Heidi Splete

The 2009 influenza A(H1N1) virus has not disappeared, and Georgia has seen a surge in hospitalizations among adults due to H1N1 flu over the past several weeks, a federal official reported during a teleconference.

Most new hospitalizations related to the H1N1 flu in Georgia have occurred in adults with chronic conditions, such as diabetes, heart disease, and asthma, said Dr. Anne Schuchat, director of the Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases.

“We are continuing to see people with serious illness from the pandemic H1N1 virus,” Dr. Schuchat said. Disease rates in most parts of the United States are, on average, lower than they were last fall, but individuals continue to get sick, become hospitalized, and die, she emphasized.

No states are currently reporting widespread activity, but three states—Georgia, Alabama, and South Carolina—are reporting regional flu activity, and the rate of laboratory-confirmed hospitalizations for H1N1 illness in Georgia has returned to levels similar to those seen last fall.

Early in March, Georgia public health officials requested the CDC's help in investigating the cause of the surge in hospitalizations, and this investigation is ongoing.

“The findings we have so far suggest the value of vaccination, particularly among adults with chronic illness or advanced age, who are more likely to become severely ill if they encounter the H1N1 virus,” Dr. Schuchat said. “We don't have any evidence that the H1N1 virus has changed.”

“The CDC strongly urges people with underlying health conditions and those over 64 years to get vaccinated. We have an excellent safety record now for the H1N1 vaccine,” she added.

U.S. Surgeon General Regina Benjamin emphasized the continuing need to educate the public about the value of H1N1 vaccination, especially minority groups, who are more likely to have the chronic medical conditions that put people at increased risk. “The flu season is not over yet,” Dr. Benjamin said. “Vaccination is the best protection.”

Dr. Schuchat confirmed that the H1N1 virus will be part of a trivalent influenza vaccine that will be available this fall. The CDC recommends vaccination with the current H1N1 vaccine now for protection in the months ahead until the trivalent vaccine becomes available, Dr. Schuchat said.

The 2009 influenza A(H1N1) virus has not disappeared, and Georgia has seen a surge in hospitalizations among adults due to H1N1 flu over the past several weeks, a federal official reported during a teleconference.

Most new hospitalizations related to the H1N1 flu in Georgia have occurred in adults with chronic conditions, such as diabetes, heart disease, and asthma, said Dr. Anne Schuchat, director of the Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases.

“We are continuing to see people with serious illness from the pandemic H1N1 virus,” Dr. Schuchat said. Disease rates in most parts of the United States are, on average, lower than they were last fall, but individuals continue to get sick, become hospitalized, and die, she emphasized.

No states are currently reporting widespread activity, but three states—Georgia, Alabama, and South Carolina—are reporting regional flu activity, and the rate of laboratory-confirmed hospitalizations for H1N1 illness in Georgia has returned to levels similar to those seen last fall.

Early in March, Georgia public health officials requested the CDC's help in investigating the cause of the surge in hospitalizations, and this investigation is ongoing.

“The findings we have so far suggest the value of vaccination, particularly among adults with chronic illness or advanced age, who are more likely to become severely ill if they encounter the H1N1 virus,” Dr. Schuchat said. “We don't have any evidence that the H1N1 virus has changed.”

“The CDC strongly urges people with underlying health conditions and those over 64 years to get vaccinated. We have an excellent safety record now for the H1N1 vaccine,” she added.

U.S. Surgeon General Regina Benjamin emphasized the continuing need to educate the public about the value of H1N1 vaccination, especially minority groups, who are more likely to have the chronic medical conditions that put people at increased risk. “The flu season is not over yet,” Dr. Benjamin said. “Vaccination is the best protection.”

Dr. Schuchat confirmed that the H1N1 virus will be part of a trivalent influenza vaccine that will be available this fall. The CDC recommends vaccination with the current H1N1 vaccine now for protection in the months ahead until the trivalent vaccine becomes available, Dr. Schuchat said.

The 2009 influenza A(H1N1) virus has not disappeared, and Georgia has seen a surge in hospitalizations among adults due to H1N1 flu over the past several weeks, a federal official reported during a teleconference.

Most new hospitalizations related to the H1N1 flu in Georgia have occurred in adults with chronic conditions, such as diabetes, heart disease, and asthma, said Dr. Anne Schuchat, director of the Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases.

“We are continuing to see people with serious illness from the pandemic H1N1 virus,” Dr. Schuchat said. Disease rates in most parts of the United States are, on average, lower than they were last fall, but individuals continue to get sick, become hospitalized, and die, she emphasized.

No states are currently reporting widespread activity, but three states—Georgia, Alabama, and South Carolina—are reporting regional flu activity, and the rate of laboratory-confirmed hospitalizations for H1N1 illness in Georgia has returned to levels similar to those seen last fall.

Early in March, Georgia public health officials requested the CDC's help in investigating the cause of the surge in hospitalizations, and this investigation is ongoing.

“The findings we have so far suggest the value of vaccination, particularly among adults with chronic illness or advanced age, who are more likely to become severely ill if they encounter the H1N1 virus,” Dr. Schuchat said. “We don't have any evidence that the H1N1 virus has changed.”

“The CDC strongly urges people with underlying health conditions and those over 64 years to get vaccinated. We have an excellent safety record now for the H1N1 vaccine,” she added.

U.S. Surgeon General Regina Benjamin emphasized the continuing need to educate the public about the value of H1N1 vaccination, especially minority groups, who are more likely to have the chronic medical conditions that put people at increased risk. “The flu season is not over yet,” Dr. Benjamin said. “Vaccination is the best protection.”

Dr. Schuchat confirmed that the H1N1 virus will be part of a trivalent influenza vaccine that will be available this fall. The CDC recommends vaccination with the current H1N1 vaccine now for protection in the months ahead until the trivalent vaccine becomes available, Dr. Schuchat said.

NEW ORLEANS - Colchicine is an effective steroid-sparing agent that can be used to treat refractory chronic idiopathic urticaria, based on data from a review of adults who received colchicine for CIU between 2003 and 2008.

Colchicine has been shown to decrease mast cell degranulation, suppress leukotriene generation, and decrease leukocyte adhesiveness and migration, said Dr. Mary S. Georgy of Northwestern University in Chicago and her associates.

To assess the agent's effectiveness in this setting, the investigators reviewed charts from 55 patients with CIU who were treated with colchicine for at least 7 days, focusing on the type of urticaria, type of response, and use of oral steroids before and after colchicine treatment.

Overall, 24 patients responded to colchicine, 2 partially responded, and 29 did not respond (44%, 4%, and 53%, respectively). The average number of steroid courses in the responders dropped significantly between the 6 months prior to and the 6 months after colchicine use (2.44 vs. 0.33). Information on the average number of steroid courses was available only for the responders. The study findings were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Response was defined as subjective improvement and a decrease in the oral steroid dosage of at least 50% within 3 months of beginning colchicine. A partial response was defined as a subjective improvement with no decrease in oral steroids by 50% within 3 months of beginning colchicine.
Skin biopsies from 27 patients, including 14 responders, 12 nonresponders, and 1 partial responder, showed neutrophilic urticaria in 86% of responders and in 25% of nonresponders.

"Colchicine was particularly effective in patients with neutrophilic urticaria," the researchers noted.

Overall, 10 responders, 5 nonresponders, and 1 partial responder (29% of the patients) reported gastrointestinal complaints, but the differences among the groups were not significant.

"Colchicine has a relatively safe profile in chronic idiopathic urticaria," the researchers noted.

Dr. Georgy had no financial conflicts to disclose.

NEW ORLEANS - Colchicine is an effective steroid-sparing agent that can be used to treat refractory chronic idiopathic urticaria, based on data from a review of adults who received colchicine for CIU between 2003 and 2008.

Colchicine has been shown to decrease mast cell degranulation, suppress leukotriene generation, and decrease leukocyte adhesiveness and migration, said Dr. Mary S. Georgy of Northwestern University in Chicago and her associates.

To assess the agent's effectiveness in this setting, the investigators reviewed charts from 55 patients with CIU who were treated with colchicine for at least 7 days, focusing on the type of urticaria, type of response, and use of oral steroids before and after colchicine treatment.

Overall, 24 patients responded to colchicine, 2 partially responded, and 29 did not respond (44%, 4%, and 53%, respectively). The average number of steroid courses in the responders dropped significantly between the 6 months prior to and the 6 months after colchicine use (2.44 vs. 0.33). Information on the average number of steroid courses was available only for the responders. The study findings were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Response was defined as subjective improvement and a decrease in the oral steroid dosage of at least 50% within 3 months of beginning colchicine. A partial response was defined as a subjective improvement with no decrease in oral steroids by 50% within 3 months of beginning colchicine.
Skin biopsies from 27 patients, including 14 responders, 12 nonresponders, and 1 partial responder, showed neutrophilic urticaria in 86% of responders and in 25% of nonresponders.

"Colchicine was particularly effective in patients with neutrophilic urticaria," the researchers noted.

