Sherry Boschert

SAN DIEGO – A year of using the experimental drug ospemifene for vulvar and vaginal atrophy produced no clinically significant estrogenic or adverse endometrial effects, compared with placebo in a study of 180 women.

Patients from an initial 12-week efficacy and safety study at 51 sites continued on the same blinded courses of 30 mg or 60 mg of ospemifene or placebo daily for up to 52 weeks in the long-term safety extension study.

After a year, endometrial thickness decreased slightly in the placebo group and increased slightly in the ospemifene groups by approximately 1 mm on average, Dr. Steven R. Goldstein and his associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

Endometrial biopsies in the 30-mg ospemifene group after 1 year showed atrophic, inactive, or insufficient endometrial tissue in approximately 95% of patients; weakly proliferative tissue in 2%; and atypical epithelial proliferation in 2%. In the 60-mg ospemifene group, 96% had atrophic, inactive, or insufficient endometrial tissue; 2% had weakly proliferative tissue; and 2% showed atrophic-type polyps. All biopsies in the placebo group showed atrophic, inactive, or insufficient endometrial tissue, said Dr. Goldstein, professor of ob.gyn. at New York University Langone Medical Center.

The category of "weakly proliferative" basically represents inactive atrophic endometrium with a few mitotic figures, and can be considered clinically to be in a category with atrophic, inactive, or insufficient tissue, he said.

Two patients in the 30-mg group and one in the 60-mg group developed vaginal bleeding or spotting. One had intermittent spotting, one had 2 days of bleeding, and the third had 4 days of bleeding. Endometrial biopsy results for all three were reported as atrophic.

The patients had no endometrial pathology at baseline biopsy. Forty patients discontinued treatment before 1 year, including 17% of the 60-mg group, 21% of the 30-mg group, and 31% of the placebo group, usually because of withdrawal of patient consent to continue. "This probably represents people who were upset with failure of efficacy" on placebo or low-dose ospemifene, he said.

There were no cases of endometrial hyperplasia or carcinoma. Although 2% of endometrial biopsy results were proliferative in the drug treatment groups, "the overwhelming majority of all endometrial tissue was atrophic or inactive," Dr. Goldstein said.

The findings echo results from a similar previous study in Europe that also found minimal endometrial impact – a 2% incidence of proliferative endometrium after 1 year, he noted (Menopause 2010;17:642-53).

Ospemifene is an investigational selective estrogen-receptor modulator (SERM). The incidence of proliferation with ospemifene (2%) compares favorably with a 3% rate of proliferation seen after 1 year in studies of raloxifene, another SERM, he said.

Only estrogens are approved in the United States for the treatment of moderate to severe vulvar or vaginal atrophy. The package insert for one clinically available low-dose estrogen vaginal tablet (Vagifem 10 mcg) lists the incidences of endometrial carcinoma and complex hyperplasia as approximately 1% each, he said.

Different SERMs have been shown to have different effects on the endometrium. Previous studies have reported estrogenic action in the vaginal epithelium from ospemifene use, prompting the current study.

Dr. Goldstein reported financial associations with Shionogi, which has applied for Food and Drug Administration approval for ospemifene, and with Amgen, Bayer, Cook Ob.Gyn., Eli Lilly, Novo Nordisk, Merck, Pfizer, Philips Ultrasound, and Warner Chilcott.

SAN DIEGO – A year of using the experimental drug ospemifene for vulvar and vaginal atrophy produced no clinically significant estrogenic or adverse endometrial effects, compared with placebo in a study of 180 women.

Patients from an initial 12-week efficacy and safety study at 51 sites continued on the same blinded courses of 30 mg or 60 mg of ospemifene or placebo daily for up to 52 weeks in the long-term safety extension study.

After a year, endometrial thickness decreased slightly in the placebo group and increased slightly in the ospemifene groups by approximately 1 mm on average, Dr. Steven R. Goldstein and his associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

Endometrial biopsies in the 30-mg ospemifene group after 1 year showed atrophic, inactive, or insufficient endometrial tissue in approximately 95% of patients; weakly proliferative tissue in 2%; and atypical epithelial proliferation in 2%. In the 60-mg ospemifene group, 96% had atrophic, inactive, or insufficient endometrial tissue; 2% had weakly proliferative tissue; and 2% showed atrophic-type polyps. All biopsies in the placebo group showed atrophic, inactive, or insufficient endometrial tissue, said Dr. Goldstein, professor of ob.gyn. at New York University Langone Medical Center.

The category of "weakly proliferative" basically represents inactive atrophic endometrium with a few mitotic figures, and can be considered clinically to be in a category with atrophic, inactive, or insufficient tissue, he said.

Two patients in the 30-mg group and one in the 60-mg group developed vaginal bleeding or spotting. One had intermittent spotting, one had 2 days of bleeding, and the third had 4 days of bleeding. Endometrial biopsy results for all three were reported as atrophic.

The patients had no endometrial pathology at baseline biopsy. Forty patients discontinued treatment before 1 year, including 17% of the 60-mg group, 21% of the 30-mg group, and 31% of the placebo group, usually because of withdrawal of patient consent to continue. "This probably represents people who were upset with failure of efficacy" on placebo or low-dose ospemifene, he said.

There were no cases of endometrial hyperplasia or carcinoma. Although 2% of endometrial biopsy results were proliferative in the drug treatment groups, "the overwhelming majority of all endometrial tissue was atrophic or inactive," Dr. Goldstein said.

The findings echo results from a similar previous study in Europe that also found minimal endometrial impact – a 2% incidence of proliferative endometrium after 1 year, he noted (Menopause 2010;17:642-53).

Ospemifene is an investigational selective estrogen-receptor modulator (SERM). The incidence of proliferation with ospemifene (2%) compares favorably with a 3% rate of proliferation seen after 1 year in studies of raloxifene, another SERM, he said.

Only estrogens are approved in the United States for the treatment of moderate to severe vulvar or vaginal atrophy. The package insert for one clinically available low-dose estrogen vaginal tablet (Vagifem 10 mcg) lists the incidences of endometrial carcinoma and complex hyperplasia as approximately 1% each, he said.

Different SERMs have been shown to have different effects on the endometrium. Previous studies have reported estrogenic action in the vaginal epithelium from ospemifene use, prompting the current study.

Dr. Goldstein reported financial associations with Shionogi, which has applied for Food and Drug Administration approval for ospemifene, and with Amgen, Bayer, Cook Ob.Gyn., Eli Lilly, Novo Nordisk, Merck, Pfizer, Philips Ultrasound, and Warner Chilcott.

SAN DIEGO – A year of using the experimental drug ospemifene for vulvar and vaginal atrophy produced no clinically significant estrogenic or adverse endometrial effects, compared with placebo in a study of 180 women.

Patients from an initial 12-week efficacy and safety study at 51 sites continued on the same blinded courses of 30 mg or 60 mg of ospemifene or placebo daily for up to 52 weeks in the long-term safety extension study.

After a year, endometrial thickness decreased slightly in the placebo group and increased slightly in the ospemifene groups by approximately 1 mm on average, Dr. Steven R. Goldstein and his associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

Endometrial biopsies in the 30-mg ospemifene group after 1 year showed atrophic, inactive, or insufficient endometrial tissue in approximately 95% of patients; weakly proliferative tissue in 2%; and atypical epithelial proliferation in 2%. In the 60-mg ospemifene group, 96% had atrophic, inactive, or insufficient endometrial tissue; 2% had weakly proliferative tissue; and 2% showed atrophic-type polyps. All biopsies in the placebo group showed atrophic, inactive, or insufficient endometrial tissue, said Dr. Goldstein, professor of ob.gyn. at New York University Langone Medical Center.

The category of "weakly proliferative" basically represents inactive atrophic endometrium with a few mitotic figures, and can be considered clinically to be in a category with atrophic, inactive, or insufficient tissue, he said.

Two patients in the 30-mg group and one in the 60-mg group developed vaginal bleeding or spotting. One had intermittent spotting, one had 2 days of bleeding, and the third had 4 days of bleeding. Endometrial biopsy results for all three were reported as atrophic.

The patients had no endometrial pathology at baseline biopsy. Forty patients discontinued treatment before 1 year, including 17% of the 60-mg group, 21% of the 30-mg group, and 31% of the placebo group, usually because of withdrawal of patient consent to continue. "This probably represents people who were upset with failure of efficacy" on placebo or low-dose ospemifene, he said.

There were no cases of endometrial hyperplasia or carcinoma. Although 2% of endometrial biopsy results were proliferative in the drug treatment groups, "the overwhelming majority of all endometrial tissue was atrophic or inactive," Dr. Goldstein said.

The findings echo results from a similar previous study in Europe that also found minimal endometrial impact – a 2% incidence of proliferative endometrium after 1 year, he noted (Menopause 2010;17:642-53).

Ospemifene is an investigational selective estrogen-receptor modulator (SERM). The incidence of proliferation with ospemifene (2%) compares favorably with a 3% rate of proliferation seen after 1 year in studies of raloxifene, another SERM, he said.

Only estrogens are approved in the United States for the treatment of moderate to severe vulvar or vaginal atrophy. The package insert for one clinically available low-dose estrogen vaginal tablet (Vagifem 10 mcg) lists the incidences of endometrial carcinoma and complex hyperplasia as approximately 1% each, he said.

Different SERMs have been shown to have different effects on the endometrium. Previous studies have reported estrogenic action in the vaginal epithelium from ospemifene use, prompting the current study.

Dr. Goldstein reported financial associations with Shionogi, which has applied for Food and Drug Administration approval for ospemifene, and with Amgen, Bayer, Cook Ob.Gyn., Eli Lilly, Novo Nordisk, Merck, Pfizer, Philips Ultrasound, and Warner Chilcott.

SAN DIEGO – Biometric findings on third-trimester ultrasound predicted increased risk for shoulder dystocia at term in a chart review of 132 pregnancies in women without diabetes.

The risk of shoulder dystocia doubled with every unit deviation from the mean for the ratio of femur length to head circumference and the ratio of head circumference to abdominal circumference, Dr. Stephanie M. Melka and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Other factors that independently predicted a statistically significant 4%-17% increased risk for shoulder dystocia at term included estimated fetal weight, femur length, abdominal circumference, and the ratio of femur length to biparietal diameter, reported Dr. Melka of Mount Sinai School of Medicine, New York.

The only standard measurements and ratios on prenatal ultrasound that were not significantly associated with increased risk for shoulder dystocia were head circumference and the ratio of femur length to abdominal circumference.

Several previous studies have shown that prenatal sonographic findings can predict shoulder dystocia at term in diabetic mothers, but this appears to be the first study of elective third-trimester sonography in low-risk nondiabetic women, the investigators noted.

The study identified 44 cases of shoulder dystocia during vaginal delivery at Mount Sinai in 2008-2009 in which the mothers underwent ultrasound examination early in the third trimester prior to 37 weeks. Each case was matched with two women who had a third-trimester ultrasound on the same day, for a total of 88 women in the control group.

The ratio of femur length to head circumference averaged 21 in the control group and 21.6 in the shoulder dystocia group. The ratio of head circumference to abdominal circumference averaged 1.05 in the control group and 1 in the dystocia group.

Biometric measurements and estimated fetal weight ascertained from third-trimester prenatal ultrasound can be used to counsel mothers on the risk for shoulder dystocia, the investigators concluded.

Other, classic risk factors for shoulder dystocia include maternal diabetes, obesity, a history of shoulder dystocia, and excessive weight gain during pregnancy.

The study did not control for the effects of obesity or weight gain on the risk for shoulder dystocia. It also did not assess the influence of differences in gestational age at the time of the sonograms.

Shoulder dystocia occurs in approximately 1% of all deliveries. Half of cases have been thought to be unpredictable.

Dr. Melka reported having no relevant financial disclosures.

SAN DIEGO – Biometric findings on third-trimester ultrasound predicted increased risk for shoulder dystocia at term in a chart review of 132 pregnancies in women without diabetes.

