Patrice Wendling

CHICAGO — Diabetes mellitus appears to delay the onset of motor symptoms in patients with amyotrophic lateral sclerosis, but it also may be associated with diminished cognitive functioning in these patients, according to the findings of a retrospective study.

Although a cause-and-effect relationship could not be determined, it is hoped the data will stimulate research into whether increasing blood glucose level might benefit patients who have ALS, said the study's lead investigator Dr. Paul E. Schulz of Baylor College of Medicine, Houston.

Among 2,359 consecutive patients with ALS, mean patient age at the onset of motor symptoms was significantly greater in 174 patients with diabetes than in 2,185 patients without diabetes (60.3 years vs. 56.3 years). Patients in the study were diagnosed with ALS from 1977 to 2006, and were tested for diabetes at ALS diagnosis.

Overall, the mean age at first ALS symptom was 56.6 years; 62% of the patients were male and 89% were white. Later age of onset for ALS is typically associated with a faster rate of progression of motor symptoms.

However, the mean rate of progression on the Appel scale (3.1) and the mean duration of ALS (3.2 years) were similar between diabetics and nondiabetics at baseline, Dr. Schulz and his associates reported in a poster at the annual meeting of the American Academy of Neurology.

“To my knowledge, diabetes mellitus is the first factor that has been associated with a later age of onset for ALS, and hence one that might be protective against ALS,” Dr. Schulz, director of the cognitive disorders clinics at Baylor, said in an interview.

On neuropsychological testing that controlled for age, ALS patients with diabetes performed significantly worse than did nondiabetics on memory tasks, confrontation naming, semantics, and processing speed. Some of these domains tend to be relatively preserved in ALS, Dr. Schulz said.

ALS patients with diabetes also did significantly worse on executive function tasks, including the Verbal Series Attention Test, both time to completion (VSAT-T) and errors (VSAT-E), and phonemic fluency (FAS test).

Cognitive status by FAS scores was “intact” in 228 patients, of which 3% were diabetic; “mild” in 163 patients, of which 5.5% were diabetic; and “moderate” in 50 patients, of which 16% were diabetic. The difference between diabetics and nondiabetics was significant, indicating that the severity of cognitive function correlated with the presence of diabetes, he said.

ALS patients with diabetes were also significantly more likely than nondiabetics to have depression on the Beck Depression Inventory.

There are several possible explanations for the poor cognitive findings, Dr. Schulz said. It could be that diabetes advances the loss of neurons in the cognitive areas of the brain or that diabetes protects against motor neuron loss, but not cognitive neuronal loss.

Or, “it could be that diabetes produces a different kind of dementia than we normally see in ALS patients, which is frontotemporal dementia,” Dr. Schulz said.

Previous work has shown some degree of cognitive impairment in about 50% of patients with ALS.

Dr. Schulz disclosed that he has given talks on Alzheimer's disease that were sponsored by Pfizer Inc. and Forest Pharmaceuticals Inc., which market Aricept (donepezil) and Namenda (memantine), respectively.

CHICAGO — Diabetes mellitus appears to delay the onset of motor symptoms in patients with amyotrophic lateral sclerosis, but it also may be associated with diminished cognitive functioning in these patients, according to the findings of a retrospective study.

Although a cause-and-effect relationship could not be determined, it is hoped the data will stimulate research into whether increasing blood glucose level might benefit patients who have ALS, said the study's lead investigator Dr. Paul E. Schulz of Baylor College of Medicine, Houston.

Among 2,359 consecutive patients with ALS, mean patient age at the onset of motor symptoms was significantly greater in 174 patients with diabetes than in 2,185 patients without diabetes (60.3 years vs. 56.3 years). Patients in the study were diagnosed with ALS from 1977 to 2006, and were tested for diabetes at ALS diagnosis.

Overall, the mean age at first ALS symptom was 56.6 years; 62% of the patients were male and 89% were white. Later age of onset for ALS is typically associated with a faster rate of progression of motor symptoms.

However, the mean rate of progression on the Appel scale (3.1) and the mean duration of ALS (3.2 years) were similar between diabetics and nondiabetics at baseline, Dr. Schulz and his associates reported in a poster at the annual meeting of the American Academy of Neurology.

“To my knowledge, diabetes mellitus is the first factor that has been associated with a later age of onset for ALS, and hence one that might be protective against ALS,” Dr. Schulz, director of the cognitive disorders clinics at Baylor, said in an interview.

On neuropsychological testing that controlled for age, ALS patients with diabetes performed significantly worse than did nondiabetics on memory tasks, confrontation naming, semantics, and processing speed. Some of these domains tend to be relatively preserved in ALS, Dr. Schulz said.

ALS patients with diabetes also did significantly worse on executive function tasks, including the Verbal Series Attention Test, both time to completion (VSAT-T) and errors (VSAT-E), and phonemic fluency (FAS test).

Cognitive status by FAS scores was “intact” in 228 patients, of which 3% were diabetic; “mild” in 163 patients, of which 5.5% were diabetic; and “moderate” in 50 patients, of which 16% were diabetic. The difference between diabetics and nondiabetics was significant, indicating that the severity of cognitive function correlated with the presence of diabetes, he said.

ALS patients with diabetes were also significantly more likely than nondiabetics to have depression on the Beck Depression Inventory.

There are several possible explanations for the poor cognitive findings, Dr. Schulz said. It could be that diabetes advances the loss of neurons in the cognitive areas of the brain or that diabetes protects against motor neuron loss, but not cognitive neuronal loss.

Or, “it could be that diabetes produces a different kind of dementia than we normally see in ALS patients, which is frontotemporal dementia,” Dr. Schulz said.

Previous work has shown some degree of cognitive impairment in about 50% of patients with ALS.

Dr. Schulz disclosed that he has given talks on Alzheimer's disease that were sponsored by Pfizer Inc. and Forest Pharmaceuticals Inc., which market Aricept (donepezil) and Namenda (memantine), respectively.

CHICAGO — Diabetes mellitus appears to delay the onset of motor symptoms in patients with amyotrophic lateral sclerosis, but it also may be associated with diminished cognitive functioning in these patients, according to the findings of a retrospective study.

Although a cause-and-effect relationship could not be determined, it is hoped the data will stimulate research into whether increasing blood glucose level might benefit patients who have ALS, said the study's lead investigator Dr. Paul E. Schulz of Baylor College of Medicine, Houston.

Among 2,359 consecutive patients with ALS, mean patient age at the onset of motor symptoms was significantly greater in 174 patients with diabetes than in 2,185 patients without diabetes (60.3 years vs. 56.3 years). Patients in the study were diagnosed with ALS from 1977 to 2006, and were tested for diabetes at ALS diagnosis.

Overall, the mean age at first ALS symptom was 56.6 years; 62% of the patients were male and 89% were white. Later age of onset for ALS is typically associated with a faster rate of progression of motor symptoms.

However, the mean rate of progression on the Appel scale (3.1) and the mean duration of ALS (3.2 years) were similar between diabetics and nondiabetics at baseline, Dr. Schulz and his associates reported in a poster at the annual meeting of the American Academy of Neurology.

“To my knowledge, diabetes mellitus is the first factor that has been associated with a later age of onset for ALS, and hence one that might be protective against ALS,” Dr. Schulz, director of the cognitive disorders clinics at Baylor, said in an interview.

On neuropsychological testing that controlled for age, ALS patients with diabetes performed significantly worse than did nondiabetics on memory tasks, confrontation naming, semantics, and processing speed. Some of these domains tend to be relatively preserved in ALS, Dr. Schulz said.

ALS patients with diabetes also did significantly worse on executive function tasks, including the Verbal Series Attention Test, both time to completion (VSAT-T) and errors (VSAT-E), and phonemic fluency (FAS test).

Cognitive status by FAS scores was “intact” in 228 patients, of which 3% were diabetic; “mild” in 163 patients, of which 5.5% were diabetic; and “moderate” in 50 patients, of which 16% were diabetic. The difference between diabetics and nondiabetics was significant, indicating that the severity of cognitive function correlated with the presence of diabetes, he said.

ALS patients with diabetes were also significantly more likely than nondiabetics to have depression on the Beck Depression Inventory.

There are several possible explanations for the poor cognitive findings, Dr. Schulz said. It could be that diabetes advances the loss of neurons in the cognitive areas of the brain or that diabetes protects against motor neuron loss, but not cognitive neuronal loss.

Or, “it could be that diabetes produces a different kind of dementia than we normally see in ALS patients, which is frontotemporal dementia,” Dr. Schulz said.

Previous work has shown some degree of cognitive impairment in about 50% of patients with ALS.

Dr. Schulz disclosed that he has given talks on Alzheimer's disease that were sponsored by Pfizer Inc. and Forest Pharmaceuticals Inc., which market Aricept (donepezil) and Namenda (memantine), respectively.

CHICAGO — Patients suffering from depression at the time of malignant brain astrocytoma surgery had significantly reduced survival compared with nondepressed patients in a retrospective analysis of 1,052 patients.

Although no causative association can be inferred because of the study's retrospective design, recognizing and treating preoperative depression could maximize survival in patients with malignant brain tumors, Dr. Alfredo Quiñones-Hinojosa said at the annual meeting of the American Association of Neurological Surgeons.

Currently, patient age, tumor grade, and functional status are known preoperative prognostic indicators of survival. Identification of any reversible comorbidity would be important, as malignant astrocytoma, also known as glioma or glioblastoma multiforme, typically results in death in about 1 year, even with the latest, most effective therapies.

Researchers at Johns Hopkins University in Baltimore, led by Dr. Matthew J. McGirt, analyzed the outcomes of 1,052 patients with malignant astrocytoma who underwent surgery from 1995 to 2006.

Of these patients, 605 underwent primary resection, 410 underwent secondary resection, and 37 had a biopsy only. Excluding the biopsies, 213 tumors were World Health Organization grade III and 802 tumors were grade IV.

A total of 204 patients received subtotal resection, 274 received adjuvant therapy, and 136 required subsequent resection.

Only 49 patients (5%) who were found to be taking antidepressant medication for clinical depression at the time they underwent surgery met the study's definition of having depression. All demographic and clinical characteristics were similar between the two groups, said Dr. Quiñones-Hinojosa. Their mean age was 51 years and median preoperative Karnofsky Performance Scale (KPS) score was 80. Among survivors, the median follow-up was 12 months (range 3–18 months).