Overall, 10 responders, 5 nonresponders, and 1 partial responder (29% of the patients) reported gastrointestinal complaints, but the differences among the groups were not significant.

"Colchicine has a relatively safe profile in chronic idiopathic urticaria," the researchers noted.

Dr. Georgy had no financial conflicts to disclose.

NEW ORLEANS - Colchicine is an effective steroid-sparing agent that can be used to treat refractory chronic idiopathic urticaria, based on data from a review of adults who received colchicine for CIU between 2003 and 2008.

Colchicine has been shown to decrease mast cell degranulation, suppress leukotriene generation, and decrease leukocyte adhesiveness and migration, said Dr. Mary S. Georgy of Northwestern University in Chicago and her associates.

To assess the agent's effectiveness in this setting, the investigators reviewed charts from 55 patients with CIU who were treated with colchicine for at least 7 days, focusing on the type of urticaria, type of response, and use of oral steroids before and after colchicine treatment.

Overall, 24 patients responded to colchicine, 2 partially responded, and 29 did not respond (44%, 4%, and 53%, respectively). The average number of steroid courses in the responders dropped significantly between the 6 months prior to and the 6 months after colchicine use (2.44 vs. 0.33). Information on the average number of steroid courses was available only for the responders. The study findings were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

Response was defined as subjective improvement and a decrease in the oral steroid dosage of at least 50% within 3 months of beginning colchicine. A partial response was defined as a subjective improvement with no decrease in oral steroids by 50% within 3 months of beginning colchicine.
Skin biopsies from 27 patients, including 14 responders, 12 nonresponders, and 1 partial responder, showed neutrophilic urticaria in 86% of responders and in 25% of nonresponders.

"Colchicine was particularly effective in patients with neutrophilic urticaria," the researchers noted.

Overall, 10 responders, 5 nonresponders, and 1 partial responder (29% of the patients) reported gastrointestinal complaints, but the differences among the groups were not significant.

"Colchicine has a relatively safe profile in chronic idiopathic urticaria," the researchers noted.

Dr. Georgy had no financial conflicts to disclose.

SAN FRANCISCO — Women who drank more than 2.5 cups of coffee daily had a significantly lower risk of endometrial cancer compared with those who did not drink coffee, according to a study of more than 20,000 postmenopausal women.

Previous studies have shown that coffee has an inverse association with endometrial cancer risk, said Dr. Stefano Uccella of the Mayo Clinic in Rochester, Minn.

In a poster presented at the annual meeting of the Society of Gynecologic Oncologists, Dr. Uccella and his colleagues reviewed the impact of coffee and other sources of caffeine on endometrial cancer risk among participants in the Iowa Women's Health Study, which is a large, prospective cohort investigation of postmenopausal women that has been ongoing since 1986. The study population included 23,356 women, 5,218 of whom met criteria for obesity.

The women completed a 126-item food frequency questionnaire at enrollment.

The researchers identified 471 cases of endometrial cancer through 2005, using information from the Iowa SEER (Surveillance Epidemiology and End Results) cancer registry.

Overall, women who consumed more than 2.5 cups of coffee daily were significantly less likely to develop endometrial cancer, compared with women who drank no coffee (odds ratio 0.65), after investigators controlled for variables including smoking, diabetes, hypertension, estrogen use, reproductive history, body mass index, body fat distribution, alcohol use, and caloric intake.

Overall caffeine intake greater than 385 mg/day also was significantly associated with a reduced risk of endometrial cancer, compared with a daily caffeine intake of less than 30 mg (OR 0.80).

But no significant associations were found between endometrial cancer risk and the consumption of tea, regular or diet cola, chocolate candy, or chocolate baked goods.

“The association appeared to be related to coffee per se, and not other sources of caffeine,” the researchers noted.

When the results were separated by body mass index, the association between coffee and a reduced risk of endometrial cancer remained significant in the subset of obese women (BMI 30 kg/m

The significance of the association between coffee consumption and the risk of endometrial cancer was somewhat attenuated in women with a BMI less than 30 (OR 0.77).

The results support findings from previous studies, and suggest that more research is needed to assess coffee's potential protective effect against endometrial cancer, the researchers wrote.

Dr. Uccella reported having no conflicts of interest.

Women who drank more than 2.5 cups a day had significantly reduced risk.

Source ©ranplett/iStockphoto.com

SAN FRANCISCO — Women who drank more than 2.5 cups of coffee daily had a significantly lower risk of endometrial cancer compared with those who did not drink coffee, according to a study of more than 20,000 postmenopausal women.

Previous studies have shown that coffee has an inverse association with endometrial cancer risk, said Dr. Stefano Uccella of the Mayo Clinic in Rochester, Minn.

In a poster presented at the annual meeting of the Society of Gynecologic Oncologists, Dr. Uccella and his colleagues reviewed the impact of coffee and other sources of caffeine on endometrial cancer risk among participants in the Iowa Women's Health Study, which is a large, prospective cohort investigation of postmenopausal women that has been ongoing since 1986. The study population included 23,356 women, 5,218 of whom met criteria for obesity.

The women completed a 126-item food frequency questionnaire at enrollment.

The researchers identified 471 cases of endometrial cancer through 2005, using information from the Iowa SEER (Surveillance Epidemiology and End Results) cancer registry.

Overall, women who consumed more than 2.5 cups of coffee daily were significantly less likely to develop endometrial cancer, compared with women who drank no coffee (odds ratio 0.65), after investigators controlled for variables including smoking, diabetes, hypertension, estrogen use, reproductive history, body mass index, body fat distribution, alcohol use, and caloric intake.

Overall caffeine intake greater than 385 mg/day also was significantly associated with a reduced risk of endometrial cancer, compared with a daily caffeine intake of less than 30 mg (OR 0.80).

But no significant associations were found between endometrial cancer risk and the consumption of tea, regular or diet cola, chocolate candy, or chocolate baked goods.

“The association appeared to be related to coffee per se, and not other sources of caffeine,” the researchers noted.

When the results were separated by body mass index, the association between coffee and a reduced risk of endometrial cancer remained significant in the subset of obese women (BMI 30 kg/m

The significance of the association between coffee consumption and the risk of endometrial cancer was somewhat attenuated in women with a BMI less than 30 (OR 0.77).

The results support findings from previous studies, and suggest that more research is needed to assess coffee's potential protective effect against endometrial cancer, the researchers wrote.

Dr. Uccella reported having no conflicts of interest.

Women who drank more than 2.5 cups a day had significantly reduced risk.

Source ©ranplett/iStockphoto.com

SAN FRANCISCO — Women who drank more than 2.5 cups of coffee daily had a significantly lower risk of endometrial cancer compared with those who did not drink coffee, according to a study of more than 20,000 postmenopausal women.

Previous studies have shown that coffee has an inverse association with endometrial cancer risk, said Dr. Stefano Uccella of the Mayo Clinic in Rochester, Minn.

In a poster presented at the annual meeting of the Society of Gynecologic Oncologists, Dr. Uccella and his colleagues reviewed the impact of coffee and other sources of caffeine on endometrial cancer risk among participants in the Iowa Women's Health Study, which is a large, prospective cohort investigation of postmenopausal women that has been ongoing since 1986. The study population included 23,356 women, 5,218 of whom met criteria for obesity.

The women completed a 126-item food frequency questionnaire at enrollment.

The researchers identified 471 cases of endometrial cancer through 2005, using information from the Iowa SEER (Surveillance Epidemiology and End Results) cancer registry.

Overall, women who consumed more than 2.5 cups of coffee daily were significantly less likely to develop endometrial cancer, compared with women who drank no coffee (odds ratio 0.65), after investigators controlled for variables including smoking, diabetes, hypertension, estrogen use, reproductive history, body mass index, body fat distribution, alcohol use, and caloric intake.

Overall caffeine intake greater than 385 mg/day also was significantly associated with a reduced risk of endometrial cancer, compared with a daily caffeine intake of less than 30 mg (OR 0.80).

But no significant associations were found between endometrial cancer risk and the consumption of tea, regular or diet cola, chocolate candy, or chocolate baked goods.

“The association appeared to be related to coffee per se, and not other sources of caffeine,” the researchers noted.

When the results were separated by body mass index, the association between coffee and a reduced risk of endometrial cancer remained significant in the subset of obese women (BMI 30 kg/m

The significance of the association between coffee consumption and the risk of endometrial cancer was somewhat attenuated in women with a BMI less than 30 (OR 0.77).

The results support findings from previous studies, and suggest that more research is needed to assess coffee's potential protective effect against endometrial cancer, the researchers wrote.

Dr. Uccella reported having no conflicts of interest.

Women who drank more than 2.5 cups a day had significantly reduced risk.

Source ©ranplett/iStockphoto.com

SAN FRANCISCO — Women who drank more than 2.5 cups of coffee daily had a significantly lower risk of endometrial cancer, compared with women who didn't drink coffee, according to a study of more than 20,000 postmenopausal women.

