Heidi Splete

ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

ORLANDO — Daily application of 3.75% imiquimod cream with a 2-week dosing cycle was well tolerated and effective for treating actinic keratoses in adults, based on data from two studies.

In current treatment regimens, some patients use a 5% concentration imiquimod (Aldara, Graceway) cream twice a week over a treatment period as long as 16 weeks, but a lower dose may allow a shorter treatment period, said Dr. Neil Swanson of Oregon Health and Science University, Portland.

Dr. Swanson and his colleagues randomized 160 patients to 3.75% imiquimod cream, 160 patients to 2.5% imiquimod cream, and 159 patients to a placebo cream. The patients, aged 18 years and older, had 5-20 clinically diagnosed actinic keratoses (AKs) on the face or balding scalp. The study results were presented in a poster at the Orlando Dermatology Aesthetic and Clinical Conference.

Both the 3.75% and 2.5% creams were significantly more effective than placebo at fully clearing AKs after 2 weeks of daily use. Overall, 36% of the 3.75% group and 31% of the 2.5% group achieved complete clearance, vs. 6% of the placebo group.

The 3.75% cream, however, was significantly better than the 2.5% cream for partial clearance and lesion reduction. Approximately 60% of the 3.75% group achieved partial clearance (defined as at least 75%), compared with 48% of the 2.5% group and 23% of the placebo group.

Both concentrations of imiquimod were well tolerated, and most local skin reactions were mild to moderate. Local skin reactions occurred in 1% of the placebo group, 21% of the 2.5% group, and 34% of the 3.75% group. The most common local skin reactions in both groups were erythema, scabbing or crusting, and erosion or ulceration.

"Median percent lesion reduction of 81.8% was comparable to that observed for imiquimod 5% cream applied for 16 weeks in treating a smaller area of fewer lesions," the researchers noted. By comparison, the median lesion reduction from baseline was 71.8% in the 2.5% group and 25% in the placebo group. The average lesion count at baseline was 11 in all three groups.

Patients applied the treatment cream or placebo daily to the treatment areas for approximately 8 hours or overnight and then removed it. The study included two 2-week cycles separated by a 2-week no-treatment period.

In a companion study also presented as a poster at the meeting, there was no significant improvement in effectiveness with either imiquimod 2.5% or 3.75% cream for treating AKs when used daily for two 3-week cycles separated by a 3-week no-treatment period. The study randomized 164 patients to a placebo cream, 164 patients to imiquimod 2.5% cream, and 162 patients to imiquimod 3.75% cream.

Both imiquimod creams were adequately tolerated and significantly more effective than placebo, reported Dr. C. William Hanke, a dermatologic surgeon in Carmel, Ind., and colleagues.

When both studies were evaluated together, though, "efficacy was better with imiquimod 3.75% than with 2.5%. Extending the cycle duration from 2 weeks to 3 weeks did not further increase efficacy," Dr. Hanke and his associates wrote.

Both studies were funded by Graceway Pharmaceuticals. Both Dr. Swanson and Dr. Hanke have served as investigators and consultants for Graceway. Coauthors on both studies include other investigators, consultants, and employees of Graceway.

Women of Korean, Chinese, and Filipino descent are more than twice as likely to develop gestational diabetes as Caucasian or African American women, according to a data analysis of more than 16,000 pregnant women in Hawaii published in the Ethnicity and Disease journal.

Gestational diabetes occurs in 4%-8% of all pregnant women, wrote Kathryn L. Pedula and her colleagues. Data from a pair of recent U.S. studies suggested that Asians have a higher prevalence of gestational diabetes mellitus (GDM) than do other ethnicities, but differences among subcategories of Asian populations have not been well studied.

Ms. Pedula and her associates at the Center for Health Research, Kaiser Permanente Northwest in Portland, Ore., reviewed 10 years' worth of data from 22,110 pregnancies in 16,757 women. Hawaii was chosen for the study because of its ethnically diverse population, the researchers said (Ethn. Dis. 2009;19:414-9).

A total of 353 women had pre-existing diabetes. The remaining women underwent screening for GDM between 24 and 28 weeks of pregnancy, using the 50-gram, 1-hour glucose challenge test (GCT). Women with plasma glucose levels greater than 200 mg/dL on the GCT were deemed to have GDM and were not tested further. The remaining women with a GCT value greater than 140 mg/dL underwent the 100-gram, 3-hour oral glucose tolerance test.

Overall, 20.9% of the women had a positive GCT (plasma glucose at least 140 mg/dL). Approximately 4% had GDM based on the National Diabetes Data Group (NDDG) criteria, and 7% had GDM based on the Carpenter and Coustan (C&C) criteria.

After adjusting for age, the investigators found that 10% of the Korean women had GDM based on the C&C criteria, followed by 9.8% of Chinese women and 8.3% among Filipino women. The prevalence was lowest among African Americans (3.3%) and Caucasians (4.2%).

Based on the NDDG criteria, Puerto Rican women had the highest age-adjusted prevalence of GDM (7.4%), but this was barely higher than the average when C&C criteria were applied. However, Korean, Filipino, and Chinese women had the next highest prevalences of GDM, at 6.4%, 5.8%, and 5.6%, respectively, based on the NDDG criteria. Again, Caucasians and African Americans had the lowest prevalence of GDM, at 2.5% and 2.2%, respectively.

The study included women aged 13-39 years who gave birth in Hawaii between 1995 and 2003. The Asian population was divided into five subgroups: Korean, Chinese, Japanese, Vietnamese, and Filipino. Additional groups included Samoan, Puerto Rican, Native Hawaiian, Caucasian, African American, Native American, other Hispanic, and other Pacific Islander.

The results suggest that the risks for developing GDM may vary greatly depending on specific ethnic background.

“These findings point to the need for further research along several avenues, such as maternal-child outcome differences and perhaps ethnic-specific guidelines for GDM diagnosis,” the researchers said.

Disclosures: The study was funded by the American Diabetes Association. Coauthor Dr. Teresa A. Hillier was funded by a 1-year ADA-European Association for the Study of Diabetes Trans-Atlantic Fellowship.

Using two sets of criteria, investigators found a high prevalence of GDM in Asian women.

Source ©Thye Aun Ngo/Fotolia.com

Women of Korean, Chinese, and Filipino descent are more than twice as likely to develop gestational diabetes as Caucasian or African American women, according to a data analysis of more than 16,000 pregnant women in Hawaii published in the Ethnicity and Disease journal.

Gestational diabetes occurs in 4%-8% of all pregnant women, wrote Kathryn L. Pedula and her colleagues. Data from a pair of recent U.S. studies suggested that Asians have a higher prevalence of gestational diabetes mellitus (GDM) than do other ethnicities, but differences among subcategories of Asian populations have not been well studied.

