Sharon Worcester

HOLLYWOOD, FLA. — Maintaining hemodynamic stability is particularly important in the anesthetic management of parturients with aortic stenosis, and the use of a slowly titrated epidural or combined spinal-epidural with a reduced spinal anesthesia dose appears to provide this stability in most patients, findings from a case series suggest.

The cases, including six patients with moderate aortic stenosis and six with severe aortic stenosis, also suggest that invasive monitoring facilitates anesthetic management in some patients, and that special attention to postoperative analgesia, monitoring, and volume status can prevent hemodynamic instability and complications, Dr. Alexander Ioscovich reported in a poster at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

The 12 patients were treated at two university hospitals, and compose all the cases of aortic stenosis in parturients seen at those hospitals from 1990 to 2005. Five of six patients with moderate aortic stenosis, and three of six with severe aortic stenosis had regional anesthesia; two with moderate aortic stenosis, and four with severe aortic stenosis had invasive monitoring; and one with critical symptomatic aortic stenosis had intraoperative transesophageal echocardiography under general anesthesia. There were no cases of hemodynamic instability or anesthetic complications, although one patient had a failed epidural, wrote Dr. Ioscovich of Sunnybrook Women's College Hospital, Toronto.

Although neuraxial anesthesia has traditionally been considered contraindicated in aortic stenosis patients, the findings suggest this approach is useful in all but the most severe cases, he concluded.

HOLLYWOOD, FLA. — Maintaining hemodynamic stability is particularly important in the anesthetic management of parturients with aortic stenosis, and the use of a slowly titrated epidural or combined spinal-epidural with a reduced spinal anesthesia dose appears to provide this stability in most patients, findings from a case series suggest.

The cases, including six patients with moderate aortic stenosis and six with severe aortic stenosis, also suggest that invasive monitoring facilitates anesthetic management in some patients, and that special attention to postoperative analgesia, monitoring, and volume status can prevent hemodynamic instability and complications, Dr. Alexander Ioscovich reported in a poster at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

The 12 patients were treated at two university hospitals, and compose all the cases of aortic stenosis in parturients seen at those hospitals from 1990 to 2005. Five of six patients with moderate aortic stenosis, and three of six with severe aortic stenosis had regional anesthesia; two with moderate aortic stenosis, and four with severe aortic stenosis had invasive monitoring; and one with critical symptomatic aortic stenosis had intraoperative transesophageal echocardiography under general anesthesia. There were no cases of hemodynamic instability or anesthetic complications, although one patient had a failed epidural, wrote Dr. Ioscovich of Sunnybrook Women's College Hospital, Toronto.

Although neuraxial anesthesia has traditionally been considered contraindicated in aortic stenosis patients, the findings suggest this approach is useful in all but the most severe cases, he concluded.

HOLLYWOOD, FLA. — Maintaining hemodynamic stability is particularly important in the anesthetic management of parturients with aortic stenosis, and the use of a slowly titrated epidural or combined spinal-epidural with a reduced spinal anesthesia dose appears to provide this stability in most patients, findings from a case series suggest.

The cases, including six patients with moderate aortic stenosis and six with severe aortic stenosis, also suggest that invasive monitoring facilitates anesthetic management in some patients, and that special attention to postoperative analgesia, monitoring, and volume status can prevent hemodynamic instability and complications, Dr. Alexander Ioscovich reported in a poster at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

The 12 patients were treated at two university hospitals, and compose all the cases of aortic stenosis in parturients seen at those hospitals from 1990 to 2005. Five of six patients with moderate aortic stenosis, and three of six with severe aortic stenosis had regional anesthesia; two with moderate aortic stenosis, and four with severe aortic stenosis had invasive monitoring; and one with critical symptomatic aortic stenosis had intraoperative transesophageal echocardiography under general anesthesia. There were no cases of hemodynamic instability or anesthetic complications, although one patient had a failed epidural, wrote Dr. Ioscovich of Sunnybrook Women's College Hospital, Toronto.

Although neuraxial anesthesia has traditionally been considered contraindicated in aortic stenosis patients, the findings suggest this approach is useful in all but the most severe cases, he concluded.

ATLANTA — The recently approved quadrivalent human papillomavirus vaccine shown to be effective for preventing most HPV-related cervical cancers is also expected to prevent most vulvar and vaginal cancers, Dr. Jorma Paavonen reported at the annual meeting of the American Society of Clinical Oncology.

The vaccine (Gardisil, Merck & Co.) received approval from the U.S. Food and Drug Administration in June, after winning unanimous support from an FDA advisory panel.

Gardisil targets HPV 6 and 11, which are associated with anogenital warts, and HPV 16 and 18, which cause most cervical cancers. HPV 16 and 18 are the most common causes of vulvar and vaginal cancers, said Dr. Paavonen of the University of Helsinki.

The FUTURE II study was a combined analysis of data from three randomized, placebo-controlled trials that studied the impact of the vaccine on rates of HPV 16- and 18-related vulvar and vaginal intraepithelial neoplasia grade 2/3. FUTURE II showed that the vaccine was 100% effective up to 2 years of follow-up for preventing these precancerous lesions, said Dr. Paavonen, who has served as a consultant to Merck & Co. and received research funding from the company.

A total of 18,150 women aged 16–26 were randomized in these trials to receive either the vaccine or placebo. Vaccination occurred at day 1 and at 2 and 6 months. Genital tract specimens were obtained at day 1 and then at 6- to 12-month intervals for up to 48 months, with colposcopy performed as needed following algorithm-based referrals.

On per-protocol analysis, there were 10 cases of vulvar intraepithelial neoplasia (VIN) 2/3 or vaginal intraepithelial neoplasia (VaIN) 2/3 in the placebo group, and none in the vaccine group, at an average of 18 months of follow-up. On modified intention-to-treat analysis, there were 24 histologically confirmed cases of VIN 2/3 or VaIN 2/3 in the placebo group, at an average of 2 years of follow-up.

“The burden of HPV disease is not restricted to the cervix. HPV is present in nearly 80% of the 6,000 cases of vaginal and vulvar cancers that are diagnosed in the United States each year,” Dr. Paavonen said.

ATLANTA — The recently approved quadrivalent human papillomavirus vaccine shown to be effective for preventing most HPV-related cervical cancers is also expected to prevent most vulvar and vaginal cancers, Dr. Jorma Paavonen reported at the annual meeting of the American Society of Clinical Oncology.

The vaccine (Gardisil, Merck & Co.) received approval from the U.S. Food and Drug Administration in June, after winning unanimous support from an FDA advisory panel.

