Doug Brunk

SANTA FE, N.M. — IUDs, once considered an unsafe method of birth control, appear to be making a comeback.

Recent data from the Centers for Disease Control and Prevention suggest that about 5.5% of women aged 15-44 years use IUDs for contraception, which is equivalent to those who choose natural family planning as their primary form of birth control (Vital Health Stat. 2010;23[29]:1-44). That's up significantly from 1995, when fewer than 1% women used IUDs.

“IUDs that we currently have available in the United States are safe,” Dr. Sarah W. Prager said at the meeting. “They're highly efficacious and they're still vastly underused in the United States. It would behoove us, for our patients' sake, to get beyond some of our biases based on our past negative associations.”

In her opinion, the downfall of IUDs emerged soon after the Dalkon Shield was introduced in 1971. Insertion of that device was associated with septic abortion and death, and it caused a fivefold increased risk of pelvic inflammatory disease (PID), compared with other IUDs from that time period, said Dr. Prager of the University of Washington, Seattle. Hypothesized reasons for the problems included the braided polyfilament strings and the fact that a smaller Dalkon Shield was marketed specifically to nulliparous women.

“There is no question that nulliparous women are less likely to be married and therefore more likely to have more partners, which puts them at an increased risk for a sexually transmitted infection,” Dr. Prager said. “Another hypothesis is that the increased surface area of the shield made it more able to drag bacteria from the vagina into the uterus. Also, it was not very effective, with a 2% failure rate per year.”

Of the estimated 6 million pregnancies annually in the United States, almost half are unintended, she said. Of those unintended pregnancies, slightly more than half occur in women who are using some form of contraception. “The pill is still the most commonly used method of reversible contraception, followed by condoms, followed by nothing, followed by [intrauterine contraception].”

Family planning clinicians are increasingly recommending IUDs, she added, because the two devices that are currently available in the United States – the copper T 380A (Teva Women's Health Inc.'s ParaGard) and the LNG IUS (levonorgestrel intrauterine system, marketed as Mirena by Bayer Healthcare Pharmaceuticals) – are just as effective in preventing pregnancy as is female sterilization. “So effectively, you have reversible sterilization with these products, which is amazing for women who want more long-term prevention of pregnancy,” Dr. Prager said, noting the products' 0.5% failure rate over 5 years.

She credits the pendulum shift in part to mechanical improvements in contemporary IUDs, compared with those from years gone by. For example, plastic IUDs from yesteryear “were less effective in preventing pregnancy. They would depend on surface area for their function and they would cause sterile inflammation based on mass effect.”

ParaGard, on the other hand, is made of copper, which decreases the motility and viability of sperm. “It also disrupts oocyte division and sterilization,” she said. “Secondarily, it inhibits implantation.” It is approved for 10 years of use.

Mirena inhibits fertilization primarily by thickening cervical mucus. It also inhibits sperm motility and function, suppresses the endometrium, causes a weak foreign body reaction, and inhibits ovulation cycles in about 10% of women. It is approved for 5 years of use.

Another factor in the widening acceptance of IUDs, Dr. Prager said, is that there were biases in many studies linking infection and infertility risk to the use of devices that were being used in the 1970s, when about 10% of women used IUDs. “Inappropriate comparison groups were sometimes used,” she said. “Women using contraceptives that lower the risk of PIDs' is probably not an appropriate comparison group. Systematic overdiagnosis of PID in IUD users is also a possibility in a lot of these studies, because [that] was a concern after the early 1970s. Another reason is the inability to control for a number of confounders, such as number of sexual partners.”

Disclosures: Dr. Prager disclosed that she is an Implanon speaker/trainer for Schering-Plough. She has also received salary support from a grant partially subsidized by Ortho-McNeil Pharmaceuticals.

SANTA FE, N.M. — IUDs, once considered an unsafe method of birth control, appear to be making a comeback.

Recent data from the Centers for Disease Control and Prevention suggest that about 5.5% of women aged 15-44 years use IUDs for contraception, which is equivalent to those who choose natural family planning as their primary form of birth control (Vital Health Stat. 2010;23[29]:1-44). That's up significantly from 1995, when fewer than 1% women used IUDs.

