with ultraviolet B as the most common form of phototherapy, methotrexate as the top oral agent, and etanercept and adalimumab as the most common biological agents.

The authors said that the study had some limitations. The results may have underestimated the data in the general population, because NPF members are more involved in their health care. Also, severity of the disease at the time of the survey may not have been representative of the patients’ disease course, they noted.

"Going forward, it will be important for us to better understand why psoriasis patients are being undertreated and their reasons for treatment dissatisfaction and discontinuation so that, as physicians, we can provide better care to our psoriasis patients," Dr. Takeshita said.

Dr. Armstrong has received research grants or consultant honoraria from Abbott, Amgen, and Janssen. Dr. Takeshita is a former recipient of the National Psoriasis Foundation’s research fellowship in 2011-2012 and 2012-2013.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

Despite advancements in therapies for psoriasis, a large proportion of patients are not treated or are receiving suboptimal treatment, according to analysis of a series of comprehensive patient surveys.

The analysis showed that nearly half of the patients with mild psoriasis were receiving no treatments at all in 2011, while 42% of them were treated only with topical agents. In other words, they were undertreated.

On a positive note, the proportion of patients with severe psoriasis who reported receiving no treatment dropped from 30% in the early 2000s to 9% in 2011. Still, 22% of them were undertreated and were prescribed topical medications alone (JAMA Dermatol. 2013 Aug. 14 [doi: 10.1001/jamadermatol.2013.5264]).

The study also revealed that many of the patients were dissatisfied with their treatment, highlighting "a call to action for [dermatologists] to actively seek feedback from psoriasis patients, and find out how their condition is being treated from their perspective," said Dr. April W. Armstrong, lead author of the study and associate professor of dermatology at the University of California, Davis.

"And since many new medications are coming up as well, we should be up to date on the data and literature, and be comfortable with using all sorts of different treatment modalities so that we can offer patients a wide range of treatment options and be able to individualize the treatments," Dr. Armstrong said in an interview.

Meanwhile, the type of health insurance can limit treatment options. In two of the surveys, patients were asked why they discontinued using biological agents. Lack of health insurance was among the top reasons.

"Hopefully, payers will pay attention and find a way to work with providers to make therapies more accessible," Dr. Armstrong said. "Many of our patients need systemic treatments, and I hope payers will pay attention and understand consequences."

Some estimates show that the cost of psoriasis is nearly $11 billion in the United States. But there’s a dearth of studies on patients’ perspectives and the extent to which patients are treated, the authors noted.

One source that has captured such data is the National Psoriasis Foundation’s (NPF’s) biannual surveys of its members. A 2007 study of the survey data was the first to show that as many as 40% of patients with moderate to severe psoriasis didn’t receive treatment (J. Am. Acad. Dermatol. 2007;57:957-62).

For their analysis, Dr. Armstrong and her colleagues examined 13 NPF surveys conducted during 2003-2011. More than 5,600 patients with psoriasis and/or psoriatic arthritis completed the surveys. They had a mean age of 50 years, and most were white.

The analysis showed that the proportion of patients with mild psoriasis who didn’t receive any treatment rose from 42% in the 2003-2005 period to 49% in 2011. The percentage of untreated patients with moderate psoriasis dropped from 36% to 24% during that period, and from 30% to 9% for patients with severe psoriasis.

Dr. Armstrong said there are several explanations for why patients go untreated. Psoriasis is chronic, and after going to one, two, or three doctors and not getting satisfactory results, the patients may give up, she said. "Some of the untreated patients might have sought help before and decided that nothing could be done, and resolved [themselves] to their situation."

Meanwhile, she expressed her concern with the proportion of patients who were undertreated. Close to 30% of patients with moderate psoriasis and 22% of those with severe psoriasis were treated only with topical agents, and the proportions were higher in 2011 than in the 2003-2005 period.

Patients said the top three reasons they used topical agents alone were because they had fewer adverse effects than other treatments, their disease wasn’t serious enough for other kinds of treatments, and their physician wouldn’t prescribe any other treatments. 