Gardisil targets HPV 6 and 11, which are associated with anogenital warts, and HPV 16 and 18, which cause most cervical cancers. HPV 16 and 18 are the most common causes of vulvar and vaginal cancers, said Dr. Paavonen of the University of Helsinki.

The FUTURE II study was a combined analysis of data from three randomized, placebo-controlled trials that studied the impact of the vaccine on rates of HPV 16- and 18-related vulvar and vaginal intraepithelial neoplasia grade 2/3. FUTURE II showed that the vaccine was 100% effective up to 2 years of follow-up for preventing these precancerous lesions, said Dr. Paavonen, who has served as a consultant to Merck & Co. and received research funding from the company.

A total of 18,150 women aged 16–26 were randomized in these trials to receive either the vaccine or placebo. Vaccination occurred at day 1 and at 2 and 6 months. Genital tract specimens were obtained at day 1 and then at 6- to 12-month intervals for up to 48 months, with colposcopy performed as needed following algorithm-based referrals.

On per-protocol analysis, there were 10 cases of vulvar intraepithelial neoplasia (VIN) 2/3 or vaginal intraepithelial neoplasia (VaIN) 2/3 in the placebo group, and none in the vaccine group, at an average of 18 months of follow-up. On modified intention-to-treat analysis, there were 24 histologically confirmed cases of VIN 2/3 or VaIN 2/3 in the placebo group, at an average of 2 years of follow-up.

“The burden of HPV disease is not restricted to the cervix. HPV is present in nearly 80% of the 6,000 cases of vaginal and vulvar cancers that are diagnosed in the United States each year,” Dr. Paavonen said.

ATLANTA — The recently approved quadrivalent human papillomavirus vaccine shown to be effective for preventing most HPV-related cervical cancers is also expected to prevent most vulvar and vaginal cancers, Dr. Jorma Paavonen reported at the annual meeting of the American Society of Clinical Oncology.

The vaccine (Gardisil, Merck & Co.) received approval from the U.S. Food and Drug Administration in June, after winning unanimous support from an FDA advisory panel.

Gardisil targets HPV 6 and 11, which are associated with anogenital warts, and HPV 16 and 18, which cause most cervical cancers. HPV 16 and 18 are the most common causes of vulvar and vaginal cancers, said Dr. Paavonen of the University of Helsinki.

The FUTURE II study was a combined analysis of data from three randomized, placebo-controlled trials that studied the impact of the vaccine on rates of HPV 16- and 18-related vulvar and vaginal intraepithelial neoplasia grade 2/3. FUTURE II showed that the vaccine was 100% effective up to 2 years of follow-up for preventing these precancerous lesions, said Dr. Paavonen, who has served as a consultant to Merck & Co. and received research funding from the company.

A total of 18,150 women aged 16–26 were randomized in these trials to receive either the vaccine or placebo. Vaccination occurred at day 1 and at 2 and 6 months. Genital tract specimens were obtained at day 1 and then at 6- to 12-month intervals for up to 48 months, with colposcopy performed as needed following algorithm-based referrals.

On per-protocol analysis, there were 10 cases of vulvar intraepithelial neoplasia (VIN) 2/3 or vaginal intraepithelial neoplasia (VaIN) 2/3 in the placebo group, and none in the vaccine group, at an average of 18 months of follow-up. On modified intention-to-treat analysis, there were 24 histologically confirmed cases of VIN 2/3 or VaIN 2/3 in the placebo group, at an average of 2 years of follow-up.

“The burden of HPV disease is not restricted to the cervix. HPV is present in nearly 80% of the 6,000 cases of vaginal and vulvar cancers that are diagnosed in the United States each year,” Dr. Paavonen said.

Certain whole grain barley products can now officially bear the claim that they may reduce the risk of heart disease.

The U.S. Food and Drug Administration finalized a rule that allows labeling on such products to state that “soluble fiber from food such as [name of food], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x] grams of the soluble fiber necessary per day to have this effect.”

This claim was allowed beginning in December 2005 under an interim final rule. No comments warranting changes to this interim final rule were received during a 75-day comment period, thus allowing finalization of the rule, according to the FDA.

The rule applies to whole barley and dry-milled barley products such as flakes, grits, flour, meal, and barley meal that provide at least 0.75 g of soluble fiber per serving.

Scientific evidence has shown that such foods, when included as part of a healthy diet, can lower LDL and total cholesterol levels, thereby reducing the risk of heart disease, the FDAsaid.

The barley product labeling rule is part of the FDA's pursuit of new initiatives to help consumers improve the choices they have for healthy and nutritious diets, according to a statement from Dr. Scott Gottlieb, FDA deputy commissioner.

“We firmly believe that one of the best ways to encourage healthier eating habits is to help consumers get truthful, up-to-date, science-based information about food products so that they can make choices that are based on a better understanding of the health consequences of their diets,” he said.

Certain whole grain barley products can now officially bear the claim that they may reduce the risk of heart disease.

The U.S. Food and Drug Administration finalized a rule that allows labeling on such products to state that “soluble fiber from food such as [name of food], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x] grams of the soluble fiber necessary per day to have this effect.”

This claim was allowed beginning in December 2005 under an interim final rule. No comments warranting changes to this interim final rule were received during a 75-day comment period, thus allowing finalization of the rule, according to the FDA.

The rule applies to whole barley and dry-milled barley products such as flakes, grits, flour, meal, and barley meal that provide at least 0.75 g of soluble fiber per serving.

Scientific evidence has shown that such foods, when included as part of a healthy diet, can lower LDL and total cholesterol levels, thereby reducing the risk of heart disease, the FDAsaid.

The barley product labeling rule is part of the FDA's pursuit of new initiatives to help consumers improve the choices they have for healthy and nutritious diets, according to a statement from Dr. Scott Gottlieb, FDA deputy commissioner.

“We firmly believe that one of the best ways to encourage healthier eating habits is to help consumers get truthful, up-to-date, science-based information about food products so that they can make choices that are based on a better understanding of the health consequences of their diets,” he said.

Certain whole grain barley products can now officially bear the claim that they may reduce the risk of heart disease.

The U.S. Food and Drug Administration finalized a rule that allows labeling on such products to state that “soluble fiber from food such as [name of food], as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies [x] grams of the soluble fiber necessary per day to have this effect.”

This claim was allowed beginning in December 2005 under an interim final rule. No comments warranting changes to this interim final rule were received during a 75-day comment period, thus allowing finalization of the rule, according to the FDA.

The rule applies to whole barley and dry-milled barley products such as flakes, grits, flour, meal, and barley meal that provide at least 0.75 g of soluble fiber per serving.

Scientific evidence has shown that such foods, when included as part of a healthy diet, can lower LDL and total cholesterol levels, thereby reducing the risk of heart disease, the FDAsaid.

