Sherry Boschert

LOS ANGELES – Evidence from a preliminary study suggests that the arteriopathy called fibromuscular dysplasia appears differently in children than in adults.

In fact, what most neurologists diagnose as fibromuscular dysplasia in children with arterial ischemic stroke might not be fibromuscular dysplasia at all, but is more likely to be transient cerebral arteriopathy (TCA) of childhood, Dr. Adam Kirton said at the conference.

Little is know about the causes of arteriopathy, the most common cause of childhood arterial ischemic stroke. One cause is fibromuscular dysplasia, a group of idiopathic, noninflammatory arteriopathies that classically involve cerebral and renal vessels in whites.

"There’s never been a systematic look at the role of fibromuscular dysplasia in childhood stroke," said Dr. Kirton, director of the pediatric stroke program at Alberta (Calgary) Children’s Hospital. He and his associates analyzed data from 81 cases of childhood stroke that had references to fibromuscular dysplasia or renal artery disease.

Of the 15 cases obtained from two large Canadian registries and 66 cases gleaned from the medical literature, 27 had pathologically proven fibromuscular dysplasia, 31 were clinically diagnosed, and the remaining 23 cases were grouped as "other" diagnoses.

The records provided sufficient detail on 19 of the 27 pathologically proven cases to show that 17 of the 19 (89%) were classified as intimal fibroplasia, a type that is rarely seen in adults. Angiography of these patients showed nonspecific findings such as focal narrowing or stenosis, he said at the meeting, sponsored by the American Heart Association.

The other 2 of the 19 cases were classified as medial hyperplasia, and the remaining 8 cases could not be classified. Notably, none of the 19 had medial fibroplasia or dysplasia, the type typically seen in adults with stroke. "This is the one you learn about in medical school" that has a unique "string of beads" appearance on angiography, he said.

Conventional angiography was performed in 26 of 27 children with pathologically-proven fibromuscular dysplasia. Only 5 (20%) showed a "string of beads" appearance, compared with more than half of the clinically diagnosed group, a significant difference. The pathologically-proven group, however, had significantly higher rates of the moyamoya intake pattern and of renal artery stenosis or renal hypertension than did the clinically diagnosed group.

Of 21 children in the pathologically-proven group who underwent systemic evaluations, 16 (76%) had evidence of systemic arteriopathy outside of the brain and kidneys, "supporting the idea that a lot of fibromuscular dysplasia is really a systemic arterial disease in children," Dr. Kirton said.

There was no evidence of the female predominance for fibromuscular dysplasia that has been observed in adult cases. Nine children in the pathologically-proven group (33%) first presented with neurological symptoms in the first year of life, compared with only three children in the clinically diagnosed group (10%).

Children in the pathologically proven group were significantly more likely to have poor outcomes, to have disease recurrence, and to die, compared with the clinically diagnosed group.

Among 23 patients with pathologically proven fibromuscular dysplasia who were followed for an average of 43 months, 15 had poor outcomes (65%), 8 had recurrences (35%) and 10 died (43%). "There’s a selection bias here, because some of these children died before they could get to pathology," Dr. Kirton noted.

Among 30 children in the clinically diagnosed group who were followed for an average of 22 months, 10 had poor outcomes (33%), 2 had recurrences (7%) and 1 died (3%).

The clinically diagnosed cases more closely resembled TCA than fibromuscular dysplasia, he suggested. The former were more likely to be previously healthy patients with unilateral disease that had a "string of beads" appearance, less likely to have renal artery stenosis or hypertension, and less likely to develop recurrence.

"We are not able to accurately diagnose fibromuscular dysplasia clinically," Dr. Kirton said. "If you see a ‘string of beads,’ it doesn’t necessarily mean fibromuscular dysplasia. In fact, our data would argue that it suggests something else."

Dr. Kirton said the investigators have no relevant conflicts of interest.

LOS ANGELES – Evidence from a preliminary study suggests that the arteriopathy called fibromuscular dysplasia appears differently in children than in adults.

In fact, what most neurologists diagnose as fibromuscular dysplasia in children with arterial ischemic stroke might not be fibromuscular dysplasia at all, but is more likely to be transient cerebral arteriopathy (TCA) of childhood, Dr. Adam Kirton said at the conference.

Little is know about the causes of arteriopathy, the most common cause of childhood arterial ischemic stroke. One cause is fibromuscular dysplasia, a group of idiopathic, noninflammatory arteriopathies that classically involve cerebral and renal vessels in whites.

"There’s never been a systematic look at the role of fibromuscular dysplasia in childhood stroke," said Dr. Kirton, director of the pediatric stroke program at Alberta (Calgary) Children’s Hospital. He and his associates analyzed data from 81 cases of childhood stroke that had references to fibromuscular dysplasia or renal artery disease.

Of the 15 cases obtained from two large Canadian registries and 66 cases gleaned from the medical literature, 27 had pathologically proven fibromuscular dysplasia, 31 were clinically diagnosed, and the remaining 23 cases were grouped as "other" diagnoses.

The records provided sufficient detail on 19 of the 27 pathologically proven cases to show that 17 of the 19 (89%) were classified as intimal fibroplasia, a type that is rarely seen in adults. Angiography of these patients showed nonspecific findings such as focal narrowing or stenosis, he said at the meeting, sponsored by the American Heart Association.

The other 2 of the 19 cases were classified as medial hyperplasia, and the remaining 8 cases could not be classified. Notably, none of the 19 had medial fibroplasia or dysplasia, the type typically seen in adults with stroke. "This is the one you learn about in medical school" that has a unique "string of beads" appearance on angiography, he said.

Conventional angiography was performed in 26 of 27 children with pathologically-proven fibromuscular dysplasia. Only 5 (20%) showed a "string of beads" appearance, compared with more than half of the clinically diagnosed group, a significant difference. The pathologically-proven group, however, had significantly higher rates of the moyamoya intake pattern and of renal artery stenosis or renal hypertension than did the clinically diagnosed group.