Previous studies have shown that coffee has an inverse association with endometrial cancer risk, said Dr. Stefano Uccella of the Mayo Clinic in Rochester, Minn.

In a poster presented at the annual meeting of the Society of Gynecologic Oncologists, Dr. Uccella and his colleagues reviewed the impact of coffee and other sources of caffeine on endometrial cancer risk among participants in the Iowa Women's Health Study, a large, prospective cohort investigation of postmenopausal women that has been ongoing since 1986.

The study population included 23,356 women, 5,218 of whom met criteria for obesity.

The women completed a 126-item food frequency questionnaire at enrollment.

The researchers identified 471 cases of endometrial cancer through 2005, using information from the Iowa SEER (Surveillance Epidemiology and End Results) cancer registry.

Overall, women who consumed more than 2.5 cups of coffee daily were significantly less likely to develop endometrial cancer, compared with women who drank no coffee (odds ratio, 0.65), after investigators controlled for variables including smoking, diabetes, hypertension, estrogen use, reproductive history, body mass index, body fat distribution, alcohol use, and caloric intake.

Overall caffeine intake greater than 385 mg/day also was significantly associated with a reduced risk of endometrial cancer, compared with a daily caffeine intake of less than 30 mg (OR, 0.80).

However, no significant associations were found between endometrial cancer risk and the consumption of tea, regular or diet cola, chocolate candy, or chocolate baked goods.

“The association appeared to be related to coffee per se, and not other sources of caffeine,” the researchers noted.

When the results were separated by BMI, the association between coffee and a reduced risk of endometrial cancer remained significant in the subset of obese women (BMI 30 kg/m

The significance of the association between coffee consumption and the risk of endometrial cancer was somewhat attenuated in women with a BMI less than 30 (OR, 0.77).

The results support findings from previous studies, and suggest that more research is needed to assess coffee's potential protective effect against endometrial cancer, the researchers wrote.

Disclosures: None was reported.

In the study, consuming more than 2.5 cups of coffee daily significantly lowered endometrial cancer risk.

Source ©ranplett/iStockphoto.com

SAN FRANCISCO — Women who drank more than 2.5 cups of coffee daily had a significantly lower risk of endometrial cancer, compared with women who didn't drink coffee, according to a study of more than 20,000 postmenopausal women.

Previous studies have shown that coffee has an inverse association with endometrial cancer risk, said Dr. Stefano Uccella of the Mayo Clinic in Rochester, Minn.

In a poster presented at the annual meeting of the Society of Gynecologic Oncologists, Dr. Uccella and his colleagues reviewed the impact of coffee and other sources of caffeine on endometrial cancer risk among participants in the Iowa Women's Health Study, a large, prospective cohort investigation of postmenopausal women that has been ongoing since 1986.

The study population included 23,356 women, 5,218 of whom met criteria for obesity.

The women completed a 126-item food frequency questionnaire at enrollment.

The researchers identified 471 cases of endometrial cancer through 2005, using information from the Iowa SEER (Surveillance Epidemiology and End Results) cancer registry.

Overall, women who consumed more than 2.5 cups of coffee daily were significantly less likely to develop endometrial cancer, compared with women who drank no coffee (odds ratio, 0.65), after investigators controlled for variables including smoking, diabetes, hypertension, estrogen use, reproductive history, body mass index, body fat distribution, alcohol use, and caloric intake.

Overall caffeine intake greater than 385 mg/day also was significantly associated with a reduced risk of endometrial cancer, compared with a daily caffeine intake of less than 30 mg (OR, 0.80).

However, no significant associations were found between endometrial cancer risk and the consumption of tea, regular or diet cola, chocolate candy, or chocolate baked goods.

“The association appeared to be related to coffee per se, and not other sources of caffeine,” the researchers noted.

When the results were separated by BMI, the association between coffee and a reduced risk of endometrial cancer remained significant in the subset of obese women (BMI 30 kg/m

The significance of the association between coffee consumption and the risk of endometrial cancer was somewhat attenuated in women with a BMI less than 30 (OR, 0.77).

The results support findings from previous studies, and suggest that more research is needed to assess coffee's potential protective effect against endometrial cancer, the researchers wrote.

Disclosures: None was reported.

In the study, consuming more than 2.5 cups of coffee daily significantly lowered endometrial cancer risk.

Source ©ranplett/iStockphoto.com

SAN FRANCISCO — Women who drank more than 2.5 cups of coffee daily had a significantly lower risk of endometrial cancer, compared with women who didn't drink coffee, according to a study of more than 20,000 postmenopausal women.

Previous studies have shown that coffee has an inverse association with endometrial cancer risk, said Dr. Stefano Uccella of the Mayo Clinic in Rochester, Minn.

In a poster presented at the annual meeting of the Society of Gynecologic Oncologists, Dr. Uccella and his colleagues reviewed the impact of coffee and other sources of caffeine on endometrial cancer risk among participants in the Iowa Women's Health Study, a large, prospective cohort investigation of postmenopausal women that has been ongoing since 1986.

The study population included 23,356 women, 5,218 of whom met criteria for obesity.

The women completed a 126-item food frequency questionnaire at enrollment.

The researchers identified 471 cases of endometrial cancer through 2005, using information from the Iowa SEER (Surveillance Epidemiology and End Results) cancer registry.

Overall, women who consumed more than 2.5 cups of coffee daily were significantly less likely to develop endometrial cancer, compared with women who drank no coffee (odds ratio, 0.65), after investigators controlled for variables including smoking, diabetes, hypertension, estrogen use, reproductive history, body mass index, body fat distribution, alcohol use, and caloric intake.

Overall caffeine intake greater than 385 mg/day also was significantly associated with a reduced risk of endometrial cancer, compared with a daily caffeine intake of less than 30 mg (OR, 0.80).

However, no significant associations were found between endometrial cancer risk and the consumption of tea, regular or diet cola, chocolate candy, or chocolate baked goods.

“The association appeared to be related to coffee per se, and not other sources of caffeine,” the researchers noted.

When the results were separated by BMI, the association between coffee and a reduced risk of endometrial cancer remained significant in the subset of obese women (BMI 30 kg/m

The significance of the association between coffee consumption and the risk of endometrial cancer was somewhat attenuated in women with a BMI less than 30 (OR, 0.77).

The results support findings from previous studies, and suggest that more research is needed to assess coffee's potential protective effect against endometrial cancer, the researchers wrote.

Disclosures: None was reported.

In the study, consuming more than 2.5 cups of coffee daily significantly lowered endometrial cancer risk.

Source ©ranplett/iStockphoto.com

Major Finding: Intraoperative complication rates for the older and younger groups were similar at around 7%.

Data Source: A study comparing endometrial cancer outcomes after robotic surgery in 27 octogenarians and nonagenarians with 395 younger controls.

Disclosures: Dr. Lowe has served as a consultant for Intuitive Surgical Inc.

SAN FRANCISCO — Robotic surgery for endometrial cancer is a safe option for patients in their 80s and 90s, based on data from a study comparing outcomes from 27 octogenarians and nonagenarians with 395 younger controls.

“Age should not be a contraindication to robotic surgical management of patients with endometrial cancer,” said Dr. M. Patrick Lowe of Northwestern University in Chicago and his colleagues in a poster presentation at the annual meeting of the Society of Gynecologic Oncologists.

The investigators created a multi-institutional HIPAA-compliant database and analyzed all adult women who underwent robotic-assisted surgery with staging for endometrial cancer between April 2003 and January 2009.

They compared perioperative outcomes for patients aged 80-95 years with those of controls younger than 80 years. The median age of the study population was 84 years, and the median body mass index was 28 kg/m

Approximately half of the patients reported a prior abdominal surgery, and a final analysis showed that 75% had stage I or stage II disease.

No statistically significant differences were seen between the older patients and the controls in operative time (192 minutes vs. 167 minutes), blood loss (55 cc in both groups), and node count (16 in both groups).

None of the patients received a blood transfusion, and the average hospital stay was 1 day for both groups.

The overall intraoperative and postoperative complication rates in the older group were 7% and 33%, respectively.

The intraoperative rate was similar to that seen in the younger control group.

The postoperative complication rate was higher in the elderly group, but the difference was not significant.

“Patients 80 years and older who undergo robotic surgery for endometrial cancer can expect surgical outcomes similar to those of the general population,” Dr. Lowe and his associates wrote.

Major Finding: Intraoperative complication rates for the older and younger groups were similar at around 7%.

Data Source: A study comparing endometrial cancer outcomes after robotic surgery in 27 octogenarians and nonagenarians with 395 younger controls.

Disclosures: Dr. Lowe has served as a consultant for Intuitive Surgical Inc.

SAN FRANCISCO — Robotic surgery for endometrial cancer is a safe option for patients in their 80s and 90s, based on data from a study comparing outcomes from 27 octogenarians and nonagenarians with 395 younger controls.

