Heidi Splete

Major Finding: The prevalence of aortic valve ring stenosis was 38% in women aged 65 years and older who took nitrogen-containing bisphosphonates, vs. 59% in women who didn't take bisphosphonates.

Data Source: A cross-sectional study of 3,710 women aged 45–84 years.

Disclosures: Dr. Elmariah has received grant support from the New York Academy of Medicine; the National Heart, Lung, and Blood Institute; and GlaxoSmithKline.

WASHINGTON — Nitrogen-containing bisphosphonates were associated with a significantly decreased prevalence of cardiovascular calcification in women older than 65 years, based on data from 3,710 women who are part of a large, ongoing study.

“Early on in the analysis, we came across a very unexpected finding,” said Dr. Sammy Elmariah of Mount Sinai School of Medicine in New York. “The association with bisphosphonate use was dependent on the patient's age.”

The data were taken from the Multi-Ethnic Study of Atherosclerosis (MESA), a longitudinal cohort study of 6,814 asymptomatic men and women aged 45–84 years.

Overall, the bisphosphonate users were more likely to be older and white. In the current study, Dr. Elmariah and his colleagues examined the impact of bisphosphonates on cardiovascular calcification in women.

Clinical studies have shown that bisphosphonates have an effect on serum lipids, Dr. Elmariah said. Some experimental data, including data from animal models and dialysis patients, suggest that nitrogen-containing bisphosphonates (NCBPs) may limit cardiovascular calcification. In addition, the results of one recent study showed that patients on bisphosphonates for osteoporosis had a slower progression of aortic stenosis, he noted.

The prevalence of aortic valve ring stenosis was 38% in women aged 65 years and older who used NCBPs, which was significantly lower than in non-NCBP users of the same age (59%). Aortic valve ring stenosis prevalence also was 38% in women younger than 65 years who used NCBPs; it was significantly lower at 17% among similarly aged non-NCBP users.

Significant patterns also were seen for stenosis of the thoracic aorta and mitral annulus. The relationship between bisphosphonate use and the decrease in cardiovascular calcification in the 65-years-and-older group did not reach statistical significance for the prevalence of aortic valve stenosis and coronary artery stenosis, but the trends were similar.

This study is the first evaluation of the relationship between bisphosphonate use and the prevalence of cardiovascular calcification in a healthy patient population, Dr. Elmariah said.

Cardiovascular calcification was measured using cardiac CT. Bisphosphate use was defined as use of either oral or intravenous bisphosphonates at the time of the cardiac CT. The average age of the NCBP users was 67 years, and the average age of the nonusers was 62 years. Approximately 60% of the women were white.

After adjustment for variables including age, body mass index, diabetes, hypertension, smoking, race, insurance status, education, and income level, the significance remained, Dr. Elmariah said.

“We get a fairly dramatic reduction in the prevalence of cardiovascular calcification in bisphosphonate users over the age of 65,” he added.

When the researchers divided the study population into 10-year age groups, they saw a gradual reduction in cardiovascular calcification with increasing age, he noted.

The study was limited by its cross-sectional design and by the lack of data on the duration of bisphosphonate use. “It's unclear whether this finding is due to true age-related differences in the pathogenesis of cardiovascular calcification or in the effect of bisphosphonates,” said Dr. Elmariah. But the results merit additional studies to tease out the reason for the age-related impact of bisphosphonates on cardiovascular calcification in women, he said.

NCBPs significantly cut cardiovascular calcification in women over 65, said Dr. Sammy Elmariah.

Source Courtesy Dr. Sammy Elmariah

Major Finding: The prevalence of aortic valve ring stenosis was 38% in women aged 65 years and older who took nitrogen-containing bisphosphonates, vs. 59% in women who didn't take bisphosphonates.

Data Source: A cross-sectional study of 3,710 women aged 45–84 years.

Disclosures: Dr. Elmariah has received grant support from the New York Academy of Medicine; the National Heart, Lung, and Blood Institute; and GlaxoSmithKline.

WASHINGTON — Nitrogen-containing bisphosphonates were associated with a significantly decreased prevalence of cardiovascular calcification in women older than 65 years, based on data from 3,710 women who are part of a large, ongoing study.

“Early on in the analysis, we came across a very unexpected finding,” said Dr. Sammy Elmariah of Mount Sinai School of Medicine in New York. “The association with bisphosphonate use was dependent on the patient's age.”

The data were taken from the Multi-Ethnic Study of Atherosclerosis (MESA), a longitudinal cohort study of 6,814 asymptomatic men and women aged 45–84 years.

Overall, the bisphosphonate users were more likely to be older and white. In the current study, Dr. Elmariah and his colleagues examined the impact of bisphosphonates on cardiovascular calcification in women.

Clinical studies have shown that bisphosphonates have an effect on serum lipids, Dr. Elmariah said. Some experimental data, including data from animal models and dialysis patients, suggest that nitrogen-containing bisphosphonates (NCBPs) may limit cardiovascular calcification. In addition, the results of one recent study showed that patients on bisphosphonates for osteoporosis had a slower progression of aortic stenosis, he noted.

The prevalence of aortic valve ring stenosis was 38% in women aged 65 years and older who used NCBPs, which was significantly lower than in non-NCBP users of the same age (59%). Aortic valve ring stenosis prevalence also was 38% in women younger than 65 years who used NCBPs; it was significantly lower at 17% among similarly aged non-NCBP users.

Significant patterns also were seen for stenosis of the thoracic aorta and mitral annulus. The relationship between bisphosphonate use and the decrease in cardiovascular calcification in the 65-years-and-older group did not reach statistical significance for the prevalence of aortic valve stenosis and coronary artery stenosis, but the trends were similar.

This study is the first evaluation of the relationship between bisphosphonate use and the prevalence of cardiovascular calcification in a healthy patient population, Dr. Elmariah said.

Cardiovascular calcification was measured using cardiac CT. Bisphosphate use was defined as use of either oral or intravenous bisphosphonates at the time of the cardiac CT. The average age of the NCBP users was 67 years, and the average age of the nonusers was 62 years. Approximately 60% of the women were white.

After adjustment for variables including age, body mass index, diabetes, hypertension, smoking, race, insurance status, education, and income level, the significance remained, Dr. Elmariah said.

“We get a fairly dramatic reduction in the prevalence of cardiovascular calcification in bisphosphonate users over the age of 65,” he added.

When the researchers divided the study population into 10-year age groups, they saw a gradual reduction in cardiovascular calcification with increasing age, he noted.

The study was limited by its cross-sectional design and by the lack of data on the duration of bisphosphonate use. “It's unclear whether this finding is due to true age-related differences in the pathogenesis of cardiovascular calcification or in the effect of bisphosphonates,” said Dr. Elmariah. But the results merit additional studies to tease out the reason for the age-related impact of bisphosphonates on cardiovascular calcification in women, he said.

NCBPs significantly cut cardiovascular calcification in women over 65, said Dr. Sammy Elmariah.

Source Courtesy Dr. Sammy Elmariah

Major Finding: The prevalence of aortic valve ring stenosis was 38% in women aged 65 years and older who took nitrogen-containing bisphosphonates, vs. 59% in women who didn't take bisphosphonates.

Data Source: A cross-sectional study of 3,710 women aged 45–84 years.

Disclosures: Dr. Elmariah has received grant support from the New York Academy of Medicine; the National Heart, Lung, and Blood Institute; and GlaxoSmithKline.

WASHINGTON — Nitrogen-containing bisphosphonates were associated with a significantly decreased prevalence of cardiovascular calcification in women older than 65 years, based on data from 3,710 women who are part of a large, ongoing study.

“Early on in the analysis, we came across a very unexpected finding,” said Dr. Sammy Elmariah of Mount Sinai School of Medicine in New York. “The association with bisphosphonate use was dependent on the patient's age.”

The data were taken from the Multi-Ethnic Study of Atherosclerosis (MESA), a longitudinal cohort study of 6,814 asymptomatic men and women aged 45–84 years.

Overall, the bisphosphonate users were more likely to be older and white. In the current study, Dr. Elmariah and his colleagues examined the impact of bisphosphonates on cardiovascular calcification in women.

Clinical studies have shown that bisphosphonates have an effect on serum lipids, Dr. Elmariah said. Some experimental data, including data from animal models and dialysis patients, suggest that nitrogen-containing bisphosphonates (NCBPs) may limit cardiovascular calcification. In addition, the results of one recent study showed that patients on bisphosphonates for osteoporosis had a slower progression of aortic stenosis, he noted.

The prevalence of aortic valve ring stenosis was 38% in women aged 65 years and older who used NCBPs, which was significantly lower than in non-NCBP users of the same age (59%). Aortic valve ring stenosis prevalence also was 38% in women younger than 65 years who used NCBPs; it was significantly lower at 17% among similarly aged non-NCBP users.

Significant patterns also were seen for stenosis of the thoracic aorta and mitral annulus. The relationship between bisphosphonate use and the decrease in cardiovascular calcification in the 65-years-and-older group did not reach statistical significance for the prevalence of aortic valve stenosis and coronary artery stenosis, but the trends were similar.

This study is the first evaluation of the relationship between bisphosphonate use and the prevalence of cardiovascular calcification in a healthy patient population, Dr. Elmariah said.

Cardiovascular calcification was measured using cardiac CT. Bisphosphate use was defined as use of either oral or intravenous bisphosphonates at the time of the cardiac CT. The average age of the NCBP users was 67 years, and the average age of the nonusers was 62 years. Approximately 60% of the women were white.

After adjustment for variables including age, body mass index, diabetes, hypertension, smoking, race, insurance status, education, and income level, the significance remained, Dr. Elmariah said.

“We get a fairly dramatic reduction in the prevalence of cardiovascular calcification in bisphosphonate users over the age of 65,” he added.

When the researchers divided the study population into 10-year age groups, they saw a gradual reduction in cardiovascular calcification with increasing age, he noted.

The study was limited by its cross-sectional design and by the lack of data on the duration of bisphosphonate use. “It's unclear whether this finding is due to true age-related differences in the pathogenesis of cardiovascular calcification or in the effect of bisphosphonates,” said Dr. Elmariah. But the results merit additional studies to tease out the reason for the age-related impact of bisphosphonates on cardiovascular calcification in women, he said.