Of 21 children in the pathologically-proven group who underwent systemic evaluations, 16 (76%) had evidence of systemic arteriopathy outside of the brain and kidneys, "supporting the idea that a lot of fibromuscular dysplasia is really a systemic arterial disease in children," Dr. Kirton said.

There was no evidence of the female predominance for fibromuscular dysplasia that has been observed in adult cases. Nine children in the pathologically-proven group (33%) first presented with neurological symptoms in the first year of life, compared with only three children in the clinically diagnosed group (10%).

Children in the pathologically proven group were significantly more likely to have poor outcomes, to have disease recurrence, and to die, compared with the clinically diagnosed group.

Among 23 patients with pathologically proven fibromuscular dysplasia who were followed for an average of 43 months, 15 had poor outcomes (65%), 8 had recurrences (35%) and 10 died (43%). "There’s a selection bias here, because some of these children died before they could get to pathology," Dr. Kirton noted.

Among 30 children in the clinically diagnosed group who were followed for an average of 22 months, 10 had poor outcomes (33%), 2 had recurrences (7%) and 1 died (3%).

The clinically diagnosed cases more closely resembled TCA than fibromuscular dysplasia, he suggested. The former were more likely to be previously healthy patients with unilateral disease that had a "string of beads" appearance, less likely to have renal artery stenosis or hypertension, and less likely to develop recurrence.

"We are not able to accurately diagnose fibromuscular dysplasia clinically," Dr. Kirton said. "If you see a ‘string of beads,’ it doesn’t necessarily mean fibromuscular dysplasia. In fact, our data would argue that it suggests something else."

Dr. Kirton said the investigators have no relevant conflicts of interest.

LOS ANGELES – Evidence from a preliminary study suggests that the arteriopathy called fibromuscular dysplasia appears differently in children than in adults.

In fact, what most neurologists diagnose as fibromuscular dysplasia in children with arterial ischemic stroke might not be fibromuscular dysplasia at all, but is more likely to be transient cerebral arteriopathy (TCA) of childhood, Dr. Adam Kirton said at the conference.

Little is know about the causes of arteriopathy, the most common cause of childhood arterial ischemic stroke. One cause is fibromuscular dysplasia, a group of idiopathic, noninflammatory arteriopathies that classically involve cerebral and renal vessels in whites.

"There’s never been a systematic look at the role of fibromuscular dysplasia in childhood stroke," said Dr. Kirton, director of the pediatric stroke program at Alberta (Calgary) Children’s Hospital. He and his associates analyzed data from 81 cases of childhood stroke that had references to fibromuscular dysplasia or renal artery disease.

Of the 15 cases obtained from two large Canadian registries and 66 cases gleaned from the medical literature, 27 had pathologically proven fibromuscular dysplasia, 31 were clinically diagnosed, and the remaining 23 cases were grouped as "other" diagnoses.

The records provided sufficient detail on 19 of the 27 pathologically proven cases to show that 17 of the 19 (89%) were classified as intimal fibroplasia, a type that is rarely seen in adults. Angiography of these patients showed nonspecific findings such as focal narrowing or stenosis, he said at the meeting, sponsored by the American Heart Association.

The other 2 of the 19 cases were classified as medial hyperplasia, and the remaining 8 cases could not be classified. Notably, none of the 19 had medial fibroplasia or dysplasia, the type typically seen in adults with stroke. "This is the one you learn about in medical school" that has a unique "string of beads" appearance on angiography, he said.

Conventional angiography was performed in 26 of 27 children with pathologically-proven fibromuscular dysplasia. Only 5 (20%) showed a "string of beads" appearance, compared with more than half of the clinically diagnosed group, a significant difference. The pathologically-proven group, however, had significantly higher rates of the moyamoya intake pattern and of renal artery stenosis or renal hypertension than did the clinically diagnosed group.

Of 21 children in the pathologically-proven group who underwent systemic evaluations, 16 (76%) had evidence of systemic arteriopathy outside of the brain and kidneys, "supporting the idea that a lot of fibromuscular dysplasia is really a systemic arterial disease in children," Dr. Kirton said.

There was no evidence of the female predominance for fibromuscular dysplasia that has been observed in adult cases. Nine children in the pathologically-proven group (33%) first presented with neurological symptoms in the first year of life, compared with only three children in the clinically diagnosed group (10%).

Children in the pathologically proven group were significantly more likely to have poor outcomes, to have disease recurrence, and to die, compared with the clinically diagnosed group.

Among 23 patients with pathologically proven fibromuscular dysplasia who were followed for an average of 43 months, 15 had poor outcomes (65%), 8 had recurrences (35%) and 10 died (43%). "There’s a selection bias here, because some of these children died before they could get to pathology," Dr. Kirton noted.

Among 30 children in the clinically diagnosed group who were followed for an average of 22 months, 10 had poor outcomes (33%), 2 had recurrences (7%) and 1 died (3%).

The clinically diagnosed cases more closely resembled TCA than fibromuscular dysplasia, he suggested. The former were more likely to be previously healthy patients with unilateral disease that had a "string of beads" appearance, less likely to have renal artery stenosis or hypertension, and less likely to develop recurrence.

"We are not able to accurately diagnose fibromuscular dysplasia clinically," Dr. Kirton said. "If you see a ‘string of beads,’ it doesn’t necessarily mean fibromuscular dysplasia. In fact, our data would argue that it suggests something else."

Dr. Kirton said the investigators have no relevant conflicts of interest.

LOS ANGELES – Evidence from a preliminary study suggests that the arteriopathy called fibromuscular dysplasia appears differently in children than in adults.

In fact, what most neurologists diagnose as fibromuscular dysplasia in children with arterial ischemic stroke might not be fibromuscular dysplasia at all, but is more likely to be transient cerebral arteriopathy (TCA) of childhood, Dr. Adam Kirton said at the conference.

Little is know about the causes of arteriopathy, the most common cause of childhood arterial ischemic stroke. One cause is fibromuscular dysplasia, a group of idiopathic, noninflammatory arteriopathies that classically involve cerebral and renal vessels in whites.