“Age should not be a contraindication to robotic surgical management of patients with endometrial cancer,” said Dr. M. Patrick Lowe of Northwestern University in Chicago and his colleagues in a poster presentation at the annual meeting of the Society of Gynecologic Oncologists.

The investigators created a multi-institutional HIPAA-compliant database and analyzed all adult women who underwent robotic-assisted surgery with staging for endometrial cancer between April 2003 and January 2009.

They compared perioperative outcomes for patients aged 80-95 years with those of controls younger than 80 years. The median age of the study population was 84 years, and the median body mass index was 28 kg/m

Approximately half of the patients reported a prior abdominal surgery, and a final analysis showed that 75% had stage I or stage II disease.

No statistically significant differences were seen between the older patients and the controls in operative time (192 minutes vs. 167 minutes), blood loss (55 cc in both groups), and node count (16 in both groups).

None of the patients received a blood transfusion, and the average hospital stay was 1 day for both groups.

The overall intraoperative and postoperative complication rates in the older group were 7% and 33%, respectively.

The intraoperative rate was similar to that seen in the younger control group.

The postoperative complication rate was higher in the elderly group, but the difference was not significant.

“Patients 80 years and older who undergo robotic surgery for endometrial cancer can expect surgical outcomes similar to those of the general population,” Dr. Lowe and his associates wrote.

Major Finding: Intraoperative complication rates for the older and younger groups were similar at around 7%.

Data Source: A study comparing endometrial cancer outcomes after robotic surgery in 27 octogenarians and nonagenarians with 395 younger controls.

Disclosures: Dr. Lowe has served as a consultant for Intuitive Surgical Inc.

SAN FRANCISCO — Robotic surgery for endometrial cancer is a safe option for patients in their 80s and 90s, based on data from a study comparing outcomes from 27 octogenarians and nonagenarians with 395 younger controls.

“Age should not be a contraindication to robotic surgical management of patients with endometrial cancer,” said Dr. M. Patrick Lowe of Northwestern University in Chicago and his colleagues in a poster presentation at the annual meeting of the Society of Gynecologic Oncologists.

The investigators created a multi-institutional HIPAA-compliant database and analyzed all adult women who underwent robotic-assisted surgery with staging for endometrial cancer between April 2003 and January 2009.

They compared perioperative outcomes for patients aged 80-95 years with those of controls younger than 80 years. The median age of the study population was 84 years, and the median body mass index was 28 kg/m

Approximately half of the patients reported a prior abdominal surgery, and a final analysis showed that 75% had stage I or stage II disease.

No statistically significant differences were seen between the older patients and the controls in operative time (192 minutes vs. 167 minutes), blood loss (55 cc in both groups), and node count (16 in both groups).

None of the patients received a blood transfusion, and the average hospital stay was 1 day for both groups.

The overall intraoperative and postoperative complication rates in the older group were 7% and 33%, respectively.

The intraoperative rate was similar to that seen in the younger control group.

The postoperative complication rate was higher in the elderly group, but the difference was not significant.

“Patients 80 years and older who undergo robotic surgery for endometrial cancer can expect surgical outcomes similar to those of the general population,” Dr. Lowe and his associates wrote.

Major Finding: The median length of hospital stay was 1 day for robotically assisted laparoscopies and 2 days for standard laparoscopies. This difference was significant, with 71% of RBT patients discharged on postoperative day 1, vs. only 20% of LSC patients.

Data Source: A study comparing 153 RBTs and 214 LSCs in women with endometrial cancer.

Disclosures: Dr. Leitao is a consultant for Genzyme. He has also received financial support from Intuitive Surgical Inc.

SAN FRANCISCO — Surgical outcomes for patients with endometrial cancer were similar regardless of whether they received robotically assisted laparoscopic surgery or standard transperitoneal laparoscopic surgery, but the robotically assisted approach lessened the postoperative hospitalization time, according to a poster presented at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Mario M. Leitao Jr. and colleagues at Memorial Sloan-Kettering Cancer Center in New York compared 153 robotically assisted laparoscopies (RBTs) and 214 standard laparoscopies (LSCs) in women with endometrial cancer. The surgeries were performed between May 2007 and August 2009, and demographics were similar between the two groups.

The median pelvic, para-aortic, and total nodal counts for RBTs were 14, 6, and 21, respectively, compared with 16, 5, and 23 for LSCs.

Conversions to laparotomy were similar between the RBT and LSC groups (10% vs. 14%).

Operating room time (ORT) was measured from patient arrival to exit from the OR, and operative time was measured from skin incision to full surgical closure. The median ORT was significantly longer in the RBTs vs. LSCs (315 minutes vs. 268 minutes). Similarly, the median operative time was significantly longer in the RBTs vs. LSCs (235 minutes vs. 194 minutes).

But the investigators did see a learning curve with regard to RBTs. “More experienced RBT surgeons had significantly shorter ORTs,” Dr. Leitao and associates noted.

The median length of hospital stay was 1 day for RBTs and 2 days for LSCs. This difference was significant, with 71% of RBT patients discharged on postoperative day 1, vs. only 20% of LSC patients.

In addition, transfusion rates were similar for both groups, but the median estimated blood loss was significantly lower in the RBT patients vs. LSC patients (75 mL vs. 100 mL). The median change from preoperative to postoperative hemoglobin was significantly lower in RBT patients vs. LSC patients (−0.5 g/dL vs. −0.7 g/dL), and the median change from preoperative to postoperative hematocrit was significantly lower in RBT patients vs. LSC patients (−1.35% vs. −2.3%). These changes are not likely clinically significant, but they may reflect the additional precision achieved in the RBT procedures, they noted.

“Both RBT and LSC approaches are feasible and result in good outcomes in patients with endometrial cancer,” they said.

Major Finding: The median length of hospital stay was 1 day for robotically assisted laparoscopies and 2 days for standard laparoscopies. This difference was significant, with 71% of RBT patients discharged on postoperative day 1, vs. only 20% of LSC patients.

Data Source: A study comparing 153 RBTs and 214 LSCs in women with endometrial cancer.

Disclosures: Dr. Leitao is a consultant for Genzyme. He has also received financial support from Intuitive Surgical Inc.

SAN FRANCISCO — Surgical outcomes for patients with endometrial cancer were similar regardless of whether they received robotically assisted laparoscopic surgery or standard transperitoneal laparoscopic surgery, but the robotically assisted approach lessened the postoperative hospitalization time, according to a poster presented at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Mario M. Leitao Jr. and colleagues at Memorial Sloan-Kettering Cancer Center in New York compared 153 robotically assisted laparoscopies (RBTs) and 214 standard laparoscopies (LSCs) in women with endometrial cancer. The surgeries were performed between May 2007 and August 2009, and demographics were similar between the two groups.

The median pelvic, para-aortic, and total nodal counts for RBTs were 14, 6, and 21, respectively, compared with 16, 5, and 23 for LSCs.

Conversions to laparotomy were similar between the RBT and LSC groups (10% vs. 14%).

Operating room time (ORT) was measured from patient arrival to exit from the OR, and operative time was measured from skin incision to full surgical closure. The median ORT was significantly longer in the RBTs vs. LSCs (315 minutes vs. 268 minutes). Similarly, the median operative time was significantly longer in the RBTs vs. LSCs (235 minutes vs. 194 minutes).

But the investigators did see a learning curve with regard to RBTs. “More experienced RBT surgeons had significantly shorter ORTs,” Dr. Leitao and associates noted.

The median length of hospital stay was 1 day for RBTs and 2 days for LSCs. This difference was significant, with 71% of RBT patients discharged on postoperative day 1, vs. only 20% of LSC patients.

In addition, transfusion rates were similar for both groups, but the median estimated blood loss was significantly lower in the RBT patients vs. LSC patients (75 mL vs. 100 mL). The median change from preoperative to postoperative hemoglobin was significantly lower in RBT patients vs. LSC patients (−0.5 g/dL vs. −0.7 g/dL), and the median change from preoperative to postoperative hematocrit was significantly lower in RBT patients vs. LSC patients (−1.35% vs. −2.3%). These changes are not likely clinically significant, but they may reflect the additional precision achieved in the RBT procedures, they noted.

“Both RBT and LSC approaches are feasible and result in good outcomes in patients with endometrial cancer,” they said.

Major Finding: The median length of hospital stay was 1 day for robotically assisted laparoscopies and 2 days for standard laparoscopies. This difference was significant, with 71% of RBT patients discharged on postoperative day 1, vs. only 20% of LSC patients.

Data Source: A study comparing 153 RBTs and 214 LSCs in women with endometrial cancer.

Disclosures: Dr. Leitao is a consultant for Genzyme. He has also received financial support from Intuitive Surgical Inc.

SAN FRANCISCO — Surgical outcomes for patients with endometrial cancer were similar regardless of whether they received robotically assisted laparoscopic surgery or standard transperitoneal laparoscopic surgery, but the robotically assisted approach lessened the postoperative hospitalization time, according to a poster presented at the annual meeting of the Society of Gynecologic Oncologists.