NCBPs significantly cut cardiovascular calcification in women over 65, said Dr. Sammy Elmariah.

Source Courtesy Dr. Sammy Elmariah

NEW ORLEANS — Maternal asthma has a significant effect on several adverse pregnancy outcomes including preeclampsia, preterm delivery, and low birth weight, based on a meta-analysis of 30 studies.

Pregnant asthmatic women have been reported to have an overall increased risk of adverse perinatal outcomes, but study results are conflicting, Dr. Jennifer Namazy said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“Our meta-analysis was conducted to see whether the risks were real,” said Dr. Namazy of Scripps Health in San Diego.

Dr. Namazy and her colleagues' review included prospective cohort studies and retrospective studies conducted between 1975 and 2009, in which pregnancy outcomes were compared between women with asthma and nonasthmatic controls. The 30 studies included 8 studies involving asthma management.

Compared with control women without asthma, asthmatic women had a significantly increased risk of preeclampsia (relative risk, 1.54). Low birth weight (defined as 2,500 g or less) was significantly more likely in babies of women with asthma (RR, 1.46). Babies born prematurely (birth after less than 37 weeks' gestation) or small for gestational age were significantly more likely among women with asthma compared with controls (RR, 1.41 and 1.22). Neonatal death was significantly more likely in babies of women with asthma (RR, 1.49). Perinatal mortality (stillbirth plus neonatal death) was significantly more likely in babies of women with asthma (RR, 1.25). No significant associations were seen between maternal asthma and an increased risk of congenital anomalies (RR, 1.08).

“The data suggest that active management may reduce some, but not other perinatal complications,” she said. But active management may not ensure adequate asthma control, and more research is needed to specifically assess the effect of asthma control on perinatal outcomes.

Disclosures: Dr. Namazy has served as a consultant for Genentech.

NEW ORLEANS — Maternal asthma has a significant effect on several adverse pregnancy outcomes including preeclampsia, preterm delivery, and low birth weight, based on a meta-analysis of 30 studies.

Pregnant asthmatic women have been reported to have an overall increased risk of adverse perinatal outcomes, but study results are conflicting, Dr. Jennifer Namazy said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“Our meta-analysis was conducted to see whether the risks were real,” said Dr. Namazy of Scripps Health in San Diego.

Dr. Namazy and her colleagues' review included prospective cohort studies and retrospective studies conducted between 1975 and 2009, in which pregnancy outcomes were compared between women with asthma and nonasthmatic controls. The 30 studies included 8 studies involving asthma management.

Compared with control women without asthma, asthmatic women had a significantly increased risk of preeclampsia (relative risk, 1.54). Low birth weight (defined as 2,500 g or less) was significantly more likely in babies of women with asthma (RR, 1.46). Babies born prematurely (birth after less than 37 weeks' gestation) or small for gestational age were significantly more likely among women with asthma compared with controls (RR, 1.41 and 1.22). Neonatal death was significantly more likely in babies of women with asthma (RR, 1.49). Perinatal mortality (stillbirth plus neonatal death) was significantly more likely in babies of women with asthma (RR, 1.25). No significant associations were seen between maternal asthma and an increased risk of congenital anomalies (RR, 1.08).

“The data suggest that active management may reduce some, but not other perinatal complications,” she said. But active management may not ensure adequate asthma control, and more research is needed to specifically assess the effect of asthma control on perinatal outcomes.

Disclosures: Dr. Namazy has served as a consultant for Genentech.

NEW ORLEANS — Maternal asthma has a significant effect on several adverse pregnancy outcomes including preeclampsia, preterm delivery, and low birth weight, based on a meta-analysis of 30 studies.

Pregnant asthmatic women have been reported to have an overall increased risk of adverse perinatal outcomes, but study results are conflicting, Dr. Jennifer Namazy said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

“Our meta-analysis was conducted to see whether the risks were real,” said Dr. Namazy of Scripps Health in San Diego.

Dr. Namazy and her colleagues' review included prospective cohort studies and retrospective studies conducted between 1975 and 2009, in which pregnancy outcomes were compared between women with asthma and nonasthmatic controls. The 30 studies included 8 studies involving asthma management.

Compared with control women without asthma, asthmatic women had a significantly increased risk of preeclampsia (relative risk, 1.54). Low birth weight (defined as 2,500 g or less) was significantly more likely in babies of women with asthma (RR, 1.46). Babies born prematurely (birth after less than 37 weeks' gestation) or small for gestational age were significantly more likely among women with asthma compared with controls (RR, 1.41 and 1.22). Neonatal death was significantly more likely in babies of women with asthma (RR, 1.49). Perinatal mortality (stillbirth plus neonatal death) was significantly more likely in babies of women with asthma (RR, 1.25). No significant associations were seen between maternal asthma and an increased risk of congenital anomalies (RR, 1.08).

“The data suggest that active management may reduce some, but not other perinatal complications,” she said. But active management may not ensure adequate asthma control, and more research is needed to specifically assess the effect of asthma control on perinatal outcomes.

Disclosures: Dr. Namazy has served as a consultant for Genentech.

Major Finding: Median progression-free survival reached 13.7 months for women treated with combination docetaxel and carboplatin therapy, vs. 8.4 months for those treated with sequential therapy.

Data Source: A randomized trial of 150 women with recurrent platinum-sensitive ovarian cancer.

Disclosures: Dr. Alvarez-Secord has received grants and research support from or served as a consultant to several pharmaceutical companies and device manufacturers, including GlaxoSmithKline, Eli Lilly & Co., Sanofi-Aventis, Precision Therapeutics Inc., and Intuitive Surgical Inc.

SAN FRANCISCO — Combination docetaxel and carboplatin therapy significantly improved progression-free survival among women with recurrent platinum-sensitive ovarian cancer, compared with sequential therapy, in a randomized trial of 150 patients.

The improvement was associated with higher neurotoxicity, however, and quality of life studies are ongoing, Dr. Angeles Alvarez-Secord of Duke University in Durham, N.C., said at the annual meeting of the Society of Gynecologic Oncologists.

Combination therapy with docetaxel and carboplatin has been shown to improve survival in platinum-sensitive ovarian cancer patients, but it had not been compared with sequential therapy regarding efficacy and adverse events, Dr. Alvarez-Secord said.

In this multicenter, phase II study, median progression-free survival (the primary end point) reached 13.7 months for women who were treated with combination therapy, vs. 8.4 months for those who received the same drugs in sequence.

Median overall survival was similar at 33 months and 30 months.

After clinical variables were controlled for, women who were treated with sequential therapy had a 62% increased risk of disease progression, compared with those who received combination therapy.

The study population included women with platinum-sensitive peritoneal, ovarian, or tubal cancer who were enrolled between January 2004 and March 2009.

Their average age was 64 years; demographic characteristics were similar between the two groups.

One group of 75 women received 30 mg/m

The overall response rates for the combination and sequential therapies were 55% and 43%.

The incidence of grade 2 or 3 neurotoxicity was higher in the combination therapy group (11.7% vs. 8.5%), as was the incidence of grade 3 or 4 neutropenia (36.8% vs. 11.3%).

“I was very surprised to see that the quality of life was superior for those patients that were treated with sequential monotherapy, compared with combination therapy,” Dr. Alvarez-Secord said in an interview.

The clinical implication of the study is that combination therapy, although yielding a survival benefit, was associated with a worse quality of life, she said.

“It becomes a counseling issue,” she continued.

The results contribute to the larger goal of being able to customize cancer care to a patient's preferences and priorities, rather than taking a one-size-fits-all approach, Dr. Alvarez-Secord said.

Major Finding: Median progression-free survival reached 13.7 months for women treated with combination docetaxel and carboplatin therapy, vs. 8.4 months for those treated with sequential therapy.

Data Source: A randomized trial of 150 women with recurrent platinum-sensitive ovarian cancer.

Disclosures: Dr. Alvarez-Secord has received grants and research support from or served as a consultant to several pharmaceutical companies and device manufacturers, including GlaxoSmithKline, Eli Lilly & Co., Sanofi-Aventis, Precision Therapeutics Inc., and Intuitive Surgical Inc.

SAN FRANCISCO — Combination docetaxel and carboplatin therapy significantly improved progression-free survival among women with recurrent platinum-sensitive ovarian cancer, compared with sequential therapy, in a randomized trial of 150 patients.

The improvement was associated with higher neurotoxicity, however, and quality of life studies are ongoing, Dr. Angeles Alvarez-Secord of Duke University in Durham, N.C., said at the annual meeting of the Society of Gynecologic Oncologists.

Combination therapy with docetaxel and carboplatin has been shown to improve survival in platinum-sensitive ovarian cancer patients, but it had not been compared with sequential therapy regarding efficacy and adverse events, Dr. Alvarez-Secord said.

In this multicenter, phase II study, median progression-free survival (the primary end point) reached 13.7 months for women who were treated with combination therapy, vs. 8.4 months for those who received the same drugs in sequence.

Median overall survival was similar at 33 months and 30 months.

After clinical variables were controlled for, women who were treated with sequential therapy had a 62% increased risk of disease progression, compared with those who received combination therapy.

The study population included women with platinum-sensitive peritoneal, ovarian, or tubal cancer who were enrolled between January 2004 and March 2009.

Their average age was 64 years; demographic characteristics were similar between the two groups.

One group of 75 women received 30 mg/m

The overall response rates for the combination and sequential therapies were 55% and 43%.

The incidence of grade 2 or 3 neurotoxicity was higher in the combination therapy group (11.7% vs. 8.5%), as was the incidence of grade 3 or 4 neutropenia (36.8% vs. 11.3%).

“I was very surprised to see that the quality of life was superior for those patients that were treated with sequential monotherapy, compared with combination therapy,” Dr. Alvarez-Secord said in an interview.

The clinical implication of the study is that combination therapy, although yielding a survival benefit, was associated with a worse quality of life, she said.

“It becomes a counseling issue,” she continued.

The results contribute to the larger goal of being able to customize cancer care to a patient's preferences and priorities, rather than taking a one-size-fits-all approach, Dr. Alvarez-Secord said.

Major Finding: Median progression-free survival reached 13.7 months for women treated with combination docetaxel and carboplatin therapy, vs. 8.4 months for those treated with sequential therapy.

