Similar Surgical Outcomes Seen for Endometrial Cancer

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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.

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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.

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Rapid H1N1 Test May Be Useful in Younger Kids

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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.

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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.

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FDA Advises Clinicians To Suspend Rotarix Use

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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.

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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.

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Step-Up With LABAs Controlled Asthma Best

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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.

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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.

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Coffee May Reduce Endometrial Cancer Risk

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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

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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

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Coffee Consumption May Curb Risk Of Developing Endometrial Cancer

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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 did not drink any coffee at all, 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 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,” Dr. Uccella and his coauthors 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 of interest.

“The association appeared to be related to coffee … and not other sources of caffeine.”

Source ©ranplett/iStockphoto.com

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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 did not drink any coffee at all, 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 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,” Dr. Uccella and his coauthors 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 of interest.

“The association appeared to be related to coffee … and not other sources of caffeine.”

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 did not drink any coffee at all, 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 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,” Dr. Uccella and his coauthors 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 of interest.

“The association appeared to be related to coffee … and not other sources of caffeine.”

Source ©ranplett/iStockphoto.com

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Add-On LTRA May Not Help in Perennial Allergic Rhinitis

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Major Finding: Adding a leukotriene receptor antagonist to intranasal steroids had no significant effect on nasal symptoms in perennial allergic rhinitis patients.

Data Source: Small randomized, double-blind, placebo-controlled add-on trial.

Disclosures: Dr. Esteitie had no financial conflicts to disclose. The study was funded by Merck, which markets montelukast, and the McHugh Otolaryngology Research Fund.

NEW ORLEANS — Adding a leukotriene receptor antagonist to fluticasone propionate had no significant effect on nasal symptoms in patients with perennial allergic rhinitis, based on results of a small randomized trial.

Previous clinical trials have shown that approximately half of patients with perennial allergic rhinitis obtain excellent symptom control with intranasal steroids alone, leaving the other half looking for additional relief, said Dr. Rania Esteitie of the University of Chicago.

In the study, 102 patients with perennial allergic rhinitis completed a baseline Rhinitis Quality of Life Questionnaire (RQLQ), and then received fluticasone propionate nasal spray (50 mcg per spray). The patients were instructed to use two sprays in each nostril once daily for 2 weeks (a total of 200 mcg per day).

The patients ranged in age from 18 years to 55 years (mean, 34 years), and 35% were male. The study results were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

After 2 weeks, the 54 patients whose Total Symptom Scores (including non-nasal symptoms) were greater than 4 out of a total possible score of 24 (with higher scores representing worse symptoms) were randomized to use either 10 mg/day of montelukast (28 patients) or placebo (26 patients) as add-on to continuing therapy with fluticasone, the researchers reported.

Over the next 2 weeks, the patients' symptoms and quality of life continued to improve, but there was no significant difference between the montelukast and placebo groups. The median changes in Total Nasal Symptom Scores from baseline for montelukast and placebo, respectively, were −0.22 and −0.25 for sneezes, −0.52 and −0.29 for runny nose, −0.41 and −0.47 for stuffy nose, and −0.24 and −0.14 for other symptoms, Dr. Esteitie and her associates wrote.

“We expected to see an improvement in symptoms after the addition of montelukast. However, we did not see any added benefit,” Dr. Esteitie said in an interview.

Although montelukast did not seem to provide additional relief for allergic rhinitis symptoms, the study was limited by the small number of patients, and additional research is needed to evaluate clinical benefits, she added.

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Major Finding: Adding a leukotriene receptor antagonist to intranasal steroids had no significant effect on nasal symptoms in perennial allergic rhinitis patients.

Data Source: Small randomized, double-blind, placebo-controlled add-on trial.

Disclosures: Dr. Esteitie had no financial conflicts to disclose. The study was funded by Merck, which markets montelukast, and the McHugh Otolaryngology Research Fund.

NEW ORLEANS — Adding a leukotriene receptor antagonist to fluticasone propionate had no significant effect on nasal symptoms in patients with perennial allergic rhinitis, based on results of a small randomized trial.