Dr. Mario M. Leitao Jr. and colleagues at Memorial Sloan-Kettering Cancer Center in New York compared 153 robotically assisted laparoscopies (RBTs) and 214 standard laparoscopies (LSCs) in women with endometrial cancer. The surgeries were performed between May 2007 and August 2009, and demographics were similar between the two groups.

The median pelvic, para-aortic, and total nodal counts for RBTs were 14, 6, and 21, respectively, compared with 16, 5, and 23 for LSCs.

Conversions to laparotomy were similar between the RBT and LSC groups (10% vs. 14%).

Operating room time (ORT) was measured from patient arrival to exit from the OR, and operative time was measured from skin incision to full surgical closure. The median ORT was significantly longer in the RBTs vs. LSCs (315 minutes vs. 268 minutes). Similarly, the median operative time was significantly longer in the RBTs vs. LSCs (235 minutes vs. 194 minutes).

But the investigators did see a learning curve with regard to RBTs. “More experienced RBT surgeons had significantly shorter ORTs,” Dr. Leitao and associates noted.

The median length of hospital stay was 1 day for RBTs and 2 days for LSCs. This difference was significant, with 71% of RBT patients discharged on postoperative day 1, vs. only 20% of LSC patients.

In addition, transfusion rates were similar for both groups, but the median estimated blood loss was significantly lower in the RBT patients vs. LSC patients (75 mL vs. 100 mL). The median change from preoperative to postoperative hemoglobin was significantly lower in RBT patients vs. LSC patients (−0.5 g/dL vs. −0.7 g/dL), and the median change from preoperative to postoperative hematocrit was significantly lower in RBT patients vs. LSC patients (−1.35% vs. −2.3%). These changes are not likely clinically significant, but they may reflect the additional precision achieved in the RBT procedures, they noted.

“Both RBT and LSC approaches are feasible and result in good outcomes in patients with endometrial cancer,” they said.

Major Finding: The sensitivity of RIDT for H1N1 influenza in children was 62%.

Data Source: A prospective study of 820 children aged 0–17 years.

Disclosures: The researchers had no financial conflicts to disclose. The study was supported in part by grants from the Canadian Institutes of Health Research/SickKids Foundation, the Canadian Institutes of Health Research, and the University of Toronto Dean's Fund.

The overall sensitivity of a rapid influenza diagnostic test to the 2009 influenza A(H1N1) virus in children aged 0–17 years was 62%, and the specificity was 99%, based on data from a prospective study of 820 children.

In addition, rapid influenza diagnostic testing (RIDT) was more sensitive in children aged 5 years and younger than in those older than 5 years, and test sensitivity was higher in patients who were tested within 2 days of the onset of flulike symptoms, compared with those tested more than 2 days after symptom onset.

Previous studies have shown that RIDT identifies the H1N1 virus, but data on the effectiveness of RIDT at detecting the H1N1 virus in clinical specimens, especially in a pediatric population, are limited, said Dr. Michael Hawkes of the University of Toronto.

To determine the diagnostic accuracy of RIDT for H1N1 influenza, Dr. Hawkes and his colleagues enrolled 651 children from an emergency department and 169 from a pediatric clinic who presented with influenzalike illness over two flu seasons, including 194 from 2008–2009 and 626 from 2008–2009. A total of 107 specimens collected between May 22 and July 25, 2009, were positive for the 2009 H1N1 virus, based on reverse-transcription polymerase chain reaction testing (RT-PCR). Another 110 specimens were positive for seasonal influenza A and 77 specimens were positive for seasonal influenza B. Specimens were obtained via nasolabial swabs.

The researchers compared the performance of RIDT and direct fluorescent antibody testing (DFA) against RT-PCR as a reference standard to identify the H1N1 virus.

Overall, the RIDT sensitivity of 62% was significantly less than the DFA sensitivity of 83%, but the specificity of RIDT and DFA were similar (99% vs. 96%). The overall diagnostic accuracies of RIDT and DFA, compared with RT-PCR, were 76% and 88%, (Pediatrics 2010 Feb. 15 [doi:10.1542/peds.2009-2669

However, RIDT sensitivity was significantly higher for detecting the H1N1 virus in children aged 5 years and younger than in those older than 5 years (71% vs. 61%). In addition, RIDT was significantly more sensitive to H1N1 in patients who were tested within 2 days of presenting with flulike symptoms, compared with those who were tested more than 2 days after the onset of symptoms (70% vs. 50%). Similarly, RIDT was significantly more sensitive to both influenza A and influenza B in children aged 5 years and younger, versus those older than 5 years, and in children who were tested within 2 days of symptom onset, versus those who were tested more than 2 days after symptom onset.

The findings may not be generalizable to children with preexisting medical conditions. But the results suggest that RIDT might be useful in identifying the H1N1 virus in young children (who are more likely to develop complications from the flu) and in children who present within 2 days (when they are most likely to benefit from antiviral therapy), the researchers noted.

“Our findings support a recent Centers for Disease Control and Prevention interim guidance statement that, when influenza viruses are circulating in a community, a positive RIDT result indicates that influenza infection is likely present; however, a negative test does not rule out infection,” the researchers said. Additional studies are needed to examine the cost effectiveness and clinical usefulness of RIDT in light of the 2009 H1N1 pandemic, they added.

Major Finding: The sensitivity of RIDT for H1N1 influenza in children was 62%.

Data Source: A prospective study of 820 children aged 0–17 years.

Disclosures: The researchers had no financial conflicts to disclose. The study was supported in part by grants from the Canadian Institutes of Health Research/SickKids Foundation, the Canadian Institutes of Health Research, and the University of Toronto Dean's Fund.

The overall sensitivity of a rapid influenza diagnostic test to the 2009 influenza A(H1N1) virus in children aged 0–17 years was 62%, and the specificity was 99%, based on data from a prospective study of 820 children.

In addition, rapid influenza diagnostic testing (RIDT) was more sensitive in children aged 5 years and younger than in those older than 5 years, and test sensitivity was higher in patients who were tested within 2 days of the onset of flulike symptoms, compared with those tested more than 2 days after symptom onset.

Previous studies have shown that RIDT identifies the H1N1 virus, but data on the effectiveness of RIDT at detecting the H1N1 virus in clinical specimens, especially in a pediatric population, are limited, said Dr. Michael Hawkes of the University of Toronto.

To determine the diagnostic accuracy of RIDT for H1N1 influenza, Dr. Hawkes and his colleagues enrolled 651 children from an emergency department and 169 from a pediatric clinic who presented with influenzalike illness over two flu seasons, including 194 from 2008–2009 and 626 from 2008–2009. A total of 107 specimens collected between May 22 and July 25, 2009, were positive for the 2009 H1N1 virus, based on reverse-transcription polymerase chain reaction testing (RT-PCR). Another 110 specimens were positive for seasonal influenza A and 77 specimens were positive for seasonal influenza B. Specimens were obtained via nasolabial swabs.

The researchers compared the performance of RIDT and direct fluorescent antibody testing (DFA) against RT-PCR as a reference standard to identify the H1N1 virus.

Overall, the RIDT sensitivity of 62% was significantly less than the DFA sensitivity of 83%, but the specificity of RIDT and DFA were similar (99% vs. 96%). The overall diagnostic accuracies of RIDT and DFA, compared with RT-PCR, were 76% and 88%, (Pediatrics 2010 Feb. 15 [doi:10.1542/peds.2009-2669

However, RIDT sensitivity was significantly higher for detecting the H1N1 virus in children aged 5 years and younger than in those older than 5 years (71% vs. 61%). In addition, RIDT was significantly more sensitive to H1N1 in patients who were tested within 2 days of presenting with flulike symptoms, compared with those who were tested more than 2 days after the onset of symptoms (70% vs. 50%). Similarly, RIDT was significantly more sensitive to both influenza A and influenza B in children aged 5 years and younger, versus those older than 5 years, and in children who were tested within 2 days of symptom onset, versus those who were tested more than 2 days after symptom onset.

The findings may not be generalizable to children with preexisting medical conditions. But the results suggest that RIDT might be useful in identifying the H1N1 virus in young children (who are more likely to develop complications from the flu) and in children who present within 2 days (when they are most likely to benefit from antiviral therapy), the researchers noted.

“Our findings support a recent Centers for Disease Control and Prevention interim guidance statement that, when influenza viruses are circulating in a community, a positive RIDT result indicates that influenza infection is likely present; however, a negative test does not rule out infection,” the researchers said. Additional studies are needed to examine the cost effectiveness and clinical usefulness of RIDT in light of the 2009 H1N1 pandemic, they added.

Major Finding: The sensitivity of RIDT for H1N1 influenza in children was 62%.

Data Source: A prospective study of 820 children aged 0–17 years.

Disclosures: The researchers had no financial conflicts to disclose. The study was supported in part by grants from the Canadian Institutes of Health Research/SickKids Foundation, the Canadian Institutes of Health Research, and the University of Toronto Dean's Fund.