The barley product labeling rule is part of the FDA's pursuit of new initiatives to help consumers improve the choices they have for healthy and nutritious diets, according to a statement from Dr. Scott Gottlieb, FDA deputy commissioner.

“We firmly believe that one of the best ways to encourage healthier eating habits is to help consumers get truthful, up-to-date, science-based information about food products so that they can make choices that are based on a better understanding of the health consequences of their diets,” he said.

ATLANTA — The recently approved quadrivalent human papillomavirus vaccine shown to be effective for preventing most HPV-related cervical cancers may also prevent most vulvar and vaginal cancers, Dr. Jorma Paavonen reported at the annual meeting of the American Society of Clinical Oncology.

The vaccine (Gardisil, Merck & Co.) received approval from the Food and Drug Administration this month.

Gardisil targets HPV 6 and 11, which are associated with anogenital warts, and HPV 16 and 18, which cause most cervical cancers. HPV 16 and 18 are also the most common causes of vulvar and vaginal cancers, said Dr. Paavonen, professor and chief physician in obstetrics and gynecology at the University of Helsinki, Finland.

The FUTURE II study was a combined analysis of data from three randomized, placebo-controlled trials that studied the impact of the vaccine on rates of HPV 16- and 18-related vulvar and vaginal intraepithelial neoplasia grade 2/3.

FUTURE II showed that the vaccine was 100% effective up to 2 years of follow-up for preventing these precancerous lesions, said Dr. Paavonen, who has served as a consultant to Merck & Co. and received research funding from the company.

A total of 18,150 women aged 16–26 were randomized in these trials to receive either the vaccine or placebo. Vaccination occurred at day 1 and at 2 and 6 months. Genital tract specimens were obtained at day 1 and then at 6- to 12-month intervals for up to 48 months, with colposcopy performed as needed following algorithm-based referrals.

On per-protocol analysis, there were 10 cases of vulvar intraepithelial neoplasia (VIN) 2/3 or vaginal intraepithelial neoplasia (VaIN) 2/3 in the placebo group, and none in the vaccine group, at an average of 18 months of follow-up. On modified intention-to-treat analysis, there were 24 histologically confirmed cases of VIN 2/3 or VaIN 2/3 in the placebo group, at an average of 2 years of follow-up.

“The burden of HPV disease is not restricted to the cervix. HPV is present in nearly 80% of the 6,000 cases of vaginal and vulvar cancers that are diagnosed in the United States each year,” Dr. Paavonen said. The vaccine is expected, based on these findings, to greatly reduce the risk of vulvar and vaginal cancers, he noted.

ATLANTA — The recently approved quadrivalent human papillomavirus vaccine shown to be effective for preventing most HPV-related cervical cancers may also prevent most vulvar and vaginal cancers, Dr. Jorma Paavonen reported at the annual meeting of the American Society of Clinical Oncology.

The vaccine (Gardisil, Merck & Co.) received approval from the Food and Drug Administration this month.

Gardisil targets HPV 6 and 11, which are associated with anogenital warts, and HPV 16 and 18, which cause most cervical cancers. HPV 16 and 18 are also the most common causes of vulvar and vaginal cancers, said Dr. Paavonen, professor and chief physician in obstetrics and gynecology at the University of Helsinki, Finland.

The FUTURE II study was a combined analysis of data from three randomized, placebo-controlled trials that studied the impact of the vaccine on rates of HPV 16- and 18-related vulvar and vaginal intraepithelial neoplasia grade 2/3.

FUTURE II showed that the vaccine was 100% effective up to 2 years of follow-up for preventing these precancerous lesions, said Dr. Paavonen, who has served as a consultant to Merck & Co. and received research funding from the company.

A total of 18,150 women aged 16–26 were randomized in these trials to receive either the vaccine or placebo. Vaccination occurred at day 1 and at 2 and 6 months. Genital tract specimens were obtained at day 1 and then at 6- to 12-month intervals for up to 48 months, with colposcopy performed as needed following algorithm-based referrals.

On per-protocol analysis, there were 10 cases of vulvar intraepithelial neoplasia (VIN) 2/3 or vaginal intraepithelial neoplasia (VaIN) 2/3 in the placebo group, and none in the vaccine group, at an average of 18 months of follow-up. On modified intention-to-treat analysis, there were 24 histologically confirmed cases of VIN 2/3 or VaIN 2/3 in the placebo group, at an average of 2 years of follow-up.

“The burden of HPV disease is not restricted to the cervix. HPV is present in nearly 80% of the 6,000 cases of vaginal and vulvar cancers that are diagnosed in the United States each year,” Dr. Paavonen said. The vaccine is expected, based on these findings, to greatly reduce the risk of vulvar and vaginal cancers, he noted.

ATLANTA — The recently approved quadrivalent human papillomavirus vaccine shown to be effective for preventing most HPV-related cervical cancers may also prevent most vulvar and vaginal cancers, Dr. Jorma Paavonen reported at the annual meeting of the American Society of Clinical Oncology.

The vaccine (Gardisil, Merck & Co.) received approval from the Food and Drug Administration this month.

Gardisil targets HPV 6 and 11, which are associated with anogenital warts, and HPV 16 and 18, which cause most cervical cancers. HPV 16 and 18 are also the most common causes of vulvar and vaginal cancers, said Dr. Paavonen, professor and chief physician in obstetrics and gynecology at the University of Helsinki, Finland.

The FUTURE II study was a combined analysis of data from three randomized, placebo-controlled trials that studied the impact of the vaccine on rates of HPV 16- and 18-related vulvar and vaginal intraepithelial neoplasia grade 2/3.

FUTURE II showed that the vaccine was 100% effective up to 2 years of follow-up for preventing these precancerous lesions, said Dr. Paavonen, who has served as a consultant to Merck & Co. and received research funding from the company.

A total of 18,150 women aged 16–26 were randomized in these trials to receive either the vaccine or placebo. Vaccination occurred at day 1 and at 2 and 6 months. Genital tract specimens were obtained at day 1 and then at 6- to 12-month intervals for up to 48 months, with colposcopy performed as needed following algorithm-based referrals.

On per-protocol analysis, there were 10 cases of vulvar intraepithelial neoplasia (VIN) 2/3 or vaginal intraepithelial neoplasia (VaIN) 2/3 in the placebo group, and none in the vaccine group, at an average of 18 months of follow-up. On modified intention-to-treat analysis, there were 24 histologically confirmed cases of VIN 2/3 or VaIN 2/3 in the placebo group, at an average of 2 years of follow-up.