The risk of shoulder dystocia doubled with every unit deviation from the mean for the ratio of femur length to head circumference and the ratio of head circumference to abdominal circumference, Dr. Stephanie M. Melka and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Other factors that independently predicted a statistically significant 4%-17% increased risk for shoulder dystocia at term included estimated fetal weight, femur length, abdominal circumference, and the ratio of femur length to biparietal diameter, reported Dr. Melka of Mount Sinai School of Medicine, New York.

The only standard measurements and ratios on prenatal ultrasound that were not significantly associated with increased risk for shoulder dystocia were head circumference and the ratio of femur length to abdominal circumference.

Several previous studies have shown that prenatal sonographic findings can predict shoulder dystocia at term in diabetic mothers, but this appears to be the first study of elective third-trimester sonography in low-risk nondiabetic women, the investigators noted.

The study identified 44 cases of shoulder dystocia during vaginal delivery at Mount Sinai in 2008-2009 in which the mothers underwent ultrasound examination early in the third trimester prior to 37 weeks. Each case was matched with two women who had a third-trimester ultrasound on the same day, for a total of 88 women in the control group.

The ratio of femur length to head circumference averaged 21 in the control group and 21.6 in the shoulder dystocia group. The ratio of head circumference to abdominal circumference averaged 1.05 in the control group and 1 in the dystocia group.

Biometric measurements and estimated fetal weight ascertained from third-trimester prenatal ultrasound can be used to counsel mothers on the risk for shoulder dystocia, the investigators concluded.

Other, classic risk factors for shoulder dystocia include maternal diabetes, obesity, a history of shoulder dystocia, and excessive weight gain during pregnancy.

The study did not control for the effects of obesity or weight gain on the risk for shoulder dystocia. It also did not assess the influence of differences in gestational age at the time of the sonograms.

Shoulder dystocia occurs in approximately 1% of all deliveries. Half of cases have been thought to be unpredictable.

Dr. Melka reported having no relevant financial disclosures.

SAN DIEGO – Biometric findings on third-trimester ultrasound predicted increased risk for shoulder dystocia at term in a chart review of 132 pregnancies in women without diabetes.

The risk of shoulder dystocia doubled with every unit deviation from the mean for the ratio of femur length to head circumference and the ratio of head circumference to abdominal circumference, Dr. Stephanie M. Melka and her associates reported in a poster presentation at the annual meeting of the American College of Obstetricians and Gynecologists.

Other factors that independently predicted a statistically significant 4%-17% increased risk for shoulder dystocia at term included estimated fetal weight, femur length, abdominal circumference, and the ratio of femur length to biparietal diameter, reported Dr. Melka of Mount Sinai School of Medicine, New York.

The only standard measurements and ratios on prenatal ultrasound that were not significantly associated with increased risk for shoulder dystocia were head circumference and the ratio of femur length to abdominal circumference.

Several previous studies have shown that prenatal sonographic findings can predict shoulder dystocia at term in diabetic mothers, but this appears to be the first study of elective third-trimester sonography in low-risk nondiabetic women, the investigators noted.

The study identified 44 cases of shoulder dystocia during vaginal delivery at Mount Sinai in 2008-2009 in which the mothers underwent ultrasound examination early in the third trimester prior to 37 weeks. Each case was matched with two women who had a third-trimester ultrasound on the same day, for a total of 88 women in the control group.

The ratio of femur length to head circumference averaged 21 in the control group and 21.6 in the shoulder dystocia group. The ratio of head circumference to abdominal circumference averaged 1.05 in the control group and 1 in the dystocia group.

Biometric measurements and estimated fetal weight ascertained from third-trimester prenatal ultrasound can be used to counsel mothers on the risk for shoulder dystocia, the investigators concluded.

Other, classic risk factors for shoulder dystocia include maternal diabetes, obesity, a history of shoulder dystocia, and excessive weight gain during pregnancy.

The study did not control for the effects of obesity or weight gain on the risk for shoulder dystocia. It also did not assess the influence of differences in gestational age at the time of the sonograms.

Shoulder dystocia occurs in approximately 1% of all deliveries. Half of cases have been thought to be unpredictable.

Dr. Melka reported having no relevant financial disclosures.

SAN DIEGO – Focusing routine screening for Chlamydia trachomatis infection on women younger than 25 years may be inappropriate in some states in which older women are at significant risk for infection, an analysis of data from 326,601 tests suggest.

The 2010 guidelines on STDs by the Centers for Disease Control and Prevention recommend routine annual screening for chlamydia in sexually active females younger than 25 years and selective screening in older nonpregnant women with increased risk for infection, such as those with new or multiple sexual partners (MMWR 2010;59 [No. RR-12]).

Sherry Boschert/IMNG Medical Media

U.S. Preventive Services Task Force guidelines are similar, and recommend against routine screening in women aged 25 years or older unless they have risk factors for infection (Ann. Intern. Med. 2007;147:128-34).

Those guidelines emphasize age because infection rates drop off steeply after age 24 years, but chlamydia rates also vary significantly by region, race, and socioeconomic status, Dr. Mark G. Martens said at the annual meeting of the American College of Obstetricians and Gynecologists.

A retrospective analysis of routine screening tests sent to one microbiology laboratory found that seven states had infection rates of at least 2% in women aged 25 years and older, reported Dr. Martens of Jersey Shore University Medical Center, Neptune, N.J. and his associates.

Meanwhile, prevalence rates for females younger than 25 years were less than 2% in eight states (California, Connecticut, Idaho, Kansas, Maine, New Hampshire, North Carolina, and Washington) and Puerto Rico.

"Perhaps screening by age isn’t the best answer," he said. "Perhaps we should be screening women who are over 25 years of age in some states, but not in others." That may be difficult to do but warranted, he added.

Two percent of all the tests in the analysis were positive for C. trachomatis. The tests were submitted to Bio-Reference Laboratories from January 2010 through June 2011 from 40 states, Washington, and Puerto Rico. The patients tested consisted mainly of middle-class women seen in insured office practices.

Approximately 5% of the 105,921 tests in females under 25 years old were positive, compared with 1% of the 220,680 tests in older women. Those results are similar to findings from the studies on which the federal guidelines are based.

In women aged 25 years or older in the current study, at least 2% of tests were positive in Arkansas, Delaware, Minnesota, New Hampshire, New Mexico, Oregon, and Wisconsin – a rate twice as high as the 1% "cut-off" that federal guidelines used to decide against routine screening in this age group, Dr. Martens noted.

Positivity rates in those same states varied greatly for women younger than 25 years, ranging from 0% in New Hampshire to more than 11% in Arkansas.

The three states with the highest rates of C. trachomatis infection rates in females younger than 25 years were Arkansas (11.4% positive), Louisiana (10.5%) and Mississippi (10.5%).

Chlamydia is one of the most common sexually transmitted infections, with approximately 4 million U.S. cases per year. More than 50% of infected women are asymptomatic, with an ongoing reservoir for infection. If untreated, approximately 30% of infected women will develop pelvic inflammatory disease with upper genital tract involvement and serious sequelae such as chronic abdominal pain, ectopic pregnancy, and infertility. Recurrent and persistent chlamydia infections are common.

Dr. Martens has been a speaker and adviser for Bio-Reference Laboratories, which conducted the tests.

SAN DIEGO – Focusing routine screening for Chlamydia trachomatis infection on women younger than 25 years may be inappropriate in some states in which older women are at significant risk for infection, an analysis of data from 326,601 tests suggest.

The 2010 guidelines on STDs by the Centers for Disease Control and Prevention recommend routine annual screening for chlamydia in sexually active females younger than 25 years and selective screening in older nonpregnant women with increased risk for infection, such as those with new or multiple sexual partners (MMWR 2010;59 [No. RR-12]).

Sherry Boschert/IMNG Medical Media

U.S. Preventive Services Task Force guidelines are similar, and recommend against routine screening in women aged 25 years or older unless they have risk factors for infection (Ann. Intern. Med. 2007;147:128-34).

Those guidelines emphasize age because infection rates drop off steeply after age 24 years, but chlamydia rates also vary significantly by region, race, and socioeconomic status, Dr. Mark G. Martens said at the annual meeting of the American College of Obstetricians and Gynecologists.

A retrospective analysis of routine screening tests sent to one microbiology laboratory found that seven states had infection rates of at least 2% in women aged 25 years and older, reported Dr. Martens of Jersey Shore University Medical Center, Neptune, N.J. and his associates.

Meanwhile, prevalence rates for females younger than 25 years were less than 2% in eight states (California, Connecticut, Idaho, Kansas, Maine, New Hampshire, North Carolina, and Washington) and Puerto Rico.

"Perhaps screening by age isn’t the best answer," he said. "Perhaps we should be screening women who are over 25 years of age in some states, but not in others." That may be difficult to do but warranted, he added.

Two percent of all the tests in the analysis were positive for C. trachomatis. The tests were submitted to Bio-Reference Laboratories from January 2010 through June 2011 from 40 states, Washington, and Puerto Rico. The patients tested consisted mainly of middle-class women seen in insured office practices.

Approximately 5% of the 105,921 tests in females under 25 years old were positive, compared with 1% of the 220,680 tests in older women. Those results are similar to findings from the studies on which the federal guidelines are based.

In women aged 25 years or older in the current study, at least 2% of tests were positive in Arkansas, Delaware, Minnesota, New Hampshire, New Mexico, Oregon, and Wisconsin – a rate twice as high as the 1% "cut-off" that federal guidelines used to decide against routine screening in this age group, Dr. Martens noted.

Positivity rates in those same states varied greatly for women younger than 25 years, ranging from 0% in New Hampshire to more than 11% in Arkansas.

The three states with the highest rates of C. trachomatis infection rates in females younger than 25 years were Arkansas (11.4% positive), Louisiana (10.5%) and Mississippi (10.5%).

Chlamydia is one of the most common sexually transmitted infections, with approximately 4 million U.S. cases per year. More than 50% of infected women are asymptomatic, with an ongoing reservoir for infection. If untreated, approximately 30% of infected women will develop pelvic inflammatory disease with upper genital tract involvement and serious sequelae such as chronic abdominal pain, ectopic pregnancy, and infertility. Recurrent and persistent chlamydia infections are common.

Dr. Martens has been a speaker and adviser for Bio-Reference Laboratories, which conducted the tests.

SAN DIEGO – Focusing routine screening for Chlamydia trachomatis infection on women younger than 25 years may be inappropriate in some states in which older women are at significant risk for infection, an analysis of data from 326,601 tests suggest.

The 2010 guidelines on STDs by the Centers for Disease Control and Prevention recommend routine annual screening for chlamydia in sexually active females younger than 25 years and selective screening in older nonpregnant women with increased risk for infection, such as those with new or multiple sexual partners (MMWR 2010;59 [No. RR-12]).

Sherry Boschert/IMNG Medical Media

U.S. Preventive Services Task Force guidelines are similar, and recommend against routine screening in women aged 25 years or older unless they have risk factors for infection (Ann. Intern. Med. 2007;147:128-34).

Those guidelines emphasize age because infection rates drop off steeply after age 24 years, but chlamydia rates also vary significantly by region, race, and socioeconomic status, Dr. Mark G. Martens said at the annual meeting of the American College of Obstetricians and Gynecologists.

A retrospective analysis of routine screening tests sent to one microbiology laboratory found that seven states had infection rates of at least 2% in women aged 25 years and older, reported Dr. Martens of Jersey Shore University Medical Center, Neptune, N.J. and his associates.

Meanwhile, prevalence rates for females younger than 25 years were less than 2% in eight states (California, Connecticut, Idaho, Kansas, Maine, New Hampshire, North Carolina, and Washington) and Puerto Rico.

"Perhaps screening by age isn’t the best answer," he said. "Perhaps we should be screening women who are over 25 years of age in some states, but not in others." That may be difficult to do but warranted, he added.

Two percent of all the tests in the analysis were positive for C. trachomatis. The tests were submitted to Bio-Reference Laboratories from January 2010 through June 2011 from 40 states, Washington, and Puerto Rico. The patients tested consisted mainly of middle-class women seen in insured office practices.

