Betsy Bates

RENO, NEV. — Patients taking extended-cycle oral contraceptives experienced about the same number of total bleeding days over 6 months as women taking a standard, 28-day oral contraception regimen, but they had significantly fewer days of moderate to heavy bleeding, a new study indicates.

“There is lower serum and urinary estrogen, [as well as] smaller ovaries and follicles, thinner endometrium, and improved patient symptomatology with a continuous oral contraceptive pill regimen,” Dr. Richard S. Legro reported at the annual meeting of the Society for Gynecologic Investigation.

The findings support the use of extended cycle suppression with oral estrogen (20 mcg) and progestin norethindrone acetate (1 mg) in a continuous regimen for indications such as endometriosis, hirsutism, and acne, Dr. Legro said at the meeting, where he presented the findings in poster form.

No pharmaceutical companies contributed funding for the study, which was financed in part by the National Institutes of Health, said Dr. Legro, a reproductive endocrinologist at Pennsylvania State University in Hershey, Pa.

Dr. Legro and his coinvestigators enrolled 62 normally cycling women in a double-blind, randomized controlled trial and followed them for symptoms, bleeding patterns, endometrial histology, follicular development, and serum and urinary levels of sex steroids. The women either took the standard regimen of oral contraceptives for 28 days per month with the traditional 7-day pill-free interval or they took the contraceptives continuously.

Although the number of bleeding days was reduced in women on the continuous OC regimen, the difference was not statistically significant due to a rebound in bleeding days by the study's conclusion, explained Dr. Legro.

The number of moderate to heavy bleeding days dropped to 1 day/month or less by cycle 2 in the continuous OC group, decreasing more slowly over time in women taking the 28-day OC regimen.

“If you biopsy, you get absolutely nothing [in patients on the continuous regimen]. There is no endometrium there,” Dr. Legro said in an interview at the meeting.

He said breakthrough bleeding in these patients might be explained by endometrial atrophy due to ovarian suppression, whereas in the 28-day group there was evidence for rebound follicular activity and ovulation following the pill-free interval.

Women taking continuous OC pills had a 25%–30% greater suppression of serum estrogen levels than those on the 28-day regimen.

Total ovarian volume, maximum diameter of the largest follicle, and endometrial thickness were all reduced significantly more in patients on the continuous regimen.

Scores on premenstrual pain, behavior, and distress scales were also lower for women assigned to receive continuous OC pills.

No differences were found between groups in terms of safety on measures of blood pressure, glucose and insulin levels, liver and renal profiles, thyroid-stimulating hormone, or lipids.

In patients on the continuous regimen, there is no endometrium there when you biopsy. DR. LEGRO

RENO, NEV. — Patients taking extended-cycle oral contraceptives experienced about the same number of total bleeding days over 6 months as women taking a standard, 28-day oral contraception regimen, but they had significantly fewer days of moderate to heavy bleeding, a new study indicates.

“There is lower serum and urinary estrogen, [as well as] smaller ovaries and follicles, thinner endometrium, and improved patient symptomatology with a continuous oral contraceptive pill regimen,” Dr. Richard S. Legro reported at the annual meeting of the Society for Gynecologic Investigation.

The findings support the use of extended cycle suppression with oral estrogen (20 mcg) and progestin norethindrone acetate (1 mg) in a continuous regimen for indications such as endometriosis, hirsutism, and acne, Dr. Legro said at the meeting, where he presented the findings in poster form.

No pharmaceutical companies contributed funding for the study, which was financed in part by the National Institutes of Health, said Dr. Legro, a reproductive endocrinologist at Pennsylvania State University in Hershey, Pa.

Dr. Legro and his coinvestigators enrolled 62 normally cycling women in a double-blind, randomized controlled trial and followed them for symptoms, bleeding patterns, endometrial histology, follicular development, and serum and urinary levels of sex steroids. The women either took the standard regimen of oral contraceptives for 28 days per month with the traditional 7-day pill-free interval or they took the contraceptives continuously.

Although the number of bleeding days was reduced in women on the continuous OC regimen, the difference was not statistically significant due to a rebound in bleeding days by the study's conclusion, explained Dr. Legro.

The number of moderate to heavy bleeding days dropped to 1 day/month or less by cycle 2 in the continuous OC group, decreasing more slowly over time in women taking the 28-day OC regimen.

“If you biopsy, you get absolutely nothing [in patients on the continuous regimen]. There is no endometrium there,” Dr. Legro said in an interview at the meeting.

He said breakthrough bleeding in these patients might be explained by endometrial atrophy due to ovarian suppression, whereas in the 28-day group there was evidence for rebound follicular activity and ovulation following the pill-free interval.

Women taking continuous OC pills had a 25%–30% greater suppression of serum estrogen levels than those on the 28-day regimen.

Total ovarian volume, maximum diameter of the largest follicle, and endometrial thickness were all reduced significantly more in patients on the continuous regimen.

Scores on premenstrual pain, behavior, and distress scales were also lower for women assigned to receive continuous OC pills.

No differences were found between groups in terms of safety on measures of blood pressure, glucose and insulin levels, liver and renal profiles, thyroid-stimulating hormone, or lipids.

In patients on the continuous regimen, there is no endometrium there when you biopsy. DR. LEGRO

RENO, NEV. — Patients taking extended-cycle oral contraceptives experienced about the same number of total bleeding days over 6 months as women taking a standard, 28-day oral contraception regimen, but they had significantly fewer days of moderate to heavy bleeding, a new study indicates.

“There is lower serum and urinary estrogen, [as well as] smaller ovaries and follicles, thinner endometrium, and improved patient symptomatology with a continuous oral contraceptive pill regimen,” Dr. Richard S. Legro reported at the annual meeting of the Society for Gynecologic Investigation.

The findings support the use of extended cycle suppression with oral estrogen (20 mcg) and progestin norethindrone acetate (1 mg) in a continuous regimen for indications such as endometriosis, hirsutism, and acne, Dr. Legro said at the meeting, where he presented the findings in poster form.

No pharmaceutical companies contributed funding for the study, which was financed in part by the National Institutes of Health, said Dr. Legro, a reproductive endocrinologist at Pennsylvania State University in Hershey, Pa.

Dr. Legro and his coinvestigators enrolled 62 normally cycling women in a double-blind, randomized controlled trial and followed them for symptoms, bleeding patterns, endometrial histology, follicular development, and serum and urinary levels of sex steroids. The women either took the standard regimen of oral contraceptives for 28 days per month with the traditional 7-day pill-free interval or they took the contraceptives continuously.

Although the number of bleeding days was reduced in women on the continuous OC regimen, the difference was not statistically significant due to a rebound in bleeding days by the study's conclusion, explained Dr. Legro.

The number of moderate to heavy bleeding days dropped to 1 day/month or less by cycle 2 in the continuous OC group, decreasing more slowly over time in women taking the 28-day OC regimen.

“If you biopsy, you get absolutely nothing [in patients on the continuous regimen]. There is no endometrium there,” Dr. Legro said in an interview at the meeting.

He said breakthrough bleeding in these patients might be explained by endometrial atrophy due to ovarian suppression, whereas in the 28-day group there was evidence for rebound follicular activity and ovulation following the pill-free interval.

Women taking continuous OC pills had a 25%–30% greater suppression of serum estrogen levels than those on the 28-day regimen.

Total ovarian volume, maximum diameter of the largest follicle, and endometrial thickness were all reduced significantly more in patients on the continuous regimen.

Scores on premenstrual pain, behavior, and distress scales were also lower for women assigned to receive continuous OC pills.

No differences were found between groups in terms of safety on measures of blood pressure, glucose and insulin levels, liver and renal profiles, thyroid-stimulating hormone, or lipids.

In patients on the continuous regimen, there is no endometrium there when you biopsy. DR. LEGRO

SAN DIEGO — Roughly two-thirds of new chlamydia cases are being missed because of lax attention to screening guidelines by primary care physicians, obstetrician-gynecologists, and pediatricians, Dr. David E. Soper said at the annual meeting of the American College of Obstetricians and Gynecologists.

Chlamydia remains the most common sexually transmitted disease in the United States, with more than 976,000 new cases reported each year and an estimated 2 million cases going undiagnosed.

Women with undetected, untreated chlamydia face at least a 40% chance of being diagnosed with pelvic inflammatory disease (PID). “We're not screening like we really should, despite highly sensitive and very specific tests,” said Dr. Soper, professor of ob.gyn. at the Medical University of South Carolina, Charleston.

“I think collectively we're not doing a good job.”

Screening is particularly lacking for adolescents, who have the highest rates of chlamydia in the United States, and for privately insured women, he said during a press conference highlighting the issue.

Among women covered by Medicare, “modest gains” were made in 2006, with almost half of sexually active women aged 25 and younger being screened annually, as recommended by ACOG, the Centers for Disease Control and Prevention, and the U.S. Preventive Services Task Force.

Far fewer commercially insured women—“maybe 35% or 40%”—are receiving annual screening, according to data from State of Health Care Quality reports, he said.

“We'd like to see these rates go up to the 90% range,” Dr. Soper said.

Besides the annual screening of women aged 25 years and younger, screening is recommended for other women in high-risk groups as well, including those with new or multiple sexual partners and those with a prior history of sexually transmitted disease.

Routine screening of men is not currently recommended, although it may be considered in areas of high prevalence.

Currently, the prevalence of chlamydia ranges from 4% to 12%; recent testing of asymptomatic female Army recruits in the San Francisco area identified 9% with the infection.

If women were screened as recommended and treated, if infected, with a single dose of 1 g of azithromycin, an estimated 140,000 cases of PID a year could be prevented, Dr. Soper said.

This has the potential of saving $45 in health costs for every woman screened, making chlamydia screening one of the most effective but underutilized preventive health services targeted by the CDC and the Agency for Healthcare Research and Quality.

Treatment of PID and its consequences—including infertility, ectopic pregnancy, and chronic pelvic pain—now exceeds $3.5 billion a year.

Dr. Laura E. Riley, medical director of labor and delivery at Massachusetts General Hospital, Boston, called the sequelae of untreated chlamydia “devastating,” not only for women, but for their exposed infants.

Babies born to mothers with untreated chlamydia have a 25%–30% chance of developing chlamydial conjunctivitis, and up to a 40% chance of developing chlamydial pneumonia.

During pregnancy, a single dose of azithromycin can be used to treat chlamydia, but women should be retested for proof of cure after 3 weeks to ensure that the disease has cleared. Infants can be treated with erythromycin; however, many require retreatment, she said.

Both physicians stressed the efficacy of the nucleic acid amplification testing (NAAT) method and noted that urine samples, as well as endocervical or vaginal swabs, may be used to make the diagnosis.

They urged physicians not only to screen for chlamydia, but to regularly talk with patients about STD prevention strategies, including abstinence, monogamy, or use of a condom during every sexual contact.

SAN DIEGO — Roughly two-thirds of new chlamydia cases are being missed because of lax attention to screening guidelines by primary care physicians, obstetrician-gynecologists, and pediatricians, Dr. David E. Soper said at the annual meeting of the American College of Obstetricians and Gynecologists.

Chlamydia remains the most common sexually transmitted disease in the United States, with more than 976,000 new cases reported each year and an estimated 2 million cases going undiagnosed.

Women with undetected, untreated chlamydia face at least a 40% chance of being diagnosed with pelvic inflammatory disease (PID). “We're not screening like we really should, despite highly sensitive and very specific tests,” said Dr. Soper, professor of ob.gyn. at the Medical University of South Carolina, Charleston.

“I think collectively we're not doing a good job.”

Screening is particularly lacking for adolescents, who have the highest rates of chlamydia in the United States, and for privately insured women, he said during a press conference highlighting the issue.

Among women covered by Medicare, “modest gains” were made in 2006, with almost half of sexually active women aged 25 and younger being screened annually, as recommended by ACOG, the Centers for Disease Control and Prevention, and the U.S. Preventive Services Task Force.

Far fewer commercially insured women—“maybe 35% or 40%”—are receiving annual screening, according to data from State of Health Care Quality reports, he said.