“The burden of HPV disease is not restricted to the cervix. HPV is present in nearly 80% of the 6,000 cases of vaginal and vulvar cancers that are diagnosed in the United States each year,” Dr. Paavonen said. The vaccine is expected, based on these findings, to greatly reduce the risk of vulvar and vaginal cancers, he noted.

HOLLYWOOD, FLA. — Women need to be better educated about the risks of type 2 diabetes in pregnancy, Dr. Erin Keely said at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

“Type 2 diabetes is at least as dangerous in pregnancy as type 1 diabetes,” said Dr. Keely of the University of Ottawa.

The incidence of type 2 diabetes is on the rise—largely due to the increasing prevalence of obesity. Since 1991, there has been more than a 60% increase in the prevalence of obesity.

Currently, about 6% of women of childbearing age are morbidly obese (body mass index over 40), and obesity is associated with substantially increased risk of gestational diabetes and type 2 diabetes.

In fact, 90% of women with type 2 diabetes are overweight, Dr. Keely noted.

The problem of increasing type 2 diabetes in pregnancy is compounded by the fact that the age of onset of type 2 diabetes is decreasing, and maternal age is increasing, she said.

Research suggests that type 2 diabetes is associated with double the risk of stillbirth, 2.5 times the risk of perinatal mortality, and 11 times the risk of congenital anomalies as healthy pregnancies.

Hypertension, anesthesia-related mortality, and preeclampsia are also increased.

Furthermore, maternal diabetes appears to have long-term health consequences for offspring, who have a dramatically increased risk of diabetes and other health problems throughout life.

The perception that type 2 diabetes is not as dangerous as type 1 diabetes leaves many pregnant women with the condition with less “prepregnancy optimization,” Dr. Keely noted.

Many of these women do not have specialized care, she explained, and as a result they receive less education about the seriousness of the illness.

HOLLYWOOD, FLA. — Women need to be better educated about the risks of type 2 diabetes in pregnancy, Dr. Erin Keely said at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

“Type 2 diabetes is at least as dangerous in pregnancy as type 1 diabetes,” said Dr. Keely of the University of Ottawa.

The incidence of type 2 diabetes is on the rise—largely due to the increasing prevalence of obesity. Since 1991, there has been more than a 60% increase in the prevalence of obesity.

Currently, about 6% of women of childbearing age are morbidly obese (body mass index over 40), and obesity is associated with substantially increased risk of gestational diabetes and type 2 diabetes.

In fact, 90% of women with type 2 diabetes are overweight, Dr. Keely noted.

The problem of increasing type 2 diabetes in pregnancy is compounded by the fact that the age of onset of type 2 diabetes is decreasing, and maternal age is increasing, she said.

Research suggests that type 2 diabetes is associated with double the risk of stillbirth, 2.5 times the risk of perinatal mortality, and 11 times the risk of congenital anomalies as healthy pregnancies.

Hypertension, anesthesia-related mortality, and preeclampsia are also increased.

Furthermore, maternal diabetes appears to have long-term health consequences for offspring, who have a dramatically increased risk of diabetes and other health problems throughout life.

The perception that type 2 diabetes is not as dangerous as type 1 diabetes leaves many pregnant women with the condition with less “prepregnancy optimization,” Dr. Keely noted.

Many of these women do not have specialized care, she explained, and as a result they receive less education about the seriousness of the illness.

HOLLYWOOD, FLA. — Women need to be better educated about the risks of type 2 diabetes in pregnancy, Dr. Erin Keely said at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

“Type 2 diabetes is at least as dangerous in pregnancy as type 1 diabetes,” said Dr. Keely of the University of Ottawa.

The incidence of type 2 diabetes is on the rise—largely due to the increasing prevalence of obesity. Since 1991, there has been more than a 60% increase in the prevalence of obesity.

Currently, about 6% of women of childbearing age are morbidly obese (body mass index over 40), and obesity is associated with substantially increased risk of gestational diabetes and type 2 diabetes.

In fact, 90% of women with type 2 diabetes are overweight, Dr. Keely noted.

The problem of increasing type 2 diabetes in pregnancy is compounded by the fact that the age of onset of type 2 diabetes is decreasing, and maternal age is increasing, she said.

Research suggests that type 2 diabetes is associated with double the risk of stillbirth, 2.5 times the risk of perinatal mortality, and 11 times the risk of congenital anomalies as healthy pregnancies.

Hypertension, anesthesia-related mortality, and preeclampsia are also increased.

Furthermore, maternal diabetes appears to have long-term health consequences for offspring, who have a dramatically increased risk of diabetes and other health problems throughout life.

The perception that type 2 diabetes is not as dangerous as type 1 diabetes leaves many pregnant women with the condition with less “prepregnancy optimization,” Dr. Keely noted.

Many of these women do not have specialized care, she explained, and as a result they receive less education about the seriousness of the illness.

Paroxetine may increase the risk of suicidal behavior in adults, particularly in young adults, findings from a recent metaanalysis suggest.

“It is therefore important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated,” the Food and Drug Administration and GlaxoSmithKline, the drug's maker and the sponsor of the study, stated in a “Dear Healthcare Provider” letter announcing a related update to the warnings section of the drug's label.

The metaanalysis, which included data from 8,958 patients with psychiatric disorders treated with paroxetine and 5,953 treated with placebo, showed that suicidal behavior occurred more often overall in adults aged 18–24 in the paroxetine (Paxil) group, compared with those in that age group in the placebo group (17 of 776, or 2.19% vs. 5 of 542, or 0.92%). The difference was not statistically significant but was observed in patients with depressive and nondepressive conditions, according to the letter.

A similar difference was not seen for adults in older age groups.

However, the metaanalysis found that among all adults in the study with major depressive disorder (MDD), suicidal behavior was significantly more common in the paroxetine group than in the placebo group (11 of 3,455, or 0.32% vs. 1 of 1,978, or 0.05%). This was despite substantial evidence showing that paroxetine was efficacious, compared with placebo for the treatment of MDD.

Of the 11 suicide attempts, none was fatal. Almost all were associated with an identified social stressor, and eight occurred in those aged 18–30 years. But because the absolute numbers are small, the FDA and GlaxoSmithKline warn that the data should be interpreted with caution.

“GSK continues to believe that the overall risk:benefit of paroxetine in the treatment of adult patients with MDD and other nondepressive psychiatric disorders remains positive,” the letter states.

Physicians are applauding the release of the metaanalysis results.

“I'm glad to see that the data were released to the public as soon as it was available,” Dr. David Fassler, of the department of psychiatry at the University of Vermont, Burlington, said when asked about the added label warnings.

He added that the findings do not prove that paroxetine increases the risk of suicide during treatment but that they underscore the need for closely monitoring patients and maintaining close contact.