The overall sensitivity of a rapid influenza diagnostic test to the 2009 influenza A(H1N1) virus in children aged 0–17 years was 62%, and the specificity was 99%, based on data from a prospective study of 820 children.

In addition, rapid influenza diagnostic testing (RIDT) was more sensitive in children aged 5 years and younger than in those older than 5 years, and test sensitivity was higher in patients who were tested within 2 days of the onset of flulike symptoms, compared with those tested more than 2 days after symptom onset.

Previous studies have shown that RIDT identifies the H1N1 virus, but data on the effectiveness of RIDT at detecting the H1N1 virus in clinical specimens, especially in a pediatric population, are limited, said Dr. Michael Hawkes of the University of Toronto.

To determine the diagnostic accuracy of RIDT for H1N1 influenza, Dr. Hawkes and his colleagues enrolled 651 children from an emergency department and 169 from a pediatric clinic who presented with influenzalike illness over two flu seasons, including 194 from 2008–2009 and 626 from 2008–2009. A total of 107 specimens collected between May 22 and July 25, 2009, were positive for the 2009 H1N1 virus, based on reverse-transcription polymerase chain reaction testing (RT-PCR). Another 110 specimens were positive for seasonal influenza A and 77 specimens were positive for seasonal influenza B. Specimens were obtained via nasolabial swabs.

The researchers compared the performance of RIDT and direct fluorescent antibody testing (DFA) against RT-PCR as a reference standard to identify the H1N1 virus.

Overall, the RIDT sensitivity of 62% was significantly less than the DFA sensitivity of 83%, but the specificity of RIDT and DFA were similar (99% vs. 96%). The overall diagnostic accuracies of RIDT and DFA, compared with RT-PCR, were 76% and 88%, (Pediatrics 2010 Feb. 15 [doi:10.1542/peds.2009-2669

However, RIDT sensitivity was significantly higher for detecting the H1N1 virus in children aged 5 years and younger than in those older than 5 years (71% vs. 61%). In addition, RIDT was significantly more sensitive to H1N1 in patients who were tested within 2 days of presenting with flulike symptoms, compared with those who were tested more than 2 days after the onset of symptoms (70% vs. 50%). Similarly, RIDT was significantly more sensitive to both influenza A and influenza B in children aged 5 years and younger, versus those older than 5 years, and in children who were tested within 2 days of symptom onset, versus those who were tested more than 2 days after symptom onset.

The findings may not be generalizable to children with preexisting medical conditions. But the results suggest that RIDT might be useful in identifying the H1N1 virus in young children (who are more likely to develop complications from the flu) and in children who present within 2 days (when they are most likely to benefit from antiviral therapy), the researchers noted.

“Our findings support a recent Centers for Disease Control and Prevention interim guidance statement that, when influenza viruses are circulating in a community, a positive RIDT result indicates that influenza infection is likely present; however, a negative test does not rule out infection,” the researchers said. Additional studies are needed to examine the cost effectiveness and clinical usefulness of RIDT in light of the 2009 H1N1 pandemic, they added.

The Food and Drug Administration is advising clinicians to temporarily suspend use of the oral rotavirus vaccine Rotarix because of the unexpected finding of DNA from porcine circovirus type 1 in the product, FDA Commissioner Margaret A. Hamburg said in a teleconference

“There is no evidence at this time that this material from PCV1 in Rotarix poses any safety risk,” she said.

“We are not taking the vaccine off the market, we are just asking clinicians to suspend using it in their practices during the 4- to 6-week period when we are collecting additional information,” Dr. Hamburg added.

PCV1 is a virus that is often found in meat and other foods, and it is not known to cause disease in humans or animals.

The virus was identified in Rotarix (manufactured by GlaxoSmithKline) as part of an academic research exercise, and the finding was unanticipated, Dr. Hamburg said.

The rotavirus vaccine is typically given orally to children aged 6 weeks and older to protect them against the diarrhea and vomiting associated with a rotavirus infection.

“PCV1 is a virus, not an animal product, and this has nothing to do with food safety,” Dr. Hamburg emphasized.

The FDA conducted its own studies and confirmed that PCV1 has been present in Rotarix since its initial development, said Dr. Hamburg.

The FDA is reviewing the data and will convene an advisory committee in approximately 4–6 weeks to make recommendations about the use of Rotarix, she said in the teleconference.

Rotarix was studied extensively before and after its 2008 FDA approval and has an excellent safety record, Dr. Hamburg said.

But the FDA is obtaining additional information about the presence of PCV1 DNA in Rotarix, including whether DNA fragments or an intact virus is present. The agency is also studying how the virus came to be in the vaccine.

Meanwhile, the FDA recommends continuing vaccination of children in the United States using RotaTeq, a separate rotavirus vaccine manufactured by Merck & Co. that uses a different process from the one used by Rotarix. Studies of RotaTeq had not shown any evidence of PCV1, said Dr. Hamburg, adding that the take-home message for clinicians is to reassure parents and continue to vaccinate children on schedule with RotaTeq.

“We are definitely recommending that if you have given one dose of Rotarix, you follow that with two doses of RotaTeq in order to provide the full regimen to protect against rotavirus, and we are definitely encouraging ongoing rotavirus vaccination,” she said.

Dr. Hamburg noted that the FDA recommendations apply to clinicians in the United States only, because of the relatively low burden of disease and the availability of an alternative product.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the Rotarix findings and concluded that no action is necessary at this time, according to a statement issued by CHMP.

The Food and Drug Administration is advising clinicians to temporarily suspend use of the oral rotavirus vaccine Rotarix because of the unexpected finding of DNA from porcine circovirus type 1 in the product, FDA Commissioner Margaret A. Hamburg said in a teleconference

“There is no evidence at this time that this material from PCV1 in Rotarix poses any safety risk,” she said.

“We are not taking the vaccine off the market, we are just asking clinicians to suspend using it in their practices during the 4- to 6-week period when we are collecting additional information,” Dr. Hamburg added.

PCV1 is a virus that is often found in meat and other foods, and it is not known to cause disease in humans or animals.

The virus was identified in Rotarix (manufactured by GlaxoSmithKline) as part of an academic research exercise, and the finding was unanticipated, Dr. Hamburg said.

The rotavirus vaccine is typically given orally to children aged 6 weeks and older to protect them against the diarrhea and vomiting associated with a rotavirus infection.

“PCV1 is a virus, not an animal product, and this has nothing to do with food safety,” Dr. Hamburg emphasized.

The FDA conducted its own studies and confirmed that PCV1 has been present in Rotarix since its initial development, said Dr. Hamburg.

The FDA is reviewing the data and will convene an advisory committee in approximately 4–6 weeks to make recommendations about the use of Rotarix, she said in the teleconference.

Rotarix was studied extensively before and after its 2008 FDA approval and has an excellent safety record, Dr. Hamburg said.

But the FDA is obtaining additional information about the presence of PCV1 DNA in Rotarix, including whether DNA fragments or an intact virus is present. The agency is also studying how the virus came to be in the vaccine.

Meanwhile, the FDA recommends continuing vaccination of children in the United States using RotaTeq, a separate rotavirus vaccine manufactured by Merck & Co. that uses a different process from the one used by Rotarix. Studies of RotaTeq had not shown any evidence of PCV1, said Dr. Hamburg, adding that the take-home message for clinicians is to reassure parents and continue to vaccinate children on schedule with RotaTeq.

“We are definitely recommending that if you have given one dose of Rotarix, you follow that with two doses of RotaTeq in order to provide the full regimen to protect against rotavirus, and we are definitely encouraging ongoing rotavirus vaccination,” she said.

Dr. Hamburg noted that the FDA recommendations apply to clinicians in the United States only, because of the relatively low burden of disease and the availability of an alternative product.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the Rotarix findings and concluded that no action is necessary at this time, according to a statement issued by CHMP.

The Food and Drug Administration is advising clinicians to temporarily suspend use of the oral rotavirus vaccine Rotarix because of the unexpected finding of DNA from porcine circovirus type 1 in the product, FDA Commissioner Margaret A. Hamburg said in a teleconference

“There is no evidence at this time that this material from PCV1 in Rotarix poses any safety risk,” she said.

“We are not taking the vaccine off the market, we are just asking clinicians to suspend using it in their practices during the 4- to 6-week period when we are collecting additional information,” Dr. Hamburg added.

PCV1 is a virus that is often found in meat and other foods, and it is not known to cause disease in humans or animals.

The virus was identified in Rotarix (manufactured by GlaxoSmithKline) as part of an academic research exercise, and the finding was unanticipated, Dr. Hamburg said.

The rotavirus vaccine is typically given orally to children aged 6 weeks and older to protect them against the diarrhea and vomiting associated with a rotavirus infection.

“PCV1 is a virus, not an animal product, and this has nothing to do with food safety,” Dr. Hamburg emphasized.

