Bruce Jancin

GOTHENBURG, SWEDEN – The treatment regimens currently recommended for nongonococcal urethritis and cervicitis by the Centers for Disease Control and Prevention have significant drawbacks for infections caused by Mycoplasma genitalium, according to Dr. Carin Anagrius.

Multiple studies – reported since the CDC guidelines were released in 2006 – indicate that M. genitalium is the second most common cause of nongonococcal urethritis (NGU), with a prevalence about half that of Chlamydia trachomatis, Dr. Anagrius said at the congress.

The first-line treatment options recommended by the CDC for NGU and presumptive treatment of cervicitis (doxycycline and azithromycin) both have problems, said Dr. Anagrius of Falu Hospital in Falun, Sweden. Doxycycline at 100 mg twice daily for 7 days has an unacceptable eradication rate for M. genitalium, and azithromycin in a single 1-g dose promotes emergence of macrolide-resistant organisms.

For this reason, she said, a revision of the guidelines is in order. The best solution would be to elevate azithromycin given over 5 days to preferred first-line therapy status. This regimen consists of 500 mg of azithromycin on day 1 followed by 250 mg on days 2-5. Studies found it has a 95% M. genitalium eradication rate and a substantially lower risk of inducing azithromycin resistance than with a single 1-g dose, she said.

An observational study by Dr. Anagrius and coworkers showed that eradication rates in symptomatic M. genitalium NGU in Scandinavia were about 85% for azithromycin 1 g and less than 30% for doxycycline (Sex. Transm. Infect. 2008; 84:72-6). Similar rates have been confirmed by other investigators, she noted.

For example, University of Mississippi investigators randomized men with known M. genitalium urethritis at a New Orleans STD clinic to doxycycline (100 mg twice a day for 7 days) or azithromycin (1 g as a single dose). The cure rates at the first follow-up visit were 87% with azithromycin, compared with 45% with doxycycline; 47% of those who were initially cured experienced clinical relapse in the next 2-6 weeks (Clin. Infect. Dis. 2009;48:1649-54).

The latest data from large population studies suggest M. genitalium causes about 15% of all NGU, noted Dr. Anagrius. Since there is as no commercially available diagnostic assay for M. genitalium infections, for every 1,000 patients with NGU who are treated with doxycycline, roughly 84 will return with persistent symptomatic M. genitalium urethritis. However, if the 1,000 patients were treated with single-dose azithro-mycin at 1 g, only 18 would return with persistent symptomatic M. genitalium urethritis.

Dr. Anagrius' studies indicate roughly 70% of these unsuccessfully treated patients would as a consequence of this unsuccessful treatment develop resistance to azithromycin in the form of a single base mutation in domain V of the 23S rRNA gene. Extended azithromycin as second-line therapy is unlikely to be successful in these patients. For them the only effective second-line antimicrobials are moxifloxacin and gatifloxacin. And there is as yet no third-line therapy.

If, on the other hand, 1,000 NGU patients were treated with 1.5 g of azithromycin over 5 days, only 6 would return because of persistent M. genitalium urethritis, she said. Thus, the number of individuals with azithromycin-resistant M. genitalium infections would be reduced by two-thirds, compared with the count if azithromycin 1 g was used.

The impact of using azithromycin 1 g as first-line therapy for NGU is illustrated by the markedly contrasting prevalence of macrolide-resistant M. genitalium in Sweden and neighboring Denmark. In Sweden, where using 1 g of azithromycin to treat NGU is uncommon, Dr. Anagrius and coworkers found the prevalence of azithromycin resistance to be only 1.6% among 181 patients presenting with new confirmed M. genitalium.

In Denmark, where azithromycin 1 g is widely prescribed as first-line therapy, Dr. Anagrius' Danish collaborators found a 40% prevalence of macrolide resistance in 415 patients presenting with new confirmed M. genitalium urethritis.

Dr. Anagrius noted that discussion about screening for M. genitalium infection in asymptomatic individuals in high-prevalence settings is starting to occur among venereologists and public health officials. The problem is the lack of a commercial polymerase chain reaction assay, which must be a high developmental priority. In the meantime, Dr. Anagrius urged physicians to “think M. genitalium” in patients with repeated urinary tract infections, abnormal bleeding, lower abdominal pain, persistent discharge, epididymitis, prostatitis, and what is often labeled treatment-resistant candidiasis.

And since M. genitalium NGU and cervicitis are sexually transmitted infections, optimal care includes treatment of the patient's partner or partners, she stressed.

Dr. Anagrius disclosed having no financial conflicts.

A revision of the guidelines for treating NGU and cervicitis is in order.

Source DR. ANAGRIUS

GOTHENBURG, SWEDEN – The treatment regimens currently recommended for nongonococcal urethritis and cervicitis by the Centers for Disease Control and Prevention have significant drawbacks for infections caused by Mycoplasma genitalium, according to Dr. Carin Anagrius.

Multiple studies – reported since the CDC guidelines were released in 2006 – indicate that M. genitalium is the second most common cause of nongonococcal urethritis (NGU), with a prevalence about half that of Chlamydia trachomatis, Dr. Anagrius said at the congress.

The first-line treatment options recommended by the CDC for NGU and presumptive treatment of cervicitis (doxycycline and azithromycin) both have problems, said Dr. Anagrius of Falu Hospital in Falun, Sweden. Doxycycline at 100 mg twice daily for 7 days has an unacceptable eradication rate for M. genitalium, and azithromycin in a single 1-g dose promotes emergence of macrolide-resistant organisms.

For this reason, she said, a revision of the guidelines is in order. The best solution would be to elevate azithromycin given over 5 days to preferred first-line therapy status. This regimen consists of 500 mg of azithromycin on day 1 followed by 250 mg on days 2-5. Studies found it has a 95% M. genitalium eradication rate and a substantially lower risk of inducing azithromycin resistance than with a single 1-g dose, she said.

An observational study by Dr. Anagrius and coworkers showed that eradication rates in symptomatic M. genitalium NGU in Scandinavia were about 85% for azithromycin 1 g and less than 30% for doxycycline (Sex. Transm. Infect. 2008; 84:72-6). Similar rates have been confirmed by other investigators, she noted.

For example, University of Mississippi investigators randomized men with known M. genitalium urethritis at a New Orleans STD clinic to doxycycline (100 mg twice a day for 7 days) or azithromycin (1 g as a single dose). The cure rates at the first follow-up visit were 87% with azithromycin, compared with 45% with doxycycline; 47% of those who were initially cured experienced clinical relapse in the next 2-6 weeks (Clin. Infect. Dis. 2009;48:1649-54).

The latest data from large population studies suggest M. genitalium causes about 15% of all NGU, noted Dr. Anagrius. Since there is as no commercially available diagnostic assay for M. genitalium infections, for every 1,000 patients with NGU who are treated with doxycycline, roughly 84 will return with persistent symptomatic M. genitalium urethritis. However, if the 1,000 patients were treated with single-dose azithro-mycin at 1 g, only 18 would return with persistent symptomatic M. genitalium urethritis.

Dr. Anagrius' studies indicate roughly 70% of these unsuccessfully treated patients would as a consequence of this unsuccessful treatment develop resistance to azithromycin in the form of a single base mutation in domain V of the 23S rRNA gene. Extended azithromycin as second-line therapy is unlikely to be successful in these patients. For them the only effective second-line antimicrobials are moxifloxacin and gatifloxacin. And there is as yet no third-line therapy.

If, on the other hand, 1,000 NGU patients were treated with 1.5 g of azithromycin over 5 days, only 6 would return because of persistent M. genitalium urethritis, she said. Thus, the number of individuals with azithromycin-resistant M. genitalium infections would be reduced by two-thirds, compared with the count if azithromycin 1 g was used.

The impact of using azithromycin 1 g as first-line therapy for NGU is illustrated by the markedly contrasting prevalence of macrolide-resistant M. genitalium in Sweden and neighboring Denmark. In Sweden, where using 1 g of azithromycin to treat NGU is uncommon, Dr. Anagrius and coworkers found the prevalence of azithromycin resistance to be only 1.6% among 181 patients presenting with new confirmed M. genitalium.

In Denmark, where azithromycin 1 g is widely prescribed as first-line therapy, Dr. Anagrius' Danish collaborators found a 40% prevalence of macrolide resistance in 415 patients presenting with new confirmed M. genitalium urethritis.

Dr. Anagrius noted that discussion about screening for M. genitalium infection in asymptomatic individuals in high-prevalence settings is starting to occur among venereologists and public health officials. The problem is the lack of a commercial polymerase chain reaction assay, which must be a high developmental priority. In the meantime, Dr. Anagrius urged physicians to “think M. genitalium” in patients with repeated urinary tract infections, abnormal bleeding, lower abdominal pain, persistent discharge, epididymitis, prostatitis, and what is often labeled treatment-resistant candidiasis.

And since M. genitalium NGU and cervicitis are sexually transmitted infections, optimal care includes treatment of the patient's partner or partners, she stressed.

Dr. Anagrius disclosed having no financial conflicts.

A revision of the guidelines for treating NGU and cervicitis is in order.

Source DR. ANAGRIUS

GOTHENBURG, SWEDEN – The treatment regimens currently recommended for nongonococcal urethritis and cervicitis by the Centers for Disease Control and Prevention have significant drawbacks for infections caused by Mycoplasma genitalium, according to Dr. Carin Anagrius.

Multiple studies – reported since the CDC guidelines were released in 2006 – indicate that M. genitalium is the second most common cause of nongonococcal urethritis (NGU), with a prevalence about half that of Chlamydia trachomatis, Dr. Anagrius said at the congress.

The first-line treatment options recommended by the CDC for NGU and presumptive treatment of cervicitis (doxycycline and azithromycin) both have problems, said Dr. Anagrius of Falu Hospital in Falun, Sweden. Doxycycline at 100 mg twice daily for 7 days has an unacceptable eradication rate for M. genitalium, and azithromycin in a single 1-g dose promotes emergence of macrolide-resistant organisms.

For this reason, she said, a revision of the guidelines is in order. The best solution would be to elevate azithromycin given over 5 days to preferred first-line therapy status. This regimen consists of 500 mg of azithromycin on day 1 followed by 250 mg on days 2-5. Studies found it has a 95% M. genitalium eradication rate and a substantially lower risk of inducing azithromycin resistance than with a single 1-g dose, she said.

An observational study by Dr. Anagrius and coworkers showed that eradication rates in symptomatic M. genitalium NGU in Scandinavia were about 85% for azithromycin 1 g and less than 30% for doxycycline (Sex. Transm. Infect. 2008; 84:72-6). Similar rates have been confirmed by other investigators, she noted.

For example, University of Mississippi investigators randomized men with known M. genitalium urethritis at a New Orleans STD clinic to doxycycline (100 mg twice a day for 7 days) or azithromycin (1 g as a single dose). The cure rates at the first follow-up visit were 87% with azithromycin, compared with 45% with doxycycline; 47% of those who were initially cured experienced clinical relapse in the next 2-6 weeks (Clin. Infect. Dis. 2009;48:1649-54).

The latest data from large population studies suggest M. genitalium causes about 15% of all NGU, noted Dr. Anagrius. Since there is as no commercially available diagnostic assay for M. genitalium infections, for every 1,000 patients with NGU who are treated with doxycycline, roughly 84 will return with persistent symptomatic M. genitalium urethritis. However, if the 1,000 patients were treated with single-dose azithro-mycin at 1 g, only 18 would return with persistent symptomatic M. genitalium urethritis.

