Diana Mahoney

MINNEAPOLIS – Sleep is in short supply, thanks to our "24-hour society" in which trading sleep for work or play is commonplace and sleep deprivation is worn as a badge of honor, according to Dr. Michel Cramer Bornemann, codirector of the Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center in Minneapolis.

Not only have we become accustomed to trading sleep for work, Dr. Cramer Bornemann said at the annual meeting of the Associated Professional Sleep Societies, "lack of sleep is synonymous with hard work or achievement, when really it can impede both."

In fact, the effects of insufficient shut-eye extend across multiple domains, according to a collection of independent studies presented at this year’s meeting. For example, sleep loss was linked to the development or exacerbation of symptoms of ADHD in early childhood, an individual’s genetic risk of obesity, inhibitory response to images of high-calorie foods, and even marital discontent.

ADHD and Sleep Loss

In a study designed to tease out the complex relationship between sleep problems – particularly falling asleep and staying asleep – and the development or worsening of inattention and hyperactivity and impulsivity in children and adolescents diagnosed with ADHD, Erika Gaylor, Ph.D., of SRI International in Menlo Park, Calif., and her colleagues analyzed data from the preschool and kindergarten waves of the Early Childhood Longitudinal Study-Birth Cohort. The cohort comprises a representative sample of approximately 6,860 children and their families living the United States.

The investigators calculated total nighttime sleep duration based on parent-reported bedtime and wake time, and assessed children’s behavior using brief measures of attention and task persistence, Dr. Gaylor reported.

"We performed two sets of regression analyses to identify whether sleep duration in preschool-age children predicts attention and hyperactivity at kindergarten entry and [whether] attention and hyperactivity symptoms at preschool predict sleep duration at kindergarten," she explained.

Controlling for the outcome of interest at the preschool time point, sex, ethnicity, and family income, researchers found that less sleep at preschool significantly predicted worse scores on parent-reported hyperactivity and attention at kindergarten, whereas parent-reported hyperactivity and attention at preschool did not predict sleep duration at kindergarten, Dr. Gaylor stated.

"These findings suggest that some children who are not getting adequate sleep may be at risk for developing behavioral problems manifested by hyperactivity, impulsivity, and problems sitting still and paying attention," she said. The results extend those of a previous study in which she and her colleagues determined that having a consistent bedtime was the most reliable predictor of positive developmental outcomes by age 4 years, she noted.

The Link Between Sleep and Obesity

In a twin study designed to look more closely at the previously reported link between short sleep duration and elevated body mass index, Dr. Nathaniel Watson of the University of Washington in Seattle and his colleagues determined that short sleep may potentiate an underlying genetic mechanism for obesity.

The investigators examined whether sleep duration modified genetic and environmental influences on BMI in 1,811 pairs of twins drawn from the population-based University of Washington Twin Registry. The mean age of the study participants was 36.6 years. The participants provided self-reported information on height and weight, which was used to calculate BMI, as well as on habitual sleep duration, Dr. Watson said. The mean BMI of the group was 25.4 kg/m², and the mean sleep duration was 7.18 hours, he said.

©Nozomi Stall/Fotolia.com

Using behavioral genetic interaction models, the investigators found significant relationships between habitual sleep duration and genetic and shared environmental influences on BMI. Specifically, longer sleep duration was associated with decreased BMI, Dr. Watson reported.

"When sleep duration was 7 hours, the heritability of BMI was more than double [70%] that observed when sleep duration was 9 hours [33%]," he said, noting that "there appears to be something about short sleep that creates a permissive environment for expression of obesity-related genes." Similarly, he added, longer sleep duration may suppress genetic influences on body weight.

The findings are an important addition to the existing body of research on the relationship between sleep duration and BMI, Dr. Watson said. "Studies attempting to identify specific genotypes for BMI may benefit from considering the moderating role of sleep duration."

A connection between sleepiness and lack of self-control with respect to dietary choices may also contribute to the sleep loss/obesity equation, according to a study presented by William Killgore, Ph.D., of Harvard Medical School in Boston.

To test their hypothesis that greater daytime sleepiness correlates with reduced prefrontal cortex response during passive viewing of images of high-calorie foods, Dr. Killgore and his colleagues analyzed the functional magnetic resonance imaging (fMRI) scans of 12 healthy adults obtained while they were shown pictures of high-calorie foods, low-calorie foods, and control images of plants and rocks. Using a second-level regression model, the researchers correlated the fMRI findings with subjects’ self-reported daytime sleepiness, assessed via the Epworth Sleepiness Scale (ESS).

"Greater ESS scores correlated with reduced activation in the dorsolateral prefrontal cortex when high-calorie vs. low-calorie food images were perceived," Dr. Killgore reported, noting that this region is typically implicated in attention and inhibitory processing. Similarly, greater daytime sleepiness was also associated with increased activation in the right parietal and inferior temporal cortex, he said.

The findings suggest the possibility that sleepiness may affect an individual’s inhibitory control when he or she is exposed to highly appetizing, high-calorie foods, according to Dr. Killgore, although it’s uncertain as of yet whether the observed patterns relate to actual food consumption, he said.

Marital Discord

Although most sleep research focuses on the individual, the fact that sleep problems and relationship trouble often co-occur led Wendy M. Troxel, Ph.D., of the University of Pittsburgh, and her colleagues to consider the dyadic nature of sleep in a recent study. The investigators examined the bidirectional links between nightly sleep and daily marital interactions among 35 healthy married couples (mean age, 32 years) by correlating the actigraph results for sleep latency, wakefulness after sleep onset, and total sleep time of each partner over 10 nights, with daily self-reported positive and negative marital interactions assessed via electronic diaries during the same period.

"We found stronger evidence linking sleep to the next day’s marital interactions, rather than the reverse direction," Dr. Troxel reported.

Specifically, wives’ prolonged sleep latency significantly predicted their own and their husbands’ reports of more negative and less positive interactions the next day, even after adjustment for depressive symptoms, whereas the quality of marital interactions did not appear to predict sleep measures in women, she said. The sleep quality of husbands did not appear to affect their own or their wives’ reports of next-day marital interactions; however, for men, a higher level of positive marital interactions predicted shorter total sleep duration the next night.

The findings suggest, perhaps, that "men are more likely to repress their feelings or not be as aware" of mood changes, whereas women are more likely to express their emotional concerns and to "drive the emotional climate of the relationship," Dr. Troxel said. The results highlight the potential interpersonal consequences of sleep disorders, and as such may have important clinical implications, she said.

In March of this year, the Centers for Disease Control and Prevention reported that nearly a third of the country’s adults get fewer than the minimum recommended 7 hours of sleep per night, and it’s not because they’re not tired: Nearly 40% of the survey population reported unintentionally falling asleep during the day, and nearly 5% reported nodding off while driving in the preceding 30 days (MMWR 2011;60:233-8).

In addition to the negative consequences of sleep deprivation noted above, previous studies have linked sleep insufficiency to a range of adverse health outcomes, including cardiovascular disease, asthma, diabetes, and stroke, according to the report.

The presenters reported no financial conflicts of interest relevant to their respective presentations.

MINNEAPOLIS – Sleep is in short supply, thanks to our "24-hour society" in which trading sleep for work or play is commonplace and sleep deprivation is worn as a badge of honor, according to Dr. Michel Cramer Bornemann, codirector of the Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center in Minneapolis.

Not only have we become accustomed to trading sleep for work, Dr. Cramer Bornemann said at the annual meeting of the Associated Professional Sleep Societies, "lack of sleep is synonymous with hard work or achievement, when really it can impede both."

In fact, the effects of insufficient shut-eye extend across multiple domains, according to a collection of independent studies presented at this year’s meeting. For example, sleep loss was linked to the development or exacerbation of symptoms of ADHD in early childhood, an individual’s genetic risk of obesity, inhibitory response to images of high-calorie foods, and even marital discontent.

ADHD and Sleep Loss

In a study designed to tease out the complex relationship between sleep problems – particularly falling asleep and staying asleep – and the development or worsening of inattention and hyperactivity and impulsivity in children and adolescents diagnosed with ADHD, Erika Gaylor, Ph.D., of SRI International in Menlo Park, Calif., and her colleagues analyzed data from the preschool and kindergarten waves of the Early Childhood Longitudinal Study-Birth Cohort. The cohort comprises a representative sample of approximately 6,860 children and their families living the United States.

The investigators calculated total nighttime sleep duration based on parent-reported bedtime and wake time, and assessed children’s behavior using brief measures of attention and task persistence, Dr. Gaylor reported.

"We performed two sets of regression analyses to identify whether sleep duration in preschool-age children predicts attention and hyperactivity at kindergarten entry and [whether] attention and hyperactivity symptoms at preschool predict sleep duration at kindergarten," she explained.

Controlling for the outcome of interest at the preschool time point, sex, ethnicity, and family income, researchers found that less sleep at preschool significantly predicted worse scores on parent-reported hyperactivity and attention at kindergarten, whereas parent-reported hyperactivity and attention at preschool did not predict sleep duration at kindergarten, Dr. Gaylor stated.

"These findings suggest that some children who are not getting adequate sleep may be at risk for developing behavioral problems manifested by hyperactivity, impulsivity, and problems sitting still and paying attention," she said. The results extend those of a previous study in which she and her colleagues determined that having a consistent bedtime was the most reliable predictor of positive developmental outcomes by age 4 years, she noted.

The Link Between Sleep and Obesity

In a twin study designed to look more closely at the previously reported link between short sleep duration and elevated body mass index, Dr. Nathaniel Watson of the University of Washington in Seattle and his colleagues determined that short sleep may potentiate an underlying genetic mechanism for obesity.

The investigators examined whether sleep duration modified genetic and environmental influences on BMI in 1,811 pairs of twins drawn from the population-based University of Washington Twin Registry. The mean age of the study participants was 36.6 years. The participants provided self-reported information on height and weight, which was used to calculate BMI, as well as on habitual sleep duration, Dr. Watson said. The mean BMI of the group was 25.4 kg/m², and the mean sleep duration was 7.18 hours, he said.

©Nozomi Stall/Fotolia.com

Using behavioral genetic interaction models, the investigators found significant relationships between habitual sleep duration and genetic and shared environmental influences on BMI. Specifically, longer sleep duration was associated with decreased BMI, Dr. Watson reported.

"When sleep duration was 7 hours, the heritability of BMI was more than double [70%] that observed when sleep duration was 9 hours [33%]," he said, noting that "there appears to be something about short sleep that creates a permissive environment for expression of obesity-related genes." Similarly, he added, longer sleep duration may suppress genetic influences on body weight.

The findings are an important addition to the existing body of research on the relationship between sleep duration and BMI, Dr. Watson said. "Studies attempting to identify specific genotypes for BMI may benefit from considering the moderating role of sleep duration."

A connection between sleepiness and lack of self-control with respect to dietary choices may also contribute to the sleep loss/obesity equation, according to a study presented by William Killgore, Ph.D., of Harvard Medical School in Boston.

To test their hypothesis that greater daytime sleepiness correlates with reduced prefrontal cortex response during passive viewing of images of high-calorie foods, Dr. Killgore and his colleagues analyzed the functional magnetic resonance imaging (fMRI) scans of 12 healthy adults obtained while they were shown pictures of high-calorie foods, low-calorie foods, and control images of plants and rocks. Using a second-level regression model, the researchers correlated the fMRI findings with subjects’ self-reported daytime sleepiness, assessed via the Epworth Sleepiness Scale (ESS).

"Greater ESS scores correlated with reduced activation in the dorsolateral prefrontal cortex when high-calorie vs. low-calorie food images were perceived," Dr. Killgore reported, noting that this region is typically implicated in attention and inhibitory processing. Similarly, greater daytime sleepiness was also associated with increased activation in the right parietal and inferior temporal cortex, he said.

The findings suggest the possibility that sleepiness may affect an individual’s inhibitory control when he or she is exposed to highly appetizing, high-calorie foods, according to Dr. Killgore, although it’s uncertain as of yet whether the observed patterns relate to actual food consumption, he said.

Marital Discord

Although most sleep research focuses on the individual, the fact that sleep problems and relationship trouble often co-occur led Wendy M. Troxel, Ph.D., of the University of Pittsburgh, and her colleagues to consider the dyadic nature of sleep in a recent study. The investigators examined the bidirectional links between nightly sleep and daily marital interactions among 35 healthy married couples (mean age, 32 years) by correlating the actigraph results for sleep latency, wakefulness after sleep onset, and total sleep time of each partner over 10 nights, with daily self-reported positive and negative marital interactions assessed via electronic diaries during the same period.

"We found stronger evidence linking sleep to the next day’s marital interactions, rather than the reverse direction," Dr. Troxel reported.

Specifically, wives’ prolonged sleep latency significantly predicted their own and their husbands’ reports of more negative and less positive interactions the next day, even after adjustment for depressive symptoms, whereas the quality of marital interactions did not appear to predict sleep measures in women, she said. The sleep quality of husbands did not appear to affect their own or their wives’ reports of next-day marital interactions; however, for men, a higher level of positive marital interactions predicted shorter total sleep duration the next night.

The findings suggest, perhaps, that "men are more likely to repress their feelings or not be as aware" of mood changes, whereas women are more likely to express their emotional concerns and to "drive the emotional climate of the relationship," Dr. Troxel said. The results highlight the potential interpersonal consequences of sleep disorders, and as such may have important clinical implications, she said.

In March of this year, the Centers for Disease Control and Prevention reported that nearly a third of the country’s adults get fewer than the minimum recommended 7 hours of sleep per night, and it’s not because they’re not tired: Nearly 40% of the survey population reported unintentionally falling asleep during the day, and nearly 5% reported nodding off while driving in the preceding 30 days (MMWR 2011;60:233-8).

In addition to the negative consequences of sleep deprivation noted above, previous studies have linked sleep insufficiency to a range of adverse health outcomes, including cardiovascular disease, asthma, diabetes, and stroke, according to the report.

The presenters reported no financial conflicts of interest relevant to their respective presentations.

MINNEAPOLIS – Sleep is in short supply, thanks to our "24-hour society" in which trading sleep for work or play is commonplace and sleep deprivation is worn as a badge of honor, according to Dr. Michel Cramer Bornemann, codirector of the Minnesota Regional Sleep Disorders Center at Hennepin County Medical Center in Minneapolis.

Not only have we become accustomed to trading sleep for work, Dr. Cramer Bornemann said at the annual meeting of the Associated Professional Sleep Societies, "lack of sleep is synonymous with hard work or achievement, when really it can impede both."

In fact, the effects of insufficient shut-eye extend across multiple domains, according to a collection of independent studies presented at this year’s meeting. For example, sleep loss was linked to the development or exacerbation of symptoms of ADHD in early childhood, an individual’s genetic risk of obesity, inhibitory response to images of high-calorie foods, and even marital discontent.

ADHD and Sleep Loss

In a study designed to tease out the complex relationship between sleep problems – particularly falling asleep and staying asleep – and the development or worsening of inattention and hyperactivity and impulsivity in children and adolescents diagnosed with ADHD, Erika Gaylor, Ph.D., of SRI International in Menlo Park, Calif., and her colleagues analyzed data from the preschool and kindergarten waves of the Early Childhood Longitudinal Study-Birth Cohort. The cohort comprises a representative sample of approximately 6,860 children and their families living the United States.

The investigators calculated total nighttime sleep duration based on parent-reported bedtime and wake time, and assessed children’s behavior using brief measures of attention and task persistence, Dr. Gaylor reported.

"We performed two sets of regression analyses to identify whether sleep duration in preschool-age children predicts attention and hyperactivity at kindergarten entry and [whether] attention and hyperactivity symptoms at preschool predict sleep duration at kindergarten," she explained.

Controlling for the outcome of interest at the preschool time point, sex, ethnicity, and family income, researchers found that less sleep at preschool significantly predicted worse scores on parent-reported hyperactivity and attention at kindergarten, whereas parent-reported hyperactivity and attention at preschool did not predict sleep duration at kindergarten, Dr. Gaylor stated.

"These findings suggest that some children who are not getting adequate sleep may be at risk for developing behavioral problems manifested by hyperactivity, impulsivity, and problems sitting still and paying attention," she said. The results extend those of a previous study in which she and her colleagues determined that having a consistent bedtime was the most reliable predictor of positive developmental outcomes by age 4 years, she noted.

The Link Between Sleep and Obesity

In a twin study designed to look more closely at the previously reported link between short sleep duration and elevated body mass index, Dr. Nathaniel Watson of the University of Washington in Seattle and his colleagues determined that short sleep may potentiate an underlying genetic mechanism for obesity.

The investigators examined whether sleep duration modified genetic and environmental influences on BMI in 1,811 pairs of twins drawn from the population-based University of Washington Twin Registry. The mean age of the study participants was 36.6 years. The participants provided self-reported information on height and weight, which was used to calculate BMI, as well as on habitual sleep duration, Dr. Watson said. The mean BMI of the group was 25.4 kg/m², and the mean sleep duration was 7.18 hours, he said.

©Nozomi Stall/Fotolia.com

Using behavioral genetic interaction models, the investigators found significant relationships between habitual sleep duration and genetic and shared environmental influences on BMI. Specifically, longer sleep duration was associated with decreased BMI, Dr. Watson reported.