Data Source: A randomized trial of 150 women with recurrent platinum-sensitive ovarian cancer.

Disclosures: Dr. Alvarez-Secord has received grants and research support from or served as a consultant to several pharmaceutical companies and device manufacturers, including GlaxoSmithKline, Eli Lilly & Co., Sanofi-Aventis, Precision Therapeutics Inc., and Intuitive Surgical Inc.

SAN FRANCISCO — Combination docetaxel and carboplatin therapy significantly improved progression-free survival among women with recurrent platinum-sensitive ovarian cancer, compared with sequential therapy, in a randomized trial of 150 patients.

The improvement was associated with higher neurotoxicity, however, and quality of life studies are ongoing, Dr. Angeles Alvarez-Secord of Duke University in Durham, N.C., said at the annual meeting of the Society of Gynecologic Oncologists.

Combination therapy with docetaxel and carboplatin has been shown to improve survival in platinum-sensitive ovarian cancer patients, but it had not been compared with sequential therapy regarding efficacy and adverse events, Dr. Alvarez-Secord said.

In this multicenter, phase II study, median progression-free survival (the primary end point) reached 13.7 months for women who were treated with combination therapy, vs. 8.4 months for those who received the same drugs in sequence.

Median overall survival was similar at 33 months and 30 months.

After clinical variables were controlled for, women who were treated with sequential therapy had a 62% increased risk of disease progression, compared with those who received combination therapy.

The study population included women with platinum-sensitive peritoneal, ovarian, or tubal cancer who were enrolled between January 2004 and March 2009.

Their average age was 64 years; demographic characteristics were similar between the two groups.

One group of 75 women received 30 mg/m

The overall response rates for the combination and sequential therapies were 55% and 43%.

The incidence of grade 2 or 3 neurotoxicity was higher in the combination therapy group (11.7% vs. 8.5%), as was the incidence of grade 3 or 4 neutropenia (36.8% vs. 11.3%).

“I was very surprised to see that the quality of life was superior for those patients that were treated with sequential monotherapy, compared with combination therapy,” Dr. Alvarez-Secord said in an interview.

The clinical implication of the study is that combination therapy, although yielding a survival benefit, was associated with a worse quality of life, she said.

“It becomes a counseling issue,” she continued.

The results contribute to the larger goal of being able to customize cancer care to a patient's preferences and priorities, rather than taking a one-size-fits-all approach, Dr. Alvarez-Secord said.

Major Finding: The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

Data Source: A Gynecologic Oncology Group study of 350 women with early-stage epithelial ovarian cancer.

Disclosures: Dr. Chan has served on the speakers bureau for Ortho Biotech Inc. and GlaxoSmithKline. Dr. Rustin said he had no financial conflicts to disclose.

SAN FRANCISCO — Normalization of CA 125 levels after one cycle of chemotherapy is a significant predictor of recurrence-free and overall survival in women with high-risk, early-stage epithelial ovarian cancer, based on data from 350 patients.

“Identifying subsets of early-stage, high-risk patients with good prognosis may improve the individualization of care,” said Dr. John Chan in a presentation of the Gynecologic Oncology Group (GOG) study results at the Society of Gynecologic Oncologists annual meeting.

Previous research has shown that prechemotherapy levels of CA 125 are predictive of 5-year overall survival, but there is a lack of data on patterns of normalization in CA 125, said Dr. Chan of the cancer center at the University of California, San Francisco.

Reviewing data from GOG study 157, a multicenter, randomized, phase III trial, Dr. Chan and colleagues assessed the clinical impact of CA 125 normalization patterns. CA 125 levels of 35 IU/mL or less were considered normal.

All patients had one of the following types of epithelial ovarian cancer: stage IA/IB grade 3, stage IC, or stage II.

The patients had previously undergone primary surgery, and all received either three or six cycles of carboplatin/paclitaxel chemotherapy every 21 days.

Overall, 74% of the patients achieved normal CA 125 levels after one chemotherapy cycle, and 88% reached that threshold after two cycles.

The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

At 84 months, the recurrence-free survival rate in women whose CA 125 remained normal after one cycle of chemotherapy was 87%, vs. 80% in women whose level changed from elevated to normal, and 68% in women whose level remained elevated.

The overall survival rates at 84 months in these three groups were 92% vs. 88% vs. 77%, respectively (P = .009)

“There was no difference with respect to stage and cell type in elevated CA 125 vs. normal CA 125,” Dr. Chan noted.

In a discussion of the study, Dr. Gordon Rustin noted that its strengths included a large patient population and a clear indication of improved rates of recurrence-free survival with CA 125 normalization.

“But there is no accounting for the impact of surgery on CA 125,” said Dr. Rustin of the Mount Vernon Cancer Centre in Northwood, England.

“What is the value [of CA 125]? Is it going to make any difference in our management?” he asked.

Dr. Chan responded that more research is needed to identify subgroups of high-risk patients who may not require additional chemotherapy.

Major Finding: The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

Data Source: A Gynecologic Oncology Group study of 350 women with early-stage epithelial ovarian cancer.

Disclosures: Dr. Chan has served on the speakers bureau for Ortho Biotech Inc. and GlaxoSmithKline. Dr. Rustin said he had no financial conflicts to disclose.

SAN FRANCISCO — Normalization of CA 125 levels after one cycle of chemotherapy is a significant predictor of recurrence-free and overall survival in women with high-risk, early-stage epithelial ovarian cancer, based on data from 350 patients.

“Identifying subsets of early-stage, high-risk patients with good prognosis may improve the individualization of care,” said Dr. John Chan in a presentation of the Gynecologic Oncology Group (GOG) study results at the Society of Gynecologic Oncologists annual meeting.

Previous research has shown that prechemotherapy levels of CA 125 are predictive of 5-year overall survival, but there is a lack of data on patterns of normalization in CA 125, said Dr. Chan of the cancer center at the University of California, San Francisco.

Reviewing data from GOG study 157, a multicenter, randomized, phase III trial, Dr. Chan and colleagues assessed the clinical impact of CA 125 normalization patterns. CA 125 levels of 35 IU/mL or less were considered normal.

All patients had one of the following types of epithelial ovarian cancer: stage IA/IB grade 3, stage IC, or stage II.

The patients had previously undergone primary surgery, and all received either three or six cycles of carboplatin/paclitaxel chemotherapy every 21 days.

Overall, 74% of the patients achieved normal CA 125 levels after one chemotherapy cycle, and 88% reached that threshold after two cycles.

The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

At 84 months, the recurrence-free survival rate in women whose CA 125 remained normal after one cycle of chemotherapy was 87%, vs. 80% in women whose level changed from elevated to normal, and 68% in women whose level remained elevated.

The overall survival rates at 84 months in these three groups were 92% vs. 88% vs. 77%, respectively (P = .009)

“There was no difference with respect to stage and cell type in elevated CA 125 vs. normal CA 125,” Dr. Chan noted.

In a discussion of the study, Dr. Gordon Rustin noted that its strengths included a large patient population and a clear indication of improved rates of recurrence-free survival with CA 125 normalization.

“But there is no accounting for the impact of surgery on CA 125,” said Dr. Rustin of the Mount Vernon Cancer Centre in Northwood, England.

“What is the value [of CA 125]? Is it going to make any difference in our management?” he asked.

Dr. Chan responded that more research is needed to identify subgroups of high-risk patients who may not require additional chemotherapy.

Major Finding: The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

Data Source: A Gynecologic Oncology Group study of 350 women with early-stage epithelial ovarian cancer.

Disclosures: Dr. Chan has served on the speakers bureau for Ortho Biotech Inc. and GlaxoSmithKline. Dr. Rustin said he had no financial conflicts to disclose.

SAN FRANCISCO — Normalization of CA 125 levels after one cycle of chemotherapy is a significant predictor of recurrence-free and overall survival in women with high-risk, early-stage epithelial ovarian cancer, based on data from 350 patients.

“Identifying subsets of early-stage, high-risk patients with good prognosis may improve the individualization of care,” said Dr. John Chan in a presentation of the Gynecologic Oncology Group (GOG) study results at the Society of Gynecologic Oncologists annual meeting.

Previous research has shown that prechemotherapy levels of CA 125 are predictive of 5-year overall survival, but there is a lack of data on patterns of normalization in CA 125, said Dr. Chan of the cancer center at the University of California, San Francisco.

Reviewing data from GOG study 157, a multicenter, randomized, phase III trial, Dr. Chan and colleagues assessed the clinical impact of CA 125 normalization patterns. CA 125 levels of 35 IU/mL or less were considered normal.

All patients had one of the following types of epithelial ovarian cancer: stage IA/IB grade 3, stage IC, or stage II.

The patients had previously undergone primary surgery, and all received either three or six cycles of carboplatin/paclitaxel chemotherapy every 21 days.

Overall, 74% of the patients achieved normal CA 125 levels after one chemotherapy cycle, and 88% reached that threshold after two cycles.

The recurrence-free survival rate was 81% in patients who had normalization of CA 125 after one cycle of chemotherapy, vs. 65% in patients who had CA 125 normalization after two cycles.

At 84 months, the recurrence-free survival rate in women whose CA 125 remained normal after one cycle of chemotherapy was 87%, vs. 80% in women whose level changed from elevated to normal, and 68% in women whose level remained elevated.

The overall survival rates at 84 months in these three groups were 92% vs. 88% vs. 77%, respectively (P = .009)

“There was no difference with respect to stage and cell type in elevated CA 125 vs. normal CA 125,” Dr. Chan noted.

In a discussion of the study, Dr. Gordon Rustin noted that its strengths included a large patient population and a clear indication of improved rates of recurrence-free survival with CA 125 normalization.

“But there is no accounting for the impact of surgery on CA 125,” said Dr. Rustin of the Mount Vernon Cancer Centre in Northwood, England.

“What is the value [of CA 125]? Is it going to make any difference in our management?” he asked.

Dr. Chan responded that more research is needed to identify subgroups of high-risk patients who may not require additional chemotherapy.

Major Finding: Significantly more patients who took 12 mg/day or 24 mg/day of alemtuzumab were clinically disease-free after 4 years, compared with patients who received subcutaneous interferon beta-1a (71% vs. 35%).

Data Source: A subset of patients from a phase II trial of 334 patients with relapsing-remitting MS.