“We'd like to see these rates go up to the 90% range,” Dr. Soper said.

Besides the annual screening of women aged 25 years and younger, screening is recommended for other women in high-risk groups as well, including those with new or multiple sexual partners and those with a prior history of sexually transmitted disease.

Routine screening of men is not currently recommended, although it may be considered in areas of high prevalence.

Currently, the prevalence of chlamydia ranges from 4% to 12%; recent testing of asymptomatic female Army recruits in the San Francisco area identified 9% with the infection.

If women were screened as recommended and treated, if infected, with a single dose of 1 g of azithromycin, an estimated 140,000 cases of PID a year could be prevented, Dr. Soper said.

This has the potential of saving $45 in health costs for every woman screened, making chlamydia screening one of the most effective but underutilized preventive health services targeted by the CDC and the Agency for Healthcare Research and Quality.

Treatment of PID and its consequences—including infertility, ectopic pregnancy, and chronic pelvic pain—now exceeds $3.5 billion a year.

Dr. Laura E. Riley, medical director of labor and delivery at Massachusetts General Hospital, Boston, called the sequelae of untreated chlamydia “devastating,” not only for women, but for their exposed infants.

Babies born to mothers with untreated chlamydia have a 25%–30% chance of developing chlamydial conjunctivitis, and up to a 40% chance of developing chlamydial pneumonia.

During pregnancy, a single dose of azithromycin can be used to treat chlamydia, but women should be retested for proof of cure after 3 weeks to ensure that the disease has cleared. Infants can be treated with erythromycin; however, many require retreatment, she said.

Both physicians stressed the efficacy of the nucleic acid amplification testing (NAAT) method and noted that urine samples, as well as endocervical or vaginal swabs, may be used to make the diagnosis.

They urged physicians not only to screen for chlamydia, but to regularly talk with patients about STD prevention strategies, including abstinence, monogamy, or use of a condom during every sexual contact.

SAN DIEGO — Roughly two-thirds of new chlamydia cases are being missed because of lax attention to screening guidelines by primary care physicians, obstetrician-gynecologists, and pediatricians, Dr. David E. Soper said at the annual meeting of the American College of Obstetricians and Gynecologists.

Chlamydia remains the most common sexually transmitted disease in the United States, with more than 976,000 new cases reported each year and an estimated 2 million cases going undiagnosed.

Women with undetected, untreated chlamydia face at least a 40% chance of being diagnosed with pelvic inflammatory disease (PID). “We're not screening like we really should, despite highly sensitive and very specific tests,” said Dr. Soper, professor of ob.gyn. at the Medical University of South Carolina, Charleston.

“I think collectively we're not doing a good job.”

Screening is particularly lacking for adolescents, who have the highest rates of chlamydia in the United States, and for privately insured women, he said during a press conference highlighting the issue.

Among women covered by Medicare, “modest gains” were made in 2006, with almost half of sexually active women aged 25 and younger being screened annually, as recommended by ACOG, the Centers for Disease Control and Prevention, and the U.S. Preventive Services Task Force.

Far fewer commercially insured women—“maybe 35% or 40%”—are receiving annual screening, according to data from State of Health Care Quality reports, he said.

“We'd like to see these rates go up to the 90% range,” Dr. Soper said.

Besides the annual screening of women aged 25 years and younger, screening is recommended for other women in high-risk groups as well, including those with new or multiple sexual partners and those with a prior history of sexually transmitted disease.

Routine screening of men is not currently recommended, although it may be considered in areas of high prevalence.

Currently, the prevalence of chlamydia ranges from 4% to 12%; recent testing of asymptomatic female Army recruits in the San Francisco area identified 9% with the infection.

If women were screened as recommended and treated, if infected, with a single dose of 1 g of azithromycin, an estimated 140,000 cases of PID a year could be prevented, Dr. Soper said.

This has the potential of saving $45 in health costs for every woman screened, making chlamydia screening one of the most effective but underutilized preventive health services targeted by the CDC and the Agency for Healthcare Research and Quality.

Treatment of PID and its consequences—including infertility, ectopic pregnancy, and chronic pelvic pain—now exceeds $3.5 billion a year.

Dr. Laura E. Riley, medical director of labor and delivery at Massachusetts General Hospital, Boston, called the sequelae of untreated chlamydia “devastating,” not only for women, but for their exposed infants.

Babies born to mothers with untreated chlamydia have a 25%–30% chance of developing chlamydial conjunctivitis, and up to a 40% chance of developing chlamydial pneumonia.

During pregnancy, a single dose of azithromycin can be used to treat chlamydia, but women should be retested for proof of cure after 3 weeks to ensure that the disease has cleared. Infants can be treated with erythromycin; however, many require retreatment, she said.

Both physicians stressed the efficacy of the nucleic acid amplification testing (NAAT) method and noted that urine samples, as well as endocervical or vaginal swabs, may be used to make the diagnosis.

They urged physicians not only to screen for chlamydia, but to regularly talk with patients about STD prevention strategies, including abstinence, monogamy, or use of a condom during every sexual contact.

SAN DIEGO — Roughly two-thirds of new chlamydia cases are currently being missed because of lax attention to screening guidelines by primary care physicians, obstetrician-gynecologists, and pediatricians, Dr. David E. Soper said at the annual meeting of the American College of Obstetricians and Gynecologists.

A sexually transmitted bacterial infection, chlamydia remains the most common sexually transmitted disease in the United States, with more than 976,000 new cases reported each year and an estimated 2 million cases going undiagnosed.

Women with undetected, untreated chlamydia face at least a 40% chance of being diagnosed with pelvic inflammatory disease (PID).

“We're not screening like we really should, despite highly sensitive and very specific tests,” said Dr. Soper, professor of ob.gyn. at the Medical University of South Carolina, Charleston. “I think collectively we're not doing a good job.”

Screening is particularly lacking for adolescents, who have the highest rates of chlamydia in the United States, and for privately insured women, he said during a press conference highlighting the issue.

Among women covered by Medicare, “modest gains” were made in 2006, with almost half of sexually active women aged 25 and younger being screened annually, as recommended by ACOG, the Centers for Disease Control and Prevention, and the U.S. Preventive Services Task Force.

Far fewer commercially insured women —“maybe 35% or 40%”—are receiving annual screening, according to data from State of Health Care Quality reports, he said. “We'd like to see these rates go up to the 90% range.”

Besides the annual screening of women aged 25 years and younger, screening is recommended for other women in high-risk groups as well, including those with new or multiple sexual partners and those with a prior history of sexually transmitted disease. Routine screening of men is not currently recommended, although it may be considered in areas of high prevalence.

Currently, the prevalence of chlamydia ranges from 4% to 12%; recent testing of asymptomatic female Army recruits in the San Francisco area identified 9% with the infection. If women were screened as recommended and treated, if infected, with a single dose of 1 g of azithro- mycin, about 140,000 cases of PID a year could be prevented, Dr. Soper said. This could save $45 in health costs for every woman screened, making chlamydia screening one of the most effective but underutilized preventive health services targeted by the CDC and the Agency for Healthcare Research and Quality.

Treatment of PID and its consequences—including infertility, ectopic pregnancy, and chronic pelvic pain—now exceeds $3.5 billion a year.

Dr. Laura E. Riley, medical director of labor and delivery at Massachusetts General Hospital, Boston, called the sequelae of untreated chlamydia “devastating,” not only for women, but for their exposed infants.

Babies born to mothers with untreated chlamydia have a 25%–30% chance of developing chlamydial conjunctivitis, and up to a 40% chance of developing chlamydial pneumonia.

During pregnancy, a single dose of azithromycin can be used to treat chlamydia, but women should be retested for proof of cure after 3 weeks to ensure that the disease has cleared. Infants can be treated with erythromycin; however, many require retreatment, she said.

Both physicians stressed the efficacy of the nucleic acid amplification testing (NAAT) method and noted that urine samples, as well as endocervical or vaginal swabs, may be used to make the diagnosis.

They urged physicians not only to screen for chlamydia, but to regularly talk with their patients about STD prevention strategies, including abstinence, monogamy, or use of a condom during every sexual contact.

SAN DIEGO — Roughly two-thirds of new chlamydia cases are currently being missed because of lax attention to screening guidelines by primary care physicians, obstetrician-gynecologists, and pediatricians, Dr. David E. Soper said at the annual meeting of the American College of Obstetricians and Gynecologists.

A sexually transmitted bacterial infection, chlamydia remains the most common sexually transmitted disease in the United States, with more than 976,000 new cases reported each year and an estimated 2 million cases going undiagnosed.

Women with undetected, untreated chlamydia face at least a 40% chance of being diagnosed with pelvic inflammatory disease (PID).

“We're not screening like we really should, despite highly sensitive and very specific tests,” said Dr. Soper, professor of ob.gyn. at the Medical University of South Carolina, Charleston. “I think collectively we're not doing a good job.”

Screening is particularly lacking for adolescents, who have the highest rates of chlamydia in the United States, and for privately insured women, he said during a press conference highlighting the issue.

Among women covered by Medicare, “modest gains” were made in 2006, with almost half of sexually active women aged 25 and younger being screened annually, as recommended by ACOG, the Centers for Disease Control and Prevention, and the U.S. Preventive Services Task Force.

Far fewer commercially insured women —“maybe 35% or 40%”—are receiving annual screening, according to data from State of Health Care Quality reports, he said. “We'd like to see these rates go up to the 90% range.”

Besides the annual screening of women aged 25 years and younger, screening is recommended for other women in high-risk groups as well, including those with new or multiple sexual partners and those with a prior history of sexually transmitted disease. Routine screening of men is not currently recommended, although it may be considered in areas of high prevalence.

Currently, the prevalence of chlamydia ranges from 4% to 12%; recent testing of asymptomatic female Army recruits in the San Francisco area identified 9% with the infection. If women were screened as recommended and treated, if infected, with a single dose of 1 g of azithro- mycin, about 140,000 cases of PID a year could be prevented, Dr. Soper said. This could save $45 in health costs for every woman screened, making chlamydia screening one of the most effective but underutilized preventive health services targeted by the CDC and the Agency for Healthcare Research and Quality.

Treatment of PID and its consequences—including infertility, ectopic pregnancy, and chronic pelvic pain—now exceeds $3.5 billion a year.

Dr. Laura E. Riley, medical director of labor and delivery at Massachusetts General Hospital, Boston, called the sequelae of untreated chlamydia “devastating,” not only for women, but for their exposed infants.

Babies born to mothers with untreated chlamydia have a 25%–30% chance of developing chlamydial conjunctivitis, and up to a 40% chance of developing chlamydial pneumonia.

During pregnancy, a single dose of azithromycin can be used to treat chlamydia, but women should be retested for proof of cure after 3 weeks to ensure that the disease has cleared. Infants can be treated with erythromycin; however, many require retreatment, she said.

Both physicians stressed the efficacy of the nucleic acid amplification testing (NAAT) method and noted that urine samples, as well as endocervical or vaginal swabs, may be used to make the diagnosis.

They urged physicians not only to screen for chlamydia, but to regularly talk with their patients about STD prevention strategies, including abstinence, monogamy, or use of a condom during every sexual contact.

SAN DIEGO — Roughly two-thirds of new chlamydia cases are currently being missed because of lax attention to screening guidelines by primary care physicians, obstetrician-gynecologists, and pediatricians, Dr. David E. Soper said at the annual meeting of the American College of Obstetricians and Gynecologists.

A sexually transmitted bacterial infection, chlamydia remains the most common sexually transmitted disease in the United States, with more than 976,000 new cases reported each year and an estimated 2 million cases going undiagnosed.

Women with undetected, untreated chlamydia face at least a 40% chance of being diagnosed with pelvic inflammatory disease (PID).

“We're not screening like we really should, despite highly sensitive and very specific tests,” said Dr. Soper, professor of ob.gyn. at the Medical University of South Carolina, Charleston. “I think collectively we're not doing a good job.”

Screening is particularly lacking for adolescents, who have the highest rates of chlamydia in the United States, and for privately insured women, he said during a press conference highlighting the issue.