"When sleep duration was 7 hours, the heritability of BMI was more than double [70%] that observed when sleep duration was 9 hours [33%]," he said, noting that "there appears to be something about short sleep that creates a permissive environment for expression of obesity-related genes." Similarly, he added, longer sleep duration may suppress genetic influences on body weight.

The findings are an important addition to the existing body of research on the relationship between sleep duration and BMI, Dr. Watson said. "Studies attempting to identify specific genotypes for BMI may benefit from considering the moderating role of sleep duration."

A connection between sleepiness and lack of self-control with respect to dietary choices may also contribute to the sleep loss/obesity equation, according to a study presented by William Killgore, Ph.D., of Harvard Medical School in Boston.

To test their hypothesis that greater daytime sleepiness correlates with reduced prefrontal cortex response during passive viewing of images of high-calorie foods, Dr. Killgore and his colleagues analyzed the functional magnetic resonance imaging (fMRI) scans of 12 healthy adults obtained while they were shown pictures of high-calorie foods, low-calorie foods, and control images of plants and rocks. Using a second-level regression model, the researchers correlated the fMRI findings with subjects’ self-reported daytime sleepiness, assessed via the Epworth Sleepiness Scale (ESS).

"Greater ESS scores correlated with reduced activation in the dorsolateral prefrontal cortex when high-calorie vs. low-calorie food images were perceived," Dr. Killgore reported, noting that this region is typically implicated in attention and inhibitory processing. Similarly, greater daytime sleepiness was also associated with increased activation in the right parietal and inferior temporal cortex, he said.

The findings suggest the possibility that sleepiness may affect an individual’s inhibitory control when he or she is exposed to highly appetizing, high-calorie foods, according to Dr. Killgore, although it’s uncertain as of yet whether the observed patterns relate to actual food consumption, he said.

Marital Discord

Although most sleep research focuses on the individual, the fact that sleep problems and relationship trouble often co-occur led Wendy M. Troxel, Ph.D., of the University of Pittsburgh, and her colleagues to consider the dyadic nature of sleep in a recent study. The investigators examined the bidirectional links between nightly sleep and daily marital interactions among 35 healthy married couples (mean age, 32 years) by correlating the actigraph results for sleep latency, wakefulness after sleep onset, and total sleep time of each partner over 10 nights, with daily self-reported positive and negative marital interactions assessed via electronic diaries during the same period.

"We found stronger evidence linking sleep to the next day’s marital interactions, rather than the reverse direction," Dr. Troxel reported.

Specifically, wives’ prolonged sleep latency significantly predicted their own and their husbands’ reports of more negative and less positive interactions the next day, even after adjustment for depressive symptoms, whereas the quality of marital interactions did not appear to predict sleep measures in women, she said. The sleep quality of husbands did not appear to affect their own or their wives’ reports of next-day marital interactions; however, for men, a higher level of positive marital interactions predicted shorter total sleep duration the next night.

The findings suggest, perhaps, that "men are more likely to repress their feelings or not be as aware" of mood changes, whereas women are more likely to express their emotional concerns and to "drive the emotional climate of the relationship," Dr. Troxel said. The results highlight the potential interpersonal consequences of sleep disorders, and as such may have important clinical implications, she said.

In March of this year, the Centers for Disease Control and Prevention reported that nearly a third of the country’s adults get fewer than the minimum recommended 7 hours of sleep per night, and it’s not because they’re not tired: Nearly 40% of the survey population reported unintentionally falling asleep during the day, and nearly 5% reported nodding off while driving in the preceding 30 days (MMWR 2011;60:233-8).

In addition to the negative consequences of sleep deprivation noted above, previous studies have linked sleep insufficiency to a range of adverse health outcomes, including cardiovascular disease, asthma, diabetes, and stroke, according to the report.

The presenters reported no financial conflicts of interest relevant to their respective presentations.

BOSTON - The density of facial bone seems to decrease significantly with age, a finding that suggests that the maxilla and mandible are subject to the same metabolic factors that cause osteoporosis in the axial skeleton, according to Dr. Robert B. Shaw Jr.

In a study designed to quantify age-related changes to facial bone density and compare them with age-related bone density decreases in the axial skeleton, Dr. Shaw, of the University of Rochester (N.Y.) Medical Center and his colleagues obtained dual-emission x-ray absorptiometry (DXA) scans of the facial bones and lumbar spine from 30 female and 30 male patients. The study included 10 patients of each gender in each of three age categories: 20-40 years, 41-60 years, and older than 60 years. Patients with osteoporosis were excluded from the study.

For each subject, the investigators recorded maxillary bone density (mean density of the left and right maxilla), mandibular ramus bone density (mean density of the left and right mandibular ramus), and lumbar spine bone density (mean density of L1-L4 vertebrae), Dr. Shaw said at the annual  meeting of the American Society for Aesthetic Plastic Surgery.

The investigators observed significant decreases with age for both genders between the middle- and old-age groups for lumbar spine density and between the young and middle-age groups for the maxillary and mandibular ramus bone density, Dr. Shaw reported.

Specifically, the respective mean lumbar spine densities for the young, middle-age, and older-age groups of men were 1.29, 1.29, and 1.15 g/cm², and for the women were 1.23, 1.24, and 1.08 g/cm². For the maxillary bone density, the respective measures across the age groups for the men were 1.90, 1.58, and 1.56 g/cm², and for the women they were 1.75, 1.55, and 1.50 g/cm². For the mandibular bone density, the respective measures for the male subjects were 1.52, 1.33, and 1.35 g/cm², and for the female subjects they were 1.52, 1.32, and 1.18 g/cm².

Within each age group, "lumbar spine and maxilla bone density decreases were more pronounced in female vs. male subjects," he said.

The study findings are consistent with those of an investigation published earlier this year in which Dr. Shaw and his colleagues compared three-dimensional reconstructions of CT scans of the facial bones in 120 men and women in young, middle-age, and older-age groups. The investigators observed recession of the eye socket bones and volume loss to midface bones, including the brow bone, nose, and upper jaw. The bone-loss patterns observed in the study differed by gender, with men experiencing the most pronounced decrease in bone volume beginning in the oldest age category, while the process starts in earnest for women in the middle age group, he said (Plast. Reconstr. Surg. 2011;127:374-83).

The results of the current study suggest that "facial bone aging may be linked to the same metabolic factors that cause osteoporosis in the axial skeleton," said Dr. Shaw. They also offer insight into why certain facial rejuvenation strategies may not meet patients' expectations, he said, noting, for example, that although skin tightening alone may effectively minimize wrinkles and improve skin texture, it won't compensate for the underlying structural changes that alter the three-dimensional contour of the face.

Skeletal augmentation via dermal fillers or facial implants, together with skin tightening, can potentially improve outcomes by making up for some of the lost volume, he said, "but it will not make a 60-year-old look 20 years old again." Gaining a better understanding of facial bone strength, however, may lead to new possibilities for facial rejuvenation, he said.

Dr. Shaw reported having no financial conflicts of interest with respect to his presentation.

BOSTON - The density of facial bone seems to decrease significantly with age, a finding that suggests that the maxilla and mandible are subject to the same metabolic factors that cause osteoporosis in the axial skeleton, according to Dr. Robert B. Shaw Jr.

In a study designed to quantify age-related changes to facial bone density and compare them with age-related bone density decreases in the axial skeleton, Dr. Shaw, of the University of Rochester (N.Y.) Medical Center and his colleagues obtained dual-emission x-ray absorptiometry (DXA) scans of the facial bones and lumbar spine from 30 female and 30 male patients. The study included 10 patients of each gender in each of three age categories: 20-40 years, 41-60 years, and older than 60 years. Patients with osteoporosis were excluded from the study.

For each subject, the investigators recorded maxillary bone density (mean density of the left and right maxilla), mandibular ramus bone density (mean density of the left and right mandibular ramus), and lumbar spine bone density (mean density of L1-L4 vertebrae), Dr. Shaw said at the annual  meeting of the American Society for Aesthetic Plastic Surgery.

The investigators observed significant decreases with age for both genders between the middle- and old-age groups for lumbar spine density and between the young and middle-age groups for the maxillary and mandibular ramus bone density, Dr. Shaw reported.

Specifically, the respective mean lumbar spine densities for the young, middle-age, and older-age groups of men were 1.29, 1.29, and 1.15 g/cm², and for the women were 1.23, 1.24, and 1.08 g/cm². For the maxillary bone density, the respective measures across the age groups for the men were 1.90, 1.58, and 1.56 g/cm², and for the women they were 1.75, 1.55, and 1.50 g/cm². For the mandibular bone density, the respective measures for the male subjects were 1.52, 1.33, and 1.35 g/cm², and for the female subjects they were 1.52, 1.32, and 1.18 g/cm².

Within each age group, "lumbar spine and maxilla bone density decreases were more pronounced in female vs. male subjects," he said.

The study findings are consistent with those of an investigation published earlier this year in which Dr. Shaw and his colleagues compared three-dimensional reconstructions of CT scans of the facial bones in 120 men and women in young, middle-age, and older-age groups. The investigators observed recession of the eye socket bones and volume loss to midface bones, including the brow bone, nose, and upper jaw. The bone-loss patterns observed in the study differed by gender, with men experiencing the most pronounced decrease in bone volume beginning in the oldest age category, while the process starts in earnest for women in the middle age group, he said (Plast. Reconstr. Surg. 2011;127:374-83).

The results of the current study suggest that "facial bone aging may be linked to the same metabolic factors that cause osteoporosis in the axial skeleton," said Dr. Shaw. They also offer insight into why certain facial rejuvenation strategies may not meet patients' expectations, he said, noting, for example, that although skin tightening alone may effectively minimize wrinkles and improve skin texture, it won't compensate for the underlying structural changes that alter the three-dimensional contour of the face.

Skeletal augmentation via dermal fillers or facial implants, together with skin tightening, can potentially improve outcomes by making up for some of the lost volume, he said, "but it will not make a 60-year-old look 20 years old again." Gaining a better understanding of facial bone strength, however, may lead to new possibilities for facial rejuvenation, he said.

Dr. Shaw reported having no financial conflicts of interest with respect to his presentation.

BOSTON - The density of facial bone seems to decrease significantly with age, a finding that suggests that the maxilla and mandible are subject to the same metabolic factors that cause osteoporosis in the axial skeleton, according to Dr. Robert B. Shaw Jr.

In a study designed to quantify age-related changes to facial bone density and compare them with age-related bone density decreases in the axial skeleton, Dr. Shaw, of the University of Rochester (N.Y.) Medical Center and his colleagues obtained dual-emission x-ray absorptiometry (DXA) scans of the facial bones and lumbar spine from 30 female and 30 male patients. The study included 10 patients of each gender in each of three age categories: 20-40 years, 41-60 years, and older than 60 years. Patients with osteoporosis were excluded from the study.

For each subject, the investigators recorded maxillary bone density (mean density of the left and right maxilla), mandibular ramus bone density (mean density of the left and right mandibular ramus), and lumbar spine bone density (mean density of L1-L4 vertebrae), Dr. Shaw said at the annual  meeting of the American Society for Aesthetic Plastic Surgery.

The investigators observed significant decreases with age for both genders between the middle- and old-age groups for lumbar spine density and between the young and middle-age groups for the maxillary and mandibular ramus bone density, Dr. Shaw reported.

Specifically, the respective mean lumbar spine densities for the young, middle-age, and older-age groups of men were 1.29, 1.29, and 1.15 g/cm², and for the women were 1.23, 1.24, and 1.08 g/cm². For the maxillary bone density, the respective measures across the age groups for the men were 1.90, 1.58, and 1.56 g/cm², and for the women they were 1.75, 1.55, and 1.50 g/cm². For the mandibular bone density, the respective measures for the male subjects were 1.52, 1.33, and 1.35 g/cm², and for the female subjects they were 1.52, 1.32, and 1.18 g/cm².

Within each age group, "lumbar spine and maxilla bone density decreases were more pronounced in female vs. male subjects," he said.

The study findings are consistent with those of an investigation published earlier this year in which Dr. Shaw and his colleagues compared three-dimensional reconstructions of CT scans of the facial bones in 120 men and women in young, middle-age, and older-age groups. The investigators observed recession of the eye socket bones and volume loss to midface bones, including the brow bone, nose, and upper jaw. The bone-loss patterns observed in the study differed by gender, with men experiencing the most pronounced decrease in bone volume beginning in the oldest age category, while the process starts in earnest for women in the middle age group, he said (Plast. Reconstr. Surg. 2011;127:374-83).

The results of the current study suggest that "facial bone aging may be linked to the same metabolic factors that cause osteoporosis in the axial skeleton," said Dr. Shaw. They also offer insight into why certain facial rejuvenation strategies may not meet patients' expectations, he said, noting, for example, that although skin tightening alone may effectively minimize wrinkles and improve skin texture, it won't compensate for the underlying structural changes that alter the three-dimensional contour of the face.

Skeletal augmentation via dermal fillers or facial implants, together with skin tightening, can potentially improve outcomes by making up for some of the lost volume, he said, "but it will not make a 60-year-old look 20 years old again." Gaining a better understanding of facial bone strength, however, may lead to new possibilities for facial rejuvenation, he said.

Dr. Shaw reported having no financial conflicts of interest with respect to his presentation.

Catastrophic antiphospholipid syndrome is a potentially fatal thrombotic disease that develops in a subset of patients with antiphospholipid syndrome. Survival of patients with the rare condition, which is characterized by the development of multiple organ thromboses over a short period of time, depends on the vigilance of the treating clinicians, early diagnosis, and aggressive therapy, all of which can be compromised by multiple factors including the overlap of clinical and laboratory features with other autoimmune and infectious conditions, according to rheumatologist Dr. Doruk Erkan.

Dr. Erkan (along with Dr. Gerard Espinosa and Dr. Ricard Cervera of the Hospital Clinic Barcelona) recently published a summary of the diagnostic challenges associated with catastrophic antiphospholipid syndrome (APS) and proposed updated diagnostic algorithms to streamline its management (Autoimmun. Rev. 2010;10:74-9). In this column, Dr. Erkan discusses the critical diagnostic and management considerations necessary to improve the outcomes of catastrophic APS patients.

INTERNAL MEDICINE NEWS: What are the characteristic signs and symptoms of catastrophic APS?

DR. ERKAN: Multiple organ dysfunction, driven mainly by thrombotic microangiopathy, is responsible for the majority of the clinical events in catastrophic APS, although large venous or arterial thrombosis can also occur. The three most commonly involved organs are kidneys (renal thrombotic microangiopathy, and renal artery/vein thrombosis), lungs (pulmonary infarction and/or hemorrhage, and acute respiratory distress syndrome), and brain (stroke, seizure, and encephalopathy). However, thromboses in atypical locations are common in catastrophic APS patients. Any organ system can be involved, including the myocardial, skin, hepatic, and adrenal systems. Intestinal infarctions and peripheral gangrene can also develop, and hematologic manifestations such as thrombocytopenia and schistocytic hemolytic anemia commonly occur, creating a diagnostic challenge for physicians.

IMN: What risk factors, if any, have been identified for catastrophic APS?

DR. ERKAN: The presence of multiple thrombosis risk factors is associated with a higher risk of thrombosis in individuals with antiphospholipid antibodies (aPL) and even in aPL-negative populations. A "trigger event" such as surgery, pregnancy, infection, or oral contraceptive use is commonly identified in aPL-positive patients when they develop thrombosis. Similarly, about 50%-60% of patients with catastrophic APS have an identifiable "trigger event." However, it is not well understood why some aPL-positive patients develop only single-vessel thrombosis and others go on to develop the rapidly progressive microthrombosis and organ failure that are seen in catastrophic APS. Potential genetic risk factors that may predispose aPL-positive patients to catastrophic APS are under investigation (Am. J. Med. 2011;124:290-6).

IMN: What are the key elements for establishing a timely, accurate diagnosis of catastrophic APS?

DR. ERKAN: The first step in diagnosis is to obtain an accurate history. Previous APS diagnosis and/or persistent clinically significant aPL positivity (as determined by a positive lupus anticoagulant [LA] test and/or moderate- to high-titer aPL on ELISA) is of great importance for diagnosis. However, almost half of the patients who develop catastrophic APS do not have any previous history of a thrombosis or aPL positivity. In this group of patients, the diagnosis is a particular challenge as multiple factors can impede the timely diagnosis, as in the following examples:

• A positive aPL test can be associated with infections (usually low-titer aPL ELISA) or anticoagulation (positive LA test); thus, at times it can be difficult to exclude the possibility that positive aPL tests are occurring as bystanders, not necessarily as contributors for thrombosis.

• False-negative aPL results may occur during acute catastrophic APS events.

• A continuum of thrombotic microangiopathic conditions exists, accounting for patients with thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS), HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome, and catastrophic APS.

• Both sepsis and heparin-induced thrombocytopenia share similarities with catastrophic APS, and these three conditions may overlap.