Disclosures: The trial was sponsored by Genzyme. Dr. Khan has received research support and personal compensation from Teva Neuroscience, Biogen Idec, EMD Serono, and Bayer Healthcare. He also has received personal compensation from Novartis. Dr. Brinar has received research support from Genzyme.

TORONTO — Data further gleaned from a phase II study of low or high dose alemtuzumab indicate that the drug kept nearly three-fourths of multiple sclerosis patients clinically disease free for 4 years and was effective in halting disease activity even in patients who suffered autoimmune adverse events.

Dr. Omar Khan of Wayne State University, Detroit, and his colleagues reported 4-year follow-up results for a subset of patients in the CAMMS223 trial, an assessor-blinded study that randomized 334 patients to either 12 mg/day or 24 mg/day of alemtuzumab (Campath) against 44 mcg of subcutaneous interferon beta 1-a (IFN beta-1a, Rebif) 3 times a week.

Campath already is approved as a single agent for the treatment of B-cell chronic lymphocytic leukemia.

Data on follow-up at 4 years were available for 42 patients who received IFN beta-1a, 63 patients who received 12 mg/day of alemtuzumab, and 71 patients who received 24 mg/day of alemtuzumab. Treatment with alemtuzumab consisted of two to three cycles each year that each lasted 3–5 days. A total of 110 patients received only two cycles of alemtuzumab annually. The demographics of this subset of patients were similar to those in the original study group, Dr. Khan and his associates reported in a poster session at the annual meeting of the American Academy of Neurology.

After 4 years, no clinical disease activity had occurred in 71% of all patients treated with alemtuzumab and in 72% of those who received only two cycles of alemtuzumab. In comparison, significantly fewer patients in the IFN beta-1a group (35%) were free from clinical disease activity. Alemtuzumab-treated patients also had significantly higher rates of freedom from sustained accumulation of disability, compared with patients treated with IFN beta-1a (91% vs. 68%).

In addition, significantly more patients in the alemtuzumab groups (77%) were relapse-free than were those in the IFN beta-1a group (49%).

Comparisons between the IFN beta-1a group and each of the two alemtuzumab groups drew similar efficacy conclusions, Dr. Khan wrote.

Another analysis of the trial suggested that alemtuzumab may halt disease progression in the subset of MS patients who experienced autoimmune adverse events. In a poster at the meeting, Dr. Vesna Brinar of University Hospital Center in Zagreb, Croatia, and her colleagues reviewed 3-year follow-up data from 216 patients treated with alemtuzumab and 107 patients treated with IFN beta-1a in the phase II trial.

After 3 years, autoimmune adverse events had occurred in 47 patients who received alemtuzumab and in 3 patients who received IFN beta-1a. The most common events in alemtuzumab-treated patients included hyperthyroidism (21 patients), hypothyroidism (13 patients), and autoimmune thyroiditis (8 patients).

By 36 months, 12% of alemtuzumab-treated patients had experienced sustained accumulation of disability, compared with 26% of patients treated with IFN beta-1a.

The annualized relapse rate was significantly lower among the alemtuzumab-treated patients with autoimmune problems, compared with patients treated with IFN beta-1a (0.09 vs. 0.36), according to Dr. Brinar.

In addition, those who experienced autoimmune problems on alemtuzumab had a significant mean improvement on the Expanded Disability Status Scale of −0.44 points from baseline.

Ongoing phase III studies are in place to confirm and further expand the results, the researchers said.

Major Finding: Significantly more patients who took 12 mg/day or 24 mg/day of alemtuzumab were clinically disease-free after 4 years, compared with patients who received subcutaneous interferon beta-1a (71% vs. 35%).

Data Source: A subset of patients from a phase II trial of 334 patients with relapsing-remitting MS.

Disclosures: The trial was sponsored by Genzyme. Dr. Khan has received research support and personal compensation from Teva Neuroscience, Biogen Idec, EMD Serono, and Bayer Healthcare. He also has received personal compensation from Novartis. Dr. Brinar has received research support from Genzyme.

TORONTO — Data further gleaned from a phase II study of low or high dose alemtuzumab indicate that the drug kept nearly three-fourths of multiple sclerosis patients clinically disease free for 4 years and was effective in halting disease activity even in patients who suffered autoimmune adverse events.

Dr. Omar Khan of Wayne State University, Detroit, and his colleagues reported 4-year follow-up results for a subset of patients in the CAMMS223 trial, an assessor-blinded study that randomized 334 patients to either 12 mg/day or 24 mg/day of alemtuzumab (Campath) against 44 mcg of subcutaneous interferon beta 1-a (IFN beta-1a, Rebif) 3 times a week.

Campath already is approved as a single agent for the treatment of B-cell chronic lymphocytic leukemia.

Data on follow-up at 4 years were available for 42 patients who received IFN beta-1a, 63 patients who received 12 mg/day of alemtuzumab, and 71 patients who received 24 mg/day of alemtuzumab. Treatment with alemtuzumab consisted of two to three cycles each year that each lasted 3–5 days. A total of 110 patients received only two cycles of alemtuzumab annually. The demographics of this subset of patients were similar to those in the original study group, Dr. Khan and his associates reported in a poster session at the annual meeting of the American Academy of Neurology.

After 4 years, no clinical disease activity had occurred in 71% of all patients treated with alemtuzumab and in 72% of those who received only two cycles of alemtuzumab. In comparison, significantly fewer patients in the IFN beta-1a group (35%) were free from clinical disease activity. Alemtuzumab-treated patients also had significantly higher rates of freedom from sustained accumulation of disability, compared with patients treated with IFN beta-1a (91% vs. 68%).

In addition, significantly more patients in the alemtuzumab groups (77%) were relapse-free than were those in the IFN beta-1a group (49%).

Comparisons between the IFN beta-1a group and each of the two alemtuzumab groups drew similar efficacy conclusions, Dr. Khan wrote.

Another analysis of the trial suggested that alemtuzumab may halt disease progression in the subset of MS patients who experienced autoimmune adverse events. In a poster at the meeting, Dr. Vesna Brinar of University Hospital Center in Zagreb, Croatia, and her colleagues reviewed 3-year follow-up data from 216 patients treated with alemtuzumab and 107 patients treated with IFN beta-1a in the phase II trial.

After 3 years, autoimmune adverse events had occurred in 47 patients who received alemtuzumab and in 3 patients who received IFN beta-1a. The most common events in alemtuzumab-treated patients included hyperthyroidism (21 patients), hypothyroidism (13 patients), and autoimmune thyroiditis (8 patients).

By 36 months, 12% of alemtuzumab-treated patients had experienced sustained accumulation of disability, compared with 26% of patients treated with IFN beta-1a.

The annualized relapse rate was significantly lower among the alemtuzumab-treated patients with autoimmune problems, compared with patients treated with IFN beta-1a (0.09 vs. 0.36), according to Dr. Brinar.

In addition, those who experienced autoimmune problems on alemtuzumab had a significant mean improvement on the Expanded Disability Status Scale of −0.44 points from baseline.

Ongoing phase III studies are in place to confirm and further expand the results, the researchers said.

Major Finding: Significantly more patients who took 12 mg/day or 24 mg/day of alemtuzumab were clinically disease-free after 4 years, compared with patients who received subcutaneous interferon beta-1a (71% vs. 35%).

Data Source: A subset of patients from a phase II trial of 334 patients with relapsing-remitting MS.

Disclosures: The trial was sponsored by Genzyme. Dr. Khan has received research support and personal compensation from Teva Neuroscience, Biogen Idec, EMD Serono, and Bayer Healthcare. He also has received personal compensation from Novartis. Dr. Brinar has received research support from Genzyme.

TORONTO — Data further gleaned from a phase II study of low or high dose alemtuzumab indicate that the drug kept nearly three-fourths of multiple sclerosis patients clinically disease free for 4 years and was effective in halting disease activity even in patients who suffered autoimmune adverse events.

Dr. Omar Khan of Wayne State University, Detroit, and his colleagues reported 4-year follow-up results for a subset of patients in the CAMMS223 trial, an assessor-blinded study that randomized 334 patients to either 12 mg/day or 24 mg/day of alemtuzumab (Campath) against 44 mcg of subcutaneous interferon beta 1-a (IFN beta-1a, Rebif) 3 times a week.

Campath already is approved as a single agent for the treatment of B-cell chronic lymphocytic leukemia.

Data on follow-up at 4 years were available for 42 patients who received IFN beta-1a, 63 patients who received 12 mg/day of alemtuzumab, and 71 patients who received 24 mg/day of alemtuzumab. Treatment with alemtuzumab consisted of two to three cycles each year that each lasted 3–5 days. A total of 110 patients received only two cycles of alemtuzumab annually. The demographics of this subset of patients were similar to those in the original study group, Dr. Khan and his associates reported in a poster session at the annual meeting of the American Academy of Neurology.

After 4 years, no clinical disease activity had occurred in 71% of all patients treated with alemtuzumab and in 72% of those who received only two cycles of alemtuzumab. In comparison, significantly fewer patients in the IFN beta-1a group (35%) were free from clinical disease activity. Alemtuzumab-treated patients also had significantly higher rates of freedom from sustained accumulation of disability, compared with patients treated with IFN beta-1a (91% vs. 68%).

In addition, significantly more patients in the alemtuzumab groups (77%) were relapse-free than were those in the IFN beta-1a group (49%).

Comparisons between the IFN beta-1a group and each of the two alemtuzumab groups drew similar efficacy conclusions, Dr. Khan wrote.

Another analysis of the trial suggested that alemtuzumab may halt disease progression in the subset of MS patients who experienced autoimmune adverse events. In a poster at the meeting, Dr. Vesna Brinar of University Hospital Center in Zagreb, Croatia, and her colleagues reviewed 3-year follow-up data from 216 patients treated with alemtuzumab and 107 patients treated with IFN beta-1a in the phase II trial.

After 3 years, autoimmune adverse events had occurred in 47 patients who received alemtuzumab and in 3 patients who received IFN beta-1a. The most common events in alemtuzumab-treated patients included hyperthyroidism (21 patients), hypothyroidism (13 patients), and autoimmune thyroiditis (8 patients).