Dr. Gregory Simon, a psychiatrist and researcher with Group Health Cooperative, Seattle, said in an interview that the new warnings are justified, despite the small number of suicide attempts in the study. On one hand, the small numbers are encouraging, suggesting that suicidal behavior is rare in these populations. On the other, they suggest that younger adult patients may indeed be at higher risk, he said. Dr. Simon also pointed out that although the findings are important, they do not offer proof of causation.

Prescribing information for paroxetine and all other antidepressants already contains warnings that patients with MDD may be at increased risk for worsening of depression or emergence of suicidal ideation and behavior, regardless of whether they are taking antidepressants, and the FDA has previously warned that paroxetine should not be used for the treatment of depression in children.

GlaxoSmithKline stressed that findings from the current metaanalysis do not indicate a causal relationship. The company also emphasized that the label is being amended voluntarily to emphasize the importance of careful patient monitoring.

GlaxoSmithKline asks that any adverse events associated with paroxetine be reported. Reporting options include calling GlaxoSmithKline at 888-825-5249, and visiting the FDA's MedWatch adverse event reporting program online at www.fda.gov/MedWatch/report.htm

Paroxetine may increase the risk of suicidal behavior in adults, particularly in young adults, findings from a recent metaanalysis suggest.

“It is therefore important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated,” the Food and Drug Administration and GlaxoSmithKline, the drug's maker and the sponsor of the study, stated in a “Dear Healthcare Provider” letter announcing a related update to the warnings section of the drug's label.

The metaanalysis, which included data from 8,958 patients with psychiatric disorders treated with paroxetine and 5,953 treated with placebo, showed that suicidal behavior occurred more often overall in adults aged 18–24 in the paroxetine (Paxil) group, compared with those in that age group in the placebo group (17 of 776, or 2.19% vs. 5 of 542, or 0.92%). The difference was not statistically significant but was observed in patients with depressive and nondepressive conditions, according to the letter.

A similar difference was not seen for adults in older age groups.

However, the metaanalysis found that among all adults in the study with major depressive disorder (MDD), suicidal behavior was significantly more common in the paroxetine group than in the placebo group (11 of 3,455, or 0.32% vs. 1 of 1,978, or 0.05%). This was despite substantial evidence showing that paroxetine was efficacious, compared with placebo for the treatment of MDD.

Of the 11 suicide attempts, none was fatal. Almost all were associated with an identified social stressor, and eight occurred in those aged 18–30 years. But because the absolute numbers are small, the FDA and GlaxoSmithKline warn that the data should be interpreted with caution.

“GSK continues to believe that the overall risk:benefit of paroxetine in the treatment of adult patients with MDD and other nondepressive psychiatric disorders remains positive,” the letter states.

Physicians are applauding the release of the metaanalysis results.

“I'm glad to see that the data were released to the public as soon as it was available,” Dr. David Fassler, of the department of psychiatry at the University of Vermont, Burlington, said when asked about the added label warnings.

He added that the findings do not prove that paroxetine increases the risk of suicide during treatment but that they underscore the need for closely monitoring patients and maintaining close contact.

Dr. Gregory Simon, a psychiatrist and researcher with Group Health Cooperative, Seattle, said in an interview that the new warnings are justified, despite the small number of suicide attempts in the study. On one hand, the small numbers are encouraging, suggesting that suicidal behavior is rare in these populations. On the other, they suggest that younger adult patients may indeed be at higher risk, he said. Dr. Simon also pointed out that although the findings are important, they do not offer proof of causation.

Prescribing information for paroxetine and all other antidepressants already contains warnings that patients with MDD may be at increased risk for worsening of depression or emergence of suicidal ideation and behavior, regardless of whether they are taking antidepressants, and the FDA has previously warned that paroxetine should not be used for the treatment of depression in children.

GlaxoSmithKline stressed that findings from the current metaanalysis do not indicate a causal relationship. The company also emphasized that the label is being amended voluntarily to emphasize the importance of careful patient monitoring.

GlaxoSmithKline asks that any adverse events associated with paroxetine be reported. Reporting options include calling GlaxoSmithKline at 888-825-5249, and visiting the FDA's MedWatch adverse event reporting program online at www.fda.gov/MedWatch/report.htm

Paroxetine may increase the risk of suicidal behavior in adults, particularly in young adults, findings from a recent metaanalysis suggest.

“It is therefore important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated,” the Food and Drug Administration and GlaxoSmithKline, the drug's maker and the sponsor of the study, stated in a “Dear Healthcare Provider” letter announcing a related update to the warnings section of the drug's label.

The metaanalysis, which included data from 8,958 patients with psychiatric disorders treated with paroxetine and 5,953 treated with placebo, showed that suicidal behavior occurred more often overall in adults aged 18–24 in the paroxetine (Paxil) group, compared with those in that age group in the placebo group (17 of 776, or 2.19% vs. 5 of 542, or 0.92%). The difference was not statistically significant but was observed in patients with depressive and nondepressive conditions, according to the letter.

A similar difference was not seen for adults in older age groups.

However, the metaanalysis found that among all adults in the study with major depressive disorder (MDD), suicidal behavior was significantly more common in the paroxetine group than in the placebo group (11 of 3,455, or 0.32% vs. 1 of 1,978, or 0.05%). This was despite substantial evidence showing that paroxetine was efficacious, compared with placebo for the treatment of MDD.

Of the 11 suicide attempts, none was fatal. Almost all were associated with an identified social stressor, and eight occurred in those aged 18–30 years. But because the absolute numbers are small, the FDA and GlaxoSmithKline warn that the data should be interpreted with caution.

“GSK continues to believe that the overall risk:benefit of paroxetine in the treatment of adult patients with MDD and other nondepressive psychiatric disorders remains positive,” the letter states.

Physicians are applauding the release of the metaanalysis results.

“I'm glad to see that the data were released to the public as soon as it was available,” Dr. David Fassler, of the department of psychiatry at the University of Vermont, Burlington, said when asked about the added label warnings.

He added that the findings do not prove that paroxetine increases the risk of suicide during treatment but that they underscore the need for closely monitoring patients and maintaining close contact.

Dr. Gregory Simon, a psychiatrist and researcher with Group Health Cooperative, Seattle, said in an interview that the new warnings are justified, despite the small number of suicide attempts in the study. On one hand, the small numbers are encouraging, suggesting that suicidal behavior is rare in these populations. On the other, they suggest that younger adult patients may indeed be at higher risk, he said. Dr. Simon also pointed out that although the findings are important, they do not offer proof of causation.

Prescribing information for paroxetine and all other antidepressants already contains warnings that patients with MDD may be at increased risk for worsening of depression or emergence of suicidal ideation and behavior, regardless of whether they are taking antidepressants, and the FDA has previously warned that paroxetine should not be used for the treatment of depression in children.