"There’s never been a systematic look at the role of fibromuscular dysplasia in childhood stroke," said Dr. Kirton, director of the pediatric stroke program at Alberta (Calgary) Children’s Hospital. He and his associates analyzed data from 81 cases of childhood stroke that had references to fibromuscular dysplasia or renal artery disease.

Of the 15 cases obtained from two large Canadian registries and 66 cases gleaned from the medical literature, 27 had pathologically proven fibromuscular dysplasia, 31 were clinically diagnosed, and the remaining 23 cases were grouped as "other" diagnoses.

The records provided sufficient detail on 19 of the 27 pathologically proven cases to show that 17 of the 19 (89%) were classified as intimal fibroplasia, a type that is rarely seen in adults. Angiography of these patients showed nonspecific findings such as focal narrowing or stenosis, he said at the meeting, sponsored by the American Heart Association.

The other 2 of the 19 cases were classified as medial hyperplasia, and the remaining 8 cases could not be classified. Notably, none of the 19 had medial fibroplasia or dysplasia, the type typically seen in adults with stroke. "This is the one you learn about in medical school" that has a unique "string of beads" appearance on angiography, he said.

Conventional angiography was performed in 26 of 27 children with pathologically-proven fibromuscular dysplasia. Only 5 (20%) showed a "string of beads" appearance, compared with more than half of the clinically diagnosed group, a significant difference. The pathologically-proven group, however, had significantly higher rates of the moyamoya intake pattern and of renal artery stenosis or renal hypertension than did the clinically diagnosed group.

Of 21 children in the pathologically-proven group who underwent systemic evaluations, 16 (76%) had evidence of systemic arteriopathy outside of the brain and kidneys, "supporting the idea that a lot of fibromuscular dysplasia is really a systemic arterial disease in children," Dr. Kirton said.

There was no evidence of the female predominance for fibromuscular dysplasia that has been observed in adult cases. Nine children in the pathologically-proven group (33%) first presented with neurological symptoms in the first year of life, compared with only three children in the clinically diagnosed group (10%).

Children in the pathologically proven group were significantly more likely to have poor outcomes, to have disease recurrence, and to die, compared with the clinically diagnosed group.

Among 23 patients with pathologically proven fibromuscular dysplasia who were followed for an average of 43 months, 15 had poor outcomes (65%), 8 had recurrences (35%) and 10 died (43%). "There’s a selection bias here, because some of these children died before they could get to pathology," Dr. Kirton noted.

Among 30 children in the clinically diagnosed group who were followed for an average of 22 months, 10 had poor outcomes (33%), 2 had recurrences (7%) and 1 died (3%).

The clinically diagnosed cases more closely resembled TCA than fibromuscular dysplasia, he suggested. The former were more likely to be previously healthy patients with unilateral disease that had a "string of beads" appearance, less likely to have renal artery stenosis or hypertension, and less likely to develop recurrence.

"We are not able to accurately diagnose fibromuscular dysplasia clinically," Dr. Kirton said. "If you see a ‘string of beads,’ it doesn’t necessarily mean fibromuscular dysplasia. In fact, our data would argue that it suggests something else."

Dr. Kirton said the investigators have no relevant conflicts of interest.

LOS ANGELES – Evidence from a preliminary study suggests that the arteriopathy called fibromuscular dysplasia appears differently in children than in adults.

In fact, what most neurologists diagnose as fibromuscular dysplasia in children with arterial ischemic stroke might not be fibromuscular dysplasia at all, but is more likely to be transient cerebral arteriopathy (TCA) of childhood, Dr. Adam Kirton said at the conference.

Little is know about the causes of arteriopathy, the most common cause of childhood arterial ischemic stroke. One cause is fibromuscular dysplasia, a group of idiopathic, noninflammatory arteriopathies that classically involve cerebral and renal vessels in whites.

"There’s never been a systematic look at the role of fibromuscular dysplasia in childhood stroke," said Dr. Kirton, director of the pediatric stroke program at Alberta (Calgary) Children’s Hospital. He and his associates analyzed data from 81 cases of childhood stroke that had references to fibromuscular dysplasia or renal artery disease.

Of the 15 cases obtained from two large Canadian registries and 66 cases gleaned from the medical literature, 27 had pathologically proven fibromuscular dysplasia, 31 were clinically diagnosed, and the remaining 23 cases were grouped as "other" diagnoses.

The records provided sufficient detail on 19 of the 27 pathologically proven cases to show that 17 of the 19 (89%) were classified as intimal fibroplasia, a type that is rarely seen in adults. Angiography of these patients showed nonspecific findings such as focal narrowing or stenosis, he said at the meeting, sponsored by the American Heart Association.

The other 2 of the 19 cases were classified as medial hyperplasia, and the remaining 8 cases could not be classified. Notably, none of the 19 had medial fibroplasia or dysplasia, the type typically seen in adults with stroke. "This is the one you learn about in medical school" that has a unique "string of beads" appearance on angiography, he said.

Conventional angiography was performed in 26 of 27 children with pathologically-proven fibromuscular dysplasia. Only 5 (20%) showed a "string of beads" appearance, compared with more than half of the clinically diagnosed group, a significant difference. The pathologically-proven group, however, had significantly higher rates of the moyamoya intake pattern and of renal artery stenosis or renal hypertension than did the clinically diagnosed group.

Of 21 children in the pathologically-proven group who underwent systemic evaluations, 16 (76%) had evidence of systemic arteriopathy outside of the brain and kidneys, "supporting the idea that a lot of fibromuscular dysplasia is really a systemic arterial disease in children," Dr. Kirton said.

There was no evidence of the female predominance for fibromuscular dysplasia that has been observed in adult cases. Nine children in the pathologically-proven group (33%) first presented with neurological symptoms in the first year of life, compared with only three children in the clinically diagnosed group (10%).

Children in the pathologically proven group were significantly more likely to have poor outcomes, to have disease recurrence, and to die, compared with the clinically diagnosed group.