Approximately 5% of the 105,921 tests in females under 25 years old were positive, compared with 1% of the 220,680 tests in older women. Those results are similar to findings from the studies on which the federal guidelines are based.

In women aged 25 years or older in the current study, at least 2% of tests were positive in Arkansas, Delaware, Minnesota, New Hampshire, New Mexico, Oregon, and Wisconsin – a rate twice as high as the 1% "cut-off" that federal guidelines used to decide against routine screening in this age group, Dr. Martens noted.

Positivity rates in those same states varied greatly for women younger than 25 years, ranging from 0% in New Hampshire to more than 11% in Arkansas.

The three states with the highest rates of C. trachomatis infection rates in females younger than 25 years were Arkansas (11.4% positive), Louisiana (10.5%) and Mississippi (10.5%).

Chlamydia is one of the most common sexually transmitted infections, with approximately 4 million U.S. cases per year. More than 50% of infected women are asymptomatic, with an ongoing reservoir for infection. If untreated, approximately 30% of infected women will develop pelvic inflammatory disease with upper genital tract involvement and serious sequelae such as chronic abdominal pain, ectopic pregnancy, and infertility. Recurrent and persistent chlamydia infections are common.

Dr. Martens has been a speaker and adviser for Bio-Reference Laboratories, which conducted the tests.

SAN DIEGO – Mandating circumcision in the United States would prevent 24 more cases of HIV than does the traditional optional approach to circumcision, but would increase costs by approximately $389 million, making it far less cost effective, an analysis of published data suggests.

The investigators assumed that the overall incidence of HIV in the United States is 27 cases/100,000 people and the lifetime cost of care for someone with HIV is $119,000, based on published data from government statistics and peer-reviewed studies. Using the $392 cost of a circumcision at their institution, they developed computer-generated estimates of the cost-effectiveness of mandatory or traditional circumcision strategies for various populations, said Dr. Sarah E. Drennan, a third-year resident in ob.gyn. at Ochsner Medical Center, New Orleans.

Sherry Boschert/IMNG Medical Media

For the overall U.S. population, mandatory circumcision would prevent 494 cases of HIV at a cost of approximately $790 million. Traditional circumcision – in which the parents choose whether or not to circumcise a newborn – would prevent 470 cases of HIV at a cost of approximately $401 million, she reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The idea of mandatory circumcision policies in the United States has come up because of randomized, controlled trials in Africa showing that male circumcision reduces the risk of female-to-male transmission of HIV by 50%-60%, Dr. Drennan said.

She and coinvestigator Dr. Rajiv Gala, also of the Ochsner Medical Center, conducted the current analysis to account for key differences between the two geographical regions. HIV is spread mainly through heterosexual contact in Africa and by intravenous drug use or men having sex with men in the United States. The prevalence of HIV is 5% in sub-Saharan Africa and 0.6% in North America

The study also compared the two strategies in the United States among African American and Hispanic populations, who have lower rates of circumcision and a higher prevalence of HIV, compared with the population as a whole. Traditional circumcision was the more cost-effective strategy in those subgroups too, although not as strongly as in the population as a whole, she said.

For African Americans, mandatory circumcision would prevent 1,878 cases of HIV at a cost of approximately $816 million. Traditional circumcision would prevent 1,807 cases of HIV at a cost of approximately $613 million.

For Hispanics, mandatory circumcision would prevent 472 cases of HIV at a cost of approximately $792 million. Traditional circumcision would prevent 435 cases of HIV at a cost of approximately $342 million.

"Given the U.S. incidence of HIV, recommendations for mandatory circumcision are not supported" and require more U.S. studies on the role of circumcision in HIV prevention, Dr. Drennan said.

Circumcision would have to cost a mere $2.90 for the two strategies to be equally cost effective in the overall population, she said. The price of circumcision would need to be no more than $3.80 for Hispanics or $15.50 for African Americans for the two strategies to be equally cost effective in those subgroups.

Alternatively, the lifetime cost of HIV would need to be $15 million/case for the two circumcision strategies to be equally cost effective in the general population.

The topic has generated controversy in recent years as the Centers for Disease Control and Prevention was said to be considering recommendations promoting routine circumcision for HIV prevention. The CDC still is considering what might be recommended, but any recommendations will be voluntary in nature, according to the CDC website.

The analysis was limited by a lack of data from randomized clinical trials and by the subjective nature of measuring behavioral risk, she said. The study also did not consider adverse events associated with circumcision or other health benefits other than prevention of HIV.

Dr. Drennan reported having no relevant financial disclosures.

SAN DIEGO – Mandating circumcision in the United States would prevent 24 more cases of HIV than does the traditional optional approach to circumcision, but would increase costs by approximately $389 million, making it far less cost effective, an analysis of published data suggests.

The investigators assumed that the overall incidence of HIV in the United States is 27 cases/100,000 people and the lifetime cost of care for someone with HIV is $119,000, based on published data from government statistics and peer-reviewed studies. Using the $392 cost of a circumcision at their institution, they developed computer-generated estimates of the cost-effectiveness of mandatory or traditional circumcision strategies for various populations, said Dr. Sarah E. Drennan, a third-year resident in ob.gyn. at Ochsner Medical Center, New Orleans.

Sherry Boschert/IMNG Medical Media

For the overall U.S. population, mandatory circumcision would prevent 494 cases of HIV at a cost of approximately $790 million. Traditional circumcision – in which the parents choose whether or not to circumcise a newborn – would prevent 470 cases of HIV at a cost of approximately $401 million, she reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The idea of mandatory circumcision policies in the United States has come up because of randomized, controlled trials in Africa showing that male circumcision reduces the risk of female-to-male transmission of HIV by 50%-60%, Dr. Drennan said.

She and coinvestigator Dr. Rajiv Gala, also of the Ochsner Medical Center, conducted the current analysis to account for key differences between the two geographical regions. HIV is spread mainly through heterosexual contact in Africa and by intravenous drug use or men having sex with men in the United States. The prevalence of HIV is 5% in sub-Saharan Africa and 0.6% in North America

The study also compared the two strategies in the United States among African American and Hispanic populations, who have lower rates of circumcision and a higher prevalence of HIV, compared with the population as a whole. Traditional circumcision was the more cost-effective strategy in those subgroups too, although not as strongly as in the population as a whole, she said.

For African Americans, mandatory circumcision would prevent 1,878 cases of HIV at a cost of approximately $816 million. Traditional circumcision would prevent 1,807 cases of HIV at a cost of approximately $613 million.

For Hispanics, mandatory circumcision would prevent 472 cases of HIV at a cost of approximately $792 million. Traditional circumcision would prevent 435 cases of HIV at a cost of approximately $342 million.

"Given the U.S. incidence of HIV, recommendations for mandatory circumcision are not supported" and require more U.S. studies on the role of circumcision in HIV prevention, Dr. Drennan said.

Circumcision would have to cost a mere $2.90 for the two strategies to be equally cost effective in the overall population, she said. The price of circumcision would need to be no more than $3.80 for Hispanics or $15.50 for African Americans for the two strategies to be equally cost effective in those subgroups.

Alternatively, the lifetime cost of HIV would need to be $15 million/case for the two circumcision strategies to be equally cost effective in the general population.

The topic has generated controversy in recent years as the Centers for Disease Control and Prevention was said to be considering recommendations promoting routine circumcision for HIV prevention. The CDC still is considering what might be recommended, but any recommendations will be voluntary in nature, according to the CDC website.

The analysis was limited by a lack of data from randomized clinical trials and by the subjective nature of measuring behavioral risk, she said. The study also did not consider adverse events associated with circumcision or other health benefits other than prevention of HIV.

Dr. Drennan reported having no relevant financial disclosures.

SAN DIEGO – Mandating circumcision in the United States would prevent 24 more cases of HIV than does the traditional optional approach to circumcision, but would increase costs by approximately $389 million, making it far less cost effective, an analysis of published data suggests.

The investigators assumed that the overall incidence of HIV in the United States is 27 cases/100,000 people and the lifetime cost of care for someone with HIV is $119,000, based on published data from government statistics and peer-reviewed studies. Using the $392 cost of a circumcision at their institution, they developed computer-generated estimates of the cost-effectiveness of mandatory or traditional circumcision strategies for various populations, said Dr. Sarah E. Drennan, a third-year resident in ob.gyn. at Ochsner Medical Center, New Orleans.

Sherry Boschert/IMNG Medical Media

For the overall U.S. population, mandatory circumcision would prevent 494 cases of HIV at a cost of approximately $790 million. Traditional circumcision – in which the parents choose whether or not to circumcise a newborn – would prevent 470 cases of HIV at a cost of approximately $401 million, she reported at the annual meeting of the American College of Obstetricians and Gynecologists.

The idea of mandatory circumcision policies in the United States has come up because of randomized, controlled trials in Africa showing that male circumcision reduces the risk of female-to-male transmission of HIV by 50%-60%, Dr. Drennan said.

She and coinvestigator Dr. Rajiv Gala, also of the Ochsner Medical Center, conducted the current analysis to account for key differences between the two geographical regions. HIV is spread mainly through heterosexual contact in Africa and by intravenous drug use or men having sex with men in the United States. The prevalence of HIV is 5% in sub-Saharan Africa and 0.6% in North America

The study also compared the two strategies in the United States among African American and Hispanic populations, who have lower rates of circumcision and a higher prevalence of HIV, compared with the population as a whole. Traditional circumcision was the more cost-effective strategy in those subgroups too, although not as strongly as in the population as a whole, she said.

For African Americans, mandatory circumcision would prevent 1,878 cases of HIV at a cost of approximately $816 million. Traditional circumcision would prevent 1,807 cases of HIV at a cost of approximately $613 million.

For Hispanics, mandatory circumcision would prevent 472 cases of HIV at a cost of approximately $792 million. Traditional circumcision would prevent 435 cases of HIV at a cost of approximately $342 million.

"Given the U.S. incidence of HIV, recommendations for mandatory circumcision are not supported" and require more U.S. studies on the role of circumcision in HIV prevention, Dr. Drennan said.

Circumcision would have to cost a mere $2.90 for the two strategies to be equally cost effective in the overall population, she said. The price of circumcision would need to be no more than $3.80 for Hispanics or $15.50 for African Americans for the two strategies to be equally cost effective in those subgroups.

Alternatively, the lifetime cost of HIV would need to be $15 million/case for the two circumcision strategies to be equally cost effective in the general population.

The topic has generated controversy in recent years as the Centers for Disease Control and Prevention was said to be considering recommendations promoting routine circumcision for HIV prevention. The CDC still is considering what might be recommended, but any recommendations will be voluntary in nature, according to the CDC website.

The analysis was limited by a lack of data from randomized clinical trials and by the subjective nature of measuring behavioral risk, she said. The study also did not consider adverse events associated with circumcision or other health benefits other than prevention of HIV.

Dr. Drennan reported having no relevant financial disclosures.

SAN FRANCISCO – Perioperative infusions of sodium bicarbonate failed to reduce the risk of kidney injury in patients undergoing cardiac surgery in a multicenter randomized, double-blind, placebo-controlled trial in 427 patients.

The bicarbonate infusion increased the pH of both blood and urine in the 215-patient treatment group compared with 213 patients in a control group who got sodium chloride (saline) infusions, but 45% of the bicarbonate group and 44% of the placebo group developed kidney injury, a nonsignificant difference, Dr. Shay McGuinness and his associates reported at an international conference of the American Thoracic Society.

The study excluded patients with end-stage renal disease; patients having emergency cardiac surgery or planned off-pump cardiac surgery; and patients with known blood-borne infectious disease, chronic inflammatory disease, immunosuppression, or chronic moderate- to high-dose corticosteroid use.

"We cannot recommend the use of perioperative infusions of sodium bicarbonate to reduce cardiac surgery–associated kidney injury in these patients, and we do not believe further investigation of this therapy is justified," said Dr. McGuinness, an intensive care specialist at Auckland City Hospital, New Zealand.