Dr. Anagrius' studies indicate roughly 70% of these unsuccessfully treated patients would as a consequence of this unsuccessful treatment develop resistance to azithromycin in the form of a single base mutation in domain V of the 23S rRNA gene. Extended azithromycin as second-line therapy is unlikely to be successful in these patients. For them the only effective second-line antimicrobials are moxifloxacin and gatifloxacin. And there is as yet no third-line therapy.

If, on the other hand, 1,000 NGU patients were treated with 1.5 g of azithromycin over 5 days, only 6 would return because of persistent M. genitalium urethritis, she said. Thus, the number of individuals with azithromycin-resistant M. genitalium infections would be reduced by two-thirds, compared with the count if azithromycin 1 g was used.

The impact of using azithromycin 1 g as first-line therapy for NGU is illustrated by the markedly contrasting prevalence of macrolide-resistant M. genitalium in Sweden and neighboring Denmark. In Sweden, where using 1 g of azithromycin to treat NGU is uncommon, Dr. Anagrius and coworkers found the prevalence of azithromycin resistance to be only 1.6% among 181 patients presenting with new confirmed M. genitalium.

In Denmark, where azithromycin 1 g is widely prescribed as first-line therapy, Dr. Anagrius' Danish collaborators found a 40% prevalence of macrolide resistance in 415 patients presenting with new confirmed M. genitalium urethritis.

Dr. Anagrius noted that discussion about screening for M. genitalium infection in asymptomatic individuals in high-prevalence settings is starting to occur among venereologists and public health officials. The problem is the lack of a commercial polymerase chain reaction assay, which must be a high developmental priority. In the meantime, Dr. Anagrius urged physicians to “think M. genitalium” in patients with repeated urinary tract infections, abnormal bleeding, lower abdominal pain, persistent discharge, epididymitis, prostatitis, and what is often labeled treatment-resistant candidiasis.

And since M. genitalium NGU and cervicitis are sexually transmitted infections, optimal care includes treatment of the patient's partner or partners, she stressed.

Dr. Anagrius disclosed having no financial conflicts.

A revision of the guidelines for treating NGU and cervicitis is in order.

Source DR. ANAGRIUS

Major Finding: Surgeons rated the quality of the visual field as good or excellent 85% of the time when the oral preparation was used and, similarly, 91% of the time with the enema.

Data Source: A single-center prospective study in which 145 women undergoing gynecologic laparoscopic surgery were randomized to oral sodium phosphate solution or a sodium phosphate enema as bowel preparation.

Disclosures: Dr. Yang declared she has no relevant financial interests.

DENVER – The use of oral sodium phosphate solution for mechanical bowel preparation in gynecologic laparoscopy doesn't provide a better-quality visual field than does a single sodium phosphate enema – and patients much prefer the enema, according to randomized trial results.

On balance, the enema may be the better regimen for gynecologic laparoscopic surgeries, as it causes significantly fewer side effects. And as the study demonstrated, surgeons can't tell the difference between the oral solution and enema in terms of surgical field visualization, Dr. Linda C. Yang said.

Mechanical bowel preparation was embraced by general surgeons several decades ago in a belief that a decreased fecal load at the time of surgery would mean fewer infectious complications. However, recent published trials in colorectal surgery have not shown a significant benefit. And while mechanical bowel preparation is popular among gynecologic laparoscopic surgeons, its pros and cons in the context of this highly specialized form of surgery have not previously been well defined, observed Dr. Yang of Beth Israel Deaconess Medical Center, Boston.

This was the impetus for her single-center prospective study in which 145 women undergoing gynecologic laparoscopic surgery were randomized to oral sodium phosphate solution or a sodium phosphate enema. Surgeons were blinded as to patient allocation assignment.

The primary study end point was the visual quality of the surgical field at the beginning and conclusion of the operation as assessed by the surgeons, who completed a detailed same-day questionnaire. They rated the quality of the visual field as good or excellent 85% of the time when the oral preparation was used and, similarly, 91% of the time with the enema. There were no significant differences between the two groups in terms of surgeons' ratings of need for additional maneuvers to enhance exposure, degree of difficulty in bowel manipulation using laparoscopic instruments, surgical difficulty, or ability to visualize the uterus, right and left adnexal structures, and posterior cul-de-sac.

Surgeons were able to accurately predict which group their patients were in only 52% of the time: “Essentially, a flip of the coin,” Dr. Yang noted.

Patients self-rated the severity of 12 symptoms on a visual analog scale. The oral sodium phosphate group characterized six symptoms as significantly more severe: abdominal bloating, thirst, weakness, dizziness, nausea, and fecal incontinence. Severity of the other six symptoms was not significantly different between the two groups. Two-thirds of the enema group rated their bowel preparation as easy. That was the case for 26% of those in the oral preparation group.

Ninety-seven percent of patients in the enema group said they would be willing to do the same preparation again, compared with 44% of patients in the oral preparation group.

The enema causes significantly fewer side effects.

Source DR. YANG

Major Finding: Surgeons rated the quality of the visual field as good or excellent 85% of the time when the oral preparation was used and, similarly, 91% of the time with the enema.

Data Source: A single-center prospective study in which 145 women undergoing gynecologic laparoscopic surgery were randomized to oral sodium phosphate solution or a sodium phosphate enema as bowel preparation.

Disclosures: Dr. Yang declared she has no relevant financial interests.

DENVER – The use of oral sodium phosphate solution for mechanical bowel preparation in gynecologic laparoscopy doesn't provide a better-quality visual field than does a single sodium phosphate enema – and patients much prefer the enema, according to randomized trial results.

On balance, the enema may be the better regimen for gynecologic laparoscopic surgeries, as it causes significantly fewer side effects. And as the study demonstrated, surgeons can't tell the difference between the oral solution and enema in terms of surgical field visualization, Dr. Linda C. Yang said.

Mechanical bowel preparation was embraced by general surgeons several decades ago in a belief that a decreased fecal load at the time of surgery would mean fewer infectious complications. However, recent published trials in colorectal surgery have not shown a significant benefit. And while mechanical bowel preparation is popular among gynecologic laparoscopic surgeons, its pros and cons in the context of this highly specialized form of surgery have not previously been well defined, observed Dr. Yang of Beth Israel Deaconess Medical Center, Boston.

This was the impetus for her single-center prospective study in which 145 women undergoing gynecologic laparoscopic surgery were randomized to oral sodium phosphate solution or a sodium phosphate enema. Surgeons were blinded as to patient allocation assignment.

The primary study end point was the visual quality of the surgical field at the beginning and conclusion of the operation as assessed by the surgeons, who completed a detailed same-day questionnaire. They rated the quality of the visual field as good or excellent 85% of the time when the oral preparation was used and, similarly, 91% of the time with the enema. There were no significant differences between the two groups in terms of surgeons' ratings of need for additional maneuvers to enhance exposure, degree of difficulty in bowel manipulation using laparoscopic instruments, surgical difficulty, or ability to visualize the uterus, right and left adnexal structures, and posterior cul-de-sac.

Surgeons were able to accurately predict which group their patients were in only 52% of the time: “Essentially, a flip of the coin,” Dr. Yang noted.

Patients self-rated the severity of 12 symptoms on a visual analog scale. The oral sodium phosphate group characterized six symptoms as significantly more severe: abdominal bloating, thirst, weakness, dizziness, nausea, and fecal incontinence. Severity of the other six symptoms was not significantly different between the two groups. Two-thirds of the enema group rated their bowel preparation as easy. That was the case for 26% of those in the oral preparation group.

Ninety-seven percent of patients in the enema group said they would be willing to do the same preparation again, compared with 44% of patients in the oral preparation group.

The enema causes significantly fewer side effects.

Source DR. YANG

Major Finding: Surgeons rated the quality of the visual field as good or excellent 85% of the time when the oral preparation was used and, similarly, 91% of the time with the enema.

Data Source: A single-center prospective study in which 145 women undergoing gynecologic laparoscopic surgery were randomized to oral sodium phosphate solution or a sodium phosphate enema as bowel preparation.

Disclosures: Dr. Yang declared she has no relevant financial interests.

DENVER – The use of oral sodium phosphate solution for mechanical bowel preparation in gynecologic laparoscopy doesn't provide a better-quality visual field than does a single sodium phosphate enema – and patients much prefer the enema, according to randomized trial results.

On balance, the enema may be the better regimen for gynecologic laparoscopic surgeries, as it causes significantly fewer side effects. And as the study demonstrated, surgeons can't tell the difference between the oral solution and enema in terms of surgical field visualization, Dr. Linda C. Yang said.

Mechanical bowel preparation was embraced by general surgeons several decades ago in a belief that a decreased fecal load at the time of surgery would mean fewer infectious complications. However, recent published trials in colorectal surgery have not shown a significant benefit. And while mechanical bowel preparation is popular among gynecologic laparoscopic surgeons, its pros and cons in the context of this highly specialized form of surgery have not previously been well defined, observed Dr. Yang of Beth Israel Deaconess Medical Center, Boston.

This was the impetus for her single-center prospective study in which 145 women undergoing gynecologic laparoscopic surgery were randomized to oral sodium phosphate solution or a sodium phosphate enema. Surgeons were blinded as to patient allocation assignment.

The primary study end point was the visual quality of the surgical field at the beginning and conclusion of the operation as assessed by the surgeons, who completed a detailed same-day questionnaire. They rated the quality of the visual field as good or excellent 85% of the time when the oral preparation was used and, similarly, 91% of the time with the enema. There were no significant differences between the two groups in terms of surgeons' ratings of need for additional maneuvers to enhance exposure, degree of difficulty in bowel manipulation using laparoscopic instruments, surgical difficulty, or ability to visualize the uterus, right and left adnexal structures, and posterior cul-de-sac.

Surgeons were able to accurately predict which group their patients were in only 52% of the time: “Essentially, a flip of the coin,” Dr. Yang noted.

Patients self-rated the severity of 12 symptoms on a visual analog scale. The oral sodium phosphate group characterized six symptoms as significantly more severe: abdominal bloating, thirst, weakness, dizziness, nausea, and fecal incontinence. Severity of the other six symptoms was not significantly different between the two groups. Two-thirds of the enema group rated their bowel preparation as easy. That was the case for 26% of those in the oral preparation group.

Ninety-seven percent of patients in the enema group said they would be willing to do the same preparation again, compared with 44% of patients in the oral preparation group.

The enema causes significantly fewer side effects.

Source DR. YANG

Major Finding: Having been in a physically abusive relationship within the past year was associated with a 2.8-fold increased risk of unintended pregnancy at 2-year schools and a 4.5-fold elevated risk at 4-year colleges.

Data Source: Data from the Spring 2007 National College Health Assessment.

Disclosures: Dr. Lindley said she had no relevant financial conflicts.

DENVER – Unintended pregnancies are threefold more frequent among unmarried sexually active female college students at 2-year as opposed to 4-year institutions.

Data from the Spring 2007 National College Health Assessment showed that, overall, 2.6% of unmarried sexually active female students aged 18-24 years at western U.S. colleges experienced an unwanted pregnancy during the past year.

The rate was 5.3% among 1,433 attendees at 2-year colleges and 1.8% in 4,732 at 4-year schools, Lisa L. Lindley, Dr. P.H., reported at the meeting.

A multivariate logistic regression analysis identified 9 risk factors associated with unintended pregnancy in young women attending 2-year institutions and 11 risk factors operative at 4-year schools. Some of these risk factors were common to both types of schools, while others were unique to one or the other.

Among the most striking shared risk factors was having been in a physically abusive relationship within the past year. This was associated with a 2.8-fold increased risk of unintended pregnancy at 2-year schools and a 4.5-fold elevated risk at 4-year colleges, according to Dr. Lindley of George Mason University, Fairfax, Va.