Among 23 patients with pathologically proven fibromuscular dysplasia who were followed for an average of 43 months, 15 had poor outcomes (65%), 8 had recurrences (35%) and 10 died (43%). "There’s a selection bias here, because some of these children died before they could get to pathology," Dr. Kirton noted.

Among 30 children in the clinically diagnosed group who were followed for an average of 22 months, 10 had poor outcomes (33%), 2 had recurrences (7%) and 1 died (3%).

The clinically diagnosed cases more closely resembled TCA than fibromuscular dysplasia, he suggested. The former were more likely to be previously healthy patients with unilateral disease that had a "string of beads" appearance, less likely to have renal artery stenosis or hypertension, and less likely to develop recurrence.

"We are not able to accurately diagnose fibromuscular dysplasia clinically," Dr. Kirton said. "If you see a ‘string of beads,’ it doesn’t necessarily mean fibromuscular dysplasia. In fact, our data would argue that it suggests something else."

Dr. Kirton said the investigators have no relevant conflicts of interest.

LOS ANGELES – Evidence from a preliminary study suggests that the arteriopathy called fibromuscular dysplasia appears differently in children than in adults.

In fact, what most neurologists diagnose as fibromuscular dysplasia in children with arterial ischemic stroke might not be fibromuscular dysplasia at all, but is more likely to be transient cerebral arteriopathy (TCA) of childhood, Dr. Adam Kirton said at the conference.

Little is know about the causes of arteriopathy, the most common cause of childhood arterial ischemic stroke. One cause is fibromuscular dysplasia, a group of idiopathic, noninflammatory arteriopathies that classically involve cerebral and renal vessels in whites.

"There’s never been a systematic look at the role of fibromuscular dysplasia in childhood stroke," said Dr. Kirton, director of the pediatric stroke program at Alberta (Calgary) Children’s Hospital. He and his associates analyzed data from 81 cases of childhood stroke that had references to fibromuscular dysplasia or renal artery disease.

Of the 15 cases obtained from two large Canadian registries and 66 cases gleaned from the medical literature, 27 had pathologically proven fibromuscular dysplasia, 31 were clinically diagnosed, and the remaining 23 cases were grouped as "other" diagnoses.

The records provided sufficient detail on 19 of the 27 pathologically proven cases to show that 17 of the 19 (89%) were classified as intimal fibroplasia, a type that is rarely seen in adults. Angiography of these patients showed nonspecific findings such as focal narrowing or stenosis, he said at the meeting, sponsored by the American Heart Association.

The other 2 of the 19 cases were classified as medial hyperplasia, and the remaining 8 cases could not be classified. Notably, none of the 19 had medial fibroplasia or dysplasia, the type typically seen in adults with stroke. "This is the one you learn about in medical school" that has a unique "string of beads" appearance on angiography, he said.

Conventional angiography was performed in 26 of 27 children with pathologically-proven fibromuscular dysplasia. Only 5 (20%) showed a "string of beads" appearance, compared with more than half of the clinically diagnosed group, a significant difference. The pathologically-proven group, however, had significantly higher rates of the moyamoya intake pattern and of renal artery stenosis or renal hypertension than did the clinically diagnosed group.

Of 21 children in the pathologically-proven group who underwent systemic evaluations, 16 (76%) had evidence of systemic arteriopathy outside of the brain and kidneys, "supporting the idea that a lot of fibromuscular dysplasia is really a systemic arterial disease in children," Dr. Kirton said.

There was no evidence of the female predominance for fibromuscular dysplasia that has been observed in adult cases. Nine children in the pathologically-proven group (33%) first presented with neurological symptoms in the first year of life, compared with only three children in the clinically diagnosed group (10%).

Children in the pathologically proven group were significantly more likely to have poor outcomes, to have disease recurrence, and to die, compared with the clinically diagnosed group.

Among 23 patients with pathologically proven fibromuscular dysplasia who were followed for an average of 43 months, 15 had poor outcomes (65%), 8 had recurrences (35%) and 10 died (43%). "There’s a selection bias here, because some of these children died before they could get to pathology," Dr. Kirton noted.

Among 30 children in the clinically diagnosed group who were followed for an average of 22 months, 10 had poor outcomes (33%), 2 had recurrences (7%) and 1 died (3%).

The clinically diagnosed cases more closely resembled TCA than fibromuscular dysplasia, he suggested. The former were more likely to be previously healthy patients with unilateral disease that had a "string of beads" appearance, less likely to have renal artery stenosis or hypertension, and less likely to develop recurrence.

"We are not able to accurately diagnose fibromuscular dysplasia clinically," Dr. Kirton said. "If you see a ‘string of beads,’ it doesn’t necessarily mean fibromuscular dysplasia. In fact, our data would argue that it suggests something else."

Dr. Kirton said the investigators have no relevant conflicts of interest.

LAS VEGAS – Counties that have up to two dermatologists per 100,000 people have the lowest mortality from melanoma, compared with counties with no dermatologists, according to an analysis of national data.

The analysis also found that having more dermatologists does not decrease melanoma mortality further.

A "dermatologist density" greater than zero and up to one dermatologist per 100,000 people was associated with a 35% reduction in deaths from melanoma compared with counties with no dermatologists, Dr. Jeremy S. Bordeaux reported at the annual meeting of the American College of Mohs Surgery.

Counties with more than one and up to two dermatologists per 100,000 people had an even greater reduction in melanoma mortality – 53% lower than counties with no dermatologists, the multivariate analysis showed. Beyond that, counties with more than two dermatologists had slightly but not significantly higher melanoma mortality rates, compared with counties with more than one and up to two dermatologists.

"Once you get past two per 100,000, it didn't make any difference. If you had 10 per 100,000, it didn't change mortality," said Dr. Bordeaux of the department of dermatology at Case Western Reserve University, Cleveland.

A map of dermatologist density created from U.S. Department of Health and Human Services data showed huge swaths of counties in the middle part of the country with no dermatologists. The study's findings suggest that enticing some dermatologists on the East and West coasts to move to those counties could reduce melanoma mortality.