The study defined kidney injury as an increase in creatinine of at least 25% from baseline or at least 0.5 mg/dL within the first 5 postoperative days.

The bicarbonate group and placebo group did not differ significantly in mean time on ventilation (21 and 25 hours, respectively), length of stay in the ICU (2 days each), length of stay in the hospital (13 days each), mortality in the ICU (3% and 2%, respectively), or 90-day mortality (4% and 2%).

The infusion strategy had started to catch on in New Zealand and Australia, but it’s unclear if anyone in the United States has pursued it, he said.

The study identified a high-risk group, got a plausible physiological treatment effect, and had good compliance and follow-up rates, but the clinical results were "absolutely negative," Dr. McGuinness said.

The investigators still are analyzing subgroups in the study, but "my gut feeling is that this is a completely negative study. There’s not even a hint of benefit. Walk away from it and find something else to study," he said.

To be in the study, patients having cardiac surgery at three centers in New Zealand and Australia had to have one or more risk factors for associated kidney injury. The rates of risk factors were similar between groups, including age over 70 (a mean of 58% of patients), preexisting renal impairment (14%), left ventricular ejection fraction below 35% (6%), valvular surgery with or without coronary artery surgery (72%), previous cardiac surgery involving sternotomy (16%), or insulin-dependent diabetes mellitus (6%). Measures of baseline renal function were similar between groups.

"What you see is standard cardiosurgical higher-risk patients" in the cohort, Dr. McGuinness said.

Infusions commenced at the start of anesthesia with a 1-mmol/mL solution, followed by 0.5 mmol/kg for 1 hour and 0.2 mmol/kg per hour for 23 hours.

Acid-base status and plasma levels of bicarbonate were similar between groups at baseline, but statistically and clinically significant differences emerged between groups at several time points after the infusion started.

Mean plasma bicarbonate levels in the bicarbonate and placebo groups were 25.72 mmol/L and 25.91 mmol/L at baseline, respectively, 27.03 and 24.35 mmol/L at 6 hours, 29.74 and 23.7 mmol/L at 24 hours, and 29.14 and 25.35 mmol/L at 48 hours.

Mean plasma pH levels in the bicarbonate and placebo groups were 7.40 and 7.41 at baseline, 7.40 and 7.37 at 6 hours, and 7.44 and 7.36 at 24 hours, respectively.

Mean urinary pH measures were 5.8 and 5.5 at baseline, 6.5 and 5.8 at 6 hours, and 7.3 and 5.2 at 24 hours, respectively.

Up to half of the 1 million patients who undergo open heart surgery each year will develop associated kidney injury with increased risk for further morbidity or death. The overall incidence of cardiac surgery–related kidney injury is approximately 5%-10% and probably is increasing, he said.

A previous pilot study by Dr. McGuinness and his associates of 100 patients at a single site had suggested that prophylactic perioperative infusions of sodium bicarbonate might reduce the risk of kidney injury. The investigators conducted the phase II trial before deciding whether or not to pursue a large phase III trial, which will not be happening based on these results.

The study was funded by Fisher & Paykel Healthcare and New Zealand medical organizations. Dr. McGuinness reported having no disclosures.

SAN FRANCISCO – Perioperative infusions of sodium bicarbonate failed to reduce the risk of kidney injury in patients undergoing cardiac surgery in a multicenter randomized, double-blind, placebo-controlled trial in 427 patients.

The bicarbonate infusion increased the pH of both blood and urine in the 215-patient treatment group compared with 213 patients in a control group who got sodium chloride (saline) infusions, but 45% of the bicarbonate group and 44% of the placebo group developed kidney injury, a nonsignificant difference, Dr. Shay McGuinness and his associates reported at an international conference of the American Thoracic Society.

The study excluded patients with end-stage renal disease; patients having emergency cardiac surgery or planned off-pump cardiac surgery; and patients with known blood-borne infectious disease, chronic inflammatory disease, immunosuppression, or chronic moderate- to high-dose corticosteroid use.

"We cannot recommend the use of perioperative infusions of sodium bicarbonate to reduce cardiac surgery–associated kidney injury in these patients, and we do not believe further investigation of this therapy is justified," said Dr. McGuinness, an intensive care specialist at Auckland City Hospital, New Zealand.

The study defined kidney injury as an increase in creatinine of at least 25% from baseline or at least 0.5 mg/dL within the first 5 postoperative days.

The bicarbonate group and placebo group did not differ significantly in mean time on ventilation (21 and 25 hours, respectively), length of stay in the ICU (2 days each), length of stay in the hospital (13 days each), mortality in the ICU (3% and 2%, respectively), or 90-day mortality (4% and 2%).

The infusion strategy had started to catch on in New Zealand and Australia, but it’s unclear if anyone in the United States has pursued it, he said.

The study identified a high-risk group, got a plausible physiological treatment effect, and had good compliance and follow-up rates, but the clinical results were "absolutely negative," Dr. McGuinness said.

The investigators still are analyzing subgroups in the study, but "my gut feeling is that this is a completely negative study. There’s not even a hint of benefit. Walk away from it and find something else to study," he said.

To be in the study, patients having cardiac surgery at three centers in New Zealand and Australia had to have one or more risk factors for associated kidney injury. The rates of risk factors were similar between groups, including age over 70 (a mean of 58% of patients), preexisting renal impairment (14%), left ventricular ejection fraction below 35% (6%), valvular surgery with or without coronary artery surgery (72%), previous cardiac surgery involving sternotomy (16%), or insulin-dependent diabetes mellitus (6%). Measures of baseline renal function were similar between groups.

"What you see is standard cardiosurgical higher-risk patients" in the cohort, Dr. McGuinness said.

Infusions commenced at the start of anesthesia with a 1-mmol/mL solution, followed by 0.5 mmol/kg for 1 hour and 0.2 mmol/kg per hour for 23 hours.

Acid-base status and plasma levels of bicarbonate were similar between groups at baseline, but statistically and clinically significant differences emerged between groups at several time points after the infusion started.

Mean plasma bicarbonate levels in the bicarbonate and placebo groups were 25.72 mmol/L and 25.91 mmol/L at baseline, respectively, 27.03 and 24.35 mmol/L at 6 hours, 29.74 and 23.7 mmol/L at 24 hours, and 29.14 and 25.35 mmol/L at 48 hours.

Mean plasma pH levels in the bicarbonate and placebo groups were 7.40 and 7.41 at baseline, 7.40 and 7.37 at 6 hours, and 7.44 and 7.36 at 24 hours, respectively.

Mean urinary pH measures were 5.8 and 5.5 at baseline, 6.5 and 5.8 at 6 hours, and 7.3 and 5.2 at 24 hours, respectively.

Up to half of the 1 million patients who undergo open heart surgery each year will develop associated kidney injury with increased risk for further morbidity or death. The overall incidence of cardiac surgery–related kidney injury is approximately 5%-10% and probably is increasing, he said.

A previous pilot study by Dr. McGuinness and his associates of 100 patients at a single site had suggested that prophylactic perioperative infusions of sodium bicarbonate might reduce the risk of kidney injury. The investigators conducted the phase II trial before deciding whether or not to pursue a large phase III trial, which will not be happening based on these results.

The study was funded by Fisher & Paykel Healthcare and New Zealand medical organizations. Dr. McGuinness reported having no disclosures.

SAN FRANCISCO – Perioperative infusions of sodium bicarbonate failed to reduce the risk of kidney injury in patients undergoing cardiac surgery in a multicenter randomized, double-blind, placebo-controlled trial in 427 patients.

The bicarbonate infusion increased the pH of both blood and urine in the 215-patient treatment group compared with 213 patients in a control group who got sodium chloride (saline) infusions, but 45% of the bicarbonate group and 44% of the placebo group developed kidney injury, a nonsignificant difference, Dr. Shay McGuinness and his associates reported at an international conference of the American Thoracic Society.

The study excluded patients with end-stage renal disease; patients having emergency cardiac surgery or planned off-pump cardiac surgery; and patients with known blood-borne infectious disease, chronic inflammatory disease, immunosuppression, or chronic moderate- to high-dose corticosteroid use.

"We cannot recommend the use of perioperative infusions of sodium bicarbonate to reduce cardiac surgery–associated kidney injury in these patients, and we do not believe further investigation of this therapy is justified," said Dr. McGuinness, an intensive care specialist at Auckland City Hospital, New Zealand.

The study defined kidney injury as an increase in creatinine of at least 25% from baseline or at least 0.5 mg/dL within the first 5 postoperative days.

The bicarbonate group and placebo group did not differ significantly in mean time on ventilation (21 and 25 hours, respectively), length of stay in the ICU (2 days each), length of stay in the hospital (13 days each), mortality in the ICU (3% and 2%, respectively), or 90-day mortality (4% and 2%).

The infusion strategy had started to catch on in New Zealand and Australia, but it’s unclear if anyone in the United States has pursued it, he said.

The study identified a high-risk group, got a plausible physiological treatment effect, and had good compliance and follow-up rates, but the clinical results were "absolutely negative," Dr. McGuinness said.

The investigators still are analyzing subgroups in the study, but "my gut feeling is that this is a completely negative study. There’s not even a hint of benefit. Walk away from it and find something else to study," he said.

To be in the study, patients having cardiac surgery at three centers in New Zealand and Australia had to have one or more risk factors for associated kidney injury. The rates of risk factors were similar between groups, including age over 70 (a mean of 58% of patients), preexisting renal impairment (14%), left ventricular ejection fraction below 35% (6%), valvular surgery with or without coronary artery surgery (72%), previous cardiac surgery involving sternotomy (16%), or insulin-dependent diabetes mellitus (6%). Measures of baseline renal function were similar between groups.

"What you see is standard cardiosurgical higher-risk patients" in the cohort, Dr. McGuinness said.

Infusions commenced at the start of anesthesia with a 1-mmol/mL solution, followed by 0.5 mmol/kg for 1 hour and 0.2 mmol/kg per hour for 23 hours.

Acid-base status and plasma levels of bicarbonate were similar between groups at baseline, but statistically and clinically significant differences emerged between groups at several time points after the infusion started.

Mean plasma bicarbonate levels in the bicarbonate and placebo groups were 25.72 mmol/L and 25.91 mmol/L at baseline, respectively, 27.03 and 24.35 mmol/L at 6 hours, 29.74 and 23.7 mmol/L at 24 hours, and 29.14 and 25.35 mmol/L at 48 hours.

Mean plasma pH levels in the bicarbonate and placebo groups were 7.40 and 7.41 at baseline, 7.40 and 7.37 at 6 hours, and 7.44 and 7.36 at 24 hours, respectively.

Mean urinary pH measures were 5.8 and 5.5 at baseline, 6.5 and 5.8 at 6 hours, and 7.3 and 5.2 at 24 hours, respectively.

Up to half of the 1 million patients who undergo open heart surgery each year will develop associated kidney injury with increased risk for further morbidity or death. The overall incidence of cardiac surgery–related kidney injury is approximately 5%-10% and probably is increasing, he said.

A previous pilot study by Dr. McGuinness and his associates of 100 patients at a single site had suggested that prophylactic perioperative infusions of sodium bicarbonate might reduce the risk of kidney injury. The investigators conducted the phase II trial before deciding whether or not to pursue a large phase III trial, which will not be happening based on these results.

The study was funded by Fisher & Paykel Healthcare and New Zealand medical organizations. Dr. McGuinness reported having no disclosures.

SAN DIEGO – The risk of C-section doubled in women undergoing induction of labor who received an epidural before 4 -cm dilation, compared with later epidural administration, a retrospective study found.

In 281 singleton pregnancies at gestational ages greater than 36 weeks that underwent induction of labor from 2008 to 2009 at one institution, 83% of mothers received an epidural. The C-section rate was significantly higher among the 233 women who received an epidural, compared with the 48 women who did not get an epidural – 30% vs. 8%.