Use of the emergency contraceptive pill within the previous year was another risk factor for unintended pregnancy common to students at both types of colleges. It was associated with a 2.6-fold increased risk in unmarried sexually active students at 2-year schools and a 2.8-fold risk in those at 4-year schools.

Having a C or lower grade average was associated with a 2.2-fold increased likelihood of unintended pregnancy in women attending a 4-year college, but was not a significant risk factor at 2-year colleges. On the other hand, having unprotected sex in the past year as a consequence of drinking alcohol was a significant risk factor for unintended pregnancy at 2-year, but not 4-year institutions. Having had a gynecologic exam during the past year was associated with a 2.7-fold increased likelihood of unintended pregnancy among women at 2-year schools but wasn't a significant factor at 4-year colleges.

Race was not a significant predictor of unintended pregnancy among the college students. This is an intriguing finding in light of the marked racial disparity in pregnancy rates among young women as a whole in the United States, Dr. Lindley said. For example, in 2004 the pregnancy rates among 20- to 24-year-old black and Hispanic women were 259 and 245 per 1,000 population, respectively, compared with 123 per 1,000 in similarly aged white women.

Dr. Lindley explained that the college study was undertaken in an effort to better understand the phenomenon of unintended pregnancy. Half of all pregnancies in the United States are unintended. Among young unmarried women this figure is far higher: 73% among 20- to 24-year-olds, and 86% in those under age 20.

Solid progress has been made in reducing the national pregnancy rate among 15- to 17-year-olds. But pregnancy rates among 18- to 24-year-olds remain excessive, she said.

A key lesson from the college study lies in the importance of addressing multiple risk factors at once for unwanted pregnancy, including abusive relationships – physical, emotional, and sexual – as well as alcohol use and proper use of the emergency contraceptive pill, Dr. Lindley added.

Major Finding: Having been in a physically abusive relationship within the past year was associated with a 2.8-fold increased risk of unintended pregnancy at 2-year schools and a 4.5-fold elevated risk at 4-year colleges.

Data Source: Data from the Spring 2007 National College Health Assessment.

Disclosures: Dr. Lindley said she had no relevant financial conflicts.

DENVER – Unintended pregnancies are threefold more frequent among unmarried sexually active female college students at 2-year as opposed to 4-year institutions.

Data from the Spring 2007 National College Health Assessment showed that, overall, 2.6% of unmarried sexually active female students aged 18-24 years at western U.S. colleges experienced an unwanted pregnancy during the past year.

The rate was 5.3% among 1,433 attendees at 2-year colleges and 1.8% in 4,732 at 4-year schools, Lisa L. Lindley, Dr. P.H., reported at the meeting.

A multivariate logistic regression analysis identified 9 risk factors associated with unintended pregnancy in young women attending 2-year institutions and 11 risk factors operative at 4-year schools. Some of these risk factors were common to both types of schools, while others were unique to one or the other.

Among the most striking shared risk factors was having been in a physically abusive relationship within the past year. This was associated with a 2.8-fold increased risk of unintended pregnancy at 2-year schools and a 4.5-fold elevated risk at 4-year colleges, according to Dr. Lindley of George Mason University, Fairfax, Va.

Use of the emergency contraceptive pill within the previous year was another risk factor for unintended pregnancy common to students at both types of colleges. It was associated with a 2.6-fold increased risk in unmarried sexually active students at 2-year schools and a 2.8-fold risk in those at 4-year schools.

Having a C or lower grade average was associated with a 2.2-fold increased likelihood of unintended pregnancy in women attending a 4-year college, but was not a significant risk factor at 2-year colleges. On the other hand, having unprotected sex in the past year as a consequence of drinking alcohol was a significant risk factor for unintended pregnancy at 2-year, but not 4-year institutions. Having had a gynecologic exam during the past year was associated with a 2.7-fold increased likelihood of unintended pregnancy among women at 2-year schools but wasn't a significant factor at 4-year colleges.

Race was not a significant predictor of unintended pregnancy among the college students. This is an intriguing finding in light of the marked racial disparity in pregnancy rates among young women as a whole in the United States, Dr. Lindley said. For example, in 2004 the pregnancy rates among 20- to 24-year-old black and Hispanic women were 259 and 245 per 1,000 population, respectively, compared with 123 per 1,000 in similarly aged white women.

Dr. Lindley explained that the college study was undertaken in an effort to better understand the phenomenon of unintended pregnancy. Half of all pregnancies in the United States are unintended. Among young unmarried women this figure is far higher: 73% among 20- to 24-year-olds, and 86% in those under age 20.

Solid progress has been made in reducing the national pregnancy rate among 15- to 17-year-olds. But pregnancy rates among 18- to 24-year-olds remain excessive, she said.

A key lesson from the college study lies in the importance of addressing multiple risk factors at once for unwanted pregnancy, including abusive relationships – physical, emotional, and sexual – as well as alcohol use and proper use of the emergency contraceptive pill, Dr. Lindley added.

Major Finding: Having been in a physically abusive relationship within the past year was associated with a 2.8-fold increased risk of unintended pregnancy at 2-year schools and a 4.5-fold elevated risk at 4-year colleges.

Data Source: Data from the Spring 2007 National College Health Assessment.

Disclosures: Dr. Lindley said she had no relevant financial conflicts.

DENVER – Unintended pregnancies are threefold more frequent among unmarried sexually active female college students at 2-year as opposed to 4-year institutions.

Data from the Spring 2007 National College Health Assessment showed that, overall, 2.6% of unmarried sexually active female students aged 18-24 years at western U.S. colleges experienced an unwanted pregnancy during the past year.

The rate was 5.3% among 1,433 attendees at 2-year colleges and 1.8% in 4,732 at 4-year schools, Lisa L. Lindley, Dr. P.H., reported at the meeting.

A multivariate logistic regression analysis identified 9 risk factors associated with unintended pregnancy in young women attending 2-year institutions and 11 risk factors operative at 4-year schools. Some of these risk factors were common to both types of schools, while others were unique to one or the other.

Among the most striking shared risk factors was having been in a physically abusive relationship within the past year. This was associated with a 2.8-fold increased risk of unintended pregnancy at 2-year schools and a 4.5-fold elevated risk at 4-year colleges, according to Dr. Lindley of George Mason University, Fairfax, Va.

Use of the emergency contraceptive pill within the previous year was another risk factor for unintended pregnancy common to students at both types of colleges. It was associated with a 2.6-fold increased risk in unmarried sexually active students at 2-year schools and a 2.8-fold risk in those at 4-year schools.

Having a C or lower grade average was associated with a 2.2-fold increased likelihood of unintended pregnancy in women attending a 4-year college, but was not a significant risk factor at 2-year colleges. On the other hand, having unprotected sex in the past year as a consequence of drinking alcohol was a significant risk factor for unintended pregnancy at 2-year, but not 4-year institutions. Having had a gynecologic exam during the past year was associated with a 2.7-fold increased likelihood of unintended pregnancy among women at 2-year schools but wasn't a significant factor at 4-year colleges.

Race was not a significant predictor of unintended pregnancy among the college students. This is an intriguing finding in light of the marked racial disparity in pregnancy rates among young women as a whole in the United States, Dr. Lindley said. For example, in 2004 the pregnancy rates among 20- to 24-year-old black and Hispanic women were 259 and 245 per 1,000 population, respectively, compared with 123 per 1,000 in similarly aged white women.

Dr. Lindley explained that the college study was undertaken in an effort to better understand the phenomenon of unintended pregnancy. Half of all pregnancies in the United States are unintended. Among young unmarried women this figure is far higher: 73% among 20- to 24-year-olds, and 86% in those under age 20.

Solid progress has been made in reducing the national pregnancy rate among 15- to 17-year-olds. But pregnancy rates among 18- to 24-year-olds remain excessive, she said.

A key lesson from the college study lies in the importance of addressing multiple risk factors at once for unwanted pregnancy, including abusive relationships – physical, emotional, and sexual – as well as alcohol use and proper use of the emergency contraceptive pill, Dr. Lindley added.

Major Finding: Six of eight SF-36 categories and domains improved significantly at cycle 15 compared with baseline. Scores on the AMCOQ indicated patients experienced a consistent improvement in daily activities that are impacted by cyclic heavy menstrual bleeding.

Data Source: An open-label study of quality of life in 723 women who took oral tranexamic acid at 1.3 g three times per day for a maximum of 5 days per menstrual cycle, starting with the onset of heavy menstrual bleeding.

Disclosures: The study was funded by Xanodyne Pharmaceuticals and Ferring Pharmaceuticals, which acquired global marketing rights to Lysteda last May. Dr. Muse disclosed that he has received research grants and served as an adviser to Xanodyne.

DENVER – A novel oral formulation of tranexamic acid provided immediate and enduring improvement in two quality of life measures among women with menorrhagia in a large open-label study.

The improved quality of life benefits were noted during the first menstrual cycle after initiating treatment.

Also, the benefits were maintained throughout the 15-cycle study, Dr. Ken Muse reported at the meeting.

Tranexamic acid is a lysine analogue that acts as a competitive plasmin inhibitor and an antifibrinolytic agent. The oral formulation was approved by the Food and Drug Administration late last year for the treatment of cyclic heavy menstrual bleeding and is marketed under the trade name Lysteda.

It's a valuable alternative to surgical or hormonal treatments for this disorder, which affects up to 22 million Americans, said Dr. Muse of the University of Kentucky, Lexington.

Oral tranexamic acid won marketing approval on the strength of studies showing it reduced menstrual flow by nearly 40%.

The quality of life study was conducted because what drives many women to consult a physician regarding menorrhagia is the disorder's negative impact on their daily activities.

The study involved 723 women who took oral tranexamic acid at 1.3 g three times per day for a maximum of 5 days per menstrual cycle, starting with the onset of heavy menstrual bleeding.

General quality of life was assessed using the 36-Item Short Form Health Survey. The Aberdeen Menorrhagia Clinical Outcome Questionnaire (AMCOQ) was used as a disease-specific measure of the impact of treatment.

Significant improvements were noted in six of eight SF-36 categories and domains at cycle 15 compared with baseline.

The greatest improvements were in vitality, with a 13.5% gain, and social functioning, with an 8.3% gain.

Patients also showed significant long-term improvements in bodily pain, mental health, role-physical, and role-emotional items. Only physical functioning and general health weren't significantly different at cycle 15 compared with baseline.

Women on oral tranexamic acid had a mean 5.4% long-term improvement in the mental health component of the SF-36, and a less robust but nonetheless significant 1.7% gain in the physical functioning component, according to Dr. Muse.

Oral tranexamic acid was well tolerated. Adverse events deemed by investigators to be probably or definitely treatment related occurred in 7.3% of subjects; these were mild to moderate in nature and most often consisted of headache, menstrual discomfort, or back pain. There were few gastrointestinal side effects, and no thrombotic or thromboembolic events.

Scores on the AMCOQ indicated patients had a consistent improvement in daily activities that are affected by cyclic heavy menstrual bleeding.

Major Finding: Six of eight SF-36 categories and domains improved significantly at cycle 15 compared with baseline. Scores on the AMCOQ indicated patients experienced a consistent improvement in daily activities that are impacted by cyclic heavy menstrual bleeding.

Data Source: An open-label study of quality of life in 723 women who took oral tranexamic acid at 1.3 g three times per day for a maximum of 5 days per menstrual cycle, starting with the onset of heavy menstrual bleeding.

Disclosures: The study was funded by Xanodyne Pharmaceuticals and Ferring Pharmaceuticals, which acquired global marketing rights to Lysteda last May. Dr. Muse disclosed that he has received research grants and served as an adviser to Xanodyne.

DENVER – A novel oral formulation of tranexamic acid provided immediate and enduring improvement in two quality of life measures among women with menorrhagia in a large open-label study.