Ms. Pedula and her associates at the Center for Health Research, Kaiser Permanente Northwest in Portland, Ore., reviewed 10 years' worth of data from 22,110 pregnancies in 16,757 women. Hawaii was chosen for the study because of its ethnically diverse population, the researchers said (Ethn. Dis. 2009;19:414-9).

A total of 353 women had pre-existing diabetes. The remaining women underwent screening for GDM between 24 and 28 weeks of pregnancy, using the 50-gram, 1-hour glucose challenge test (GCT). Women with plasma glucose levels greater than 200 mg/dL on the GCT were deemed to have GDM and were not tested further. The remaining women with a GCT value greater than 140 mg/dL underwent the 100-gram, 3-hour oral glucose tolerance test.

Overall, 20.9% of the women had a positive GCT (plasma glucose at least 140 mg/dL). Approximately 4% had GDM based on the National Diabetes Data Group (NDDG) criteria, and 7% had GDM based on the Carpenter and Coustan (C&C) criteria.

After adjusting for age, the investigators found that 10% of the Korean women had GDM based on the C&C criteria, followed by 9.8% of Chinese women and 8.3% among Filipino women. The prevalence was lowest among African Americans (3.3%) and Caucasians (4.2%).

Based on the NDDG criteria, Puerto Rican women had the highest age-adjusted prevalence of GDM (7.4%), but this was barely higher than the average when C&C criteria were applied. However, Korean, Filipino, and Chinese women had the next highest prevalences of GDM, at 6.4%, 5.8%, and 5.6%, respectively, based on the NDDG criteria. Again, Caucasians and African Americans had the lowest prevalence of GDM, at 2.5% and 2.2%, respectively.

The study included women aged 13-39 years who gave birth in Hawaii between 1995 and 2003. The Asian population was divided into five subgroups: Korean, Chinese, Japanese, Vietnamese, and Filipino. Additional groups included Samoan, Puerto Rican, Native Hawaiian, Caucasian, African American, Native American, other Hispanic, and other Pacific Islander.

The results suggest that the risks for developing GDM may vary greatly depending on specific ethnic background.

“These findings point to the need for further research along several avenues, such as maternal-child outcome differences and perhaps ethnic-specific guidelines for GDM diagnosis,” the researchers said.

Disclosures: The study was funded by the American Diabetes Association. Coauthor Dr. Teresa A. Hillier was funded by a 1-year ADA-European Association for the Study of Diabetes Trans-Atlantic Fellowship.

Using two sets of criteria, investigators found a high prevalence of GDM in Asian women.

Source ©Thye Aun Ngo/Fotolia.com

Women of Korean, Chinese, and Filipino descent are more than twice as likely to develop gestational diabetes as Caucasian or African American women, according to a data analysis of more than 16,000 pregnant women in Hawaii published in the Ethnicity and Disease journal.

Gestational diabetes occurs in 4%-8% of all pregnant women, wrote Kathryn L. Pedula and her colleagues. Data from a pair of recent U.S. studies suggested that Asians have a higher prevalence of gestational diabetes mellitus (GDM) than do other ethnicities, but differences among subcategories of Asian populations have not been well studied.

Ms. Pedula and her associates at the Center for Health Research, Kaiser Permanente Northwest in Portland, Ore., reviewed 10 years' worth of data from 22,110 pregnancies in 16,757 women. Hawaii was chosen for the study because of its ethnically diverse population, the researchers said (Ethn. Dis. 2009;19:414-9).

A total of 353 women had pre-existing diabetes. The remaining women underwent screening for GDM between 24 and 28 weeks of pregnancy, using the 50-gram, 1-hour glucose challenge test (GCT). Women with plasma glucose levels greater than 200 mg/dL on the GCT were deemed to have GDM and were not tested further. The remaining women with a GCT value greater than 140 mg/dL underwent the 100-gram, 3-hour oral glucose tolerance test.

Overall, 20.9% of the women had a positive GCT (plasma glucose at least 140 mg/dL). Approximately 4% had GDM based on the National Diabetes Data Group (NDDG) criteria, and 7% had GDM based on the Carpenter and Coustan (C&C) criteria.

After adjusting for age, the investigators found that 10% of the Korean women had GDM based on the C&C criteria, followed by 9.8% of Chinese women and 8.3% among Filipino women. The prevalence was lowest among African Americans (3.3%) and Caucasians (4.2%).

Based on the NDDG criteria, Puerto Rican women had the highest age-adjusted prevalence of GDM (7.4%), but this was barely higher than the average when C&C criteria were applied. However, Korean, Filipino, and Chinese women had the next highest prevalences of GDM, at 6.4%, 5.8%, and 5.6%, respectively, based on the NDDG criteria. Again, Caucasians and African Americans had the lowest prevalence of GDM, at 2.5% and 2.2%, respectively.

The study included women aged 13-39 years who gave birth in Hawaii between 1995 and 2003. The Asian population was divided into five subgroups: Korean, Chinese, Japanese, Vietnamese, and Filipino. Additional groups included Samoan, Puerto Rican, Native Hawaiian, Caucasian, African American, Native American, other Hispanic, and other Pacific Islander.

The results suggest that the risks for developing GDM may vary greatly depending on specific ethnic background.

“These findings point to the need for further research along several avenues, such as maternal-child outcome differences and perhaps ethnic-specific guidelines for GDM diagnosis,” the researchers said.

Disclosures: The study was funded by the American Diabetes Association. Coauthor Dr. Teresa A. Hillier was funded by a 1-year ADA-European Association for the Study of Diabetes Trans-Atlantic Fellowship.

Using two sets of criteria, investigators found a high prevalence of GDM in Asian women.

Source ©Thye Aun Ngo/Fotolia.com

Disclosures: The study was funded by the American Diabetes Association. Coauthor Dr. Teresa A. Hillier was funded by a 1-year ADA-European Association for the Study of Diabetes Trans-Atlantic Fellowship.

Women of Korean, Chinese, and Filipino descent are more than twice as likely to develop gestational diabetes as Caucasian or African American women, according to a data analysis of more than 16,000 pregnant women in Hawaii.

Gestational diabetes occurs in 4%-8% of all pregnant women, wrote Kathryn L. Pedula and her colleagues. Data from a pair of recent U.S. studies suggested that Asians have a higher prevalence of gestational diabetes mellitus (GDM) than do other ethnicities, but differences among subcategories of Asian populations have not been well studied.

Ms. Pedula and her associates at the Center for Health Research, Kaiser Permanente Northwest in Portland, Ore., reviewed 10 years' worth of data from 22,110 pregnancies in 16,757 women. Hawaii was chosen for the study because of its ethnically diverse population (Ethn. Dis. 2009;19:414-9).