Previous clinical trials have shown that approximately half of patients with perennial allergic rhinitis obtain excellent symptom control with intranasal steroids alone, leaving the other half looking for additional relief, said Dr. Rania Esteitie of the University of Chicago.

In the study, 102 patients with perennial allergic rhinitis completed a baseline Rhinitis Quality of Life Questionnaire (RQLQ), and then received fluticasone propionate nasal spray (50 mcg per spray). The patients were instructed to use two sprays in each nostril once daily for 2 weeks (a total of 200 mcg per day).

The patients ranged in age from 18 years to 55 years (mean, 34 years), and 35% were male. The study results were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

After 2 weeks, the 54 patients whose Total Symptom Scores (including non-nasal symptoms) were greater than 4 out of a total possible score of 24 (with higher scores representing worse symptoms) were randomized to use either 10 mg/day of montelukast (28 patients) or placebo (26 patients) as add-on to continuing therapy with fluticasone, the researchers reported.

Over the next 2 weeks, the patients' symptoms and quality of life continued to improve, but there was no significant difference between the montelukast and placebo groups. The median changes in Total Nasal Symptom Scores from baseline for montelukast and placebo, respectively, were −0.22 and −0.25 for sneezes, −0.52 and −0.29 for runny nose, −0.41 and −0.47 for stuffy nose, and −0.24 and −0.14 for other symptoms, Dr. Esteitie and her associates wrote.

“We expected to see an improvement in symptoms after the addition of montelukast. However, we did not see any added benefit,” Dr. Esteitie said in an interview.

Although montelukast did not seem to provide additional relief for allergic rhinitis symptoms, the study was limited by the small number of patients, and additional research is needed to evaluate clinical benefits, she added.

Major Finding: Adding a leukotriene receptor antagonist to intranasal steroids had no significant effect on nasal symptoms in perennial allergic rhinitis patients.

Data Source: Small randomized, double-blind, placebo-controlled add-on trial.

Disclosures: Dr. Esteitie had no financial conflicts to disclose. The study was funded by Merck, which markets montelukast, and the McHugh Otolaryngology Research Fund.

NEW ORLEANS — Adding a leukotriene receptor antagonist to fluticasone propionate had no significant effect on nasal symptoms in patients with perennial allergic rhinitis, based on results of a small randomized trial.

Previous clinical trials have shown that approximately half of patients with perennial allergic rhinitis obtain excellent symptom control with intranasal steroids alone, leaving the other half looking for additional relief, said Dr. Rania Esteitie of the University of Chicago.

In the study, 102 patients with perennial allergic rhinitis completed a baseline Rhinitis Quality of Life Questionnaire (RQLQ), and then received fluticasone propionate nasal spray (50 mcg per spray). The patients were instructed to use two sprays in each nostril once daily for 2 weeks (a total of 200 mcg per day).

The patients ranged in age from 18 years to 55 years (mean, 34 years), and 35% were male. The study results were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma, and Immunology.

After 2 weeks, the 54 patients whose Total Symptom Scores (including non-nasal symptoms) were greater than 4 out of a total possible score of 24 (with higher scores representing worse symptoms) were randomized to use either 10 mg/day of montelukast (28 patients) or placebo (26 patients) as add-on to continuing therapy with fluticasone, the researchers reported.

Over the next 2 weeks, the patients' symptoms and quality of life continued to improve, but there was no significant difference between the montelukast and placebo groups. The median changes in Total Nasal Symptom Scores from baseline for montelukast and placebo, respectively, were −0.22 and −0.25 for sneezes, −0.52 and −0.29 for runny nose, −0.41 and −0.47 for stuffy nose, and −0.24 and −0.14 for other symptoms, Dr. Esteitie and her associates wrote.

“We expected to see an improvement in symptoms after the addition of montelukast. However, we did not see any added benefit,” Dr. Esteitie said in an interview.

Although montelukast did not seem to provide additional relief for allergic rhinitis symptoms, the study was limited by the small number of patients, and additional research is needed to evaluate clinical benefits, she added.