The improved quality of life benefits were noted during the first menstrual cycle after initiating treatment.

Also, the benefits were maintained throughout the 15-cycle study, Dr. Ken Muse reported at the meeting.

Tranexamic acid is a lysine analogue that acts as a competitive plasmin inhibitor and an antifibrinolytic agent. The oral formulation was approved by the Food and Drug Administration late last year for the treatment of cyclic heavy menstrual bleeding and is marketed under the trade name Lysteda.

It's a valuable alternative to surgical or hormonal treatments for this disorder, which affects up to 22 million Americans, said Dr. Muse of the University of Kentucky, Lexington.

Oral tranexamic acid won marketing approval on the strength of studies showing it reduced menstrual flow by nearly 40%.

The quality of life study was conducted because what drives many women to consult a physician regarding menorrhagia is the disorder's negative impact on their daily activities.

The study involved 723 women who took oral tranexamic acid at 1.3 g three times per day for a maximum of 5 days per menstrual cycle, starting with the onset of heavy menstrual bleeding.

General quality of life was assessed using the 36-Item Short Form Health Survey. The Aberdeen Menorrhagia Clinical Outcome Questionnaire (AMCOQ) was used as a disease-specific measure of the impact of treatment.

Significant improvements were noted in six of eight SF-36 categories and domains at cycle 15 compared with baseline.

The greatest improvements were in vitality, with a 13.5% gain, and social functioning, with an 8.3% gain.

Patients also showed significant long-term improvements in bodily pain, mental health, role-physical, and role-emotional items. Only physical functioning and general health weren't significantly different at cycle 15 compared with baseline.

Women on oral tranexamic acid had a mean 5.4% long-term improvement in the mental health component of the SF-36, and a less robust but nonetheless significant 1.7% gain in the physical functioning component, according to Dr. Muse.

Oral tranexamic acid was well tolerated. Adverse events deemed by investigators to be probably or definitely treatment related occurred in 7.3% of subjects; these were mild to moderate in nature and most often consisted of headache, menstrual discomfort, or back pain. There were few gastrointestinal side effects, and no thrombotic or thromboembolic events.

Scores on the AMCOQ indicated patients had a consistent improvement in daily activities that are affected by cyclic heavy menstrual bleeding.

Major Finding: Six of eight SF-36 categories and domains improved significantly at cycle 15 compared with baseline. Scores on the AMCOQ indicated patients experienced a consistent improvement in daily activities that are impacted by cyclic heavy menstrual bleeding.

Data Source: An open-label study of quality of life in 723 women who took oral tranexamic acid at 1.3 g three times per day for a maximum of 5 days per menstrual cycle, starting with the onset of heavy menstrual bleeding.

Disclosures: The study was funded by Xanodyne Pharmaceuticals and Ferring Pharmaceuticals, which acquired global marketing rights to Lysteda last May. Dr. Muse disclosed that he has received research grants and served as an adviser to Xanodyne.

DENVER – A novel oral formulation of tranexamic acid provided immediate and enduring improvement in two quality of life measures among women with menorrhagia in a large open-label study.

The improved quality of life benefits were noted during the first menstrual cycle after initiating treatment.

Also, the benefits were maintained throughout the 15-cycle study, Dr. Ken Muse reported at the meeting.

Tranexamic acid is a lysine analogue that acts as a competitive plasmin inhibitor and an antifibrinolytic agent. The oral formulation was approved by the Food and Drug Administration late last year for the treatment of cyclic heavy menstrual bleeding and is marketed under the trade name Lysteda.

It's a valuable alternative to surgical or hormonal treatments for this disorder, which affects up to 22 million Americans, said Dr. Muse of the University of Kentucky, Lexington.

Oral tranexamic acid won marketing approval on the strength of studies showing it reduced menstrual flow by nearly 40%.

The quality of life study was conducted because what drives many women to consult a physician regarding menorrhagia is the disorder's negative impact on their daily activities.

The study involved 723 women who took oral tranexamic acid at 1.3 g three times per day for a maximum of 5 days per menstrual cycle, starting with the onset of heavy menstrual bleeding.

General quality of life was assessed using the 36-Item Short Form Health Survey. The Aberdeen Menorrhagia Clinical Outcome Questionnaire (AMCOQ) was used as a disease-specific measure of the impact of treatment.

Significant improvements were noted in six of eight SF-36 categories and domains at cycle 15 compared with baseline.

The greatest improvements were in vitality, with a 13.5% gain, and social functioning, with an 8.3% gain.

Patients also showed significant long-term improvements in bodily pain, mental health, role-physical, and role-emotional items. Only physical functioning and general health weren't significantly different at cycle 15 compared with baseline.

Women on oral tranexamic acid had a mean 5.4% long-term improvement in the mental health component of the SF-36, and a less robust but nonetheless significant 1.7% gain in the physical functioning component, according to Dr. Muse.

Oral tranexamic acid was well tolerated. Adverse events deemed by investigators to be probably or definitely treatment related occurred in 7.3% of subjects; these were mild to moderate in nature and most often consisted of headache, menstrual discomfort, or back pain. There were few gastrointestinal side effects, and no thrombotic or thromboembolic events.

Scores on the AMCOQ indicated patients had a consistent improvement in daily activities that are affected by cyclic heavy menstrual bleeding.

GOTHENBURG, SWEDEN — Swedes with systemic lupus erythematosus tend to die early and at a substantially higher rate than does the general population.

During 13 years of prospective follow-up, 20% of 208 Swedish SLE patients died at a quite young mean age of 60 years. That translates into an age-adjusted 3.3-fold increased rate of all-cause mortality, Dr. Elisabet Svenungsson reported at the congress.

Cardiovascular disease accounted for 52% of the deaths, a proportion similar to what's seen in the general population. The difference is that cardiovascular death in the SLE cohort occurred predominantly in women at a substantially younger age than is common in women without SLE, observed Dr. Svenungsson, a rheumatologist at Karolinska University Hospital in Stockholm.

In addition to cardiovascular disease, patients with SLE have a number of other comorbidities, including osteoporosis, Sjögren's syndrome, and autoimmune thyroid disease, she reported.

Vascular disease is one of the most common of the many comorbidities associated with SLE, she said. In a cross-sectional study of 597 patients in the Swedish SLE Network, 11% had ischemic heart disease, 10% had ischemic cerebrovascular disease, and 16% had a history of venous thromboembolism.

The conventional Framingham risk factors don't explain the accelerated atherosclerosis present in patients with SLE. In a prospective cohort study involving 182 SLE patients with a mean age of 44 years, all of whom were free of known cardiovascular disease at baseline, Dr. Svenungsson and coworkers found that the incidence of a first cardiovascular event was 13% during a mean 8.3 years of follow-up. In an age-adjusted, Cox multivariate regression analysis, the only conventional risk factors independently associated with a first cardiovascular event were smoking and age.

The other independent predictors of a first cardiovascular event were the presence of any positive antiphospholipid antibody test, which conferred a 4.23-fold increased risk; elevated von Willebrand factor level, associated with a 1.97-fold risk; and the presence of thrombocytopenia, which was a protective factor associated with a 65% reduction in risk of a cardiovascular event, Dr. Svenungsson said in her keynote lecture at the meeting of the European Society of Cutaneous Lupus Erythematosus, which was held in conjunction with EADV congress.

Multiple studies have established that one or more antiphospholipid antibodies are present in 30%-50% of SLE patients. Among a cohort of 320 SLE patients who were being followed by Dr. Svenungsson and her associates, 18% fulfilled strict 2006 criteria for antiphospholipid syndrome. SLE patients with antiphospholipid syndrome have a high rate of thrombotic events that don't track with SLE disease activity.

“They just hit here and there; you never really know when,” the rheumatologist observed.

Turning to osteoporosis and SLE, Dr. Svenungsson cited a new cross-sectional study by rheumatologists at the University of Gothenburg, who obtained x-rays of the thoracic and lumbar spine in 150 women with SLE who had a median age of 47 years and disease duration of 11 years. Although 29% of the SLE patients had at least one radiologic vertebral compression fracture, only 4% had been diagnosed with a compression fracture.

“You have here a lot of women with a subclinical history of vertebral fractures. That we don't detect most of these fractures may be one reason why patients with SLE often complain about pain,” according to Dr. Svenungsson.

In the Gothenburg study, advanced age was an independent risk factor for one or more vertebral fractures at any site, whereas low bone mineral density in the total hip was associated with vertebral fracture in the lumbar spine. Interestingly, cumulative glucocorticoid dose wasn't predictive of vertebral fracture risk (Arthritis Res. Ther. 2010 Aug. 2 [doi:10.1186/ar3104]).

A number of autoimmune diseases commonly overlap with SLE. Among them is autoimmune thyroid disease, which was present in 17% of 331 SLE patients being followed by Dr. Svenungsson and her associates at Karolinska, compared with 8% of matched controls. Hypothyroidism was far more common than hyperthyroid disease in the Karolinska cohort, as has been reported in other SLE studies.

Another autoimmune disease commonly overlapping with SLE is Sjögren's syndrome. In the Karolinska cohort, 25% of SLE patients met strict diagnostic criteria for Sjögren's syndrome. Dry mouth was reported by 40% of patients, compared with 7% of matched controls. Dry eyes were reported by 32% of SLE patients vs. 7% of controls.

In addition to cardiovascular disease, osteoporosis, Sjögren's syndrome, antiphospholipid syndrome, and autoimmune thyroid disease, other conditions that occur at an increased rate in patients with SLE include malignancies, rheumatoid arthritis, systemic sclerosis, myositis, and vasculitis.

“Lupus is an imitator. It's difficult to say what is comorbidity and what is really a manifestation of lupus,” Dr. Svenungsson concluded.

She declared that she has no relevant financial interests.

'Lupus is an imitator. It's difficult to say what is comorbidity and what is really a manifestation.'

Source DR. SVENUNGSSON

GOTHENBURG, SWEDEN — Swedes with systemic lupus erythematosus tend to die early and at a substantially higher rate than does the general population.

During 13 years of prospective follow-up, 20% of 208 Swedish SLE patients died at a quite young mean age of 60 years. That translates into an age-adjusted 3.3-fold increased rate of all-cause mortality, Dr. Elisabet Svenungsson reported at the congress.

Cardiovascular disease accounted for 52% of the deaths, a proportion similar to what's seen in the general population. The difference is that cardiovascular death in the SLE cohort occurred predominantly in women at a substantially younger age than is common in women without SLE, observed Dr. Svenungsson, a rheumatologist at Karolinska University Hospital in Stockholm.

In addition to cardiovascular disease, patients with SLE have a number of other comorbidities, including osteoporosis, Sjögren's syndrome, and autoimmune thyroid disease, she reported.

Vascular disease is one of the most common of the many comorbidities associated with SLE, she said. In a cross-sectional study of 597 patients in the Swedish SLE Network, 11% had ischemic heart disease, 10% had ischemic cerebrovascular disease, and 16% had a history of venous thromboembolism.

The conventional Framingham risk factors don't explain the accelerated atherosclerosis present in patients with SLE. In a prospective cohort study involving 182 SLE patients with a mean age of 44 years, all of whom were free of known cardiovascular disease at baseline, Dr. Svenungsson and coworkers found that the incidence of a first cardiovascular event was 13% during a mean 8.3 years of follow-up. In an age-adjusted, Cox multivariate regression analysis, the only conventional risk factors independently associated with a first cardiovascular event were smoking and age.

The other independent predictors of a first cardiovascular event were the presence of any positive antiphospholipid antibody test, which conferred a 4.23-fold increased risk; elevated von Willebrand factor level, associated with a 1.97-fold risk; and the presence of thrombocytopenia, which was a protective factor associated with a 65% reduction in risk of a cardiovascular event, Dr. Svenungsson said in her keynote lecture at the meeting of the European Society of Cutaneous Lupus Erythematosus, which was held in conjunction with EADV congress.