GlaxoSmithKline stressed that findings from the current metaanalysis do not indicate a causal relationship. The company also emphasized that the label is being amended voluntarily to emphasize the importance of careful patient monitoring.

GlaxoSmithKline asks that any adverse events associated with paroxetine be reported. Reporting options include calling GlaxoSmithKline at 888-825-5249, and visiting the FDA's MedWatch adverse event reporting program online at www.fda.gov/MedWatch/report.htm

HOLLYWOOD, FLA. — Women need to be better educated about the risks of type 2 diabetes in pregnancy, Dr. Erin Keely said at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

“Type 2 diabetes is at least as dangerous in pregnancy as type 1 diabetes,” said Dr. Keely of the University of Ottawa.

The incidence of type 2 diabetes is on the rise—largely due to the increasing prevalence of obesity. Since 1991, there has been more than a 60% increase in the prevalence of obesity.

About 6% of women of childbearing age are morbidly obese (body mass index over 40), and obesity is associated with substantially increased risk of gestational diabetes and type 2 diabetes. In fact, 90% of women with type 2 diabetes are overweight, she noted.

The problem of increasing type 2 diabetes in pregnancy is compounded by the fact that the age of onset of type 2 diabetes is decreasing, and maternal age is increasing, she said.

Research suggests type 2 diabetes is linked to double the risk of stillbirth, 2.5 times the risk of perinatal mortality, and 11 times the risk of congenital anomalies. Hypertension, anesthesia-related mortality, and preeclampsia are also increased.

Maternal diabetes also seems to have long-term effects for offspring, who have a dramatically increased risk of diabetes and other problems throughout life.

HOLLYWOOD, FLA. — Women need to be better educated about the risks of type 2 diabetes in pregnancy, Dr. Erin Keely said at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

“Type 2 diabetes is at least as dangerous in pregnancy as type 1 diabetes,” said Dr. Keely of the University of Ottawa.

The incidence of type 2 diabetes is on the rise—largely due to the increasing prevalence of obesity. Since 1991, there has been more than a 60% increase in the prevalence of obesity.

About 6% of women of childbearing age are morbidly obese (body mass index over 40), and obesity is associated with substantially increased risk of gestational diabetes and type 2 diabetes. In fact, 90% of women with type 2 diabetes are overweight, she noted.

The problem of increasing type 2 diabetes in pregnancy is compounded by the fact that the age of onset of type 2 diabetes is decreasing, and maternal age is increasing, she said.

Research suggests type 2 diabetes is linked to double the risk of stillbirth, 2.5 times the risk of perinatal mortality, and 11 times the risk of congenital anomalies. Hypertension, anesthesia-related mortality, and preeclampsia are also increased.

Maternal diabetes also seems to have long-term effects for offspring, who have a dramatically increased risk of diabetes and other problems throughout life.

HOLLYWOOD, FLA. — Women need to be better educated about the risks of type 2 diabetes in pregnancy, Dr. Erin Keely said at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

“Type 2 diabetes is at least as dangerous in pregnancy as type 1 diabetes,” said Dr. Keely of the University of Ottawa.

The incidence of type 2 diabetes is on the rise—largely due to the increasing prevalence of obesity. Since 1991, there has been more than a 60% increase in the prevalence of obesity.

About 6% of women of childbearing age are morbidly obese (body mass index over 40), and obesity is associated with substantially increased risk of gestational diabetes and type 2 diabetes. In fact, 90% of women with type 2 diabetes are overweight, she noted.

The problem of increasing type 2 diabetes in pregnancy is compounded by the fact that the age of onset of type 2 diabetes is decreasing, and maternal age is increasing, she said.

Research suggests type 2 diabetes is linked to double the risk of stillbirth, 2.5 times the risk of perinatal mortality, and 11 times the risk of congenital anomalies. Hypertension, anesthesia-related mortality, and preeclampsia are also increased.

Maternal diabetes also seems to have long-term effects for offspring, who have a dramatically increased risk of diabetes and other problems throughout life.

HOLLYWOOD, FLA. — Combined spinal-epidural analgesia did not significantly improve the rate of successful external cephalic version, compared with systemic opioid analgesia for breech presentation, but it did improve maternal pain and satisfaction, Dr. John T. Sullivan reported at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

A total of 86 women with singleton breech presentation were randomized to receive combined spinal-epidural (CSE)analgesia (2.5-mg intrathecal bupivacaine) plus 15-mcg fentanyl, followed by a 45-mg lidocaine and 15-mcg epinephrine epidural test dose, or 50 mcg of IV fentanyl.

Patients received analgesic intervention and terbutaline timed to provide peak analgesic and uterine relaxant effect at the time of external cephalic version, said Dr. Sullivan of Northwestern University, Chicago.

The success rate of external cephalic version was 43% in the CSE group and 33% in the systemic analgesia group. Vaginal deliveries occurred in 36% of those in the CSE group and 24% of those in the systemic analgesia group. The differences were not statistically significant.

However, pain scores were significantly lower in the CSE group (mean visual analog scale score of 11 vs. 36), and patient satisfaction with analgesic technique was higher in that group (median verbal rating of satisfaction score of 10 vs. 7).

Higher parity, greater estimated gestational age, and shorter procedure duration were significantly associated with version success, Dr. Sullivan noted.

Data regarding the impact of neuraxial anesthesia on the success rate of external cephalic version have been conflicting, and because improved success with external cephalic version has been suggested as a means for lowering cesarean section rates, further study is warranted, he said, noting that additional cases will be randomized for this study in an attempt to improve its power.

HOLLYWOOD, FLA. — Combined spinal-epidural analgesia did not significantly improve the rate of successful external cephalic version, compared with systemic opioid analgesia for breech presentation, but it did improve maternal pain and satisfaction, Dr. John T. Sullivan reported at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

A total of 86 women with singleton breech presentation were randomized to receive combined spinal-epidural (CSE)analgesia (2.5-mg intrathecal bupivacaine) plus 15-mcg fentanyl, followed by a 45-mg lidocaine and 15-mcg epinephrine epidural test dose, or 50 mcg of IV fentanyl.

Patients received analgesic intervention and terbutaline timed to provide peak analgesic and uterine relaxant effect at the time of external cephalic version, said Dr. Sullivan of Northwestern University, Chicago.

The success rate of external cephalic version was 43% in the CSE group and 33% in the systemic analgesia group. Vaginal deliveries occurred in 36% of those in the CSE group and 24% of those in the systemic analgesia group. The differences were not statistically significant.