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Data Show Weight Loss Cuts Osteoarthritis Pain

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Data Show Weight Loss Cuts Osteoarthritis Pain

Major Finding: Pooled data from two new systemic reviews showed improvements in pain (ES, 0.20) and physical function (ES, 0.23) after an average weight loss of 6.1 kg (approximately 13 pounds).

Data Source: An analysis of 65 systematic reviews, 266 randomized, controlled trials, and 21 economic evaluations.

Disclosures: Lead author Dr. Zhang had no financial conflicts to disclose. Several of the co-authors have received consulting fees, honoraria, and research support from multiple drug and device manufacturers. No conflict of interest was identified that would prevent any OARSI Ethics Committee members from participating in the review.

Some osteoarthritis treatments are less effective than previously thought, judging from findings from a review of research conducted since 2006.

The goal of the update of published evidence is to determine whether the current Osteoarthritis Research Society International's (OARSI) recommendations for the treatment of OA, published in 2008, need to be modified. After reviewing this update and collecting feedback, the OARSI Treatment Guidelines Committee will determine whether changes are needed in 2010.

Acetaminophen use and surgical lavage and debridement were among the therapies that may be falling out of favor to treat knee and hip OA, but evidence supporting weight reduction is on the upswing, said Dr. Weiya Zhang, a rheumatologist at the University of Nottingham (England), and colleagues.

The researchers identified 64 systematic reviews, 266 randomized controlled trials, and 21 economic evaluations related to hip and knee OA that were published between January 2006 and January 2009.

“Of the 51 modalities of treatment addressed in the OARSI recommendations, 35 have now been systematically reviewed with 16 new or updated systematic reviews in the last 3 years,” the researchers wrote (Osteoarthritis Cartilage 2010 Feb. [Epub 10.1016/j.joca.2010.01.013

The reviewers assessed the best available evidence for effect size (ES) with 95% confidence intervals for improving function and relieving pain and stiffness associated with OA.

The new evidence for nonpharmacological therapies included several studies supporting weight reduction. Pooled data from two new systemic reviews showed improvements in pain (ES, 0.20) and physical function (ES, 0.23) after an average weight loss of 6.1 kg (approximately 13 pounds). The ES for pain relief for hip and knee OA were not significantly changed for acupuncture, education, exercise, and self-management.

New research on electromagnetic therapy showed a relatively small improvement in function (ES, 0.33) and no significant effect on pain reduction (ES, 0.16), in contrast to data from a 2002 Cochrane review showing an ES of 0.77 that almost led to electromagnetic therapy's inclusion in the 2008 OARSI guidelines (it was not included).

The review also yielded changes in evidence for pharmacological treatments for OA, notably for acetaminophen.

A review of five new studies of acetaminophen for knee OA showed no significant reductions in effect size for pain relief (pooled ES, 0.14).

Other recent studies showed an increased risk of hospitalization due to perforation, peptic ulceration, and bleeding when acetaminophen doses of more than 3 grams per day were used to treat OA (hazard ratio 1.20). No data from recent studies identified significant changes in the risks and benefits of oral or topical nonsteroidal anti-inflammatory agents, diacerhein, or interarticular corticosteroid injections for treating OA.

For surgical treatments, pooled results showed no benefit for lavage, debridement, or a combination of the two for treating OA compared with placebo. Effect sizes for pain relief, improvement in function, and reduction in stiffness were 0.21, 0.11, and 0.05, respectively.

For alternative medicine treatments, recent studies showed a reduced effect size for pain relief of OA with treatments including glucosamine sulphate, chondroitin sulphate, intra-articular hyaluronic acid injections, and avocado soybean unsponifiables. Recent studies of these treatments also showed increased evidence of publication bias and heterogeneous outcomes.

The results of the review were limited by many factors, including the inability to make comparisons across treatments when meta-analyses and systematic reviews had different inclusion and exclusion criteria than randomized controlled trials.

The researchers noted that there is a need for “a continuously updated, comprehensive, and coherent database of well-characterized trials of all modalities of treatment of OA.”