The FDA conducted its own studies and confirmed that PCV1 has been present in Rotarix since its initial development, said Dr. Hamburg.

The FDA is reviewing the data and will convene an advisory committee in approximately 4–6 weeks to make recommendations about the use of Rotarix, she said in the teleconference.

Rotarix was studied extensively before and after its 2008 FDA approval and has an excellent safety record, Dr. Hamburg said.

But the FDA is obtaining additional information about the presence of PCV1 DNA in Rotarix, including whether DNA fragments or an intact virus is present. The agency is also studying how the virus came to be in the vaccine.

Meanwhile, the FDA recommends continuing vaccination of children in the United States using RotaTeq, a separate rotavirus vaccine manufactured by Merck & Co. that uses a different process from the one used by Rotarix. Studies of RotaTeq had not shown any evidence of PCV1, said Dr. Hamburg, adding that the take-home message for clinicians is to reassure parents and continue to vaccinate children on schedule with RotaTeq.

“We are definitely recommending that if you have given one dose of Rotarix, you follow that with two doses of RotaTeq in order to provide the full regimen to protect against rotavirus, and we are definitely encouraging ongoing rotavirus vaccination,” she said.

Dr. Hamburg noted that the FDA recommendations apply to clinicians in the United States only, because of the relatively low burden of disease and the availability of an alternative product.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) reviewed the Rotarix findings and concluded that no action is necessary at this time, according to a statement issued by CHMP.

NEW ORLEANS — About 98% of children with uncontrolled asthma experienced clinically significant improvements on each of three types of step-up therapy, but treatment with long-acting beta-agonists yielded significantly better responses, according to a new study.

“Step-up with long-acting beta-agonists was more than one and a half times more likely to produce the best response,” Dr. Robert F. Lemanske Jr. said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. The results were presented at the meeting and published online in the New England Journal of Medicine.

Asthma treatment with long-acting beta-agonists (LABAs) has come under scrutiny in the wake of recent recommendations from the Food and Drug Administration to step down the use of these drugs in asthmatic children once their asthma is controlled. But few data are available to guide clinicians on the next steps in the treatment of children with asthma who are already using a low-dose inhaled corticosteroid (ICS), said Dr. Lemanske of the University of Wisconsin, Madison. He and his colleagues developed the Best Add-on Therapy Giving Effective Responses (BADGER) trial (N. Engl. J. Med. 2010 March 2 [doi: 10.1056/NEJMoa1001278

“This trial was not intended to look at safety,” Dr. Lemanske emphasized.

In the study, the researchers randomized 182 children aged 6-17 years with uncontrolled mild to moderate asthma to one of three therapies in three 16-week study periods. Every patient received each of the three therapies for 16 weeks. The first 4 weeks of the last two 16-week periods were considered run-in and washout periods. A total of 25 treatment failures occurred, and complete data were available for 157 patients.

The three therapies were ICS step-up therapy, consisting of 250 mcg of fluticasone twice daily; LABA step-up therapy, consisting of 100 mcg of fluticasone plus 50 mcg of salmeterol twice daily; or leukotriene-receptor antagonist therapy (LTRA), consisting of 100 mcg of fluticasone twice daily plus an age-appropriate dose (5 or 10 mg) of montelukast daily.

In pair comparisons, the proportion of children who responded best to LABA was 52% vs. LTRA (34%), and 54% vs. ICS (32%). The differences between LABA and each of the other two protocols were significant, but the differences between LTRA and ICS were not.

Of several primary factors used to predict best response, only a higher baseline score (greater than 19) on the Asthma Control Test or Childhood Asthma Control Test (depending on age) was a significant predictor of best response to the LABA therapy.

Of several secondary predictors, children without eczema were significantly more likely to have a best response to LABA therapy. In addition, race was a significant predictor of response. Black children were equally likely to have a best response to LABA or ICS therapy, and least likely to have a best response to LTRA therapy. Non-Hispanic white children and Hispanic children were most likely to have their best response to LABA therapy.

The findings suggest a ceiling effect beyond which low-dose ICS therapy is not effective, the researchers wrote.

Although the proportion of children who had a best response to LABA was significantly greater than with the other two treatments, “many children demonstrated a best response to either ICS or LTRA step-up therapy, highlighting the need to regularly monitor and appropriately adjust each child's asthma therapy,” Dr. Lemanske said at the meeting.

A total of seven serious adverse events were reported. The most common serious adverse event was asthma exacerbation.

Dr. Lemanske has received consulting fees and grant support from multiple pharmaceutical companies, including MAP Pharmaceuticals Inc., Gray Consulting Inc., Merck & Co., AstraZeneca, and Genentech Inc. The study was funded in part by the National Heart, Lung, and Blood Institute, and the study drugs and matching placebos were supplied by GlaxoSmithKline and Merck.

NEW ORLEANS — About 98% of children with uncontrolled asthma experienced clinically significant improvements on each of three types of step-up therapy, but treatment with long-acting beta-agonists yielded significantly better responses, according to a new study.

“Step-up with long-acting beta-agonists was more than one and a half times more likely to produce the best response,” Dr. Robert F. Lemanske Jr. said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. The results were presented at the meeting and published online in the New England Journal of Medicine.

Asthma treatment with long-acting beta-agonists (LABAs) has come under scrutiny in the wake of recent recommendations from the Food and Drug Administration to step down the use of these drugs in asthmatic children once their asthma is controlled. But few data are available to guide clinicians on the next steps in the treatment of children with asthma who are already using a low-dose inhaled corticosteroid (ICS), said Dr. Lemanske of the University of Wisconsin, Madison. He and his colleagues developed the Best Add-on Therapy Giving Effective Responses (BADGER) trial (N. Engl. J. Med. 2010 March 2 [doi: 10.1056/NEJMoa1001278

“This trial was not intended to look at safety,” Dr. Lemanske emphasized.

In the study, the researchers randomized 182 children aged 6-17 years with uncontrolled mild to moderate asthma to one of three therapies in three 16-week study periods. Every patient received each of the three therapies for 16 weeks. The first 4 weeks of the last two 16-week periods were considered run-in and washout periods. A total of 25 treatment failures occurred, and complete data were available for 157 patients.

The three therapies were ICS step-up therapy, consisting of 250 mcg of fluticasone twice daily; LABA step-up therapy, consisting of 100 mcg of fluticasone plus 50 mcg of salmeterol twice daily; or leukotriene-receptor antagonist therapy (LTRA), consisting of 100 mcg of fluticasone twice daily plus an age-appropriate dose (5 or 10 mg) of montelukast daily.

In pair comparisons, the proportion of children who responded best to LABA was 52% vs. LTRA (34%), and 54% vs. ICS (32%). The differences between LABA and each of the other two protocols were significant, but the differences between LTRA and ICS were not.

Of several primary factors used to predict best response, only a higher baseline score (greater than 19) on the Asthma Control Test or Childhood Asthma Control Test (depending on age) was a significant predictor of best response to the LABA therapy.

Of several secondary predictors, children without eczema were significantly more likely to have a best response to LABA therapy. In addition, race was a significant predictor of response. Black children were equally likely to have a best response to LABA or ICS therapy, and least likely to have a best response to LTRA therapy. Non-Hispanic white children and Hispanic children were most likely to have their best response to LABA therapy.

The findings suggest a ceiling effect beyond which low-dose ICS therapy is not effective, the researchers wrote.

Although the proportion of children who had a best response to LABA was significantly greater than with the other two treatments, “many children demonstrated a best response to either ICS or LTRA step-up therapy, highlighting the need to regularly monitor and appropriately adjust each child's asthma therapy,” Dr. Lemanske said at the meeting.

A total of seven serious adverse events were reported. The most common serious adverse event was asthma exacerbation.

Dr. Lemanske has received consulting fees and grant support from multiple pharmaceutical companies, including MAP Pharmaceuticals Inc., Gray Consulting Inc., Merck & Co., AstraZeneca, and Genentech Inc. The study was funded in part by the National Heart, Lung, and Blood Institute, and the study drugs and matching placebos were supplied by GlaxoSmithKline and Merck.

NEW ORLEANS — About 98% of children with uncontrolled asthma experienced clinically significant improvements on each of three types of step-up therapy, but treatment with long-acting beta-agonists yielded significantly better responses, according to a new study.

“Step-up with long-acting beta-agonists was more than one and a half times more likely to produce the best response,” Dr. Robert F. Lemanske Jr. said at the annual meeting of the American Academy of Allergy, Asthma, and Immunology. The results were presented at the meeting and published online in the New England Journal of Medicine.

Asthma treatment with long-acting beta-agonists (LABAs) has come under scrutiny in the wake of recent recommendations from the Food and Drug Administration to step down the use of these drugs in asthmatic children once their asthma is controlled. But few data are available to guide clinicians on the next steps in the treatment of children with asthma who are already using a low-dose inhaled corticosteroid (ICS), said Dr. Lemanske of the University of Wisconsin, Madison. He and his colleagues developed the Best Add-on Therapy Giving Effective Responses (BADGER) trial (N. Engl. J. Med. 2010 March 2 [doi: 10.1056/NEJMoa1001278

“This trial was not intended to look at safety,” Dr. Lemanske emphasized.