Among women covered by Medicare, “modest gains” were made in 2006, with almost half of sexually active women aged 25 and younger being screened annually, as recommended by ACOG, the Centers for Disease Control and Prevention, and the U.S. Preventive Services Task Force.

Far fewer commercially insured women —“maybe 35% or 40%”—are receiving annual screening, according to data from State of Health Care Quality reports, he said. “We'd like to see these rates go up to the 90% range.”

Besides the annual screening of women aged 25 years and younger, screening is recommended for other women in high-risk groups as well, including those with new or multiple sexual partners and those with a prior history of sexually transmitted disease. Routine screening of men is not currently recommended, although it may be considered in areas of high prevalence.

Currently, the prevalence of chlamydia ranges from 4% to 12%; recent testing of asymptomatic female Army recruits in the San Francisco area identified 9% with the infection. If women were screened as recommended and treated, if infected, with a single dose of 1 g of azithro- mycin, about 140,000 cases of PID a year could be prevented, Dr. Soper said. This could save $45 in health costs for every woman screened, making chlamydia screening one of the most effective but underutilized preventive health services targeted by the CDC and the Agency for Healthcare Research and Quality.

Treatment of PID and its consequences—including infertility, ectopic pregnancy, and chronic pelvic pain—now exceeds $3.5 billion a year.

Dr. Laura E. Riley, medical director of labor and delivery at Massachusetts General Hospital, Boston, called the sequelae of untreated chlamydia “devastating,” not only for women, but for their exposed infants.

Babies born to mothers with untreated chlamydia have a 25%–30% chance of developing chlamydial conjunctivitis, and up to a 40% chance of developing chlamydial pneumonia.

During pregnancy, a single dose of azithromycin can be used to treat chlamydia, but women should be retested for proof of cure after 3 weeks to ensure that the disease has cleared. Infants can be treated with erythromycin; however, many require retreatment, she said.

Both physicians stressed the efficacy of the nucleic acid amplification testing (NAAT) method and noted that urine samples, as well as endocervical or vaginal swabs, may be used to make the diagnosis.

They urged physicians not only to screen for chlamydia, but to regularly talk with their patients about STD prevention strategies, including abstinence, monogamy, or use of a condom during every sexual contact.

RENO, NEV. — Significant racial differences in proinflammatory biomarkers during pregnancy may help to illuminate reasons for disparate rates of preterm birth between black and white women, according to speakers at the annual meeting of the Society for Gynecologic Investigation.

In one study, researchers seeking to establish normal ranges of serum C-reactive protein (CRP) during pregnancy discovered that mean CRP values were elevated for both black and white women, establishing that normal pregnancy is an inflammatory state.

Surprisingly, however, they found that serum CRP values were much higher for black women than for white women, independent of maternal weight, and these differences persisted from earliest pregnancy through 26 weeks' gestation—the last point at which they were measured in the study.

“[By using a multivariate analysis model] … we discovered that black race and sociodemographic characteristics were the strongest predictors of elevated CRP values [in pregnancy],” reported Dr. Amy H. Picklesimer, a fellow in maternal-fetal medicine at the University of North Carolina, Chapel Hill.

Meanwhile, a second study found highly significant differences in concentrations of tumor necrosis factor-α (TNA-α) in black women who gave birth at less than 37 weeks, compared with black women who gave birth at term, but no differences between white women with preterm and those with term deliveries.

“These findings alone do not explain the racial difference in preterm birth rates between blacks and whites,” Dr. Ramkumar Menon said, referring to the results of his study conducted at the Perinatal Research Center of Nashville, Tenn., in conjunction with Vanderbilt University, Nashville, and the North Atlantic Neuro Epidemiologic Alliance of Aarhus University (Denmark).

“However, they do suggest a substantial racial difference in one of the important hypothesized pathways,” he said.

The two studies were featured in an oral scientific session on parturition.

Dr. Picklesimer and associates conducted a secondary analysis of a cross-sectional study of 775 women aimed at assessing oral health in pregnancy. Highly sensitive ELISA assays were used to characterize CRP values in serum specimens drawn prior to 26 weeks in the cohort, which consisted of 48% white women, 46% black women, and 6% women of other ethnicities.

CRP is an acute-phase reactant produced in response to stress, trauma, or other stimuli. In nonpregnant women, it is increasingly viewed as an important noninvasive marker of vascular inflammation relevant to cardiovascular disease, with a threshold of more than 3 mg/L deemed to indicate high risk, she said.

The median serum CRP in pregnant women surpassed that threshold, at 4.8 mg/L, with an interquartile range of 0.63–15.7 mg/L.

Among white women, median CRP values were significantly higher in the second trimester than in the first.

Black women had much higher values than white women at enrollment (7.68 mg/L vs. 2.59 mg/L), and these values remained persistently elevated in the second trimester.

Statistical analysis determined that black race was the characteristic most strongly associated with CRP values in the 75th percentile, along with maternal weight at enrollment, eligibility for the Women, Infants and Children nutrition program or food stamps, lack of private insurance, unmarried status, and previous preterm birth.

A multivariate analysis confirmed the independent association of black race and socioeconomic factors, even when statistical adjustment was made for known associations such as maternal weight.

“The most important implication of our result is to caution investigators and clinicians in their interpretations of CRP values in pregnant women and to illuminate the important influence that socioeconomic characteristics seem to have on these values,” Dr. Picklesimer said.

She postulated that genetic polymorphisms could play a role in the disparity.

“Another explanation may lie in the broader social and environmental differences observed between racial groups … [with] elevated CRP [resulting] from chronic stress caused by a lifetime of socioeconomic disadvantages,” Dr. Picklesimer said.

Dr. Menon's group examined inflammatory markers during active labor in the amniotic fluid of 158 women (52 black women and 106 white women) who spontaneously delivered prior to 37 weeks and 175 women (87 black women and 88 white women) who delivered spontaneously at 37 weeks or beyond.

No significant differences were seen between black and white women in terms of demographic or clinical features such as fever.

Among all women, TNF-α concentrations were higher in amniotic fluid from preterm births; however, this difference was almost fully accounted for by black women.

Black women who gave birth early had a 22.5-fold increase in TNF-α concentration, compared with black women who had term deliveries, but there was no significant difference between white women who had preterm or at term deliveries.

The same pattern was seen in soluble TNF-receptor concentrations, Dr. Menon reported.

A high degree of disparity between black and white women in the molar ratio of TNF-α and soluble TNF-receptor concentration “may be indicative of a TNF-α-mediated pathological process of preterm birth in blacks, but maybe not in whites,” he said at the meeting.

RENO, NEV. — Significant racial differences in proinflammatory biomarkers during pregnancy may help to illuminate reasons for disparate rates of preterm birth between black and white women, according to speakers at the annual meeting of the Society for Gynecologic Investigation.

In one study, researchers seeking to establish normal ranges of serum C-reactive protein (CRP) during pregnancy discovered that mean CRP values were elevated for both black and white women, establishing that normal pregnancy is an inflammatory state.

Surprisingly, however, they found that serum CRP values were much higher for black women than for white women, independent of maternal weight, and these differences persisted from earliest pregnancy through 26 weeks' gestation—the last point at which they were measured in the study.

“[By using a multivariate analysis model] … we discovered that black race and sociodemographic characteristics were the strongest predictors of elevated CRP values [in pregnancy],” reported Dr. Amy H. Picklesimer, a fellow in maternal-fetal medicine at the University of North Carolina, Chapel Hill.

Meanwhile, a second study found highly significant differences in concentrations of tumor necrosis factor-α (TNA-α) in black women who gave birth at less than 37 weeks, compared with black women who gave birth at term, but no differences between white women with preterm and those with term deliveries.

“These findings alone do not explain the racial difference in preterm birth rates between blacks and whites,” Dr. Ramkumar Menon said, referring to the results of his study conducted at the Perinatal Research Center of Nashville, Tenn., in conjunction with Vanderbilt University, Nashville, and the North Atlantic Neuro Epidemiologic Alliance of Aarhus University (Denmark).

“However, they do suggest a substantial racial difference in one of the important hypothesized pathways,” he said.

The two studies were featured in an oral scientific session on parturition.

Dr. Picklesimer and associates conducted a secondary analysis of a cross-sectional study of 775 women aimed at assessing oral health in pregnancy. Highly sensitive ELISA assays were used to characterize CRP values in serum specimens drawn prior to 26 weeks in the cohort, which consisted of 48% white women, 46% black women, and 6% women of other ethnicities.

CRP is an acute-phase reactant produced in response to stress, trauma, or other stimuli. In nonpregnant women, it is increasingly viewed as an important noninvasive marker of vascular inflammation relevant to cardiovascular disease, with a threshold of more than 3 mg/L deemed to indicate high risk, she said.

The median serum CRP in pregnant women surpassed that threshold, at 4.8 mg/L, with an interquartile range of 0.63–15.7 mg/L.

Among white women, median CRP values were significantly higher in the second trimester than in the first.

Black women had much higher values than white women at enrollment (7.68 mg/L vs. 2.59 mg/L), and these values remained persistently elevated in the second trimester.

Statistical analysis determined that black race was the characteristic most strongly associated with CRP values in the 75th percentile, along with maternal weight at enrollment, eligibility for the Women, Infants and Children nutrition program or food stamps, lack of private insurance, unmarried status, and previous preterm birth.

A multivariate analysis confirmed the independent association of black race and socioeconomic factors, even when statistical adjustment was made for known associations such as maternal weight.

“The most important implication of our result is to caution investigators and clinicians in their interpretations of CRP values in pregnant women and to illuminate the important influence that socioeconomic characteristics seem to have on these values,” Dr. Picklesimer said.

She postulated that genetic polymorphisms could play a role in the disparity.

“Another explanation may lie in the broader social and environmental differences observed between racial groups … [with] elevated CRP [resulting] from chronic stress caused by a lifetime of socioeconomic disadvantages,” Dr. Picklesimer said.

Dr. Menon's group examined inflammatory markers during active labor in the amniotic fluid of 158 women (52 black women and 106 white women) who spontaneously delivered prior to 37 weeks and 175 women (87 black women and 88 white women) who delivered spontaneously at 37 weeks or beyond.

No significant differences were seen between black and white women in terms of demographic or clinical features such as fever.

Among all women, TNF-α concentrations were higher in amniotic fluid from preterm births; however, this difference was almost fully accounted for by black women.

Black women who gave birth early had a 22.5-fold increase in TNF-α concentration, compared with black women who had term deliveries, but there was no significant difference between white women who had preterm or at term deliveries.

The same pattern was seen in soluble TNF-receptor concentrations, Dr. Menon reported.

A high degree of disparity between black and white women in the molar ratio of TNF-α and soluble TNF-receptor concentration “may be indicative of a TNF-α-mediated pathological process of preterm birth in blacks, but maybe not in whites,” he said at the meeting.

RENO, NEV. — Significant racial differences in proinflammatory biomarkers during pregnancy may help to illuminate reasons for disparate rates of preterm birth between black and white women, according to speakers at the annual meeting of the Society for Gynecologic Investigation.

In one study, researchers seeking to establish normal ranges of serum C-reactive protein (CRP) during pregnancy discovered that mean CRP values were elevated for both black and white women, establishing that normal pregnancy is an inflammatory state.

Surprisingly, however, they found that serum CRP values were much higher for black women than for white women, independent of maternal weight, and these differences persisted from earliest pregnancy through 26 weeks' gestation—the last point at which they were measured in the study.

“[By using a multivariate analysis model] … we discovered that black race and sociodemographic characteristics were the strongest predictors of elevated CRP values [in pregnancy],” reported Dr. Amy H. Picklesimer, a fellow in maternal-fetal medicine at the University of North Carolina, Chapel Hill.

Meanwhile, a second study found highly significant differences in concentrations of tumor necrosis factor-α (TNA-α) in black women who gave birth at less than 37 weeks, compared with black women who gave birth at term, but no differences between white women with preterm and those with term deliveries.

“These findings alone do not explain the racial difference in preterm birth rates between blacks and whites,” Dr. Ramkumar Menon said, referring to the results of his study conducted at the Perinatal Research Center of Nashville, Tenn., in conjunction with Vanderbilt University, Nashville, and the North Atlantic Neuro Epidemiologic Alliance of Aarhus University (Denmark).