By 36 months, 12% of alemtuzumab-treated patients had experienced sustained accumulation of disability, compared with 26% of patients treated with IFN beta-1a.

The annualized relapse rate was significantly lower among the alemtuzumab-treated patients with autoimmune problems, compared with patients treated with IFN beta-1a (0.09 vs. 0.36), according to Dr. Brinar.

In addition, those who experienced autoimmune problems on alemtuzumab had a significant mean improvement on the Expanded Disability Status Scale of −0.44 points from baseline.

Ongoing phase III studies are in place to confirm and further expand the results, the researchers said.

Major Finding: The annualized relapse rate was reduced by 54% in multiple sclerosis patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. After 24 months, around 70% of patients given fingolimod were relapse free, compared with 46% of the placebo group.

Data Source: A randomized, double-blind, placebo-controlled phase III study of 1,272 adults with MS.

Disclosures: The study was supported by Novartis Pharma AG. Dr. Kappos has received research support from multiple pharmaceutical companies, including Novartis. Dr. O'Connor has served as a consultant and received research support for multiple pharmaceutical companies, including Novartis.

TORONTO — The investigational drug fingolimod at doses of 0.5 mg and 1.25 mg appears to be a safe and effective treatment for adults with multiple sclerosis, based on data from more than 1,000 patients.

In previous studies, fingolimod had “a clear-cut effect on inflammatory outcomes,” in relapsing-remitting multiple sclerosis patients, said Dr. Ludwig Kappos of University Hospital in Basel, Switzerland.

The current phase III study addressed whether the effects of fingolimod (FTY720) persisted over time, and whether a 0.5-mg dose is as effective as the previously studied 1.25-mg dose. The main outcome was relapse rate per year over a 2-year follow-up period.

The Food and Drug Administration has scheduled a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review the safety and efficacy data for fingolimod in June.

The Fingolimod (FTY720) vs. Placebo in Relapsing-Remitting Multiple Sclerosis (FREEDOMS) study included 1,272 patients aged 18–55 years.

The average age of the patients was 37 years, and the average duration of MS was 8 years. Patients with systemic or immune system disease were excluded, and 1,033 patients completed the study.

Patients were randomized to receive a daily dose of 1.25 mg fingolimod, 0.5 mg fingolimod, or a placebo.

The annualized relapse rate was reduced by 54% in patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. There was no significant difference in effectiveness between the doses, and both doses were significantly more effective than was placebo.

After 24 months, significantly more patients in either fingolimod group (70%–75%) were relapse free, compared with 46% of the placebo group.

In addition, both the 1.25-mg and 0.5-mg doses of fingolimod were associated with reductions of 32% and 30%, respectively, in the risk of 3-month confirmed disability progression.

Both reductions were significant, compared with placebo. Similarly, both the 1.25-mg and 0.5-mg doses were associated with reductions in risk of 6-month confirmed disability progression of 40% and 37%, also significant compared with placebo.

The study results were presented at the annual meeting of the American Academy of Neurology.

Safety and tolerability data for the study population were presented separately in a poster by Dr. Paul O'Connor of St. Michael's Hospital in Toronto, and colleagues.

In the safety analysis, the researchers evaluated all patients at baseline screening, week 2, and months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24.

Overall, the incidence of any adverse event was 94% in both fingolimod groups and 93% in the placebo group. The incidence of an adverse event that caused a patient to stop treatment was 14% in the 1.25-mg group, and 8% in both the 0.5-mg and placebo groups.

Serious adverse events were reported in 51 patients (12%) in the 1.25-mg group, 42 patients (10%) in the 0.5-mg group, and 56 patients (13%) in the placebo group. Serious adverse events included cardiovascular disorders, neoplasms, nervous system disorders, macular edema, and abnormal liver function test results.

Sinus bradycardia, the most common ECG finding, occurred in 47 patients (11%) in the 1.25-mg group, 20 patients (5%) in the 0.5-mg group, and 6 patients (2%) in the placebo group. In addition, first- and second-degree atrioventricular blocks were reported in 20 patients (5%) and 1 patient (0.2%), respectively, in the 0.5-mg group, compared with 37 patients (9%) and 4 patients (1%), respectively, in the 1.25-mg group.

Malignant neoplasms were reported in 4 patients in each of the fingolimod groups, and in 10 patients in the placebo group. All 11 cases of skin cancer reported in the study were successfully treated with excision.

Abnormal liver function tests were reported more than twice as frequently in the fingolimod 1.25-mg and 0.5-mg groups, compared with placebo (19%, 16%, and 5%, respectively). But “liver enzyme elevations were asymptomatic and improved once therapy was discontinued; no patient developed liver failure,” the researchers wrote.

In the 1.25-mg group, one case of ischemic stroke occurred during the study period, and a transient ischemic attack occurred 8 months after the discontinuation of treatment. No clinically relevant pulmonary function changes were observed in any of the groups.

All seven reported cases of macular edema occurred in the 1.25-mg group, and all cases resolved after treatment was discontinued.

The overall incidence of infections was similar (69%–72%) for all three groups, and included herpesvirus infections, lower respiratory tract infections, and urinary tract infections.

The results support safety data from previous studies and suggest that most patients with MS tolerate oral fingolimod, the researchers said. Also consistent with previous studies, “the overall safety profile of fingolimod 0.5 mg appears to be more favorable than that of the 1.25-mg dose,” they added.

Major Finding: The annualized relapse rate was reduced by 54% in multiple sclerosis patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. After 24 months, around 70% of patients given fingolimod were relapse free, compared with 46% of the placebo group.

Data Source: A randomized, double-blind, placebo-controlled phase III study of 1,272 adults with MS.

Disclosures: The study was supported by Novartis Pharma AG. Dr. Kappos has received research support from multiple pharmaceutical companies, including Novartis. Dr. O'Connor has served as a consultant and received research support for multiple pharmaceutical companies, including Novartis.

TORONTO — The investigational drug fingolimod at doses of 0.5 mg and 1.25 mg appears to be a safe and effective treatment for adults with multiple sclerosis, based on data from more than 1,000 patients.

In previous studies, fingolimod had “a clear-cut effect on inflammatory outcomes,” in relapsing-remitting multiple sclerosis patients, said Dr. Ludwig Kappos of University Hospital in Basel, Switzerland.

The current phase III study addressed whether the effects of fingolimod (FTY720) persisted over time, and whether a 0.5-mg dose is as effective as the previously studied 1.25-mg dose. The main outcome was relapse rate per year over a 2-year follow-up period.

The Food and Drug Administration has scheduled a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review the safety and efficacy data for fingolimod in June.

The Fingolimod (FTY720) vs. Placebo in Relapsing-Remitting Multiple Sclerosis (FREEDOMS) study included 1,272 patients aged 18–55 years.

The average age of the patients was 37 years, and the average duration of MS was 8 years. Patients with systemic or immune system disease were excluded, and 1,033 patients completed the study.

Patients were randomized to receive a daily dose of 1.25 mg fingolimod, 0.5 mg fingolimod, or a placebo.

The annualized relapse rate was reduced by 54% in patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. There was no significant difference in effectiveness between the doses, and both doses were significantly more effective than was placebo.

After 24 months, significantly more patients in either fingolimod group (70%–75%) were relapse free, compared with 46% of the placebo group.

In addition, both the 1.25-mg and 0.5-mg doses of fingolimod were associated with reductions of 32% and 30%, respectively, in the risk of 3-month confirmed disability progression.

Both reductions were significant, compared with placebo. Similarly, both the 1.25-mg and 0.5-mg doses were associated with reductions in risk of 6-month confirmed disability progression of 40% and 37%, also significant compared with placebo.

The study results were presented at the annual meeting of the American Academy of Neurology.

Safety and tolerability data for the study population were presented separately in a poster by Dr. Paul O'Connor of St. Michael's Hospital in Toronto, and colleagues.

In the safety analysis, the researchers evaluated all patients at baseline screening, week 2, and months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24.

Overall, the incidence of any adverse event was 94% in both fingolimod groups and 93% in the placebo group. The incidence of an adverse event that caused a patient to stop treatment was 14% in the 1.25-mg group, and 8% in both the 0.5-mg and placebo groups.

Serious adverse events were reported in 51 patients (12%) in the 1.25-mg group, 42 patients (10%) in the 0.5-mg group, and 56 patients (13%) in the placebo group. Serious adverse events included cardiovascular disorders, neoplasms, nervous system disorders, macular edema, and abnormal liver function test results.

Sinus bradycardia, the most common ECG finding, occurred in 47 patients (11%) in the 1.25-mg group, 20 patients (5%) in the 0.5-mg group, and 6 patients (2%) in the placebo group. In addition, first- and second-degree atrioventricular blocks were reported in 20 patients (5%) and 1 patient (0.2%), respectively, in the 0.5-mg group, compared with 37 patients (9%) and 4 patients (1%), respectively, in the 1.25-mg group.

Malignant neoplasms were reported in 4 patients in each of the fingolimod groups, and in 10 patients in the placebo group. All 11 cases of skin cancer reported in the study were successfully treated with excision.

Abnormal liver function tests were reported more than twice as frequently in the fingolimod 1.25-mg and 0.5-mg groups, compared with placebo (19%, 16%, and 5%, respectively). But “liver enzyme elevations were asymptomatic and improved once therapy was discontinued; no patient developed liver failure,” the researchers wrote.

In the 1.25-mg group, one case of ischemic stroke occurred during the study period, and a transient ischemic attack occurred 8 months after the discontinuation of treatment. No clinically relevant pulmonary function changes were observed in any of the groups.

All seven reported cases of macular edema occurred in the 1.25-mg group, and all cases resolved after treatment was discontinued.

The overall incidence of infections was similar (69%–72%) for all three groups, and included herpesvirus infections, lower respiratory tract infections, and urinary tract infections.

The results support safety data from previous studies and suggest that most patients with MS tolerate oral fingolimod, the researchers said. Also consistent with previous studies, “the overall safety profile of fingolimod 0.5 mg appears to be more favorable than that of the 1.25-mg dose,” they added.

Major Finding: The annualized relapse rate was reduced by 54% in multiple sclerosis patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. After 24 months, around 70% of patients given fingolimod were relapse free, compared with 46% of the placebo group.

Data Source: A randomized, double-blind, placebo-controlled phase III study of 1,272 adults with MS.