In the study, the researchers randomized 182 children aged 6-17 years with uncontrolled mild to moderate asthma to one of three therapies in three 16-week study periods. Every patient received each of the three therapies for 16 weeks. The first 4 weeks of the last two 16-week periods were considered run-in and washout periods. A total of 25 treatment failures occurred, and complete data were available for 157 patients.

The three therapies were ICS step-up therapy, consisting of 250 mcg of fluticasone twice daily; LABA step-up therapy, consisting of 100 mcg of fluticasone plus 50 mcg of salmeterol twice daily; or leukotriene-receptor antagonist therapy (LTRA), consisting of 100 mcg of fluticasone twice daily plus an age-appropriate dose (5 or 10 mg) of montelukast daily.

In pair comparisons, the proportion of children who responded best to LABA was 52% vs. LTRA (34%), and 54% vs. ICS (32%). The differences between LABA and each of the other two protocols were significant, but the differences between LTRA and ICS were not.

Of several primary factors used to predict best response, only a higher baseline score (greater than 19) on the Asthma Control Test or Childhood Asthma Control Test (depending on age) was a significant predictor of best response to the LABA therapy.

Of several secondary predictors, children without eczema were significantly more likely to have a best response to LABA therapy. In addition, race was a significant predictor of response. Black children were equally likely to have a best response to LABA or ICS therapy, and least likely to have a best response to LTRA therapy. Non-Hispanic white children and Hispanic children were most likely to have their best response to LABA therapy.

The findings suggest a ceiling effect beyond which low-dose ICS therapy is not effective, the researchers wrote.

Although the proportion of children who had a best response to LABA was significantly greater than with the other two treatments, “many children demonstrated a best response to either ICS or LTRA step-up therapy, highlighting the need to regularly monitor and appropriately adjust each child's asthma therapy,” Dr. Lemanske said at the meeting.

A total of seven serious adverse events were reported. The most common serious adverse event was asthma exacerbation.

Dr. Lemanske has received consulting fees and grant support from multiple pharmaceutical companies, including MAP Pharmaceuticals Inc., Gray Consulting Inc., Merck & Co., AstraZeneca, and Genentech Inc. The study was funded in part by the National Heart, Lung, and Blood Institute, and the study drugs and matching placebos were supplied by GlaxoSmithKline and Merck.

SAN FRANCISCO — Women who drank more than 2.5 cups of coffee daily had a significantly lower risk of endometrial cancer, compared with women who didn't drink coffee, according to a study of more than 20,000 postmenopausal women.

Previous studies have shown that coffee has an inverse association with endometrial cancer risk, Dr. Stefano Uccella of the Mayo Clinic in Rochester, Minn., said in a poster presented at the annual meeting of the Society of Gynecologic Oncologists.

He and his colleagues reviewed the impact of coffee and other sources of caffeine on endometrial cancer risk in the Iowa Women's Health Study, a prospective cohort investigation of postmenopausal women that has been ongoing since 1986. The study population included 23,356 women, 5,218 of whom met criteria for obesity. The women completed a 126-item food frequency questionnaire at enrollment.

The researchers identified 471 cases of endometrial cancer through 2005, using information from the Iowa SEER (Surveillance Epidemiology and End Results) cancer registry.

Overall, women who consumed more than 2.5 cups of coffee daily were significantly less likely to develop endometrial cancer, compared with women who drank no coffee (odds ratio 0.65), after investigators controlled for variables including smoking, diabetes, hypertension, estrogen use, reproductive history, body mass index, body fat distribution, alcohol use, and caloric intake.

Overall caffeine intake greater than 385 mg/day also was significantly associated with a reduced risk of endometrial cancer, compared with a daily caffeine intake of less than 30 mg (OR 0.80). But no significant associations were found between endometrial cancer risk and the consumption of tea, regular or diet cola, chocolate candy, or chocolate baked goods, the researchers noted.

When the results were separated by BMI, the association between coffee and a reduced risk of endometrial cancer remained significant in the subset of obese women (BMI 30 kg/m

The significance of the association between coffee consumption and the risk of endometrial cancer was somewhat attenuated in women with a BMI less than 30 (OR 0.77).

The results support findings from previous studies, and suggest that more research is needed to assess coffee's potential protective effect against endometrial cancer, the researchers wrote.

Disclosures: Dr. Uccella reported having no conflicts.

Postmenopausal women who drank 2.5 cups nearly halved their endometrial cancer risk.

Source ©ranplett/iStockphoto.com

SAN FRANCISCO — Women who drank more than 2.5 cups of coffee daily had a significantly lower risk of endometrial cancer, compared with women who didn't drink coffee, according to a study of more than 20,000 postmenopausal women.

Previous studies have shown that coffee has an inverse association with endometrial cancer risk, Dr. Stefano Uccella of the Mayo Clinic in Rochester, Minn., said in a poster presented at the annual meeting of the Society of Gynecologic Oncologists.

He and his colleagues reviewed the impact of coffee and other sources of caffeine on endometrial cancer risk in the Iowa Women's Health Study, a prospective cohort investigation of postmenopausal women that has been ongoing since 1986. The study population included 23,356 women, 5,218 of whom met criteria for obesity. The women completed a 126-item food frequency questionnaire at enrollment.

The researchers identified 471 cases of endometrial cancer through 2005, using information from the Iowa SEER (Surveillance Epidemiology and End Results) cancer registry.

Overall, women who consumed more than 2.5 cups of coffee daily were significantly less likely to develop endometrial cancer, compared with women who drank no coffee (odds ratio 0.65), after investigators controlled for variables including smoking, diabetes, hypertension, estrogen use, reproductive history, body mass index, body fat distribution, alcohol use, and caloric intake.

Overall caffeine intake greater than 385 mg/day also was significantly associated with a reduced risk of endometrial cancer, compared with a daily caffeine intake of less than 30 mg (OR 0.80). But no significant associations were found between endometrial cancer risk and the consumption of tea, regular or diet cola, chocolate candy, or chocolate baked goods, the researchers noted.

When the results were separated by BMI, the association between coffee and a reduced risk of endometrial cancer remained significant in the subset of obese women (BMI 30 kg/m

The significance of the association between coffee consumption and the risk of endometrial cancer was somewhat attenuated in women with a BMI less than 30 (OR 0.77).

The results support findings from previous studies, and suggest that more research is needed to assess coffee's potential protective effect against endometrial cancer, the researchers wrote.

Disclosures: Dr. Uccella reported having no conflicts.

Postmenopausal women who drank 2.5 cups nearly halved their endometrial cancer risk.

Source ©ranplett/iStockphoto.com

SAN FRANCISCO — Women who drank more than 2.5 cups of coffee daily had a significantly lower risk of endometrial cancer, compared with women who didn't drink coffee, according to a study of more than 20,000 postmenopausal women.

Previous studies have shown that coffee has an inverse association with endometrial cancer risk, Dr. Stefano Uccella of the Mayo Clinic in Rochester, Minn., said in a poster presented at the annual meeting of the Society of Gynecologic Oncologists.

He and his colleagues reviewed the impact of coffee and other sources of caffeine on endometrial cancer risk in the Iowa Women's Health Study, a prospective cohort investigation of postmenopausal women that has been ongoing since 1986. The study population included 23,356 women, 5,218 of whom met criteria for obesity. The women completed a 126-item food frequency questionnaire at enrollment.

The researchers identified 471 cases of endometrial cancer through 2005, using information from the Iowa SEER (Surveillance Epidemiology and End Results) cancer registry.

Overall, women who consumed more than 2.5 cups of coffee daily were significantly less likely to develop endometrial cancer, compared with women who drank no coffee (odds ratio 0.65), after investigators controlled for variables including smoking, diabetes, hypertension, estrogen use, reproductive history, body mass index, body fat distribution, alcohol use, and caloric intake.

Overall caffeine intake greater than 385 mg/day also was significantly associated with a reduced risk of endometrial cancer, compared with a daily caffeine intake of less than 30 mg (OR 0.80). But no significant associations were found between endometrial cancer risk and the consumption of tea, regular or diet cola, chocolate candy, or chocolate baked goods, the researchers noted.

When the results were separated by BMI, the association between coffee and a reduced risk of endometrial cancer remained significant in the subset of obese women (BMI 30 kg/m

The significance of the association between coffee consumption and the risk of endometrial cancer was somewhat attenuated in women with a BMI less than 30 (OR 0.77).

The results support findings from previous studies, and suggest that more research is needed to assess coffee's potential protective effect against endometrial cancer, the researchers wrote.

Disclosures: Dr. Uccella reported having no conflicts.

Postmenopausal women who drank 2.5 cups nearly halved their endometrial cancer risk.

Source ©ranplett/iStockphoto.com