“IUDs that we currently have available in the United States are safe,” Dr. Sarah W. Prager said at the meeting. “They're highly efficacious and they're still vastly underused in the United States. It would behoove us, for our patients' sake, to get beyond some of our biases based on our past negative associations.”

In her opinion, the downfall of IUDs emerged soon after the Dalkon Shield was introduced in 1971. Insertion of that device was associated with septic abortion and death, and it caused a fivefold increased risk of pelvic inflammatory disease (PID), compared with other IUDs from that time period, said Dr. Prager of the University of Washington, Seattle. Hypothesized reasons for the problems included the braided polyfilament strings and the fact that a smaller Dalkon Shield was marketed specifically to nulliparous women.

“There is no question that nulliparous women are less likely to be married and therefore more likely to have more partners, which puts them at an increased risk for a sexually transmitted infection,” Dr. Prager said. “Another hypothesis is that the increased surface area of the shield made it more able to drag bacteria from the vagina into the uterus. Also, it was not very effective, with a 2% failure rate per year.”

Of the estimated 6 million pregnancies annually in the United States, almost half are unintended, she said. Of those unintended pregnancies, slightly more than half occur in women who are using some form of contraception. “The pill is still the most commonly used method of reversible contraception, followed by condoms, followed by nothing, followed by [intrauterine contraception].”

Family planning clinicians are increasingly recommending IUDs, she added, because the two devices that are currently available in the United States – the copper T 380A (Teva Women's Health Inc.'s ParaGard) and the LNG IUS (levonorgestrel intrauterine system, marketed as Mirena by Bayer Healthcare Pharmaceuticals) – are just as effective in preventing pregnancy as is female sterilization. “So effectively, you have reversible sterilization with these products, which is amazing for women who want more long-term prevention of pregnancy,” Dr. Prager said, noting the products' 0.5% failure rate over 5 years.

She credits the pendulum shift in part to mechanical improvements in contemporary IUDs, compared with those from years gone by. For example, plastic IUDs from yesteryear “were less effective in preventing pregnancy. They would depend on surface area for their function and they would cause sterile inflammation based on mass effect.”

ParaGard, on the other hand, is made of copper, which decreases the motility and viability of sperm. “It also disrupts oocyte division and sterilization,” she said. “Secondarily, it inhibits implantation.” It is approved for 10 years of use.

Mirena inhibits fertilization primarily by thickening cervical mucus. It also inhibits sperm motility and function, suppresses the endometrium, causes a weak foreign body reaction, and inhibits ovulation cycles in about 10% of women. It is approved for 5 years of use.

Another factor in the widening acceptance of IUDs, Dr. Prager said, is that there were biases in many studies linking infection and infertility risk to the use of devices that were being used in the 1970s, when about 10% of women used IUDs. “Inappropriate comparison groups were sometimes used,” she said. “Women using contraceptives that lower the risk of PIDs' is probably not an appropriate comparison group. Systematic overdiagnosis of PID in IUD users is also a possibility in a lot of these studies, because [that] was a concern after the early 1970s. Another reason is the inability to control for a number of confounders, such as number of sexual partners.”

Disclosures: Dr. Prager disclosed that she is an Implanon speaker/trainer for Schering-Plough. She has also received salary support from a grant partially subsidized by Ortho-McNeil Pharmaceuticals.

SANTA FE, N.M. — IUDs, once considered an unsafe method of birth control, appear to be making a comeback.

Recent data from the Centers for Disease Control and Prevention suggest that about 5.5% of women aged 15-44 years use IUDs for contraception, which is equivalent to those who choose natural family planning as their primary form of birth control (Vital Health Stat. 2010;23[29]:1-44). That's up significantly from 1995, when fewer than 1% women used IUDs.

“IUDs that we currently have available in the United States are safe,” Dr. Sarah W. Prager said at the meeting. “They're highly efficacious and they're still vastly underused in the United States. It would behoove us, for our patients' sake, to get beyond some of our biases based on our past negative associations.”

In her opinion, the downfall of IUDs emerged soon after the Dalkon Shield was introduced in 1971. Insertion of that device was associated with septic abortion and death, and it caused a fivefold increased risk of pelvic inflammatory disease (PID), compared with other IUDs from that time period, said Dr. Prager of the University of Washington, Seattle. Hypothesized reasons for the problems included the braided polyfilament strings and the fact that a smaller Dalkon Shield was marketed specifically to nulliparous women.