Disclosures: The study was supported by Novartis Pharma AG. Dr. Kappos has received research support from multiple pharmaceutical companies, including Novartis. Dr. O'Connor has served as a consultant and received research support for multiple pharmaceutical companies, including Novartis.

TORONTO — The investigational drug fingolimod at doses of 0.5 mg and 1.25 mg appears to be a safe and effective treatment for adults with multiple sclerosis, based on data from more than 1,000 patients.

In previous studies, fingolimod had “a clear-cut effect on inflammatory outcomes,” in relapsing-remitting multiple sclerosis patients, said Dr. Ludwig Kappos of University Hospital in Basel, Switzerland.

The current phase III study addressed whether the effects of fingolimod (FTY720) persisted over time, and whether a 0.5-mg dose is as effective as the previously studied 1.25-mg dose. The main outcome was relapse rate per year over a 2-year follow-up period.

The Food and Drug Administration has scheduled a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review the safety and efficacy data for fingolimod in June.

The Fingolimod (FTY720) vs. Placebo in Relapsing-Remitting Multiple Sclerosis (FREEDOMS) study included 1,272 patients aged 18–55 years.

The average age of the patients was 37 years, and the average duration of MS was 8 years. Patients with systemic or immune system disease were excluded, and 1,033 patients completed the study.

Patients were randomized to receive a daily dose of 1.25 mg fingolimod, 0.5 mg fingolimod, or a placebo.

The annualized relapse rate was reduced by 54% in patients who took 0.5 mg of fingolimod and by 60% in those who took 1.25 mg of fingolimod. There was no significant difference in effectiveness between the doses, and both doses were significantly more effective than was placebo.

After 24 months, significantly more patients in either fingolimod group (70%–75%) were relapse free, compared with 46% of the placebo group.

In addition, both the 1.25-mg and 0.5-mg doses of fingolimod were associated with reductions of 32% and 30%, respectively, in the risk of 3-month confirmed disability progression.

Both reductions were significant, compared with placebo. Similarly, both the 1.25-mg and 0.5-mg doses were associated with reductions in risk of 6-month confirmed disability progression of 40% and 37%, also significant compared with placebo.

The study results were presented at the annual meeting of the American Academy of Neurology.

Safety and tolerability data for the study population were presented separately in a poster by Dr. Paul O'Connor of St. Michael's Hospital in Toronto, and colleagues.

In the safety analysis, the researchers evaluated all patients at baseline screening, week 2, and months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 24.

Overall, the incidence of any adverse event was 94% in both fingolimod groups and 93% in the placebo group. The incidence of an adverse event that caused a patient to stop treatment was 14% in the 1.25-mg group, and 8% in both the 0.5-mg and placebo groups.

Serious adverse events were reported in 51 patients (12%) in the 1.25-mg group, 42 patients (10%) in the 0.5-mg group, and 56 patients (13%) in the placebo group. Serious adverse events included cardiovascular disorders, neoplasms, nervous system disorders, macular edema, and abnormal liver function test results.

Sinus bradycardia, the most common ECG finding, occurred in 47 patients (11%) in the 1.25-mg group, 20 patients (5%) in the 0.5-mg group, and 6 patients (2%) in the placebo group. In addition, first- and second-degree atrioventricular blocks were reported in 20 patients (5%) and 1 patient (0.2%), respectively, in the 0.5-mg group, compared with 37 patients (9%) and 4 patients (1%), respectively, in the 1.25-mg group.

Malignant neoplasms were reported in 4 patients in each of the fingolimod groups, and in 10 patients in the placebo group. All 11 cases of skin cancer reported in the study were successfully treated with excision.

Abnormal liver function tests were reported more than twice as frequently in the fingolimod 1.25-mg and 0.5-mg groups, compared with placebo (19%, 16%, and 5%, respectively). But “liver enzyme elevations were asymptomatic and improved once therapy was discontinued; no patient developed liver failure,” the researchers wrote.

In the 1.25-mg group, one case of ischemic stroke occurred during the study period, and a transient ischemic attack occurred 8 months after the discontinuation of treatment. No clinically relevant pulmonary function changes were observed in any of the groups.

All seven reported cases of macular edema occurred in the 1.25-mg group, and all cases resolved after treatment was discontinued.

The overall incidence of infections was similar (69%–72%) for all three groups, and included herpesvirus infections, lower respiratory tract infections, and urinary tract infections.

The results support safety data from previous studies and suggest that most patients with MS tolerate oral fingolimod, the researchers said. Also consistent with previous studies, “the overall safety profile of fingolimod 0.5 mg appears to be more favorable than that of the 1.25-mg dose,” they added.

Major Finding: The number of falls in MS patients seen at an outpatient neurology clinic was strongly correlated with higher scores on the Expanded Disease Severity Scale (r = 0.64) and lower scores on the Activities-Specific Balance Confidence scale (r = −0.77).

Data Source: A study of 50 consecutive MS outpatients aged 16–68 years.

Disclosures: Dr. Cameron has served as a speaker or consultant for Teva Neurosciences, California Education Connection, and Mettler Electronics. This study was sponsored by a grant from the National Multiple Sclerosis Society.

TORONTO — Poor scores on questionnaires related to balance confidence and disease severity were significant predictors of falls in adults with multiple sclerosis, based on data from a study of outpatients at a single facility.

Previous European studies have suggested an association between multiple sclerosis (MS) disease severity and the frequency of falling, but data on similar associations in U.S. patients are limited, said Dr. Michelle Cameron, a postdoctoral fellow at Oregon Health & Science University, Portland.

Dr. Cameron used two questionnaires to assess fall frequency in 50 consecutive MS patients during a clinical visit. Patients completed the Activities-Specific Balance Confidence (ABC) Scale and the self-reported Expanded Disease Severity Scale (EDSS). The patients' EDSS scores ranged from 1 to 5, with an average score of 3.

The patients ranged in age from 16–68 years, with a mean age of 46 years, and 74% were women. A total of 31 patients (62%) reported falling at least once in the year prior to the study, and 14 (28%) reported falling at least six times in the year prior to the study. In addition, three of the patients (6%) reported falling at least six times during the 2 months prior to the study.

The number of falls was strongly correlated with higher scores on the EDSS (r = 0.64) and lower scores on the ABC scale (r = −0.77). The number of falls over a 12-month period was strongly correlated with lower ABC scale scores (r = −0.74).

The results suggest that a majority of MS patients fall and more than one-fourth of them fall frequently, said Dr. Cameron, who presented her study in a poster at the annual meeting of the American Academy of Neurology. “Falls occur more often in those with lower balance confidence,” she said.

The ABC scale and a simple questionnaire about falls can easily be administered in a clinical setting, Dr. Cameron noted, and clinicians who identify patients at risk for falls can work with them to improve balance confidence.

Major Finding: The number of falls in MS patients seen at an outpatient neurology clinic was strongly correlated with higher scores on the Expanded Disease Severity Scale (r = 0.64) and lower scores on the Activities-Specific Balance Confidence scale (r = −0.77).

Data Source: A study of 50 consecutive MS outpatients aged 16–68 years.

Disclosures: Dr. Cameron has served as a speaker or consultant for Teva Neurosciences, California Education Connection, and Mettler Electronics. This study was sponsored by a grant from the National Multiple Sclerosis Society.

TORONTO — Poor scores on questionnaires related to balance confidence and disease severity were significant predictors of falls in adults with multiple sclerosis, based on data from a study of outpatients at a single facility.

Previous European studies have suggested an association between multiple sclerosis (MS) disease severity and the frequency of falling, but data on similar associations in U.S. patients are limited, said Dr. Michelle Cameron, a postdoctoral fellow at Oregon Health & Science University, Portland.

Dr. Cameron used two questionnaires to assess fall frequency in 50 consecutive MS patients during a clinical visit. Patients completed the Activities-Specific Balance Confidence (ABC) Scale and the self-reported Expanded Disease Severity Scale (EDSS). The patients' EDSS scores ranged from 1 to 5, with an average score of 3.

The patients ranged in age from 16–68 years, with a mean age of 46 years, and 74% were women. A total of 31 patients (62%) reported falling at least once in the year prior to the study, and 14 (28%) reported falling at least six times in the year prior to the study. In addition, three of the patients (6%) reported falling at least six times during the 2 months prior to the study.

The number of falls was strongly correlated with higher scores on the EDSS (r = 0.64) and lower scores on the ABC scale (r = −0.77). The number of falls over a 12-month period was strongly correlated with lower ABC scale scores (r = −0.74).

The results suggest that a majority of MS patients fall and more than one-fourth of them fall frequently, said Dr. Cameron, who presented her study in a poster at the annual meeting of the American Academy of Neurology. “Falls occur more often in those with lower balance confidence,” she said.

The ABC scale and a simple questionnaire about falls can easily be administered in a clinical setting, Dr. Cameron noted, and clinicians who identify patients at risk for falls can work with them to improve balance confidence.

Major Finding: The number of falls in MS patients seen at an outpatient neurology clinic was strongly correlated with higher scores on the Expanded Disease Severity Scale (r = 0.64) and lower scores on the Activities-Specific Balance Confidence scale (r = −0.77).

Data Source: A study of 50 consecutive MS outpatients aged 16–68 years.

Disclosures: Dr. Cameron has served as a speaker or consultant for Teva Neurosciences, California Education Connection, and Mettler Electronics. This study was sponsored by a grant from the National Multiple Sclerosis Society.

TORONTO — Poor scores on questionnaires related to balance confidence and disease severity were significant predictors of falls in adults with multiple sclerosis, based on data from a study of outpatients at a single facility.

Previous European studies have suggested an association between multiple sclerosis (MS) disease severity and the frequency of falling, but data on similar associations in U.S. patients are limited, said Dr. Michelle Cameron, a postdoctoral fellow at Oregon Health & Science University, Portland.

Dr. Cameron used two questionnaires to assess fall frequency in 50 consecutive MS patients during a clinical visit. Patients completed the Activities-Specific Balance Confidence (ABC) Scale and the self-reported Expanded Disease Severity Scale (EDSS). The patients' EDSS scores ranged from 1 to 5, with an average score of 3.