In unadjusted results for women who got an epidural, "early" administration before 4-cm dilation was associated with a 38% chance of C-section, compared with a 24% C-section rate with "late" epidural administration when dilation reached at least 4 cm, Monica Rincon and her associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

After adjusting for the effects of age, race, body mass index (BMI), parity, and Bishop score, the risk for C-section was doubled with early vs. late epidural, said Ms. Rincon, a senior research assistant in the women’s health research unit at Oregon Health and Science University, Portland.

A non-reassuring fetal heart tracing was significantly more likely to be an indication for C-section in the early epidural group (18%), compared with the late epidural group (9%). Arrest of labor was the indication for C-section in 25% of the early epidural group and 21% of the late epidural group, which was not a statistically significant difference, she said.

Women in the early epidural group were significantly more likely to be white (80%), compared with the late epidural group (66%).

Several other factors besides timing of the epidural were associated with significantly increased risk for C-section after adjusting for confounders. The risk doubled with a Bishop score less than 5 at the time of admission, compared with higher Bishop scores. Maternal age of at least 35 years tripled the risk for C-section, compared with younger age. The risk for C-section quadrupled with a body mass index of at least 30 kg/m², compared with lower BMI. Nonwhite women had a fivefold increased risk for C-section, compared with white women. Nulliparous women had a 13-fold increased risk for C-section, compared with multiparous women.

The early and late epidural groups did not differ significantly by age, BMI, gestational age, birth weight, reason for induction of labor, or the proportions of women who were nulliparous or who had a Bishop score greater than 5 at admission.

Among all 281 deliveries (including those without an epidural), 68% were spontaneous vaginal deliveries, 6% were assisted vaginal deliveries, 8% were C-sections for non-reassuring fetal heart tracings, and 18% were C-sections because of arrest of labor.

Approximately 22% of U.S. labors in 2006 were induced, Ms. Rincon said. Previous studies of nulliparous women have shown a higher rate of C-section after labor induction, compared with spontaneous labor. Studies of multiparous women with induced labor provide conflicting results for the risk of C-section, with some reporting no increase in risk of C-section and others reporting increased C-section rates.

Among 2,231 deliveries in 2011 at Oregon Health and Science University, 41% involved labor induction, 56% used an epidural, and 27% were C-section deliveries, she said.

The current study excluded twin deliveries, vaginal births after C-section deliveries, and patients whose epidural status was unknown.

Ms. Rincon reported having no financial disclosures.

SAN DIEGO – The risk of C-section doubled in women undergoing induction of labor who received an epidural before 4 -cm dilation, compared with later epidural administration, a retrospective study found.

In 281 singleton pregnancies at gestational ages greater than 36 weeks that underwent induction of labor from 2008 to 2009 at one institution, 83% of mothers received an epidural. The C-section rate was significantly higher among the 233 women who received an epidural, compared with the 48 women who did not get an epidural – 30% vs. 8%.

In unadjusted results for women who got an epidural, "early" administration before 4-cm dilation was associated with a 38% chance of C-section, compared with a 24% C-section rate with "late" epidural administration when dilation reached at least 4 cm, Monica Rincon and her associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

After adjusting for the effects of age, race, body mass index (BMI), parity, and Bishop score, the risk for C-section was doubled with early vs. late epidural, said Ms. Rincon, a senior research assistant in the women’s health research unit at Oregon Health and Science University, Portland.

A non-reassuring fetal heart tracing was significantly more likely to be an indication for C-section in the early epidural group (18%), compared with the late epidural group (9%). Arrest of labor was the indication for C-section in 25% of the early epidural group and 21% of the late epidural group, which was not a statistically significant difference, she said.

Women in the early epidural group were significantly more likely to be white (80%), compared with the late epidural group (66%).

Several other factors besides timing of the epidural were associated with significantly increased risk for C-section after adjusting for confounders. The risk doubled with a Bishop score less than 5 at the time of admission, compared with higher Bishop scores. Maternal age of at least 35 years tripled the risk for C-section, compared with younger age. The risk for C-section quadrupled with a body mass index of at least 30 kg/m², compared with lower BMI. Nonwhite women had a fivefold increased risk for C-section, compared with white women. Nulliparous women had a 13-fold increased risk for C-section, compared with multiparous women.

The early and late epidural groups did not differ significantly by age, BMI, gestational age, birth weight, reason for induction of labor, or the proportions of women who were nulliparous or who had a Bishop score greater than 5 at admission.

Among all 281 deliveries (including those without an epidural), 68% were spontaneous vaginal deliveries, 6% were assisted vaginal deliveries, 8% were C-sections for non-reassuring fetal heart tracings, and 18% were C-sections because of arrest of labor.

Approximately 22% of U.S. labors in 2006 were induced, Ms. Rincon said. Previous studies of nulliparous women have shown a higher rate of C-section after labor induction, compared with spontaneous labor. Studies of multiparous women with induced labor provide conflicting results for the risk of C-section, with some reporting no increase in risk of C-section and others reporting increased C-section rates.

Among 2,231 deliveries in 2011 at Oregon Health and Science University, 41% involved labor induction, 56% used an epidural, and 27% were C-section deliveries, she said.

The current study excluded twin deliveries, vaginal births after C-section deliveries, and patients whose epidural status was unknown.

Ms. Rincon reported having no financial disclosures.

SAN DIEGO – The risk of C-section doubled in women undergoing induction of labor who received an epidural before 4 -cm dilation, compared with later epidural administration, a retrospective study found.

In 281 singleton pregnancies at gestational ages greater than 36 weeks that underwent induction of labor from 2008 to 2009 at one institution, 83% of mothers received an epidural. The C-section rate was significantly higher among the 233 women who received an epidural, compared with the 48 women who did not get an epidural – 30% vs. 8%.

In unadjusted results for women who got an epidural, "early" administration before 4-cm dilation was associated with a 38% chance of C-section, compared with a 24% C-section rate with "late" epidural administration when dilation reached at least 4 cm, Monica Rincon and her associates reported at the annual meeting of the American College of Obstetricians and Gynecologists.

After adjusting for the effects of age, race, body mass index (BMI), parity, and Bishop score, the risk for C-section was doubled with early vs. late epidural, said Ms. Rincon, a senior research assistant in the women’s health research unit at Oregon Health and Science University, Portland.

A non-reassuring fetal heart tracing was significantly more likely to be an indication for C-section in the early epidural group (18%), compared with the late epidural group (9%). Arrest of labor was the indication for C-section in 25% of the early epidural group and 21% of the late epidural group, which was not a statistically significant difference, she said.

Women in the early epidural group were significantly more likely to be white (80%), compared with the late epidural group (66%).

Several other factors besides timing of the epidural were associated with significantly increased risk for C-section after adjusting for confounders. The risk doubled with a Bishop score less than 5 at the time of admission, compared with higher Bishop scores. Maternal age of at least 35 years tripled the risk for C-section, compared with younger age. The risk for C-section quadrupled with a body mass index of at least 30 kg/m², compared with lower BMI. Nonwhite women had a fivefold increased risk for C-section, compared with white women. Nulliparous women had a 13-fold increased risk for C-section, compared with multiparous women.

The early and late epidural groups did not differ significantly by age, BMI, gestational age, birth weight, reason for induction of labor, or the proportions of women who were nulliparous or who had a Bishop score greater than 5 at admission.

Among all 281 deliveries (including those without an epidural), 68% were spontaneous vaginal deliveries, 6% were assisted vaginal deliveries, 8% were C-sections for non-reassuring fetal heart tracings, and 18% were C-sections because of arrest of labor.

Approximately 22% of U.S. labors in 2006 were induced, Ms. Rincon said. Previous studies of nulliparous women have shown a higher rate of C-section after labor induction, compared with spontaneous labor. Studies of multiparous women with induced labor provide conflicting results for the risk of C-section, with some reporting no increase in risk of C-section and others reporting increased C-section rates.

Among 2,231 deliveries in 2011 at Oregon Health and Science University, 41% involved labor induction, 56% used an epidural, and 27% were C-section deliveries, she said.

The current study excluded twin deliveries, vaginal births after C-section deliveries, and patients whose epidural status was unknown.

Ms. Rincon reported having no financial disclosures.

SAN DIEGO (EGMN) – Giving acetaminophen to patients who reported consuming ethanol did not adversely affect markers of liver damage in a meta-analysis of randomized, controlled trials.

"One of the questions we often get asked is the role of acetaminophen in patients with liver disease," said Dr. Kennon J. Heard, an emergency medicine physician at the University of Colorado and director of the Medical Toxicology Fellowship at the Rocky Mountain Poison and Drug Center, Denver.

The findings of the meta-analysis suggest that "acetaminophen is safe in alcoholics," he said at the annual meeting of the Society of Hospital Medicine.

The meta-analysis included five trials involving 901 subjects (including patients who reported drinking ethanol) who were randomized to receive acetaminophen or placebo. Dr. Heard and his associates looked at daily ALT measurements out to a mean of 4 days, a time period for which most of the studies had data. They also looked for any evidence of liver injury or dysfunction, hepatotoxicity, or death.

The alanine aminotransferase (ALT) levels changed by a mean of 0.04 IU/L after starting acetaminophen or placebo, "less than a tenth of a point in ALT," reported Dr. Heard. "Essentially, in this group of patients who consume alcohol, if you give them acetaminophen for 4 days, you don’t see any change in their ALT."

The study is to be published in the journal Pharmacotherapy.

When acetaminophen consumption continued beyond 4 days, ALT levels increased in most patients who consumed alcohol but also increased in 60% of non-drinkers. "The changes in the alcoholics look exactly like the changes in the non-alcoholics," he said. The median increase in ALT was between 10-20 IU/L.

Among patients who drink alcohol, the highest ALT level in the acetaminophen group was 312 IU/L, "which is pretty impressive until you see that in the placebo group, somebody went up 288" IU/L, he said. The biggest increase in ALT was in a healthy nondrinking patient on acetaminophen, whose ALT increased by 638 IU/L.

Most importantly, none of the 551 people who received acetaminophen in those trials developed an increase in International Normalized Ratio, bilirubin level, or symptomatic liver injury, he added.

Dr. Heard and his associates are now finishing a separate study that appears to confirm that these are asymptomatic, self-limiting elevations in ALT that will go away even if people stay on acetaminophen.

"It is worth knowing that if you have someone who has an ALT elevation while taking acetaminophen, it may be the cause, and it is reasonable to stop the acetaminophen and see if their ALT elevations go away rather than do an extensive workup for hepatitis," he said.

Dr. Heard has been a consultant or received research grants from Cadence Pharmaceuticals, McNeil Consumer Healthcare, and Cumberland Pharmaceuticals.

SAN DIEGO (EGMN) – Giving acetaminophen to patients who reported consuming ethanol did not adversely affect markers of liver damage in a meta-analysis of randomized, controlled trials.

"One of the questions we often get asked is the role of acetaminophen in patients with liver disease," said Dr. Kennon J. Heard, an emergency medicine physician at the University of Colorado and director of the Medical Toxicology Fellowship at the Rocky Mountain Poison and Drug Center, Denver.

The findings of the meta-analysis suggest that "acetaminophen is safe in alcoholics," he said at the annual meeting of the Society of Hospital Medicine.

The meta-analysis included five trials involving 901 subjects (including patients who reported drinking ethanol) who were randomized to receive acetaminophen or placebo. Dr. Heard and his associates looked at daily ALT measurements out to a mean of 4 days, a time period for which most of the studies had data. They also looked for any evidence of liver injury or dysfunction, hepatotoxicity, or death.

The alanine aminotransferase (ALT) levels changed by a mean of 0.04 IU/L after starting acetaminophen or placebo, "less than a tenth of a point in ALT," reported Dr. Heard. "Essentially, in this group of patients who consume alcohol, if you give them acetaminophen for 4 days, you don’t see any change in their ALT."

The study is to be published in the journal Pharmacotherapy.

When acetaminophen consumption continued beyond 4 days, ALT levels increased in most patients who consumed alcohol but also increased in 60% of non-drinkers. "The changes in the alcoholics look exactly like the changes in the non-alcoholics," he said. The median increase in ALT was between 10-20 IU/L.