For these reasons, the timely diagnosis of catastrophic APS can be challenging. At times, the differential diagnosis cannot be narrowed to a single disease during the acute period, and thus continuous assessment of patients is warranted. The most recent updated algorithms provide a "step-by-step" approach for clinicians in the assessment of patients with multiorgan thrombosis. Important steps of the diagnostic algorithms include the assessment of a history of APS or persistent aPL positivity; three or more new organ new thromboses developing in less than a week; biopsy diagnosis of microthrombosis; and other explanations for multiple organ thromboses and/or microthrombosis.

IMN: Once a diagnosis has been established, what are the most important management considerations?

DR. ERKAN: If catastrophic APS is suspected, aggressive multimodal treatment is required without any delay. The most important treatment consideration is the timely administration of the right combination of medications in addition to the elimination of the potential triggers. Although there are no controlled studies, based on the analysis of the International CAPS (catastrophic APS) Registry, patients who receive the combination of anticoagulation plus corticosteroids plus plasma exchange or intravenous immunoglobulins have the highest survival rate. In the case of a deteriorating clinical situation, an additional agent, such as cyclophosphamide (especially in lupus patients) or rituximab (especially in patients with severe thrombocytopenia or hemolytic anemia) can be considered. Despite optimal therapy, the mortality rate is estimated to be approximately 30%, and may be higher if publication bias is considered.

The most pressing treatment challenges in catastrophic APS include delay in diagnosis for the reasons discussed above, ongoing thrombosis despite anticoagulation, high risk of simultaneous thrombosis and bleeding, and high prevalence of accompanying comorbidities (such as sepsis) that directly affect the mortality.

IMN: How has the availability of the International CAPS Registry changed the understanding and management of catastrophic APS?

DR. ERKAN: Our current knowledge of catastrophic APS is mostly based on the international Web-based registry, coordinated by Dr. Cervera. Patients with a catastrophic APS diagnosis have been included in this registry since 2000 through published or voluntary physician reports. The registry, which can be acc essed freely contains clinical, laboratory, and therapeutic data on all reported cases of catastrophic APS, with approximately 300 patients as of May 2011; the most recent descriptive analysis of the registry reported by Dr. Cervera on behalf of the CAPS Registry group was published in April 2010 (Lupus 2010;19:412-8).

Because of the rarity of catastrophic APS, it is very difficult to study this life-threatening disease. The CAPS Registry is currently the only source that allows researchers to systematically analyze the demographic and clinical characteristics of these patients. Furthermore, there are no randomized, controlled trials evaluating the efficacy of various therapies, and the treatment outcome data are also based on the analysis of the registry. Thus, the registry has been crucial in our understanding as well as the management of catastrophic APS.

Dr. Erkan is an associate physician-scientist at the Barbara Volcker Center for Women and Rheumatic Diseases; assistant attending rheumatologist and clinical researcher at Hospital for Special Surgery; and assistant professor of medicine at Weill Cornell Medical College in New York. Dr. Erkan disclosed having a research grant from Genentech.

--Reported and written by Diana Mahoney

Catastrophic antiphospholipid syndrome is a potentially fatal thrombotic disease that develops in a subset of patients with antiphospholipid syndrome. Survival of patients with the rare condition, which is characterized by the development of multiple organ thromboses over a short period of time, depends on the vigilance of the treating clinicians, early diagnosis, and aggressive therapy, all of which can be compromised by multiple factors including the overlap of clinical and laboratory features with other autoimmune and infectious conditions, according to rheumatologist Dr. Doruk Erkan.

Dr. Erkan (along with Dr. Gerard Espinosa and Dr. Ricard Cervera of the Hospital Clinic Barcelona) recently published a summary of the diagnostic challenges associated with catastrophic antiphospholipid syndrome (APS) and proposed updated diagnostic algorithms to streamline its management (Autoimmun. Rev. 2010;10:74-9). In this column, Dr. Erkan discusses the critical diagnostic and management considerations necessary to improve the outcomes of catastrophic APS patients.

INTERNAL MEDICINE NEWS: What are the characteristic signs and symptoms of catastrophic APS?

DR. ERKAN: Multiple organ dysfunction, driven mainly by thrombotic microangiopathy, is responsible for the majority of the clinical events in catastrophic APS, although large venous or arterial thrombosis can also occur. The three most commonly involved organs are kidneys (renal thrombotic microangiopathy, and renal artery/vein thrombosis), lungs (pulmonary infarction and/or hemorrhage, and acute respiratory distress syndrome), and brain (stroke, seizure, and encephalopathy). However, thromboses in atypical locations are common in catastrophic APS patients. Any organ system can be involved, including the myocardial, skin, hepatic, and adrenal systems. Intestinal infarctions and peripheral gangrene can also develop, and hematologic manifestations such as thrombocytopenia and schistocytic hemolytic anemia commonly occur, creating a diagnostic challenge for physicians.

IMN: What risk factors, if any, have been identified for catastrophic APS?

DR. ERKAN: The presence of multiple thrombosis risk factors is associated with a higher risk of thrombosis in individuals with antiphospholipid antibodies (aPL) and even in aPL-negative populations. A "trigger event" such as surgery, pregnancy, infection, or oral contraceptive use is commonly identified in aPL-positive patients when they develop thrombosis. Similarly, about 50%-60% of patients with catastrophic APS have an identifiable "trigger event." However, it is not well understood why some aPL-positive patients develop only single-vessel thrombosis and others go on to develop the rapidly progressive microthrombosis and organ failure that are seen in catastrophic APS. Potential genetic risk factors that may predispose aPL-positive patients to catastrophic APS are under investigation (Am. J. Med. 2011;124:290-6).

IMN: What are the key elements for establishing a timely, accurate diagnosis of catastrophic APS?

DR. ERKAN: The first step in diagnosis is to obtain an accurate history. Previous APS diagnosis and/or persistent clinically significant aPL positivity (as determined by a positive lupus anticoagulant [LA] test and/or moderate- to high-titer aPL on ELISA) is of great importance for diagnosis. However, almost half of the patients who develop catastrophic APS do not have any previous history of a thrombosis or aPL positivity. In this group of patients, the diagnosis is a particular challenge as multiple factors can impede the timely diagnosis, as in the following examples:

• A positive aPL test can be associated with infections (usually low-titer aPL ELISA) or anticoagulation (positive LA test); thus, at times it can be difficult to exclude the possibility that positive aPL tests are occurring as bystanders, not necessarily as contributors for thrombosis.

• False-negative aPL results may occur during acute catastrophic APS events.

• A continuum of thrombotic microangiopathic conditions exists, accounting for patients with thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS), HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome, and catastrophic APS.

• Both sepsis and heparin-induced thrombocytopenia share similarities with catastrophic APS, and these three conditions may overlap.

For these reasons, the timely diagnosis of catastrophic APS can be challenging. At times, the differential diagnosis cannot be narrowed to a single disease during the acute period, and thus continuous assessment of patients is warranted. The most recent updated algorithms provide a "step-by-step" approach for clinicians in the assessment of patients with multiorgan thrombosis. Important steps of the diagnostic algorithms include the assessment of a history of APS or persistent aPL positivity; three or more new organ new thromboses developing in less than a week; biopsy diagnosis of microthrombosis; and other explanations for multiple organ thromboses and/or microthrombosis.

IMN: Once a diagnosis has been established, what are the most important management considerations?

DR. ERKAN: If catastrophic APS is suspected, aggressive multimodal treatment is required without any delay. The most important treatment consideration is the timely administration of the right combination of medications in addition to the elimination of the potential triggers. Although there are no controlled studies, based on the analysis of the International CAPS (catastrophic APS) Registry, patients who receive the combination of anticoagulation plus corticosteroids plus plasma exchange or intravenous immunoglobulins have the highest survival rate. In the case of a deteriorating clinical situation, an additional agent, such as cyclophosphamide (especially in lupus patients) or rituximab (especially in patients with severe thrombocytopenia or hemolytic anemia) can be considered. Despite optimal therapy, the mortality rate is estimated to be approximately 30%, and may be higher if publication bias is considered.

The most pressing treatment challenges in catastrophic APS include delay in diagnosis for the reasons discussed above, ongoing thrombosis despite anticoagulation, high risk of simultaneous thrombosis and bleeding, and high prevalence of accompanying comorbidities (such as sepsis) that directly affect the mortality.

IMN: How has the availability of the International CAPS Registry changed the understanding and management of catastrophic APS?

DR. ERKAN: Our current knowledge of catastrophic APS is mostly based on the international Web-based registry, coordinated by Dr. Cervera. Patients with a catastrophic APS diagnosis have been included in this registry since 2000 through published or voluntary physician reports. The registry, which can be acc essed freely contains clinical, laboratory, and therapeutic data on all reported cases of catastrophic APS, with approximately 300 patients as of May 2011; the most recent descriptive analysis of the registry reported by Dr. Cervera on behalf of the CAPS Registry group was published in April 2010 (Lupus 2010;19:412-8).

Because of the rarity of catastrophic APS, it is very difficult to study this life-threatening disease. The CAPS Registry is currently the only source that allows researchers to systematically analyze the demographic and clinical characteristics of these patients. Furthermore, there are no randomized, controlled trials evaluating the efficacy of various therapies, and the treatment outcome data are also based on the analysis of the registry. Thus, the registry has been crucial in our understanding as well as the management of catastrophic APS.

Dr. Erkan is an associate physician-scientist at the Barbara Volcker Center for Women and Rheumatic Diseases; assistant attending rheumatologist and clinical researcher at Hospital for Special Surgery; and assistant professor of medicine at Weill Cornell Medical College in New York. Dr. Erkan disclosed having a research grant from Genentech.

--Reported and written by Diana Mahoney

Catastrophic antiphospholipid syndrome is a potentially fatal thrombotic disease that develops in a subset of patients with antiphospholipid syndrome. Survival of patients with the rare condition, which is characterized by the development of multiple organ thromboses over a short period of time, depends on the vigilance of the treating clinicians, early diagnosis, and aggressive therapy, all of which can be compromised by multiple factors including the overlap of clinical and laboratory features with other autoimmune and infectious conditions, according to rheumatologist Dr. Doruk Erkan.

Dr. Erkan (along with Dr. Gerard Espinosa and Dr. Ricard Cervera of the Hospital Clinic Barcelona) recently published a summary of the diagnostic challenges associated with catastrophic antiphospholipid syndrome (APS) and proposed updated diagnostic algorithms to streamline its management (Autoimmun. Rev. 2010;10:74-9). In this column, Dr. Erkan discusses the critical diagnostic and management considerations necessary to improve the outcomes of catastrophic APS patients.

INTERNAL MEDICINE NEWS: What are the characteristic signs and symptoms of catastrophic APS?

DR. ERKAN: Multiple organ dysfunction, driven mainly by thrombotic microangiopathy, is responsible for the majority of the clinical events in catastrophic APS, although large venous or arterial thrombosis can also occur. The three most commonly involved organs are kidneys (renal thrombotic microangiopathy, and renal artery/vein thrombosis), lungs (pulmonary infarction and/or hemorrhage, and acute respiratory distress syndrome), and brain (stroke, seizure, and encephalopathy). However, thromboses in atypical locations are common in catastrophic APS patients. Any organ system can be involved, including the myocardial, skin, hepatic, and adrenal systems. Intestinal infarctions and peripheral gangrene can also develop, and hematologic manifestations such as thrombocytopenia and schistocytic hemolytic anemia commonly occur, creating a diagnostic challenge for physicians.

IMN: What risk factors, if any, have been identified for catastrophic APS?

DR. ERKAN: The presence of multiple thrombosis risk factors is associated with a higher risk of thrombosis in individuals with antiphospholipid antibodies (aPL) and even in aPL-negative populations. A "trigger event" such as surgery, pregnancy, infection, or oral contraceptive use is commonly identified in aPL-positive patients when they develop thrombosis. Similarly, about 50%-60% of patients with catastrophic APS have an identifiable "trigger event." However, it is not well understood why some aPL-positive patients develop only single-vessel thrombosis and others go on to develop the rapidly progressive microthrombosis and organ failure that are seen in catastrophic APS. Potential genetic risk factors that may predispose aPL-positive patients to catastrophic APS are under investigation (Am. J. Med. 2011;124:290-6).

IMN: What are the key elements for establishing a timely, accurate diagnosis of catastrophic APS?

DR. ERKAN: The first step in diagnosis is to obtain an accurate history. Previous APS diagnosis and/or persistent clinically significant aPL positivity (as determined by a positive lupus anticoagulant [LA] test and/or moderate- to high-titer aPL on ELISA) is of great importance for diagnosis. However, almost half of the patients who develop catastrophic APS do not have any previous history of a thrombosis or aPL positivity. In this group of patients, the diagnosis is a particular challenge as multiple factors can impede the timely diagnosis, as in the following examples:

• A positive aPL test can be associated with infections (usually low-titer aPL ELISA) or anticoagulation (positive LA test); thus, at times it can be difficult to exclude the possibility that positive aPL tests are occurring as bystanders, not necessarily as contributors for thrombosis.

• False-negative aPL results may occur during acute catastrophic APS events.

• A continuum of thrombotic microangiopathic conditions exists, accounting for patients with thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS), HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome, and catastrophic APS.

• Both sepsis and heparin-induced thrombocytopenia share similarities with catastrophic APS, and these three conditions may overlap.

For these reasons, the timely diagnosis of catastrophic APS can be challenging. At times, the differential diagnosis cannot be narrowed to a single disease during the acute period, and thus continuous assessment of patients is warranted. The most recent updated algorithms provide a "step-by-step" approach for clinicians in the assessment of patients with multiorgan thrombosis. Important steps of the diagnostic algorithms include the assessment of a history of APS or persistent aPL positivity; three or more new organ new thromboses developing in less than a week; biopsy diagnosis of microthrombosis; and other explanations for multiple organ thromboses and/or microthrombosis.

IMN: Once a diagnosis has been established, what are the most important management considerations?

DR. ERKAN: If catastrophic APS is suspected, aggressive multimodal treatment is required without any delay. The most important treatment consideration is the timely administration of the right combination of medications in addition to the elimination of the potential triggers. Although there are no controlled studies, based on the analysis of the International CAPS (catastrophic APS) Registry, patients who receive the combination of anticoagulation plus corticosteroids plus plasma exchange or intravenous immunoglobulins have the highest survival rate. In the case of a deteriorating clinical situation, an additional agent, such as cyclophosphamide (especially in lupus patients) or rituximab (especially in patients with severe thrombocytopenia or hemolytic anemia) can be considered. Despite optimal therapy, the mortality rate is estimated to be approximately 30%, and may be higher if publication bias is considered.

The most pressing treatment challenges in catastrophic APS include delay in diagnosis for the reasons discussed above, ongoing thrombosis despite anticoagulation, high risk of simultaneous thrombosis and bleeding, and high prevalence of accompanying comorbidities (such as sepsis) that directly affect the mortality.

IMN: How has the availability of the International CAPS Registry changed the understanding and management of catastrophic APS?

DR. ERKAN: Our current knowledge of catastrophic APS is mostly based on the international Web-based registry, coordinated by Dr. Cervera. Patients with a catastrophic APS diagnosis have been included in this registry since 2000 through published or voluntary physician reports. The registry, which can be acc essed freely contains clinical, laboratory, and therapeutic data on all reported cases of catastrophic APS, with approximately 300 patients as of May 2011; the most recent descriptive analysis of the registry reported by Dr. Cervera on behalf of the CAPS Registry group was published in April 2010 (Lupus 2010;19:412-8).

Because of the rarity of catastrophic APS, it is very difficult to study this life-threatening disease. The CAPS Registry is currently the only source that allows researchers to systematically analyze the demographic and clinical characteristics of these patients. Furthermore, there are no randomized, controlled trials evaluating the efficacy of various therapies, and the treatment outcome data are also based on the analysis of the registry. Thus, the registry has been crucial in our understanding as well as the management of catastrophic APS.

Dr. Erkan is an associate physician-scientist at the Barbara Volcker Center for Women and Rheumatic Diseases; assistant attending rheumatologist and clinical researcher at Hospital for Special Surgery; and assistant professor of medicine at Weill Cornell Medical College in New York. Dr. Erkan disclosed having a research grant from Genentech.

--Reported and written by Diana Mahoney

Catastrophic antiphospholipid syndrome is a potentially fatal thrombotic disease that develops in a subset of patients with antiphospholipid syndrome. Survival of patients with the rare condition, which is characterized by the development of multiple organ thromboses over a short period of time, depends on the vigilance of the treating clinicians, early diagnosis, and aggressive therapy, all of which can be compromised by multiple factors including the overlap of clinical and laboratory features with other autoimmune and infectious conditions, according to rheumatologist Dr. Doruk Erkan.

Dr. Erkan (along with Dr. Gerard Espinosa and Dr. Ricard Cervera of the Hospital Clinic Barcelona) recently published a summary of the diagnostic challenges associated with catastrophic antiphospholipid syndrome (APS) and proposed updated diagnostic algorithms to streamline its management (Autoimmun. Rev. 2010;10:74-9). In this column, Dr. Erkan discusses the critical diagnostic and management considerations necessary to improve the outcomes of catastrophic APS patients.

SKIN & ALLERGY NEWS: What are the characteristic signs and symptoms of catastrophic APS?