"If we could get people to go where people don't want to live, I guess that could save lives, but people don’t want to live there for a reason," he said. Perhaps dermatology residency programs could place dermatologists in underserved counties, or loan repayment programs could be tied to contracts to serve in those counties, he suggested.

Dr. Bordeaux and his associates analyzed data from 3,141 U.S. counties from multiple databases, including the National Cancer Institute's Surveillance, Epidemiology and End Results database, the National Program of Cancer Registries, the Centers for Disease Control and Prevention’s National Vital Statistics System, and the U.S. Census Bureau.

Two other factors were associated with decreased melanoma mortality. Counties classified as metropolitan had a 30% lower death rate from melanoma, compared with nonmetropolitan counties. Each hospital that provided oncology services conferred nearly a 2% reduction in melanoma mortality. In Dr. Bordeaux’s county, for example, which has a dozen or so hospitals that offer oncology services, melanoma mortality would be more than 20% lower than in a county with no hospital-based oncology services.

Several factors were associated with higher melanoma mortality. For every 1% increase in the proportion of the population that was white, the melanoma mortality increased 1.5%. Not surprisingly, a higher incidence of melanoma was associated with higher mortality; for each additional case of melanoma per 100,000 people, mortality increased 2.3%. A third factor puzzled Dr. Bordeaux. For each additional percent of the population covered by health insurance, the melanoma mortality rate increased by 1.5%.

Factors that appeared to have no effect on melanoma mortality included the density of primary care providers, the percentage of the population older than 65 years, education level, median household income, and unemployment rate.

Dr. Bordeaux speculated the "plateau effect" that limited mortality reductions to a density of two dermatologists per 100,000 people may reflect the limitations of current therapeutics. Or, areas with greater dermatologist density may represent academic centers, and dermatologists may not be working full time.

Multiple studies have found the need to increase the number of primary care physicians, but the density of primary care physicians did not affect melanoma mortality in the current study, Dr. Bordeaux noted. Other articles in the literature, however, have shown specialist care to be associated with better cancer outcomes in both urology and dermatology.

In one study, higher densities of either dermatologists or internists were associated with better prognosis in patients with melanoma, but a higher density of family physicians was associated with a worse prognosis (J. Amer. Acad. Dermatol. 2009;60:51-8).

Dr. Bordeaux and his fellow investigators had no relevant conflicts of interest to report.

LAS VEGAS – Counties that have up to two dermatologists per 100,000 people have the lowest mortality from melanoma, compared with counties with no dermatologists, according to an analysis of national data.

The analysis also found that having more dermatologists does not decrease melanoma mortality further.

A "dermatologist density" greater than zero and up to one dermatologist per 100,000 people was associated with a 35% reduction in deaths from melanoma compared with counties with no dermatologists, Dr. Jeremy S. Bordeaux reported at the annual meeting of the American College of Mohs Surgery.

Counties with more than one and up to two dermatologists per 100,000 people had an even greater reduction in melanoma mortality – 53% lower than counties with no dermatologists, the multivariate analysis showed. Beyond that, counties with more than two dermatologists had slightly but not significantly higher melanoma mortality rates, compared with counties with more than one and up to two dermatologists.

"Once you get past two per 100,000, it didn't make any difference. If you had 10 per 100,000, it didn't change mortality," said Dr. Bordeaux of the department of dermatology at Case Western Reserve University, Cleveland.

A map of dermatologist density created from U.S. Department of Health and Human Services data showed huge swaths of counties in the middle part of the country with no dermatologists. The study's findings suggest that enticing some dermatologists on the East and West coasts to move to those counties could reduce melanoma mortality.

"If we could get people to go where people don't want to live, I guess that could save lives, but people don’t want to live there for a reason," he said. Perhaps dermatology residency programs could place dermatologists in underserved counties, or loan repayment programs could be tied to contracts to serve in those counties, he suggested.

Dr. Bordeaux and his associates analyzed data from 3,141 U.S. counties from multiple databases, including the National Cancer Institute's Surveillance, Epidemiology and End Results database, the National Program of Cancer Registries, the Centers for Disease Control and Prevention’s National Vital Statistics System, and the U.S. Census Bureau.

Two other factors were associated with decreased melanoma mortality. Counties classified as metropolitan had a 30% lower death rate from melanoma, compared with nonmetropolitan counties. Each hospital that provided oncology services conferred nearly a 2% reduction in melanoma mortality. In Dr. Bordeaux’s county, for example, which has a dozen or so hospitals that offer oncology services, melanoma mortality would be more than 20% lower than in a county with no hospital-based oncology services.

Several factors were associated with higher melanoma mortality. For every 1% increase in the proportion of the population that was white, the melanoma mortality increased 1.5%. Not surprisingly, a higher incidence of melanoma was associated with higher mortality; for each additional case of melanoma per 100,000 people, mortality increased 2.3%. A third factor puzzled Dr. Bordeaux. For each additional percent of the population covered by health insurance, the melanoma mortality rate increased by 1.5%.

Factors that appeared to have no effect on melanoma mortality included the density of primary care providers, the percentage of the population older than 65 years, education level, median household income, and unemployment rate.

Dr. Bordeaux speculated the "plateau effect" that limited mortality reductions to a density of two dermatologists per 100,000 people may reflect the limitations of current therapeutics. Or, areas with greater dermatologist density may represent academic centers, and dermatologists may not be working full time.

Multiple studies have found the need to increase the number of primary care physicians, but the density of primary care physicians did not affect melanoma mortality in the current study, Dr. Bordeaux noted. Other articles in the literature, however, have shown specialist care to be associated with better cancer outcomes in both urology and dermatology.

In one study, higher densities of either dermatologists or internists were associated with better prognosis in patients with melanoma, but a higher density of family physicians was associated with a worse prognosis (J. Amer. Acad. Dermatol. 2009;60:51-8).

Dr. Bordeaux and his fellow investigators had no relevant conflicts of interest to report.