"There is still much to be learned about exactly why psoriasis patients are undertreated," Dr. Junko Takeshita of the University of Pennsylvania said via e-mail.

But, "it is essential that patients be properly educated about the risks and benefits of various therapies so that they can make informed treatment choices. It is also important for physicians to be aware of and inform their psoriasis patients about the overall health implications of psoriasis itself (i.e., associations with cardiovascular and metabolic diseases as well as emerging associations with other comorbid diseases)," said Dr. Takeshita, who was not involved in the study.

The study also showed the most common forms of various treatment modalities, with ultraviolet B as the most common form of phototherapy, methotrexate as the top oral agent, and etanercept and adalimumab as the most common biological agents.

The authors said that the study had some limitations. The results may have underestimated the data in the general population, because NPF members are more involved in their health care. Also, severity of the disease at the time of the survey may not have been representative of the patients’ disease course, they noted.

"Going forward, it will be important for us to better understand why psoriasis patients are being undertreated and their reasons for treatment dissatisfaction and discontinuation so that, as physicians, we can provide better care to our psoriasis patients," Dr. Takeshita said.

Dr. Armstrong has received research grants or consultant honoraria from Abbott, Amgen, and Janssen. Dr. Takeshita is a former recipient of the National Psoriasis Foundation’s research fellowship in 2011-2012 and 2012-2013.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

CHICAGO – Patients with type 1 diabetes who had impaired awareness of hypoglycemia and were provided with education and support, had equal biochemical outcomes whether they were on insulin pump therapy or daily injections.

Researchers also found that the outcomes were equal for patients whether they were on conventional or real-time glucose monitoring.

Patrice Wendling/IMNG Medical Media

Impaired awareness of hypoglycemia, or IAH, affects roughly 20% of adults with type 1 diabetes. Also, severe hypoglycemia is six times more likely in these adults, said Dr. Stuart A. Little of Newcastle upon Tyne, England, who presented the results of Hypo COMPaSS, a 24-week, randomized controlled trial of 96 participants, at the annual scientific sessions of the American Diabetes Association. 

"Sometimes patients with impaired awareness say that they don’t even feel it, and they think it’s okay," said Marjorie Cypress, Ph.D., the 2013 president-elect of ADA’s health care and education committee. "They need to learn that it’s not okay, that they’re not getting those warning signs, but they’re losing glucose from their brain."

Most of the participants in the trial were women (63%), their mean age was 49 years, their diabetes duration was about 29 years, and their mean HbA_1c level was 66 mmol/mol, or about 8.2%.

Dr. Little and his colleagues randomized the 96 participants to a multiple daily injection (MDI) group (50 patients) and an insulin pump therapy (CSII) group (46). In the MDI group, 24 patients did not have real-time (RT) continuous glucose monitoring, and 26 did. And in the CSII group, 24 patients had no RT, and 22 did.

The primary endpoint of the study was the difference in 24-week Gold score, with an 80% power to detect a Gold score difference of 1.1 on a 7-point Likert scale.

Secondary endpoints included overall glycemic control and patient-reported outcomes.

All patients received equal support and had a treatment goal of rigorous avoidance of biochemical hypoglycemia without relaxation of overall hemoglobin A_1c. They all had Gold scores of at least 4, indicating IAH.

Within 4 weeks, the patients’ biochemical hypoglycemia was reduced significantly, from 3.7% to 1.7% of the time, from 53 minutes/day to under half an hour. The reduction was maintained throughout the study.

The median Gold score also showed a statistically significant reduction by week 24 among all participants, dropping from 5 at baseline to 4 at the end of the study period. 

There was also a dramatic reduction in severe hypoglycemic events, said Dr. Little. While 92% of the patients were affected by the condition the year before the study, and 77% were affected 6 months before the trial, only 19% were affected during the trial. 

Fear of hypoglycemia was significantly reduced and treatment satisfaction improved among all participants. The mean HbA_1c did not change throughout the study among the participants.

When the investigators compared the MDI and CSII groups, the Gold score and severe hypoglycemia were not significantly different, nor were the HbA_1c levels or insulin units. And although the fear of hypoglycemia did not differ significantly between the two groups, the treatment satisfaction was significantly higher in the CSII group.