“However, they do suggest a substantial racial difference in one of the important hypothesized pathways,” he said.

The two studies were featured in an oral scientific session on parturition.

Dr. Picklesimer and associates conducted a secondary analysis of a cross-sectional study of 775 women aimed at assessing oral health in pregnancy. Highly sensitive ELISA assays were used to characterize CRP values in serum specimens drawn prior to 26 weeks in the cohort, which consisted of 48% white women, 46% black women, and 6% women of other ethnicities.

CRP is an acute-phase reactant produced in response to stress, trauma, or other stimuli. In nonpregnant women, it is increasingly viewed as an important noninvasive marker of vascular inflammation relevant to cardiovascular disease, with a threshold of more than 3 mg/L deemed to indicate high risk, she said.

The median serum CRP in pregnant women surpassed that threshold, at 4.8 mg/L, with an interquartile range of 0.63–15.7 mg/L.

Among white women, median CRP values were significantly higher in the second trimester than in the first.

Black women had much higher values than white women at enrollment (7.68 mg/L vs. 2.59 mg/L), and these values remained persistently elevated in the second trimester.

Statistical analysis determined that black race was the characteristic most strongly associated with CRP values in the 75th percentile, along with maternal weight at enrollment, eligibility for the Women, Infants and Children nutrition program or food stamps, lack of private insurance, unmarried status, and previous preterm birth.

A multivariate analysis confirmed the independent association of black race and socioeconomic factors, even when statistical adjustment was made for known associations such as maternal weight.

“The most important implication of our result is to caution investigators and clinicians in their interpretations of CRP values in pregnant women and to illuminate the important influence that socioeconomic characteristics seem to have on these values,” Dr. Picklesimer said.

She postulated that genetic polymorphisms could play a role in the disparity.

“Another explanation may lie in the broader social and environmental differences observed between racial groups … [with] elevated CRP [resulting] from chronic stress caused by a lifetime of socioeconomic disadvantages,” Dr. Picklesimer said.

Dr. Menon's group examined inflammatory markers during active labor in the amniotic fluid of 158 women (52 black women and 106 white women) who spontaneously delivered prior to 37 weeks and 175 women (87 black women and 88 white women) who delivered spontaneously at 37 weeks or beyond.

No significant differences were seen between black and white women in terms of demographic or clinical features such as fever.

Among all women, TNF-α concentrations were higher in amniotic fluid from preterm births; however, this difference was almost fully accounted for by black women.

Black women who gave birth early had a 22.5-fold increase in TNF-α concentration, compared with black women who had term deliveries, but there was no significant difference between white women who had preterm or at term deliveries.

The same pattern was seen in soluble TNF-receptor concentrations, Dr. Menon reported.

A high degree of disparity between black and white women in the molar ratio of TNF-α and soluble TNF-receptor concentration “may be indicative of a TNF-α-mediated pathological process of preterm birth in blacks, but maybe not in whites,” he said at the meeting.

RENO, NEV. — Five key factors predicted successful external cephalic version in a meta-analysis of 43 primary articles describing 8,089 cases, reported Dr. Marjolein Kok at the annual meeting of the Society for Gynecologic Investigation.

Predictors of success, in order, included the following:

▸ Uterine relaxation (odds ratio 19; 95% confidence interval 3.1–3.9).

▸ Nonengagement (OR 10; CI 6.6–15).

▸ Palpable fetal head (OR 9.4; CI 6.0–15).

▸ Multiparity (OR 3.5; CI 3.1–3.9).

▸ Maternal weight less than 65 kg (OR 1.8; CI 1.2–2.6).

Most studies included in the review were prospective cohort studies, said Dr. Kok in an interview at the meeting, where she presented her findings in poster form.

Studies were reviewed from Medline, Embase, Cochrane Library, and manual searching of bibliographies of known primary and review articles. Articles were included if they reported on both potential clinical prognosticators and external cephalic version success rates.

The final conclusions not only illuminated factors associated with success but offer a way to weigh the importance of each factor. For example, a relaxed uterus is 20 times more likely to predict success, making it a more important prognostic variable than maternal weight.

Dr. Kok, an obstetrician and registrar at the Academic Medical Center in Amsterdam, was assisted in the study by colleagues in the ob.gyn. department at her institution and by Dr. Ben Willem Mol of Maxima Medical Centre Veldhoven in the Netherlands.

RENO, NEV. — Five key factors predicted successful external cephalic version in a meta-analysis of 43 primary articles describing 8,089 cases, reported Dr. Marjolein Kok at the annual meeting of the Society for Gynecologic Investigation.

Predictors of success, in order, included the following:

▸ Uterine relaxation (odds ratio 19; 95% confidence interval 3.1–3.9).

▸ Nonengagement (OR 10; CI 6.6–15).

▸ Palpable fetal head (OR 9.4; CI 6.0–15).

▸ Multiparity (OR 3.5; CI 3.1–3.9).

▸ Maternal weight less than 65 kg (OR 1.8; CI 1.2–2.6).

Most studies included in the review were prospective cohort studies, said Dr. Kok in an interview at the meeting, where she presented her findings in poster form.

Studies were reviewed from Medline, Embase, Cochrane Library, and manual searching of bibliographies of known primary and review articles. Articles were included if they reported on both potential clinical prognosticators and external cephalic version success rates.

The final conclusions not only illuminated factors associated with success but offer a way to weigh the importance of each factor. For example, a relaxed uterus is 20 times more likely to predict success, making it a more important prognostic variable than maternal weight.

Dr. Kok, an obstetrician and registrar at the Academic Medical Center in Amsterdam, was assisted in the study by colleagues in the ob.gyn. department at her institution and by Dr. Ben Willem Mol of Maxima Medical Centre Veldhoven in the Netherlands.

RENO, NEV. — Five key factors predicted successful external cephalic version in a meta-analysis of 43 primary articles describing 8,089 cases, reported Dr. Marjolein Kok at the annual meeting of the Society for Gynecologic Investigation.

Predictors of success, in order, included the following:

▸ Uterine relaxation (odds ratio 19; 95% confidence interval 3.1–3.9).

▸ Nonengagement (OR 10; CI 6.6–15).

▸ Palpable fetal head (OR 9.4; CI 6.0–15).

▸ Multiparity (OR 3.5; CI 3.1–3.9).

▸ Maternal weight less than 65 kg (OR 1.8; CI 1.2–2.6).

Most studies included in the review were prospective cohort studies, said Dr. Kok in an interview at the meeting, where she presented her findings in poster form.

Studies were reviewed from Medline, Embase, Cochrane Library, and manual searching of bibliographies of known primary and review articles. Articles were included if they reported on both potential clinical prognosticators and external cephalic version success rates.

The final conclusions not only illuminated factors associated with success but offer a way to weigh the importance of each factor. For example, a relaxed uterus is 20 times more likely to predict success, making it a more important prognostic variable than maternal weight.

Dr. Kok, an obstetrician and registrar at the Academic Medical Center in Amsterdam, was assisted in the study by colleagues in the ob.gyn. department at her institution and by Dr. Ben Willem Mol of Maxima Medical Centre Veldhoven in the Netherlands.

NEW ORLEANS — Rosuvastatin slowed the progression of carotid intima-media thickness in asymptomatic subjects at low risk of cardiovascular events but who nonetheless had subclinical atherosclerosis, Dr. John R. Crouse III reported at a conference sponsored by the American College of Cardiology.

The agent “basically halted progression” of intima-media thickness, Dr. Crouse said during a late-breaking clinical trials session at the meeting.

Unlike previous clinical trials of the drug involving high-risk subjects or patients with known cardiovascular disease, the METEOR (Measuring Effects on Intima-Media Thickness: An Evaluation of Rosuvastatin) trial assessed asymptomatic people aged 45–70 years who were at low cardiovascular risk and had only moderately elevated cholesterol, but were found to have a relatively high carotid wall thickness on ultrasound examination.

The low-risk population was intentionally chosen for the study so that a placebo arm could ethically be included, said Dr. Crouse, professor of medicine and public health sciences at Wake Forest University in Winston-Salem, N.C.

A total of 984 subjects were enrolled in the study in August 2002-March 2004 at 61 medical centers in the United States and Europe and were followed with serial carotid imaging for 2 years. The study was funded by AstraZeneca Pharmaceuticals LP, maker of rosuvastatin (Crestor).

Ultrasound measurements of carotid intima-media thickness were performed at enrollment and at 6-month intervals for 2 years. Measurements were made at 12 carotid artery sites in each patient, including the near and far walls of the right and left common carotid artery, carotid bulb, and internal carotid artery.

Results were available for 252 subjects who had been randomly assigned to receive placebo and 624 who had been assigned to receive 40 mg of rosuvastatin daily. This is not the recommended starting dosage but was selected “to provide the maximum efficacy expected to slow or delay progression of atherosclerosis,” Dr. Crouse wrote in a report that was published at the time of the presentation (JAMA 2007;297:1344–53).

Carotid intima-media thickness progressed in the placebo group. It regressed in the rosuvastatin group, but the difference from baseline did not reach significance except at the common carotid artery.

The significant difference in progression between the placebo and rosuvastatin groups persisted across all clinical subgroups, regardless of subject age, sex, geo-graphical location, race, body mass index, risk factors, blood pressure levels, or lipid levels, Dr. Crouse said.

Rosuvastatin did not induce regression of carotid atherosclerosis, as it has been shown to do in previous studies involving patients with more advanced disease. “This was focused on low-risk participants without advanced atherosclerosis, and this may have limited the opportunity to achieve disease regression,” Dr. Crouse said.

LDL cholesterol declined by 49% and HDL cholesterol increased by 8% in patients taking rosuvastatin during the 2-year study. The frequency of adverse events was similar between the two groups, and most were of mild or moderate severity. Myalgia was the most commonly reported adverse effect.

In an editorial comment accompanying the published report, Dr. Michael S. Lauer of the Cleveland Clinic Heart Center said, “At first glance, the METEOR findings suggest there may be a role for routine arterial imaging” in low-risk people, and that routine rosuvastatin therapy may be warranted for those found to have increased carotid intima-media thickness.

But this would be “a radically different approach to primary prevention than that recommended by current guidelines,” and the results clearly do not justify such a change, he said (JAMA 2007;297:1376–8).

For one thing, carotid intima-media thickness is merely a surrogate end point for clinical events, and the medical literature is rife with “numerous bad experiences whereby agents that improved surrogate end points yielded no benefit or were even found to cause harm when tested for their ability to prevent clinical events. Classic examples of this include vitamin E and postmenopausal hormone therapy,” he wrote.

Moreover, there is only limited evidence that statin-induced changes in carotid intima-media thickness actually correlate with a decrease in atherosclerotic events.

The METEOR study had two additional weaknesses. “A fair number of enrolled patients failed to complete the protocol and were lost to follow-up. … [A] higher rate of follow-up clearly would have increased the credibility of the findings,” he noted.

And the study was not powered to evaluate the drug's effect on clinical events. In nearly 1,000 subjects, only six ischemic events occurred—all of them, “curiously,” in subjects taking the study drug. “Ambitious event-based randomized trials involving large numbers of patients and communities must be done,” Dr. Lauer said.

NEW ORLEANS — Rosuvastatin slowed the progression of carotid intima-media thickness in asymptomatic subjects at low risk of cardiovascular events but who nonetheless had subclinical atherosclerosis, Dr. John R. Crouse III reported at a conference sponsored by the American College of Cardiology.

The agent “basically halted progression” of intima-media thickness, Dr. Crouse said during a late-breaking clinical trials session at the meeting.

Unlike previous clinical trials of the drug involving high-risk subjects or patients with known cardiovascular disease, the METEOR (Measuring Effects on Intima-Media Thickness: An Evaluation of Rosuvastatin) trial assessed asymptomatic people aged 45–70 years who were at low cardiovascular risk and had only moderately elevated cholesterol, but were found to have a relatively high carotid wall thickness on ultrasound examination.