A total of 353 women had pre-existing diabetes. The remaining women underwent screening for GDM between 24 and 28 weeks of pregnancy, using the 50-gram, 1-hour glucose challenge test (GCT). Women with plasma glucose levels greater than 200 mg/dL on the GCT were deemed to have GDM and were not tested further. The remaining women with a GCT value greater than 140 mg/dL underwent the 100-gram, 3-hour oral glucose tolerance test.

Overall, 20.9% of the women had a positive GCT (plasma glucose at least 140 mg/dL). Approximately 4% had GDM based on the National Diabetes Data Group (NDDG) criteria, and 7% had GDM based on the Carpenter and Coustan (C&C) criteria.

After adjusting for age, the investigators found that 10% of the Korean women had GDM based on the C&C criteria, followed by 9.8% of Chinese women and 8.3% among Filipino women. The prevalence was lowest among African Americans (3.3%) and Caucasians (4.2%).

Based on the NDDG criteria, Puerto Rican women had the highest age-adjusted prevalence of GDM (7.4%), but this was barely higher than the average when C&C criteria were applied. However, Korean, Filipino, and Chinese women had the next highest prevalences of GDM, at 6.4%, 5.8%, and 5.6%, respectively, based on the NDDG criteria. Again, Caucasians and African Americans had the lowest prevalence of GDM, at 2.5% and 2.2%, respectively.

The study included women aged 13-39 years who gave birth in Hawaii between 1995 and 2003. The Asian population was divided into five subgroups: Korean, Chinese, Japanese, Vietnamese, and Filipino. Additional groups included Samoan, Puerto Rican, Native Hawaiian, Caucasian, African American, Native American, other Hispanic, and other Pacific Islander.

The results suggest that the risks for developing GDM may vary greatly depending on specific ethnic background. “These findings point to the need for further research along several avenues, such as maternal-child outcome differences and perhaps ethnic-specific guidelines for GDM diagnosis,” the researchers said.

Chinese women had a high gestational diabetes prevalence at 5.6%.

Source ©Thye Aun Ngo/Fotolia.com

Disclosures: The study was funded by the American Diabetes Association. Coauthor Dr. Teresa A. Hillier was funded by a 1-year ADA-European Association for the Study of Diabetes Trans-Atlantic Fellowship.

Women of Korean, Chinese, and Filipino descent are more than twice as likely to develop gestational diabetes as Caucasian or African American women, according to a data analysis of more than 16,000 pregnant women in Hawaii.

Gestational diabetes occurs in 4%-8% of all pregnant women, wrote Kathryn L. Pedula and her colleagues. Data from a pair of recent U.S. studies suggested that Asians have a higher prevalence of gestational diabetes mellitus (GDM) than do other ethnicities, but differences among subcategories of Asian populations have not been well studied.

Ms. Pedula and her associates at the Center for Health Research, Kaiser Permanente Northwest in Portland, Ore., reviewed 10 years' worth of data from 22,110 pregnancies in 16,757 women. Hawaii was chosen for the study because of its ethnically diverse population (Ethn. Dis. 2009;19:414-9).

A total of 353 women had pre-existing diabetes. The remaining women underwent screening for GDM between 24 and 28 weeks of pregnancy, using the 50-gram, 1-hour glucose challenge test (GCT). Women with plasma glucose levels greater than 200 mg/dL on the GCT were deemed to have GDM and were not tested further. The remaining women with a GCT value greater than 140 mg/dL underwent the 100-gram, 3-hour oral glucose tolerance test.

Overall, 20.9% of the women had a positive GCT (plasma glucose at least 140 mg/dL). Approximately 4% had GDM based on the National Diabetes Data Group (NDDG) criteria, and 7% had GDM based on the Carpenter and Coustan (C&C) criteria.

After adjusting for age, the investigators found that 10% of the Korean women had GDM based on the C&C criteria, followed by 9.8% of Chinese women and 8.3% among Filipino women. The prevalence was lowest among African Americans (3.3%) and Caucasians (4.2%).

Based on the NDDG criteria, Puerto Rican women had the highest age-adjusted prevalence of GDM (7.4%), but this was barely higher than the average when C&C criteria were applied. However, Korean, Filipino, and Chinese women had the next highest prevalences of GDM, at 6.4%, 5.8%, and 5.6%, respectively, based on the NDDG criteria. Again, Caucasians and African Americans had the lowest prevalence of GDM, at 2.5% and 2.2%, respectively.

The study included women aged 13-39 years who gave birth in Hawaii between 1995 and 2003. The Asian population was divided into five subgroups: Korean, Chinese, Japanese, Vietnamese, and Filipino. Additional groups included Samoan, Puerto Rican, Native Hawaiian, Caucasian, African American, Native American, other Hispanic, and other Pacific Islander.

The results suggest that the risks for developing GDM may vary greatly depending on specific ethnic background. “These findings point to the need for further research along several avenues, such as maternal-child outcome differences and perhaps ethnic-specific guidelines for GDM diagnosis,” the researchers said.

Chinese women had a high gestational diabetes prevalence at 5.6%.

Source ©Thye Aun Ngo/Fotolia.com

Disclosures: The study was funded by the American Diabetes Association. Coauthor Dr. Teresa A. Hillier was funded by a 1-year ADA-European Association for the Study of Diabetes Trans-Atlantic Fellowship.

Women of Korean, Chinese, and Filipino descent are more than twice as likely to develop gestational diabetes as Caucasian or African American women, according to a data analysis of more than 16,000 pregnant women in Hawaii.

Gestational diabetes occurs in 4%-8% of all pregnant women, wrote Kathryn L. Pedula and her colleagues. Data from a pair of recent U.S. studies suggested that Asians have a higher prevalence of gestational diabetes mellitus (GDM) than do other ethnicities, but differences among subcategories of Asian populations have not been well studied.

Ms. Pedula and her associates at the Center for Health Research, Kaiser Permanente Northwest in Portland, Ore., reviewed 10 years' worth of data from 22,110 pregnancies in 16,757 women. Hawaii was chosen for the study because of its ethnically diverse population (Ethn. Dis. 2009;19:414-9).

A total of 353 women had pre-existing diabetes. The remaining women underwent screening for GDM between 24 and 28 weeks of pregnancy, using the 50-gram, 1-hour glucose challenge test (GCT). Women with plasma glucose levels greater than 200 mg/dL on the GCT were deemed to have GDM and were not tested further. The remaining women with a GCT value greater than 140 mg/dL underwent the 100-gram, 3-hour oral glucose tolerance test.

Overall, 20.9% of the women had a positive GCT (plasma glucose at least 140 mg/dL). Approximately 4% had GDM based on the National Diabetes Data Group (NDDG) criteria, and 7% had GDM based on the Carpenter and Coustan (C&C) criteria.