Comparing the patients based on real-time glucose monitoring or self-monitoring showed no statistically significant difference in Gold score, severe hypoglycemia, HbA_1c levels, or insulin units. There were also no significant differences in fear of hypoglycemia and treatment satisfaction.

"The bottom line is, if you give people education about hypoglycemia, they do better. We’ve seen this before in other studies. Teach people, and they can avoid hypoglycemia," said Dr. Cypress.

Dr. Little and Dr. Cypress had no disclosures.

nmiller@frontlinemedcom.com
On Twitter @NaseemSMiller

CHICAGO – Patients with type 1 diabetes who had impaired awareness of hypoglycemia and were provided with education and support, had equal biochemical outcomes whether they were on insulin pump therapy or daily injections.

Researchers also found that the outcomes were equal for patients whether they were on conventional or real-time glucose monitoring.

Patrice Wendling/IMNG Medical Media

Impaired awareness of hypoglycemia, or IAH, affects roughly 20% of adults with type 1 diabetes. Also, severe hypoglycemia is six times more likely in these adults, said Dr. Stuart A. Little of Newcastle upon Tyne, England, who presented the results of Hypo COMPaSS, a 24-week, randomized controlled trial of 96 participants, at the annual scientific sessions of the American Diabetes Association. 

"Sometimes patients with impaired awareness say that they don’t even feel it, and they think it’s okay," said Marjorie Cypress, Ph.D., the 2013 president-elect of ADA’s health care and education committee. "They need to learn that it’s not okay, that they’re not getting those warning signs, but they’re losing glucose from their brain."

Most of the participants in the trial were women (63%), their mean age was 49 years, their diabetes duration was about 29 years, and their mean HbA_1c level was 66 mmol/mol, or about 8.2%.

Dr. Little and his colleagues randomized the 96 participants to a multiple daily injection (MDI) group (50 patients) and an insulin pump therapy (CSII) group (46). In the MDI group, 24 patients did not have real-time (RT) continuous glucose monitoring, and 26 did. And in the CSII group, 24 patients had no RT, and 22 did.

The primary endpoint of the study was the difference in 24-week Gold score, with an 80% power to detect a Gold score difference of 1.1 on a 7-point Likert scale.

Secondary endpoints included overall glycemic control and patient-reported outcomes.

All patients received equal support and had a treatment goal of rigorous avoidance of biochemical hypoglycemia without relaxation of overall hemoglobin A_1c. They all had Gold scores of at least 4, indicating IAH.

Within 4 weeks, the patients’ biochemical hypoglycemia was reduced significantly, from 3.7% to 1.7% of the time, from 53 minutes/day to under half an hour. The reduction was maintained throughout the study.

The median Gold score also showed a statistically significant reduction by week 24 among all participants, dropping from 5 at baseline to 4 at the end of the study period. 

There was also a dramatic reduction in severe hypoglycemic events, said Dr. Little. While 92% of the patients were affected by the condition the year before the study, and 77% were affected 6 months before the trial, only 19% were affected during the trial. 

Fear of hypoglycemia was significantly reduced and treatment satisfaction improved among all participants. The mean HbA_1c did not change throughout the study among the participants.

When the investigators compared the MDI and CSII groups, the Gold score and severe hypoglycemia were not significantly different, nor were the HbA_1c levels or insulin units. And although the fear of hypoglycemia did not differ significantly between the two groups, the treatment satisfaction was significantly higher in the CSII group.

Comparing the patients based on real-time glucose monitoring or self-monitoring showed no statistically significant difference in Gold score, severe hypoglycemia, HbA_1c levels, or insulin units. There were also no significant differences in fear of hypoglycemia and treatment satisfaction.

"The bottom line is, if you give people education about hypoglycemia, they do better. We’ve seen this before in other studies. Teach people, and they can avoid hypoglycemia," said Dr. Cypress.

Dr. Little and Dr. Cypress had no disclosures.

nmiller@frontlinemedcom.com
On Twitter @NaseemSMiller

CHICAGO – Patients with type 1 diabetes who had impaired awareness of hypoglycemia and were provided with education and support, had equal biochemical outcomes whether they were on insulin pump therapy or daily injections.