The low-risk population was intentionally chosen for the study so that a placebo arm could ethically be included, said Dr. Crouse, professor of medicine and public health sciences at Wake Forest University in Winston-Salem, N.C.

A total of 984 subjects were enrolled in the study in August 2002-March 2004 at 61 medical centers in the United States and Europe and were followed with serial carotid imaging for 2 years. The study was funded by AstraZeneca Pharmaceuticals LP, maker of rosuvastatin (Crestor).

Ultrasound measurements of carotid intima-media thickness were performed at enrollment and at 6-month intervals for 2 years. Measurements were made at 12 carotid artery sites in each patient, including the near and far walls of the right and left common carotid artery, carotid bulb, and internal carotid artery.

Results were available for 252 subjects who had been randomly assigned to receive placebo and 624 who had been assigned to receive 40 mg of rosuvastatin daily. This is not the recommended starting dosage but was selected “to provide the maximum efficacy expected to slow or delay progression of atherosclerosis,” Dr. Crouse wrote in a report that was published at the time of the presentation (JAMA 2007;297:1344–53).

Carotid intima-media thickness progressed in the placebo group. It regressed in the rosuvastatin group, but the difference from baseline did not reach significance except at the common carotid artery.

The significant difference in progression between the placebo and rosuvastatin groups persisted across all clinical subgroups, regardless of subject age, sex, geo-graphical location, race, body mass index, risk factors, blood pressure levels, or lipid levels, Dr. Crouse said.

Rosuvastatin did not induce regression of carotid atherosclerosis, as it has been shown to do in previous studies involving patients with more advanced disease. “This was focused on low-risk participants without advanced atherosclerosis, and this may have limited the opportunity to achieve disease regression,” Dr. Crouse said.

LDL cholesterol declined by 49% and HDL cholesterol increased by 8% in patients taking rosuvastatin during the 2-year study. The frequency of adverse events was similar between the two groups, and most were of mild or moderate severity. Myalgia was the most commonly reported adverse effect.

In an editorial comment accompanying the published report, Dr. Michael S. Lauer of the Cleveland Clinic Heart Center said, “At first glance, the METEOR findings suggest there may be a role for routine arterial imaging” in low-risk people, and that routine rosuvastatin therapy may be warranted for those found to have increased carotid intima-media thickness.

But this would be “a radically different approach to primary prevention than that recommended by current guidelines,” and the results clearly do not justify such a change, he said (JAMA 2007;297:1376–8).

For one thing, carotid intima-media thickness is merely a surrogate end point for clinical events, and the medical literature is rife with “numerous bad experiences whereby agents that improved surrogate end points yielded no benefit or were even found to cause harm when tested for their ability to prevent clinical events. Classic examples of this include vitamin E and postmenopausal hormone therapy,” he wrote.

Moreover, there is only limited evidence that statin-induced changes in carotid intima-media thickness actually correlate with a decrease in atherosclerotic events.

The METEOR study had two additional weaknesses. “A fair number of enrolled patients failed to complete the protocol and were lost to follow-up. … [A] higher rate of follow-up clearly would have increased the credibility of the findings,” he noted.

And the study was not powered to evaluate the drug's effect on clinical events. In nearly 1,000 subjects, only six ischemic events occurred—all of them, “curiously,” in subjects taking the study drug. “Ambitious event-based randomized trials involving large numbers of patients and communities must be done,” Dr. Lauer said.

NEW ORLEANS — Rosuvastatin slowed the progression of carotid intima-media thickness in asymptomatic subjects at low risk of cardiovascular events but who nonetheless had subclinical atherosclerosis, Dr. John R. Crouse III reported at a conference sponsored by the American College of Cardiology.

The agent “basically halted progression” of intima-media thickness, Dr. Crouse said during a late-breaking clinical trials session at the meeting.

Unlike previous clinical trials of the drug involving high-risk subjects or patients with known cardiovascular disease, the METEOR (Measuring Effects on Intima-Media Thickness: An Evaluation of Rosuvastatin) trial assessed asymptomatic people aged 45–70 years who were at low cardiovascular risk and had only moderately elevated cholesterol, but were found to have a relatively high carotid wall thickness on ultrasound examination.

The low-risk population was intentionally chosen for the study so that a placebo arm could ethically be included, said Dr. Crouse, professor of medicine and public health sciences at Wake Forest University in Winston-Salem, N.C.

A total of 984 subjects were enrolled in the study in August 2002-March 2004 at 61 medical centers in the United States and Europe and were followed with serial carotid imaging for 2 years. The study was funded by AstraZeneca Pharmaceuticals LP, maker of rosuvastatin (Crestor).

Ultrasound measurements of carotid intima-media thickness were performed at enrollment and at 6-month intervals for 2 years. Measurements were made at 12 carotid artery sites in each patient, including the near and far walls of the right and left common carotid artery, carotid bulb, and internal carotid artery.

Results were available for 252 subjects who had been randomly assigned to receive placebo and 624 who had been assigned to receive 40 mg of rosuvastatin daily. This is not the recommended starting dosage but was selected “to provide the maximum efficacy expected to slow or delay progression of atherosclerosis,” Dr. Crouse wrote in a report that was published at the time of the presentation (JAMA 2007;297:1344–53).

Carotid intima-media thickness progressed in the placebo group. It regressed in the rosuvastatin group, but the difference from baseline did not reach significance except at the common carotid artery.

The significant difference in progression between the placebo and rosuvastatin groups persisted across all clinical subgroups, regardless of subject age, sex, geo-graphical location, race, body mass index, risk factors, blood pressure levels, or lipid levels, Dr. Crouse said.

Rosuvastatin did not induce regression of carotid atherosclerosis, as it has been shown to do in previous studies involving patients with more advanced disease. “This was focused on low-risk participants without advanced atherosclerosis, and this may have limited the opportunity to achieve disease regression,” Dr. Crouse said.

LDL cholesterol declined by 49% and HDL cholesterol increased by 8% in patients taking rosuvastatin during the 2-year study. The frequency of adverse events was similar between the two groups, and most were of mild or moderate severity. Myalgia was the most commonly reported adverse effect.

In an editorial comment accompanying the published report, Dr. Michael S. Lauer of the Cleveland Clinic Heart Center said, “At first glance, the METEOR findings suggest there may be a role for routine arterial imaging” in low-risk people, and that routine rosuvastatin therapy may be warranted for those found to have increased carotid intima-media thickness.

But this would be “a radically different approach to primary prevention than that recommended by current guidelines,” and the results clearly do not justify such a change, he said (JAMA 2007;297:1376–8).

For one thing, carotid intima-media thickness is merely a surrogate end point for clinical events, and the medical literature is rife with “numerous bad experiences whereby agents that improved surrogate end points yielded no benefit or were even found to cause harm when tested for their ability to prevent clinical events. Classic examples of this include vitamin E and postmenopausal hormone therapy,” he wrote.

Moreover, there is only limited evidence that statin-induced changes in carotid intima-media thickness actually correlate with a decrease in atherosclerotic events.

The METEOR study had two additional weaknesses. “A fair number of enrolled patients failed to complete the protocol and were lost to follow-up. … [A] higher rate of follow-up clearly would have increased the credibility of the findings,” he noted.

And the study was not powered to evaluate the drug's effect on clinical events. In nearly 1,000 subjects, only six ischemic events occurred—all of them, “curiously,” in subjects taking the study drug. “Ambitious event-based randomized trials involving large numbers of patients and communities must be done,” Dr. Lauer said.

Researchers at the Mayo Clinic and elsewhere are racing to develop rapid-detection tests for Staphylococcus aureus, both to better tailor appropriate antibiotic prescribing and to halt the galloping spread of methicillin-resistant strains of the bacteria.

“There are many companies now developing rapid tests,” Betsy McCaughey, Ph.D., said in an interview.

Among the contenders are Innovative Biosensors Inc. in College Park, Md., which is using light-based technology developed at the Massachusetts Institute of Technology; Cepheid, a Sunnyvale, Calif.-based company about to introduce another genetic-based rapid test; and 3M, which has “waded deep into this territory,” said Dr. McCaughey, director of the New York City-based nonprofit Committee to Reduce Infection Deaths.

Progress has been keenest in identifying colonized patients prior to or during hospitalization to help reduce the spread of resistant bacteria.

At the University of Maryland Medical Center in Baltimore, for example, patients considered at risk for methicillin-resistant S. aureus (MRSA) can be screened in 2 hours with a polymerase chain reaction (PCR) DNA test developed by Becton, Dickinson & Co., rather than waiting 24–48 hours to get an answer by culturing for the bacteria.

All intensive care unit patients are being screened at admission, on a weekly basis, and on discharge so that infected patients can be identified and treated with appropriate isolation and contact precautions, said Richard Venezia, Ph.D., professor of pathology and director of clinical microbiology at the university.

“This is the first of a generation of tests that are going to be using 'within-the-tube' closed systems,” based on either DNA or immunology, that represent a major technological advance in the way risky bacteria are identified, Dr. Venezia said.

The tests do not require complex interpretation nor the level of training or sophisticated precautions against cross-contamination that were necessary with previous PCR procedures developed in research laboratories.

The new tests are currently confined to hospital or community laboratories, but Dr. Venezia said that they will almost certainly be available for bedside or community office practices within 5 years.

At the Mayo Clinic in Rochester, Minn., two swab-based PCR tests are being developed, one to signal the presence of S. aureus and the other to identify MRSA, Dr. Mark Pittelkow, professor of dermatology, said in an interview.

S. aureus is rapidly overcoming streptococcus as the bacteria of concern, Dr. Pittelkow said.

The Mayo tests, to be marketed by Roche Pharmaceuticals, use a specially designed swab that does not wick samples in the same way as a cotton-tipped swab. For now, it still requires laboratory technicians to transfer material from the applicator to a plate for analysis, but the technology is heading toward a self-contained swab similar to those used for rapid strep tests in physicians' offices.

The Becton, Dickinson & Co. test, available since early 2006, is approved only for detecting colonization, not to guide antibiotic choices in individual patients. It requires laboratories to make an initial investment of more than $20,000 for a real-time PCR cycler, plus $20-$30 for each test performed. The equipment, however, can be used to perform other cutting-edge tests for detection of influenza, respiratory syncytial virus, and vancomycin-resistant enterococci, Dr. Venezia said.

Rapid, practical, easy-to-perform tests for S. aureus will become even more necessary for hospitals, because the Centers for Medicare and Medicaid Services has proposed that Medicare diagnosis-related group reimbursements for nosocomial infections be stopped.

The advent of such restrictions on payments for hospital-acquired illnesses might lead some institutions to universally test patients on admission and throughout their stays. Treatment of an MRSA infection can run as much as $36,000, said Barbara Kalavik, director of worldwide public relations for Becton, Dickinson & Co.

Just who pays for the tests is still a matter of contention.

When a physician orders a test to pinpoint the best antibiotic to treat a patient, the cost can be charged to the patient or insurance. Who will bear the cost of screening hospital patients is less clear, Ms. Kalavik said.

“Most hospitals absorb the cost of these programs,” she said, but “starting Jan. 1, 2007, new CPT codes have been instituted that allow for hospitals to be reimbursed approximately $49 for screening outpatients” for MRSA.

Staphylococcus aureus is rapidly overcoming streptococcus as the bacteria of concern. DR. PITTELKOW

Researchers at the Mayo Clinic and elsewhere are racing to develop rapid-detection tests for Staphylococcus aureus, both to better tailor appropriate antibiotic prescribing and to halt the galloping spread of methicillin-resistant strains of the bacteria.

“There are many companies now developing rapid tests,” Betsy McCaughey, Ph.D., said in an interview.

Among the contenders are Innovative Biosensors Inc. in College Park, Md., which is using light-based technology developed at the Massachusetts Institute of Technology; Cepheid, a Sunnyvale, Calif.-based company about to introduce another genetic-based rapid test; and 3M, which has “waded deep into this territory,” said Dr. McCaughey, director of the New York City-based nonprofit Committee to Reduce Infection Deaths.

Progress has been keenest in identifying colonized patients prior to or during hospitalization to help reduce the spread of resistant bacteria.