“There is no question that nulliparous women are less likely to be married and therefore more likely to have more partners, which puts them at an increased risk for a sexually transmitted infection,” Dr. Prager said. “Another hypothesis is that the increased surface area of the shield made it more able to drag bacteria from the vagina into the uterus. Also, it was not very effective, with a 2% failure rate per year.”

Of the estimated 6 million pregnancies annually in the United States, almost half are unintended, she said. Of those unintended pregnancies, slightly more than half occur in women who are using some form of contraception. “The pill is still the most commonly used method of reversible contraception, followed by condoms, followed by nothing, followed by [intrauterine contraception].”

Family planning clinicians are increasingly recommending IUDs, she added, because the two devices that are currently available in the United States – the copper T 380A (Teva Women's Health Inc.'s ParaGard) and the LNG IUS (levonorgestrel intrauterine system, marketed as Mirena by Bayer Healthcare Pharmaceuticals) – are just as effective in preventing pregnancy as is female sterilization. “So effectively, you have reversible sterilization with these products, which is amazing for women who want more long-term prevention of pregnancy,” Dr. Prager said, noting the products' 0.5% failure rate over 5 years.

She credits the pendulum shift in part to mechanical improvements in contemporary IUDs, compared with those from years gone by. For example, plastic IUDs from yesteryear “were less effective in preventing pregnancy. They would depend on surface area for their function and they would cause sterile inflammation based on mass effect.”

ParaGard, on the other hand, is made of copper, which decreases the motility and viability of sperm. “It also disrupts oocyte division and sterilization,” she said. “Secondarily, it inhibits implantation.” It is approved for 10 years of use.

Mirena inhibits fertilization primarily by thickening cervical mucus. It also inhibits sperm motility and function, suppresses the endometrium, causes a weak foreign body reaction, and inhibits ovulation cycles in about 10% of women. It is approved for 5 years of use.

Another factor in the widening acceptance of IUDs, Dr. Prager said, is that there were biases in many studies linking infection and infertility risk to the use of devices that were being used in the 1970s, when about 10% of women used IUDs. “Inappropriate comparison groups were sometimes used,” she said. “Women using contraceptives that lower the risk of PIDs' is probably not an appropriate comparison group. Systematic overdiagnosis of PID in IUD users is also a possibility in a lot of these studies, because [that] was a concern after the early 1970s. Another reason is the inability to control for a number of confounders, such as number of sexual partners.”

Disclosures: Dr. Prager disclosed that she is an Implanon speaker/trainer for Schering-Plough. She has also received salary support from a grant partially subsidized by Ortho-McNeil Pharmaceuticals.

Major Finding: Adults with vitamin D deficiency were 3.4 times more likely to die from heart failure, compared with those who had normal levels of vitamin D. They were also 1.45 times as likely to die prematurely, compared with those who had normal levels of vitamin D.

Data Source: A total of 13,131 men and women aged 35 and older enrolled in the prospective cohort of the NHANES III from 1988 to 1994.

Disclosures: The researchers had no relevant financial disclosures to make.

SAN DIEGO — Adults with decreased levels of serum 25-hydroxyvitamin D are significantly more likely to die from heart failure or die prematurely, compared with adults who have normal serum levels of vitamin D, results from a large analysis found.

“This may be additional justification for a study of vitamin D supplementation in appropriate patients to determine if there is causality and if this is a treatable condition,” Dr. Howard J. Eisen said at the meeting.

In a study led by his associate, Dr. Longjian Liu of the department of epidemiology and biostatistics at Drexel University School of Public Health, Philadelphia, the researchers reviewed data from 13,131 individuals (6,130 men and 7,001 women) aged 35 and older who were enrolled in the prospective cohort of the Third National Health and Nutrition Examination Survey (NHANES III) from 1988 to 1994 and followed for mortality through the year 2000. At baseline, a radioimmunoassay kit was used to measure the serum vitamin D level of each participant.

Vitamin D deficiency was defined as a serum level below 20 ng/mL, and vitamin D insufficiency was defined as a serum level of 20-29 ng/mL. Normal levels were defined as 30 ng/mL or greater, said Dr. Eisen of the department of medicine at Drexel University, Philadelphia.