But they emphasized that treatment guidelines must be based on the best evidence, not simply on updated cumulative evidence.

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Major Finding: Pooled data from two new systemic reviews showed improvements in pain (ES, 0.20) and physical function (ES, 0.23) after an average weight loss of 6.1 kg (approximately 13 pounds).

Data Source: An analysis of 65 systematic reviews, 266 randomized, controlled trials, and 21 economic evaluations.

Disclosures: Lead author Dr. Zhang had no financial conflicts to disclose. Several of the co-authors have received consulting fees, honoraria, and research support from multiple drug and device manufacturers. No conflict of interest was identified that would prevent any OARSI Ethics Committee members from participating in the review.

Some osteoarthritis treatments are less effective than previously thought, judging from findings from a review of research conducted since 2006.

The goal of the update of published evidence is to determine whether the current Osteoarthritis Research Society International's (OARSI) recommendations for the treatment of OA, published in 2008, need to be modified. After reviewing this update and collecting feedback, the OARSI Treatment Guidelines Committee will determine whether changes are needed in 2010.

Acetaminophen use and surgical lavage and debridement were among the therapies that may be falling out of favor to treat knee and hip OA, but evidence supporting weight reduction is on the upswing, said Dr. Weiya Zhang, a rheumatologist at the University of Nottingham (England), and colleagues.

The researchers identified 64 systematic reviews, 266 randomized controlled trials, and 21 economic evaluations related to hip and knee OA that were published between January 2006 and January 2009.

“Of the 51 modalities of treatment addressed in the OARSI recommendations, 35 have now been systematically reviewed with 16 new or updated systematic reviews in the last 3 years,” the researchers wrote (Osteoarthritis Cartilage 2010 Feb. [Epub 10.1016/j.joca.2010.01.013

The reviewers assessed the best available evidence for effect size (ES) with 95% confidence intervals for improving function and relieving pain and stiffness associated with OA.

The new evidence for nonpharmacological therapies included several studies supporting weight reduction. Pooled data from two new systemic reviews showed improvements in pain (ES, 0.20) and physical function (ES, 0.23) after an average weight loss of 6.1 kg (approximately 13 pounds). The ES for pain relief for hip and knee OA were not significantly changed for acupuncture, education, exercise, and self-management.

New research on electromagnetic therapy showed a relatively small improvement in function (ES, 0.33) and no significant effect on pain reduction (ES, 0.16), in contrast to data from a 2002 Cochrane review showing an ES of 0.77 that almost led to electromagnetic therapy's inclusion in the 2008 OARSI guidelines (it was not included).

The review also yielded changes in evidence for pharmacological treatments for OA, notably for acetaminophen.

A review of five new studies of acetaminophen for knee OA showed no significant reductions in effect size for pain relief (pooled ES, 0.14).

Other recent studies showed an increased risk of hospitalization due to perforation, peptic ulceration, and bleeding when acetaminophen doses of more than 3 grams per day were used to treat OA (hazard ratio 1.20). No data from recent studies identified significant changes in the risks and benefits of oral or topical nonsteroidal anti-inflammatory agents, diacerhein, or interarticular corticosteroid injections for treating OA.

For surgical treatments, pooled results showed no benefit for lavage, debridement, or a combination of the two for treating OA compared with placebo. Effect sizes for pain relief, improvement in function, and reduction in stiffness were 0.21, 0.11, and 0.05, respectively.

For alternative medicine treatments, recent studies showed a reduced effect size for pain relief of OA with treatments including glucosamine sulphate, chondroitin sulphate, intra-articular hyaluronic acid injections, and avocado soybean unsponifiables. Recent studies of these treatments also showed increased evidence of publication bias and heterogeneous outcomes.

The results of the review were limited by many factors, including the inability to make comparisons across treatments when meta-analyses and systematic reviews had different inclusion and exclusion criteria than randomized controlled trials.

The researchers noted that there is a need for “a continuously updated, comprehensive, and coherent database of well-characterized trials of all modalities of treatment of OA.”