In a Kaplan Meier analysis, patients with depression had more than a 40% increase in the relative risk of mortality compared with nondepressed patients (relative risk 1.41), regardless of KPS, WHO tumor grade, patient age, or clinical presentation. This association was independent of extent of resection and postoperative treatment with either adjuvant temozolomide chemotherapy or Gliadel wafer use, Dr. Quiñones-Hinojosa said.

Median survival was 7 months among patients with depression, vs. 11 months in those without depression.

At 2 years post surgery, 5% of patients with depression were alive, compared with 23% of nondepressed patients. The difference was significant, he said.

Dr. Quiñones-Hinojosa acknowledged that the investigators could not be certain that the patients' depression was not a response to the recent diagnosis of a terminal disease. In addition, many patients with clinical depression may have been undiagnosed and unmedicated, lowering the sensitivity of the classification scheme.

Discussant Stephen B. Tatter, a neurosurgery professor at Wake Forest University, Winston-Salem, N.C., said treating depression in this patient population is important as it might influence a variety of patient decisions, particularly when to stop treatment. “We don't want just to prolong life but to provide quality that is acceptable to patients,” Dr. Tatter said.

CHICAGO — Patients suffering from depression at the time of malignant brain astrocytoma surgery had significantly reduced survival compared with nondepressed patients in a retrospective analysis of 1,052 patients.

Although no causative association can be inferred because of the study's retrospective design, recognizing and treating preoperative depression could maximize survival in patients with malignant brain tumors, Dr. Alfredo Quiñones-Hinojosa said at the annual meeting of the American Association of Neurological Surgeons.

Currently, patient age, tumor grade, and functional status are known preoperative prognostic indicators of survival. Identification of any reversible comorbidity would be important, as malignant astrocytoma, also known as glioma or glioblastoma multiforme, typically results in death in about 1 year, even with the latest, most effective therapies.

Researchers at Johns Hopkins University in Baltimore, led by Dr. Matthew J. McGirt, analyzed the outcomes of 1,052 patients with malignant astrocytoma who underwent surgery from 1995 to 2006.

Of these patients, 605 underwent primary resection, 410 underwent secondary resection, and 37 had a biopsy only. Excluding the biopsies, 213 tumors were World Health Organization grade III and 802 tumors were grade IV.

A total of 204 patients received subtotal resection, 274 received adjuvant therapy, and 136 required subsequent resection.

Only 49 patients (5%) who were found to be taking antidepressant medication for clinical depression at the time they underwent surgery met the study's definition of having depression. All demographic and clinical characteristics were similar between the two groups, said Dr. Quiñones-Hinojosa. Their mean age was 51 years and median preoperative Karnofsky Performance Scale (KPS) score was 80. Among survivors, the median follow-up was 12 months (range 3–18 months).

In a Kaplan Meier analysis, patients with depression had more than a 40% increase in the relative risk of mortality compared with nondepressed patients (relative risk 1.41), regardless of KPS, WHO tumor grade, patient age, or clinical presentation. This association was independent of extent of resection and postoperative treatment with either adjuvant temozolomide chemotherapy or Gliadel wafer use, Dr. Quiñones-Hinojosa said.

Median survival was 7 months among patients with depression, vs. 11 months in those without depression.

At 2 years post surgery, 5% of patients with depression were alive, compared with 23% of nondepressed patients. The difference was significant, he said.

Dr. Quiñones-Hinojosa acknowledged that the investigators could not be certain that the patients' depression was not a response to the recent diagnosis of a terminal disease. In addition, many patients with clinical depression may have been undiagnosed and unmedicated, lowering the sensitivity of the classification scheme.

Discussant Stephen B. Tatter, a neurosurgery professor at Wake Forest University, Winston-Salem, N.C., said treating depression in this patient population is important as it might influence a variety of patient decisions, particularly when to stop treatment. “We don't want just to prolong life but to provide quality that is acceptable to patients,” Dr. Tatter said.

CHICAGO — Patients suffering from depression at the time of malignant brain astrocytoma surgery had significantly reduced survival compared with nondepressed patients in a retrospective analysis of 1,052 patients.

Although no causative association can be inferred because of the study's retrospective design, recognizing and treating preoperative depression could maximize survival in patients with malignant brain tumors, Dr. Alfredo Quiñones-Hinojosa said at the annual meeting of the American Association of Neurological Surgeons.

Currently, patient age, tumor grade, and functional status are known preoperative prognostic indicators of survival. Identification of any reversible comorbidity would be important, as malignant astrocytoma, also known as glioma or glioblastoma multiforme, typically results in death in about 1 year, even with the latest, most effective therapies.

Researchers at Johns Hopkins University in Baltimore, led by Dr. Matthew J. McGirt, analyzed the outcomes of 1,052 patients with malignant astrocytoma who underwent surgery from 1995 to 2006.

Of these patients, 605 underwent primary resection, 410 underwent secondary resection, and 37 had a biopsy only. Excluding the biopsies, 213 tumors were World Health Organization grade III and 802 tumors were grade IV.

A total of 204 patients received subtotal resection, 274 received adjuvant therapy, and 136 required subsequent resection.

Only 49 patients (5%) who were found to be taking antidepressant medication for clinical depression at the time they underwent surgery met the study's definition of having depression. All demographic and clinical characteristics were similar between the two groups, said Dr. Quiñones-Hinojosa. Their mean age was 51 years and median preoperative Karnofsky Performance Scale (KPS) score was 80. Among survivors, the median follow-up was 12 months (range 3–18 months).

In a Kaplan Meier analysis, patients with depression had more than a 40% increase in the relative risk of mortality compared with nondepressed patients (relative risk 1.41), regardless of KPS, WHO tumor grade, patient age, or clinical presentation. This association was independent of extent of resection and postoperative treatment with either adjuvant temozolomide chemotherapy or Gliadel wafer use, Dr. Quiñones-Hinojosa said.

Median survival was 7 months among patients with depression, vs. 11 months in those without depression.

At 2 years post surgery, 5% of patients with depression were alive, compared with 23% of nondepressed patients. The difference was significant, he said.

Dr. Quiñones-Hinojosa acknowledged that the investigators could not be certain that the patients' depression was not a response to the recent diagnosis of a terminal disease. In addition, many patients with clinical depression may have been undiagnosed and unmedicated, lowering the sensitivity of the classification scheme.

Discussant Stephen B. Tatter, a neurosurgery professor at Wake Forest University, Winston-Salem, N.C., said treating depression in this patient population is important as it might influence a variety of patient decisions, particularly when to stop treatment. “We don't want just to prolong life but to provide quality that is acceptable to patients,” Dr. Tatter said.

Patient-held vaccination records were associated with improved childhood immunization rates in an analysis of National Immunization Survey data.

The rate of up-to-date vaccinations was 84% for children with a patient-held vaccination record, 77% for those without one.

Dr. James T. McElligott, who reported the findings at the American Federation for Medical Research Southern Regional meeting in New Orleans, said that having a patient-held vaccination record was associated with a 54% increase in the odds of being up to date on immunizations, even after controlling for race/ethnicity, maternal education, poverty level, language, number of children in the home, and number of vaccine providers as part of a multivariate logistic regression analysis.

The National Vaccine Advisory Committee's Standards for Child and Adolescent Immunization Practices recommend handheld records that document each vaccine received, including the date and the name of the health care professional who administered the vaccine.

However, the impact of these cards on immunization rates has been largely undefined.

“A significant obstacle to the use of the shot card is the perception of its usefulness,” Dr. McElligott explained in an interview. “By encouraging families to keep track of their child's records and be involved in their health care, we can potentially make a significant improvement in vaccination rates.”

For the study, data were analyzed from 60,605 children in the 2004–2006 National Immunization Survey of households with children 19–35 months of age. The data were statistically weighted to represent nearly 6 million children.

A provider record of being up to date on immunizations was defined as four diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccinations; three polio; one measles; three Haemophilus influenzae type B; and three hepatitis B vaccinations.

Overall, 81% of the weighted sample, or roughly 4.8 million children, were up to date on vaccinations and 41% or 2.4 million children had a vaccination card, according to Dr. McElligott and coinvestigator Dr. Paul Darden, both of the department of pediatrics at the Medical University of South Carolina, Charleston.

Patient-held records appeared to be most useful when children had multiple vaccine providers, immunization rates of 83% vs. 72% for those without hand-held patient records, when children had mothers with low educational levels (82% vs. 73%), and when children lived in households with four or more children (76% vs. 70%). All of the differences were statistically significant and were seen across all ages.

For those below the poverty line, having a patient-held vaccination card improved the up-to-date vaccination status from 78% to 84%. For those above the poverty line, it improved the rate from 81% to 88%, Dr. McElligott reported.

Most, if not all, children in South Carolina are provided with a vaccination card at birth, but keeping those cards up to date can be a challenge, said Dr. McElligott, who acknowledged that their use is inconsistent even in his own practice. It is hoped that the study's findings will encourage greater use of the cards as part of an overall plan that incorporates other simple, validated means of improving vaccination rates.

The study was supported by the Agency for Health Care Research and Quality National Research Service Award fellowship, and the Department of Health and Human Services. The investigators had no conflict-of-interest disclosures.

Patient-held vaccination records were associated with improved childhood immunization rates in an analysis of National Immunization Survey data.

The rate of up-to-date vaccinations was 84% for children with a patient-held vaccination record, 77% for those without one.

Dr. James T. McElligott, who reported the findings at the American Federation for Medical Research Southern Regional meeting in New Orleans, said that having a patient-held vaccination record was associated with a 54% increase in the odds of being up to date on immunizations, even after controlling for race/ethnicity, maternal education, poverty level, language, number of children in the home, and number of vaccine providers as part of a multivariate logistic regression analysis.

The National Vaccine Advisory Committee's Standards for Child and Adolescent Immunization Practices recommend handheld records that document each vaccine received, including the date and the name of the health care professional who administered the vaccine.

However, the impact of these cards on immunization rates has been largely undefined.

“A significant obstacle to the use of the shot card is the perception of its usefulness,” Dr. McElligott explained in an interview. “By encouraging families to keep track of their child's records and be involved in their health care, we can potentially make a significant improvement in vaccination rates.”

For the study, data were analyzed from 60,605 children in the 2004–2006 National Immunization Survey of households with children 19–35 months of age. The data were statistically weighted to represent nearly 6 million children.

A provider record of being up to date on immunizations was defined as four diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccinations; three polio; one measles; three Haemophilus influenzae type B; and three hepatitis B vaccinations.