DR. ERKAN: Multiple organ dysfunction, driven mainly by thrombotic microangiopathy, is responsible for the majority of the clinical events in catastrophic APS, although large venous or arterial thrombosis can also occur. The three most commonly involved organs are kidneys (renal thrombotic microangiopathy, and renal artery/vein thrombosis), lungs (pulmonary infarction and/or hemorrhage, and acute respiratory distress syndrome), and brain (stroke, seizure, and encephalopathy). However, thromboses in atypical locations are common in catastrophic APS patients. Any organ system can be involved, including the myocardial, skin, hepatic, and adrenal systems. Intestinal infarctions and peripheral gangrene can also develop, and hematologic manifestations such as thrombocytopenia and schistocytic hemolytic anemia commonly occur, creating a diagnostic challenge for physicians.

SAN: What risk factors, if any, have been identified for catastrophic APS?

DR. ERKAN: The presence of multiple thrombosis risk factors is associated with a higher risk of thrombosis in individuals with antiphospholipid antibodies (aPL) and even in aPL-negative populations. A "trigger event" such as surgery, pregnancy, infection, or oral contraceptive use is commonly identified in aPL-positive patients when they develop thrombosis. Similarly, about 50%-60% of patients with catastrophic APS have an identifiable "trigger event." However, it is not well understood why some aPL-positive patients develop only single-vessel thrombosis and others go on to develop the rapidly progressive microthrombosis and organ failure that are seen in catastrophic APS. Potential genetic risk factors that may predispose aPL-positive patients to catastrophic APS are under investigation (Am. J. Med. 2011;124:290-6).

SAN: What are the key elements for establishing a timely, accurate diagnosis of catastrophic APS?

DR. ERKAN: The first step in diagnosis is to obtain an accurate history. Previous APS diagnosis and/or persistent clinically significant aPL positivity (as determined by a positive lupus anticoagulant [LA] test and/or moderate- to high-titer aPL on ELISA) is of great importance for diagnosis. However, almost half of the patients who develop catastrophic APS do not have any previous history of a thrombosis or aPL positivity. In this group of patients, the diagnosis is a particular challenge as multiple factors can impede the timely diagnosis, as in the following examples:

• A positive aPL test can be associated with infections (usually low-titer aPL ELISA) or anticoagulation (positive LA test); thus, at times it can be difficult to exclude the possibility that positive aPL tests are occurring as bystanders, not necessarily as contributors for thrombosis.

• False-negative aPL results may occur during acute catastrophic APS events.

• A continuum of thrombotic microangiopathic conditions exists, accounting for patients with thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS), HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome, and catastrophic APS.

• Both sepsis and heparin-induced thrombocytopenia share similarities with catastrophic APS, and these three conditions may overlap.

For these reasons, the timely diagnosis of catastrophic APS can be challenging. At times, the differential diagnosis cannot be narrowed to a single disease during the acute period, and thus continuous assessment of patients is warranted. The most recent updated algorithms provide a "step-by-step" approach for clinicians in the assessment of patients with multiorgan thrombosis. Important steps of the diagnostic algorithms include the assessment of a history of APS or persistent aPL positivity; three or more new organ new thromboses developing in less than a week; biopsy diagnosis of microthrombosis; and other explanations for multiple organ thromboses and/or microthrombosis.

SAN: Once a diagnosis has been established, what are the most important management considerations?

DR. ERKAN: If catastrophic APS is suspected, aggressive multimodal treatment is required without any delay. The most important treatment consideration is the timely administration of the right combination of medications in addition to the elimination of the potential triggers. Although there are no controlled studies, based on the analysis of the International CAPS (catastrophic APS) Registry, patients who receive the combination of anticoagulation plus corticosteroids plus plasma exchange or intravenous immunoglobulins have the highest survival rate. In the case of a deteriorating clinical situation, an additional agent, such as cyclophosphamide (especially in lupus patients) or rituximab (especially in patients with severe thrombocytopenia or hemolytic anemia) can be considered. Despite optimal therapy, the mortality rate is estimated to be approximately 30%, and may be higher if publication bias is considered.

The most pressing treatment challenges in catastrophic APS include delay in diagnosis for the reasons discussed above, ongoing thrombosis despite anticoagulation, high risk of simultaneous thrombosis and bleeding, and high prevalence of accompanying comorbidities (such as sepsis) that directly affect the mortality.

SAN: How has the availability of the International CAPS Registry changed the understanding and management of catastrophic APS?

DR. ERKAN: Our current knowledge of catastrophic APS is mostly based on the international Web-based registry, coordinated by Dr. Cervera. Patients with a catastrophic APS diagnosis have been included in this registry since 2000 through published or voluntary physician reports. The registry, which can be acc essed freely contains clinical, laboratory, and therapeutic data on all reported cases of catastrophic APS, with approximately 300 patients as of May 2011; the most recent descriptive analysis of the registry reported by Dr. Cervera on behalf of the CAPS Registry group was published in April 2010 (Lupus 2010;19:412-8).

Because of the rarity of catastrophic APS, it is very difficult to study this life-threatening disease. The CAPS Registry is currently the only source that allows researchers to systematically analyze the demographic and clinical characteristics of these patients. Furthermore, there are no randomized, controlled trials evaluating the efficacy of various therapies, and the treatment outcome data are also based on the analysis of the registry. Thus, the registry has been crucial in our understanding as well as the management of catastrophic APS.

Dr. Erkan is an associate physician-scientist at the Barbara Volcker Center for Women and Rheumatic Diseases; assistant attending rheumatologist and clinical researcher at Hospital for Special Surgery; and assistant professor of medicine at Weill Cornell Medical College in New York. Dr. Erkan disclosed having a research grant from Genentech.

--Reported and written by Diana Mahoney

Catastrophic antiphospholipid syndrome is a potentially fatal thrombotic disease that develops in a subset of patients with antiphospholipid syndrome. Survival of patients with the rare condition, which is characterized by the development of multiple organ thromboses over a short period of time, depends on the vigilance of the treating clinicians, early diagnosis, and aggressive therapy, all of which can be compromised by multiple factors including the overlap of clinical and laboratory features with other autoimmune and infectious conditions, according to rheumatologist Dr. Doruk Erkan.

Dr. Erkan (along with Dr. Gerard Espinosa and Dr. Ricard Cervera of the Hospital Clinic Barcelona) recently published a summary of the diagnostic challenges associated with catastrophic antiphospholipid syndrome (APS) and proposed updated diagnostic algorithms to streamline its management (Autoimmun. Rev. 2010;10:74-9). In this column, Dr. Erkan discusses the critical diagnostic and management considerations necessary to improve the outcomes of catastrophic APS patients.

SKIN & ALLERGY NEWS: What are the characteristic signs and symptoms of catastrophic APS?

DR. ERKAN: Multiple organ dysfunction, driven mainly by thrombotic microangiopathy, is responsible for the majority of the clinical events in catastrophic APS, although large venous or arterial thrombosis can also occur. The three most commonly involved organs are kidneys (renal thrombotic microangiopathy, and renal artery/vein thrombosis), lungs (pulmonary infarction and/or hemorrhage, and acute respiratory distress syndrome), and brain (stroke, seizure, and encephalopathy). However, thromboses in atypical locations are common in catastrophic APS patients. Any organ system can be involved, including the myocardial, skin, hepatic, and adrenal systems. Intestinal infarctions and peripheral gangrene can also develop, and hematologic manifestations such as thrombocytopenia and schistocytic hemolytic anemia commonly occur, creating a diagnostic challenge for physicians.

SAN: What risk factors, if any, have been identified for catastrophic APS?

DR. ERKAN: The presence of multiple thrombosis risk factors is associated with a higher risk of thrombosis in individuals with antiphospholipid antibodies (aPL) and even in aPL-negative populations. A "trigger event" such as surgery, pregnancy, infection, or oral contraceptive use is commonly identified in aPL-positive patients when they develop thrombosis. Similarly, about 50%-60% of patients with catastrophic APS have an identifiable "trigger event." However, it is not well understood why some aPL-positive patients develop only single-vessel thrombosis and others go on to develop the rapidly progressive microthrombosis and organ failure that are seen in catastrophic APS. Potential genetic risk factors that may predispose aPL-positive patients to catastrophic APS are under investigation (Am. J. Med. 2011;124:290-6).

SAN: What are the key elements for establishing a timely, accurate diagnosis of catastrophic APS?

DR. ERKAN: The first step in diagnosis is to obtain an accurate history. Previous APS diagnosis and/or persistent clinically significant aPL positivity (as determined by a positive lupus anticoagulant [LA] test and/or moderate- to high-titer aPL on ELISA) is of great importance for diagnosis. However, almost half of the patients who develop catastrophic APS do not have any previous history of a thrombosis or aPL positivity. In this group of patients, the diagnosis is a particular challenge as multiple factors can impede the timely diagnosis, as in the following examples:

• A positive aPL test can be associated with infections (usually low-titer aPL ELISA) or anticoagulation (positive LA test); thus, at times it can be difficult to exclude the possibility that positive aPL tests are occurring as bystanders, not necessarily as contributors for thrombosis.

• False-negative aPL results may occur during acute catastrophic APS events.

• A continuum of thrombotic microangiopathic conditions exists, accounting for patients with thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS), HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome, and catastrophic APS.

• Both sepsis and heparin-induced thrombocytopenia share similarities with catastrophic APS, and these three conditions may overlap.

For these reasons, the timely diagnosis of catastrophic APS can be challenging. At times, the differential diagnosis cannot be narrowed to a single disease during the acute period, and thus continuous assessment of patients is warranted. The most recent updated algorithms provide a "step-by-step" approach for clinicians in the assessment of patients with multiorgan thrombosis. Important steps of the diagnostic algorithms include the assessment of a history of APS or persistent aPL positivity; three or more new organ new thromboses developing in less than a week; biopsy diagnosis of microthrombosis; and other explanations for multiple organ thromboses and/or microthrombosis.

SAN: Once a diagnosis has been established, what are the most important management considerations?

DR. ERKAN: If catastrophic APS is suspected, aggressive multimodal treatment is required without any delay. The most important treatment consideration is the timely administration of the right combination of medications in addition to the elimination of the potential triggers. Although there are no controlled studies, based on the analysis of the International CAPS (catastrophic APS) Registry, patients who receive the combination of anticoagulation plus corticosteroids plus plasma exchange or intravenous immunoglobulins have the highest survival rate. In the case of a deteriorating clinical situation, an additional agent, such as cyclophosphamide (especially in lupus patients) or rituximab (especially in patients with severe thrombocytopenia or hemolytic anemia) can be considered. Despite optimal therapy, the mortality rate is estimated to be approximately 30%, and may be higher if publication bias is considered.

The most pressing treatment challenges in catastrophic APS include delay in diagnosis for the reasons discussed above, ongoing thrombosis despite anticoagulation, high risk of simultaneous thrombosis and bleeding, and high prevalence of accompanying comorbidities (such as sepsis) that directly affect the mortality.

SAN: How has the availability of the International CAPS Registry changed the understanding and management of catastrophic APS?

DR. ERKAN: Our current knowledge of catastrophic APS is mostly based on the international Web-based registry, coordinated by Dr. Cervera. Patients with a catastrophic APS diagnosis have been included in this registry since 2000 through published or voluntary physician reports. The registry, which can be acc essed freely contains clinical, laboratory, and therapeutic data on all reported cases of catastrophic APS, with approximately 300 patients as of May 2011; the most recent descriptive analysis of the registry reported by Dr. Cervera on behalf of the CAPS Registry group was published in April 2010 (Lupus 2010;19:412-8).

Because of the rarity of catastrophic APS, it is very difficult to study this life-threatening disease. The CAPS Registry is currently the only source that allows researchers to systematically analyze the demographic and clinical characteristics of these patients. Furthermore, there are no randomized, controlled trials evaluating the efficacy of various therapies, and the treatment outcome data are also based on the analysis of the registry. Thus, the registry has been crucial in our understanding as well as the management of catastrophic APS.

Dr. Erkan is an associate physician-scientist at the Barbara Volcker Center for Women and Rheumatic Diseases; assistant attending rheumatologist and clinical researcher at Hospital for Special Surgery; and assistant professor of medicine at Weill Cornell Medical College in New York. Dr. Erkan disclosed having a research grant from Genentech.

--Reported and written by Diana Mahoney

Catastrophic antiphospholipid syndrome is a potentially fatal thrombotic disease that develops in a subset of patients with antiphospholipid syndrome. Survival of patients with the rare condition, which is characterized by the development of multiple organ thromboses over a short period of time, depends on the vigilance of the treating clinicians, early diagnosis, and aggressive therapy, all of which can be compromised by multiple factors including the overlap of clinical and laboratory features with other autoimmune and infectious conditions, according to rheumatologist Dr. Doruk Erkan.

Dr. Erkan (along with Dr. Gerard Espinosa and Dr. Ricard Cervera of the Hospital Clinic Barcelona) recently published a summary of the diagnostic challenges associated with catastrophic antiphospholipid syndrome (APS) and proposed updated diagnostic algorithms to streamline its management (Autoimmun. Rev. 2010;10:74-9). In this column, Dr. Erkan discusses the critical diagnostic and management considerations necessary to improve the outcomes of catastrophic APS patients.

SKIN & ALLERGY NEWS: What are the characteristic signs and symptoms of catastrophic APS?

DR. ERKAN: Multiple organ dysfunction, driven mainly by thrombotic microangiopathy, is responsible for the majority of the clinical events in catastrophic APS, although large venous or arterial thrombosis can also occur. The three most commonly involved organs are kidneys (renal thrombotic microangiopathy, and renal artery/vein thrombosis), lungs (pulmonary infarction and/or hemorrhage, and acute respiratory distress syndrome), and brain (stroke, seizure, and encephalopathy). However, thromboses in atypical locations are common in catastrophic APS patients. Any organ system can be involved, including the myocardial, skin, hepatic, and adrenal systems. Intestinal infarctions and peripheral gangrene can also develop, and hematologic manifestations such as thrombocytopenia and schistocytic hemolytic anemia commonly occur, creating a diagnostic challenge for physicians.

SAN: What risk factors, if any, have been identified for catastrophic APS?

DR. ERKAN: The presence of multiple thrombosis risk factors is associated with a higher risk of thrombosis in individuals with antiphospholipid antibodies (aPL) and even in aPL-negative populations. A "trigger event" such as surgery, pregnancy, infection, or oral contraceptive use is commonly identified in aPL-positive patients when they develop thrombosis. Similarly, about 50%-60% of patients with catastrophic APS have an identifiable "trigger event." However, it is not well understood why some aPL-positive patients develop only single-vessel thrombosis and others go on to develop the rapidly progressive microthrombosis and organ failure that are seen in catastrophic APS. Potential genetic risk factors that may predispose aPL-positive patients to catastrophic APS are under investigation (Am. J. Med. 2011;124:290-6).

SAN: What are the key elements for establishing a timely, accurate diagnosis of catastrophic APS?

DR. ERKAN: The first step in diagnosis is to obtain an accurate history. Previous APS diagnosis and/or persistent clinically significant aPL positivity (as determined by a positive lupus anticoagulant [LA] test and/or moderate- to high-titer aPL on ELISA) is of great importance for diagnosis. However, almost half of the patients who develop catastrophic APS do not have any previous history of a thrombosis or aPL positivity. In this group of patients, the diagnosis is a particular challenge as multiple factors can impede the timely diagnosis, as in the following examples:

• A positive aPL test can be associated with infections (usually low-titer aPL ELISA) or anticoagulation (positive LA test); thus, at times it can be difficult to exclude the possibility that positive aPL tests are occurring as bystanders, not necessarily as contributors for thrombosis.

• False-negative aPL results may occur during acute catastrophic APS events.

• A continuum of thrombotic microangiopathic conditions exists, accounting for patients with thrombotic thrombocytopenic purpura (TTP), hemolytic uremic syndrome (HUS), HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome, and catastrophic APS.

• Both sepsis and heparin-induced thrombocytopenia share similarities with catastrophic APS, and these three conditions may overlap.

For these reasons, the timely diagnosis of catastrophic APS can be challenging. At times, the differential diagnosis cannot be narrowed to a single disease during the acute period, and thus continuous assessment of patients is warranted. The most recent updated algorithms provide a "step-by-step" approach for clinicians in the assessment of patients with multiorgan thrombosis. Important steps of the diagnostic algorithms include the assessment of a history of APS or persistent aPL positivity; three or more new organ new thromboses developing in less than a week; biopsy diagnosis of microthrombosis; and other explanations for multiple organ thromboses and/or microthrombosis.

SAN: Once a diagnosis has been established, what are the most important management considerations?

DR. ERKAN: If catastrophic APS is suspected, aggressive multimodal treatment is required without any delay. The most important treatment consideration is the timely administration of the right combination of medications in addition to the elimination of the potential triggers. Although there are no controlled studies, based on the analysis of the International CAPS (catastrophic APS) Registry, patients who receive the combination of anticoagulation plus corticosteroids plus plasma exchange or intravenous immunoglobulins have the highest survival rate. In the case of a deteriorating clinical situation, an additional agent, such as cyclophosphamide (especially in lupus patients) or rituximab (especially in patients with severe thrombocytopenia or hemolytic anemia) can be considered. Despite optimal therapy, the mortality rate is estimated to be approximately 30%, and may be higher if publication bias is considered.