Among patients who drink alcohol, the highest ALT level in the acetaminophen group was 312 IU/L, "which is pretty impressive until you see that in the placebo group, somebody went up 288" IU/L, he said. The biggest increase in ALT was in a healthy nondrinking patient on acetaminophen, whose ALT increased by 638 IU/L.

Most importantly, none of the 551 people who received acetaminophen in those trials developed an increase in International Normalized Ratio, bilirubin level, or symptomatic liver injury, he added.

Dr. Heard and his associates are now finishing a separate study that appears to confirm that these are asymptomatic, self-limiting elevations in ALT that will go away even if people stay on acetaminophen.

"It is worth knowing that if you have someone who has an ALT elevation while taking acetaminophen, it may be the cause, and it is reasonable to stop the acetaminophen and see if their ALT elevations go away rather than do an extensive workup for hepatitis," he said.

Dr. Heard has been a consultant or received research grants from Cadence Pharmaceuticals, McNeil Consumer Healthcare, and Cumberland Pharmaceuticals.

SAN DIEGO (EGMN) – Giving acetaminophen to patients who reported consuming ethanol did not adversely affect markers of liver damage in a meta-analysis of randomized, controlled trials.

"One of the questions we often get asked is the role of acetaminophen in patients with liver disease," said Dr. Kennon J. Heard, an emergency medicine physician at the University of Colorado and director of the Medical Toxicology Fellowship at the Rocky Mountain Poison and Drug Center, Denver.

The findings of the meta-analysis suggest that "acetaminophen is safe in alcoholics," he said at the annual meeting of the Society of Hospital Medicine.

The meta-analysis included five trials involving 901 subjects (including patients who reported drinking ethanol) who were randomized to receive acetaminophen or placebo. Dr. Heard and his associates looked at daily ALT measurements out to a mean of 4 days, a time period for which most of the studies had data. They also looked for any evidence of liver injury or dysfunction, hepatotoxicity, or death.

The alanine aminotransferase (ALT) levels changed by a mean of 0.04 IU/L after starting acetaminophen or placebo, "less than a tenth of a point in ALT," reported Dr. Heard. "Essentially, in this group of patients who consume alcohol, if you give them acetaminophen for 4 days, you don’t see any change in their ALT."

The study is to be published in the journal Pharmacotherapy.

When acetaminophen consumption continued beyond 4 days, ALT levels increased in most patients who consumed alcohol but also increased in 60% of non-drinkers. "The changes in the alcoholics look exactly like the changes in the non-alcoholics," he said. The median increase in ALT was between 10-20 IU/L.

Among patients who drink alcohol, the highest ALT level in the acetaminophen group was 312 IU/L, "which is pretty impressive until you see that in the placebo group, somebody went up 288" IU/L, he said. The biggest increase in ALT was in a healthy nondrinking patient on acetaminophen, whose ALT increased by 638 IU/L.

Most importantly, none of the 551 people who received acetaminophen in those trials developed an increase in International Normalized Ratio, bilirubin level, or symptomatic liver injury, he added.

Dr. Heard and his associates are now finishing a separate study that appears to confirm that these are asymptomatic, self-limiting elevations in ALT that will go away even if people stay on acetaminophen.

"It is worth knowing that if you have someone who has an ALT elevation while taking acetaminophen, it may be the cause, and it is reasonable to stop the acetaminophen and see if their ALT elevations go away rather than do an extensive workup for hepatitis," he said.

Dr. Heard has been a consultant or received research grants from Cadence Pharmaceuticals, McNeil Consumer Healthcare, and Cumberland Pharmaceuticals.

BELLEVUE, WASH. – There’s no evidence that asking about an eating disorder will cause one, so busy clinicians should ask a few key questions to zero in quickly on adolescents who may have an eating disorder, one expert said.

General questions start with asking the teen what his or her maximum and minimum weights have been, and what their desired weight is, Dr. Cora C. Breuner said at the conference, which was sponsored by the North Pacific Pediatric Society.

Ask adolescents if they eat with their families (not counting eating fast food in a car). A family that doesn’t eat together at least three to five times per week is a red flag, said Dr. Breuner, professor of pediatrics and adolescent medicine at the University of Washington, Seattle.

Ask teenagers if there are any foods that they or their families consider "off limits," and whether any friends or family members have abnormal eating behaviors. Does the teen think he or she should be dieting?

Some useful questions come in pairs, Dr. Breuner said. Follow "How much do you exercise?" with "How do you feel if you can’t exercise?" If "Do you ever eat more than feels comfortable to you?" elicits a positive response, be sure to ask, "What do you do if you do that?"

Ask the adolescent to describe a typical day’s eating routine, and whether "energy drinks" are part of that. "Sadly, many don’t eat breakfast," she said.

To quickly identify physical symptoms of anorexia, ask the adolescent about amenorrhea, cold hands or feet, headaches, fainting or dizziness, and dry skin. Also query they about hair loss when brushing hair, or finding hair on the pillow in the morning.

Ask also about constipation. "Many kids don’t know what this means," Dr. Breuner said. Inquire if they have lost appetite and don’t get enough to eat.

To hone in on mental symptoms of eating disorders, ask about difficulty making decisions and about poor concentration – does it take longer to finish a test than it used to? A big symptom with teenagers is irritability: "Are you snapping at your friends?" Dr. Breuner suggests asking.

Inquire about depression and social withdrawal, which can be symptoms of eating disorders, as well as obsessiveness about food, guilt, or anxiety.

Some 50%-75% of adolescents with eating disorders have comorbid depression. With anorexia, more than 60% have comorbid anxiety, and more than 40% have comorbid obsessive-compulsive disorder (OCD).

"I think eating-disordered kids are anxious first, then find they’re less anxious if they don’t eat. We need to give them something else for the anxiety" or for the OCD, to replace the harmful don’t-eat strategy, she said.

Substance abuse also can be a red flag. Among patients with bulimia, 30%-37% also have substance abuse, studies suggest. Among the approximately half of patients with anorexia who will develop bulimia, 40% develop substance abuse, she said.

If the answers to these questions raise suspicion of an eating disorder, refer the patient for evaluation or look for clinical signs of eating disorders in your physical exam.

Physical signs of anorexia include hypothermia, acrocyanosis, resting bradycardia, hypotension, orthostatic blood pressure and pulse, and loss of muscle mass.

"A lot of times what I bill for is what I find on the physical exam" because coding the bill for an eating disorder slots the case into mental-health categories with lower reimbursements, Dr. Breuner said. "This is a medical problem, not just a mental problem."

Physical signs of binge eating include weight gain, bloating, fullness, lethargy, and salivary gland enlargement. Mental signs include guilt, depression, and anxiety.

Physical signs of vomiting or laxative abuse include weight loss, electrolyte disturbance, hypokalemia, hypochloremic metabolic alkalosis, dental enamel erosion, hypovolemia, or knuckle calluses. Mental signs include guilt, depression, anxiety, or confusion.

Dr. Breuner reported having no relevant financial disclosures.

BELLEVUE, WASH. – There’s no evidence that asking about an eating disorder will cause one, so busy clinicians should ask a few key questions to zero in quickly on adolescents who may have an eating disorder, one expert said.

General questions start with asking the teen what his or her maximum and minimum weights have been, and what their desired weight is, Dr. Cora C. Breuner said at the conference, which was sponsored by the North Pacific Pediatric Society.

Ask adolescents if they eat with their families (not counting eating fast food in a car). A family that doesn’t eat together at least three to five times per week is a red flag, said Dr. Breuner, professor of pediatrics and adolescent medicine at the University of Washington, Seattle.

Ask teenagers if there are any foods that they or their families consider "off limits," and whether any friends or family members have abnormal eating behaviors. Does the teen think he or she should be dieting?

Some useful questions come in pairs, Dr. Breuner said. Follow "How much do you exercise?" with "How do you feel if you can’t exercise?" If "Do you ever eat more than feels comfortable to you?" elicits a positive response, be sure to ask, "What do you do if you do that?"

Ask the adolescent to describe a typical day’s eating routine, and whether "energy drinks" are part of that. "Sadly, many don’t eat breakfast," she said.

To quickly identify physical symptoms of anorexia, ask the adolescent about amenorrhea, cold hands or feet, headaches, fainting or dizziness, and dry skin. Also query they about hair loss when brushing hair, or finding hair on the pillow in the morning.

Ask also about constipation. "Many kids don’t know what this means," Dr. Breuner said. Inquire if they have lost appetite and don’t get enough to eat.

To hone in on mental symptoms of eating disorders, ask about difficulty making decisions and about poor concentration – does it take longer to finish a test than it used to? A big symptom with teenagers is irritability: "Are you snapping at your friends?" Dr. Breuner suggests asking.

Inquire about depression and social withdrawal, which can be symptoms of eating disorders, as well as obsessiveness about food, guilt, or anxiety.

Some 50%-75% of adolescents with eating disorders have comorbid depression. With anorexia, more than 60% have comorbid anxiety, and more than 40% have comorbid obsessive-compulsive disorder (OCD).

"I think eating-disordered kids are anxious first, then find they’re less anxious if they don’t eat. We need to give them something else for the anxiety" or for the OCD, to replace the harmful don’t-eat strategy, she said.

Substance abuse also can be a red flag. Among patients with bulimia, 30%-37% also have substance abuse, studies suggest. Among the approximately half of patients with anorexia who will develop bulimia, 40% develop substance abuse, she said.

If the answers to these questions raise suspicion of an eating disorder, refer the patient for evaluation or look for clinical signs of eating disorders in your physical exam.

Physical signs of anorexia include hypothermia, acrocyanosis, resting bradycardia, hypotension, orthostatic blood pressure and pulse, and loss of muscle mass.

"A lot of times what I bill for is what I find on the physical exam" because coding the bill for an eating disorder slots the case into mental-health categories with lower reimbursements, Dr. Breuner said. "This is a medical problem, not just a mental problem."

Physical signs of binge eating include weight gain, bloating, fullness, lethargy, and salivary gland enlargement. Mental signs include guilt, depression, and anxiety.

Physical signs of vomiting or laxative abuse include weight loss, electrolyte disturbance, hypokalemia, hypochloremic metabolic alkalosis, dental enamel erosion, hypovolemia, or knuckle calluses. Mental signs include guilt, depression, anxiety, or confusion.

Dr. Breuner reported having no relevant financial disclosures.

BELLEVUE, WASH. – There’s no evidence that asking about an eating disorder will cause one, so busy clinicians should ask a few key questions to zero in quickly on adolescents who may have an eating disorder, one expert said.

General questions start with asking the teen what his or her maximum and minimum weights have been, and what their desired weight is, Dr. Cora C. Breuner said at the conference, which was sponsored by the North Pacific Pediatric Society.

Ask adolescents if they eat with their families (not counting eating fast food in a car). A family that doesn’t eat together at least three to five times per week is a red flag, said Dr. Breuner, professor of pediatrics and adolescent medicine at the University of Washington, Seattle.

Ask teenagers if there are any foods that they or their families consider "off limits," and whether any friends or family members have abnormal eating behaviors. Does the teen think he or she should be dieting?

Some useful questions come in pairs, Dr. Breuner said. Follow "How much do you exercise?" with "How do you feel if you can’t exercise?" If "Do you ever eat more than feels comfortable to you?" elicits a positive response, be sure to ask, "What do you do if you do that?"

Ask the adolescent to describe a typical day’s eating routine, and whether "energy drinks" are part of that. "Sadly, many don’t eat breakfast," she said.

To quickly identify physical symptoms of anorexia, ask the adolescent about amenorrhea, cold hands or feet, headaches, fainting or dizziness, and dry skin. Also query they about hair loss when brushing hair, or finding hair on the pillow in the morning.

Ask also about constipation. "Many kids don’t know what this means," Dr. Breuner said. Inquire if they have lost appetite and don’t get enough to eat.

To hone in on mental symptoms of eating disorders, ask about difficulty making decisions and about poor concentration – does it take longer to finish a test than it used to? A big symptom with teenagers is irritability: "Are you snapping at your friends?" Dr. Breuner suggests asking.