But they emphasized that treatment guidelines must be based on the best evidence, not simply on updated cumulative evidence.

Major Finding: Pooled data from two new systemic reviews showed improvements in pain (ES, 0.20) and physical function (ES, 0.23) after an average weight loss of 6.1 kg (approximately 13 pounds).

Data Source: An analysis of 65 systematic reviews, 266 randomized, controlled trials, and 21 economic evaluations.

Disclosures: Lead author Dr. Zhang had no financial conflicts to disclose. Several of the co-authors have received consulting fees, honoraria, and research support from multiple drug and device manufacturers. No conflict of interest was identified that would prevent any OARSI Ethics Committee members from participating in the review.

Some osteoarthritis treatments are less effective than previously thought, judging from findings from a review of research conducted since 2006.

The goal of the update of published evidence is to determine whether the current Osteoarthritis Research Society International's (OARSI) recommendations for the treatment of OA, published in 2008, need to be modified. After reviewing this update and collecting feedback, the OARSI Treatment Guidelines Committee will determine whether changes are needed in 2010.

Acetaminophen use and surgical lavage and debridement were among the therapies that may be falling out of favor to treat knee and hip OA, but evidence supporting weight reduction is on the upswing, said Dr. Weiya Zhang, a rheumatologist at the University of Nottingham (England), and colleagues.

The researchers identified 64 systematic reviews, 266 randomized controlled trials, and 21 economic evaluations related to hip and knee OA that were published between January 2006 and January 2009.

“Of the 51 modalities of treatment addressed in the OARSI recommendations, 35 have now been systematically reviewed with 16 new or updated systematic reviews in the last 3 years,” the researchers wrote (Osteoarthritis Cartilage 2010 Feb. [Epub 10.1016/j.joca.2010.01.013

The reviewers assessed the best available evidence for effect size (ES) with 95% confidence intervals for improving function and relieving pain and stiffness associated with OA.

The new evidence for nonpharmacological therapies included several studies supporting weight reduction. Pooled data from two new systemic reviews showed improvements in pain (ES, 0.20) and physical function (ES, 0.23) after an average weight loss of 6.1 kg (approximately 13 pounds). The ES for pain relief for hip and knee OA were not significantly changed for acupuncture, education, exercise, and self-management.

New research on electromagnetic therapy showed a relatively small improvement in function (ES, 0.33) and no significant effect on pain reduction (ES, 0.16), in contrast to data from a 2002 Cochrane review showing an ES of 0.77 that almost led to electromagnetic therapy's inclusion in the 2008 OARSI guidelines (it was not included).

The review also yielded changes in evidence for pharmacological treatments for OA, notably for acetaminophen.

A review of five new studies of acetaminophen for knee OA showed no significant reductions in effect size for pain relief (pooled ES, 0.14).

Other recent studies showed an increased risk of hospitalization due to perforation, peptic ulceration, and bleeding when acetaminophen doses of more than 3 grams per day were used to treat OA (hazard ratio 1.20). No data from recent studies identified significant changes in the risks and benefits of oral or topical nonsteroidal anti-inflammatory agents, diacerhein, or interarticular corticosteroid injections for treating OA.

For surgical treatments, pooled results showed no benefit for lavage, debridement, or a combination of the two for treating OA compared with placebo. Effect sizes for pain relief, improvement in function, and reduction in stiffness were 0.21, 0.11, and 0.05, respectively.

For alternative medicine treatments, recent studies showed a reduced effect size for pain relief of OA with treatments including glucosamine sulphate, chondroitin sulphate, intra-articular hyaluronic acid injections, and avocado soybean unsponifiables. Recent studies of these treatments also showed increased evidence of publication bias and heterogeneous outcomes.

The results of the review were limited by many factors, including the inability to make comparisons across treatments when meta-analyses and systematic reviews had different inclusion and exclusion criteria than randomized controlled trials.

The researchers noted that there is a need for “a continuously updated, comprehensive, and coherent database of well-characterized trials of all modalities of treatment of OA.”