Multiple studies have established that one or more antiphospholipid antibodies are present in 30%-50% of SLE patients. Among a cohort of 320 SLE patients who were being followed by Dr. Svenungsson and her associates, 18% fulfilled strict 2006 criteria for antiphospholipid syndrome. SLE patients with antiphospholipid syndrome have a high rate of thrombotic events that don't track with SLE disease activity.

“They just hit here and there; you never really know when,” the rheumatologist observed.

Turning to osteoporosis and SLE, Dr. Svenungsson cited a new cross-sectional study by rheumatologists at the University of Gothenburg, who obtained x-rays of the thoracic and lumbar spine in 150 women with SLE who had a median age of 47 years and disease duration of 11 years. Although 29% of the SLE patients had at least one radiologic vertebral compression fracture, only 4% had been diagnosed with a compression fracture.

“You have here a lot of women with a subclinical history of vertebral fractures. That we don't detect most of these fractures may be one reason why patients with SLE often complain about pain,” according to Dr. Svenungsson.

In the Gothenburg study, advanced age was an independent risk factor for one or more vertebral fractures at any site, whereas low bone mineral density in the total hip was associated with vertebral fracture in the lumbar spine. Interestingly, cumulative glucocorticoid dose wasn't predictive of vertebral fracture risk (Arthritis Res. Ther. 2010 Aug. 2 [doi:10.1186/ar3104]).

A number of autoimmune diseases commonly overlap with SLE. Among them is autoimmune thyroid disease, which was present in 17% of 331 SLE patients being followed by Dr. Svenungsson and her associates at Karolinska, compared with 8% of matched controls. Hypothyroidism was far more common than hyperthyroid disease in the Karolinska cohort, as has been reported in other SLE studies.

Another autoimmune disease commonly overlapping with SLE is Sjögren's syndrome. In the Karolinska cohort, 25% of SLE patients met strict diagnostic criteria for Sjögren's syndrome. Dry mouth was reported by 40% of patients, compared with 7% of matched controls. Dry eyes were reported by 32% of SLE patients vs. 7% of controls.

In addition to cardiovascular disease, osteoporosis, Sjögren's syndrome, antiphospholipid syndrome, and autoimmune thyroid disease, other conditions that occur at an increased rate in patients with SLE include malignancies, rheumatoid arthritis, systemic sclerosis, myositis, and vasculitis.

“Lupus is an imitator. It's difficult to say what is comorbidity and what is really a manifestation of lupus,” Dr. Svenungsson concluded.

She declared that she has no relevant financial interests.

'Lupus is an imitator. It's difficult to say what is comorbidity and what is really a manifestation.'

Source DR. SVENUNGSSON

GOTHENBURG, SWEDEN — Swedes with systemic lupus erythematosus tend to die early and at a substantially higher rate than does the general population.

During 13 years of prospective follow-up, 20% of 208 Swedish SLE patients died at a quite young mean age of 60 years. That translates into an age-adjusted 3.3-fold increased rate of all-cause mortality, Dr. Elisabet Svenungsson reported at the congress.

Cardiovascular disease accounted for 52% of the deaths, a proportion similar to what's seen in the general population. The difference is that cardiovascular death in the SLE cohort occurred predominantly in women at a substantially younger age than is common in women without SLE, observed Dr. Svenungsson, a rheumatologist at Karolinska University Hospital in Stockholm.

In addition to cardiovascular disease, patients with SLE have a number of other comorbidities, including osteoporosis, Sjögren's syndrome, and autoimmune thyroid disease, she reported.

Vascular disease is one of the most common of the many comorbidities associated with SLE, she said. In a cross-sectional study of 597 patients in the Swedish SLE Network, 11% had ischemic heart disease, 10% had ischemic cerebrovascular disease, and 16% had a history of venous thromboembolism.

The conventional Framingham risk factors don't explain the accelerated atherosclerosis present in patients with SLE. In a prospective cohort study involving 182 SLE patients with a mean age of 44 years, all of whom were free of known cardiovascular disease at baseline, Dr. Svenungsson and coworkers found that the incidence of a first cardiovascular event was 13% during a mean 8.3 years of follow-up. In an age-adjusted, Cox multivariate regression analysis, the only conventional risk factors independently associated with a first cardiovascular event were smoking and age.

The other independent predictors of a first cardiovascular event were the presence of any positive antiphospholipid antibody test, which conferred a 4.23-fold increased risk; elevated von Willebrand factor level, associated with a 1.97-fold risk; and the presence of thrombocytopenia, which was a protective factor associated with a 65% reduction in risk of a cardiovascular event, Dr. Svenungsson said in her keynote lecture at the meeting of the European Society of Cutaneous Lupus Erythematosus, which was held in conjunction with EADV congress.

Multiple studies have established that one or more antiphospholipid antibodies are present in 30%-50% of SLE patients. Among a cohort of 320 SLE patients who were being followed by Dr. Svenungsson and her associates, 18% fulfilled strict 2006 criteria for antiphospholipid syndrome. SLE patients with antiphospholipid syndrome have a high rate of thrombotic events that don't track with SLE disease activity.

“They just hit here and there; you never really know when,” the rheumatologist observed.

Turning to osteoporosis and SLE, Dr. Svenungsson cited a new cross-sectional study by rheumatologists at the University of Gothenburg, who obtained x-rays of the thoracic and lumbar spine in 150 women with SLE who had a median age of 47 years and disease duration of 11 years. Although 29% of the SLE patients had at least one radiologic vertebral compression fracture, only 4% had been diagnosed with a compression fracture.

“You have here a lot of women with a subclinical history of vertebral fractures. That we don't detect most of these fractures may be one reason why patients with SLE often complain about pain,” according to Dr. Svenungsson.

In the Gothenburg study, advanced age was an independent risk factor for one or more vertebral fractures at any site, whereas low bone mineral density in the total hip was associated with vertebral fracture in the lumbar spine. Interestingly, cumulative glucocorticoid dose wasn't predictive of vertebral fracture risk (Arthritis Res. Ther. 2010 Aug. 2 [doi:10.1186/ar3104]).

A number of autoimmune diseases commonly overlap with SLE. Among them is autoimmune thyroid disease, which was present in 17% of 331 SLE patients being followed by Dr. Svenungsson and her associates at Karolinska, compared with 8% of matched controls. Hypothyroidism was far more common than hyperthyroid disease in the Karolinska cohort, as has been reported in other SLE studies.

Another autoimmune disease commonly overlapping with SLE is Sjögren's syndrome. In the Karolinska cohort, 25% of SLE patients met strict diagnostic criteria for Sjögren's syndrome. Dry mouth was reported by 40% of patients, compared with 7% of matched controls. Dry eyes were reported by 32% of SLE patients vs. 7% of controls.

In addition to cardiovascular disease, osteoporosis, Sjögren's syndrome, antiphospholipid syndrome, and autoimmune thyroid disease, other conditions that occur at an increased rate in patients with SLE include malignancies, rheumatoid arthritis, systemic sclerosis, myositis, and vasculitis.

“Lupus is an imitator. It's difficult to say what is comorbidity and what is really a manifestation of lupus,” Dr. Svenungsson concluded.

She declared that she has no relevant financial interests.

'Lupus is an imitator. It's difficult to say what is comorbidity and what is really a manifestation.'

Source DR. SVENUNGSSON

CHICAGO – Six months of high-dose clopidogrel were no better than standard-dose clopidogrel for preventing cardiovascular events in patients with high residual platelet reactivity after percutaneous coronary intervention in the GRAVITAS trial.

This large randomized study does not support the common practice of doubling the standard 75-mg/day dosing of clopidogrel as a default strategy in patients who are nonresponsive to the drug, Dr. Matthew J. Price said at the meeting.

“The high dose of clopidogrel doesn't appear to improve outcomes, so alternative treatment strategies should be tested,” according to Dr. Price, chair of GRAVITAS (Gauging Responsiveness With a VerifyNow Assay–Impact on Thrombosis and Safety) and director of the cardiac catheterization laboratory at the Scripps Clinic, La Jolla, Calif.

The GRAVITAS trial included 2,214 patients who displayed high residual platelet reactivity on the Accumetrics VerifyNow P2Y12 test 12-24 hours after undergoing elective or urgent PCI with stenting. They were randomized to 6 months of clopidogrel (Plavix) at the standard dose of 75 mg daily or to a 600-mg loading dose followed by high-dose therapy at 150 mg/day.

The primary study end point of cardiovascular death, nonfatal MI, or stent thrombosis at 6 months occurred in 2.3% of patients in each study arm. On the plus side, at least there was no significant difference in moderate to severe GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) bleeding, which occurred in 1.4% of patients on high-dose clopidogrel and 2.3% on standard-dose therapy, he noted.

High-dose therapy provided what the cardiologist deemed a “modest” but statistically significant pharmacodynamic effect in the form of an absolute 22% reduction in persistently high platelet reactivity at 30 days, compared with the 62% rate in the standard-dose arm.

Discussant Dr. Jessica L. Mega said one possible explanation for the neutral results in GRAVITAS is that high residual platelet reactivity is a risk marker but not a modifiable risk factor. It's not known yet whether that's true.

Another possibility worthy of future study is that a tailored approach to antiplatelet therapy would be beneficial in patients with high residual reactivity if an even higher dose of clopidogrel or an alternative, more potent agent were to be employed, added Dr. Mega of Brigham and Women's Hospital, Boston.

The GRAVITAS trial was sponsored by Accumetrics. Dr. Price said that he serves as a consultant to the company as well as to Sanofi-Aventis and Bristol-Myers Squibb, which provided the clopidogrel used in the study. Dr. Mega has received clinical research grants through the TIMI Study Group from Accumetrics and other companies, and has served as a consultant to Sanofi-Aventis and Bristol-Myers Squibb.

A high dose isn't better than the standard dose, so 'alternative treatment strategies should be tested.'

Source DR. PRICE

Perhaps an even higher dose of clopidogrel, or a more powerful agent, would be beneficial for these patients.

Source DR. MEGA

CHICAGO – Six months of high-dose clopidogrel were no better than standard-dose clopidogrel for preventing cardiovascular events in patients with high residual platelet reactivity after percutaneous coronary intervention in the GRAVITAS trial.

This large randomized study does not support the common practice of doubling the standard 75-mg/day dosing of clopidogrel as a default strategy in patients who are nonresponsive to the drug, Dr. Matthew J. Price said at the meeting.

“The high dose of clopidogrel doesn't appear to improve outcomes, so alternative treatment strategies should be tested,” according to Dr. Price, chair of GRAVITAS (Gauging Responsiveness With a VerifyNow Assay–Impact on Thrombosis and Safety) and director of the cardiac catheterization laboratory at the Scripps Clinic, La Jolla, Calif.

The GRAVITAS trial included 2,214 patients who displayed high residual platelet reactivity on the Accumetrics VerifyNow P2Y12 test 12-24 hours after undergoing elective or urgent PCI with stenting. They were randomized to 6 months of clopidogrel (Plavix) at the standard dose of 75 mg daily or to a 600-mg loading dose followed by high-dose therapy at 150 mg/day.

The primary study end point of cardiovascular death, nonfatal MI, or stent thrombosis at 6 months occurred in 2.3% of patients in each study arm. On the plus side, at least there was no significant difference in moderate to severe GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) bleeding, which occurred in 1.4% of patients on high-dose clopidogrel and 2.3% on standard-dose therapy, he noted.