The most pressing treatment challenges in catastrophic APS include delay in diagnosis for the reasons discussed above, ongoing thrombosis despite anticoagulation, high risk of simultaneous thrombosis and bleeding, and high prevalence of accompanying comorbidities (such as sepsis) that directly affect the mortality.

SAN: How has the availability of the International CAPS Registry changed the understanding and management of catastrophic APS?

DR. ERKAN: Our current knowledge of catastrophic APS is mostly based on the international Web-based registry, coordinated by Dr. Cervera. Patients with a catastrophic APS diagnosis have been included in this registry since 2000 through published or voluntary physician reports. The registry, which can be acc essed freely contains clinical, laboratory, and therapeutic data on all reported cases of catastrophic APS, with approximately 300 patients as of May 2011; the most recent descriptive analysis of the registry reported by Dr. Cervera on behalf of the CAPS Registry group was published in April 2010 (Lupus 2010;19:412-8).

Because of the rarity of catastrophic APS, it is very difficult to study this life-threatening disease. The CAPS Registry is currently the only source that allows researchers to systematically analyze the demographic and clinical characteristics of these patients. Furthermore, there are no randomized, controlled trials evaluating the efficacy of various therapies, and the treatment outcome data are also based on the analysis of the registry. Thus, the registry has been crucial in our understanding as well as the management of catastrophic APS.

Dr. Erkan is an associate physician-scientist at the Barbara Volcker Center for Women and Rheumatic Diseases; assistant attending rheumatologist and clinical researcher at Hospital for Special Surgery; and assistant professor of medicine at Weill Cornell Medical College in New York. Dr. Erkan disclosed having a research grant from Genentech.

--Reported and written by Diana Mahoney

There is limited proof that any of the multifaceted or individualized programs designed to prevent falls in the elderly both inside and outside the hospital setting are effective, according to a comprehensive literature review.

Additionally, an assessment of existing fall-prevention techniques "indicates that many of these interventions were designed using expert opinion or statistical trends and that there is no conclusive medical evidence that any of them qualifies as an evidence-based guideline," wrote Dr. Terry A. Clyburn and Dr. John A. Heydemann of the University of Texas, Houston. The only exception, they noted, are interventions that address delirium (J. Am. Acad. Orthop. Surg. 2011;19: 402-9).

Courtesy of Ashley Alexander

Falls are the leading cause of fatal and nonfatal injuries to older people in the United States. Approximately one-third of people aged 65 years or older and half of those aged 80 years or older fall at least once annually, and 3%-20% of hospital inpatients fall at least once during their stay, according to the authors.

Given those statistics, they wrote, "the [Centers for Disease Control and Prevention] estimates that the direct and indirect cost of all fall-related injuries, including hospitalization, payments for physician and other professional services, medical equipment, prescription drugs, changes to the home, and lost time from work and household duties will reach $54.9 billion by 2020."

Among the intrinsic risk factors that are linked to falls in the elderly are comorbidities (such as diabetes, Parkinson’s disease, osteoporosis, history of stroke, arthritis, peripheral sensory deficit, malnutrition, arrhythmia, and orthostatic hypotension) and functional disabilities (such as reduced strength, vertigo, visual impairment, inappropriate footwear, incontinence, and the use of certain high-risk medications), the authors noted. Extrinsic risk factors include environmental considerations, such as the condition of the floor, cluttered areas, throw rugs, poor lighting, the lack of or poorly placed grab rails, noncollapsing bed rails, and intravenous equipment, they wrote.

Because the Centers for Medicare and Medicaid Services has placed the financial burden for inpatient falls in particular on hospitals by denying reimbursements for fall-related injuries to those institutions that have not followed evidence-based fall-prevention guidelines, the authors sought to determine whether medical evidence exists to support the effectiveness of fall-prevention strategies. Toward this end, they reviewed the available literature related to fall-prevention modalities "that are considered to be modifiable and, therefore, effective in fall prevention."

These include medical interventions such as delirium prevention, nutrition, medications, and vision/eye care, as well as physical interventions, including bed rails, electronic bed sensors, appropriate bed and toilet seat height, footwear, flooring, identification bracelets, bed trapeze, grab rails, room and floor lighting, scheduled toileting, access to call light, bedside commode, unobstructed environment, and exercise and balance training.

With respect to prevention programs that combine multiple individual modalities, "our review of the literature reveals no conclusive medical evidence that multifactorial prevention programs in the acute hospital setting are effective," the authors wrote.

In one randomized, controlled trial comprising nearly 4,000 hospitalized patients in elderly care wards, no differences were found in fall frequency, injurious falls, or fractures between patients who spent 25 hours per week receiving targeted prevention support (fall risk assessments, education, walking aids, eyewear, environmental modifications, increased supervision, physiotherapy, and medication review and adjustments) and those in the usual care condition (BMJ 2008;336: 758-60). The authors attributed the finding to the short median duration of patient stay, and noted that similar programs have demonstrated efficacy in long-term care settings.

Of the individual, in-hospital, fall-prevention measures, addressing delirium was the only one supported by statistically significant evidence, the authors wrote. Multiple studies demonstrated a strong correlation between falls and delirium, supporting the early identification and management of the confusional state in the hospital, they stated. Efficacy studies of the delirium protocols of HELP (Hospital Elder Life Program) intervention, which focus on orientation, therapeutic activities, early mobilization, vision and hearing, oral volume repletion, and sleep enhancement, have noted a reduction in the development of delirium and in falls associated with the intervention.

In one study, 95% of medical staff working in 29 hospitals that use the program noted a decrease in falls (N. Engl. J. Med. 2009;360: 2930-3). Even so, the authors wrote, "the literature is not adequate to support its consideration as a medical evidence-based guideline."

One surprising finding noted by the authors was the fact that the rate of falls in the hospital was only slightly greater than the rate in the home. "I would have imagined that inpatients who were in unfamiliar surroundings, often post operative and in heavily medicated states would have had a significantly higher rate of falls," Dr. Clyburn said in an interview. Also unexpected, he said, was the fact that some of the multimodal fall-prevention efforts and some of the "high-tech" measures, including alarmed beds, were not more effective.

Education regarding the prevalence and nature of inpatient falls – as well as large, controlled trials to evaluate preventative measures – are warranted, the authors wrote. "We must also be aware of the potential risks of enacting measures to prevent falls that may be counterproductive to patient recovery," they stated.

Dr. Clyburn disclosed financial relationships with Nimbic Systems and ConforMIS. Dr. Heydemann disclosed a financial relationship with Merck.

There is limited proof that any of the multifaceted or individualized programs designed to prevent falls in the elderly both inside and outside the hospital setting are effective, according to a comprehensive literature review.

Additionally, an assessment of existing fall-prevention techniques "indicates that many of these interventions were designed using expert opinion or statistical trends and that there is no conclusive medical evidence that any of them qualifies as an evidence-based guideline," wrote Dr. Terry A. Clyburn and Dr. John A. Heydemann of the University of Texas, Houston. The only exception, they noted, are interventions that address delirium (J. Am. Acad. Orthop. Surg. 2011;19: 402-9).

Courtesy of Ashley Alexander

Falls are the leading cause of fatal and nonfatal injuries to older people in the United States. Approximately one-third of people aged 65 years or older and half of those aged 80 years or older fall at least once annually, and 3%-20% of hospital inpatients fall at least once during their stay, according to the authors.

Given those statistics, they wrote, "the [Centers for Disease Control and Prevention] estimates that the direct and indirect cost of all fall-related injuries, including hospitalization, payments for physician and other professional services, medical equipment, prescription drugs, changes to the home, and lost time from work and household duties will reach $54.9 billion by 2020."

Among the intrinsic risk factors that are linked to falls in the elderly are comorbidities (such as diabetes, Parkinson’s disease, osteoporosis, history of stroke, arthritis, peripheral sensory deficit, malnutrition, arrhythmia, and orthostatic hypotension) and functional disabilities (such as reduced strength, vertigo, visual impairment, inappropriate footwear, incontinence, and the use of certain high-risk medications), the authors noted. Extrinsic risk factors include environmental considerations, such as the condition of the floor, cluttered areas, throw rugs, poor lighting, the lack of or poorly placed grab rails, noncollapsing bed rails, and intravenous equipment, they wrote.

Because the Centers for Medicare and Medicaid Services has placed the financial burden for inpatient falls in particular on hospitals by denying reimbursements for fall-related injuries to those institutions that have not followed evidence-based fall-prevention guidelines, the authors sought to determine whether medical evidence exists to support the effectiveness of fall-prevention strategies. Toward this end, they reviewed the available literature related to fall-prevention modalities "that are considered to be modifiable and, therefore, effective in fall prevention."

These include medical interventions such as delirium prevention, nutrition, medications, and vision/eye care, as well as physical interventions, including bed rails, electronic bed sensors, appropriate bed and toilet seat height, footwear, flooring, identification bracelets, bed trapeze, grab rails, room and floor lighting, scheduled toileting, access to call light, bedside commode, unobstructed environment, and exercise and balance training.

With respect to prevention programs that combine multiple individual modalities, "our review of the literature reveals no conclusive medical evidence that multifactorial prevention programs in the acute hospital setting are effective," the authors wrote.

In one randomized, controlled trial comprising nearly 4,000 hospitalized patients in elderly care wards, no differences were found in fall frequency, injurious falls, or fractures between patients who spent 25 hours per week receiving targeted prevention support (fall risk assessments, education, walking aids, eyewear, environmental modifications, increased supervision, physiotherapy, and medication review and adjustments) and those in the usual care condition (BMJ 2008;336: 758-60). The authors attributed the finding to the short median duration of patient stay, and noted that similar programs have demonstrated efficacy in long-term care settings.

Of the individual, in-hospital, fall-prevention measures, addressing delirium was the only one supported by statistically significant evidence, the authors wrote. Multiple studies demonstrated a strong correlation between falls and delirium, supporting the early identification and management of the confusional state in the hospital, they stated. Efficacy studies of the delirium protocols of HELP (Hospital Elder Life Program) intervention, which focus on orientation, therapeutic activities, early mobilization, vision and hearing, oral volume repletion, and sleep enhancement, have noted a reduction in the development of delirium and in falls associated with the intervention.

In one study, 95% of medical staff working in 29 hospitals that use the program noted a decrease in falls (N. Engl. J. Med. 2009;360: 2930-3). Even so, the authors wrote, "the literature is not adequate to support its consideration as a medical evidence-based guideline."

One surprising finding noted by the authors was the fact that the rate of falls in the hospital was only slightly greater than the rate in the home. "I would have imagined that inpatients who were in unfamiliar surroundings, often post operative and in heavily medicated states would have had a significantly higher rate of falls," Dr. Clyburn said in an interview. Also unexpected, he said, was the fact that some of the multimodal fall-prevention efforts and some of the "high-tech" measures, including alarmed beds, were not more effective.

Education regarding the prevalence and nature of inpatient falls – as well as large, controlled trials to evaluate preventative measures – are warranted, the authors wrote. "We must also be aware of the potential risks of enacting measures to prevent falls that may be counterproductive to patient recovery," they stated.

Dr. Clyburn disclosed financial relationships with Nimbic Systems and ConforMIS. Dr. Heydemann disclosed a financial relationship with Merck.

There is limited proof that any of the multifaceted or individualized programs designed to prevent falls in the elderly both inside and outside the hospital setting are effective, according to a comprehensive literature review.

Additionally, an assessment of existing fall-prevention techniques "indicates that many of these interventions were designed using expert opinion or statistical trends and that there is no conclusive medical evidence that any of them qualifies as an evidence-based guideline," wrote Dr. Terry A. Clyburn and Dr. John A. Heydemann of the University of Texas, Houston. The only exception, they noted, are interventions that address delirium (J. Am. Acad. Orthop. Surg. 2011;19: 402-9).

Courtesy of Ashley Alexander

Falls are the leading cause of fatal and nonfatal injuries to older people in the United States. Approximately one-third of people aged 65 years or older and half of those aged 80 years or older fall at least once annually, and 3%-20% of hospital inpatients fall at least once during their stay, according to the authors.

Given those statistics, they wrote, "the [Centers for Disease Control and Prevention] estimates that the direct and indirect cost of all fall-related injuries, including hospitalization, payments for physician and other professional services, medical equipment, prescription drugs, changes to the home, and lost time from work and household duties will reach $54.9 billion by 2020."

Among the intrinsic risk factors that are linked to falls in the elderly are comorbidities (such as diabetes, Parkinson’s disease, osteoporosis, history of stroke, arthritis, peripheral sensory deficit, malnutrition, arrhythmia, and orthostatic hypotension) and functional disabilities (such as reduced strength, vertigo, visual impairment, inappropriate footwear, incontinence, and the use of certain high-risk medications), the authors noted. Extrinsic risk factors include environmental considerations, such as the condition of the floor, cluttered areas, throw rugs, poor lighting, the lack of or poorly placed grab rails, noncollapsing bed rails, and intravenous equipment, they wrote.

Because the Centers for Medicare and Medicaid Services has placed the financial burden for inpatient falls in particular on hospitals by denying reimbursements for fall-related injuries to those institutions that have not followed evidence-based fall-prevention guidelines, the authors sought to determine whether medical evidence exists to support the effectiveness of fall-prevention strategies. Toward this end, they reviewed the available literature related to fall-prevention modalities "that are considered to be modifiable and, therefore, effective in fall prevention."

These include medical interventions such as delirium prevention, nutrition, medications, and vision/eye care, as well as physical interventions, including bed rails, electronic bed sensors, appropriate bed and toilet seat height, footwear, flooring, identification bracelets, bed trapeze, grab rails, room and floor lighting, scheduled toileting, access to call light, bedside commode, unobstructed environment, and exercise and balance training.

With respect to prevention programs that combine multiple individual modalities, "our review of the literature reveals no conclusive medical evidence that multifactorial prevention programs in the acute hospital setting are effective," the authors wrote.

In one randomized, controlled trial comprising nearly 4,000 hospitalized patients in elderly care wards, no differences were found in fall frequency, injurious falls, or fractures between patients who spent 25 hours per week receiving targeted prevention support (fall risk assessments, education, walking aids, eyewear, environmental modifications, increased supervision, physiotherapy, and medication review and adjustments) and those in the usual care condition (BMJ 2008;336: 758-60). The authors attributed the finding to the short median duration of patient stay, and noted that similar programs have demonstrated efficacy in long-term care settings.

Of the individual, in-hospital, fall-prevention measures, addressing delirium was the only one supported by statistically significant evidence, the authors wrote. Multiple studies demonstrated a strong correlation between falls and delirium, supporting the early identification and management of the confusional state in the hospital, they stated. Efficacy studies of the delirium protocols of HELP (Hospital Elder Life Program) intervention, which focus on orientation, therapeutic activities, early mobilization, vision and hearing, oral volume repletion, and sleep enhancement, have noted a reduction in the development of delirium and in falls associated with the intervention.

In one study, 95% of medical staff working in 29 hospitals that use the program noted a decrease in falls (N. Engl. J. Med. 2009;360: 2930-3). Even so, the authors wrote, "the literature is not adequate to support its consideration as a medical evidence-based guideline."

One surprising finding noted by the authors was the fact that the rate of falls in the hospital was only slightly greater than the rate in the home. "I would have imagined that inpatients who were in unfamiliar surroundings, often post operative and in heavily medicated states would have had a significantly higher rate of falls," Dr. Clyburn said in an interview. Also unexpected, he said, was the fact that some of the multimodal fall-prevention efforts and some of the "high-tech" measures, including alarmed beds, were not more effective.

Education regarding the prevalence and nature of inpatient falls – as well as large, controlled trials to evaluate preventative measures – are warranted, the authors wrote. "We must also be aware of the potential risks of enacting measures to prevent falls that may be counterproductive to patient recovery," they stated.

Dr. Clyburn disclosed financial relationships with Nimbic Systems and ConforMIS. Dr. Heydemann disclosed a financial relationship with Merck.

There is limited proof that any of the multifaceted or individualized programs designed to prevent falls in the elderly both inside and outside the hospital setting are effective, according to a comprehensive literature review.

Additionally, an assessment of existing fall-prevention techniques "indicates that many of these interventions were designed using expert opinion or statistical trends and that there is no conclusive medical evidence that any of them qualifies as an evidence-based guideline," wrote Dr. Terry A. Clyburn and Dr. John A. Heydemann of the University of Texas, Houston. The only exception, they noted, are interventions that address delirium (J. Am. Acad. Orthop. Surg. 2011;19: 402-9).

Falls are the leading cause of fatal and nonfatal injuries to older people in the United States. Approximately one-third of people aged 65 years or older and half of those aged 80 years or older fall at least once annually, and 3%-20% of hospital inpatients fall at least once during their stay, according to the authors. Given those statistics, they wrote, "the [Centers for Disease Control and Prevention] estimates that the direct and indirect cost of all fall-related injuries, including hospitalization, payments for physician and other professional services, medical equipment, prescription drugs, changes to the home, and lost time from work and household duties will reach $54.9 billion by 2020."