After adjusting for age, the investigators found that 10% of the Korean women had GDM based on the C&C criteria, followed by 9.8% of Chinese women and 8.3% among Filipino women. The prevalence was lowest among African Americans (3.3%) and Caucasians (4.2%).

Based on the NDDG criteria, Puerto Rican women had the highest age-adjusted prevalence of GDM (7.4%), but this was barely higher than the average when C&C criteria were applied. However, Korean, Filipino, and Chinese women had the next highest prevalences of GDM, at 6.4%, 5.8%, and 5.6%, respectively, based on the NDDG criteria. Again, Caucasians and African Americans had the lowest prevalence of GDM, at 2.5% and 2.2%, respectively.

The study included women aged 13-39 years who gave birth in Hawaii between 1995 and 2003. The Asian population was divided into five subgroups: Korean, Chinese, Japanese, Vietnamese, and Filipino. Additional groups included Samoan, Puerto Rican, Native Hawaiian, Caucasian, African American, Native American, other Hispanic, and other Pacific Islander.

The results suggest that the risks for developing GDM may vary greatly depending on specific ethnic background. “These findings point to the need for further research along several avenues, such as maternal-child outcome differences and perhaps ethnic-specific guidelines for GDM diagnosis,” the researchers said.

Chinese women had a high gestational diabetes prevalence at 5.6%.

Source ©Thye Aun Ngo/Fotolia.com

WASHINGTON — Obese women are less likely to be screened for osteoporosis than are normal- or overweight women, according to findings from a study of more than 140,000 women included in an integrated health care plan database.

Previous studies have shown mixed results on the disparity in preventive health care for obese patients, compared with normal-weight patients, said Kristi Reynolds, Ph.D., of Kaiser Permanente in Pasadena, Calif., and her colleagues.

“It is largely unknown whether obesity is associated with the quality of care for osteoporosis, which is both preventable and treatable but is often undiagnosed and untreated,” the researchers said. Physicians may be less inclined to screen obese women for osteoporosis because body weight is associated with higher bone density, they noted.

Data from 146,975 health care provider visits between July 1, 2007, and June 30, 2008, were reviewed.

The average age of the women was 73 years; 35% were normal weight; 35% were overweight; and 19%, 7%, and 4% fell into obesity categories I, II, and III, respectively. Normal-weight body mass index (BMI) was defined as 18.5-24.9 kg/m

About 67% of the women had undergone bone mineral density testing within 4 years of the study, which was the criteria by which participants could be considered “screened.” Only 52% of women with a BMI of 40 kg/m

After controlling for age, race, and income, the odds ratio of osteoporosis screening for overweight women was 0.99, while the odds ratios for women in obese classes I, II, and III groups were 0.90, 0.77, and 0.60, respectively. The findings were presented in a poster at the the annual meeting of the Obesity Society.

The results suggest that many overweight and obese women aren't screened for osteoporosis. However, more research is needed to examine the health outcomes of screened versus unscreened women, and the factors that influence providers to screen women according to BMI, the researchers said.

The researchers are employees of Kaiser Permanente. They reported having no financial conflicts of interest.

WASHINGTON — Obese women are less likely to be screened for osteoporosis than are normal- or overweight women, according to findings from a study of more than 140,000 women included in an integrated health care plan database.

Previous studies have shown mixed results on the disparity in preventive health care for obese patients, compared with normal-weight patients, said Kristi Reynolds, Ph.D., of Kaiser Permanente in Pasadena, Calif., and her colleagues.

“It is largely unknown whether obesity is associated with the quality of care for osteoporosis, which is both preventable and treatable but is often undiagnosed and untreated,” the researchers said. Physicians may be less inclined to screen obese women for osteoporosis because body weight is associated with higher bone density, they noted.

Data from 146,975 health care provider visits between July 1, 2007, and June 30, 2008, were reviewed.

The average age of the women was 73 years; 35% were normal weight; 35% were overweight; and 19%, 7%, and 4% fell into obesity categories I, II, and III, respectively. Normal-weight body mass index (BMI) was defined as 18.5-24.9 kg/m

About 67% of the women had undergone bone mineral density testing within 4 years of the study, which was the criteria by which participants could be considered “screened.” Only 52% of women with a BMI of 40 kg/m

After controlling for age, race, and income, the odds ratio of osteoporosis screening for overweight women was 0.99, while the odds ratios for women in obese classes I, II, and III groups were 0.90, 0.77, and 0.60, respectively. The findings were presented in a poster at the the annual meeting of the Obesity Society.

The results suggest that many overweight and obese women aren't screened for osteoporosis. However, more research is needed to examine the health outcomes of screened versus unscreened women, and the factors that influence providers to screen women according to BMI, the researchers said.

The researchers are employees of Kaiser Permanente. They reported having no financial conflicts of interest.

WASHINGTON — Obese women are less likely to be screened for osteoporosis than are normal- or overweight women, according to findings from a study of more than 140,000 women included in an integrated health care plan database.

Previous studies have shown mixed results on the disparity in preventive health care for obese patients, compared with normal-weight patients, said Kristi Reynolds, Ph.D., of Kaiser Permanente in Pasadena, Calif., and her colleagues.

“It is largely unknown whether obesity is associated with the quality of care for osteoporosis, which is both preventable and treatable but is often undiagnosed and untreated,” the researchers said. Physicians may be less inclined to screen obese women for osteoporosis because body weight is associated with higher bone density, they noted.

Data from 146,975 health care provider visits between July 1, 2007, and June 30, 2008, were reviewed.

The average age of the women was 73 years; 35% were normal weight; 35% were overweight; and 19%, 7%, and 4% fell into obesity categories I, II, and III, respectively. Normal-weight body mass index (BMI) was defined as 18.5-24.9 kg/m

About 67% of the women had undergone bone mineral density testing within 4 years of the study, which was the criteria by which participants could be considered “screened.” Only 52% of women with a BMI of 40 kg/m

After controlling for age, race, and income, the odds ratio of osteoporosis screening for overweight women was 0.99, while the odds ratios for women in obese classes I, II, and III groups were 0.90, 0.77, and 0.60, respectively. The findings were presented in a poster at the the annual meeting of the Obesity Society.

The results suggest that many overweight and obese women aren't screened for osteoporosis. However, more research is needed to examine the health outcomes of screened versus unscreened women, and the factors that influence providers to screen women according to BMI, the researchers said.

The researchers are employees of Kaiser Permanente. They reported having no financial conflicts of interest.

Approximately 1% of 8-year-old children in the United States meet criteria for an autism spectrum disorder, based on results of a nationwide study of 8-year-olds conducted in 2006.

“No single factor explains the change in prevalence,” said Catherine Rice, Ph.D., of the National Center on Birth Defects and Developmental Disabilities. Dr. Rice presented the study results in a telebriefing.