LAS VEGAS – Counties that have up to two dermatologists per 100,000 people have the lowest mortality from melanoma, compared with counties with no dermatologists, according to an analysis of national data.

The analysis also found that having more dermatologists does not decrease melanoma mortality further.

A "dermatologist density" greater than zero and up to one dermatologist per 100,000 people was associated with a 35% reduction in deaths from melanoma compared with counties with no dermatologists, Dr. Jeremy S. Bordeaux reported at the annual meeting of the American College of Mohs Surgery.

Counties with more than one and up to two dermatologists per 100,000 people had an even greater reduction in melanoma mortality – 53% lower than counties with no dermatologists, the multivariate analysis showed. Beyond that, counties with more than two dermatologists had slightly but not significantly higher melanoma mortality rates, compared with counties with more than one and up to two dermatologists.

"Once you get past two per 100,000, it didn't make any difference. If you had 10 per 100,000, it didn't change mortality," said Dr. Bordeaux of the department of dermatology at Case Western Reserve University, Cleveland.

A map of dermatologist density created from U.S. Department of Health and Human Services data showed huge swaths of counties in the middle part of the country with no dermatologists. The study's findings suggest that enticing some dermatologists on the East and West coasts to move to those counties could reduce melanoma mortality.

"If we could get people to go where people don't want to live, I guess that could save lives, but people don’t want to live there for a reason," he said. Perhaps dermatology residency programs could place dermatologists in underserved counties, or loan repayment programs could be tied to contracts to serve in those counties, he suggested.

Dr. Bordeaux and his associates analyzed data from 3,141 U.S. counties from multiple databases, including the National Cancer Institute's Surveillance, Epidemiology and End Results database, the National Program of Cancer Registries, the Centers for Disease Control and Prevention’s National Vital Statistics System, and the U.S. Census Bureau.

Two other factors were associated with decreased melanoma mortality. Counties classified as metropolitan had a 30% lower death rate from melanoma, compared with nonmetropolitan counties. Each hospital that provided oncology services conferred nearly a 2% reduction in melanoma mortality. In Dr. Bordeaux’s county, for example, which has a dozen or so hospitals that offer oncology services, melanoma mortality would be more than 20% lower than in a county with no hospital-based oncology services.

Several factors were associated with higher melanoma mortality. For every 1% increase in the proportion of the population that was white, the melanoma mortality increased 1.5%. Not surprisingly, a higher incidence of melanoma was associated with higher mortality; for each additional case of melanoma per 100,000 people, mortality increased 2.3%. A third factor puzzled Dr. Bordeaux. For each additional percent of the population covered by health insurance, the melanoma mortality rate increased by 1.5%.

Factors that appeared to have no effect on melanoma mortality included the density of primary care providers, the percentage of the population older than 65 years, education level, median household income, and unemployment rate.

Dr. Bordeaux speculated the "plateau effect" that limited mortality reductions to a density of two dermatologists per 100,000 people may reflect the limitations of current therapeutics. Or, areas with greater dermatologist density may represent academic centers, and dermatologists may not be working full time.

Multiple studies have found the need to increase the number of primary care physicians, but the density of primary care physicians did not affect melanoma mortality in the current study, Dr. Bordeaux noted. Other articles in the literature, however, have shown specialist care to be associated with better cancer outcomes in both urology and dermatology.

In one study, higher densities of either dermatologists or internists were associated with better prognosis in patients with melanoma, but a higher density of family physicians was associated with a worse prognosis (J. Amer. Acad. Dermatol. 2009;60:51-8).

Dr. Bordeaux and his fellow investigators had no relevant conflicts of interest to report.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Ginkgo biloba and simvastatin were not helpful in patients with relapsing-remitting multiple sclerosis in separate randomized, placebo-controlled trials.

Treatment with ginkgo at 120 mg twice a day for 12 weeks produced no significant, short-term improvements in cognitive function in a study of 121 patients. The addition of simvastatin (Zocor) to interferon therapy for multiple sclerosis in a separate study did not significantly reduce the annualized relapse rate after 1-3 years, investigators reported at the annual meeting of the American Academy of Neurology.

Photo credit: Zlatko Ivancok/Fotolia.com

A previous survey of patients with multiple sclerosis in Oregon found that 20% were using ginkgo, which contains antioxidants and platelet activator factor antagonists. A pilot trial conducted in 2009 by Dr. Jesus Lovera and associates suggested that these properties had a beneficial effect on attention and executive function as measured by the Stroop Color Word Test in patients with multiple sclerosis.

However, in the current trial of patients with multiple sclerosis in Portland, Ore., and Seattle, both the ginkgo and placebo groups improved average scores on a battery of neuropsychological tests.

There were no significant differences between groups in scores on the Paced Auditory Serial Addition Test, the California Verbal Learning Test II, the Controlled Oral Word Association Test, or the Stroop Color Word Test, said Dr. Lovera of Louisiana State University, New Orleans.

The two groups also did not differ significantly in secondary outcomes (including perceived cognitive deficits, family reports of cognitive deficits, fatigue, or depression) or in rates of adverse events. In the ginkgo group, one patient had an MI and one developed a severe depressive episode requiring hospitalization, but these were not attributed to ginkgo.

While the study found no short-term cognitive benefits from ginkgo, it did not assess any potential long-term benefits, Dr. Lovera said. There are no approved treatments for impairment of cognition in people with multiple sclerosis, which affects 40%-50% of patients.

Dr. Per Soelberg Sørensen and his associates reported in a separate presentation on a study of 307 treatment-naive patients who were starting treatment with interferon-beta-1a (IFN-beta-1a, Avonex) for relapsing-remitting multiple sclerosis. They were randomized to add-on therapy with either placebo or 80 mg/day of simvastatin (40 mg/day in the first month) for 1-3 years. Patients were followed clinically every 3 months and brain MRIs were conducted at baseline and after 1 year of treatment. At least 1 year of follow-up was completed by 136 patients in the simvastatin group and 132 in the placebo group.