Overall, 81% of the weighted sample, or roughly 4.8 million children, were up to date on vaccinations and 41% or 2.4 million children had a vaccination card, according to Dr. McElligott and coinvestigator Dr. Paul Darden, both of the department of pediatrics at the Medical University of South Carolina, Charleston.

Patient-held records appeared to be most useful when children had multiple vaccine providers, immunization rates of 83% vs. 72% for those without hand-held patient records, when children had mothers with low educational levels (82% vs. 73%), and when children lived in households with four or more children (76% vs. 70%). All of the differences were statistically significant and were seen across all ages.

For those below the poverty line, having a patient-held vaccination card improved the up-to-date vaccination status from 78% to 84%. For those above the poverty line, it improved the rate from 81% to 88%, Dr. McElligott reported.

Most, if not all, children in South Carolina are provided with a vaccination card at birth, but keeping those cards up to date can be a challenge, said Dr. McElligott, who acknowledged that their use is inconsistent even in his own practice. It is hoped that the study's findings will encourage greater use of the cards as part of an overall plan that incorporates other simple, validated means of improving vaccination rates.

The study was supported by the Agency for Health Care Research and Quality National Research Service Award fellowship, and the Department of Health and Human Services. The investigators had no conflict-of-interest disclosures.

Patient-held vaccination records were associated with improved childhood immunization rates in an analysis of National Immunization Survey data.

The rate of up-to-date vaccinations was 84% for children with a patient-held vaccination record, 77% for those without one.

Dr. James T. McElligott, who reported the findings at the American Federation for Medical Research Southern Regional meeting in New Orleans, said that having a patient-held vaccination record was associated with a 54% increase in the odds of being up to date on immunizations, even after controlling for race/ethnicity, maternal education, poverty level, language, number of children in the home, and number of vaccine providers as part of a multivariate logistic regression analysis.

The National Vaccine Advisory Committee's Standards for Child and Adolescent Immunization Practices recommend handheld records that document each vaccine received, including the date and the name of the health care professional who administered the vaccine.

However, the impact of these cards on immunization rates has been largely undefined.

“A significant obstacle to the use of the shot card is the perception of its usefulness,” Dr. McElligott explained in an interview. “By encouraging families to keep track of their child's records and be involved in their health care, we can potentially make a significant improvement in vaccination rates.”

For the study, data were analyzed from 60,605 children in the 2004–2006 National Immunization Survey of households with children 19–35 months of age. The data were statistically weighted to represent nearly 6 million children.

A provider record of being up to date on immunizations was defined as four diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccinations; three polio; one measles; three Haemophilus influenzae type B; and three hepatitis B vaccinations.

Overall, 81% of the weighted sample, or roughly 4.8 million children, were up to date on vaccinations and 41% or 2.4 million children had a vaccination card, according to Dr. McElligott and coinvestigator Dr. Paul Darden, both of the department of pediatrics at the Medical University of South Carolina, Charleston.

Patient-held records appeared to be most useful when children had multiple vaccine providers, immunization rates of 83% vs. 72% for those without hand-held patient records, when children had mothers with low educational levels (82% vs. 73%), and when children lived in households with four or more children (76% vs. 70%). All of the differences were statistically significant and were seen across all ages.

For those below the poverty line, having a patient-held vaccination card improved the up-to-date vaccination status from 78% to 84%. For those above the poverty line, it improved the rate from 81% to 88%, Dr. McElligott reported.

Most, if not all, children in South Carolina are provided with a vaccination card at birth, but keeping those cards up to date can be a challenge, said Dr. McElligott, who acknowledged that their use is inconsistent even in his own practice. It is hoped that the study's findings will encourage greater use of the cards as part of an overall plan that incorporates other simple, validated means of improving vaccination rates.

The study was supported by the Agency for Health Care Research and Quality National Research Service Award fellowship, and the Department of Health and Human Services. The investigators had no conflict-of-interest disclosures.

CHICAGO — Hypoglycemic episodes increase the risk of dementia in elderly patients with diabetes, according to the first study to evaluate the association in this older patient population.

The findings suggest that possible benefits of tight glycemic control in the elderly should be weighed against potentially negative consequences on the aging brain, Dr. Rachel A. Whitmer and associates reported in a poster at the annual meeting of the American Academy of Neurology.

“We are just starting to learn that having people very tightly controlled, if they are elderly, may not be the best thing,” she said in an interview.

The analysis looked at 16,806 elderly patients with type 1 and type 2 diabetes from the Kaiser Permanente of Northern California Diabetes Registry. The patients' mean age was 66 years, 55% were male, 60% were white, and 16,667 had type 2 diabetes.

The researchers identified 1,510 patients from this larger cohort who were hospitalized at least once for hypoglycemia from 1998 to 2003. The same patient records were checked again between 2003 and Jan. 15, 2007, and 1,837 patients (11% of the total) had a diagnosis of dementia.

Compared with those with no episodes, patients with at least one hypoglycemic episode had a 45% increased risk of dementia (hazard ratio 1.45), whereas those with at least two episodes had a twofold increased risk (HR 2.27), and those with at least three episodes had a threefold increased risk of dementia (HR 3.52), after adjusting for age, body mass index, race, education, gender, and duration of diabetes.

The effect remained strong after further adjustment of the data for hypertension, stroke, cardiovascular disease and end-stage renal disease (HR 1.42 for at least one event, 1.91 for at least two events, and 2.98 for at least three events); and after final adjustments for glycosylated hemoglobin levels and diabetes treatment (HR 1.36, 1.81, and 2.20 for at least one, two and three events, respectively), said Dr. Whitmer, an investigator with the research division, Kaiser Permanente, Oakland, Calif.

Of the 1,510 patients with reported hypoglycemic events, 589 were receiving only insulin, 446 only oral hypoglycemic agents, 358 both insulin and oral hypoglycemic agents, and 117 were on a diabetes diet only.

To address the potential for reverse causality, in which patients might have early dementia not diagnosed in their charts that could cause them to stop taking their diabetes medications and develop hypoglycemia, the investigators evaluated 929 cases in which dementia was diagnosed only after 2005. The effect of severe hypoglycemia on dementia was even more robust in the 2-year lag model, with hazard ratios of 1.22 (for at least one episode), 1.93 (for at least two episodes), and 2.85 (for at least three episodes), after adjustment for all variables.

“[Elderly diabetics] are a more vulnerable group… we need to have a better understanding of how glycemic control could affect brain health,” said Dr. Whitmer.”

CHICAGO — Hypoglycemic episodes increase the risk of dementia in elderly patients with diabetes, according to the first study to evaluate the association in this older patient population.

The findings suggest that possible benefits of tight glycemic control in the elderly should be weighed against potentially negative consequences on the aging brain, Dr. Rachel A. Whitmer and associates reported in a poster at the annual meeting of the American Academy of Neurology.

“We are just starting to learn that having people very tightly controlled, if they are elderly, may not be the best thing,” she said in an interview.

The analysis looked at 16,806 elderly patients with type 1 and type 2 diabetes from the Kaiser Permanente of Northern California Diabetes Registry. The patients' mean age was 66 years, 55% were male, 60% were white, and 16,667 had type 2 diabetes.

The researchers identified 1,510 patients from this larger cohort who were hospitalized at least once for hypoglycemia from 1998 to 2003. The same patient records were checked again between 2003 and Jan. 15, 2007, and 1,837 patients (11% of the total) had a diagnosis of dementia.

Compared with those with no episodes, patients with at least one hypoglycemic episode had a 45% increased risk of dementia (hazard ratio 1.45), whereas those with at least two episodes had a twofold increased risk (HR 2.27), and those with at least three episodes had a threefold increased risk of dementia (HR 3.52), after adjusting for age, body mass index, race, education, gender, and duration of diabetes.

The effect remained strong after further adjustment of the data for hypertension, stroke, cardiovascular disease and end-stage renal disease (HR 1.42 for at least one event, 1.91 for at least two events, and 2.98 for at least three events); and after final adjustments for glycosylated hemoglobin levels and diabetes treatment (HR 1.36, 1.81, and 2.20 for at least one, two and three events, respectively), said Dr. Whitmer, an investigator with the research division, Kaiser Permanente, Oakland, Calif.

Of the 1,510 patients with reported hypoglycemic events, 589 were receiving only insulin, 446 only oral hypoglycemic agents, 358 both insulin and oral hypoglycemic agents, and 117 were on a diabetes diet only.

To address the potential for reverse causality, in which patients might have early dementia not diagnosed in their charts that could cause them to stop taking their diabetes medications and develop hypoglycemia, the investigators evaluated 929 cases in which dementia was diagnosed only after 2005. The effect of severe hypoglycemia on dementia was even more robust in the 2-year lag model, with hazard ratios of 1.22 (for at least one episode), 1.93 (for at least two episodes), and 2.85 (for at least three episodes), after adjustment for all variables.

“[Elderly diabetics] are a more vulnerable group… we need to have a better understanding of how glycemic control could affect brain health,” said Dr. Whitmer.”

CHICAGO — Hypoglycemic episodes increase the risk of dementia in elderly patients with diabetes, according to the first study to evaluate the association in this older patient population.

The findings suggest that possible benefits of tight glycemic control in the elderly should be weighed against potentially negative consequences on the aging brain, Dr. Rachel A. Whitmer and associates reported in a poster at the annual meeting of the American Academy of Neurology.

“We are just starting to learn that having people very tightly controlled, if they are elderly, may not be the best thing,” she said in an interview.

The analysis looked at 16,806 elderly patients with type 1 and type 2 diabetes from the Kaiser Permanente of Northern California Diabetes Registry. The patients' mean age was 66 years, 55% were male, 60% were white, and 16,667 had type 2 diabetes.

The researchers identified 1,510 patients from this larger cohort who were hospitalized at least once for hypoglycemia from 1998 to 2003. The same patient records were checked again between 2003 and Jan. 15, 2007, and 1,837 patients (11% of the total) had a diagnosis of dementia.

Compared with those with no episodes, patients with at least one hypoglycemic episode had a 45% increased risk of dementia (hazard ratio 1.45), whereas those with at least two episodes had a twofold increased risk (HR 2.27), and those with at least three episodes had a threefold increased risk of dementia (HR 3.52), after adjusting for age, body mass index, race, education, gender, and duration of diabetes.

The effect remained strong after further adjustment of the data for hypertension, stroke, cardiovascular disease and end-stage renal disease (HR 1.42 for at least one event, 1.91 for at least two events, and 2.98 for at least three events); and after final adjustments for glycosylated hemoglobin levels and diabetes treatment (HR 1.36, 1.81, and 2.20 for at least one, two and three events, respectively), said Dr. Whitmer, an investigator with the research division, Kaiser Permanente, Oakland, Calif.