However, pain scores were significantly lower in the CSE group (mean visual analog scale score of 11 vs. 36), and patient satisfaction with analgesic technique was higher in that group (median verbal rating of satisfaction score of 10 vs. 7).

Higher parity, greater estimated gestational age, and shorter procedure duration were significantly associated with version success, Dr. Sullivan noted.

Data regarding the impact of neuraxial anesthesia on the success rate of external cephalic version have been conflicting, and because improved success with external cephalic version has been suggested as a means for lowering cesarean section rates, further study is warranted, he said, noting that additional cases will be randomized for this study in an attempt to improve its power.

HOLLYWOOD, FLA. — Combined spinal-epidural analgesia did not significantly improve the rate of successful external cephalic version, compared with systemic opioid analgesia for breech presentation, but it did improve maternal pain and satisfaction, Dr. John T. Sullivan reported at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

A total of 86 women with singleton breech presentation were randomized to receive combined spinal-epidural (CSE)analgesia (2.5-mg intrathecal bupivacaine) plus 15-mcg fentanyl, followed by a 45-mg lidocaine and 15-mcg epinephrine epidural test dose, or 50 mcg of IV fentanyl.

Patients received analgesic intervention and terbutaline timed to provide peak analgesic and uterine relaxant effect at the time of external cephalic version, said Dr. Sullivan of Northwestern University, Chicago.

The success rate of external cephalic version was 43% in the CSE group and 33% in the systemic analgesia group. Vaginal deliveries occurred in 36% of those in the CSE group and 24% of those in the systemic analgesia group. The differences were not statistically significant.

However, pain scores were significantly lower in the CSE group (mean visual analog scale score of 11 vs. 36), and patient satisfaction with analgesic technique was higher in that group (median verbal rating of satisfaction score of 10 vs. 7).

Higher parity, greater estimated gestational age, and shorter procedure duration were significantly associated with version success, Dr. Sullivan noted.

Data regarding the impact of neuraxial anesthesia on the success rate of external cephalic version have been conflicting, and because improved success with external cephalic version has been suggested as a means for lowering cesarean section rates, further study is warranted, he said, noting that additional cases will be randomized for this study in an attempt to improve its power.

HOLLYWOOD, FLA. — Epidural analgesia given in early labor has been shown to have no significant effect on the risk of operative delivery in patients with spontaneous labor, and the same appears to hold true for patients with induced labor, according to data presented at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

In a series of 796 consecutive women with induced labor who requested early pain relief, the operative delivery rates were similar in those who did and did not receive early labor epidural analgesia (28% and 27%), Dr. Philip E. Hess reported.

Because labor induction is known to be associated with higher operative delivery rates, there was concern that the effects of epidural analgesia in induced labor might be different from its effects in spontaneous labor, Dr. Hess wrote in a poster.

The findings will hopefully put to rest the debate over whether there is a benefit with regard to operative delivery rates with delayed epidurals, Dr. Cynthia A. Wong said during a poster review session that she moderated. Dr. Wong of Northwestern University, Chicago, was lead author on a major study showing no benefit of delaying epidural analgesia in women with spontaneous labor (N. Engl. J. Med. 2005;352:655–65).

In the current study, patients undergoing labor induction who requested early pain relief (prior to 4-cm dilation) received parenteral opioid or labor epidural analgesia according to their obstetrician's protocol, reported Dr. Hess of Beth Israel Deaconess Medical Center in Boston.

A total of 350 women received epidural analgesia, and 446 received parenteral opioid. The groups were demographically similar, except the average body mass index was higher in the group that did not receive early epidural analgesia. The groups were also similar to a comparison group of 503 women with spontaneous labor who had a 21% operative delivery rate, significantly lower than the rates in the induced labor groups, he noted.

HOLLYWOOD, FLA. — Epidural analgesia given in early labor has been shown to have no significant effect on the risk of operative delivery in patients with spontaneous labor, and the same appears to hold true for patients with induced labor, according to data presented at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

In a series of 796 consecutive women with induced labor who requested early pain relief, the operative delivery rates were similar in those who did and did not receive early labor epidural analgesia (28% and 27%), Dr. Philip E. Hess reported.

Because labor induction is known to be associated with higher operative delivery rates, there was concern that the effects of epidural analgesia in induced labor might be different from its effects in spontaneous labor, Dr. Hess wrote in a poster.

The findings will hopefully put to rest the debate over whether there is a benefit with regard to operative delivery rates with delayed epidurals, Dr. Cynthia A. Wong said during a poster review session that she moderated. Dr. Wong of Northwestern University, Chicago, was lead author on a major study showing no benefit of delaying epidural analgesia in women with spontaneous labor (N. Engl. J. Med. 2005;352:655–65).

In the current study, patients undergoing labor induction who requested early pain relief (prior to 4-cm dilation) received parenteral opioid or labor epidural analgesia according to their obstetrician's protocol, reported Dr. Hess of Beth Israel Deaconess Medical Center in Boston.

A total of 350 women received epidural analgesia, and 446 received parenteral opioid. The groups were demographically similar, except the average body mass index was higher in the group that did not receive early epidural analgesia. The groups were also similar to a comparison group of 503 women with spontaneous labor who had a 21% operative delivery rate, significantly lower than the rates in the induced labor groups, he noted.

HOLLYWOOD, FLA. — Epidural analgesia given in early labor has been shown to have no significant effect on the risk of operative delivery in patients with spontaneous labor, and the same appears to hold true for patients with induced labor, according to data presented at the annual meeting of the Society for Obstetric Anesthesia and Perinatology.

In a series of 796 consecutive women with induced labor who requested early pain relief, the operative delivery rates were similar in those who did and did not receive early labor epidural analgesia (28% and 27%), Dr. Philip E. Hess reported.

Because labor induction is known to be associated with higher operative delivery rates, there was concern that the effects of epidural analgesia in induced labor might be different from its effects in spontaneous labor, Dr. Hess wrote in a poster.

The findings will hopefully put to rest the debate over whether there is a benefit with regard to operative delivery rates with delayed epidurals, Dr. Cynthia A. Wong said during a poster review session that she moderated. Dr. Wong of Northwestern University, Chicago, was lead author on a major study showing no benefit of delaying epidural analgesia in women with spontaneous labor (N. Engl. J. Med. 2005;352:655–65).

In the current study, patients undergoing labor induction who requested early pain relief (prior to 4-cm dilation) received parenteral opioid or labor epidural analgesia according to their obstetrician's protocol, reported Dr. Hess of Beth Israel Deaconess Medical Center in Boston.

A total of 350 women received epidural analgesia, and 446 received parenteral opioid. The groups were demographically similar, except the average body mass index was higher in the group that did not receive early epidural analgesia. The groups were also similar to a comparison group of 503 women with spontaneous labor who had a 21% operative delivery rate, significantly lower than the rates in the induced labor groups, he noted.