At the University of Maryland Medical Center in Baltimore, for example, patients considered at risk for methicillin-resistant S. aureus (MRSA) can be screened in 2 hours with a polymerase chain reaction (PCR) DNA test developed by Becton, Dickinson & Co., rather than waiting 24–48 hours to get an answer by culturing for the bacteria.

All intensive care unit patients are being screened at admission, on a weekly basis, and on discharge so that infected patients can be identified and treated with appropriate isolation and contact precautions, said Richard Venezia, Ph.D., professor of pathology and director of clinical microbiology at the university.

“This is the first of a generation of tests that are going to be using 'within-the-tube' closed systems,” based on either DNA or immunology, that represent a major technological advance in the way risky bacteria are identified, Dr. Venezia said.

The tests do not require complex interpretation nor the level of training or sophisticated precautions against cross-contamination that were necessary with previous PCR procedures developed in research laboratories.

The new tests are currently confined to hospital or community laboratories, but Dr. Venezia said that they will almost certainly be available for bedside or community office practices within 5 years.

At the Mayo Clinic in Rochester, Minn., two swab-based PCR tests are being developed, one to signal the presence of S. aureus and the other to identify MRSA, Dr. Mark Pittelkow, professor of dermatology, said in an interview.

S. aureus is rapidly overcoming streptococcus as the bacteria of concern, Dr. Pittelkow said.

The Mayo tests, to be marketed by Roche Pharmaceuticals, use a specially designed swab that does not wick samples in the same way as a cotton-tipped swab. For now, it still requires laboratory technicians to transfer material from the applicator to a plate for analysis, but the technology is heading toward a self-contained swab similar to those used for rapid strep tests in physicians' offices.

The Becton, Dickinson & Co. test, available since early 2006, is approved only for detecting colonization, not to guide antibiotic choices in individual patients. It requires laboratories to make an initial investment of more than $20,000 for a real-time PCR cycler, plus $20-$30 for each test performed. The equipment, however, can be used to perform other cutting-edge tests for detection of influenza, respiratory syncytial virus, and vancomycin-resistant enterococci, Dr. Venezia said.

Rapid, practical, easy-to-perform tests for S. aureus will become even more necessary for hospitals, because the Centers for Medicare and Medicaid Services has proposed that Medicare diagnosis-related group reimbursements for nosocomial infections be stopped.

The advent of such restrictions on payments for hospital-acquired illnesses might lead some institutions to universally test patients on admission and throughout their stays. Treatment of an MRSA infection can run as much as $36,000, said Barbara Kalavik, director of worldwide public relations for Becton, Dickinson & Co.

Just who pays for the tests is still a matter of contention.

When a physician orders a test to pinpoint the best antibiotic to treat a patient, the cost can be charged to the patient or insurance. Who will bear the cost of screening hospital patients is less clear, Ms. Kalavik said.

“Most hospitals absorb the cost of these programs,” she said, but “starting Jan. 1, 2007, new CPT codes have been instituted that allow for hospitals to be reimbursed approximately $49 for screening outpatients” for MRSA.

Staphylococcus aureus is rapidly overcoming streptococcus as the bacteria of concern. DR. PITTELKOW

Researchers at the Mayo Clinic and elsewhere are racing to develop rapid-detection tests for Staphylococcus aureus, both to better tailor appropriate antibiotic prescribing and to halt the galloping spread of methicillin-resistant strains of the bacteria.

“There are many companies now developing rapid tests,” Betsy McCaughey, Ph.D., said in an interview.

Among the contenders are Innovative Biosensors Inc. in College Park, Md., which is using light-based technology developed at the Massachusetts Institute of Technology; Cepheid, a Sunnyvale, Calif.-based company about to introduce another genetic-based rapid test; and 3M, which has “waded deep into this territory,” said Dr. McCaughey, director of the New York City-based nonprofit Committee to Reduce Infection Deaths.

Progress has been keenest in identifying colonized patients prior to or during hospitalization to help reduce the spread of resistant bacteria.

At the University of Maryland Medical Center in Baltimore, for example, patients considered at risk for methicillin-resistant S. aureus (MRSA) can be screened in 2 hours with a polymerase chain reaction (PCR) DNA test developed by Becton, Dickinson & Co., rather than waiting 24–48 hours to get an answer by culturing for the bacteria.

All intensive care unit patients are being screened at admission, on a weekly basis, and on discharge so that infected patients can be identified and treated with appropriate isolation and contact precautions, said Richard Venezia, Ph.D., professor of pathology and director of clinical microbiology at the university.

“This is the first of a generation of tests that are going to be using 'within-the-tube' closed systems,” based on either DNA or immunology, that represent a major technological advance in the way risky bacteria are identified, Dr. Venezia said.

The tests do not require complex interpretation nor the level of training or sophisticated precautions against cross-contamination that were necessary with previous PCR procedures developed in research laboratories.

The new tests are currently confined to hospital or community laboratories, but Dr. Venezia said that they will almost certainly be available for bedside or community office practices within 5 years.

At the Mayo Clinic in Rochester, Minn., two swab-based PCR tests are being developed, one to signal the presence of S. aureus and the other to identify MRSA, Dr. Mark Pittelkow, professor of dermatology, said in an interview.

S. aureus is rapidly overcoming streptococcus as the bacteria of concern, Dr. Pittelkow said.

The Mayo tests, to be marketed by Roche Pharmaceuticals, use a specially designed swab that does not wick samples in the same way as a cotton-tipped swab. For now, it still requires laboratory technicians to transfer material from the applicator to a plate for analysis, but the technology is heading toward a self-contained swab similar to those used for rapid strep tests in physicians' offices.

The Becton, Dickinson & Co. test, available since early 2006, is approved only for detecting colonization, not to guide antibiotic choices in individual patients. It requires laboratories to make an initial investment of more than $20,000 for a real-time PCR cycler, plus $20-$30 for each test performed. The equipment, however, can be used to perform other cutting-edge tests for detection of influenza, respiratory syncytial virus, and vancomycin-resistant enterococci, Dr. Venezia said.

Rapid, practical, easy-to-perform tests for S. aureus will become even more necessary for hospitals, because the Centers for Medicare and Medicaid Services has proposed that Medicare diagnosis-related group reimbursements for nosocomial infections be stopped.

The advent of such restrictions on payments for hospital-acquired illnesses might lead some institutions to universally test patients on admission and throughout their stays. Treatment of an MRSA infection can run as much as $36,000, said Barbara Kalavik, director of worldwide public relations for Becton, Dickinson & Co.

Just who pays for the tests is still a matter of contention.

When a physician orders a test to pinpoint the best antibiotic to treat a patient, the cost can be charged to the patient or insurance. Who will bear the cost of screening hospital patients is less clear, Ms. Kalavik said.

“Most hospitals absorb the cost of these programs,” she said, but “starting Jan. 1, 2007, new CPT codes have been instituted that allow for hospitals to be reimbursed approximately $49 for screening outpatients” for MRSA.

Staphylococcus aureus is rapidly overcoming streptococcus as the bacteria of concern. DR. PITTELKOW

NEW ORLEANS — Two doses of atorvastatin before percutaneous coronary intervention reduced the 30-day risk of major adverse cardiac events by 88% among patients with acute coronary syndromes in a study presented at the annual meeting of the American College of Cardiology.

A composite primary end point consisting of death, myocardial infarction, or target vessel revascularization occurred in 4 (5%) of 86 patients who received preprocedural atorvastatin, a significant difference from the 14 (17%) of 85 of those assigned to placebo in the randomized, multicenter trial.

A multivariate analysis found an 88% risk reduction among patients pretreated with atorvastatin.

“This is a much greater effect than that observed in other large studies using a high dose of statins in acute coronary syndromes,” noted the investigators in an article timed for release during the meeting (J. Am. Coll. Cardiol. 2007;49:1272–8).

“Lipid-independent pleiotropic actions of atorvastatin may explain such effects,” Dr. Germano Di Sciascio of the department of cardiovascular sciences at Campus Bio-Medio University in Rome said at the meeting.

Dr. Di Sciascio and associates in the ARMYDA (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) study group previously documented reduced MI during percutaneous coronary intervention (PCI) in stable angina patients pretreated with atorvastatin. They undertook the current study to determine whether patients with acute coronary syndromes would get the same benefits.

The trial enrolled 171 patients who had been referred for coronary angiography within 48 hours after presenting with unstable angina or non-ST-segment elevation acute MI.

Eligible subjects were randomly assigned to receive placebo or atorvastatin in an 80-mg loading dose given 12 hours before PCI and a 4-mg dose approximately 2 hours before the procedure. Otherwise, patients were treated according to standard protocols, receiving aspirin, clopidogrel, and intravenous heparin prior to the procedure; some patients also received glycoprotein IIb/IIIa inhibitors.

Procedures were performed at Campus Bio-Medico University of Rome; Vito Fazzi Hospital of Lecce, Italy; or University La Spienza of Rome.

Post procedure, all patients received daily aspirin and clopidogrel throughout the 30-day target period and were prescribed 40 mg/day of atorvastatin regardless of whether they received the drug or placebo before PCI.

Procedural success, defined as a reduction of stenosis to less than 30% of residual narrowing, was achieved in all patients, and no patient died in the ensuing 30 days.

The highly significant difference in incidence of major adverse cardiac events at 1 month was largely driven by postprocedural MI, which occurred in 4 (5%) of 86 patients receiving pre-PCI atorvastatin, compared with 13 (15%) of 85 on placebo. One patient in the placebo arm required target vessel revascularization.

“Our study shows 70% reduction in the incidence of periprocedural myocardial infarction: According to these data, 10 patients should be treated with atorvastatin to avoid one case of myocardial infarction,” they reported.

The investigators cautioned that the findings cannot be extrapolated to other patient groups.

Atorvastatin's 'lipid-independent pleiotropic actions' may account for its effects on the heart. DR. DI SCIASCIO

NEW ORLEANS — Two doses of atorvastatin before percutaneous coronary intervention reduced the 30-day risk of major adverse cardiac events by 88% among patients with acute coronary syndromes in a study presented at the annual meeting of the American College of Cardiology.

A composite primary end point consisting of death, myocardial infarction, or target vessel revascularization occurred in 4 (5%) of 86 patients who received preprocedural atorvastatin, a significant difference from the 14 (17%) of 85 of those assigned to placebo in the randomized, multicenter trial.

A multivariate analysis found an 88% risk reduction among patients pretreated with atorvastatin.

“This is a much greater effect than that observed in other large studies using a high dose of statins in acute coronary syndromes,” noted the investigators in an article timed for release during the meeting (J. Am. Coll. Cardiol. 2007;49:1272–8).

“Lipid-independent pleiotropic actions of atorvastatin may explain such effects,” Dr. Germano Di Sciascio of the department of cardiovascular sciences at Campus Bio-Medio University in Rome said at the meeting.

Dr. Di Sciascio and associates in the ARMYDA (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) study group previously documented reduced MI during percutaneous coronary intervention (PCI) in stable angina patients pretreated with atorvastatin. They undertook the current study to determine whether patients with acute coronary syndromes would get the same benefits.

The trial enrolled 171 patients who had been referred for coronary angiography within 48 hours after presenting with unstable angina or non-ST-segment elevation acute MI.

Eligible subjects were randomly assigned to receive placebo or atorvastatin in an 80-mg loading dose given 12 hours before PCI and a 4-mg dose approximately 2 hours before the procedure. Otherwise, patients were treated according to standard protocols, receiving aspirin, clopidogrel, and intravenous heparin prior to the procedure; some patients also received glycoprotein IIb/IIIa inhibitors.

Procedures were performed at Campus Bio-Medico University of Rome; Vito Fazzi Hospital of Lecce, Italy; or University La Spienza of Rome.

Post procedure, all patients received daily aspirin and clopidogrel throughout the 30-day target period and were prescribed 40 mg/day of atorvastatin regardless of whether they received the drug or placebo before PCI.

Procedural success, defined as a reduction of stenosis to less than 30% of residual narrowing, was achieved in all patients, and no patient died in the ensuing 30 days.