The study included health and education records from 11 communities throughout the United States participating in the Autism and Developmental Disabilities Network (ADDM). The project was funded by the Centers for Disease Control and Prevention. Dr. Rice and her colleagues at the CDC focused on 8-year-olds because most children with autism spectrum disorder (ASD) have been identified by this age. A team of clinicians reviewed the records to confirm ASD diagnoses and identified 2,757 children who met criteria for ASD (MMWR 2009;58[SS-10]:1–24).

The prevalence of ASD among 8-year-olds increased by an average of 57% between 2002 and 2006, based on data from 10 reporting communities that participated in the study in both years. This increase might be attributable to improved diagnostic techniques, but “a true increase in the risk for children to develop ASD symptoms cannot be ruled out,” the researchers said.

Increases in ASD occurred across sex, ethnicity, and cognitive function, but the most consistent pattern was the increase in ASD among boys, Dr. Rice said. Overall, the prevalence of ASD was 1 in 70 boys and 1 in 315 girls, which amounts to a four to five times higher prevalence in boys, compared with girls.

Dr. Rice advised all primary care physicians who suspect ASD in a child to refer the child for further diagnostic evaluation or intervention.

The researchers did not conduct in-person evaluations of each child, and the results were limited by variations in record keeping. The study was not designed to evaluate causes of ASD, but the findings suggest that more research is needed to determine how genetic and environmental factors interact to cause ASD spectrum symptoms, the researchers wrote.

Approximately 1% of 8-year-old children in the United States meet criteria for an autism spectrum disorder, based on results of a nationwide study of 8-year-olds conducted in 2006.

“No single factor explains the change in prevalence,” said Catherine Rice, Ph.D., of the National Center on Birth Defects and Developmental Disabilities. Dr. Rice presented the study results in a telebriefing.

The study included health and education records from 11 communities throughout the United States participating in the Autism and Developmental Disabilities Network (ADDM). The project was funded by the Centers for Disease Control and Prevention. Dr. Rice and her colleagues at the CDC focused on 8-year-olds because most children with autism spectrum disorder (ASD) have been identified by this age. A team of clinicians reviewed the records to confirm ASD diagnoses and identified 2,757 children who met criteria for ASD (MMWR 2009;58[SS-10]:1–24).

The prevalence of ASD among 8-year-olds increased by an average of 57% between 2002 and 2006, based on data from 10 reporting communities that participated in the study in both years. This increase might be attributable to improved diagnostic techniques, but “a true increase in the risk for children to develop ASD symptoms cannot be ruled out,” the researchers said.

Increases in ASD occurred across sex, ethnicity, and cognitive function, but the most consistent pattern was the increase in ASD among boys, Dr. Rice said. Overall, the prevalence of ASD was 1 in 70 boys and 1 in 315 girls, which amounts to a four to five times higher prevalence in boys, compared with girls.

Dr. Rice advised all primary care physicians who suspect ASD in a child to refer the child for further diagnostic evaluation or intervention.

The researchers did not conduct in-person evaluations of each child, and the results were limited by variations in record keeping. The study was not designed to evaluate causes of ASD, but the findings suggest that more research is needed to determine how genetic and environmental factors interact to cause ASD spectrum symptoms, the researchers wrote.

Approximately 1% of 8-year-old children in the United States meet criteria for an autism spectrum disorder, based on results of a nationwide study of 8-year-olds conducted in 2006.

“No single factor explains the change in prevalence,” said Catherine Rice, Ph.D., of the National Center on Birth Defects and Developmental Disabilities. Dr. Rice presented the study results in a telebriefing.

The study included health and education records from 11 communities throughout the United States participating in the Autism and Developmental Disabilities Network (ADDM). The project was funded by the Centers for Disease Control and Prevention. Dr. Rice and her colleagues at the CDC focused on 8-year-olds because most children with autism spectrum disorder (ASD) have been identified by this age. A team of clinicians reviewed the records to confirm ASD diagnoses and identified 2,757 children who met criteria for ASD (MMWR 2009;58[SS-10]:1–24).

The prevalence of ASD among 8-year-olds increased by an average of 57% between 2002 and 2006, based on data from 10 reporting communities that participated in the study in both years. This increase might be attributable to improved diagnostic techniques, but “a true increase in the risk for children to develop ASD symptoms cannot be ruled out,” the researchers said.

Increases in ASD occurred across sex, ethnicity, and cognitive function, but the most consistent pattern was the increase in ASD among boys, Dr. Rice said. Overall, the prevalence of ASD was 1 in 70 boys and 1 in 315 girls, which amounts to a four to five times higher prevalence in boys, compared with girls.

Dr. Rice advised all primary care physicians who suspect ASD in a child to refer the child for further diagnostic evaluation or intervention.

The researchers did not conduct in-person evaluations of each child, and the results were limited by variations in record keeping. The study was not designed to evaluate causes of ASD, but the findings suggest that more research is needed to determine how genetic and environmental factors interact to cause ASD spectrum symptoms, the researchers wrote.

The pandemic influenza A(H1N1) virus does not appear to spread among an infected person's household contacts as easily as viruses in past pandemics, according to an analysis of data collected in the United States.

Simon Cauchemez, Ph.D., of Imperial College, London, and colleagues reviewed information on the H1N1 infection in 216 households; in total, the virus was transmitted from 216 index patients to 600 household contacts. The median age of the index patient was 15 years, and each household had two to six members. Data were collected by the Centers for Disease Control and Prevention.

Overall, 78 (13%) of the 600 household contacts developed acute respiratory illness and 60 (10%) developed an influenzalike illness.

In 156 households (72%), no household contacts developed acute respiratory illness. In 46 households (21%), one household contact developed acute respiratory illness, and in 14 households (6%), more than one contact developed acute respiratory illness. These secondary cases were not systematically confirmed as H1N1 illness (N. Engl. J. Med. 2009;361:2619–27).

In the secondary cases of possible H1N1 influenza, household contacts who were aged 18 years and younger were about twice as likely to develop either acute respiratory illness or flulike illness, compared with household contacts aged 19 years and older. The median age of the household contacts was 26 years, but the median age of contacts with acute respiratory illness was 16.5 years and the median age of contacts with flulike illness was 14.5 years.

The average time between the onset of illness in an index patient and the onset of illness in one of his or her household contacts was 2.6 days.

The estimates of transmissibility in households were lower than those seen in previous pandemics, but they were similar to transmissibility data from the early phase of the H1N1 pandemic in Mexico. No specific symptom was associated with increased transmission of illness, and the findings showed no link between increased transmission of illness and the index patient's age, the researchers noted.

The findings were limited by several factors, including a lack of data about antiviral therapy in household contacts.

Dr. Cauchemez has received consulting fees from Sanofi Pasteur. The study was supported in part by grants from several organizations including the Medical Research Council and the Bill and Melinda Gates Foundation.