Researchers also found that the outcomes were equal for patients whether they were on conventional or real-time glucose monitoring.

Patrice Wendling/IMNG Medical Media

Impaired awareness of hypoglycemia, or IAH, affects roughly 20% of adults with type 1 diabetes. Also, severe hypoglycemia is six times more likely in these adults, said Dr. Stuart A. Little of Newcastle upon Tyne, England, who presented the results of Hypo COMPaSS, a 24-week, randomized controlled trial of 96 participants, at the annual scientific sessions of the American Diabetes Association. 

"Sometimes patients with impaired awareness say that they don’t even feel it, and they think it’s okay," said Marjorie Cypress, Ph.D., the 2013 president-elect of ADA’s health care and education committee. "They need to learn that it’s not okay, that they’re not getting those warning signs, but they’re losing glucose from their brain."

Most of the participants in the trial were women (63%), their mean age was 49 years, their diabetes duration was about 29 years, and their mean HbA_1c level was 66 mmol/mol, or about 8.2%.

Dr. Little and his colleagues randomized the 96 participants to a multiple daily injection (MDI) group (50 patients) and an insulin pump therapy (CSII) group (46). In the MDI group, 24 patients did not have real-time (RT) continuous glucose monitoring, and 26 did. And in the CSII group, 24 patients had no RT, and 22 did.

The primary endpoint of the study was the difference in 24-week Gold score, with an 80% power to detect a Gold score difference of 1.1 on a 7-point Likert scale.

Secondary endpoints included overall glycemic control and patient-reported outcomes.

All patients received equal support and had a treatment goal of rigorous avoidance of biochemical hypoglycemia without relaxation of overall hemoglobin A_1c. They all had Gold scores of at least 4, indicating IAH.

Within 4 weeks, the patients’ biochemical hypoglycemia was reduced significantly, from 3.7% to 1.7% of the time, from 53 minutes/day to under half an hour. The reduction was maintained throughout the study.

The median Gold score also showed a statistically significant reduction by week 24 among all participants, dropping from 5 at baseline to 4 at the end of the study period. 

There was also a dramatic reduction in severe hypoglycemic events, said Dr. Little. While 92% of the patients were affected by the condition the year before the study, and 77% were affected 6 months before the trial, only 19% were affected during the trial. 

Fear of hypoglycemia was significantly reduced and treatment satisfaction improved among all participants. The mean HbA_1c did not change throughout the study among the participants.

When the investigators compared the MDI and CSII groups, the Gold score and severe hypoglycemia were not significantly different, nor were the HbA_1c levels or insulin units. And although the fear of hypoglycemia did not differ significantly between the two groups, the treatment satisfaction was significantly higher in the CSII group.

Comparing the patients based on real-time glucose monitoring or self-monitoring showed no statistically significant difference in Gold score, severe hypoglycemia, HbA_1c levels, or insulin units. There were also no significant differences in fear of hypoglycemia and treatment satisfaction.

"The bottom line is, if you give people education about hypoglycemia, they do better. We’ve seen this before in other studies. Teach people, and they can avoid hypoglycemia," said Dr. Cypress.

Dr. Little and Dr. Cypress had no disclosures.

nmiller@frontlinemedcom.com
On Twitter @NaseemSMiller

Illinois has become the sixth state to ban indoor tanning for youth younger than 18 years. The bill, which was introduced earlier this year and signed into law by Gov. Patrick Quinn on Aug. 15, will take effect on Jan. 1, 2014.

"The state’s willingness to follow the examples set by the cities of Springfield and Chicago exemplifies a true commitment to protecting teens from the dangers of indoor tanning," Dr. Dirk M. Elston, president of the American Academy of Dermatology Association, said in a statement.

The academy said in a news release that the law is based on "significant scientific evidence that links indoor tanning to increased risk of developing melanoma and other forms of skin cancer."

Compared with previous years, 2013 has been an active year for tanning bed laws.