High-dose therapy provided what the cardiologist deemed a “modest” but statistically significant pharmacodynamic effect in the form of an absolute 22% reduction in persistently high platelet reactivity at 30 days, compared with the 62% rate in the standard-dose arm.

Discussant Dr. Jessica L. Mega said one possible explanation for the neutral results in GRAVITAS is that high residual platelet reactivity is a risk marker but not a modifiable risk factor. It's not known yet whether that's true.

Another possibility worthy of future study is that a tailored approach to antiplatelet therapy would be beneficial in patients with high residual reactivity if an even higher dose of clopidogrel or an alternative, more potent agent were to be employed, added Dr. Mega of Brigham and Women's Hospital, Boston.

The GRAVITAS trial was sponsored by Accumetrics. Dr. Price said that he serves as a consultant to the company as well as to Sanofi-Aventis and Bristol-Myers Squibb, which provided the clopidogrel used in the study. Dr. Mega has received clinical research grants through the TIMI Study Group from Accumetrics and other companies, and has served as a consultant to Sanofi-Aventis and Bristol-Myers Squibb.

A high dose isn't better than the standard dose, so 'alternative treatment strategies should be tested.'

Source DR. PRICE

Perhaps an even higher dose of clopidogrel, or a more powerful agent, would be beneficial for these patients.

Source DR. MEGA

CHICAGO – Six months of high-dose clopidogrel were no better than standard-dose clopidogrel for preventing cardiovascular events in patients with high residual platelet reactivity after percutaneous coronary intervention in the GRAVITAS trial.

This large randomized study does not support the common practice of doubling the standard 75-mg/day dosing of clopidogrel as a default strategy in patients who are nonresponsive to the drug, Dr. Matthew J. Price said at the meeting.

“The high dose of clopidogrel doesn't appear to improve outcomes, so alternative treatment strategies should be tested,” according to Dr. Price, chair of GRAVITAS (Gauging Responsiveness With a VerifyNow Assay–Impact on Thrombosis and Safety) and director of the cardiac catheterization laboratory at the Scripps Clinic, La Jolla, Calif.

The GRAVITAS trial included 2,214 patients who displayed high residual platelet reactivity on the Accumetrics VerifyNow P2Y12 test 12-24 hours after undergoing elective or urgent PCI with stenting. They were randomized to 6 months of clopidogrel (Plavix) at the standard dose of 75 mg daily or to a 600-mg loading dose followed by high-dose therapy at 150 mg/day.

The primary study end point of cardiovascular death, nonfatal MI, or stent thrombosis at 6 months occurred in 2.3% of patients in each study arm. On the plus side, at least there was no significant difference in moderate to severe GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) bleeding, which occurred in 1.4% of patients on high-dose clopidogrel and 2.3% on standard-dose therapy, he noted.

High-dose therapy provided what the cardiologist deemed a “modest” but statistically significant pharmacodynamic effect in the form of an absolute 22% reduction in persistently high platelet reactivity at 30 days, compared with the 62% rate in the standard-dose arm.

Discussant Dr. Jessica L. Mega said one possible explanation for the neutral results in GRAVITAS is that high residual platelet reactivity is a risk marker but not a modifiable risk factor. It's not known yet whether that's true.

Another possibility worthy of future study is that a tailored approach to antiplatelet therapy would be beneficial in patients with high residual reactivity if an even higher dose of clopidogrel or an alternative, more potent agent were to be employed, added Dr. Mega of Brigham and Women's Hospital, Boston.

The GRAVITAS trial was sponsored by Accumetrics. Dr. Price said that he serves as a consultant to the company as well as to Sanofi-Aventis and Bristol-Myers Squibb, which provided the clopidogrel used in the study. Dr. Mega has received clinical research grants through the TIMI Study Group from Accumetrics and other companies, and has served as a consultant to Sanofi-Aventis and Bristol-Myers Squibb.

A high dose isn't better than the standard dose, so 'alternative treatment strategies should be tested.'

Source DR. PRICE

Perhaps an even higher dose of clopidogrel, or a more powerful agent, would be beneficial for these patients.

Source DR. MEGA

CHICAGO – A high-normal hematocrit was associated with an increased risk of new-onset heart failure in a Framingham Heart Study analysis.

“To our knowledge, this is the only study to show such a relationship in men and women in middle age. … Our results should prompt consideration of a cautious and measured approach to the aggressive treatment of low hematocrit in a variety of disease states,” Dr. Erin E. Coglianese said at the meeting.

The mechanism by which a hematocrit (HCT) within normal range is linked to heart failure is unclear. However, animal studies suggest one possibility – that a high-normal HCT could impair vasodilation owing to scavenging of nitric oxide by hemoglobin, said Dr. Coglianese of Massachusetts General Hospital, Boston.

To explore the relationship between HCT and risk of heart failure, she and her colleagues turned to the Framingham Heart Study. They documented a strong, graded relationship between HCT level and the risk of developing heart failure in 3,523 Framingham participants aged 50-65 who were free of a history of heart failure at baseline and were followed for up to 20 years.

Indeed, individuals with a high-normal baseline HCT had almost double the risk of new-onset heart failure during follow-up, compared with those with a low HCT, even after adjustment for conventional risk factors for heart failure.

A low HCT was defined as 39% to less than 44% in men and 36% to less than 40% in women. Men with an HCT of 44% to less than 46% and women with a level of 40% to less than 42% were deemed as having a low-normal level. A normal HCT was defined as 46% to less than 50% in men and 42% to less than 46% in women. And a high-normal HCT was one greater than 50% in men or 46% in women.

When these definitions were used, the incidence of new-onset heart failure was 25/10,000 person-years in people with a low HCT level, 31/10,000 with a low-normal HCT, 38/10,000 with a normal HCT, and 48/10,000 in Framingham participants with high-normal HCT.

Analysis, showed that the risk of new-onset heart failure, compared with the risk in those with a low HCT, was 27% greater in those with a low-normal HCT, 47% greater in those with a normal HCT, and 78% greater in those with a high-normal level. The analysis was adjusted for age, sex, total cholesterol, hypertension, body mass index, left ventricular hypertrophy, pack-years of smoking, and physical activity.

The big limitation of this study is that the original Framingham cohort, included in this analysis, looks in some ways quite different from contemporary patient populations. Specifically, roughly half of the men in the original cohort were smokers, Dr. Coglianese noted.

In contrast to these new findings, many studies have shown that in patients who already have heart failure, a low HCT is associated with an increased risk of heart failure hospitalization and all-cause mortality. It is unclear whether this increased risk is due to changes induced by low HCT, or if low HCT is a marker of disease severity, she said.

Dr. Coglianese said he had no relevant financial disclosures.

CHICAGO – A high-normal hematocrit was associated with an increased risk of new-onset heart failure in a Framingham Heart Study analysis.

“To our knowledge, this is the only study to show such a relationship in men and women in middle age. … Our results should prompt consideration of a cautious and measured approach to the aggressive treatment of low hematocrit in a variety of disease states,” Dr. Erin E. Coglianese said at the meeting.

The mechanism by which a hematocrit (HCT) within normal range is linked to heart failure is unclear. However, animal studies suggest one possibility – that a high-normal HCT could impair vasodilation owing to scavenging of nitric oxide by hemoglobin, said Dr. Coglianese of Massachusetts General Hospital, Boston.

To explore the relationship between HCT and risk of heart failure, she and her colleagues turned to the Framingham Heart Study. They documented a strong, graded relationship between HCT level and the risk of developing heart failure in 3,523 Framingham participants aged 50-65 who were free of a history of heart failure at baseline and were followed for up to 20 years.

Indeed, individuals with a high-normal baseline HCT had almost double the risk of new-onset heart failure during follow-up, compared with those with a low HCT, even after adjustment for conventional risk factors for heart failure.

A low HCT was defined as 39% to less than 44% in men and 36% to less than 40% in women. Men with an HCT of 44% to less than 46% and women with a level of 40% to less than 42% were deemed as having a low-normal level. A normal HCT was defined as 46% to less than 50% in men and 42% to less than 46% in women. And a high-normal HCT was one greater than 50% in men or 46% in women.

When these definitions were used, the incidence of new-onset heart failure was 25/10,000 person-years in people with a low HCT level, 31/10,000 with a low-normal HCT, 38/10,000 with a normal HCT, and 48/10,000 in Framingham participants with high-normal HCT.

Analysis, showed that the risk of new-onset heart failure, compared with the risk in those with a low HCT, was 27% greater in those with a low-normal HCT, 47% greater in those with a normal HCT, and 78% greater in those with a high-normal level. The analysis was adjusted for age, sex, total cholesterol, hypertension, body mass index, left ventricular hypertrophy, pack-years of smoking, and physical activity.

The big limitation of this study is that the original Framingham cohort, included in this analysis, looks in some ways quite different from contemporary patient populations. Specifically, roughly half of the men in the original cohort were smokers, Dr. Coglianese noted.

In contrast to these new findings, many studies have shown that in patients who already have heart failure, a low HCT is associated with an increased risk of heart failure hospitalization and all-cause mortality. It is unclear whether this increased risk is due to changes induced by low HCT, or if low HCT is a marker of disease severity, she said.

Dr. Coglianese said he had no relevant financial disclosures.

CHICAGO – A high-normal hematocrit was associated with an increased risk of new-onset heart failure in a Framingham Heart Study analysis.

“To our knowledge, this is the only study to show such a relationship in men and women in middle age. … Our results should prompt consideration of a cautious and measured approach to the aggressive treatment of low hematocrit in a variety of disease states,” Dr. Erin E. Coglianese said at the meeting.

The mechanism by which a hematocrit (HCT) within normal range is linked to heart failure is unclear. However, animal studies suggest one possibility – that a high-normal HCT could impair vasodilation owing to scavenging of nitric oxide by hemoglobin, said Dr. Coglianese of Massachusetts General Hospital, Boston.

To explore the relationship between HCT and risk of heart failure, she and her colleagues turned to the Framingham Heart Study. They documented a strong, graded relationship between HCT level and the risk of developing heart failure in 3,523 Framingham participants aged 50-65 who were free of a history of heart failure at baseline and were followed for up to 20 years.

Indeed, individuals with a high-normal baseline HCT had almost double the risk of new-onset heart failure during follow-up, compared with those with a low HCT, even after adjustment for conventional risk factors for heart failure.

A low HCT was defined as 39% to less than 44% in men and 36% to less than 40% in women. Men with an HCT of 44% to less than 46% and women with a level of 40% to less than 42% were deemed as having a low-normal level. A normal HCT was defined as 46% to less than 50% in men and 42% to less than 46% in women. And a high-normal HCT was one greater than 50% in men or 46% in women.

When these definitions were used, the incidence of new-onset heart failure was 25/10,000 person-years in people with a low HCT level, 31/10,000 with a low-normal HCT, 38/10,000 with a normal HCT, and 48/10,000 in Framingham participants with high-normal HCT.

Analysis, showed that the risk of new-onset heart failure, compared with the risk in those with a low HCT, was 27% greater in those with a low-normal HCT, 47% greater in those with a normal HCT, and 78% greater in those with a high-normal level. The analysis was adjusted for age, sex, total cholesterol, hypertension, body mass index, left ventricular hypertrophy, pack-years of smoking, and physical activity.

The big limitation of this study is that the original Framingham cohort, included in this analysis, looks in some ways quite different from contemporary patient populations. Specifically, roughly half of the men in the original cohort were smokers, Dr. Coglianese noted.

In contrast to these new findings, many studies have shown that in patients who already have heart failure, a low HCT is associated with an increased risk of heart failure hospitalization and all-cause mortality. It is unclear whether this increased risk is due to changes induced by low HCT, or if low HCT is a marker of disease severity, she said.