The pandemic influenza A(H1N1) virus does not appear to spread among an infected person's household contacts as easily as viruses in past pandemics, according to an analysis of data collected in the United States.

Simon Cauchemez, Ph.D., of Imperial College, London, and colleagues reviewed information on the H1N1 infection in 216 households; in total, the virus was transmitted from 216 index patients to 600 household contacts. The median age of the index patient was 15 years, and each household had two to six members. Data were collected by the Centers for Disease Control and Prevention.

Overall, 78 (13%) of the 600 household contacts developed acute respiratory illness and 60 (10%) developed an influenzalike illness.

In 156 households (72%), no household contacts developed acute respiratory illness. In 46 households (21%), one household contact developed acute respiratory illness, and in 14 households (6%), more than one contact developed acute respiratory illness. These secondary cases were not systematically confirmed as H1N1 illness (N. Engl. J. Med. 2009;361:2619–27).

In the secondary cases of possible H1N1 influenza, household contacts who were aged 18 years and younger were about twice as likely to develop either acute respiratory illness or flulike illness, compared with household contacts aged 19 years and older. The median age of the household contacts was 26 years, but the median age of contacts with acute respiratory illness was 16.5 years and the median age of contacts with flulike illness was 14.5 years.

The average time between the onset of illness in an index patient and the onset of illness in one of his or her household contacts was 2.6 days.

The estimates of transmissibility in households were lower than those seen in previous pandemics, but they were similar to transmissibility data from the early phase of the H1N1 pandemic in Mexico. No specific symptom was associated with increased transmission of illness, and the findings showed no link between increased transmission of illness and the index patient's age, the researchers noted.

The findings were limited by several factors, including a lack of data about antiviral therapy in household contacts.

Dr. Cauchemez has received consulting fees from Sanofi Pasteur. The study was supported in part by grants from several organizations including the Medical Research Council and the Bill and Melinda Gates Foundation.

The pandemic influenza A(H1N1) virus does not appear to spread among an infected person's household contacts as easily as viruses in past pandemics, according to an analysis of data collected in the United States.

Simon Cauchemez, Ph.D., of Imperial College, London, and colleagues reviewed information on the H1N1 infection in 216 households; in total, the virus was transmitted from 216 index patients to 600 household contacts. The median age of the index patient was 15 years, and each household had two to six members. Data were collected by the Centers for Disease Control and Prevention.

Overall, 78 (13%) of the 600 household contacts developed acute respiratory illness and 60 (10%) developed an influenzalike illness.

In 156 households (72%), no household contacts developed acute respiratory illness. In 46 households (21%), one household contact developed acute respiratory illness, and in 14 households (6%), more than one contact developed acute respiratory illness. These secondary cases were not systematically confirmed as H1N1 illness (N. Engl. J. Med. 2009;361:2619–27).

In the secondary cases of possible H1N1 influenza, household contacts who were aged 18 years and younger were about twice as likely to develop either acute respiratory illness or flulike illness, compared with household contacts aged 19 years and older. The median age of the household contacts was 26 years, but the median age of contacts with acute respiratory illness was 16.5 years and the median age of contacts with flulike illness was 14.5 years.

The average time between the onset of illness in an index patient and the onset of illness in one of his or her household contacts was 2.6 days.

The estimates of transmissibility in households were lower than those seen in previous pandemics, but they were similar to transmissibility data from the early phase of the H1N1 pandemic in Mexico. No specific symptom was associated with increased transmission of illness, and the findings showed no link between increased transmission of illness and the index patient's age, the researchers noted.

The findings were limited by several factors, including a lack of data about antiviral therapy in household contacts.

Dr. Cauchemez has received consulting fees from Sanofi Pasteur. The study was supported in part by grants from several organizations including the Medical Research Council and the Bill and Melinda Gates Foundation.

BOSTON — Initial serum lactate measurements are not reliable predictors of major injuries in children with severe blunt trauma, based on data from a prospective study of 200 children in a university pediatric emergency department.

Serum lactate levels are often used to measure tissue hypoperfusion in adult sepsis patients and in trauma patients who don't show signs of shock. “Elevated blood lactate reflects anaerobic metabolism due to hypoperfusion,” Dr. Antonio E. Muniz said at the annual meeting of the American Academy of Emergency Physicians.

Dr. Muniz of the University of Texas Health Sciences Center at Houston reviewed serum lactate levels in children aged 2–18 who had suffered blunt trauma. Serum lactate levels were elevated in 56 (28%) of the children. For predicting the 102 major injuries, the sensitivity of elevated lactate was 47% and the specificity was 86%, suggesting that initial levels of serum lactate are not helpful, he noted. The positive predictive value was 71%, and the negative predictive value was 68%.

Extremity fractures accounted for about 25% of the major injuries. Other types of major injuries included facial fracture, pelvic fracture, liver laceration, and spleen laceration. Most of the blunt trauma injuries were caused by motor vehicle accidents (152 children), followed by being hit by a car (24 children), falls (12 children), bicycle accidents (8 children), and gunshot wounds (4 children).

Data from other studies suggest that measuring serum lactate at later intervals after blunt trauma might be useful for assessing injuries, Dr. Muniz noted. He had no financial conflicts to disclose.

BOSTON — Initial serum lactate measurements are not reliable predictors of major injuries in children with severe blunt trauma, based on data from a prospective study of 200 children in a university pediatric emergency department.

Serum lactate levels are often used to measure tissue hypoperfusion in adult sepsis patients and in trauma patients who don't show signs of shock. “Elevated blood lactate reflects anaerobic metabolism due to hypoperfusion,” Dr. Antonio E. Muniz said at the annual meeting of the American Academy of Emergency Physicians.

Dr. Muniz of the University of Texas Health Sciences Center at Houston reviewed serum lactate levels in children aged 2–18 who had suffered blunt trauma. Serum lactate levels were elevated in 56 (28%) of the children. For predicting the 102 major injuries, the sensitivity of elevated lactate was 47% and the specificity was 86%, suggesting that initial levels of serum lactate are not helpful, he noted. The positive predictive value was 71%, and the negative predictive value was 68%.

Extremity fractures accounted for about 25% of the major injuries. Other types of major injuries included facial fracture, pelvic fracture, liver laceration, and spleen laceration. Most of the blunt trauma injuries were caused by motor vehicle accidents (152 children), followed by being hit by a car (24 children), falls (12 children), bicycle accidents (8 children), and gunshot wounds (4 children).

Data from other studies suggest that measuring serum lactate at later intervals after blunt trauma might be useful for assessing injuries, Dr. Muniz noted. He had no financial conflicts to disclose.

BOSTON — Initial serum lactate measurements are not reliable predictors of major injuries in children with severe blunt trauma, based on data from a prospective study of 200 children in a university pediatric emergency department.