The highly significant difference in incidence of major adverse cardiac events at 1 month was largely driven by postprocedural MI, which occurred in 4 (5%) of 86 patients receiving pre-PCI atorvastatin, compared with 13 (15%) of 85 on placebo. One patient in the placebo arm required target vessel revascularization.

“Our study shows 70% reduction in the incidence of periprocedural myocardial infarction: According to these data, 10 patients should be treated with atorvastatin to avoid one case of myocardial infarction,” they reported.

The investigators cautioned that the findings cannot be extrapolated to other patient groups.

Atorvastatin's 'lipid-independent pleiotropic actions' may account for its effects on the heart. DR. DI SCIASCIO

NEW ORLEANS — Two doses of atorvastatin before percutaneous coronary intervention reduced the 30-day risk of major adverse cardiac events by 88% among patients with acute coronary syndromes in a study presented at the annual meeting of the American College of Cardiology.

A composite primary end point consisting of death, myocardial infarction, or target vessel revascularization occurred in 4 (5%) of 86 patients who received preprocedural atorvastatin, a significant difference from the 14 (17%) of 85 of those assigned to placebo in the randomized, multicenter trial.

A multivariate analysis found an 88% risk reduction among patients pretreated with atorvastatin.

“This is a much greater effect than that observed in other large studies using a high dose of statins in acute coronary syndromes,” noted the investigators in an article timed for release during the meeting (J. Am. Coll. Cardiol. 2007;49:1272–8).

“Lipid-independent pleiotropic actions of atorvastatin may explain such effects,” Dr. Germano Di Sciascio of the department of cardiovascular sciences at Campus Bio-Medio University in Rome said at the meeting.

Dr. Di Sciascio and associates in the ARMYDA (Atorvastatin for Reduction of Myocardial Damage During Angioplasty) study group previously documented reduced MI during percutaneous coronary intervention (PCI) in stable angina patients pretreated with atorvastatin. They undertook the current study to determine whether patients with acute coronary syndromes would get the same benefits.

The trial enrolled 171 patients who had been referred for coronary angiography within 48 hours after presenting with unstable angina or non-ST-segment elevation acute MI.

Eligible subjects were randomly assigned to receive placebo or atorvastatin in an 80-mg loading dose given 12 hours before PCI and a 4-mg dose approximately 2 hours before the procedure. Otherwise, patients were treated according to standard protocols, receiving aspirin, clopidogrel, and intravenous heparin prior to the procedure; some patients also received glycoprotein IIb/IIIa inhibitors.

Procedures were performed at Campus Bio-Medico University of Rome; Vito Fazzi Hospital of Lecce, Italy; or University La Spienza of Rome.

Post procedure, all patients received daily aspirin and clopidogrel throughout the 30-day target period and were prescribed 40 mg/day of atorvastatin regardless of whether they received the drug or placebo before PCI.

Procedural success, defined as a reduction of stenosis to less than 30% of residual narrowing, was achieved in all patients, and no patient died in the ensuing 30 days.

The highly significant difference in incidence of major adverse cardiac events at 1 month was largely driven by postprocedural MI, which occurred in 4 (5%) of 86 patients receiving pre-PCI atorvastatin, compared with 13 (15%) of 85 on placebo. One patient in the placebo arm required target vessel revascularization.

“Our study shows 70% reduction in the incidence of periprocedural myocardial infarction: According to these data, 10 patients should be treated with atorvastatin to avoid one case of myocardial infarction,” they reported.

The investigators cautioned that the findings cannot be extrapolated to other patient groups.

Atorvastatin's 'lipid-independent pleiotropic actions' may account for its effects on the heart. DR. DI SCIASCIO

LOS ANGELES — The number of Americans diagnosed with AIDS is now approaching the 1 million mark, with more than a half-million deaths since the epidemic began and 17,000 more people dying of the disease each year, Dr. Harold Jaffe said during a plenary session at the 14th Conference on Retroviruses and Opportunistic Infections.

That mortality—58 per million—is “twice as high as any country in the European Union and 10 times as high as in the United Kingdom,” said Dr. Jaffe, former director of HIV prevention for the Centers for Disease Control and Prevention and currently head of the department of public health at Oxford University, England.

A troubling jump in incidence in 2005, the latest year for which data are available points to the critical need for community leadership, personal responsibility, and support of preventive efforts proven to work, he said.

“The need for treatment is critical, but I agree with my colleague Dr. Kevin De Cock [WHO director of HIV/AIDS] that we are not going to be able to treat our way out of this epidemic.”

“I guess it seems obvious that we should be implementing what works, evaluating what might work, and stop trying to do what doesn't work,” added Dr. Jaffe, who singled out federal funding for abstinence-only education as an example of a strategy based on beliefs rather than science.

A “very comprehensive” study in press in the Cochrane Review, for example, reviewed eight published randomized controlled trials of abstinence-only programs, compared with standard sex education or safe-sex programs, involving 13,191 American youths.

With a median follow-up of 12 months, none of the abstinence-only programs demonstrated a significant decline in self-reported sexual activity or any biological outcome such as pregnancy or diagnosis with a sexually transmitted disease (STD), compared with the other approaches, said Dr. Jaffe at the conference, sponsored by the Foundation for Retrovirology and Human Health.

A recent University of Pennsylvania study of 662 African American children (median age, 12 years) did show significantly less sexual activity among those receiving abstinence-only education, compared with those exposed to other interventions; even so, nearly a third of the virgins in the abstinence-only group became sexually active over the course of the 2-year study.

Dr. Jaffe said it cannot be entirely ruled out that abstinence-only education could benefit “very specific groups,” but the preponderance of evidence suggests it is not efficacious.

By contrast, he pointed to condom promotion, shown to be “highly efficacious” in preventing HIV transmission, and needle- and syringe-exchange programs, which demonstrate at least modest evidence of reducing intermediate-level activities with the capacity to spread HIV, as more effective approaches.

Condom distribution campaigns are currently being opposed by individuals who believe availability will undermine abstinence-only programs.

President Bush's proposed 2007 budget includes $204 million in support of abstinence-only education, while “no administration, Democrat or Republican, has ever put any [federal] money whatsoever into needle-exchange programs in this country, in contrast to many other countries, including the U.K.,” Dr. Jaffe said.

Purely behavioral interventions, primarily skill-building sessions aimed at reducing risky activities among high-risk individuals, are highly significantly efficacious in reducing unprotected sex and acquiring STDs, he said.

Finally, HIV testing by itself is a profound risk-reducing strategy, because individuals who learn they have been exposed to the virus sharply reduce behaviors that could lead to transmission to others, he noted.

Public health prevention strategies can go only so far in curbing the epidemic, emphasized Dr. Jaffe, particularly when it comes to sexual behavior change.

However, some indicators suggest that resources must be quickly marshaled to stem a rising tide of cases, especially among men who have sex with men and among African Americans and other ethnic minorities.

LOS ANGELES — The number of Americans diagnosed with AIDS is now approaching the 1 million mark, with more than a half-million deaths since the epidemic began and 17,000 more people dying of the disease each year, Dr. Harold Jaffe said during a plenary session at the 14th Conference on Retroviruses and Opportunistic Infections.

That mortality—58 per million—is “twice as high as any country in the European Union and 10 times as high as in the United Kingdom,” said Dr. Jaffe, former director of HIV prevention for the Centers for Disease Control and Prevention and currently head of the department of public health at Oxford University, England.

A troubling jump in incidence in 2005, the latest year for which data are available points to the critical need for community leadership, personal responsibility, and support of preventive efforts proven to work, he said.

“The need for treatment is critical, but I agree with my colleague Dr. Kevin De Cock [WHO director of HIV/AIDS] that we are not going to be able to treat our way out of this epidemic.”

“I guess it seems obvious that we should be implementing what works, evaluating what might work, and stop trying to do what doesn't work,” added Dr. Jaffe, who singled out federal funding for abstinence-only education as an example of a strategy based on beliefs rather than science.

A “very comprehensive” study in press in the Cochrane Review, for example, reviewed eight published randomized controlled trials of abstinence-only programs, compared with standard sex education or safe-sex programs, involving 13,191 American youths.

With a median follow-up of 12 months, none of the abstinence-only programs demonstrated a significant decline in self-reported sexual activity or any biological outcome such as pregnancy or diagnosis with a sexually transmitted disease (STD), compared with the other approaches, said Dr. Jaffe at the conference, sponsored by the Foundation for Retrovirology and Human Health.

A recent University of Pennsylvania study of 662 African American children (median age, 12 years) did show significantly less sexual activity among those receiving abstinence-only education, compared with those exposed to other interventions; even so, nearly a third of the virgins in the abstinence-only group became sexually active over the course of the 2-year study.

Dr. Jaffe said it cannot be entirely ruled out that abstinence-only education could benefit “very specific groups,” but the preponderance of evidence suggests it is not efficacious.

By contrast, he pointed to condom promotion, shown to be “highly efficacious” in preventing HIV transmission, and needle- and syringe-exchange programs, which demonstrate at least modest evidence of reducing intermediate-level activities with the capacity to spread HIV, as more effective approaches.

Condom distribution campaigns are currently being opposed by individuals who believe availability will undermine abstinence-only programs.

President Bush's proposed 2007 budget includes $204 million in support of abstinence-only education, while “no administration, Democrat or Republican, has ever put any [federal] money whatsoever into needle-exchange programs in this country, in contrast to many other countries, including the U.K.,” Dr. Jaffe said.

Purely behavioral interventions, primarily skill-building sessions aimed at reducing risky activities among high-risk individuals, are highly significantly efficacious in reducing unprotected sex and acquiring STDs, he said.

Finally, HIV testing by itself is a profound risk-reducing strategy, because individuals who learn they have been exposed to the virus sharply reduce behaviors that could lead to transmission to others, he noted.

Public health prevention strategies can go only so far in curbing the epidemic, emphasized Dr. Jaffe, particularly when it comes to sexual behavior change.

However, some indicators suggest that resources must be quickly marshaled to stem a rising tide of cases, especially among men who have sex with men and among African Americans and other ethnic minorities.

LOS ANGELES — The number of Americans diagnosed with AIDS is now approaching the 1 million mark, with more than a half-million deaths since the epidemic began and 17,000 more people dying of the disease each year, Dr. Harold Jaffe said during a plenary session at the 14th Conference on Retroviruses and Opportunistic Infections.

That mortality—58 per million—is “twice as high as any country in the European Union and 10 times as high as in the United Kingdom,” said Dr. Jaffe, former director of HIV prevention for the Centers for Disease Control and Prevention and currently head of the department of public health at Oxford University, England.

A troubling jump in incidence in 2005, the latest year for which data are available points to the critical need for community leadership, personal responsibility, and support of preventive efforts proven to work, he said.

“The need for treatment is critical, but I agree with my colleague Dr. Kevin De Cock [WHO director of HIV/AIDS] that we are not going to be able to treat our way out of this epidemic.”

“I guess it seems obvious that we should be implementing what works, evaluating what might work, and stop trying to do what doesn't work,” added Dr. Jaffe, who singled out federal funding for abstinence-only education as an example of a strategy based on beliefs rather than science.

A “very comprehensive” study in press in the Cochrane Review, for example, reviewed eight published randomized controlled trials of abstinence-only programs, compared with standard sex education or safe-sex programs, involving 13,191 American youths.

With a median follow-up of 12 months, none of the abstinence-only programs demonstrated a significant decline in self-reported sexual activity or any biological outcome such as pregnancy or diagnosis with a sexually transmitted disease (STD), compared with the other approaches, said Dr. Jaffe at the conference, sponsored by the Foundation for Retrovirology and Human Health.

A recent University of Pennsylvania study of 662 African American children (median age, 12 years) did show significantly less sexual activity among those receiving abstinence-only education, compared with those exposed to other interventions; even so, nearly a third of the virgins in the abstinence-only group became sexually active over the course of the 2-year study.

Dr. Jaffe said it cannot be entirely ruled out that abstinence-only education could benefit “very specific groups,” but the preponderance of evidence suggests it is not efficacious.