The patients ranged in age from 16–68 years, with a mean age of 46 years, and 74% were women. A total of 31 patients (62%) reported falling at least once in the year prior to the study, and 14 (28%) reported falling at least six times in the year prior to the study. In addition, three of the patients (6%) reported falling at least six times during the 2 months prior to the study.

The number of falls was strongly correlated with higher scores on the EDSS (r = 0.64) and lower scores on the ABC scale (r = −0.77). The number of falls over a 12-month period was strongly correlated with lower ABC scale scores (r = −0.74).

The results suggest that a majority of MS patients fall and more than one-fourth of them fall frequently, said Dr. Cameron, who presented her study in a poster at the annual meeting of the American Academy of Neurology. “Falls occur more often in those with lower balance confidence,” she said.

The ABC scale and a simple questionnaire about falls can easily be administered in a clinical setting, Dr. Cameron noted, and clinicians who identify patients at risk for falls can work with them to improve balance confidence.

ORLANDO — Both the indications for, and the incidence of, adenotonsillar procedures in children have changed, according to Dr. Laura Orvidas.

“We seem to do more adenotonsillectomies for sleep-disordered breathing than we have in the past,” she said at the combined sections meeting of the Triological Society.

To evaluate changes in the incidence and indications for tonsillectomy and adenotonsillectomy, Dr. Orvidas of the Mayo Clinic in Rochester, Minn., reviewed data from the Mayo Clinic's database for a 35-year period between 1970 and 2005. The study population included 8,106 tonsillectomy and/or adenotonsillectomy patients aged 6 months to 29 years (mean age, 10.5 years).

The most interesting finding was the change in surgical indications for all procedures, said Dr. Orvidas: “Early on we were treating mostly for infection, and now it seems to be mostly for upper airway obstruction.” In 1970, treatment of infection accounted for approximately 90% of either adenotonsillectomies or tonsillectomies, while upper airway obstruction accounted for about 10%. In 2005, upper airway obstruction accounted for more than half of the indications for both procedures, while infection accounted for about 25% and a combination of both upper airway obstruction and infection accounted for approximately 20%.

The incidence of tonsillectomy or adenotonsillectomy was 369/100,000 person-years during the period from 1970 to 1974, compared with 642/100,000 person-years from 2001 to 2005, Dr. Orvidas said.

Sixty-five percent of the tonsillectomy patients, 48% of the adenotonsillectomy patients, and 55% of the patients for both conditions were female.

“Neither the indication nor the incidence for adenotonsillar surgery has been static,” Dr. Orvidas noted at the meeting, jointly sponsored by the Triological Society and the American College of Surgeons.

Adenotonsillectomy incidence increased more than tonsillectomy incidence overall, although there was a high density of tonsillectomies in adolescent females, she said. For tonsillectomy alone, the mean age across the entire study period was 16 years vs. a mean of 7 years for adenotonsillectomy.

Dr. Orvidas also noted an increase in both adenotonsillectomy and tonsillectomy procedures for younger males. The possible reasons for these two trends were not addressed in the Mayo Clinic study.

Disclosures: None was reported.

ORLANDO — Both the indications for, and the incidence of, adenotonsillar procedures in children have changed, according to Dr. Laura Orvidas.

“We seem to do more adenotonsillectomies for sleep-disordered breathing than we have in the past,” she said at the combined sections meeting of the Triological Society.

To evaluate changes in the incidence and indications for tonsillectomy and adenotonsillectomy, Dr. Orvidas of the Mayo Clinic in Rochester, Minn., reviewed data from the Mayo Clinic's database for a 35-year period between 1970 and 2005. The study population included 8,106 tonsillectomy and/or adenotonsillectomy patients aged 6 months to 29 years (mean age, 10.5 years).

The most interesting finding was the change in surgical indications for all procedures, said Dr. Orvidas: “Early on we were treating mostly for infection, and now it seems to be mostly for upper airway obstruction.” In 1970, treatment of infection accounted for approximately 90% of either adenotonsillectomies or tonsillectomies, while upper airway obstruction accounted for about 10%. In 2005, upper airway obstruction accounted for more than half of the indications for both procedures, while infection accounted for about 25% and a combination of both upper airway obstruction and infection accounted for approximately 20%.

The incidence of tonsillectomy or adenotonsillectomy was 369/100,000 person-years during the period from 1970 to 1974, compared with 642/100,000 person-years from 2001 to 2005, Dr. Orvidas said.

Sixty-five percent of the tonsillectomy patients, 48% of the adenotonsillectomy patients, and 55% of the patients for both conditions were female.

“Neither the indication nor the incidence for adenotonsillar surgery has been static,” Dr. Orvidas noted at the meeting, jointly sponsored by the Triological Society and the American College of Surgeons.

Adenotonsillectomy incidence increased more than tonsillectomy incidence overall, although there was a high density of tonsillectomies in adolescent females, she said. For tonsillectomy alone, the mean age across the entire study period was 16 years vs. a mean of 7 years for adenotonsillectomy.

Dr. Orvidas also noted an increase in both adenotonsillectomy and tonsillectomy procedures for younger males. The possible reasons for these two trends were not addressed in the Mayo Clinic study.

Disclosures: None was reported.

ORLANDO — Both the indications for, and the incidence of, adenotonsillar procedures in children have changed, according to Dr. Laura Orvidas.

“We seem to do more adenotonsillectomies for sleep-disordered breathing than we have in the past,” she said at the combined sections meeting of the Triological Society.

To evaluate changes in the incidence and indications for tonsillectomy and adenotonsillectomy, Dr. Orvidas of the Mayo Clinic in Rochester, Minn., reviewed data from the Mayo Clinic's database for a 35-year period between 1970 and 2005. The study population included 8,106 tonsillectomy and/or adenotonsillectomy patients aged 6 months to 29 years (mean age, 10.5 years).

The most interesting finding was the change in surgical indications for all procedures, said Dr. Orvidas: “Early on we were treating mostly for infection, and now it seems to be mostly for upper airway obstruction.” In 1970, treatment of infection accounted for approximately 90% of either adenotonsillectomies or tonsillectomies, while upper airway obstruction accounted for about 10%. In 2005, upper airway obstruction accounted for more than half of the indications for both procedures, while infection accounted for about 25% and a combination of both upper airway obstruction and infection accounted for approximately 20%.

The incidence of tonsillectomy or adenotonsillectomy was 369/100,000 person-years during the period from 1970 to 1974, compared with 642/100,000 person-years from 2001 to 2005, Dr. Orvidas said.

Sixty-five percent of the tonsillectomy patients, 48% of the adenotonsillectomy patients, and 55% of the patients for both conditions were female.

“Neither the indication nor the incidence for adenotonsillar surgery has been static,” Dr. Orvidas noted at the meeting, jointly sponsored by the Triological Society and the American College of Surgeons.

Adenotonsillectomy incidence increased more than tonsillectomy incidence overall, although there was a high density of tonsillectomies in adolescent females, she said. For tonsillectomy alone, the mean age across the entire study period was 16 years vs. a mean of 7 years for adenotonsillectomy.

Dr. Orvidas also noted an increase in both adenotonsillectomy and tonsillectomy procedures for younger males. The possible reasons for these two trends were not addressed in the Mayo Clinic study.

Disclosures: None was reported.

Major Finding: Of patients who stopped taking AEDs, 45% cited side effects as a reason; those taking two or more AEDs were less likely to be satisfied with the side effects than were those taking one AED.

Data Source: National Survey of Epilepsy, Comorbidities, and Health of 7,500 epilepsy patients and 2,500 controls.

Disclosures: The presenter is an employee of Ortho-McNeil Janssen Scientific Affairs LLC, which supported the study.

TORONTO — About 40% of epilepsy patients are bothered by side effects of their antiepileptic drugs, based on data from a survey of adults with epilepsy.

Information on the tolerability of antiepileptic drugs (AEDs) and the reasons for discontinuing treatment are limited, said George J. Wan, Ph.D., in a poster presentation at the annual meeting of the American Academy of Neurology.

To examine drug tolerability and treatment satisfaction, Dr. Wan, of Ortho-McNeil Janssen Scientific Affairs LLC, and his colleagues reviewed data from the National Survey of Epilepsy, Comorbidities, and Health Outcomes (EPIC), a large survey conducted in the United States in 2009 that included 7,500 epilepsy patients and 2,500 controls.

The researchers evaluated responses from 5,117 self-reporting epilepsy patients. A total of 2,395 respondents reported being formally diagnosed with epilepsy or a seizure disorder; of those, 1,415 (59%) were taking antiepilepsy drugs at the time of the survey. About 60% of the respondents reported taking one AED, 35% reported taking two or three, and 5% reported taking four or more. The respondents had been taking AEDs for an average of 115 months.

A total of 772 respondents said that they were “not at all” bothered by side effects from AEDs during the 4 weeks leading up to the survey. But 519 respondents reported some degree of bother: 22% were mildly bothered; 12%, moderately bothered; 5%, markedly bothered; and 1%, extremely bothered.

Overall, 72% of the respondents said they were either “somewhat satisfied” or “very satisfied” with their current AED regimens. But a total of 304 respondents said that they had discontinued their medications. Of those, 50% discontinued on their doctor's advice; 45% discontinued because of side effects; 30%, because of improvement in seizures or the disappearance of seizures; and 21%, because of inadequate seizure control. Some respondents indicated more than one reason for discontinuing their AEDs.

After controlling for baseline characteristics and lifetime seizures, patients who were taking two or more AEDs were less likely to be satisfied with the side effects compared with those who were taking one AED. The study was limited by the use of self-reports. “Further research is needed to quantify the impact of AED treatment on other patient-reported outcomes,” they said.

Major Finding: Of patients who stopped taking AEDs, 45% cited side effects as a reason; those taking two or more AEDs were less likely to be satisfied with the side effects than were those taking one AED.

Data Source: National Survey of Epilepsy, Comorbidities, and Health of 7,500 epilepsy patients and 2,500 controls.

Disclosures: The presenter is an employee of Ortho-McNeil Janssen Scientific Affairs LLC, which supported the study.

TORONTO — About 40% of epilepsy patients are bothered by side effects of their antiepileptic drugs, based on data from a survey of adults with epilepsy.