In a video interview earlier this month, Dr. Bruce A. Brod, the AAD’s State Policy Committee Chair, spoke about the Food and Drug Administration’s proposal to place stricter regulations on indoor tanning beds and issue stronger recommendations against their use by anyone younger than 18 years. The agency is considering the comments and may issue its final ruling by the end of 2013.

Meanwhile, in June, the Internal Revenue Service issued the final regulation on collecting a 10% tax on tanning salon receipts. The regulation was first proposed in 2010 and exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax.

Groups such as the Indoor Tanning Association and the American Suntanning Association continue to lobby against the tanning ban laws.

Illinois joins California, Vermont, Oregon, Nevada, and Texas in passing age-related restrictions on the use of tanning beds. New York, New Jersey, and Connecticut have bans for youth under 17 years of age, while the District of Columbia and West Virginia have tanning bed bans for individuals younger than 14 years.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

Illinois has become the sixth state to ban indoor tanning for youth younger than 18 years. The bill, which was introduced earlier this year and signed into law by Gov. Patrick Quinn on Aug. 15, will take effect on Jan. 1, 2014.

"The state’s willingness to follow the examples set by the cities of Springfield and Chicago exemplifies a true commitment to protecting teens from the dangers of indoor tanning," Dr. Dirk M. Elston, president of the American Academy of Dermatology Association, said in a statement.

The academy said in a news release that the law is based on "significant scientific evidence that links indoor tanning to increased risk of developing melanoma and other forms of skin cancer."

Compared with previous years, 2013 has been an active year for tanning bed laws.

In a video interview earlier this month, Dr. Bruce A. Brod, the AAD’s State Policy Committee Chair, spoke about the Food and Drug Administration’s proposal to place stricter regulations on indoor tanning beds and issue stronger recommendations against their use by anyone younger than 18 years. The agency is considering the comments and may issue its final ruling by the end of 2013.

Meanwhile, in June, the Internal Revenue Service issued the final regulation on collecting a 10% tax on tanning salon receipts. The regulation was first proposed in 2010 and exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax.

Groups such as the Indoor Tanning Association and the American Suntanning Association continue to lobby against the tanning ban laws.

Illinois joins California, Vermont, Oregon, Nevada, and Texas in passing age-related restrictions on the use of tanning beds. New York, New Jersey, and Connecticut have bans for youth under 17 years of age, while the District of Columbia and West Virginia have tanning bed bans for individuals younger than 14 years.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller

Illinois has become the sixth state to ban indoor tanning for youth younger than 18 years. The bill, which was introduced earlier this year and signed into law by Gov. Patrick Quinn on Aug. 15, will take effect on Jan. 1, 2014.

"The state’s willingness to follow the examples set by the cities of Springfield and Chicago exemplifies a true commitment to protecting teens from the dangers of indoor tanning," Dr. Dirk M. Elston, president of the American Academy of Dermatology Association, said in a statement.

The academy said in a news release that the law is based on "significant scientific evidence that links indoor tanning to increased risk of developing melanoma and other forms of skin cancer."

Compared with previous years, 2013 has been an active year for tanning bed laws.

In a video interview earlier this month, Dr. Bruce A. Brod, the AAD’s State Policy Committee Chair, spoke about the Food and Drug Administration’s proposal to place stricter regulations on indoor tanning beds and issue stronger recommendations against their use by anyone younger than 18 years. The agency is considering the comments and may issue its final ruling by the end of 2013.

Meanwhile, in June, the Internal Revenue Service issued the final regulation on collecting a 10% tax on tanning salon receipts. The regulation was first proposed in 2010 and exempts "qualified physical fitness facilities" that offer tanning services from collecting the tax.

Groups such as the Indoor Tanning Association and the American Suntanning Association continue to lobby against the tanning ban laws.

Illinois joins California, Vermont, Oregon, Nevada, and Texas in passing age-related restrictions on the use of tanning beds. New York, New Jersey, and Connecticut have bans for youth under 17 years of age, while the District of Columbia and West Virginia have tanning bed bans for individuals younger than 14 years.

nmiller@frontlinemedcom.com

On Twitter @naseemsmiller