But they emphasized that treatment guidelines must be based on the best evidence, not simply on updated cumulative evidence.

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Vitamin D Insufficiency May Be Linked to Allergies, Asthma in Kids

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New Orleans — Approximately half of children with asthma were deficient in vitamin D in a study of 99 children aged 18 and younger. The findings were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

Previous studies have indicated that vitamin D insufficiency contributes to the pathophysiology of allergic disease, but data on vitamin D’s impact on children with allergies and asthma are limited, said Dr. Daniel Searing of National Jewish Health in Denver, Colo.

In this study, Dr. Searing and colleagues identified 99 children who had asthma, atopic dermatitis, and/or a food allergy. The researchers assessed vitamin D by measuring serum 25-hydroxyvitamin D levels.

Overall, 47% of the patients had insufficient levels of vitamin D (less than 30 ng/mL). The median vitamin D level was 31 ng/mL.

To assess the impact of vitamin D on inflammation, the researchers cultured peripheral blood mononuclear cells (PBMC) from 11 patients using either 10 nM vitamin D or a placebo medium for 24 hours, and supplemented them with either 10 or 100 nM of dexamethasone for the last 3 hours of culturing. Next, they measured mitogen-activated protein kinase phosphatase-1 (MKP-1) and interleukin-10 (IL-10.)

“Vitamin D enhances glucocorticoid induction of MKP-1 and IL-10 in asthmatic PBMC in vitro,” the researchers wrote. Vitamin D addition can enhance the activity of dexamethasone more than 10-fold, they added.

“The relationship between vitamin D and corticosteroid pathways, as well as its effect on the inflammatory response, is not fully understood,” the researchers emphasized. But the results suggest that vitamin D supplementation may enhance the anti-inflammatory function of corticosteroids in asthma patients, they noted.

Median vitamin D levels were significantly lower in children taking inhaled corticosteroids (29 ng/mL), oral corticosteroids (25 ng/mL) and long-acting beta-agonists (25 ng/mL), compared with children who were not taking inhaled corticosteroids, oral corticosteroids, or long-acting beta-agonists (35 ng/mL, 32 ng/mL, and 34 ng/mL, respectively)

In addition, median vitamin D levels were significantly lower in children with positive vs. negative aeroallergen sensitivity to dog dander (29 ng/mL vs. 35 ng/mL) and house dust mites (27 ng/mL vs. 31 ng/mL).

Dr. Searing had no financial conflicts to disclose. The study was supported in part by a grant from the National Institutes of Health.

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New Orleans — Approximately half of children with asthma were deficient in vitamin D in a study of 99 children aged 18 and younger. The findings were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

Previous studies have indicated that vitamin D insufficiency contributes to the pathophysiology of allergic disease, but data on vitamin D’s impact on children with allergies and asthma are limited, said Dr. Daniel Searing of National Jewish Health in Denver, Colo.

In this study, Dr. Searing and colleagues identified 99 children who had asthma, atopic dermatitis, and/or a food allergy. The researchers assessed vitamin D by measuring serum 25-hydroxyvitamin D levels.

Overall, 47% of the patients had insufficient levels of vitamin D (less than 30 ng/mL). The median vitamin D level was 31 ng/mL.

To assess the impact of vitamin D on inflammation, the researchers cultured peripheral blood mononuclear cells (PBMC) from 11 patients using either 10 nM vitamin D or a placebo medium for 24 hours, and supplemented them with either 10 or 100 nM of dexamethasone for the last 3 hours of culturing. Next, they measured mitogen-activated protein kinase phosphatase-1 (MKP-1) and interleukin-10 (IL-10.)

“Vitamin D enhances glucocorticoid induction of MKP-1 and IL-10 in asthmatic PBMC in vitro,” the researchers wrote. Vitamin D addition can enhance the activity of dexamethasone more than 10-fold, they added.

“The relationship between vitamin D and corticosteroid pathways, as well as its effect on the inflammatory response, is not fully understood,” the researchers emphasized. But the results suggest that vitamin D supplementation may enhance the anti-inflammatory function of corticosteroids in asthma patients, they noted.