Of the 1,510 patients with reported hypoglycemic events, 589 were receiving only insulin, 446 only oral hypoglycemic agents, 358 both insulin and oral hypoglycemic agents, and 117 were on a diabetes diet only.

To address the potential for reverse causality, in which patients might have early dementia not diagnosed in their charts that could cause them to stop taking their diabetes medications and develop hypoglycemia, the investigators evaluated 929 cases in which dementia was diagnosed only after 2005. The effect of severe hypoglycemia on dementia was even more robust in the 2-year lag model, with hazard ratios of 1.22 (for at least one episode), 1.93 (for at least two episodes), and 2.85 (for at least three episodes), after adjustment for all variables.

“[Elderly diabetics] are a more vulnerable group… we need to have a better understanding of how glycemic control could affect brain health,” said Dr. Whitmer.”

CHICAGO — Burn victims who are regular smokers prior to their injuries have poorer outcomes than do nonsmokers, data presented at the annual meeting of the American Burn Association suggest.

In a retrospective analysis of 240 patients, smokers had significantly more surgical procedures than did nonsmokers (1.3 vs. 0.8) and significantly longer hospital stays (13 vs. 9.5 days).

Additionally, smokers had an 85% increased risk of infection during inpatient treatment, said lead investigator Neal Doran, Ph.D., of the University of California, San Diego. The infection rate was 51% in smokers and 36% in nonsmokers, a significant difference.

The study included 80 patients, mean age 35 years, who smoked at least weekly, and 160 nonsmokers, mean age 37 years. The total body surface area burned was similar between smokers (average 7%, range 0.5%-35%) and nonsmokers (average 6%, range 0.3%-36%). The source of burns was flame in roughly 50% of cases, scald in 20%, contact burns in 10%, and chemical, tar, steam, and sunburns in the remainder.

Impaired wound healing, defined as skin graft failure, was not significantly different between smokers and nonsmokers (10% vs. 3%), Dr. Doran said. Impaired wound healing likely was not statistically different between groups because of the relatively few graft failures in either group, and also because graft failure—as a measure of wound healing—represents the extreme negative end of the healing continuum. Still, smokers were almost four times as likely to have graft failure compared with nonsmokers (odds ratio 3.95).

Previous studies have shown that smoking is a significant impediment to wound healing because of the effects of the various chemical components of cigarette smoke such as nicotine, carbon monoxide, and hydrogen cyanide—all of which inhibit oxygen delivery to the wound site.

Because of the longer hospital stays, the cost of treatment was about $3,150 more per smoker, not including the cost of surgeries.

Burn patients are three times more likely to smoke. "When someone has had a health scare, it is an ideal time to provide a motivational intervention intended to change [that person's] behavior," he said.

An audience member observed that 55% of smokers had flame burns and that this uncommon burn pattern results in deeper tissue injuriest that may account for the longer healing times reported among smokers. Dr. Doran responded that the rate of flame burns was not significantly different between the two groups, with 46% of nonsmokers also having flame burns.

Limitations of the study, conducted by Dr. Doran and associates, include the lack of information on the exact number of cigarettes smoked prior to injury and smoking status during hospitalization. Postdischarge outcomes are currently being analyzed.

CHICAGO — Burn victims who are regular smokers prior to their injuries have poorer outcomes than do nonsmokers, data presented at the annual meeting of the American Burn Association suggest.

In a retrospective analysis of 240 patients, smokers had significantly more surgical procedures than did nonsmokers (1.3 vs. 0.8) and significantly longer hospital stays (13 vs. 9.5 days).

Additionally, smokers had an 85% increased risk of infection during inpatient treatment, said lead investigator Neal Doran, Ph.D., of the University of California, San Diego. The infection rate was 51% in smokers and 36% in nonsmokers, a significant difference.

The study included 80 patients, mean age 35 years, who smoked at least weekly, and 160 nonsmokers, mean age 37 years. The total body surface area burned was similar between smokers (average 7%, range 0.5%-35%) and nonsmokers (average 6%, range 0.3%-36%). The source of burns was flame in roughly 50% of cases, scald in 20%, contact burns in 10%, and chemical, tar, steam, and sunburns in the remainder.

Impaired wound healing, defined as skin graft failure, was not significantly different between smokers and nonsmokers (10% vs. 3%), Dr. Doran said. Impaired wound healing likely was not statistically different between groups because of the relatively few graft failures in either group, and also because graft failure—as a measure of wound healing—represents the extreme negative end of the healing continuum. Still, smokers were almost four times as likely to have graft failure compared with nonsmokers (odds ratio 3.95).

Previous studies have shown that smoking is a significant impediment to wound healing because of the effects of the various chemical components of cigarette smoke such as nicotine, carbon monoxide, and hydrogen cyanide—all of which inhibit oxygen delivery to the wound site.

Because of the longer hospital stays, the cost of treatment was about $3,150 more per smoker, not including the cost of surgeries.

Burn patients are three times more likely to smoke. "When someone has had a health scare, it is an ideal time to provide a motivational intervention intended to change [that person's] behavior," he said.

An audience member observed that 55% of smokers had flame burns and that this uncommon burn pattern results in deeper tissue injuriest that may account for the longer healing times reported among smokers. Dr. Doran responded that the rate of flame burns was not significantly different between the two groups, with 46% of nonsmokers also having flame burns.

Limitations of the study, conducted by Dr. Doran and associates, include the lack of information on the exact number of cigarettes smoked prior to injury and smoking status during hospitalization. Postdischarge outcomes are currently being analyzed.

CHICAGO — Burn victims who are regular smokers prior to their injuries have poorer outcomes than do nonsmokers, data presented at the annual meeting of the American Burn Association suggest.

In a retrospective analysis of 240 patients, smokers had significantly more surgical procedures than did nonsmokers (1.3 vs. 0.8) and significantly longer hospital stays (13 vs. 9.5 days).

Additionally, smokers had an 85% increased risk of infection during inpatient treatment, said lead investigator Neal Doran, Ph.D., of the University of California, San Diego. The infection rate was 51% in smokers and 36% in nonsmokers, a significant difference.

The study included 80 patients, mean age 35 years, who smoked at least weekly, and 160 nonsmokers, mean age 37 years. The total body surface area burned was similar between smokers (average 7%, range 0.5%-35%) and nonsmokers (average 6%, range 0.3%-36%). The source of burns was flame in roughly 50% of cases, scald in 20%, contact burns in 10%, and chemical, tar, steam, and sunburns in the remainder.

Impaired wound healing, defined as skin graft failure, was not significantly different between smokers and nonsmokers (10% vs. 3%), Dr. Doran said. Impaired wound healing likely was not statistically different between groups because of the relatively few graft failures in either group, and also because graft failure—as a measure of wound healing—represents the extreme negative end of the healing continuum. Still, smokers were almost four times as likely to have graft failure compared with nonsmokers (odds ratio 3.95).

Previous studies have shown that smoking is a significant impediment to wound healing because of the effects of the various chemical components of cigarette smoke such as nicotine, carbon monoxide, and hydrogen cyanide—all of which inhibit oxygen delivery to the wound site.

Because of the longer hospital stays, the cost of treatment was about $3,150 more per smoker, not including the cost of surgeries.

Burn patients are three times more likely to smoke. "When someone has had a health scare, it is an ideal time to provide a motivational intervention intended to change [that person's] behavior," he said.

An audience member observed that 55% of smokers had flame burns and that this uncommon burn pattern results in deeper tissue injuriest that may account for the longer healing times reported among smokers. Dr. Doran responded that the rate of flame burns was not significantly different between the two groups, with 46% of nonsmokers also having flame burns.

Limitations of the study, conducted by Dr. Doran and associates, include the lack of information on the exact number of cigarettes smoked prior to injury and smoking status during hospitalization. Postdischarge outcomes are currently being analyzed.

CHICAGO — Spray recombinant human thrombin achieved hemostasis within 20 minutes in 91.5% of patients following burn wound excision in a prospective safety study in 71 patients.

Recombinant human thrombin (rThrombin) was also minimally immunogenic, principal investigator Dr. David G. Greenhalgh said at the annual meeting of the American Burn Association (ABA).

One patient had specific, low-titer antibodies to rThrombin at baseline, but no increase in titer post treatment. A second patient developed non-neutralizing antibodies to rThrombin at day 29.

The findings are encouraging because rThrombin was developed as an alternative to bovine plasma-derived thrombin, which has been available since the 1940s, but carries a black box warning about severe bleeding risks associated with potential antibody development, explained Dr. Greenhalgh, professor and chief of burn surgery, University of California, Davis. Roughly 20%-90% of patients treated with topical bovine thrombin develop antibodies to the preparation.

In January 2008, the Food and Drug Administration approved Recothrom, the first and only rThrombin for use as a topical hemostat in combination with an absorbable gelatin sponge. The product is devoid of human or animal plasma proteins, which also minimizes the risk of pathogen transmission, he said.

The current open-label, multiple-site study evaluated the safety of spray rThrombin in 71 patients, aged 2–75 years, who received a partial- or full-thickness autologous sheet or mesh graft following excision of burn wounds covering 1%-4% of their total body surface area. The spray was applied at 5-minute intervals for up to 20 minutes. Sheet grafts were received by 53 patients and mesh grafts by 18.

Hemostasis was achieved without the use of tourniquets or clysis, which makes the 91.5% hemostasis rate even more impressive, because both reduce the rate of bleeding, Dr. Greenhalgh said.

At day 29, one graft was infected and four grafts failed. Other adverse events reported were pain (25 patients), pruritus (18), deep vein thrombosis (1), adult respiratory distress syndrome (1), and GI hemorrhage (1).

There were no study drug discontinuations or deaths in the study, which was sponsored by ZymoGenetics Inc. (Seattle); the company markets rThrombin in the United States as Recothrom.

Session moderator and former ABA president Dr. Glenn D. Warden asked whether immunogenicity might be a concern with repeated use of rThrombin over larger wounds.

Dr. Greenhalgh answered that it would be beneficial to conduct a study to evaluate repeated use, but that he felt better about human recombinant products than bovine plasma-based products because of their reduced risk of viral transfer and antibody development.

When asked if human recombinant products were too costly for regular use, Dr. Greenhalgh said, "It's not something that's going to break the bank … I think it's going to be reasonable, compared to what's available."

Dr. Greenhalgh, who reported no conflicts of interest, said he uses spray rThrombin in combination with tourniquets for excisions on hands or arms and in combination with topical and injected epinephrine and cautery for large tangential excisions on the trunk.