Premature death was defined as death before the age of 75. The researchers used Cox proportional hazards regression analysis to examine the association between serum levels of vitamin D and mortality risk.

Dr. Eisen reported that more than 60% of African American study participants were vitamin D deficient, compared with 20% of whites and about 40% of Hispanics. “This might be yet another explanation for the high prevalence of heart failure [among African Americans],” he said.

During an average follow-up period of 8 years, there were 3,266 deaths among the 13,131 participants (24.9%), including 101 heart failure deaths (0.8%). Of the total deaths, there were 1,066 premature deaths (33%). Death from cardiovascular disease accounted for as many as 34% of the total premature deaths.

The rate of vitamin D deficiency among heart failure deaths was 37%, compared with 26% among non–heart failure–related deaths, a difference that was statistically significant.

After the researchers adjusted for age, gender, race, and baseline medical conditions, study participants with vitamin D deficiency were 3.4 times more likely to die from heart failure, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 2 times more likely to die from heart failure, compared with those who had normal vitamin D levels.

In addition, study participants with vitamin D deficiency were 1.45 times more likely to die prematurely, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 1.14 times more likely to die prematurely, compared with those who had normal vitamin D levels.

Major Finding: Adults with vitamin D deficiency were 3.4 times more likely to die from heart failure, compared with those who had normal levels of vitamin D. They were also 1.45 times as likely to die prematurely, compared with those who had normal levels of vitamin D.

Data Source: A total of 13,131 men and women aged 35 and older enrolled in the prospective cohort of the NHANES III from 1988 to 1994.

Disclosures: The researchers had no relevant financial disclosures to make.

SAN DIEGO — Adults with decreased levels of serum 25-hydroxyvitamin D are significantly more likely to die from heart failure or die prematurely, compared with adults who have normal serum levels of vitamin D, results from a large analysis found.

“This may be additional justification for a study of vitamin D supplementation in appropriate patients to determine if there is causality and if this is a treatable condition,” Dr. Howard J. Eisen said at the meeting.

In a study led by his associate, Dr. Longjian Liu of the department of epidemiology and biostatistics at Drexel University School of Public Health, Philadelphia, the researchers reviewed data from 13,131 individuals (6,130 men and 7,001 women) aged 35 and older who were enrolled in the prospective cohort of the Third National Health and Nutrition Examination Survey (NHANES III) from 1988 to 1994 and followed for mortality through the year 2000. At baseline, a radioimmunoassay kit was used to measure the serum vitamin D level of each participant.

Vitamin D deficiency was defined as a serum level below 20 ng/mL, and vitamin D insufficiency was defined as a serum level of 20-29 ng/mL. Normal levels were defined as 30 ng/mL or greater, said Dr. Eisen of the department of medicine at Drexel University, Philadelphia.

Premature death was defined as death before the age of 75. The researchers used Cox proportional hazards regression analysis to examine the association between serum levels of vitamin D and mortality risk.

Dr. Eisen reported that more than 60% of African American study participants were vitamin D deficient, compared with 20% of whites and about 40% of Hispanics. “This might be yet another explanation for the high prevalence of heart failure [among African Americans],” he said.

During an average follow-up period of 8 years, there were 3,266 deaths among the 13,131 participants (24.9%), including 101 heart failure deaths (0.8%). Of the total deaths, there were 1,066 premature deaths (33%). Death from cardiovascular disease accounted for as many as 34% of the total premature deaths.

The rate of vitamin D deficiency among heart failure deaths was 37%, compared with 26% among non–heart failure–related deaths, a difference that was statistically significant.

After the researchers adjusted for age, gender, race, and baseline medical conditions, study participants with vitamin D deficiency were 3.4 times more likely to die from heart failure, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 2 times more likely to die from heart failure, compared with those who had normal vitamin D levels.

In addition, study participants with vitamin D deficiency were 1.45 times more likely to die prematurely, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 1.14 times more likely to die prematurely, compared with those who had normal vitamin D levels.

Major Finding: Adults with vitamin D deficiency were 3.4 times more likely to die from heart failure, compared with those who had normal levels of vitamin D. They were also 1.45 times as likely to die prematurely, compared with those who had normal levels of vitamin D.