Median vitamin D levels were significantly lower in children taking inhaled corticosteroids (29 ng/mL), oral corticosteroids (25 ng/mL) and long-acting beta-agonists (25 ng/mL), compared with children who were not taking inhaled corticosteroids, oral corticosteroids, or long-acting beta-agonists (35 ng/mL, 32 ng/mL, and 34 ng/mL, respectively)

In addition, median vitamin D levels were significantly lower in children with positive vs. negative aeroallergen sensitivity to dog dander (29 ng/mL vs. 35 ng/mL) and house dust mites (27 ng/mL vs. 31 ng/mL).

Dr. Searing had no financial conflicts to disclose. The study was supported in part by a grant from the National Institutes of Health.

New Orleans — Approximately half of children with asthma were deficient in vitamin D in a study of 99 children aged 18 and younger. The findings were presented in a poster at the annual meeting of the American Academy of Allergy, Asthma and Immunology.

Previous studies have indicated that vitamin D insufficiency contributes to the pathophysiology of allergic disease, but data on vitamin D’s impact on children with allergies and asthma are limited, said Dr. Daniel Searing of National Jewish Health in Denver, Colo.

In this study, Dr. Searing and colleagues identified 99 children who had asthma, atopic dermatitis, and/or a food allergy. The researchers assessed vitamin D by measuring serum 25-hydroxyvitamin D levels.

Overall, 47% of the patients had insufficient levels of vitamin D (less than 30 ng/mL). The median vitamin D level was 31 ng/mL.

To assess the impact of vitamin D on inflammation, the researchers cultured peripheral blood mononuclear cells (PBMC) from 11 patients using either 10 nM vitamin D or a placebo medium for 24 hours, and supplemented them with either 10 or 100 nM of dexamethasone for the last 3 hours of culturing. Next, they measured mitogen-activated protein kinase phosphatase-1 (MKP-1) and interleukin-10 (IL-10.)

“Vitamin D enhances glucocorticoid induction of MKP-1 and IL-10 in asthmatic PBMC in vitro,” the researchers wrote. Vitamin D addition can enhance the activity of dexamethasone more than 10-fold, they added.

“The relationship between vitamin D and corticosteroid pathways, as well as its effect on the inflammatory response, is not fully understood,” the researchers emphasized. But the results suggest that vitamin D supplementation may enhance the anti-inflammatory function of corticosteroids in asthma patients, they noted.

Median vitamin D levels were significantly lower in children taking inhaled corticosteroids (29 ng/mL), oral corticosteroids (25 ng/mL) and long-acting beta-agonists (25 ng/mL), compared with children who were not taking inhaled corticosteroids, oral corticosteroids, or long-acting beta-agonists (35 ng/mL, 32 ng/mL, and 34 ng/mL, respectively)

In addition, median vitamin D levels were significantly lower in children with positive vs. negative aeroallergen sensitivity to dog dander (29 ng/mL vs. 35 ng/mL) and house dust mites (27 ng/mL vs. 31 ng/mL).

Dr. Searing had no financial conflicts to disclose. The study was supported in part by a grant from the National Institutes of Health.

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Skin Color May Affect Visual Detection of Genital Trauma

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BOSTON — The prevalence of genital injuries was significantly higher among white patients than black patients, based on a review of 2,234 women aged 13 years and older who were examined after being raped.

This may be misleading, though, because methods of recognizing these injuries can be ineffectual in black women, said Linda Rossman, M.S.N., of Michigan State University, East Lansing, and her colleagues.

Data from previous studies have shown that direct visualization, contrast media, and colposcopy may be less effective at identifying genital injuries in darker-skinned patients, she said.

“Color awareness may be an important component of the sexual assault forensic examination,” she said in a poster presented at the annual meeting of the American College of Emergency Physicians. The researchers reviewed data from 2,234 consecutive female patients who were referred to a community-based Sexual Assault Nurse Examiner program (SANE) from four urban emergency departments during a 10-year period. In this study, genital injury was defined as any visible tissue trauma that could be categorized using the TEARS classification system (tears, ecchymoses, abrasions, redness, and swelling).