Among the intrinsic risk factors that are linked to falls in the elderly are comorbidities (such as diabetes, Parkinson’s disease, osteoporosis, history of stroke, arthritis, peripheral sensory deficit, malnutrition, arrhythmia, and orthostatic hypotension) and functional disabilities (such as reduced strength, vertigo, visual impairment, inappropriate footwear, incontinence, and the use of certain high-risk medications), the authors noted. Extrinsic risk factors include environmental considerations, such as the condition of the floor, cluttered areas, throw rugs, poor lighting, the lack of or poorly placed grab rails, noncollapsing bed rails, and intravenous equipment, they wrote.

Because the Centers for Medicare and Medicaid Services has placed the financial burden for inpatient falls in particular on hospitals by denying reimbursements for fall-related injuries to those institutions that have not followed evidence-based fall-prevention guidelines, the authors sought to determine whether medical evidence exists to support the effectiveness of fall-prevention strategies. Toward this end, they reviewed the available literature related to fall-prevention modalities "that are considered to be modifiable and, therefore, effective in fall prevention." These include medical interventions such as delirium prevention, nutrition, medications, and vision/eye care, as well as physical interventions, including bed rails, electronic bed sensors, appropriate bed and toilet seat height, footwear, flooring, identification bracelets, bed trapeze, grab rails, room and floor lighting, scheduled toileting, access to call light, bedside commode, unobstructed environment, and exercise and balance training.

With respect to prevention programs that combine multiple individual modalities, "our review of the literature reveals no conclusive medical evidence that multifactorial prevention programs in the acute hospital setting are effective," the authors wrote.

In one randomized, controlled trial comprising nearly 4,000 hospitalized patients in elderly care wards, no differences were found in fall frequency, injurious falls, or fractures between patients who spent 25 hours per week receiving targeted prevention support (fall risk assessments, education, walking aids, eyewear, environmental modifications, increased supervision, physiotherapy, and medication review and adjustments) and those in the usual care condition (BMJ 2008;336: 758-60). The authors attributed the finding to the short median duration of patient stay, and noted that similar programs have demonstrated efficacy in long-term care settings.

Of the individual, in-hospital, fall-prevention measures, addressing delirium was the only one supported by statistically significant evidence, the authors wrote. Multiple studies demonstrated a strong correlation between falls and delirium, supporting the early identification and management of the confusional state in the hospital, they stated. Efficacy studies of the delirium protocols of HELP (Hospital Elder Life Program) intervention, which focus on orientation, therapeutic activities, early mobilization, vision and hearing, oral volume repletion, and sleep enhancement, have noted a reduction in the development of delirium and in falls associated with the intervention. In one study, 95% of medical staff working in 29 hospitals that use the program noted a decrease in falls (N. Engl. J. Med. 2009;360: 2930-3). Even so, the authors wrote, "the literature is not adequate to support its consideration as a medical evidence-based guideline."

One surprising finding noted by the authors was the fact that the rate of falls in the hospital was only slightly greater than the rate in the home. "I would have imagined that inpatients who were in unfamiliar surroundings, often post operative and in heavily medicated states would have had a significantly higher rate of falls," Dr. Clyburn said in an interview. Also unexpected, he said, was the fact that some of the multimodal fall-prevention efforts and some of the "high-tech" measures, including alarmed beds, were not more effective.

Education regarding the prevalence and nature of inpatient falls – as well as large, controlled trials to evaluate preventative measures – are warranted, the authors wrote. "We must also be aware of the potential risks of enacting measures to prevent falls that may be counterproductive to patient recovery," they stated.

Dr. Clyburn disclosed financial relationships with Nimbic Systems and ConforMIS. Dr. Heydemann disclosed a financial relationship with Merck.

There is limited proof that any of the multifaceted or individualized programs designed to prevent falls in the elderly both inside and outside the hospital setting are effective, according to a comprehensive literature review.

Additionally, an assessment of existing fall-prevention techniques "indicates that many of these interventions were designed using expert opinion or statistical trends and that there is no conclusive medical evidence that any of them qualifies as an evidence-based guideline," wrote Dr. Terry A. Clyburn and Dr. John A. Heydemann of the University of Texas, Houston. The only exception, they noted, are interventions that address delirium (J. Am. Acad. Orthop. Surg. 2011;19: 402-9).

Falls are the leading cause of fatal and nonfatal injuries to older people in the United States. Approximately one-third of people aged 65 years or older and half of those aged 80 years or older fall at least once annually, and 3%-20% of hospital inpatients fall at least once during their stay, according to the authors. Given those statistics, they wrote, "the [Centers for Disease Control and Prevention] estimates that the direct and indirect cost of all fall-related injuries, including hospitalization, payments for physician and other professional services, medical equipment, prescription drugs, changes to the home, and lost time from work and household duties will reach $54.9 billion by 2020."

Among the intrinsic risk factors that are linked to falls in the elderly are comorbidities (such as diabetes, Parkinson’s disease, osteoporosis, history of stroke, arthritis, peripheral sensory deficit, malnutrition, arrhythmia, and orthostatic hypotension) and functional disabilities (such as reduced strength, vertigo, visual impairment, inappropriate footwear, incontinence, and the use of certain high-risk medications), the authors noted. Extrinsic risk factors include environmental considerations, such as the condition of the floor, cluttered areas, throw rugs, poor lighting, the lack of or poorly placed grab rails, noncollapsing bed rails, and intravenous equipment, they wrote.

Because the Centers for Medicare and Medicaid Services has placed the financial burden for inpatient falls in particular on hospitals by denying reimbursements for fall-related injuries to those institutions that have not followed evidence-based fall-prevention guidelines, the authors sought to determine whether medical evidence exists to support the effectiveness of fall-prevention strategies. Toward this end, they reviewed the available literature related to fall-prevention modalities "that are considered to be modifiable and, therefore, effective in fall prevention." These include medical interventions such as delirium prevention, nutrition, medications, and vision/eye care, as well as physical interventions, including bed rails, electronic bed sensors, appropriate bed and toilet seat height, footwear, flooring, identification bracelets, bed trapeze, grab rails, room and floor lighting, scheduled toileting, access to call light, bedside commode, unobstructed environment, and exercise and balance training.

With respect to prevention programs that combine multiple individual modalities, "our review of the literature reveals no conclusive medical evidence that multifactorial prevention programs in the acute hospital setting are effective," the authors wrote.

In one randomized, controlled trial comprising nearly 4,000 hospitalized patients in elderly care wards, no differences were found in fall frequency, injurious falls, or fractures between patients who spent 25 hours per week receiving targeted prevention support (fall risk assessments, education, walking aids, eyewear, environmental modifications, increased supervision, physiotherapy, and medication review and adjustments) and those in the usual care condition (BMJ 2008;336: 758-60). The authors attributed the finding to the short median duration of patient stay, and noted that similar programs have demonstrated efficacy in long-term care settings.

Of the individual, in-hospital, fall-prevention measures, addressing delirium was the only one supported by statistically significant evidence, the authors wrote. Multiple studies demonstrated a strong correlation between falls and delirium, supporting the early identification and management of the confusional state in the hospital, they stated. Efficacy studies of the delirium protocols of HELP (Hospital Elder Life Program) intervention, which focus on orientation, therapeutic activities, early mobilization, vision and hearing, oral volume repletion, and sleep enhancement, have noted a reduction in the development of delirium and in falls associated with the intervention. In one study, 95% of medical staff working in 29 hospitals that use the program noted a decrease in falls (N. Engl. J. Med. 2009;360: 2930-3). Even so, the authors wrote, "the literature is not adequate to support its consideration as a medical evidence-based guideline."

One surprising finding noted by the authors was the fact that the rate of falls in the hospital was only slightly greater than the rate in the home. "I would have imagined that inpatients who were in unfamiliar surroundings, often post operative and in heavily medicated states would have had a significantly higher rate of falls," Dr. Clyburn said in an interview. Also unexpected, he said, was the fact that some of the multimodal fall-prevention efforts and some of the "high-tech" measures, including alarmed beds, were not more effective.

Education regarding the prevalence and nature of inpatient falls – as well as large, controlled trials to evaluate preventative measures – are warranted, the authors wrote. "We must also be aware of the potential risks of enacting measures to prevent falls that may be counterproductive to patient recovery," they stated.

Dr. Clyburn disclosed financial relationships with Nimbic Systems and ConforMIS. Dr. Heydemann disclosed a financial relationship with Merck.

There is limited proof that any of the multifaceted or individualized programs designed to prevent falls in the elderly both inside and outside the hospital setting are effective, according to a comprehensive literature review.

Additionally, an assessment of existing fall-prevention techniques "indicates that many of these interventions were designed using expert opinion or statistical trends and that there is no conclusive medical evidence that any of them qualifies as an evidence-based guideline," wrote Dr. Terry A. Clyburn and Dr. John A. Heydemann of the University of Texas, Houston. The only exception, they noted, are interventions that address delirium (J. Am. Acad. Orthop. Surg. 2011;19: 402-9).

Falls are the leading cause of fatal and nonfatal injuries to older people in the United States. Approximately one-third of people aged 65 years or older and half of those aged 80 years or older fall at least once annually, and 3%-20% of hospital inpatients fall at least once during their stay, according to the authors. Given those statistics, they wrote, "the [Centers for Disease Control and Prevention] estimates that the direct and indirect cost of all fall-related injuries, including hospitalization, payments for physician and other professional services, medical equipment, prescription drugs, changes to the home, and lost time from work and household duties will reach $54.9 billion by 2020."

Among the intrinsic risk factors that are linked to falls in the elderly are comorbidities (such as diabetes, Parkinson’s disease, osteoporosis, history of stroke, arthritis, peripheral sensory deficit, malnutrition, arrhythmia, and orthostatic hypotension) and functional disabilities (such as reduced strength, vertigo, visual impairment, inappropriate footwear, incontinence, and the use of certain high-risk medications), the authors noted. Extrinsic risk factors include environmental considerations, such as the condition of the floor, cluttered areas, throw rugs, poor lighting, the lack of or poorly placed grab rails, noncollapsing bed rails, and intravenous equipment, they wrote.

Because the Centers for Medicare and Medicaid Services has placed the financial burden for inpatient falls in particular on hospitals by denying reimbursements for fall-related injuries to those institutions that have not followed evidence-based fall-prevention guidelines, the authors sought to determine whether medical evidence exists to support the effectiveness of fall-prevention strategies. Toward this end, they reviewed the available literature related to fall-prevention modalities "that are considered to be modifiable and, therefore, effective in fall prevention." These include medical interventions such as delirium prevention, nutrition, medications, and vision/eye care, as well as physical interventions, including bed rails, electronic bed sensors, appropriate bed and toilet seat height, footwear, flooring, identification bracelets, bed trapeze, grab rails, room and floor lighting, scheduled toileting, access to call light, bedside commode, unobstructed environment, and exercise and balance training.

With respect to prevention programs that combine multiple individual modalities, "our review of the literature reveals no conclusive medical evidence that multifactorial prevention programs in the acute hospital setting are effective," the authors wrote.

In one randomized, controlled trial comprising nearly 4,000 hospitalized patients in elderly care wards, no differences were found in fall frequency, injurious falls, or fractures between patients who spent 25 hours per week receiving targeted prevention support (fall risk assessments, education, walking aids, eyewear, environmental modifications, increased supervision, physiotherapy, and medication review and adjustments) and those in the usual care condition (BMJ 2008;336: 758-60). The authors attributed the finding to the short median duration of patient stay, and noted that similar programs have demonstrated efficacy in long-term care settings.

Of the individual, in-hospital, fall-prevention measures, addressing delirium was the only one supported by statistically significant evidence, the authors wrote. Multiple studies demonstrated a strong correlation between falls and delirium, supporting the early identification and management of the confusional state in the hospital, they stated. Efficacy studies of the delirium protocols of HELP (Hospital Elder Life Program) intervention, which focus on orientation, therapeutic activities, early mobilization, vision and hearing, oral volume repletion, and sleep enhancement, have noted a reduction in the development of delirium and in falls associated with the intervention. In one study, 95% of medical staff working in 29 hospitals that use the program noted a decrease in falls (N. Engl. J. Med. 2009;360: 2930-3). Even so, the authors wrote, "the literature is not adequate to support its consideration as a medical evidence-based guideline."

One surprising finding noted by the authors was the fact that the rate of falls in the hospital was only slightly greater than the rate in the home. "I would have imagined that inpatients who were in unfamiliar surroundings, often post operative and in heavily medicated states would have had a significantly higher rate of falls," Dr. Clyburn said in an interview. Also unexpected, he said, was the fact that some of the multimodal fall-prevention efforts and some of the "high-tech" measures, including alarmed beds, were not more effective.

Education regarding the prevalence and nature of inpatient falls – as well as large, controlled trials to evaluate preventative measures – are warranted, the authors wrote. "We must also be aware of the potential risks of enacting measures to prevent falls that may be counterproductive to patient recovery," they stated.

Dr. Clyburn disclosed financial relationships with Nimbic Systems and ConforMIS. Dr. Heydemann disclosed a financial relationship with Merck.

BOSTON – The only polymethylmethacrylate dermal filler approved by the Food and Drug Administration may be a safe and effective option for malar augmentation in patients seeking to reverse age-related volume loss to the outer upper cheek region, according to interim results from a multicenter study.

The synthetic, nonresorbable agent, Artefill, produced significant improvements in malar volume in 24 patients enrolled in a 5-year prospective study and received high patient satisfaction and physician-assessed aesthetic improvement scores at 6 and 12 months, reported Dr. Daniel C. Mills of the plastic surgery department at Loma Linda (Calif.) University at the annual meeting of the American Society for Aesthetic Plastic Surgery. "And so far, with 1.5 years of follow-up under our belt, there have been no safety issues."

To assess the safety and efficacy of the polymethylmethacrylate (PMMA)/bovine collagen filler as a malar implant, Dr. Mills and his colleagues from multiple sites across the country enrolled 24 patients seeking malar augmentation into the open-label investigation.

"Each patient received up to three injections supraperiosteally: a first injection of no more than 6 cc, followed by one or two touch-ups after a month until full correction was achieved, with no patient getting more than 8 cc of the filler," he said. "The mean total volume injected was 5.5 cc." The reason for the serial injections, he noted, was because "this is close to a permanent filler, so we start low to make sure we have the right amount, then go back and add more if necessary."

The study outcomes include baseline and post-treatment assessments (weeks 8, 26, 52, 104, and 260) of malar volume on a 5-point scale: investigator and patient global aesthetic improvement, safety data, patient satisfaction, and patient likelihood to recommend the procedure.

Of the 24 patients in the study, all but one reported being satisfied with the procedure at 8 weeks and 1 year post-injection, "and all of my patients said they had more volume fill as time went by," said Dr. Mills. "It’s worth noting that the [global aesthetic improvement] scores of the one patient who was not satisfied with the outcome did improve."

Overall, malar volume improved significantly. "We saw the lipoatrophy go up one grade across the board, and the physician-assessed aesthetic score improved 96%," Dr. Mills reported. Of the 23 patients who reported being satisfied with the outcome, "the satisfaction rating was uniformly very high and all of them said they would recommend the procedure to other patients."

To date, with close to 1.5 half years of follow-up data, no device-related adverse events or serious adverse events have been reported, said Dr. Mills. He stressed, however, that the agent being investigated is "totally different" than the black market PMMA that is available in other parts of the world.

"The compounded PMMA being used in some countries, such as Brazil and Venezuela, has caused a wide range of complications and resulted in a lot of bad press," he said. "The FDA-approved product that we’re investigating is ultrapure and very uniform."

Artefill was approved by the FDA in 2006 for the treatment of nasolabial folds around the mouth, and is the only FDA-approved filler with a documented durability over a 5-year period, said Dr. Mills.

The product is composed of PMMA microspheres and a water-based carrier gel containing bovine collagen, buffered isotonic water, lidocaine, phosphate buffer, and sodium chloride.

Unlike most of the soft-tissue dermal fillers on the market, the PMMA-based implant provides a permanent support structure for wrinkle correction. "As the bovine collagen degrades over the course of a few weeks postinjection, the PMMA is encapsulated by the patient’s own collagen to stabilize the implant, resulting in continued [aesthetic] improvement over time," he said.

The study was sponsored by Suneva Medical. Dr. Mills disclosed a financial relationship with Allergan.

BOSTON – The only polymethylmethacrylate dermal filler approved by the Food and Drug Administration may be a safe and effective option for malar augmentation in patients seeking to reverse age-related volume loss to the outer upper cheek region, according to interim results from a multicenter study.

The synthetic, nonresorbable agent, Artefill, produced significant improvements in malar volume in 24 patients enrolled in a 5-year prospective study and received high patient satisfaction and physician-assessed aesthetic improvement scores at 6 and 12 months, reported Dr. Daniel C. Mills of the plastic surgery department at Loma Linda (Calif.) University at the annual meeting of the American Society for Aesthetic Plastic Surgery. "And so far, with 1.5 years of follow-up under our belt, there have been no safety issues."

To assess the safety and efficacy of the polymethylmethacrylate (PMMA)/bovine collagen filler as a malar implant, Dr. Mills and his colleagues from multiple sites across the country enrolled 24 patients seeking malar augmentation into the open-label investigation.