KISSIMMEE, FLA. — Differences in vessel size may explain why women have higher recanalization rates than men as well as better final outcomes following intravenous thrombolysis for acute ischemic stroke, Dr. David S. Liebeskind reported at the 31st International Stroke Conference.

These differences have been demonstrated in previous studies and a number of possible pathophysiologic explanations have been offered. Intravenous thrombolysis was evaluated in 100 men and 100 women based on factors such as anatomy and flow physiology to evaluate the possibility that vessel size contributes to the differences, or more specifically, that “angio-architectural differences predispose women to recanalize more efficiently due to favorable clot geometry,” said Dr. Liebeskind.

The cross-sectional lumen areas of the proximal middle cerebral, supraclinoid internal carotid, and distal basilar arteries were measured in the participants using 3-D CT angiograms. Weight and height data were used to calculate tissue plasminogen activator (TPA) dose, and patient data were used to model clot volume and ratio of exposed surface area to total clot volume.

Intracranial arteries are significantly smaller in women than in men, said Dr. Liebeskind of the University of California, Los Angeles. The proximal middle cerebral artery (MCA) in women vs. men averaged 0.049 vs. 0.052 cm

Similar statistically significant differences were noted in terms of clot volume (proximal MCA: 0.078 vs. 0.089 cm

Women were more likely to have actual body weight above ideal body weight and greater differences between actual and ideal body weight, compared with men. This means an increased TPA-to-surface area ratio, creating discordance between TPA dosage (based on weight) and vessel size, resulting in relatively higher TPA dosing in women, compared with men.

The “theoretical thrombolysis” used in this study suggests that the smaller vessel size and lesser clot volume seen in women, along with relatively higher doses of TPA, contribute to their improved responsiveness to intravenous thrombolysis, Dr. Liebeskind said at the conference, which was sponsored by the American Stroke Association. Increases in radius or length of the patent channel that may form within the clot further accentuate the differences seen in surface area-to-clot volume ratio, he added.

Although the study is limited by its theoretical nature and simplified anatomical characterizations without regard to potentially critical pathophysiology, the findings suggest that adjusting the dosing of intravenous TPA to body frame size could optimize recanalization in both men and women, he concluded.

KISSIMMEE, FLA. — Differences in vessel size may explain why women have higher recanalization rates than men as well as better final outcomes following intravenous thrombolysis for acute ischemic stroke, Dr. David S. Liebeskind reported at the 31st International Stroke Conference.

These differences have been demonstrated in previous studies and a number of possible pathophysiologic explanations have been offered. Intravenous thrombolysis was evaluated in 100 men and 100 women based on factors such as anatomy and flow physiology to evaluate the possibility that vessel size contributes to the differences, or more specifically, that “angio-architectural differences predispose women to recanalize more efficiently due to favorable clot geometry,” said Dr. Liebeskind.

The cross-sectional lumen areas of the proximal middle cerebral, supraclinoid internal carotid, and distal basilar arteries were measured in the participants using 3-D CT angiograms. Weight and height data were used to calculate tissue plasminogen activator (TPA) dose, and patient data were used to model clot volume and ratio of exposed surface area to total clot volume.

Intracranial arteries are significantly smaller in women than in men, said Dr. Liebeskind of the University of California, Los Angeles. The proximal middle cerebral artery (MCA) in women vs. men averaged 0.049 vs. 0.052 cm

Similar statistically significant differences were noted in terms of clot volume (proximal MCA: 0.078 vs. 0.089 cm

Women were more likely to have actual body weight above ideal body weight and greater differences between actual and ideal body weight, compared with men. This means an increased TPA-to-surface area ratio, creating discordance between TPA dosage (based on weight) and vessel size, resulting in relatively higher TPA dosing in women, compared with men.

The “theoretical thrombolysis” used in this study suggests that the smaller vessel size and lesser clot volume seen in women, along with relatively higher doses of TPA, contribute to their improved responsiveness to intravenous thrombolysis, Dr. Liebeskind said at the conference, which was sponsored by the American Stroke Association. Increases in radius or length of the patent channel that may form within the clot further accentuate the differences seen in surface area-to-clot volume ratio, he added.

Although the study is limited by its theoretical nature and simplified anatomical characterizations without regard to potentially critical pathophysiology, the findings suggest that adjusting the dosing of intravenous TPA to body frame size could optimize recanalization in both men and women, he concluded.

KISSIMMEE, FLA. — Differences in vessel size may explain why women have higher recanalization rates than men as well as better final outcomes following intravenous thrombolysis for acute ischemic stroke, Dr. David S. Liebeskind reported at the 31st International Stroke Conference.

These differences have been demonstrated in previous studies and a number of possible pathophysiologic explanations have been offered. Intravenous thrombolysis was evaluated in 100 men and 100 women based on factors such as anatomy and flow physiology to evaluate the possibility that vessel size contributes to the differences, or more specifically, that “angio-architectural differences predispose women to recanalize more efficiently due to favorable clot geometry,” said Dr. Liebeskind.

The cross-sectional lumen areas of the proximal middle cerebral, supraclinoid internal carotid, and distal basilar arteries were measured in the participants using 3-D CT angiograms. Weight and height data were used to calculate tissue plasminogen activator (TPA) dose, and patient data were used to model clot volume and ratio of exposed surface area to total clot volume.

Intracranial arteries are significantly smaller in women than in men, said Dr. Liebeskind of the University of California, Los Angeles. The proximal middle cerebral artery (MCA) in women vs. men averaged 0.049 vs. 0.052 cm

Similar statistically significant differences were noted in terms of clot volume (proximal MCA: 0.078 vs. 0.089 cm

Women were more likely to have actual body weight above ideal body weight and greater differences between actual and ideal body weight, compared with men. This means an increased TPA-to-surface area ratio, creating discordance between TPA dosage (based on weight) and vessel size, resulting in relatively higher TPA dosing in women, compared with men.

The “theoretical thrombolysis” used in this study suggests that the smaller vessel size and lesser clot volume seen in women, along with relatively higher doses of TPA, contribute to their improved responsiveness to intravenous thrombolysis, Dr. Liebeskind said at the conference, which was sponsored by the American Stroke Association. Increases in radius or length of the patent channel that may form within the clot further accentuate the differences seen in surface area-to-clot volume ratio, he added.

Although the study is limited by its theoretical nature and simplified anatomical characterizations without regard to potentially critical pathophysiology, the findings suggest that adjusting the dosing of intravenous TPA to body frame size could optimize recanalization in both men and women, he concluded.