Dr. Coglianese said he had no relevant financial disclosures.

CHICAGO – Acute coronary syndrome patients randomized to dual antiplatelet therapy with ticagrelor and aspirin had fewer hospital bed days, revascularization procedures, and total health care costs over the course of 1 year, compared with patients assigned to clopidogrel plus aspirin, according to an economic substudy of the Platelet Inhibition and Patient Outcomes (PLATO) trial.

Mean 1-year total health care costs, excluding the cost of the drugs, were $18,666 in the clopidogrel (Plavix) arm and $17,988 with ticagrelor (Brilinta), an investigational, reversibly binding, oral P2Y12 receptor antagonist, based on Swedish costs per resource used. The resultant mean $678 savings in the ticagrelor group was significant, Dr. Magnus Janzon said at the meeting.

PLATO was a 43-country, double-blind randomized trial of 18,624 ACS patients. The previously reported primary composite study end point consisting of MI, stroke, or vascular death occurred in 9.8% of patients in the ticagrelor arm and 11.7% with clopidogrel, for a significant 16% relative risk reduction favoring the newer agent (N. Engl. J. Med. 2009;361:1045-57). This benefit came without any significant cost in terms of major bleeding rates, noted Dr. Janzon, head of cardiology at Linkoping (Sweden) University Hospital.

The economic substudy included the 10,686 PLATO participants with detailed 1-year follow-up data. During that time frame, the ticagrelor group collectively had 1,149 fewer hospital bed days, including 333 fewer days in the intensive care unit and 379 fewer days in the coronary care unit. The ticagrelor group also had 95 fewer percutaneous coronary interventions and 41 fewer coronary artery bypass graft procedures.

Dr. Janzon and his colleagues also calculated the 1-year mean total costs using U.S. values, which were nearly twice as high as in Sweden: $34,938 in the ticagrelor plus aspirin group, compared with $33,961 for clopidogrel plus aspirin, for a $977 reduction per patient in the ticagrelor arm.

PLATO was sponsored by AstraZeneca. Dr. Janzon declared having no relevant financial interests.

CHICAGO – Acute coronary syndrome patients randomized to dual antiplatelet therapy with ticagrelor and aspirin had fewer hospital bed days, revascularization procedures, and total health care costs over the course of 1 year, compared with patients assigned to clopidogrel plus aspirin, according to an economic substudy of the Platelet Inhibition and Patient Outcomes (PLATO) trial.

Mean 1-year total health care costs, excluding the cost of the drugs, were $18,666 in the clopidogrel (Plavix) arm and $17,988 with ticagrelor (Brilinta), an investigational, reversibly binding, oral P2Y12 receptor antagonist, based on Swedish costs per resource used. The resultant mean $678 savings in the ticagrelor group was significant, Dr. Magnus Janzon said at the meeting.

PLATO was a 43-country, double-blind randomized trial of 18,624 ACS patients. The previously reported primary composite study end point consisting of MI, stroke, or vascular death occurred in 9.8% of patients in the ticagrelor arm and 11.7% with clopidogrel, for a significant 16% relative risk reduction favoring the newer agent (N. Engl. J. Med. 2009;361:1045-57). This benefit came without any significant cost in terms of major bleeding rates, noted Dr. Janzon, head of cardiology at Linkoping (Sweden) University Hospital.

The economic substudy included the 10,686 PLATO participants with detailed 1-year follow-up data. During that time frame, the ticagrelor group collectively had 1,149 fewer hospital bed days, including 333 fewer days in the intensive care unit and 379 fewer days in the coronary care unit. The ticagrelor group also had 95 fewer percutaneous coronary interventions and 41 fewer coronary artery bypass graft procedures.

Dr. Janzon and his colleagues also calculated the 1-year mean total costs using U.S. values, which were nearly twice as high as in Sweden: $34,938 in the ticagrelor plus aspirin group, compared with $33,961 for clopidogrel plus aspirin, for a $977 reduction per patient in the ticagrelor arm.

PLATO was sponsored by AstraZeneca. Dr. Janzon declared having no relevant financial interests.

CHICAGO – Acute coronary syndrome patients randomized to dual antiplatelet therapy with ticagrelor and aspirin had fewer hospital bed days, revascularization procedures, and total health care costs over the course of 1 year, compared with patients assigned to clopidogrel plus aspirin, according to an economic substudy of the Platelet Inhibition and Patient Outcomes (PLATO) trial.

Mean 1-year total health care costs, excluding the cost of the drugs, were $18,666 in the clopidogrel (Plavix) arm and $17,988 with ticagrelor (Brilinta), an investigational, reversibly binding, oral P2Y12 receptor antagonist, based on Swedish costs per resource used. The resultant mean $678 savings in the ticagrelor group was significant, Dr. Magnus Janzon said at the meeting.

PLATO was a 43-country, double-blind randomized trial of 18,624 ACS patients. The previously reported primary composite study end point consisting of MI, stroke, or vascular death occurred in 9.8% of patients in the ticagrelor arm and 11.7% with clopidogrel, for a significant 16% relative risk reduction favoring the newer agent (N. Engl. J. Med. 2009;361:1045-57). This benefit came without any significant cost in terms of major bleeding rates, noted Dr. Janzon, head of cardiology at Linkoping (Sweden) University Hospital.

The economic substudy included the 10,686 PLATO participants with detailed 1-year follow-up data. During that time frame, the ticagrelor group collectively had 1,149 fewer hospital bed days, including 333 fewer days in the intensive care unit and 379 fewer days in the coronary care unit. The ticagrelor group also had 95 fewer percutaneous coronary interventions and 41 fewer coronary artery bypass graft procedures.

Dr. Janzon and his colleagues also calculated the 1-year mean total costs using U.S. values, which were nearly twice as high as in Sweden: $34,938 in the ticagrelor plus aspirin group, compared with $33,961 for clopidogrel plus aspirin, for a $977 reduction per patient in the ticagrelor arm.

PLATO was sponsored by AstraZeneca. Dr. Janzon declared having no relevant financial interests.

San Antonio – Psychiatric comorbidities are present in two-thirds of children with restless legs syndrome, according to a study.

Moreover, multiple psychiatric diagnoses were extremely common in this retrospective study of 376 children aged 2–18 years who met National Institutes of Health consensus criteria for definite or probable restless legs syndrome (RLS). Indeed, boys with RLS were actually more likely to have two or more psychiatric diagnoses than a single one. Multiple psychiatric comorbidities also were quite common in girls with RLS, reported Dr. Samuel J. Pullen of the Mayo Clinic, Rochester, Minn.

Attention-deficit/hyperactivity disorder (ADHD) has been shown in other studies to be common in children with RLS. That was the case in this large series as well, with 1 in 4 of the youths carrying a diagnosis of ADHD.

However, other psychiatric comorbidities were common in these patients, too. This observation constitutes a novel contribution to the field, as previously there has been uncertainty surrounding the rates of psychiatric disorders other than ADHD in children with RLS, according to Dr. Pullen.

Mood disorders were present in 21% of the youths with RLS, anxiety disorders in 12.8%, and disruptive behavior disorder in 10.6%.

ADHD and disruptive behavior disorder were more than twice as frequent in boys as in girls with RLS. Mood disorders were more common in girls.

Two psychiatric diagnoses were present in 27.8% of boys and 19.9% of girls. Three or more psychiatric diagnoses were carried by 15.6% of boys and 7.1% of girls.

Many of the children received multiple trials of psychotropic medications during the course of their treatment. This is concerning, as other studies have linked these drugs to worsening RLS symptoms, Dr. Pullen noted.

The mean serum ferritin level in the study population was 27.8 ng/mL.

Twelve of 15 study participants who underwent psychogenomic profiling displayed genetic derangement at one of three cytochrome P-450 alleles known to be associated with ultrarapid metabolism of psychotropic drugs. This may be associated with increased susceptibility to drug side effects–such as worsening of RLS symptoms. Dr. Pullen indicated that he and his coinvestigators plan further studies of this phenomenon.

The chief take-away point from this 376-patient study, he added, is that sleep specialists should inquire about psychiatric comorbidities in their patients with childhood RLS, while child psychiatrists should ask their patients about symptoms of RLS, a treatable comorbidity.

Dr. Pullen reported having no relevant financial disclosures.

San Antonio – Psychiatric comorbidities are present in two-thirds of children with restless legs syndrome, according to a study.

Moreover, multiple psychiatric diagnoses were extremely common in this retrospective study of 376 children aged 2–18 years who met National Institutes of Health consensus criteria for definite or probable restless legs syndrome (RLS). Indeed, boys with RLS were actually more likely to have two or more psychiatric diagnoses than a single one. Multiple psychiatric comorbidities also were quite common in girls with RLS, reported Dr. Samuel J. Pullen of the Mayo Clinic, Rochester, Minn.

Attention-deficit/hyperactivity disorder (ADHD) has been shown in other studies to be common in children with RLS. That was the case in this large series as well, with 1 in 4 of the youths carrying a diagnosis of ADHD.

However, other psychiatric comorbidities were common in these patients, too. This observation constitutes a novel contribution to the field, as previously there has been uncertainty surrounding the rates of psychiatric disorders other than ADHD in children with RLS, according to Dr. Pullen.

Mood disorders were present in 21% of the youths with RLS, anxiety disorders in 12.8%, and disruptive behavior disorder in 10.6%.

ADHD and disruptive behavior disorder were more than twice as frequent in boys as in girls with RLS. Mood disorders were more common in girls.

Two psychiatric diagnoses were present in 27.8% of boys and 19.9% of girls. Three or more psychiatric diagnoses were carried by 15.6% of boys and 7.1% of girls.

Many of the children received multiple trials of psychotropic medications during the course of their treatment. This is concerning, as other studies have linked these drugs to worsening RLS symptoms, Dr. Pullen noted.

The mean serum ferritin level in the study population was 27.8 ng/mL.

Twelve of 15 study participants who underwent psychogenomic profiling displayed genetic derangement at one of three cytochrome P-450 alleles known to be associated with ultrarapid metabolism of psychotropic drugs. This may be associated with increased susceptibility to drug side effects–such as worsening of RLS symptoms. Dr. Pullen indicated that he and his coinvestigators plan further studies of this phenomenon.

The chief take-away point from this 376-patient study, he added, is that sleep specialists should inquire about psychiatric comorbidities in their patients with childhood RLS, while child psychiatrists should ask their patients about symptoms of RLS, a treatable comorbidity.

Dr. Pullen reported having no relevant financial disclosures.

San Antonio – Psychiatric comorbidities are present in two-thirds of children with restless legs syndrome, according to a study.

Moreover, multiple psychiatric diagnoses were extremely common in this retrospective study of 376 children aged 2–18 years who met National Institutes of Health consensus criteria for definite or probable restless legs syndrome (RLS). Indeed, boys with RLS were actually more likely to have two or more psychiatric diagnoses than a single one. Multiple psychiatric comorbidities also were quite common in girls with RLS, reported Dr. Samuel J. Pullen of the Mayo Clinic, Rochester, Minn.

Attention-deficit/hyperactivity disorder (ADHD) has been shown in other studies to be common in children with RLS. That was the case in this large series as well, with 1 in 4 of the youths carrying a diagnosis of ADHD.

However, other psychiatric comorbidities were common in these patients, too. This observation constitutes a novel contribution to the field, as previously there has been uncertainty surrounding the rates of psychiatric disorders other than ADHD in children with RLS, according to Dr. Pullen.

Mood disorders were present in 21% of the youths with RLS, anxiety disorders in 12.8%, and disruptive behavior disorder in 10.6%.

ADHD and disruptive behavior disorder were more than twice as frequent in boys as in girls with RLS. Mood disorders were more common in girls.