"Each patient received up to three injections supraperiosteally: a first injection of no more than 6 cc, followed by one or two touch-ups after a month until full correction was achieved, with no patient getting more than 8 cc of the filler," he said. "The mean total volume injected was 5.5 cc." The reason for the serial injections, he noted, was because "this is close to a permanent filler, so we start low to make sure we have the right amount, then go back and add more if necessary."

The study outcomes include baseline and post-treatment assessments (weeks 8, 26, 52, 104, and 260) of malar volume on a 5-point scale: investigator and patient global aesthetic improvement, safety data, patient satisfaction, and patient likelihood to recommend the procedure.

Of the 24 patients in the study, all but one reported being satisfied with the procedure at 8 weeks and 1 year post-injection, "and all of my patients said they had more volume fill as time went by," said Dr. Mills. "It’s worth noting that the [global aesthetic improvement] scores of the one patient who was not satisfied with the outcome did improve."

Overall, malar volume improved significantly. "We saw the lipoatrophy go up one grade across the board, and the physician-assessed aesthetic score improved 96%," Dr. Mills reported. Of the 23 patients who reported being satisfied with the outcome, "the satisfaction rating was uniformly very high and all of them said they would recommend the procedure to other patients."

To date, with close to 1.5 half years of follow-up data, no device-related adverse events or serious adverse events have been reported, said Dr. Mills. He stressed, however, that the agent being investigated is "totally different" than the black market PMMA that is available in other parts of the world.

"The compounded PMMA being used in some countries, such as Brazil and Venezuela, has caused a wide range of complications and resulted in a lot of bad press," he said. "The FDA-approved product that we’re investigating is ultrapure and very uniform."

Artefill was approved by the FDA in 2006 for the treatment of nasolabial folds around the mouth, and is the only FDA-approved filler with a documented durability over a 5-year period, said Dr. Mills.

The product is composed of PMMA microspheres and a water-based carrier gel containing bovine collagen, buffered isotonic water, lidocaine, phosphate buffer, and sodium chloride.

Unlike most of the soft-tissue dermal fillers on the market, the PMMA-based implant provides a permanent support structure for wrinkle correction. "As the bovine collagen degrades over the course of a few weeks postinjection, the PMMA is encapsulated by the patient’s own collagen to stabilize the implant, resulting in continued [aesthetic] improvement over time," he said.

The study was sponsored by Suneva Medical. Dr. Mills disclosed a financial relationship with Allergan.

BOSTON – The only polymethylmethacrylate dermal filler approved by the Food and Drug Administration may be a safe and effective option for malar augmentation in patients seeking to reverse age-related volume loss to the outer upper cheek region, according to interim results from a multicenter study.

The synthetic, nonresorbable agent, Artefill, produced significant improvements in malar volume in 24 patients enrolled in a 5-year prospective study and received high patient satisfaction and physician-assessed aesthetic improvement scores at 6 and 12 months, reported Dr. Daniel C. Mills of the plastic surgery department at Loma Linda (Calif.) University at the annual meeting of the American Society for Aesthetic Plastic Surgery. "And so far, with 1.5 years of follow-up under our belt, there have been no safety issues."

To assess the safety and efficacy of the polymethylmethacrylate (PMMA)/bovine collagen filler as a malar implant, Dr. Mills and his colleagues from multiple sites across the country enrolled 24 patients seeking malar augmentation into the open-label investigation.

"Each patient received up to three injections supraperiosteally: a first injection of no more than 6 cc, followed by one or two touch-ups after a month until full correction was achieved, with no patient getting more than 8 cc of the filler," he said. "The mean total volume injected was 5.5 cc." The reason for the serial injections, he noted, was because "this is close to a permanent filler, so we start low to make sure we have the right amount, then go back and add more if necessary."

The study outcomes include baseline and post-treatment assessments (weeks 8, 26, 52, 104, and 260) of malar volume on a 5-point scale: investigator and patient global aesthetic improvement, safety data, patient satisfaction, and patient likelihood to recommend the procedure.

Of the 24 patients in the study, all but one reported being satisfied with the procedure at 8 weeks and 1 year post-injection, "and all of my patients said they had more volume fill as time went by," said Dr. Mills. "It’s worth noting that the [global aesthetic improvement] scores of the one patient who was not satisfied with the outcome did improve."

Overall, malar volume improved significantly. "We saw the lipoatrophy go up one grade across the board, and the physician-assessed aesthetic score improved 96%," Dr. Mills reported. Of the 23 patients who reported being satisfied with the outcome, "the satisfaction rating was uniformly very high and all of them said they would recommend the procedure to other patients."

To date, with close to 1.5 half years of follow-up data, no device-related adverse events or serious adverse events have been reported, said Dr. Mills. He stressed, however, that the agent being investigated is "totally different" than the black market PMMA that is available in other parts of the world.

"The compounded PMMA being used in some countries, such as Brazil and Venezuela, has caused a wide range of complications and resulted in a lot of bad press," he said. "The FDA-approved product that we’re investigating is ultrapure and very uniform."

Artefill was approved by the FDA in 2006 for the treatment of nasolabial folds around the mouth, and is the only FDA-approved filler with a documented durability over a 5-year period, said Dr. Mills.

The product is composed of PMMA microspheres and a water-based carrier gel containing bovine collagen, buffered isotonic water, lidocaine, phosphate buffer, and sodium chloride.

Unlike most of the soft-tissue dermal fillers on the market, the PMMA-based implant provides a permanent support structure for wrinkle correction. "As the bovine collagen degrades over the course of a few weeks postinjection, the PMMA is encapsulated by the patient’s own collagen to stabilize the implant, resulting in continued [aesthetic] improvement over time," he said.

The study was sponsored by Suneva Medical. Dr. Mills disclosed a financial relationship with Allergan.

LONDON – The quadrivalent human papillomavirus vaccine is safe for patients with systemic lupus erythematosus and should be considered for women with inactive disease who receive stable doses of standard immunomodulatory therapy, according to data presented by Dr. Chi Chiu Mok at the annual European Congress of Rheumatology.

Multiple studies have demonstrated higher rates of persistent HPV infections and precancerous lesions in women with SLE, compared with women in the general population, said Dr. Mok. Although the increased risk of HPV infection suggests that SLE patients would be good candidates for immunization against the virus, it has been hypothesized that immune dysfunction related to SLE or to treatment-induced immune suppression may prevent patients with the condition from being able to produce an effective immune response to the vaccine, and could possibly lead to disease flares or the production of new autoantibodies, he explained.

The recombinant quadrivalent HPV vaccine (Gardisil) provides protection against infection of the HPV serotypes 6, 11, 16, and 18, and it has been demonstrated to be safe and efficacious in female patients in the general population aged 9-26 years, according to Dr. Mok. Along with colleagues at Tuen Mun Hospital in Hong Kong, Dr. Mok sought to evaluate the safety and immunogenicity of the vaccine in a cohort of SLE patients.

Toward this end, the investigators recruited 50 female patients aged 18-35 years who fulfilled at least four American College of Rheumatology criteria for SLE, and who had received a stable dose of prednisolone or other immunosuppressive agent within the previous 3 months, to participate in the prospective investigation. The mean age of the study participants was 25.8 years, and their mean disease duration was 6.6 years, he reported.

All of the study subjects received intramuscular injections of the vaccine and were evaluated at baseline and at 2 and 6 months post vaccination via the SLEDAI (SLE Disease Activity Index), PGA (Physicians’ Global Assessment), and the SELENA (Safety of Estrogens in Lupus Erythematosus – National Assessment) disease flare index. Additionally, complement levels (C3 and C4) and anti-dsDNA (anti–double-stranded DNA) titers were assessed and patient-reported adverse events were recorded at the same time points, said Dr. Mok. With respect to baseline disease characteristics, the median SLEDAI score was 4; the mean anti-dsDNA titers, C3 levels, and C4 levels were 139 IU/mL, 0.81 g/dL, and 0.15 g/dL, respectively; and none of the patients had SELENA flares at baseline compared to preceding status, he said.

There were no significant changes in anti-dsDNA titers, C3 or C4 levels, or SLEDAI and PGA scores at any of the time points, Dr. Mok reported. "There were three mild to moderate mucocutaneous flares during the study period (one at month 2 and two at month 6), all of which were controlled with usual treatment," he said. "It’s unclear whether a causal relationship exists between the vaccination and the three lupus flares, but the rate of flares [0.08 per patient per year] was lower than the rate observed in our lupus cohort during the previous 5 years [0.10 per patient per year], and no other adverse events associated with the vaccination were reported."

The study findings indicate that the vaccine is safe in SLE patients, and the lack of significant alterations in the various SLE antibody measures suggests it does not induce an increased incidence of lupus flares, Dr. Mok stated. Considering the increased susceptibility to HPV infection in these patients and the link between HPV infection and cervical cancer, "vaccination is an important consideration in protecting them," he said.

Dr. Mok disclosed having no financial conflicts of interest.

LONDON – The quadrivalent human papillomavirus vaccine is safe for patients with systemic lupus erythematosus and should be considered for women with inactive disease who receive stable doses of standard immunomodulatory therapy, according to data presented by Dr. Chi Chiu Mok at the annual European Congress of Rheumatology.

Multiple studies have demonstrated higher rates of persistent HPV infections and precancerous lesions in women with SLE, compared with women in the general population, said Dr. Mok. Although the increased risk of HPV infection suggests that SLE patients would be good candidates for immunization against the virus, it has been hypothesized that immune dysfunction related to SLE or to treatment-induced immune suppression may prevent patients with the condition from being able to produce an effective immune response to the vaccine, and could possibly lead to disease flares or the production of new autoantibodies, he explained.

The recombinant quadrivalent HPV vaccine (Gardisil) provides protection against infection of the HPV serotypes 6, 11, 16, and 18, and it has been demonstrated to be safe and efficacious in female patients in the general population aged 9-26 years, according to Dr. Mok. Along with colleagues at Tuen Mun Hospital in Hong Kong, Dr. Mok sought to evaluate the safety and immunogenicity of the vaccine in a cohort of SLE patients.

Toward this end, the investigators recruited 50 female patients aged 18-35 years who fulfilled at least four American College of Rheumatology criteria for SLE, and who had received a stable dose of prednisolone or other immunosuppressive agent within the previous 3 months, to participate in the prospective investigation. The mean age of the study participants was 25.8 years, and their mean disease duration was 6.6 years, he reported.

All of the study subjects received intramuscular injections of the vaccine and were evaluated at baseline and at 2 and 6 months post vaccination via the SLEDAI (SLE Disease Activity Index), PGA (Physicians’ Global Assessment), and the SELENA (Safety of Estrogens in Lupus Erythematosus – National Assessment) disease flare index. Additionally, complement levels (C3 and C4) and anti-dsDNA (anti–double-stranded DNA) titers were assessed and patient-reported adverse events were recorded at the same time points, said Dr. Mok. With respect to baseline disease characteristics, the median SLEDAI score was 4; the mean anti-dsDNA titers, C3 levels, and C4 levels were 139 IU/mL, 0.81 g/dL, and 0.15 g/dL, respectively; and none of the patients had SELENA flares at baseline compared to preceding status, he said.

There were no significant changes in anti-dsDNA titers, C3 or C4 levels, or SLEDAI and PGA scores at any of the time points, Dr. Mok reported. "There were three mild to moderate mucocutaneous flares during the study period (one at month 2 and two at month 6), all of which were controlled with usual treatment," he said. "It’s unclear whether a causal relationship exists between the vaccination and the three lupus flares, but the rate of flares [0.08 per patient per year] was lower than the rate observed in our lupus cohort during the previous 5 years [0.10 per patient per year], and no other adverse events associated with the vaccination were reported."

The study findings indicate that the vaccine is safe in SLE patients, and the lack of significant alterations in the various SLE antibody measures suggests it does not induce an increased incidence of lupus flares, Dr. Mok stated. Considering the increased susceptibility to HPV infection in these patients and the link between HPV infection and cervical cancer, "vaccination is an important consideration in protecting them," he said.

Dr. Mok disclosed having no financial conflicts of interest.

LONDON – The quadrivalent human papillomavirus vaccine is safe for patients with systemic lupus erythematosus and should be considered for women with inactive disease who receive stable doses of standard immunomodulatory therapy, according to data presented by Dr. Chi Chiu Mok at the annual European Congress of Rheumatology.

Multiple studies have demonstrated higher rates of persistent HPV infections and precancerous lesions in women with SLE, compared with women in the general population, said Dr. Mok. Although the increased risk of HPV infection suggests that SLE patients would be good candidates for immunization against the virus, it has been hypothesized that immune dysfunction related to SLE or to treatment-induced immune suppression may prevent patients with the condition from being able to produce an effective immune response to the vaccine, and could possibly lead to disease flares or the production of new autoantibodies, he explained.

The recombinant quadrivalent HPV vaccine (Gardisil) provides protection against infection of the HPV serotypes 6, 11, 16, and 18, and it has been demonstrated to be safe and efficacious in female patients in the general population aged 9-26 years, according to Dr. Mok. Along with colleagues at Tuen Mun Hospital in Hong Kong, Dr. Mok sought to evaluate the safety and immunogenicity of the vaccine in a cohort of SLE patients.

Toward this end, the investigators recruited 50 female patients aged 18-35 years who fulfilled at least four American College of Rheumatology criteria for SLE, and who had received a stable dose of prednisolone or other immunosuppressive agent within the previous 3 months, to participate in the prospective investigation. The mean age of the study participants was 25.8 years, and their mean disease duration was 6.6 years, he reported.

All of the study subjects received intramuscular injections of the vaccine and were evaluated at baseline and at 2 and 6 months post vaccination via the SLEDAI (SLE Disease Activity Index), PGA (Physicians’ Global Assessment), and the SELENA (Safety of Estrogens in Lupus Erythematosus – National Assessment) disease flare index. Additionally, complement levels (C3 and C4) and anti-dsDNA (anti–double-stranded DNA) titers were assessed and patient-reported adverse events were recorded at the same time points, said Dr. Mok. With respect to baseline disease characteristics, the median SLEDAI score was 4; the mean anti-dsDNA titers, C3 levels, and C4 levels were 139 IU/mL, 0.81 g/dL, and 0.15 g/dL, respectively; and none of the patients had SELENA flares at baseline compared to preceding status, he said.

There were no significant changes in anti-dsDNA titers, C3 or C4 levels, or SLEDAI and PGA scores at any of the time points, Dr. Mok reported. "There were three mild to moderate mucocutaneous flares during the study period (one at month 2 and two at month 6), all of which were controlled with usual treatment," he said. "It’s unclear whether a causal relationship exists between the vaccination and the three lupus flares, but the rate of flares [0.08 per patient per year] was lower than the rate observed in our lupus cohort during the previous 5 years [0.10 per patient per year], and no other adverse events associated with the vaccination were reported."

The study findings indicate that the vaccine is safe in SLE patients, and the lack of significant alterations in the various SLE antibody measures suggests it does not induce an increased incidence of lupus flares, Dr. Mok stated. Considering the increased susceptibility to HPV infection in these patients and the link between HPV infection and cervical cancer, "vaccination is an important consideration in protecting them," he said.

Dr. Mok disclosed having no financial conflicts of interest.

LONDON – The quadrivalent human papillomavirus vaccine is safe for patients with systemic lupus erythematosus and should be considered for women with inactive disease who receive stable doses of standard immunomodulatory therapy, according to data presented by Dr. Chi Chiu Mok at the annual European Congress of Rheumatology.

Multiple studies have demonstrated higher rates of persistent HPV infections and precancerous lesions in women with SLE, compared with women in the general population, said Dr. Mok. Although the increased risk of HPV infection suggests that SLE patients would be good candidates for immunization against the virus, it has been hypothesized that immune dysfunction related to SLE or to treatment-induced immune suppression may prevent patients with the condition from being able to produce an effective immune response to the vaccine, and could possibly lead to disease flares or the production of new autoantibodies, he explained.

The recombinant quadrivalent HPV vaccine (Gardisil) provides protection against infection of the HPV serotypes 6, 11, 16, and 18, and it has been demonstrated to be safe and efficacious in female patients in the general population aged 9-26 years, according to Dr. Mok. Along with colleagues at Tuen Mun Hospital in Hong Kong, Dr. Mok sought to evaluate the safety and immunogenicity of the vaccine in a cohort of SLE patients.

Toward this end, the investigators recruited 50 female patients aged 18-35 years who fulfilled at least four American College of Rheumatology criteria for SLE, and who had received a stable dose of prednisolone or other immunosuppressive agent within the previous 3 months, to participate in the prospective investigation. The mean age of the study participants was 25.8 years, and their mean disease duration was 6.6 years, he reported.

All of the study subjects received intramuscular injections of the vaccine and were evaluated at baseline and at 2 and 6 months post vaccination via the SLEDAI (SLE Disease Activity Index), PGA (Physicians’ Global Assessment), and the SELENA (Safety of Estrogens in Lupus Erythematosus – National Assessment) disease flare index. Additionally, complement levels (C3 and C4) and anti-dsDNA (anti–double-stranded DNA) titers were assessed and patient-reported adverse events were recorded at the same time points, said Dr. Mok. With respect to baseline disease characteristics, the median SLEDAI score was 4; the mean anti-dsDNA titers, C3 levels, and C4 levels were 139 IU/mL, 0.81 g/dL, and 0.15 g/dL, respectively; and none of the patients had SELENA flares at baseline compared to preceding status, he said.