CHICAGO — Spray recombinant human thrombin achieved hemostasis within 20 minutes in 91.5% of patients following burn wound excision in a prospective safety study in 71 patients.

Recombinant human thrombin (rThrombin) was also minimally immunogenic, principal investigator Dr. David G. Greenhalgh said at the annual meeting of the American Burn Association (ABA).

One patient had specific, low-titer antibodies to rThrombin at baseline, but no increase in titer post treatment. A second patient developed non-neutralizing antibodies to rThrombin at day 29.

The findings are encouraging because rThrombin was developed as an alternative to bovine plasma-derived thrombin, which has been available since the 1940s, but carries a black box warning about severe bleeding risks associated with potential antibody development, explained Dr. Greenhalgh, professor and chief of burn surgery, University of California, Davis. Roughly 20%-90% of patients treated with topical bovine thrombin develop antibodies to the preparation.

In January 2008, the Food and Drug Administration approved Recothrom, the first and only rThrombin for use as a topical hemostat in combination with an absorbable gelatin sponge. The product is devoid of human or animal plasma proteins, which also minimizes the risk of pathogen transmission, he said.

The current open-label, multiple-site study evaluated the safety of spray rThrombin in 71 patients, aged 2–75 years, who received a partial- or full-thickness autologous sheet or mesh graft following excision of burn wounds covering 1%-4% of their total body surface area. The spray was applied at 5-minute intervals for up to 20 minutes. Sheet grafts were received by 53 patients and mesh grafts by 18.

Hemostasis was achieved without the use of tourniquets or clysis, which makes the 91.5% hemostasis rate even more impressive, because both reduce the rate of bleeding, Dr. Greenhalgh said.

At day 29, one graft was infected and four grafts failed. Other adverse events reported were pain (25 patients), pruritus (18), deep vein thrombosis (1), adult respiratory distress syndrome (1), and GI hemorrhage (1).

There were no study drug discontinuations or deaths in the study, which was sponsored by ZymoGenetics Inc. (Seattle); the company markets rThrombin in the United States as Recothrom.

Session moderator and former ABA president Dr. Glenn D. Warden asked whether immunogenicity might be a concern with repeated use of rThrombin over larger wounds.

Dr. Greenhalgh answered that it would be beneficial to conduct a study to evaluate repeated use, but that he felt better about human recombinant products than bovine plasma-based products because of their reduced risk of viral transfer and antibody development.

When asked if human recombinant products were too costly for regular use, Dr. Greenhalgh said, "It's not something that's going to break the bank … I think it's going to be reasonable, compared to what's available."

Dr. Greenhalgh, who reported no conflicts of interest, said he uses spray rThrombin in combination with tourniquets for excisions on hands or arms and in combination with topical and injected epinephrine and cautery for large tangential excisions on the trunk.

CHICAGO — Spray recombinant human thrombin achieved hemostasis within 20 minutes in 91.5% of patients following burn wound excision in a prospective safety study in 71 patients.

Recombinant human thrombin (rThrombin) was also minimally immunogenic, principal investigator Dr. David G. Greenhalgh said at the annual meeting of the American Burn Association (ABA).

One patient had specific, low-titer antibodies to rThrombin at baseline, but no increase in titer post treatment. A second patient developed non-neutralizing antibodies to rThrombin at day 29.

The findings are encouraging because rThrombin was developed as an alternative to bovine plasma-derived thrombin, which has been available since the 1940s, but carries a black box warning about severe bleeding risks associated with potential antibody development, explained Dr. Greenhalgh, professor and chief of burn surgery, University of California, Davis. Roughly 20%-90% of patients treated with topical bovine thrombin develop antibodies to the preparation.

In January 2008, the Food and Drug Administration approved Recothrom, the first and only rThrombin for use as a topical hemostat in combination with an absorbable gelatin sponge. The product is devoid of human or animal plasma proteins, which also minimizes the risk of pathogen transmission, he said.

The current open-label, multiple-site study evaluated the safety of spray rThrombin in 71 patients, aged 2–75 years, who received a partial- or full-thickness autologous sheet or mesh graft following excision of burn wounds covering 1%-4% of their total body surface area. The spray was applied at 5-minute intervals for up to 20 minutes. Sheet grafts were received by 53 patients and mesh grafts by 18.

Hemostasis was achieved without the use of tourniquets or clysis, which makes the 91.5% hemostasis rate even more impressive, because both reduce the rate of bleeding, Dr. Greenhalgh said.

At day 29, one graft was infected and four grafts failed. Other adverse events reported were pain (25 patients), pruritus (18), deep vein thrombosis (1), adult respiratory distress syndrome (1), and GI hemorrhage (1).

There were no study drug discontinuations or deaths in the study, which was sponsored by ZymoGenetics Inc. (Seattle); the company markets rThrombin in the United States as Recothrom.

Session moderator and former ABA president Dr. Glenn D. Warden asked whether immunogenicity might be a concern with repeated use of rThrombin over larger wounds.

Dr. Greenhalgh answered that it would be beneficial to conduct a study to evaluate repeated use, but that he felt better about human recombinant products than bovine plasma-based products because of their reduced risk of viral transfer and antibody development.

When asked if human recombinant products were too costly for regular use, Dr. Greenhalgh said, "It's not something that's going to break the bank … I think it's going to be reasonable, compared to what's available."

Dr. Greenhalgh, who reported no conflicts of interest, said he uses spray rThrombin in combination with tourniquets for excisions on hands or arms and in combination with topical and injected epinephrine and cautery for large tangential excisions on the trunk.

Patient-held vaccination records were associated with improved childhood immunization rates in an analysis of National Immunization Survey data.

The rate of up-to-date vaccinations was 84% for children with a patient-held vaccination record and 77% for those without one.

Dr. James T. McElligott, who reported the findings at the American Federation for Medical Research Southern Regional meeting in New Orleans, said that having a patient-held vaccination record was associated with a 54% increase in the odds of being up to date on immunizations, even after controlling for race/ethnicity, maternal education, poverty level, language, number of children in the home, and number of vaccine providers as part of a multivariate logistic regression analysis.

The National Vaccine Advisory Committee's Standards for Child and Adolescent Immunization Practices recommend handheld records that document each vaccine received, including the date and the name of the health care professional who administered the vaccine.

The impact of these cards on immunization rates, however, has been largely undefined.

"A significant obstacle to the use of the shot card is the perception of its usefulness," Dr. McElligott explained in an interview. "By encouraging families to keep track of their child's records and be involved in their health care, we can potentially make a significant improvement in vaccination rates," he said.

For the study, data were analyzed from 60,605 children in the 2004–2006 National Immunization Survey of households with children 19–35 months of age.

The data were statistically weighted to represent nearly 6 million children, Dr. McElligott said.

A provider record of being up to date on immunizations was defined as four diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccinations; three polio; one measles; three Haemophilus influenzae type B; and three hepatitis B vaccinations.

Overall, 81% of the weighted sample, or roughly 4.8 million children, were up to date on vaccinations and 41% or 2.4 million children had a vaccination card, according to Dr. McElligott and his coinvestigator Dr. Paul Darden, who are both with the department of pediatrics at the Medical University of South Carolina in Charleston.

Patient-held records appeared to be most useful when children had multiple vaccine providers, immunization rates of 83% vs. 72% for those without hand-held patient records, when children had mothers with low educational levels (82% vs. 73%), and when children lived in households with four or more children (76% vs. 70%).

All of the differences were statistically significant P < .01 and were seen across all ages.

For those below the poverty line, having a patient-held vaccination card improved the up-to-date vaccination status from 78% to 84%.

For those above the poverty line, it improved the rate from 81% to 88%, Dr. McElligott reported.

Most, if not all, of the children in South Carolina are provided with a vaccination card at birth, but keeping those cards up to date can be a challenge, explained Dr. McElligott, who acknowledged that their use is inconsistent even in his own practice.

It is hoped that the findings of this study will encourage greater use of the cards as part of an overall plan that incorporates other simple, validated means of improving vaccination rates in physicians' practices.

The study was supported by the Agency for Health Care Research and Quality National Research Service Award fellowship, and the Department of Health and Human Services.

The investigators had no personal disclosures to make.

Patient-held vaccination records were associated with improved childhood immunization rates in an analysis of National Immunization Survey data.

The rate of up-to-date vaccinations was 84% for children with a patient-held vaccination record and 77% for those without one.

Dr. James T. McElligott, who reported the findings at the American Federation for Medical Research Southern Regional meeting in New Orleans, said that having a patient-held vaccination record was associated with a 54% increase in the odds of being up to date on immunizations, even after controlling for race/ethnicity, maternal education, poverty level, language, number of children in the home, and number of vaccine providers as part of a multivariate logistic regression analysis.

The National Vaccine Advisory Committee's Standards for Child and Adolescent Immunization Practices recommend handheld records that document each vaccine received, including the date and the name of the health care professional who administered the vaccine.

The impact of these cards on immunization rates, however, has been largely undefined.

"A significant obstacle to the use of the shot card is the perception of its usefulness," Dr. McElligott explained in an interview. "By encouraging families to keep track of their child's records and be involved in their health care, we can potentially make a significant improvement in vaccination rates," he said.

For the study, data were analyzed from 60,605 children in the 2004–2006 National Immunization Survey of households with children 19–35 months of age.

The data were statistically weighted to represent nearly 6 million children, Dr. McElligott said.

A provider record of being up to date on immunizations was defined as four diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccinations; three polio; one measles; three Haemophilus influenzae type B; and three hepatitis B vaccinations.

Overall, 81% of the weighted sample, or roughly 4.8 million children, were up to date on vaccinations and 41% or 2.4 million children had a vaccination card, according to Dr. McElligott and his coinvestigator Dr. Paul Darden, who are both with the department of pediatrics at the Medical University of South Carolina in Charleston.

Patient-held records appeared to be most useful when children had multiple vaccine providers, immunization rates of 83% vs. 72% for those without hand-held patient records, when children had mothers with low educational levels (82% vs. 73%), and when children lived in households with four or more children (76% vs. 70%).

All of the differences were statistically significant P < .01 and were seen across all ages.

For those below the poverty line, having a patient-held vaccination card improved the up-to-date vaccination status from 78% to 84%.

For those above the poverty line, it improved the rate from 81% to 88%, Dr. McElligott reported.

Most, if not all, of the children in South Carolina are provided with a vaccination card at birth, but keeping those cards up to date can be a challenge, explained Dr. McElligott, who acknowledged that their use is inconsistent even in his own practice.