Statins have immunomodulatory properties that some had hoped might reduce disease activity in relapsing-remitting multiple sclerosis. In one previous small study, the combination of IFN-beta-1a plus atorvastatin (Lipitor) showed some benefits, but in another small study, atorvastatin appeared to reduce the efficacy of IFN-beta-1a.

In the study, the annualized documented relapse rate was 31% higher in the simvastatin group (0.19), compared with the placebo group (0.14), but the difference was not statistically significant, said Dr. Sørensen of the Danish Multiple Sclerosis Center in the Rigshospitalet, Copenhagen.

The annualized total rate of documented and undocumented relapses was 15% higher in the simvastatin group (0.44), compared with the placebo group (0.38). Patients who received simvastatin had more new or enlarging T2 lesions on MRI than did those who received placebo (3 vs. 2.5). These and other measures were not statistically significant differences between groups, but suggested a trend towards more disease activity in the simvastatin group compared with placebo, Dr. Sørensen said.

More patients on placebo were free of disease activity (12%), compared with the simvastatin group (6%), a difference that was of borderline statistical significance (P = .05).

"The findings cannot exclude the previously proposed antagonistic effect of statins on IFN-beta immunomodulation," he said.

Based on the findings of this multicenter study, simvastatin cannot be recommended as an add-on to IFN-beta-1a therapy for relapsing multiple sclerosis, but patients taking statins for treatment of hypercholesterolemia or to prevent cardiovascular disease should not be discouraged from taking them during IFN-beta-1a therapy, Dr. Sørensen said.

Dr. Lovera and two of his associates disclosed financial relationships with EMD Serono, Teva Pharmaceuticals, Biogen Idec, and/or Pfizer. The ginkgo and placebo were provided by Dr. Willmar Schwabe GmbH, Karlsruhe, Germany. The U.S. Department of Veterans Affairs funded his study.

Dr. Sørensen and multiple associates disclosed financial relationships with Biogen Idec, Merck Serono, Teva Neuroscience, Genmab, Novartis, Bayer Schering, and/or Sanofi-Aventis. The study was funded by Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

HONOLULU – Patients taking natalizumab showed similar or only slightly delayed humoral immune responses following vaccinations, compared with patients not taking the drug for relapsing-remitting multiple sclerosis in a multicenter, randomized, open-label study.

Natalizumab (Tysabri) acts as an immunomodulator, which raised questions about its potential effects on patients’ responses to neoantigens and recall antigens. Previous studies have shown that some other biologic immunomodulatory drugs reduce antibody responses in patients, said Dr. Gabriel Pardo, director of the Oklahoma Medical Research Foundation’s Multiple Sclerosis Center of Excellence, Oklahoma City.

Dr. Pardo and his associates studied 30 patients who had been taking natalizumab (Tysabri) for 6 months to treat their multiple sclerosis and 30 others with the disease who had never taken the drug. All 60 patients received a single tetanus toxoid vaccination in order to assess memory antibody responses to a recall antigen. At least 2 weeks later, they also received three keyhole limpet hemocyanin (KLH) vaccinations in order to assess de novo antibody responses.

Overall, 27 patients in the control group and 24 in the natalizumab group completed the study. None stopped the drug or dropped out of the study because of drug-related side effects.

A similar proportion of both groups responded to the tetanus immunization within 28 days – 15 of 16 patients in the natalizumab group (94%) and all of 24 control patients. The difference between groups was not statistically significant, Dr. Pardo and his associates reported at the annual meeting of the American Academy of Neurology.

The one patient in the natalizumab group who did not respond within 28 days had a clinical response at 56 days after immunization.

Responses were defined as at least a twofold increase in specific serum immunoglobulin G (IgG) by 28 days after immunization, compared with baseline levels.

Median antitetanus toxoid antibody levels measured before and after immunization were similar between groups.

Antibody responses to the KLH vaccines also were similar between groups at 14, 28, and 56 days after immunizations. Anti-KLH antibody levels were similar between groups at all time points.

In the natalizumab group, the numbers of various lymphocytes increased over time, including CD3-positive, CD4-positive, and CD8-positive lymphocytes and B cells and natural killer (NK) cells.

The study did not analyze humoral responses to live vaccines.

Adverse events were seen in 26 of 30 patients on natalizumab, which were most commonly disease relapse (5 patients) and influenza, paresthesia, or injection site reaction, each of which occurred in 4 patients.

Biogen Idec and Elan Pharmaceuticals, which comarket Tysabri, funded the study. Dr. Pardo disclosed financial relationships with Biogen Idec, Acorda Therapeutics, Bayer, EMD Serono, Novartis, Pfizer, and Teva Neuroscience. A coinvestigator disclosed relationships with these and other companies, and two other co-investigators were employees of Biogen Idec.

LOS ANGELES – A large population-based study found better outcomes a year after childhood arterial ischemic stroke than were reported in previous studies that analyzed hospital-based cohorts.

The prospective Study of Outcome in Childhood Stroke (SOCS) followed cases of arterial ischemic stroke in children older than 27 days and younger than 16 years that were identified by British networks of medical specialists and surveillance databases from July 2008 through June 2009. The data collected cover 6 million children – 63% of children in England.

They found 82 cases of arterial ischemic stroke, for an incidence of 1.4/100,000 children per year, Dr. Andrew A. Mallick reported. Consent for follow-up assessments in the study was not available for seven patients, and six died (though none died primarily of stroke).

The parents of the remaining 69 children completed the International Pediatric Stroke Study Recovery and Recurrence Questionnaire. Their answers suggested that 32 (46%) children had fully recovered from the stroke and that 46 (67%) needed no extra help in daily activities.

Physician assessments using the Pediatric Stroke Outcome Measure suggested that 45% of the children were normal with no stroke-related deficits a year later. In the rest, physicians rated the severity of deficits as mild in 10% of children, moderate in 20%, and severe in 25%, said Dr. Mallick of the University of Bristol (England).