Serum lactate levels are often used to measure tissue hypoperfusion in adult sepsis patients and in trauma patients who don't show signs of shock. “Elevated blood lactate reflects anaerobic metabolism due to hypoperfusion,” Dr. Antonio E. Muniz said at the annual meeting of the American Academy of Emergency Physicians.

Dr. Muniz of the University of Texas Health Sciences Center at Houston reviewed serum lactate levels in children aged 2–18 who had suffered blunt trauma. Serum lactate levels were elevated in 56 (28%) of the children. For predicting the 102 major injuries, the sensitivity of elevated lactate was 47% and the specificity was 86%, suggesting that initial levels of serum lactate are not helpful, he noted. The positive predictive value was 71%, and the negative predictive value was 68%.

Extremity fractures accounted for about 25% of the major injuries. Other types of major injuries included facial fracture, pelvic fracture, liver laceration, and spleen laceration. Most of the blunt trauma injuries were caused by motor vehicle accidents (152 children), followed by being hit by a car (24 children), falls (12 children), bicycle accidents (8 children), and gunshot wounds (4 children).

Data from other studies suggest that measuring serum lactate at later intervals after blunt trauma might be useful for assessing injuries, Dr. Muniz noted. He had no financial conflicts to disclose.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials that were presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the Food and Drug Administration. If approved, they will provide additional options for the treatment of obesity.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a phase III, double-blind trial of 1,496 adults with an average age of 44 years and an average body mass index of 36 kg/m

The study involved Orexigen Therapeutics Inc.'s combination naltrexone SR/bupropion SR combination therapy (Contrave).

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were rerandomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48).

“This was a chance to see if there was a higher dose needed,” Dr. Apovian said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

Patients in the treatment group reported significant decreases in food cravings compared with baseline, she said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation because of adverse events was low. Nausea, the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” Dr. Apovian said.

The combination drug seemed to be well tolerated, and the safety profile was consistent with previous data on the two drugs when used separately, she added.

Dr. Apovian is on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Eli Lilly & Co. and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University in Cambridge, Mass., presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects that are associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients aged 18-65 years for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center in Boston.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively.

The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients.

Patients with FDA-defined valvulopathy were included in the study, and the lorcaserin was not associated with increased valvulopathy during the study, Dr. Kaplan added.

Dr. Kaplan has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

Lorcaserin has not yet been approved by the FDA.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials that were presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the Food and Drug Administration. If approved, they will provide additional options for the treatment of obesity.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a phase III, double-blind trial of 1,496 adults with an average age of 44 years and an average body mass index of 36 kg/m

The study involved Orexigen Therapeutics Inc.'s combination naltrexone SR/bupropion SR combination therapy (Contrave).

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were rerandomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48).

“This was a chance to see if there was a higher dose needed,” Dr. Apovian said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

Patients in the treatment group reported significant decreases in food cravings compared with baseline, she said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation because of adverse events was low. Nausea, the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” Dr. Apovian said.

The combination drug seemed to be well tolerated, and the safety profile was consistent with previous data on the two drugs when used separately, she added.

Dr. Apovian is on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Eli Lilly & Co. and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University in Cambridge, Mass., presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects that are associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients aged 18-65 years for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center in Boston.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively.

The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients.

Patients with FDA-defined valvulopathy were included in the study, and the lorcaserin was not associated with increased valvulopathy during the study, Dr. Kaplan added.

Dr. Kaplan has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

Lorcaserin has not yet been approved by the FDA.

WASHINGTON — Two novel weight loss drugs led to significant losses in overweight and obese adults, according to the findings from two phase III, placebo-controlled trials that were presented at the annual meeting of the Obesity Society.

The drugs are not yet approved by the Food and Drug Administration. If approved, they will provide additional options for the treatment of obesity.

In one study, Dr. Caroline Apovian of Boston University Medical Center presented results of the Contrave Obesity Research II (COR-II) study, a phase III, double-blind trial of 1,496 adults with an average age of 44 years and an average body mass index of 36 kg/m

The study involved Orexigen Therapeutics Inc.'s combination naltrexone SR/bupropion SR combination therapy (Contrave).

Participants were randomized to a single daily oral dose of the combination drug NB32 (32 mg naltrexone/360 mg bupropion) or a placebo.

After 28 weeks, 56% of the treatment group participants achieved at least a 5% weight loss—the study's primary outcome measure—compared with 18% of the placebo group. A 10% weight loss was achieved by 27% of the treatment group and 7% of the placebo group; 15% loss was achieved by 10% and 2% of the groups, respectively. Baseline demographics were similar between the treatment and placebo groups.

After 28 weeks, participants were rerandomized to a combination drug including 48 mg naltrexone and 360 mg bupropion (NB48).

“This was a chance to see if there was a higher dose needed,” Dr. Apovian said, but at 56 weeks, there was no significant change in weight loss with NB48 compared with NB32.

Patients in the treatment group reported significant decreases in food cravings compared with baseline, she said.

Approximately half of the patients in the drug and placebo groups discontinued the study, but discontinuation because of adverse events was low. Nausea, the most common adverse event, was mild or moderate in most cases, “and occurred mostly in the first 4 weeks,” Dr. Apovian said.

The combination drug seemed to be well tolerated, and the safety profile was consistent with previous data on the two drugs when used separately, she added.

Dr. Apovian is on the advisory board of Orexigen and has received financial support from other pharmaceutical companies, including Eli Lilly & Co. and Amgen. Orexigen intends to submit the drug for FDA approval in the first half of 2010, according to a company statement.

Dr. Lee Kaplan of Harvard University in Cambridge, Mass., presented results of a study of lorcaserin, a selective 5HT2C agonist designed to promote weight loss without the cardiovascular side effects that are associated with nonspecific 5HT agonists.

The randomized, double-blind, placebo-controlled phase III study enrolled 4,008 patients aged 18-65 years for 52 weeks. The study involved patients with a BMI of 27-45 kg/m

Overall, the intent-to-treat analysis showed that a 5% weight loss was achieved by 47% of participants who took 10 mg lorcaserin twice daily, by 40% of those who took 10 mg lorcaserin once daily, and by 25% of those who took a placebo, said Dr. Kaplan, who is also director of the Massachusetts General Hospital weight center in Boston.

Patients in the twice-daily, once-daily, and placebo groups who completed the study according to the protocol lost an average of 7.7 kg, 6.5 kg, and 3.9 kg, respectively.

The most common adverse events were headache, fatigue, dizziness, and nausea, each of which occurred in less than 5% of patients.

Patients with FDA-defined valvulopathy were included in the study, and the lorcaserin was not associated with increased valvulopathy during the study, Dr. Kaplan added.

Dr. Kaplan has received financial support from lorcaserin's manufacturer, Arena Pharmaceuticals, among other pharmaceutical companies.