It is hoped that the findings of this study will encourage greater use of the cards as part of an overall plan that incorporates other simple, validated means of improving vaccination rates in physicians' practices.

The study was supported by the Agency for Health Care Research and Quality National Research Service Award fellowship, and the Department of Health and Human Services.

The investigators had no personal disclosures to make.

Patient-held vaccination records were associated with improved childhood immunization rates in an analysis of National Immunization Survey data.

The rate of up-to-date vaccinations was 84% for children with a patient-held vaccination record and 77% for those without one.

Dr. James T. McElligott, who reported the findings at the American Federation for Medical Research Southern Regional meeting in New Orleans, said that having a patient-held vaccination record was associated with a 54% increase in the odds of being up to date on immunizations, even after controlling for race/ethnicity, maternal education, poverty level, language, number of children in the home, and number of vaccine providers as part of a multivariate logistic regression analysis.

The National Vaccine Advisory Committee's Standards for Child and Adolescent Immunization Practices recommend handheld records that document each vaccine received, including the date and the name of the health care professional who administered the vaccine.

The impact of these cards on immunization rates, however, has been largely undefined.

"A significant obstacle to the use of the shot card is the perception of its usefulness," Dr. McElligott explained in an interview. "By encouraging families to keep track of their child's records and be involved in their health care, we can potentially make a significant improvement in vaccination rates," he said.

For the study, data were analyzed from 60,605 children in the 2004–2006 National Immunization Survey of households with children 19–35 months of age.

The data were statistically weighted to represent nearly 6 million children, Dr. McElligott said.

A provider record of being up to date on immunizations was defined as four diphtheria toxoid, tetanus toxoid, and acellular pertussis vaccinations; three polio; one measles; three Haemophilus influenzae type B; and three hepatitis B vaccinations.

Overall, 81% of the weighted sample, or roughly 4.8 million children, were up to date on vaccinations and 41% or 2.4 million children had a vaccination card, according to Dr. McElligott and his coinvestigator Dr. Paul Darden, who are both with the department of pediatrics at the Medical University of South Carolina in Charleston.

Patient-held records appeared to be most useful when children had multiple vaccine providers, immunization rates of 83% vs. 72% for those without hand-held patient records, when children had mothers with low educational levels (82% vs. 73%), and when children lived in households with four or more children (76% vs. 70%).

All of the differences were statistically significant P < .01 and were seen across all ages.

For those below the poverty line, having a patient-held vaccination card improved the up-to-date vaccination status from 78% to 84%.

For those above the poverty line, it improved the rate from 81% to 88%, Dr. McElligott reported.

Most, if not all, of the children in South Carolina are provided with a vaccination card at birth, but keeping those cards up to date can be a challenge, explained Dr. McElligott, who acknowledged that their use is inconsistent even in his own practice.

It is hoped that the findings of this study will encourage greater use of the cards as part of an overall plan that incorporates other simple, validated means of improving vaccination rates in physicians' practices.

The study was supported by the Agency for Health Care Research and Quality National Research Service Award fellowship, and the Department of Health and Human Services.

The investigators had no personal disclosures to make.

CHICAGO — The modified Keystone Island skin flap avoids the need for skin grafting in most patients with lower limb primary melanoma, a prospective study from Australia suggests.

The flap, which takes its name from architectural terminology because of its curvilinear, trapezoidal shape, is technically straightforward to perform, substantially reduces hospitalization, and affords better cosmesis compared with skin grafting, investigator Marc Moncrieff said at a symposium sponsored by the Society of Surgical Oncology. The flap also can be used in patients with significant comorbidities that are often regarded as contraindications for fasciocutaneous flap reconstruction in the lower limb.

"Defects resulting from incision of primary melanomas in the lower limb can usually be reconstructed using the modified Keystone flap," he said. "In our experience, a skin graft is rarely required."

Dr. Moncrieff and associates reported on a prospective cohort of 176 consecutive patients, mean age 57 years (range 21–93), with stage I or II invasive primary cutaneous melanoma treated over a 3-year-period at the Sydney Melanoma Unit, where Dr. Moncrieff is a fellow and the Keystone flap is the standard reconstruction technique for lower limb primary melanoma defects.

Major complications were reported in 5 (2.8%) patients. These included one partial flap necrosis, one total flap loss, two infections, and one deep vein thrombosis. Minor complications, including transient neuralgia, minor wound problems, and seroma, were reported in 8 patients (4.5%).

At baseline, the average Breslow thickness was 1.33 mm (range in situ to 9.0 mm), average radial margin 1.5 cm (0.5–2.0 cm), and average defect width 3 cm (1.1–6.3 cm).

The flaps were performed from the proximal lower leg to the dorsum of the foot, with 14% performed on the upper-third of the lower leg, 45% on the middle-third, and 41% on the lower-third. There was no significant increase in complications in the distal third of the limb, a traditionally difficult area to close because of its anatomical tightness, he said.

The reconstructions included 106 standard Keystone flaps, 65 modified, and 5 double-opposing type flaps. Modification of the flap design significantly reduced the major complication rate, and all double-opposing flaps healed without incident.

The standard Keystone flap originally reported by fellow Australian Dr. Felix Behan (ANZ J Surg. 2003;73:112–20) is essentially two conjoined V-Y flaps end to side that are advanced to fill the defect.

Surgeons at the Sydney Melanoma Unit modified the flap by dividing the lateral deep fascia margin to allow for adequate advancement of the flap and to improve vascularity. For larger defects, two opposing Keystone flaps can be used to fill the defect. In all three types, once the skin is incised, the subcutaneous tissue is divided by blunt dissection to preserve the integrity of the vascular network, including the fascial and muscular perforators.

Because the skin is taken from the surrounding tissue, the color match is superior to that of split-thickness skin grafts, which are typically taken from the abdomen, and can result in a crocodile-like appearance of the skin and lengthy rehabilitation, Dr. Moncrieff said.

Dr. Michael Sabel, session moderator, acknowledged that the Keystone flap is "a great improvement" over the split-thickness skin graft, but that the full-thickness skin graft is a simple and widely used technique that provides well-matched tissue from the sentinel lymph node biopsy site or abdomen, with its main disadvantage being that patients are typically immobilized for 5 days.

Dr. Moncrieff responded that the Keystone flap can be performed in the same amount of time as a full-thickness graft and that most patients elevate their limb overnight and return home and walk the next day. Of the 176 patients, 39 (22%) had the procedure performed in a day-case setting.

An audience member questioned whether the technique can be used to fill larger defects or upper limb defects. The modified Keystone flap has been used to reconstruct distal upper limb defects, and requires no special allowances when closing larger defects, said Dr. Moncrieff, who reported no conflicts of interest.

CHICAGO — The modified Keystone Island skin flap avoids the need for skin grafting in most patients with lower limb primary melanoma, a prospective study from Australia suggests.

The flap, which takes its name from architectural terminology because of its curvilinear, trapezoidal shape, is technically straightforward to perform, substantially reduces hospitalization, and affords better cosmesis compared with skin grafting, investigator Marc Moncrieff said at a symposium sponsored by the Society of Surgical Oncology. The flap also can be used in patients with significant comorbidities that are often regarded as contraindications for fasciocutaneous flap reconstruction in the lower limb.

"Defects resulting from incision of primary melanomas in the lower limb can usually be reconstructed using the modified Keystone flap," he said. "In our experience, a skin graft is rarely required."

Dr. Moncrieff and associates reported on a prospective cohort of 176 consecutive patients, mean age 57 years (range 21–93), with stage I or II invasive primary cutaneous melanoma treated over a 3-year-period at the Sydney Melanoma Unit, where Dr. Moncrieff is a fellow and the Keystone flap is the standard reconstruction technique for lower limb primary melanoma defects.

Major complications were reported in 5 (2.8%) patients. These included one partial flap necrosis, one total flap loss, two infections, and one deep vein thrombosis. Minor complications, including transient neuralgia, minor wound problems, and seroma, were reported in 8 patients (4.5%).

At baseline, the average Breslow thickness was 1.33 mm (range in situ to 9.0 mm), average radial margin 1.5 cm (0.5–2.0 cm), and average defect width 3 cm (1.1–6.3 cm).

The flaps were performed from the proximal lower leg to the dorsum of the foot, with 14% performed on the upper-third of the lower leg, 45% on the middle-third, and 41% on the lower-third. There was no significant increase in complications in the distal third of the limb, a traditionally difficult area to close because of its anatomical tightness, he said.

The reconstructions included 106 standard Keystone flaps, 65 modified, and 5 double-opposing type flaps. Modification of the flap design significantly reduced the major complication rate, and all double-opposing flaps healed without incident.

The standard Keystone flap originally reported by fellow Australian Dr. Felix Behan (ANZ J Surg. 2003;73:112–20) is essentially two conjoined V-Y flaps end to side that are advanced to fill the defect.

Surgeons at the Sydney Melanoma Unit modified the flap by dividing the lateral deep fascia margin to allow for adequate advancement of the flap and to improve vascularity. For larger defects, two opposing Keystone flaps can be used to fill the defect. In all three types, once the skin is incised, the subcutaneous tissue is divided by blunt dissection to preserve the integrity of the vascular network, including the fascial and muscular perforators.

Because the skin is taken from the surrounding tissue, the color match is superior to that of split-thickness skin grafts, which are typically taken from the abdomen, and can result in a crocodile-like appearance of the skin and lengthy rehabilitation, Dr. Moncrieff said.

Dr. Michael Sabel, session moderator, acknowledged that the Keystone flap is "a great improvement" over the split-thickness skin graft, but that the full-thickness skin graft is a simple and widely used technique that provides well-matched tissue from the sentinel lymph node biopsy site or abdomen, with its main disadvantage being that patients are typically immobilized for 5 days.

Dr. Moncrieff responded that the Keystone flap can be performed in the same amount of time as a full-thickness graft and that most patients elevate their limb overnight and return home and walk the next day. Of the 176 patients, 39 (22%) had the procedure performed in a day-case setting.

An audience member questioned whether the technique can be used to fill larger defects or upper limb defects. The modified Keystone flap has been used to reconstruct distal upper limb defects, and requires no special allowances when closing larger defects, said Dr. Moncrieff, who reported no conflicts of interest.

CHICAGO — The modified Keystone Island skin flap avoids the need for skin grafting in most patients with lower limb primary melanoma, a prospective study from Australia suggests.