By contrast, he pointed to condom promotion, shown to be “highly efficacious” in preventing HIV transmission, and needle- and syringe-exchange programs, which demonstrate at least modest evidence of reducing intermediate-level activities with the capacity to spread HIV, as more effective approaches.

Condom distribution campaigns are currently being opposed by individuals who believe availability will undermine abstinence-only programs.

President Bush's proposed 2007 budget includes $204 million in support of abstinence-only education, while “no administration, Democrat or Republican, has ever put any [federal] money whatsoever into needle-exchange programs in this country, in contrast to many other countries, including the U.K.,” Dr. Jaffe said.

Purely behavioral interventions, primarily skill-building sessions aimed at reducing risky activities among high-risk individuals, are highly significantly efficacious in reducing unprotected sex and acquiring STDs, he said.

Finally, HIV testing by itself is a profound risk-reducing strategy, because individuals who learn they have been exposed to the virus sharply reduce behaviors that could lead to transmission to others, he noted.

Public health prevention strategies can go only so far in curbing the epidemic, emphasized Dr. Jaffe, particularly when it comes to sexual behavior change.

However, some indicators suggest that resources must be quickly marshaled to stem a rising tide of cases, especially among men who have sex with men and among African Americans and other ethnic minorities.

LOS ANGELES — Visceral adipose tissue declined by 15% in HIV patients treated for 26 weeks with a growth hormone-releasing hormone (GHRH) factor analogue, while visceral fat in patients assigned to placebo increased 5%, Dr. Steven Grinspoon reported at the 14th Conference on Retroviruses and Opportunistic Infections.

“This was a very potent effect, a net change of 20% versus placebo in 6 months,” said Dr. Grinspoon, director of the Massachusetts General Hospital Program in Nutritional Metabolism in Boston.

An “emerging consensus” of data suggests that cardiovascular risk is substantially elevated in patients with HIV, underscoring the clinical importance of a shift seen in the ratio of subcutaneous and visceral fat in patients undergoing antiretroviral treatment, he said. These patients often have a reduction in subcutaneous fat, but a substantial increase in visceral fat, which is a significant independent predictor of cardiovascular risk.

In previous studies, growth hormone has been shown to be efficacious in reducing visceral fat, but its superphysiologic impact on glucose parameters and other side effects limit its clinical usefulness.

By contast, the agent used in this trial, TH9507, is an analogue of a precursor hormone to growth hormone that accomplishes visceral fat reduction “in a more gentle physiological way,” Dr. Grinspoon said.

The phase III, multicenter, double-blind trial randomized 412 HIV patients on stable triple therapy to receive one daily subcutaneous injection of 2 mg TH9507 (275 patients) or placebo (137 patients) for 6 months. Approximately 19% of the study participants had type II diabetes or glucose intolerance at baseline. Lipid-lowering agents were permitted.

Not unexpectedly, roughly 20% of study subjects failed to complete the trial, but the numbers of dropouts were comparable between treatment arms and the results were calculated using an intent-to-treat analysis.

The patients' percentage of visceral abdominal tissue was measured by computed tomography at the L4-L5 level. Secondary and safety end points included measurements of participants' lipid profiles, insulin-like growth factor 1 (IGF-1), and glucose and insulin metabolism.

The absolute 15% reduction in visceral fat was equivalent to a 3-cm reduction in waist size—“a pants size,” Dr. Grinspoon said, in spite of the fact that patients did not lose weight.

In addition to the improvement in visceral fat, trunk fat as measured by dual-energy x-ray absorptiometry also improved significantly in patients receiving TH9507, compared with patients receiving placebo (-1.0% change vs. 1.6% change, respectively; P less than 0.001).

Lipid levels were measured as well. “We saw positive effects across all lipid categories,” he said, noting a particularly robust mean 18% change in triglycerides.

Mean IGF-1 levels increased by 81% among patients receiving the growth hormone precursor analogue and decreased by 5% among patients receiving placebo.

In sharp contrast to the effect of growth hormone, TH9507 did not precipitate changes in fasting glucose, 2-hour postprandial glucose, or insulin.

“It is much more tolerated, yet you get the same bang for the buck, a 15%–20% reduction in visceral fat, and improvements across lipids,” he said at the meeting, also sponsored by the Foundation of Retrovirology and Human Health.

The two most common side effects—headache and arthralgias—were seen equally in treatment and placebo patients. However, more patients receiving TH9507 discontinued treatment because of adverse effects. Notably, six patients in the active treatment arm developed a rash, most often after 4 months of treatment, and one developed associated sweating, tachycardia, and shortness of breath.

These patients were “treated with Benadryl and did fine,” but were released from the study as a precaution, Dr. Grinspoon said. A confirmatory study currently underway in Europe will also explore the durability of effects following discontinuation of the drug, which has not received FDA approval.

Dr. Grinspoon disclosed that he is an independent investigator and consultant to Theratechnologies Inc., of Montreal, manufacturer of TH9507.

LOS ANGELES — Visceral adipose tissue declined by 15% in HIV patients treated for 26 weeks with a growth hormone-releasing hormone (GHRH) factor analogue, while visceral fat in patients assigned to placebo increased 5%, Dr. Steven Grinspoon reported at the 14th Conference on Retroviruses and Opportunistic Infections.

“This was a very potent effect, a net change of 20% versus placebo in 6 months,” said Dr. Grinspoon, director of the Massachusetts General Hospital Program in Nutritional Metabolism in Boston.

An “emerging consensus” of data suggests that cardiovascular risk is substantially elevated in patients with HIV, underscoring the clinical importance of a shift seen in the ratio of subcutaneous and visceral fat in patients undergoing antiretroviral treatment, he said. These patients often have a reduction in subcutaneous fat, but a substantial increase in visceral fat, which is a significant independent predictor of cardiovascular risk.

In previous studies, growth hormone has been shown to be efficacious in reducing visceral fat, but its superphysiologic impact on glucose parameters and other side effects limit its clinical usefulness.

By contast, the agent used in this trial, TH9507, is an analogue of a precursor hormone to growth hormone that accomplishes visceral fat reduction “in a more gentle physiological way,” Dr. Grinspoon said.

The phase III, multicenter, double-blind trial randomized 412 HIV patients on stable triple therapy to receive one daily subcutaneous injection of 2 mg TH9507 (275 patients) or placebo (137 patients) for 6 months. Approximately 19% of the study participants had type II diabetes or glucose intolerance at baseline. Lipid-lowering agents were permitted.

Not unexpectedly, roughly 20% of study subjects failed to complete the trial, but the numbers of dropouts were comparable between treatment arms and the results were calculated using an intent-to-treat analysis.

The patients' percentage of visceral abdominal tissue was measured by computed tomography at the L4-L5 level. Secondary and safety end points included measurements of participants' lipid profiles, insulin-like growth factor 1 (IGF-1), and glucose and insulin metabolism.

The absolute 15% reduction in visceral fat was equivalent to a 3-cm reduction in waist size—“a pants size,” Dr. Grinspoon said, in spite of the fact that patients did not lose weight.

In addition to the improvement in visceral fat, trunk fat as measured by dual-energy x-ray absorptiometry also improved significantly in patients receiving TH9507, compared with patients receiving placebo (-1.0% change vs. 1.6% change, respectively; P less than 0.001).

Lipid levels were measured as well. “We saw positive effects across all lipid categories,” he said, noting a particularly robust mean 18% change in triglycerides.

Mean IGF-1 levels increased by 81% among patients receiving the growth hormone precursor analogue and decreased by 5% among patients receiving placebo.

In sharp contrast to the effect of growth hormone, TH9507 did not precipitate changes in fasting glucose, 2-hour postprandial glucose, or insulin.

“It is much more tolerated, yet you get the same bang for the buck, a 15%–20% reduction in visceral fat, and improvements across lipids,” he said at the meeting, also sponsored by the Foundation of Retrovirology and Human Health.

The two most common side effects—headache and arthralgias—were seen equally in treatment and placebo patients. However, more patients receiving TH9507 discontinued treatment because of adverse effects. Notably, six patients in the active treatment arm developed a rash, most often after 4 months of treatment, and one developed associated sweating, tachycardia, and shortness of breath.

These patients were “treated with Benadryl and did fine,” but were released from the study as a precaution, Dr. Grinspoon said. A confirmatory study currently underway in Europe will also explore the durability of effects following discontinuation of the drug, which has not received FDA approval.

Dr. Grinspoon disclosed that he is an independent investigator and consultant to Theratechnologies Inc., of Montreal, manufacturer of TH9507.

LOS ANGELES — Visceral adipose tissue declined by 15% in HIV patients treated for 26 weeks with a growth hormone-releasing hormone (GHRH) factor analogue, while visceral fat in patients assigned to placebo increased 5%, Dr. Steven Grinspoon reported at the 14th Conference on Retroviruses and Opportunistic Infections.

“This was a very potent effect, a net change of 20% versus placebo in 6 months,” said Dr. Grinspoon, director of the Massachusetts General Hospital Program in Nutritional Metabolism in Boston.

An “emerging consensus” of data suggests that cardiovascular risk is substantially elevated in patients with HIV, underscoring the clinical importance of a shift seen in the ratio of subcutaneous and visceral fat in patients undergoing antiretroviral treatment, he said. These patients often have a reduction in subcutaneous fat, but a substantial increase in visceral fat, which is a significant independent predictor of cardiovascular risk.

In previous studies, growth hormone has been shown to be efficacious in reducing visceral fat, but its superphysiologic impact on glucose parameters and other side effects limit its clinical usefulness.

By contast, the agent used in this trial, TH9507, is an analogue of a precursor hormone to growth hormone that accomplishes visceral fat reduction “in a more gentle physiological way,” Dr. Grinspoon said.

The phase III, multicenter, double-blind trial randomized 412 HIV patients on stable triple therapy to receive one daily subcutaneous injection of 2 mg TH9507 (275 patients) or placebo (137 patients) for 6 months. Approximately 19% of the study participants had type II diabetes or glucose intolerance at baseline. Lipid-lowering agents were permitted.

Not unexpectedly, roughly 20% of study subjects failed to complete the trial, but the numbers of dropouts were comparable between treatment arms and the results were calculated using an intent-to-treat analysis.

The patients' percentage of visceral abdominal tissue was measured by computed tomography at the L4-L5 level. Secondary and safety end points included measurements of participants' lipid profiles, insulin-like growth factor 1 (IGF-1), and glucose and insulin metabolism.

The absolute 15% reduction in visceral fat was equivalent to a 3-cm reduction in waist size—“a pants size,” Dr. Grinspoon said, in spite of the fact that patients did not lose weight.

In addition to the improvement in visceral fat, trunk fat as measured by dual-energy x-ray absorptiometry also improved significantly in patients receiving TH9507, compared with patients receiving placebo (-1.0% change vs. 1.6% change, respectively; P less than 0.001).

Lipid levels were measured as well. “We saw positive effects across all lipid categories,” he said, noting a particularly robust mean 18% change in triglycerides.

Mean IGF-1 levels increased by 81% among patients receiving the growth hormone precursor analogue and decreased by 5% among patients receiving placebo.

In sharp contrast to the effect of growth hormone, TH9507 did not precipitate changes in fasting glucose, 2-hour postprandial glucose, or insulin.

“It is much more tolerated, yet you get the same bang for the buck, a 15%–20% reduction in visceral fat, and improvements across lipids,” he said at the meeting, also sponsored by the Foundation of Retrovirology and Human Health.

The two most common side effects—headache and arthralgias—were seen equally in treatment and placebo patients. However, more patients receiving TH9507 discontinued treatment because of adverse effects. Notably, six patients in the active treatment arm developed a rash, most often after 4 months of treatment, and one developed associated sweating, tachycardia, and shortness of breath.

These patients were “treated with Benadryl and did fine,” but were released from the study as a precaution, Dr. Grinspoon said. A confirmatory study currently underway in Europe will also explore the durability of effects following discontinuation of the drug, which has not received FDA approval.

Dr. Grinspoon disclosed that he is an independent investigator and consultant to Theratechnologies Inc., of Montreal, manufacturer of TH9507.