Inquire about depression and social withdrawal, which can be symptoms of eating disorders, as well as obsessiveness about food, guilt, or anxiety.

Some 50%-75% of adolescents with eating disorders have comorbid depression. With anorexia, more than 60% have comorbid anxiety, and more than 40% have comorbid obsessive-compulsive disorder (OCD).

"I think eating-disordered kids are anxious first, then find they’re less anxious if they don’t eat. We need to give them something else for the anxiety" or for the OCD, to replace the harmful don’t-eat strategy, she said.

Substance abuse also can be a red flag. Among patients with bulimia, 30%-37% also have substance abuse, studies suggest. Among the approximately half of patients with anorexia who will develop bulimia, 40% develop substance abuse, she said.

If the answers to these questions raise suspicion of an eating disorder, refer the patient for evaluation or look for clinical signs of eating disorders in your physical exam.

Physical signs of anorexia include hypothermia, acrocyanosis, resting bradycardia, hypotension, orthostatic blood pressure and pulse, and loss of muscle mass.

"A lot of times what I bill for is what I find on the physical exam" because coding the bill for an eating disorder slots the case into mental-health categories with lower reimbursements, Dr. Breuner said. "This is a medical problem, not just a mental problem."

Physical signs of binge eating include weight gain, bloating, fullness, lethargy, and salivary gland enlargement. Mental signs include guilt, depression, and anxiety.

Physical signs of vomiting or laxative abuse include weight loss, electrolyte disturbance, hypokalemia, hypochloremic metabolic alkalosis, dental enamel erosion, hypovolemia, or knuckle calluses. Mental signs include guilt, depression, anxiety, or confusion.

Dr. Breuner reported having no relevant financial disclosures.

SAN FRANCISCO – A phase III clinical trial ended early after preliminary results showed lower cure rates and higher death rates in patients with ventilator-associated pneumonia who were treated for 7 days with doripenem, compared with patients who received 10 days of imipenem.

With 274 patients randomized of a planned enrollment of 524 participants, the investigators conducted a modified intention-to-treat analysis of patients with qualifying bacterial organisms confirmed by bronchiolar lavage and culture. Clinical cure rates were 46% for doripenem and 57% for imipenem, and 28-day all-cause mortality rates were 22% for doripenem and 15% for imipenem, Dr. Marin H. Kollef and his associates reported in a late-breaker session at an international the conference of the American Thoracic Society.

The confidence intervals for both results crossed the threshold of no greater than a 15% difference between groups that would be required to say the doripenem regimen was noninferior to the imipenem regimen. Multiple overall and subgroup analyses showed trends favoring the safety and efficacy of the imipenem regimen, said Dr. Kollef, professor of medicine at Washington University and director of the medical ICU and of respiratory care services at Barnes-Jewish Hospital, both in St. Louis.

The difference in 28-day all-cause mortality did reach statistical significance in a subgroup of patients infected with P. aeruginosa, who were more likely to survive on imipenem therapy, he said.

Doripenem is a carbapenem antibiotic that is approved in the United States for the treatment of complicated urinary and abdominal infections caused by susceptible bacteria but is not approved for pneumonia. It is approved in many other countries for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP).

The study, known as the DORINOS3008 study, used a higher dose of doripenem than is approved in other countries for pneumonia, the thinking being that a higher dosage might allow shorter duration of treatment. Patients randomized to doripenem received 1 g of doripenem in a 4-hour infusion every 8 hours for 7 days plus a 1-hour infusion of saline placebo every 8 hours for 10 days. The imipenem group received a 4-hour infusion of placebo every 8 hours for 7 days and a 1-hour infusion of imipenem every 8 hours for 10 days.

In the doripenem group, 44% of patients reached a creatinine clearance of at least 150 mL/min, compared with 71% of patients in the imipenem group.

The findings contradict results of a previous phase III study of VAP treated for 7-10 days at the discretion of the investigator. That study, known as DORI-10, reported noninferiority between a regimen of doripenem 500 mg in 4-hour infusions every 8 hours and treatment with imipenem 500 mg in 30-minute infusions every 6 hours or 1 g in 60-minute infusions every 8 hours. In that study, more than 90% of cured patients were treated for at least 8 days, and 35% of patients were treated for at least 10 days, Dr. Kollef noted (Crit. Care Med. 2008;36:1089-96).

In countries where doripenem is approved to treat ventilator-associated pneumonia, the usual duration of treatment is 7-14 days.

"I can’t give you the absolute explanation" for the differences in results from DORI-10 and DORINOS3008, but the findings suggest that physicians should consider treating VAP for longer than 7 days, Dr. Kollef said.

The current study included adult patients who had been hospitalized for at least 5 days, who were on mechanical ventilation, and who met clinical and radiographic criteria for pneumonia.

The study was funded by Johnson & Johnson, which markets doripenem. Dr. Kollef has been a speaker for Pfizer.

SAN FRANCISCO – A phase III clinical trial ended early after preliminary results showed lower cure rates and higher death rates in patients with ventilator-associated pneumonia who were treated for 7 days with doripenem, compared with patients who received 10 days of imipenem.

With 274 patients randomized of a planned enrollment of 524 participants, the investigators conducted a modified intention-to-treat analysis of patients with qualifying bacterial organisms confirmed by bronchiolar lavage and culture. Clinical cure rates were 46% for doripenem and 57% for imipenem, and 28-day all-cause mortality rates were 22% for doripenem and 15% for imipenem, Dr. Marin H. Kollef and his associates reported in a late-breaker session at an international the conference of the American Thoracic Society.

The confidence intervals for both results crossed the threshold of no greater than a 15% difference between groups that would be required to say the doripenem regimen was noninferior to the imipenem regimen. Multiple overall and subgroup analyses showed trends favoring the safety and efficacy of the imipenem regimen, said Dr. Kollef, professor of medicine at Washington University and director of the medical ICU and of respiratory care services at Barnes-Jewish Hospital, both in St. Louis.

The difference in 28-day all-cause mortality did reach statistical significance in a subgroup of patients infected with P. aeruginosa, who were more likely to survive on imipenem therapy, he said.

Doripenem is a carbapenem antibiotic that is approved in the United States for the treatment of complicated urinary and abdominal infections caused by susceptible bacteria but is not approved for pneumonia. It is approved in many other countries for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP).

The study, known as the DORINOS3008 study, used a higher dose of doripenem than is approved in other countries for pneumonia, the thinking being that a higher dosage might allow shorter duration of treatment. Patients randomized to doripenem received 1 g of doripenem in a 4-hour infusion every 8 hours for 7 days plus a 1-hour infusion of saline placebo every 8 hours for 10 days. The imipenem group received a 4-hour infusion of placebo every 8 hours for 7 days and a 1-hour infusion of imipenem every 8 hours for 10 days.

In the doripenem group, 44% of patients reached a creatinine clearance of at least 150 mL/min, compared with 71% of patients in the imipenem group.

The findings contradict results of a previous phase III study of VAP treated for 7-10 days at the discretion of the investigator. That study, known as DORI-10, reported noninferiority between a regimen of doripenem 500 mg in 4-hour infusions every 8 hours and treatment with imipenem 500 mg in 30-minute infusions every 6 hours or 1 g in 60-minute infusions every 8 hours. In that study, more than 90% of cured patients were treated for at least 8 days, and 35% of patients were treated for at least 10 days, Dr. Kollef noted (Crit. Care Med. 2008;36:1089-96).

In countries where doripenem is approved to treat ventilator-associated pneumonia, the usual duration of treatment is 7-14 days.

"I can’t give you the absolute explanation" for the differences in results from DORI-10 and DORINOS3008, but the findings suggest that physicians should consider treating VAP for longer than 7 days, Dr. Kollef said.

The current study included adult patients who had been hospitalized for at least 5 days, who were on mechanical ventilation, and who met clinical and radiographic criteria for pneumonia.

The study was funded by Johnson & Johnson, which markets doripenem. Dr. Kollef has been a speaker for Pfizer.

SAN FRANCISCO – A phase III clinical trial ended early after preliminary results showed lower cure rates and higher death rates in patients with ventilator-associated pneumonia who were treated for 7 days with doripenem, compared with patients who received 10 days of imipenem.

With 274 patients randomized of a planned enrollment of 524 participants, the investigators conducted a modified intention-to-treat analysis of patients with qualifying bacterial organisms confirmed by bronchiolar lavage and culture. Clinical cure rates were 46% for doripenem and 57% for imipenem, and 28-day all-cause mortality rates were 22% for doripenem and 15% for imipenem, Dr. Marin H. Kollef and his associates reported in a late-breaker session at an international the conference of the American Thoracic Society.

The confidence intervals for both results crossed the threshold of no greater than a 15% difference between groups that would be required to say the doripenem regimen was noninferior to the imipenem regimen. Multiple overall and subgroup analyses showed trends favoring the safety and efficacy of the imipenem regimen, said Dr. Kollef, professor of medicine at Washington University and director of the medical ICU and of respiratory care services at Barnes-Jewish Hospital, both in St. Louis.

The difference in 28-day all-cause mortality did reach statistical significance in a subgroup of patients infected with P. aeruginosa, who were more likely to survive on imipenem therapy, he said.

Doripenem is a carbapenem antibiotic that is approved in the United States for the treatment of complicated urinary and abdominal infections caused by susceptible bacteria but is not approved for pneumonia. It is approved in many other countries for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP).

The study, known as the DORINOS3008 study, used a higher dose of doripenem than is approved in other countries for pneumonia, the thinking being that a higher dosage might allow shorter duration of treatment. Patients randomized to doripenem received 1 g of doripenem in a 4-hour infusion every 8 hours for 7 days plus a 1-hour infusion of saline placebo every 8 hours for 10 days. The imipenem group received a 4-hour infusion of placebo every 8 hours for 7 days and a 1-hour infusion of imipenem every 8 hours for 10 days.

In the doripenem group, 44% of patients reached a creatinine clearance of at least 150 mL/min, compared with 71% of patients in the imipenem group.

The findings contradict results of a previous phase III study of VAP treated for 7-10 days at the discretion of the investigator. That study, known as DORI-10, reported noninferiority between a regimen of doripenem 500 mg in 4-hour infusions every 8 hours and treatment with imipenem 500 mg in 30-minute infusions every 6 hours or 1 g in 60-minute infusions every 8 hours. In that study, more than 90% of cured patients were treated for at least 8 days, and 35% of patients were treated for at least 10 days, Dr. Kollef noted (Crit. Care Med. 2008;36:1089-96).

In countries where doripenem is approved to treat ventilator-associated pneumonia, the usual duration of treatment is 7-14 days.

"I can’t give you the absolute explanation" for the differences in results from DORI-10 and DORINOS3008, but the findings suggest that physicians should consider treating VAP for longer than 7 days, Dr. Kollef said.

The current study included adult patients who had been hospitalized for at least 5 days, who were on mechanical ventilation, and who met clinical and radiographic criteria for pneumonia.

The study was funded by Johnson & Johnson, which markets doripenem. Dr. Kollef has been a speaker for Pfizer.

BELLEVUE, WASH. – Motivational interviewing techniques aren’t just a method for getting adolescents to pursue positive changes, but are a balm for the frayed nerves of physicians and parents, according to Dr. Cora C. Breuner.

A physician talking to an adolescent about, say, the dangers of smoking may be tense and frustrated because it seems impossible to connect with the teenager, who doesn’t like the direction of the discussion. If a parent is present, he or she is tense and frustrated too because the doctor doesn’t seem to be reaching the teen, Dr. Breuner added.

The problem usually is that the adolescent is in the early steps of motivation to change, but the physician and parents want action.

"You can’t get someone to go there without going through the previous steps. It’s impossible," said Dr. Breuner, professor of pediatrics and adolescent medicine at the University of Washington, Seattle. "There’s a huge disconnect between what we want to do and what they want to do," she said at the annual meeting of the North Pacific Pediatric Society.