The flap, which takes its name from architectural terminology because of its curvilinear, trapezoidal shape, is technically straightforward to perform, substantially reduces hospitalization, and affords better cosmesis compared with skin grafting, investigator Marc Moncrieff said at a symposium sponsored by the Society of Surgical Oncology. The flap also can be used in patients with significant comorbidities that are often regarded as contraindications for fasciocutaneous flap reconstruction in the lower limb.

"Defects resulting from incision of primary melanomas in the lower limb can usually be reconstructed using the modified Keystone flap," he said. "In our experience, a skin graft is rarely required."

Dr. Moncrieff and associates reported on a prospective cohort of 176 consecutive patients, mean age 57 years (range 21–93), with stage I or II invasive primary cutaneous melanoma treated over a 3-year-period at the Sydney Melanoma Unit, where Dr. Moncrieff is a fellow and the Keystone flap is the standard reconstruction technique for lower limb primary melanoma defects.

Major complications were reported in 5 (2.8%) patients. These included one partial flap necrosis, one total flap loss, two infections, and one deep vein thrombosis. Minor complications, including transient neuralgia, minor wound problems, and seroma, were reported in 8 patients (4.5%).

At baseline, the average Breslow thickness was 1.33 mm (range in situ to 9.0 mm), average radial margin 1.5 cm (0.5–2.0 cm), and average defect width 3 cm (1.1–6.3 cm).

The flaps were performed from the proximal lower leg to the dorsum of the foot, with 14% performed on the upper-third of the lower leg, 45% on the middle-third, and 41% on the lower-third. There was no significant increase in complications in the distal third of the limb, a traditionally difficult area to close because of its anatomical tightness, he said.

The reconstructions included 106 standard Keystone flaps, 65 modified, and 5 double-opposing type flaps. Modification of the flap design significantly reduced the major complication rate, and all double-opposing flaps healed without incident.

The standard Keystone flap originally reported by fellow Australian Dr. Felix Behan (ANZ J Surg. 2003;73:112–20) is essentially two conjoined V-Y flaps end to side that are advanced to fill the defect.

Surgeons at the Sydney Melanoma Unit modified the flap by dividing the lateral deep fascia margin to allow for adequate advancement of the flap and to improve vascularity. For larger defects, two opposing Keystone flaps can be used to fill the defect. In all three types, once the skin is incised, the subcutaneous tissue is divided by blunt dissection to preserve the integrity of the vascular network, including the fascial and muscular perforators.

Because the skin is taken from the surrounding tissue, the color match is superior to that of split-thickness skin grafts, which are typically taken from the abdomen, and can result in a crocodile-like appearance of the skin and lengthy rehabilitation, Dr. Moncrieff said.

Dr. Michael Sabel, session moderator, acknowledged that the Keystone flap is "a great improvement" over the split-thickness skin graft, but that the full-thickness skin graft is a simple and widely used technique that provides well-matched tissue from the sentinel lymph node biopsy site or abdomen, with its main disadvantage being that patients are typically immobilized for 5 days.

Dr. Moncrieff responded that the Keystone flap can be performed in the same amount of time as a full-thickness graft and that most patients elevate their limb overnight and return home and walk the next day. Of the 176 patients, 39 (22%) had the procedure performed in a day-case setting.

An audience member questioned whether the technique can be used to fill larger defects or upper limb defects. The modified Keystone flap has been used to reconstruct distal upper limb defects, and requires no special allowances when closing larger defects, said Dr. Moncrieff, who reported no conflicts of interest.

DALLAS — Supplementation with vitamins C and E did not prevent preeclampsia, reduce its severity, or lower adverse neonatal outcomes in a World Health Organization randomized trial of 1,365 high-risk women.

The observed negative results are consistent with those of most previous antioxidant trials, although none of the previously reported adverse effects, such as earlier and more severe preeclampsia or reduced birth weight, were observed in the current trial, Dr. Mario Merialdi said at the annual meeting of the Society for Maternal-Fetal Medicine.

“We found no evidence of harm to either mother or fetus attributable to supplementation with vitamin C and E,” he said.

Still, lead investigator Dr. Jose Villar, a senior fellow in perinatal medicine at the University of Oxford (England), advised caution. “It is always of concern to give ineffective drugs to pregnant women, even if one study does not demonstrate harm,” he said in an interview.

The recent VIP (Vitamins in Preeclampsia) trial showed that concomitant vitamin C and E supplementation did not reduce preeclampsia among 2,395 women at risk, but did increase the rate of babies born with a low birth weight (Lancet 2006;367:1145–54).

The WHO trial parallels the VIP trial, but specifically targeted high-risk women with nutritional deficiencies who lived in India, Vietnam, South Africa, and Peru. Because previous failed antioxidant trials were conducted in women with adequate nutritional status, the investigators theorized that supplementing potentially vitamin-deficient women might produce beneficial results, explained Dr. Merialdi, a reproductive health specialist with WHO in Geneva.

In all, 687 women were randomized to daily vitamin C (1 g) and vitamin E (400 IU), and 678 women were randomized to placebo before gestational week 20. Their mean age was 27 years. Risk factors were similar between the intervention and control groups, including history of previous preeclampsia (217 vs. 205), chronic hypertension (163 vs. 170), and multiple pregnancies (81 vs. 100). Compliance was similar in both groups at about 87%.

Supplementation did not reduce the risk of preeclampsia (relative risk 1.0), eclampsia (RR 1.5), or severe gestational hypertension (RR 0.8). Adjustment for maternal age did not modify these results, he said. The incidence of preeclampsia was not significantly different between the intervention and placebo groups (24.5% vs. 23.3%).

The secondary outcomes of low birth weight (defined as less than 2,500 g, and found in 33% of the intervention group vs. 36% in controls), small size for gestational age (defined as less than 10th percentile, in 23% vs. 26%), and preterm delivery (defined as delivery before 37 weeks, in 21% vs. 24%) tended to be lower with supplementation, but were not statistically different (RR 0.9 for all three).

Perinatal death also tended to be lower with supplementation, but did not reach statistically significant levels (RR 0.8), and the trial was underpowered to test this outcome.

A stratified analysis of those women with a history of preeclampsia demonstrated similar rates of preeclampsia in the supplement and control groups (26% vs. 28%), said Dr. Merialdi, who reported no financial conflicts of interest.

DALLAS — Supplementation with vitamins C and E did not prevent preeclampsia, reduce its severity, or lower adverse neonatal outcomes in a World Health Organization randomized trial of 1,365 high-risk women.

The observed negative results are consistent with those of most previous antioxidant trials, although none of the previously reported adverse effects, such as earlier and more severe preeclampsia or reduced birth weight, were observed in the current trial, Dr. Mario Merialdi said at the annual meeting of the Society for Maternal-Fetal Medicine.

“We found no evidence of harm to either mother or fetus attributable to supplementation with vitamin C and E,” he said.

Still, lead investigator Dr. Jose Villar, a senior fellow in perinatal medicine at the University of Oxford (England), advised caution. “It is always of concern to give ineffective drugs to pregnant women, even if one study does not demonstrate harm,” he said in an interview.

The recent VIP (Vitamins in Preeclampsia) trial showed that concomitant vitamin C and E supplementation did not reduce preeclampsia among 2,395 women at risk, but did increase the rate of babies born with a low birth weight (Lancet 2006;367:1145–54).

The WHO trial parallels the VIP trial, but specifically targeted high-risk women with nutritional deficiencies who lived in India, Vietnam, South Africa, and Peru. Because previous failed antioxidant trials were conducted in women with adequate nutritional status, the investigators theorized that supplementing potentially vitamin-deficient women might produce beneficial results, explained Dr. Merialdi, a reproductive health specialist with WHO in Geneva.

In all, 687 women were randomized to daily vitamin C (1 g) and vitamin E (400 IU), and 678 women were randomized to placebo before gestational week 20. Their mean age was 27 years. Risk factors were similar between the intervention and control groups, including history of previous preeclampsia (217 vs. 205), chronic hypertension (163 vs. 170), and multiple pregnancies (81 vs. 100). Compliance was similar in both groups at about 87%.

Supplementation did not reduce the risk of preeclampsia (relative risk 1.0), eclampsia (RR 1.5), or severe gestational hypertension (RR 0.8). Adjustment for maternal age did not modify these results, he said. The incidence of preeclampsia was not significantly different between the intervention and placebo groups (24.5% vs. 23.3%).

The secondary outcomes of low birth weight (defined as less than 2,500 g, and found in 33% of the intervention group vs. 36% in controls), small size for gestational age (defined as less than 10th percentile, in 23% vs. 26%), and preterm delivery (defined as delivery before 37 weeks, in 21% vs. 24%) tended to be lower with supplementation, but were not statistically different (RR 0.9 for all three).

Perinatal death also tended to be lower with supplementation, but did not reach statistically significant levels (RR 0.8), and the trial was underpowered to test this outcome.

A stratified analysis of those women with a history of preeclampsia demonstrated similar rates of preeclampsia in the supplement and control groups (26% vs. 28%), said Dr. Merialdi, who reported no financial conflicts of interest.

DALLAS — Supplementation with vitamins C and E did not prevent preeclampsia, reduce its severity, or lower adverse neonatal outcomes in a World Health Organization randomized trial of 1,365 high-risk women.

The observed negative results are consistent with those of most previous antioxidant trials, although none of the previously reported adverse effects, such as earlier and more severe preeclampsia or reduced birth weight, were observed in the current trial, Dr. Mario Merialdi said at the annual meeting of the Society for Maternal-Fetal Medicine.

“We found no evidence of harm to either mother or fetus attributable to supplementation with vitamin C and E,” he said.

Still, lead investigator Dr. Jose Villar, a senior fellow in perinatal medicine at the University of Oxford (England), advised caution. “It is always of concern to give ineffective drugs to pregnant women, even if one study does not demonstrate harm,” he said in an interview.

The recent VIP (Vitamins in Preeclampsia) trial showed that concomitant vitamin C and E supplementation did not reduce preeclampsia among 2,395 women at risk, but did increase the rate of babies born with a low birth weight (Lancet 2006;367:1145–54).

The WHO trial parallels the VIP trial, but specifically targeted high-risk women with nutritional deficiencies who lived in India, Vietnam, South Africa, and Peru. Because previous failed antioxidant trials were conducted in women with adequate nutritional status, the investigators theorized that supplementing potentially vitamin-deficient women might produce beneficial results, explained Dr. Merialdi, a reproductive health specialist with WHO in Geneva.