There were no significant changes in anti-dsDNA titers, C3 or C4 levels, or SLEDAI and PGA scores at any of the time points, Dr. Mok reported. "There were three mild to moderate mucocutaneous flares during the study period (one at month 2 and two at month 6), all of which were controlled with usual treatment," he said. "It’s unclear whether a causal relationship exists between the vaccination and the three lupus flares, but the rate of flares [0.08 per patient per year] was lower than the rate observed in our lupus cohort during the previous 5 years [0.10 per patient per year], and no other adverse events associated with the vaccination were reported."

The study findings indicate that the vaccine is safe in SLE patients, and the lack of significant alterations in the various SLE antibody measures suggests it does not induce an increased incidence of lupus flares, Dr. Mok stated. Considering the increased susceptibility to HPV infection in these patients and the link between HPV infection and cervical cancer, "vaccination is an important consideration in protecting them," he said.

Dr. Mok disclosed having no financial conflicts of interest.

LONDON – The quadrivalent human papillomavirus vaccine is safe for patients with systemic lupus erythematosus and should be considered for women with inactive disease who receive stable doses of standard immunomodulatory therapy, according to data presented by Dr. Chi Chiu Mok at the annual European Congress of Rheumatology.

Multiple studies have demonstrated higher rates of persistent HPV infections and precancerous lesions in women with SLE, compared with women in the general population, said Dr. Mok. Although the increased risk of HPV infection suggests that SLE patients would be good candidates for immunization against the virus, it has been hypothesized that immune dysfunction related to SLE or to treatment-induced immune suppression may prevent patients with the condition from being able to produce an effective immune response to the vaccine, and could possibly lead to disease flares or the production of new autoantibodies, he explained.

The recombinant quadrivalent HPV vaccine (Gardisil) provides protection against infection of the HPV serotypes 6, 11, 16, and 18, and it has been demonstrated to be safe and efficacious in female patients in the general population aged 9-26 years, according to Dr. Mok. Along with colleagues at Tuen Mun Hospital in Hong Kong, Dr. Mok sought to evaluate the safety and immunogenicity of the vaccine in a cohort of SLE patients.

Toward this end, the investigators recruited 50 female patients aged 18-35 years who fulfilled at least four American College of Rheumatology criteria for SLE, and who had received a stable dose of prednisolone or other immunosuppressive agent within the previous 3 months, to participate in the prospective investigation. The mean age of the study participants was 25.8 years, and their mean disease duration was 6.6 years, he reported.

All of the study subjects received intramuscular injections of the vaccine and were evaluated at baseline and at 2 and 6 months post vaccination via the SLEDAI (SLE Disease Activity Index), PGA (Physicians’ Global Assessment), and the SELENA (Safety of Estrogens in Lupus Erythematosus – National Assessment) disease flare index. Additionally, complement levels (C3 and C4) and anti-dsDNA (anti–double-stranded DNA) titers were assessed and patient-reported adverse events were recorded at the same time points, said Dr. Mok. With respect to baseline disease characteristics, the median SLEDAI score was 4; the mean anti-dsDNA titers, C3 levels, and C4 levels were 139 IU/mL, 0.81 g/dL, and 0.15 g/dL, respectively; and none of the patients had SELENA flares at baseline compared to preceding status, he said.

There were no significant changes in anti-dsDNA titers, C3 or C4 levels, or SLEDAI and PGA scores at any of the time points, Dr. Mok reported. "There were three mild to moderate mucocutaneous flares during the study period (one at month 2 and two at month 6), all of which were controlled with usual treatment," he said. "It’s unclear whether a causal relationship exists between the vaccination and the three lupus flares, but the rate of flares [0.08 per patient per year] was lower than the rate observed in our lupus cohort during the previous 5 years [0.10 per patient per year], and no other adverse events associated with the vaccination were reported."

The study findings indicate that the vaccine is safe in SLE patients, and the lack of significant alterations in the various SLE antibody measures suggests it does not induce an increased incidence of lupus flares, Dr. Mok stated. Considering the increased susceptibility to HPV infection in these patients and the link between HPV infection and cervical cancer, "vaccination is an important consideration in protecting them," he said.

Dr. Mok disclosed having no financial conflicts of interest.

LONDON – The quadrivalent human papillomavirus vaccine is safe for patients with systemic lupus erythematosus and should be considered for women with inactive disease who receive stable doses of standard immunomodulatory therapy, according to data presented by Dr. Chi Chiu Mok at the annual European Congress of Rheumatology.

Multiple studies have demonstrated higher rates of persistent HPV infections and precancerous lesions in women with SLE, compared with women in the general population, said Dr. Mok. Although the increased risk of HPV infection suggests that SLE patients would be good candidates for immunization against the virus, it has been hypothesized that immune dysfunction related to SLE or to treatment-induced immune suppression may prevent patients with the condition from being able to produce an effective immune response to the vaccine, and could possibly lead to disease flares or the production of new autoantibodies, he explained.

The recombinant quadrivalent HPV vaccine (Gardisil) provides protection against infection of the HPV serotypes 6, 11, 16, and 18, and it has been demonstrated to be safe and efficacious in female patients in the general population aged 9-26 years, according to Dr. Mok. Along with colleagues at Tuen Mun Hospital in Hong Kong, Dr. Mok sought to evaluate the safety and immunogenicity of the vaccine in a cohort of SLE patients.

Toward this end, the investigators recruited 50 female patients aged 18-35 years who fulfilled at least four American College of Rheumatology criteria for SLE, and who had received a stable dose of prednisolone or other immunosuppressive agent within the previous 3 months, to participate in the prospective investigation. The mean age of the study participants was 25.8 years, and their mean disease duration was 6.6 years, he reported.

All of the study subjects received intramuscular injections of the vaccine and were evaluated at baseline and at 2 and 6 months post vaccination via the SLEDAI (SLE Disease Activity Index), PGA (Physicians’ Global Assessment), and the SELENA (Safety of Estrogens in Lupus Erythematosus – National Assessment) disease flare index. Additionally, complement levels (C3 and C4) and anti-dsDNA (anti–double-stranded DNA) titers were assessed and patient-reported adverse events were recorded at the same time points, said Dr. Mok. With respect to baseline disease characteristics, the median SLEDAI score was 4; the mean anti-dsDNA titers, C3 levels, and C4 levels were 139 IU/mL, 0.81 g/dL, and 0.15 g/dL, respectively; and none of the patients had SELENA flares at baseline compared to preceding status, he said.

There were no significant changes in anti-dsDNA titers, C3 or C4 levels, or SLEDAI and PGA scores at any of the time points, Dr. Mok reported. "There were three mild to moderate mucocutaneous flares during the study period (one at month 2 and two at month 6), all of which were controlled with usual treatment," he said. "It’s unclear whether a causal relationship exists between the vaccination and the three lupus flares, but the rate of flares [0.08 per patient per year] was lower than the rate observed in our lupus cohort during the previous 5 years [0.10 per patient per year], and no other adverse events associated with the vaccination were reported."

The study findings indicate that the vaccine is safe in SLE patients, and the lack of significant alterations in the various SLE antibody measures suggests it does not induce an increased incidence of lupus flares, Dr. Mok stated. Considering the increased susceptibility to HPV infection in these patients and the link between HPV infection and cervical cancer, "vaccination is an important consideration in protecting them," he said.

Dr. Mok disclosed having no financial conflicts of interest.

LONDON – The quadrivalent human papillomavirus vaccine is safe for patients with systemic lupus erythematosus and should be considered for women with inactive disease who receive stable doses of standard immunomodulatory therapy, according to data presented by Dr. Chi Chiu Mok at the annual European Congress of Rheumatology.

Multiple studies have demonstrated higher rates of persistent HPV infections and precancerous lesions in women with SLE, compared with women in the general population, said Dr. Mok. Although the increased risk of HPV infection suggests that SLE patients would be good candidates for immunization against the virus, it has been hypothesized that immune dysfunction related to SLE or to treatment-induced immune suppression may prevent patients with the condition from being able to produce an effective immune response to the vaccine, and could possibly lead to disease flares or the production of new autoantibodies, he explained.

The recombinant quadrivalent HPV vaccine (Gardisil) provides protection against infection of the HPV serotypes 6, 11, 16, and 18, and it has been demonstrated to be safe and efficacious in female patients in the general population aged 9-26 years, according to Dr. Mok. Along with colleagues at Tuen Mun Hospital in Hong Kong, Dr. Mok sought to evaluate the safety and immunogenicity of the vaccine in a cohort of SLE patients.

Toward this end, the investigators recruited 50 female patients aged 18-35 years who fulfilled at least four American College of Rheumatology criteria for SLE, and who had received a stable dose of prednisolone or other immunosuppressive agent within the previous 3 months, to participate in the prospective investigation. The mean age of the study participants was 25.8 years, and their mean disease duration was 6.6 years, he reported.

All of the study subjects received intramuscular injections of the vaccine and were evaluated at baseline and at 2 and 6 months post vaccination via the SLEDAI (SLE Disease Activity Index), PGA (Physicians’ Global Assessment), and the SELENA (Safety of Estrogens in Lupus Erythematosus – National Assessment) disease flare index. Additionally, complement levels (C3 and C4) and anti-dsDNA (anti–double-stranded DNA) titers were assessed and patient-reported adverse events were recorded at the same time points, said Dr. Mok. With respect to baseline disease characteristics, the median SLEDAI score was 4; the mean anti-dsDNA titers, C3 levels, and C4 levels were 139 IU/mL, 0.81 g/dL, and 0.15 g/dL, respectively; and none of the patients had SELENA flares at baseline compared to preceding status, he said.

There were no significant changes in anti-dsDNA titers, C3 or C4 levels, or SLEDAI and PGA scores at any of the time points, Dr. Mok reported. "There were three mild to moderate mucocutaneous flares during the study period (one at month 2 and two at month 6), all of which were controlled with usual treatment," he said. "It’s unclear whether a causal relationship exists between the vaccination and the three lupus flares, but the rate of flares [0.08 per patient per year] was lower than the rate observed in our lupus cohort during the previous 5 years [0.10 per patient per year], and no other adverse events associated with the vaccination were reported."

The study findings indicate that the vaccine is safe in SLE patients, and the lack of significant alterations in the various SLE antibody measures suggests it does not induce an increased incidence of lupus flares, Dr. Mok stated. Considering the increased susceptibility to HPV infection in these patients and the link between HPV infection and cervical cancer, "vaccination is an important consideration in protecting them," he said.

Dr. Mok disclosed having no financial conflicts of interest.

LONDON – The quadrivalent human papillomavirus vaccine is safe for patients with systemic lupus erythematosus and should be considered for women with inactive disease who receive stable doses of standard immunomodulatory therapy, according to data presented by Dr. Chi Chiu Mok at the annual European Congress of Rheumatology.

Multiple studies have demonstrated higher rates of persistent HPV infections and precancerous lesions in women with SLE, compared with women in the general population, said Dr. Mok. Although the increased risk of HPV infection suggests that SLE patients would be good candidates for immunization against the virus, it has been hypothesized that immune dysfunction related to SLE or to treatment-induced immune suppression may prevent patients with the condition from being able to produce an effective immune response to the vaccine, and could possibly lead to disease flares or the production of new autoantibodies, he explained.

The recombinant quadrivalent HPV vaccine (Gardisil) provides protection against infection of the HPV serotypes 6, 11, 16, and 18, and it has been demonstrated to be safe and efficacious in female patients in the general population aged 9-26 years, according to Dr. Mok. Along with colleagues at Tuen Mun Hospital in Hong Kong, Dr. Mok sought to evaluate the safety and immunogenicity of the vaccine in a cohort of SLE patients.

Toward this end, the investigators recruited 50 female patients aged 18-35 years who fulfilled at least four American College of Rheumatology criteria for SLE, and who had received a stable dose of prednisolone or other immunosuppressive agent within the previous 3 months, to participate in the prospective investigation. The mean age of the study participants was 25.8 years, and their mean disease duration was 6.6 years, he reported.

All of the study subjects received intramuscular injections of the vaccine and were evaluated at baseline and at 2 and 6 months post vaccination via the SLEDAI (SLE Disease Activity Index), PGA (Physicians’ Global Assessment), and the SELENA (Safety of Estrogens in Lupus Erythematosus – National Assessment) disease flare index. Additionally, complement levels (C3 and C4) and anti-dsDNA (anti–double-stranded DNA) titers were assessed and patient-reported adverse events were recorded at the same time points, said Dr. Mok. With respect to baseline disease characteristics, the median SLEDAI score was 4; the mean anti-dsDNA titers, C3 levels, and C4 levels were 139 IU/mL, 0.81 g/dL, and 0.15 g/dL, respectively; and none of the patients had SELENA flares at baseline compared to preceding status, he said.

There were no significant changes in anti-dsDNA titers, C3 or C4 levels, or SLEDAI and PGA scores at any of the time points, Dr. Mok reported. "There were three mild to moderate mucocutaneous flares during the study period (one at month 2 and two at month 6), all of which were controlled with usual treatment," he said. "It’s unclear whether a causal relationship exists between the vaccination and the three lupus flares, but the rate of flares [0.08 per patient per year] was lower than the rate observed in our lupus cohort during the previous 5 years [0.10 per patient per year], and no other adverse events associated with the vaccination were reported."

The study findings indicate that the vaccine is safe in SLE patients, and the lack of significant alterations in the various SLE antibody measures suggests it does not induce an increased incidence of lupus flares, Dr. Mok stated. Considering the increased susceptibility to HPV infection in these patients and the link between HPV infection and cervical cancer, "vaccination is an important consideration in protecting them," he said.

Dr. Mok disclosed having no financial conflicts of interest.

LONDON – The quadrivalent human papillomavirus vaccine is safe for patients with systemic lupus erythematosus and should be considered for women with inactive disease who receive stable doses of standard immunomodulatory therapy, according to data presented by Dr. Chi Chiu Mok at the annual European Congress of Rheumatology.

Multiple studies have demonstrated higher rates of persistent HPV infections and precancerous lesions in women with SLE, compared with women in the general population, said Dr. Mok. Although the increased risk of HPV infection suggests that SLE patients would be good candidates for immunization against the virus, it has been hypothesized that immune dysfunction related to SLE or to treatment-induced immune suppression may prevent patients with the condition from being able to produce an effective immune response to the vaccine, and could possibly lead to disease flares or the production of new autoantibodies, he explained.

The recombinant quadrivalent HPV vaccine (Gardisil) provides protection against infection of the HPV serotypes 6, 11, 16, and 18, and it has been demonstrated to be safe and efficacious in female patients in the general population aged 9-26 years, according to Dr. Mok. Along with colleagues at Tuen Mun Hospital in Hong Kong, Dr. Mok sought to evaluate the safety and immunogenicity of the vaccine in a cohort of SLE patients.

Toward this end, the investigators recruited 50 female patients aged 18-35 years who fulfilled at least four American College of Rheumatology criteria for SLE, and who had received a stable dose of prednisolone or other immunosuppressive agent within the previous 3 months, to participate in the prospective investigation. The mean age of the study participants was 25.8 years, and their mean disease duration was 6.6 years, he reported.

All of the study subjects received intramuscular injections of the vaccine and were evaluated at baseline and at 2 and 6 months post vaccination via the SLEDAI (SLE Disease Activity Index), PGA (Physicians’ Global Assessment), and the SELENA (Safety of Estrogens in Lupus Erythematosus – National Assessment) disease flare index. Additionally, complement levels (C3 and C4) and anti-dsDNA (anti–double-stranded DNA) titers were assessed and patient-reported adverse events were recorded at the same time points, said Dr. Mok. With respect to baseline disease characteristics, the median SLEDAI score was 4; the mean anti-dsDNA titers, C3 levels, and C4 levels were 139 IU/mL, 0.81 g/dL, and 0.15 g/dL, respectively; and none of the patients had SELENA flares at baseline compared to preceding status, he said.

There were no significant changes in anti-dsDNA titers, C3 or C4 levels, or SLEDAI and PGA scores at any of the time points, Dr. Mok reported. "There were three mild to moderate mucocutaneous flares during the study period (one at month 2 and two at month 6), all of which were controlled with usual treatment," he said. "It’s unclear whether a causal relationship exists between the vaccination and the three lupus flares, but the rate of flares [0.08 per patient per year] was lower than the rate observed in our lupus cohort during the previous 5 years [0.10 per patient per year], and no other adverse events associated with the vaccination were reported."

The study findings indicate that the vaccine is safe in SLE patients, and the lack of significant alterations in the various SLE antibody measures suggests it does not induce an increased incidence of lupus flares, Dr. Mok stated. Considering the increased susceptibility to HPV infection in these patients and the link between HPV infection and cervical cancer, "vaccination is an important consideration in protecting them," he said.

Dr. Mok disclosed having no financial conflicts of interest.