Two psychiatric diagnoses were present in 27.8% of boys and 19.9% of girls. Three or more psychiatric diagnoses were carried by 15.6% of boys and 7.1% of girls.

Many of the children received multiple trials of psychotropic medications during the course of their treatment. This is concerning, as other studies have linked these drugs to worsening RLS symptoms, Dr. Pullen noted.

The mean serum ferritin level in the study population was 27.8 ng/mL.

Twelve of 15 study participants who underwent psychogenomic profiling displayed genetic derangement at one of three cytochrome P-450 alleles known to be associated with ultrarapid metabolism of psychotropic drugs. This may be associated with increased susceptibility to drug side effects–such as worsening of RLS symptoms. Dr. Pullen indicated that he and his coinvestigators plan further studies of this phenomenon.

The chief take-away point from this 376-patient study, he added, is that sleep specialists should inquire about psychiatric comorbidities in their patients with childhood RLS, while child psychiatrists should ask their patients about symptoms of RLS, a treatable comorbidity.

Dr. Pullen reported having no relevant financial disclosures.

Major Finding: Only 50% of women aged 40 years or older with full health insurance got annual mammograms during the study years 2006-2009, as was widely recommended by most major guidelines during that period, including the since-revised USPSTF guidelines.

Data Source: An analysis of data on nearly 1.6 million American women aged 40 or older with full health insurance coverage and no history of breast cancer.

Disclosures: Dr. Subar's study was sponsored by Medco Health Solutions.

SAN ANTONIO – Compliance with mammographic screening guidelines is considerably less than would be expected based upon the public sound and fury that greeted the U.S. Preventive Services Task Force's November 2009 updated guidelines recommending a cutback from annual to biennial screening in 50- to 74-year-olds and dropping the routine screening of women aged 40-49 years.

“When the U.S. Preventive Services Task Force guidelines came out, there was a large outcry. We heard, 'Don't take away our right, our ability, to have a mammogram regularly.' So we thought we'd take a look at our database and see what women are actually doing, what the compliance is with the guidelines,” Dr. Milayna Subar explained at the symposium.

Her study involved nearly 1.6 million American women aged 40 or older with full health insurance coverage and no history of breast cancer. It showed that only 50% got annual mammograms during the study years 2006-2009, as was widely recommended by most major guidelines during that period, including the since-revised USPSTF guidelines.

Moreover, 40% of insured women who had access to the full range of preventive health care services did not even get the biennial mammographic screening that is recommended in the USPSTF guidelines operative today, reported Dr. Subar, who is vice president and national practice leader for oncology at Medco Health Solutions.

Of note, the widely cited American Cancer Society guidelines still recommend annual mammography in women who are aged 40 years or older, and American College of Obstetricians and Gynecologists' guidelines recommend annual mammography in women aged 50 and older, and every 1-2 years in 40- to 49-year-olds.

The reality demonstrated by the Medco study is that compliance with these more-stringent guidelines falls even further short of adherence to the cutback USPSTF guidelines, she observed.

During 2006-2009, the rate of annual screening mammography remained fairly constant over the years at 47% among women aged 40-49, compared with 54% in 50- to 64-year-olds, and 45% among those women aged 65 or older.

Screening every 2 years was obtained by 57% of women aged 40-49, 65% of those aged 50-64 years – the age when all of the guidelines (despite their other differences) agree on screening at a minimum of every 2 years – and in 53% of insured women aged 65 or older.

This study didn't examine reasons for noncompliance with mammographic guidelines among insured women.

But Dr. Subar offered several theories as to the low screening rates: fear, procedure-related discomfort, simple forgetfulness, the declining number of mammographic facilities, and the inconsistency of the guidelines.

“I think there could be some confusion about what to do,” she said.

Some women may have been put off by debate among experts as to the net benefit of screening mammography. For Dr. Alan Coates, that issue has been well answered by a recent published analysis of the Norwegian breast cancer screening program experience.

The Norwegian investigators found that during a recent 20-year period mortality due to breast cancer declined by 28% in that country, as has also been true in most other Western countries, he said.

Since the Norwegian national mammographic screening was introduced in stages regionally, the investigators were able to determine that of the 28% drop in breast cancer mortality, 18% was attributable to improved patient management, most notably the introduction of adjuvant tamoxifen and better multidisciplinary care.

The other 10% was due to the effects of earlier diagnosis through mammographic screening (N. Engl. J. Med. 2010;363:1203-10), Dr. Coates of the University of Sydney noted in his conference-closing summary of the year's highlights in early breast cancer.

Fully 40% of women with full health insurance did not even get the biennial screening recommended by USPSTF.

Source Courtesy National Cancer Institute (NCI)

Major Finding: Only 50% of women aged 40 years or older with full health insurance got annual mammograms during the study years 2006-2009, as was widely recommended by most major guidelines during that period, including the since-revised USPSTF guidelines.

Data Source: An analysis of data on nearly 1.6 million American women aged 40 or older with full health insurance coverage and no history of breast cancer.

Disclosures: Dr. Subar's study was sponsored by Medco Health Solutions.

SAN ANTONIO – Compliance with mammographic screening guidelines is considerably less than would be expected based upon the public sound and fury that greeted the U.S. Preventive Services Task Force's November 2009 updated guidelines recommending a cutback from annual to biennial screening in 50- to 74-year-olds and dropping the routine screening of women aged 40-49 years.

“When the U.S. Preventive Services Task Force guidelines came out, there was a large outcry. We heard, 'Don't take away our right, our ability, to have a mammogram regularly.' So we thought we'd take a look at our database and see what women are actually doing, what the compliance is with the guidelines,” Dr. Milayna Subar explained at the symposium.

Her study involved nearly 1.6 million American women aged 40 or older with full health insurance coverage and no history of breast cancer. It showed that only 50% got annual mammograms during the study years 2006-2009, as was widely recommended by most major guidelines during that period, including the since-revised USPSTF guidelines.

Moreover, 40% of insured women who had access to the full range of preventive health care services did not even get the biennial mammographic screening that is recommended in the USPSTF guidelines operative today, reported Dr. Subar, who is vice president and national practice leader for oncology at Medco Health Solutions.

Of note, the widely cited American Cancer Society guidelines still recommend annual mammography in women who are aged 40 years or older, and American College of Obstetricians and Gynecologists' guidelines recommend annual mammography in women aged 50 and older, and every 1-2 years in 40- to 49-year-olds.

The reality demonstrated by the Medco study is that compliance with these more-stringent guidelines falls even further short of adherence to the cutback USPSTF guidelines, she observed.

During 2006-2009, the rate of annual screening mammography remained fairly constant over the years at 47% among women aged 40-49, compared with 54% in 50- to 64-year-olds, and 45% among those women aged 65 or older.

Screening every 2 years was obtained by 57% of women aged 40-49, 65% of those aged 50-64 years – the age when all of the guidelines (despite their other differences) agree on screening at a minimum of every 2 years – and in 53% of insured women aged 65 or older.

This study didn't examine reasons for noncompliance with mammographic guidelines among insured women.

But Dr. Subar offered several theories as to the low screening rates: fear, procedure-related discomfort, simple forgetfulness, the declining number of mammographic facilities, and the inconsistency of the guidelines.

“I think there could be some confusion about what to do,” she said.

Some women may have been put off by debate among experts as to the net benefit of screening mammography. For Dr. Alan Coates, that issue has been well answered by a recent published analysis of the Norwegian breast cancer screening program experience.

The Norwegian investigators found that during a recent 20-year period mortality due to breast cancer declined by 28% in that country, as has also been true in most other Western countries, he said.

Since the Norwegian national mammographic screening was introduced in stages regionally, the investigators were able to determine that of the 28% drop in breast cancer mortality, 18% was attributable to improved patient management, most notably the introduction of adjuvant tamoxifen and better multidisciplinary care.

The other 10% was due to the effects of earlier diagnosis through mammographic screening (N. Engl. J. Med. 2010;363:1203-10), Dr. Coates of the University of Sydney noted in his conference-closing summary of the year's highlights in early breast cancer.

Fully 40% of women with full health insurance did not even get the biennial screening recommended by USPSTF.

Source Courtesy National Cancer Institute (NCI)

Major Finding: Only 50% of women aged 40 years or older with full health insurance got annual mammograms during the study years 2006-2009, as was widely recommended by most major guidelines during that period, including the since-revised USPSTF guidelines.

Data Source: An analysis of data on nearly 1.6 million American women aged 40 or older with full health insurance coverage and no history of breast cancer.

Disclosures: Dr. Subar's study was sponsored by Medco Health Solutions.

SAN ANTONIO – Compliance with mammographic screening guidelines is considerably less than would be expected based upon the public sound and fury that greeted the U.S. Preventive Services Task Force's November 2009 updated guidelines recommending a cutback from annual to biennial screening in 50- to 74-year-olds and dropping the routine screening of women aged 40-49 years.

“When the U.S. Preventive Services Task Force guidelines came out, there was a large outcry. We heard, 'Don't take away our right, our ability, to have a mammogram regularly.' So we thought we'd take a look at our database and see what women are actually doing, what the compliance is with the guidelines,” Dr. Milayna Subar explained at the symposium.

Her study involved nearly 1.6 million American women aged 40 or older with full health insurance coverage and no history of breast cancer. It showed that only 50% got annual mammograms during the study years 2006-2009, as was widely recommended by most major guidelines during that period, including the since-revised USPSTF guidelines.

Moreover, 40% of insured women who had access to the full range of preventive health care services did not even get the biennial mammographic screening that is recommended in the USPSTF guidelines operative today, reported Dr. Subar, who is vice president and national practice leader for oncology at Medco Health Solutions.

Of note, the widely cited American Cancer Society guidelines still recommend annual mammography in women who are aged 40 years or older, and American College of Obstetricians and Gynecologists' guidelines recommend annual mammography in women aged 50 and older, and every 1-2 years in 40- to 49-year-olds.

The reality demonstrated by the Medco study is that compliance with these more-stringent guidelines falls even further short of adherence to the cutback USPSTF guidelines, she observed.

During 2006-2009, the rate of annual screening mammography remained fairly constant over the years at 47% among women aged 40-49, compared with 54% in 50- to 64-year-olds, and 45% among those women aged 65 or older.

Screening every 2 years was obtained by 57% of women aged 40-49, 65% of those aged 50-64 years – the age when all of the guidelines (despite their other differences) agree on screening at a minimum of every 2 years – and in 53% of insured women aged 65 or older.

This study didn't examine reasons for noncompliance with mammographic guidelines among insured women.

But Dr. Subar offered several theories as to the low screening rates: fear, procedure-related discomfort, simple forgetfulness, the declining number of mammographic facilities, and the inconsistency of the guidelines.

“I think there could be some confusion about what to do,” she said.

Some women may have been put off by debate among experts as to the net benefit of screening mammography. For Dr. Alan Coates, that issue has been well answered by a recent published analysis of the Norwegian breast cancer screening program experience.

The Norwegian investigators found that during a recent 20-year period mortality due to breast cancer declined by 28% in that country, as has also been true in most other Western countries, he said.

Since the Norwegian national mammographic screening was introduced in stages regionally, the investigators were able to determine that of the 28% drop in breast cancer mortality, 18% was attributable to improved patient management, most notably the introduction of adjuvant tamoxifen and better multidisciplinary care.

The other 10% was due to the effects of earlier diagnosis through mammographic screening (N. Engl. J. Med. 2010;363:1203-10), Dr. Coates of the University of Sydney noted in his conference-closing summary of the year's highlights in early breast cancer.

Fully 40% of women with full health insurance did not even get the biennial screening recommended by USPSTF.

Source Courtesy National Cancer Institute (NCI)