In all, 687 women were randomized to daily vitamin C (1 g) and vitamin E (400 IU), and 678 women were randomized to placebo before gestational week 20. Their mean age was 27 years. Risk factors were similar between the intervention and control groups, including history of previous preeclampsia (217 vs. 205), chronic hypertension (163 vs. 170), and multiple pregnancies (81 vs. 100). Compliance was similar in both groups at about 87%.

Supplementation did not reduce the risk of preeclampsia (relative risk 1.0), eclampsia (RR 1.5), or severe gestational hypertension (RR 0.8). Adjustment for maternal age did not modify these results, he said. The incidence of preeclampsia was not significantly different between the intervention and placebo groups (24.5% vs. 23.3%).

The secondary outcomes of low birth weight (defined as less than 2,500 g, and found in 33% of the intervention group vs. 36% in controls), small size for gestational age (defined as less than 10th percentile, in 23% vs. 26%), and preterm delivery (defined as delivery before 37 weeks, in 21% vs. 24%) tended to be lower with supplementation, but were not statistically different (RR 0.9 for all three).

Perinatal death also tended to be lower with supplementation, but did not reach statistically significant levels (RR 0.8), and the trial was underpowered to test this outcome.

A stratified analysis of those women with a history of preeclampsia demonstrated similar rates of preeclampsia in the supplement and control groups (26% vs. 28%), said Dr. Merialdi, who reported no financial conflicts of interest.

The presence of metabolic syndrome did not affect aspirin nonresponsiveness in a study of 104 patients receiving chronic aspirin therapy.

There was no significant difference in aspirin nonresponsiveness, which was defined as platelet aggregation inhibition of less than 80%, among 41 patients with metabolic syndrome and 63 patients without metabolic syndrome (12 patients, or 29%, versus 14, or 22%, respectively).

Baseline characteristics, including age (65 years versus 64 years), male gender (30 versus 40 patients), coronary artery disease (CAD) risk factors, past medical history, past smoking history, and concomitant medications, were similar between patients with metabolic syndrome and those without. All of the patients had documented CAD, Dr. Sotir Polena and colleagues at Lenox Hill Hospital in New York reported at the American Federation for Medical Research Southern Regional meeting in New Orleans.

Metabolic syndrome was defined according to the Adult Treatment Panel III criteria, which require the presence of any three of the following five traits—hyperglycemia, abdominal obesity, hypertension, hypertriglyceridemia, and reduced HDL cholesterol level. Among the metabolic syndrome group, 21 patients had more than four traits.

The majority of patients were on 325 mg/day of aspirin, although some were on 81 mg/day. “We did not find any difference on aggregation studies while comparing different doses,” Dr. Polena said in an interview.

“We do not evaluate routinely for aspirin nonresponsiveness; [we evaluate] only for research purposes, but in the near future we are planning on starting a routine evaluation for all the patients undergoing a percutaneous evaluation,” Dr. Polena said.

The findings are reassuring because metabolic syndrome is a well-established risk factor for CAD, and literature citations indicate that aspirin resistance may occur in as little as 5% and as much as 45% of the population.

The discrepancies in prevalence are largely due to differences in the objectives of the tests, and their sensitivity and specificity to the evaluation of platelet function. In addition, the term “aspirin resistance” has been used clinically to describe several different physiological phenomena, Dr. Polena explained. One definition is the inability of aspirin to protect patients from ischemic vascular events, while the term has also been used to describe the inability of aspirin to produce anticipated effects on one or more platelet function tests, such as the inhibition of biosynthesis of thromboxane and the response to an agonist with light transmission aggregation (LTA) testing.

Investigators at Oxford (England) University have shown that the agreement among the results of the platelet function analyzer (PFA-100), VerifyNow-ASA assays, and LTA testing remained poor among 72 patients still on low-dose aspirin therapy 1 year after first being tested, with only one patient identified as a nonresponder by all three tests (Platelets 2008;19:119–24).

A study of 191 patients with stable CAD who received secondary aspirin prophylaxis showed poor agreement among three different tests—Ivy bleeding time, collagen/epinephrine closure time, and urinary 11-dehydrothromboxane B₂ excretion levels, with only 3 patients identified as aspirin-resistant by all three tests (Thromb. Res. 2007;121:413–8).

In Dr. Polena's study, platelet aggregation inhibition was measured prior to elective catheterization by Plateletworks-ICHOR using arachidonic acid as an agonist. Helena Laboratories markets the test and supplied the materials for the study.

Dr. Polena received no funding for the study and reported no conflicts of interest.

The presence of metabolic syndrome did not affect aspirin nonresponsiveness in a study of 104 patients receiving chronic aspirin therapy.

There was no significant difference in aspirin nonresponsiveness, which was defined as platelet aggregation inhibition of less than 80%, among 41 patients with metabolic syndrome and 63 patients without metabolic syndrome (12 patients, or 29%, versus 14, or 22%, respectively).

Baseline characteristics, including age (65 years versus 64 years), male gender (30 versus 40 patients), coronary artery disease (CAD) risk factors, past medical history, past smoking history, and concomitant medications, were similar between patients with metabolic syndrome and those without. All of the patients had documented CAD, Dr. Sotir Polena and colleagues at Lenox Hill Hospital in New York reported at the American Federation for Medical Research Southern Regional meeting in New Orleans.

Metabolic syndrome was defined according to the Adult Treatment Panel III criteria, which require the presence of any three of the following five traits—hyperglycemia, abdominal obesity, hypertension, hypertriglyceridemia, and reduced HDL cholesterol level. Among the metabolic syndrome group, 21 patients had more than four traits.

The majority of patients were on 325 mg/day of aspirin, although some were on 81 mg/day. “We did not find any difference on aggregation studies while comparing different doses,” Dr. Polena said in an interview.

“We do not evaluate routinely for aspirin nonresponsiveness; [we evaluate] only for research purposes, but in the near future we are planning on starting a routine evaluation for all the patients undergoing a percutaneous evaluation,” Dr. Polena said.

The findings are reassuring because metabolic syndrome is a well-established risk factor for CAD, and literature citations indicate that aspirin resistance may occur in as little as 5% and as much as 45% of the population.

The discrepancies in prevalence are largely due to differences in the objectives of the tests, and their sensitivity and specificity to the evaluation of platelet function. In addition, the term “aspirin resistance” has been used clinically to describe several different physiological phenomena, Dr. Polena explained. One definition is the inability of aspirin to protect patients from ischemic vascular events, while the term has also been used to describe the inability of aspirin to produce anticipated effects on one or more platelet function tests, such as the inhibition of biosynthesis of thromboxane and the response to an agonist with light transmission aggregation (LTA) testing.

Investigators at Oxford (England) University have shown that the agreement among the results of the platelet function analyzer (PFA-100), VerifyNow-ASA assays, and LTA testing remained poor among 72 patients still on low-dose aspirin therapy 1 year after first being tested, with only one patient identified as a nonresponder by all three tests (Platelets 2008;19:119–24).

A study of 191 patients with stable CAD who received secondary aspirin prophylaxis showed poor agreement among three different tests—Ivy bleeding time, collagen/epinephrine closure time, and urinary 11-dehydrothromboxane B₂ excretion levels, with only 3 patients identified as aspirin-resistant by all three tests (Thromb. Res. 2007;121:413–8).

In Dr. Polena's study, platelet aggregation inhibition was measured prior to elective catheterization by Plateletworks-ICHOR using arachidonic acid as an agonist. Helena Laboratories markets the test and supplied the materials for the study.

Dr. Polena received no funding for the study and reported no conflicts of interest.

The presence of metabolic syndrome did not affect aspirin nonresponsiveness in a study of 104 patients receiving chronic aspirin therapy.

There was no significant difference in aspirin nonresponsiveness, which was defined as platelet aggregation inhibition of less than 80%, among 41 patients with metabolic syndrome and 63 patients without metabolic syndrome (12 patients, or 29%, versus 14, or 22%, respectively).

Baseline characteristics, including age (65 years versus 64 years), male gender (30 versus 40 patients), coronary artery disease (CAD) risk factors, past medical history, past smoking history, and concomitant medications, were similar between patients with metabolic syndrome and those without. All of the patients had documented CAD, Dr. Sotir Polena and colleagues at Lenox Hill Hospital in New York reported at the American Federation for Medical Research Southern Regional meeting in New Orleans.

Metabolic syndrome was defined according to the Adult Treatment Panel III criteria, which require the presence of any three of the following five traits—hyperglycemia, abdominal obesity, hypertension, hypertriglyceridemia, and reduced HDL cholesterol level. Among the metabolic syndrome group, 21 patients had more than four traits.

The majority of patients were on 325 mg/day of aspirin, although some were on 81 mg/day. “We did not find any difference on aggregation studies while comparing different doses,” Dr. Polena said in an interview.

“We do not evaluate routinely for aspirin nonresponsiveness; [we evaluate] only for research purposes, but in the near future we are planning on starting a routine evaluation for all the patients undergoing a percutaneous evaluation,” Dr. Polena said.

The findings are reassuring because metabolic syndrome is a well-established risk factor for CAD, and literature citations indicate that aspirin resistance may occur in as little as 5% and as much as 45% of the population.

The discrepancies in prevalence are largely due to differences in the objectives of the tests, and their sensitivity and specificity to the evaluation of platelet function. In addition, the term “aspirin resistance” has been used clinically to describe several different physiological phenomena, Dr. Polena explained. One definition is the inability of aspirin to protect patients from ischemic vascular events, while the term has also been used to describe the inability of aspirin to produce anticipated effects on one or more platelet function tests, such as the inhibition of biosynthesis of thromboxane and the response to an agonist with light transmission aggregation (LTA) testing.

Investigators at Oxford (England) University have shown that the agreement among the results of the platelet function analyzer (PFA-100), VerifyNow-ASA assays, and LTA testing remained poor among 72 patients still on low-dose aspirin therapy 1 year after first being tested, with only one patient identified as a nonresponder by all three tests (Platelets 2008;19:119–24).

A study of 191 patients with stable CAD who received secondary aspirin prophylaxis showed poor agreement among three different tests—Ivy bleeding time, collagen/epinephrine closure time, and urinary 11-dehydrothromboxane B₂ excretion levels, with only 3 patients identified as aspirin-resistant by all three tests (Thromb. Res. 2007;121:413–8).

In Dr. Polena's study, platelet aggregation inhibition was measured prior to elective catheterization by Plateletworks-ICHOR using arachidonic acid as an agonist. Helena Laboratories markets the test and supplied the materials for the study.

Dr. Polena received no funding for the study and reported no conflicts of interest.