The percentages of children in the SOCS rated as fully recovered by parents and physicians compares favorably with the largest and most-often cited previous studies of outcome after childhood stroke, he said at the meeting, sponsored by the American Heart Association. Those studies reported normal function after arterial ischemic stroke in 32% and 13% of children (J. Child Neurol. 2000;15:316-24; Dev. Med. Child Neurol. 2000;42:455-61).

The previous studies followed patients from tertiary care children’s hospitals in Canada and England. Hospital-based registries generally include patients with more severe strokes who are at a higher risk of complications or death, he said.

The SOCS findings should affect prognosis after childhood arterial ischemic stroke and the design of clinical trials, Dr. Mallick said.

"We’ve seen from our data that almost half the children are prepared to make a full recovery. If some of the proposed therapies are relatively high risk, I think we need to carefully consider whether we want to be giving children who are going to recover anyway such potentially dangerous therapies," he said.

When neurologic deficits were seen in the SOCS, about half were sensorimotor deficits, approximately a quarter were cognition or behavioral deficits, and fewer were deficits in expressive or receptive speech, Dr. Mallick and his associates found.

He said he and his coinvestigators had no relevant financial disclosures. The Stroke Association (United Kingdom) funded the study.

LOS ANGELES – A large population-based study found better outcomes a year after childhood arterial ischemic stroke than were reported in previous studies that analyzed hospital-based cohorts.

The prospective Study of Outcome in Childhood Stroke (SOCS) followed cases of arterial ischemic stroke in children older than 27 days and younger than 16 years that were identified by British networks of medical specialists and surveillance databases from July 2008 through June 2009. The data collected cover 6 million children – 63% of children in England.

They found 82 cases of arterial ischemic stroke, for an incidence of 1.4/100,000 children per year, Dr. Andrew A. Mallick reported. Consent for follow-up assessments in the study was not available for seven patients, and six died (though none died primarily of stroke).

The parents of the remaining 69 children completed the International Pediatric Stroke Study Recovery and Recurrence Questionnaire. Their answers suggested that 32 (46%) children had fully recovered from the stroke and that 46 (67%) needed no extra help in daily activities.

Physician assessments using the Pediatric Stroke Outcome Measure suggested that 45% of the children were normal with no stroke-related deficits a year later. In the rest, physicians rated the severity of deficits as mild in 10% of children, moderate in 20%, and severe in 25%, said Dr. Mallick of the University of Bristol (England).

The percentages of children in the SOCS rated as fully recovered by parents and physicians compares favorably with the largest and most-often cited previous studies of outcome after childhood stroke, he said at the meeting, sponsored by the American Heart Association. Those studies reported normal function after arterial ischemic stroke in 32% and 13% of children (J. Child Neurol. 2000;15:316-24; Dev. Med. Child Neurol. 2000;42:455-61).

The previous studies followed patients from tertiary care children’s hospitals in Canada and England. Hospital-based registries generally include patients with more severe strokes who are at a higher risk of complications or death, he said.

The SOCS findings should affect prognosis after childhood arterial ischemic stroke and the design of clinical trials, Dr. Mallick said.

"We’ve seen from our data that almost half the children are prepared to make a full recovery. If some of the proposed therapies are relatively high risk, I think we need to carefully consider whether we want to be giving children who are going to recover anyway such potentially dangerous therapies," he said.

When neurologic deficits were seen in the SOCS, about half were sensorimotor deficits, approximately a quarter were cognition or behavioral deficits, and fewer were deficits in expressive or receptive speech, Dr. Mallick and his associates found.

He said he and his coinvestigators had no relevant financial disclosures. The Stroke Association (United Kingdom) funded the study.

LOS ANGELES – A large population-based study found better outcomes a year after childhood arterial ischemic stroke than were reported in previous studies that analyzed hospital-based cohorts.

The prospective Study of Outcome in Childhood Stroke (SOCS) followed cases of arterial ischemic stroke in children older than 27 days and younger than 16 years that were identified by British networks of medical specialists and surveillance databases from July 2008 through June 2009. The data collected cover 6 million children – 63% of children in England.

They found 82 cases of arterial ischemic stroke, for an incidence of 1.4/100,000 children per year, Dr. Andrew A. Mallick reported. Consent for follow-up assessments in the study was not available for seven patients, and six died (though none died primarily of stroke).

The parents of the remaining 69 children completed the International Pediatric Stroke Study Recovery and Recurrence Questionnaire. Their answers suggested that 32 (46%) children had fully recovered from the stroke and that 46 (67%) needed no extra help in daily activities.

Physician assessments using the Pediatric Stroke Outcome Measure suggested that 45% of the children were normal with no stroke-related deficits a year later. In the rest, physicians rated the severity of deficits as mild in 10% of children, moderate in 20%, and severe in 25%, said Dr. Mallick of the University of Bristol (England).

The percentages of children in the SOCS rated as fully recovered by parents and physicians compares favorably with the largest and most-often cited previous studies of outcome after childhood stroke, he said at the meeting, sponsored by the American Heart Association. Those studies reported normal function after arterial ischemic stroke in 32% and 13% of children (J. Child Neurol. 2000;15:316-24; Dev. Med. Child Neurol. 2000;42:455-61).

The previous studies followed patients from tertiary care children’s hospitals in Canada and England. Hospital-based registries generally include patients with more severe strokes who are at a higher risk of complications or death, he said.

The SOCS findings should affect prognosis after childhood arterial ischemic stroke and the design of clinical trials, Dr. Mallick said.

"We’ve seen from our data that almost half the children are prepared to make a full recovery. If some of the proposed therapies are relatively high risk, I think we need to carefully consider whether we want to be giving children who are going to recover anyway such potentially dangerous therapies," he said.

When neurologic deficits were seen in the SOCS, about half were sensorimotor deficits, approximately a quarter were cognition or behavioral deficits, and fewer were deficits in expressive or receptive speech, Dr. Mallick and his associates found.

He said he and his coinvestigators had no relevant financial disclosures. The Stroke Association (United Kingdom) funded the study.