Information on the tolerability of antiepileptic drugs (AEDs) and the reasons for discontinuing treatment are limited, said George J. Wan, Ph.D., in a poster presentation at the annual meeting of the American Academy of Neurology.

To examine drug tolerability and treatment satisfaction, Dr. Wan, of Ortho-McNeil Janssen Scientific Affairs LLC, and his colleagues reviewed data from the National Survey of Epilepsy, Comorbidities, and Health Outcomes (EPIC), a large survey conducted in the United States in 2009 that included 7,500 epilepsy patients and 2,500 controls.

The researchers evaluated responses from 5,117 self-reporting epilepsy patients. A total of 2,395 respondents reported being formally diagnosed with epilepsy or a seizure disorder; of those, 1,415 (59%) were taking antiepilepsy drugs at the time of the survey. About 60% of the respondents reported taking one AED, 35% reported taking two or three, and 5% reported taking four or more. The respondents had been taking AEDs for an average of 115 months.

A total of 772 respondents said that they were “not at all” bothered by side effects from AEDs during the 4 weeks leading up to the survey. But 519 respondents reported some degree of bother: 22% were mildly bothered; 12%, moderately bothered; 5%, markedly bothered; and 1%, extremely bothered.

Overall, 72% of the respondents said they were either “somewhat satisfied” or “very satisfied” with their current AED regimens. But a total of 304 respondents said that they had discontinued their medications. Of those, 50% discontinued on their doctor's advice; 45% discontinued because of side effects; 30%, because of improvement in seizures or the disappearance of seizures; and 21%, because of inadequate seizure control. Some respondents indicated more than one reason for discontinuing their AEDs.

After controlling for baseline characteristics and lifetime seizures, patients who were taking two or more AEDs were less likely to be satisfied with the side effects compared with those who were taking one AED. The study was limited by the use of self-reports. “Further research is needed to quantify the impact of AED treatment on other patient-reported outcomes,” they said.

Major Finding: Of patients who stopped taking AEDs, 45% cited side effects as a reason; those taking two or more AEDs were less likely to be satisfied with the side effects than were those taking one AED.

Data Source: National Survey of Epilepsy, Comorbidities, and Health of 7,500 epilepsy patients and 2,500 controls.

Disclosures: The presenter is an employee of Ortho-McNeil Janssen Scientific Affairs LLC, which supported the study.

TORONTO — About 40% of epilepsy patients are bothered by side effects of their antiepileptic drugs, based on data from a survey of adults with epilepsy.

Information on the tolerability of antiepileptic drugs (AEDs) and the reasons for discontinuing treatment are limited, said George J. Wan, Ph.D., in a poster presentation at the annual meeting of the American Academy of Neurology.

To examine drug tolerability and treatment satisfaction, Dr. Wan, of Ortho-McNeil Janssen Scientific Affairs LLC, and his colleagues reviewed data from the National Survey of Epilepsy, Comorbidities, and Health Outcomes (EPIC), a large survey conducted in the United States in 2009 that included 7,500 epilepsy patients and 2,500 controls.

The researchers evaluated responses from 5,117 self-reporting epilepsy patients. A total of 2,395 respondents reported being formally diagnosed with epilepsy or a seizure disorder; of those, 1,415 (59%) were taking antiepilepsy drugs at the time of the survey. About 60% of the respondents reported taking one AED, 35% reported taking two or three, and 5% reported taking four or more. The respondents had been taking AEDs for an average of 115 months.

A total of 772 respondents said that they were “not at all” bothered by side effects from AEDs during the 4 weeks leading up to the survey. But 519 respondents reported some degree of bother: 22% were mildly bothered; 12%, moderately bothered; 5%, markedly bothered; and 1%, extremely bothered.

Overall, 72% of the respondents said they were either “somewhat satisfied” or “very satisfied” with their current AED regimens. But a total of 304 respondents said that they had discontinued their medications. Of those, 50% discontinued on their doctor's advice; 45% discontinued because of side effects; 30%, because of improvement in seizures or the disappearance of seizures; and 21%, because of inadequate seizure control. Some respondents indicated more than one reason for discontinuing their AEDs.

After controlling for baseline characteristics and lifetime seizures, patients who were taking two or more AEDs were less likely to be satisfied with the side effects compared with those who were taking one AED. The study was limited by the use of self-reports. “Further research is needed to quantify the impact of AED treatment on other patient-reported outcomes,” they said.

NEW ORLEANS — Children with severe asthma have significantly higher levels of serum IgE and exhaled nitric oxide than adults, based on data from 47 consecutive patients with severe asthma.

Severe asthma affects fewer than 10% of all asthma patients, but it accounts for a disproportionate number of all asthma-related hospitalizations and emergency department visits, said Dr. Jonathan Malka of National Jewish Health in Denver.

Few studies have examined the phenotypic differences in severe asthma based on age, and recognizing the differences and similarities could help clinicians identify severe asthmatics, Dr. Malka said.

To compare levels of impairment and inflammation in children and adults, Dr. Malka and his colleagues evaluated 23 children and 24 adults with severe asthma who presented to National Jewish Health. The average age of the children was 12 years, and the average age of the adults was 47 years. The mean asthma durations were 9 years in children and 27 years in adults. The results were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Serum IgE was significantly higher in children than in adults (about 600 IU/mL vs. about 200 IU/mL). Similarly, exhaled nitric oxide levels were significantly higher in children than in adults (about 54 parts per billion vs. about 27 parts per billion).

Children with severe asthma had significantly less lung function impairment than did adults, based on two measures of lung function. Forced vital capacity (FVC) in children was 94% of the predicted value vs. 72% in adults. Forced expiratory volume in 1 second (FEV₁) in children was 73% of the predicted value vs. 56% in adults. Children also fared better than adults in terms of the FEV₁/FVC ratio and in changes in FEV₁ after using albuterol, but those differences were not significant.

Children and adults showed no significant differences in three measures of asthma morbidity: weekly albuterol use, annual asthma exacerbations, and lifetime hospitalizations.

The study was limited by the small sample size, but the biomarker findings suggest pathophysiologic differences in asthma based on age—although adults and children alike were equally compromised, Dr. Malka said. Additional research may help clinicians adjust management of their severe asthma patients based on age, he said in an interview.

Dr. Malka had no financial conflicts to disclose.

To watch an interview of Dr. Malka, go to www.youtube.com/user/ElsGlobalMedicalNews

NEW ORLEANS — Children with severe asthma have significantly higher levels of serum IgE and exhaled nitric oxide than adults, based on data from 47 consecutive patients with severe asthma.

Severe asthma affects fewer than 10% of all asthma patients, but it accounts for a disproportionate number of all asthma-related hospitalizations and emergency department visits, said Dr. Jonathan Malka of National Jewish Health in Denver.

Few studies have examined the phenotypic differences in severe asthma based on age, and recognizing the differences and similarities could help clinicians identify severe asthmatics, Dr. Malka said.

To compare levels of impairment and inflammation in children and adults, Dr. Malka and his colleagues evaluated 23 children and 24 adults with severe asthma who presented to National Jewish Health. The average age of the children was 12 years, and the average age of the adults was 47 years. The mean asthma durations were 9 years in children and 27 years in adults. The results were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Serum IgE was significantly higher in children than in adults (about 600 IU/mL vs. about 200 IU/mL). Similarly, exhaled nitric oxide levels were significantly higher in children than in adults (about 54 parts per billion vs. about 27 parts per billion).

Children with severe asthma had significantly less lung function impairment than did adults, based on two measures of lung function. Forced vital capacity (FVC) in children was 94% of the predicted value vs. 72% in adults. Forced expiratory volume in 1 second (FEV₁) in children was 73% of the predicted value vs. 56% in adults. Children also fared better than adults in terms of the FEV₁/FVC ratio and in changes in FEV₁ after using albuterol, but those differences were not significant.

Children and adults showed no significant differences in three measures of asthma morbidity: weekly albuterol use, annual asthma exacerbations, and lifetime hospitalizations.

The study was limited by the small sample size, but the biomarker findings suggest pathophysiologic differences in asthma based on age—although adults and children alike were equally compromised, Dr. Malka said. Additional research may help clinicians adjust management of their severe asthma patients based on age, he said in an interview.

Dr. Malka had no financial conflicts to disclose.

To watch an interview of Dr. Malka, go to www.youtube.com/user/ElsGlobalMedicalNews

NEW ORLEANS — Children with severe asthma have significantly higher levels of serum IgE and exhaled nitric oxide than adults, based on data from 47 consecutive patients with severe asthma.

Severe asthma affects fewer than 10% of all asthma patients, but it accounts for a disproportionate number of all asthma-related hospitalizations and emergency department visits, said Dr. Jonathan Malka of National Jewish Health in Denver.

Few studies have examined the phenotypic differences in severe asthma based on age, and recognizing the differences and similarities could help clinicians identify severe asthmatics, Dr. Malka said.

To compare levels of impairment and inflammation in children and adults, Dr. Malka and his colleagues evaluated 23 children and 24 adults with severe asthma who presented to National Jewish Health. The average age of the children was 12 years, and the average age of the adults was 47 years. The mean asthma durations were 9 years in children and 27 years in adults. The results were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Serum IgE was significantly higher in children than in adults (about 600 IU/mL vs. about 200 IU/mL). Similarly, exhaled nitric oxide levels were significantly higher in children than in adults (about 54 parts per billion vs. about 27 parts per billion).

Children with severe asthma had significantly less lung function impairment than did adults, based on two measures of lung function. Forced vital capacity (FVC) in children was 94% of the predicted value vs. 72% in adults. Forced expiratory volume in 1 second (FEV₁) in children was 73% of the predicted value vs. 56% in adults. Children also fared better than adults in terms of the FEV₁/FVC ratio and in changes in FEV₁ after using albuterol, but those differences were not significant.

Children and adults showed no significant differences in three measures of asthma morbidity: weekly albuterol use, annual asthma exacerbations, and lifetime hospitalizations.

The study was limited by the small sample size, but the biomarker findings suggest pathophysiologic differences in asthma based on age—although adults and children alike were equally compromised, Dr. Malka said. Additional research may help clinicians adjust management of their severe asthma patients based on age, he said in an interview.

Dr. Malka had no financial conflicts to disclose.

To watch an interview of Dr. Malka, go to www.youtube.com/user/ElsGlobalMedicalNews