The foundation of motivational interviewing is that change is not imposed, but elicited from the client. It’s the teenager’s task, not the counselor’s, to articulate and resolve his or her ambivalence, with the counselor’s directive assistance. The therapeutic relationship is more like a partnership or companionship than an expert/nonexpert dichotomy.

A good way to start is by talking about ambivalence, a word that adolescents love once you explain what it means. Dr. Breuner describes it as, "You’re kind of not sure. You feel two feelings, and it’s kind of crazy. You feel one thing and you think the other." That usually clicks with teenagers "because that’s their life, really," she said.

When discussing a problem behavior with an adolescent patient, she said she always writes the five stages of motivation to change on the white board in her office and describes them:

1. Precontemplation. This stage is also known as denial. The teenager may be thinking, "I don’t have a problem. You’re crazy. I’ve been smoking a long time. It’s no big deal. Everybody smokes. My mom and dad smoke."

2. Contemplation. "Maybe I have a problem, but I don’t want to do anything about it."

3. Preparation. "I have a problem and I want to do something about it, but not now. Maybe in a month."

4. Action. "I want to do something about it now. I need to stop doing this."

5. Maintenance or prevention of relapse. "How do I keep not smoking when all of my friends do?" (Or, depending on the problem, "How do I not drink when everybody around me drinks all the time? How do I stop spending so much time on the Internet, or so much time exercising, or talking, or working so hard?")

Dr. Breuner said she writes the stages on the board and asks the patient, "Where do you think you are?" Adolescents’ eyes go from glazed to engaged, and they always circle either "precontemplation" or "contemplation." Physicians and parents recognize that they are at "action."

The tension in the room instantly eases, she said. The physician and parent calm down because they’re no longer obsessing that the teenager will never listen to them. They’re now trying to understand the teen’s frame of reference and reinforce the teen’s motivation.

Dr. Breuner said she then breaks down the stage that the teen circled into a scale of 1-10. If a patient is in denial about smoking being a problem, that’s a 10 and the next stage, "contemplation," would be a 1. Dr. Breuner asks the patient where on that scale he or she fits in. If the adolescent picks, say, 8, Dr. Breuner asks what it might take to get the teen to be a 7.

The patient may say, "Tell me a little bit more about why it’s bad to be a smoker" (or bad to eat too much, or to exercise too little, or to keep his or her phone by the bed). Dr. Breuner provides some quick information in a nonjudgmental tone and ends with, "Come back and we’ll talk a little more about that."

Early follow-up is extremely important for motivational interviewing. Don’t wait 6 months for a follow-up visit, she said. Monitor the teen’s degree of readiness to change, but don’t jump ahead. Express acceptance of where the patient is in the stages, and affirm his or her freedom of choice and self-direction.

"Just try that. It’s so cool, because it works every time" to ease tensions in guiding the adolescent toward change, she said.

What doesn’t work is to argue that the patient has a problem and needs to change, or to offer direct advice or prescribe solutions to the problem without encouraging the patient to make his or her own choices. It doesn’t work when the counselor does most of the talking, functions as a unidirectional information delivery system, imposes a diagnostic label, or behaves in a punitive or coercive manner.

"That authoritative, ‘I’m perfect and you’re not’ approach – it doesn’t work," she said.

The tenets of motivational interviewing are a hot topic in medicine today, although they have been around since the 1970s, Dr. Breuner said. She drew on a 1995 article to describe motivational interviewing in her talk (Behav. Cogn. Psychother. 1995;23:325-34).

Dr. Breuner reported having no relevant financial disclosures.

BELLEVUE, WASH. – Motivational interviewing techniques aren’t just a method for getting adolescents to pursue positive changes, but are a balm for the frayed nerves of physicians and parents, according to Dr. Cora C. Breuner.

A physician talking to an adolescent about, say, the dangers of smoking may be tense and frustrated because it seems impossible to connect with the teenager, who doesn’t like the direction of the discussion. If a parent is present, he or she is tense and frustrated too because the doctor doesn’t seem to be reaching the teen, Dr. Breuner added.

The problem usually is that the adolescent is in the early steps of motivation to change, but the physician and parents want action.

"You can’t get someone to go there without going through the previous steps. It’s impossible," said Dr. Breuner, professor of pediatrics and adolescent medicine at the University of Washington, Seattle. "There’s a huge disconnect between what we want to do and what they want to do," she said at the annual meeting of the North Pacific Pediatric Society.

The foundation of motivational interviewing is that change is not imposed, but elicited from the client. It’s the teenager’s task, not the counselor’s, to articulate and resolve his or her ambivalence, with the counselor’s directive assistance. The therapeutic relationship is more like a partnership or companionship than an expert/nonexpert dichotomy.

A good way to start is by talking about ambivalence, a word that adolescents love once you explain what it means. Dr. Breuner describes it as, "You’re kind of not sure. You feel two feelings, and it’s kind of crazy. You feel one thing and you think the other." That usually clicks with teenagers "because that’s their life, really," she said.

When discussing a problem behavior with an adolescent patient, she said she always writes the five stages of motivation to change on the white board in her office and describes them:

1. Precontemplation. This stage is also known as denial. The teenager may be thinking, "I don’t have a problem. You’re crazy. I’ve been smoking a long time. It’s no big deal. Everybody smokes. My mom and dad smoke."

2. Contemplation. "Maybe I have a problem, but I don’t want to do anything about it."

3. Preparation. "I have a problem and I want to do something about it, but not now. Maybe in a month."

4. Action. "I want to do something about it now. I need to stop doing this."

5. Maintenance or prevention of relapse. "How do I keep not smoking when all of my friends do?" (Or, depending on the problem, "How do I not drink when everybody around me drinks all the time? How do I stop spending so much time on the Internet, or so much time exercising, or talking, or working so hard?")

Dr. Breuner said she writes the stages on the board and asks the patient, "Where do you think you are?" Adolescents’ eyes go from glazed to engaged, and they always circle either "precontemplation" or "contemplation." Physicians and parents recognize that they are at "action."

The tension in the room instantly eases, she said. The physician and parent calm down because they’re no longer obsessing that the teenager will never listen to them. They’re now trying to understand the teen’s frame of reference and reinforce the teen’s motivation.

Dr. Breuner said she then breaks down the stage that the teen circled into a scale of 1-10. If a patient is in denial about smoking being a problem, that’s a 10 and the next stage, "contemplation," would be a 1. Dr. Breuner asks the patient where on that scale he or she fits in. If the adolescent picks, say, 8, Dr. Breuner asks what it might take to get the teen to be a 7.

The patient may say, "Tell me a little bit more about why it’s bad to be a smoker" (or bad to eat too much, or to exercise too little, or to keep his or her phone by the bed). Dr. Breuner provides some quick information in a nonjudgmental tone and ends with, "Come back and we’ll talk a little more about that."

Early follow-up is extremely important for motivational interviewing. Don’t wait 6 months for a follow-up visit, she said. Monitor the teen’s degree of readiness to change, but don’t jump ahead. Express acceptance of where the patient is in the stages, and affirm his or her freedom of choice and self-direction.

"Just try that. It’s so cool, because it works every time" to ease tensions in guiding the adolescent toward change, she said.

What doesn’t work is to argue that the patient has a problem and needs to change, or to offer direct advice or prescribe solutions to the problem without encouraging the patient to make his or her own choices. It doesn’t work when the counselor does most of the talking, functions as a unidirectional information delivery system, imposes a diagnostic label, or behaves in a punitive or coercive manner.

"That authoritative, ‘I’m perfect and you’re not’ approach – it doesn’t work," she said.

The tenets of motivational interviewing are a hot topic in medicine today, although they have been around since the 1970s, Dr. Breuner said. She drew on a 1995 article to describe motivational interviewing in her talk (Behav. Cogn. Psychother. 1995;23:325-34).

Dr. Breuner reported having no relevant financial disclosures.

BELLEVUE, WASH. – Motivational interviewing techniques aren’t just a method for getting adolescents to pursue positive changes, but are a balm for the frayed nerves of physicians and parents, according to Dr. Cora C. Breuner.

A physician talking to an adolescent about, say, the dangers of smoking may be tense and frustrated because it seems impossible to connect with the teenager, who doesn’t like the direction of the discussion. If a parent is present, he or she is tense and frustrated too because the doctor doesn’t seem to be reaching the teen, Dr. Breuner added.

The problem usually is that the adolescent is in the early steps of motivation to change, but the physician and parents want action.

"You can’t get someone to go there without going through the previous steps. It’s impossible," said Dr. Breuner, professor of pediatrics and adolescent medicine at the University of Washington, Seattle. "There’s a huge disconnect between what we want to do and what they want to do," she said at the annual meeting of the North Pacific Pediatric Society.

The foundation of motivational interviewing is that change is not imposed, but elicited from the client. It’s the teenager’s task, not the counselor’s, to articulate and resolve his or her ambivalence, with the counselor’s directive assistance. The therapeutic relationship is more like a partnership or companionship than an expert/nonexpert dichotomy.

A good way to start is by talking about ambivalence, a word that adolescents love once you explain what it means. Dr. Breuner describes it as, "You’re kind of not sure. You feel two feelings, and it’s kind of crazy. You feel one thing and you think the other." That usually clicks with teenagers "because that’s their life, really," she said.

When discussing a problem behavior with an adolescent patient, she said she always writes the five stages of motivation to change on the white board in her office and describes them:

1. Precontemplation. This stage is also known as denial. The teenager may be thinking, "I don’t have a problem. You’re crazy. I’ve been smoking a long time. It’s no big deal. Everybody smokes. My mom and dad smoke."

2. Contemplation. "Maybe I have a problem, but I don’t want to do anything about it."

3. Preparation. "I have a problem and I want to do something about it, but not now. Maybe in a month."

4. Action. "I want to do something about it now. I need to stop doing this."

5. Maintenance or prevention of relapse. "How do I keep not smoking when all of my friends do?" (Or, depending on the problem, "How do I not drink when everybody around me drinks all the time? How do I stop spending so much time on the Internet, or so much time exercising, or talking, or working so hard?")

Dr. Breuner said she writes the stages on the board and asks the patient, "Where do you think you are?" Adolescents’ eyes go from glazed to engaged, and they always circle either "precontemplation" or "contemplation." Physicians and parents recognize that they are at "action."

The tension in the room instantly eases, she said. The physician and parent calm down because they’re no longer obsessing that the teenager will never listen to them. They’re now trying to understand the teen’s frame of reference and reinforce the teen’s motivation.

Dr. Breuner said she then breaks down the stage that the teen circled into a scale of 1-10. If a patient is in denial about smoking being a problem, that’s a 10 and the next stage, "contemplation," would be a 1. Dr. Breuner asks the patient where on that scale he or she fits in. If the adolescent picks, say, 8, Dr. Breuner asks what it might take to get the teen to be a 7.

The patient may say, "Tell me a little bit more about why it’s bad to be a smoker" (or bad to eat too much, or to exercise too little, or to keep his or her phone by the bed). Dr. Breuner provides some quick information in a nonjudgmental tone and ends with, "Come back and we’ll talk a little more about that."

Early follow-up is extremely important for motivational interviewing. Don’t wait 6 months for a follow-up visit, she said. Monitor the teen’s degree of readiness to change, but don’t jump ahead. Express acceptance of where the patient is in the stages, and affirm his or her freedom of choice and self-direction.

"Just try that. It’s so cool, because it works every time" to ease tensions in guiding the adolescent toward change, she said.

What doesn’t work is to argue that the patient has a problem and needs to change, or to offer direct advice or prescribe solutions to the problem without encouraging the patient to make his or her own choices. It doesn’t work when the counselor does most of the talking, functions as a unidirectional information delivery system, imposes a diagnostic label, or behaves in a punitive or coercive manner.

"That authoritative, ‘I’m perfect and you’re not’ approach – it doesn’t work," she said.

The tenets of motivational interviewing are a hot topic in medicine today, although they have been around since the 1970s, Dr. Breuner said. She drew on a 1995 article to describe motivational interviewing in her talk (Behav. Cogn. Psychother. 1995;23:325-34).

Dr. Breuner reported having no relevant financial disclosures.