In this community, 83% of the women were white and 17% were black, with similar demographic characteristics, and the details of the assault cases also were similar. Overall, the prevalence of documented anogenital injuries was significantly higher in whites, compared with blacks (64% vs. 54%). The pattern of anogenital injuries was similar in both groups. The injuries typically involved the fossa navicularis, followed by the posterior fourchette, labia, and hymen, the researchers said. In addition, the prevalence of documented nongenital injuries was significantly higher in whites, compared with blacks (39% vs. 26%).

Lacerations were the most common injuries in all patients, but whites had a significantly greater incidence of documented erythema, compared with blacks, the researchers noted.

Disclosures: None was reported.

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BOSTON — The prevalence of genital injuries was significantly higher among white patients than black patients, based on a review of 2,234 women aged 13 years and older who were examined after being raped.

This may be misleading, though, because methods of recognizing these injuries can be ineffectual in black women, said Linda Rossman, M.S.N., of Michigan State University, East Lansing, and her colleagues.

Data from previous studies have shown that direct visualization, contrast media, and colposcopy may be less effective at identifying genital injuries in darker-skinned patients, she said.

“Color awareness may be an important component of the sexual assault forensic examination,” she said in a poster presented at the annual meeting of the American College of Emergency Physicians. The researchers reviewed data from 2,234 consecutive female patients who were referred to a community-based Sexual Assault Nurse Examiner program (SANE) from four urban emergency departments during a 10-year period. In this study, genital injury was defined as any visible tissue trauma that could be categorized using the TEARS classification system (tears, ecchymoses, abrasions, redness, and swelling).

In this community, 83% of the women were white and 17% were black, with similar demographic characteristics, and the details of the assault cases also were similar. Overall, the prevalence of documented anogenital injuries was significantly higher in whites, compared with blacks (64% vs. 54%). The pattern of anogenital injuries was similar in both groups. The injuries typically involved the fossa navicularis, followed by the posterior fourchette, labia, and hymen, the researchers said. In addition, the prevalence of documented nongenital injuries was significantly higher in whites, compared with blacks (39% vs. 26%).

Lacerations were the most common injuries in all patients, but whites had a significantly greater incidence of documented erythema, compared with blacks, the researchers noted.

Disclosures: None was reported.

BOSTON — The prevalence of genital injuries was significantly higher among white patients than black patients, based on a review of 2,234 women aged 13 years and older who were examined after being raped.

This may be misleading, though, because methods of recognizing these injuries can be ineffectual in black women, said Linda Rossman, M.S.N., of Michigan State University, East Lansing, and her colleagues.

Data from previous studies have shown that direct visualization, contrast media, and colposcopy may be less effective at identifying genital injuries in darker-skinned patients, she said.

“Color awareness may be an important component of the sexual assault forensic examination,” she said in a poster presented at the annual meeting of the American College of Emergency Physicians. The researchers reviewed data from 2,234 consecutive female patients who were referred to a community-based Sexual Assault Nurse Examiner program (SANE) from four urban emergency departments during a 10-year period. In this study, genital injury was defined as any visible tissue trauma that could be categorized using the TEARS classification system (tears, ecchymoses, abrasions, redness, and swelling).

In this community, 83% of the women were white and 17% were black, with similar demographic characteristics, and the details of the assault cases also were similar. Overall, the prevalence of documented anogenital injuries was significantly higher in whites, compared with blacks (64% vs. 54%). The pattern of anogenital injuries was similar in both groups. The injuries typically involved the fossa navicularis, followed by the posterior fourchette, labia, and hymen, the researchers said. In addition, the prevalence of documented nongenital injuries was significantly higher in whites, compared with blacks (39% vs. 26%).

Lacerations were the most common injuries in all patients, but whites had a significantly greater incidence of documented erythema, compared with blacks, the researchers noted.

Disclosures: None was reported.

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