Lorcaserin has not yet been approved by the FDA.

WASHINGTON — Obese women are less likely to be screened for osteoporosis than are normal- or overweight women, according to a study of more than 140,000 patients in an integrated health care plan database.

Previous studies showed mixed results on the disparity in preventive health care for obese patients, compared with normal-weight patients, said Kristi Reynolds, Ph.D., and colleagues, of Kaiser Permanente, Pasadena, Calif.

“It is largely unknown whether obesity is associated with the quality of care for osteoporosis, which is both preventable and treatable but is often undiagnosed and untreated,” the researchers said. Physicians may be less inclined to screen obese women for osteoporosis because body weight is associated with higher bone density, they noted.

Data from 146,975 health care provider visits between July 1, 2007, and June 30, 2008, were reviewed.

Average age was 73 years; 35% were normal weight; 35% were overweight; and 19%, 7%, and 4% fell into obesity categories I, II, and III, respectively. Normal weight body mass index was defined as 18.5-24.9 kg/m

About 67% of the women had undergone bone mineral density testing within 4 years of the study, the criteria by which participants were considered “screened.” Only 52% of women with a BMI of 40 kg/m

After adjustment for age, race, and income, the odds ratio of osteoporosis screening for overweight women was 0.99, while the ratios for women in obese classes I, II, and III were 0.90, 0.77, and 0.60, respectively. The findings were presented in a poster at the the annual meeting of the Obesity Society.

The results suggest that many overweight and obese women aren't screened for osteoporosis, said the researchers, who reported having no conflicts of interest.

WASHINGTON — Obese women are less likely to be screened for osteoporosis than are normal- or overweight women, according to a study of more than 140,000 patients in an integrated health care plan database.

Previous studies showed mixed results on the disparity in preventive health care for obese patients, compared with normal-weight patients, said Kristi Reynolds, Ph.D., and colleagues, of Kaiser Permanente, Pasadena, Calif.

“It is largely unknown whether obesity is associated with the quality of care for osteoporosis, which is both preventable and treatable but is often undiagnosed and untreated,” the researchers said. Physicians may be less inclined to screen obese women for osteoporosis because body weight is associated with higher bone density, they noted.

Data from 146,975 health care provider visits between July 1, 2007, and June 30, 2008, were reviewed.

Average age was 73 years; 35% were normal weight; 35% were overweight; and 19%, 7%, and 4% fell into obesity categories I, II, and III, respectively. Normal weight body mass index was defined as 18.5-24.9 kg/m

About 67% of the women had undergone bone mineral density testing within 4 years of the study, the criteria by which participants were considered “screened.” Only 52% of women with a BMI of 40 kg/m

After adjustment for age, race, and income, the odds ratio of osteoporosis screening for overweight women was 0.99, while the ratios for women in obese classes I, II, and III were 0.90, 0.77, and 0.60, respectively. The findings were presented in a poster at the the annual meeting of the Obesity Society.

The results suggest that many overweight and obese women aren't screened for osteoporosis, said the researchers, who reported having no conflicts of interest.

WASHINGTON — Obese women are less likely to be screened for osteoporosis than are normal- or overweight women, according to a study of more than 140,000 patients in an integrated health care plan database.

Previous studies showed mixed results on the disparity in preventive health care for obese patients, compared with normal-weight patients, said Kristi Reynolds, Ph.D., and colleagues, of Kaiser Permanente, Pasadena, Calif.

“It is largely unknown whether obesity is associated with the quality of care for osteoporosis, which is both preventable and treatable but is often undiagnosed and untreated,” the researchers said. Physicians may be less inclined to screen obese women for osteoporosis because body weight is associated with higher bone density, they noted.

Data from 146,975 health care provider visits between July 1, 2007, and June 30, 2008, were reviewed.

Average age was 73 years; 35% were normal weight; 35% were overweight; and 19%, 7%, and 4% fell into obesity categories I, II, and III, respectively. Normal weight body mass index was defined as 18.5-24.9 kg/m

About 67% of the women had undergone bone mineral density testing within 4 years of the study, the criteria by which participants were considered “screened.” Only 52% of women with a BMI of 40 kg/m

After adjustment for age, race, and income, the odds ratio of osteoporosis screening for overweight women was 0.99, while the ratios for women in obese classes I, II, and III were 0.90, 0.77, and 0.60, respectively. The findings were presented in a poster at the the annual meeting of the Obesity Society.

The results suggest that many overweight and obese women aren't screened for osteoporosis, said the researchers, who reported having no conflicts of interest.

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9-26 years. ACIP made the recommendation at its annual fall meeting

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18. But unlike the quadrivalent vaccine (Merck & Co.'s Gardasil), the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations for the use of the bivalent vaccine.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate. Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference. The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable. The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11-12 years and recommended second and third doses at 1-2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses.

Unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC.

Source Parker Smith/Elsevier Global Medical News

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9-26 years. ACIP made the recommendation at its annual fall meeting

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18. But unlike the quadrivalent vaccine (Merck & Co.'s Gardasil), the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations for the use of the bivalent vaccine.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate. Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference. The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable. The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11-12 years and recommended second and third doses at 1-2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses.

Unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC.

Source Parker Smith/Elsevier Global Medical News

ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommended a bivalent human papillomavirus vaccine as an alternative to the quadrivalent vaccine for the prevention of cervical cancer and related precancerous conditions in women and girls aged 9-26 years. ACIP made the recommendation at its annual fall meeting

The bivalent human papillomavirus (HPV) vaccine (GlaxoSmithKline's Cervarix) was recently approved by the Food and Drug Administration. The vaccine provides clinicians with another option to vaccinate adolescent girls and young women against diseases caused by HPV types 16 and 18. But unlike the quadrivalent vaccine (Merck & Co.'s Gardasil), the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC, who presented the ACIP recommendations for the use of the bivalent vaccine.

ACIP recommended against a statement of no preference between the bivalent and quadrivalent vaccines after a lively debate. Instead, the recommendations will present the information about the two vaccines without a statement of preference or a statement of nonpreference. The recommendations state that the two vaccines can be used interchangeably to complete the three-dose series, but that using the same vaccine for the entire series is preferable. The bivalent vaccine, like the quadrivalent vaccine, is not a live vaccine, and it can be given simultaneously with other vaccines.

ACIP also voted to harmonize the age ranges for the two vaccines, with first doses given at ages 11-12 years and recommended second and third doses at 1-2 months and 6 months after the first dose. The recommended minimum dosing intervals remained as 4 weeks between the first and second dose and 12 weeks between the second and third doses.

Unlike the quadrivalent vaccine, the bivalent vaccine is not designed to protect against genital warts, noted Dr. Lauri Markowitz of the CDC.

Source Parker Smith/Elsevier Global Medical News