Data Source: A total of 13,131 men and women aged 35 and older enrolled in the prospective cohort of the NHANES III from 1988 to 1994.

Disclosures: The researchers had no relevant financial disclosures to make.

SAN DIEGO — Adults with decreased levels of serum 25-hydroxyvitamin D are significantly more likely to die from heart failure or die prematurely, compared with adults who have normal serum levels of vitamin D, results from a large analysis found.

“This may be additional justification for a study of vitamin D supplementation in appropriate patients to determine if there is causality and if this is a treatable condition,” Dr. Howard J. Eisen said at the meeting.

In a study led by his associate, Dr. Longjian Liu of the department of epidemiology and biostatistics at Drexel University School of Public Health, Philadelphia, the researchers reviewed data from 13,131 individuals (6,130 men and 7,001 women) aged 35 and older who were enrolled in the prospective cohort of the Third National Health and Nutrition Examination Survey (NHANES III) from 1988 to 1994 and followed for mortality through the year 2000. At baseline, a radioimmunoassay kit was used to measure the serum vitamin D level of each participant.

Vitamin D deficiency was defined as a serum level below 20 ng/mL, and vitamin D insufficiency was defined as a serum level of 20-29 ng/mL. Normal levels were defined as 30 ng/mL or greater, said Dr. Eisen of the department of medicine at Drexel University, Philadelphia.

Premature death was defined as death before the age of 75. The researchers used Cox proportional hazards regression analysis to examine the association between serum levels of vitamin D and mortality risk.

Dr. Eisen reported that more than 60% of African American study participants were vitamin D deficient, compared with 20% of whites and about 40% of Hispanics. “This might be yet another explanation for the high prevalence of heart failure [among African Americans],” he said.

During an average follow-up period of 8 years, there were 3,266 deaths among the 13,131 participants (24.9%), including 101 heart failure deaths (0.8%). Of the total deaths, there were 1,066 premature deaths (33%). Death from cardiovascular disease accounted for as many as 34% of the total premature deaths.

The rate of vitamin D deficiency among heart failure deaths was 37%, compared with 26% among non–heart failure–related deaths, a difference that was statistically significant.

After the researchers adjusted for age, gender, race, and baseline medical conditions, study participants with vitamin D deficiency were 3.4 times more likely to die from heart failure, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 2 times more likely to die from heart failure, compared with those who had normal vitamin D levels.

In addition, study participants with vitamin D deficiency were 1.45 times more likely to die prematurely, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 1.14 times more likely to die prematurely, compared with those who had normal vitamin D levels.

Major Finding: Investigative formulations of 2.5% and 3.75% imiquimod cream applied daily for up to 8 weeks for the treatment of external genital warts in women yielded complete clearance rates of 28% and 37%, respectively, compared with 14% in women using placebo cream.

Data Source: Two combined phase III studies of 534 women who were treated at 37 sites in the United States.

Disclosures: Dr. Baker disclosed that he is a research consultant for Graceway Pharmaceuticals.

SANTA FE, N.M. — Imiquimod 2.5% and 3.75% creams applied daily for up to 8 weeks were both well tolerated and more efficacious, compared with placebo, in treating external genital warts in women, results from two combined randomized studies showed.

In particular, the 3.75% formulation “fulfills a need for a shorter and simpler imiquimod treatment for external genital warts and provides a clinically meaningful benefit with respect to complete clearance of all baseline and new warts and a rapid reduction in wart counts, with an acceptable safety profile,” Dr. David A. Baker said at the meeting.

Imiquimod 5% cream is approved to treat external genital warts and actinic keratoses. This formulation has been shown to be safe and effective, but Dr. Baker noted that the efficacy end points “were based on the analysis of baseline target warts only, and the compliance with three times per week dosing frequency up to 16-week treatment duration may be difficult for some patients to follow.”

In two identical phase III studies, Dr. Baker and his associates randomized 534 women to placebo, imiquimod 2.5% cream, or imiquimod 3.75% cream for the treatment of genital warts. Graceway Pharmaceuticals, which manufactures imiquimod, developed the formulations “to allow daily dosing to treat external genital warts as well as actinic keratoses,” said Dr. Baker, professor of obstetrics, gynecology, and reproductive medicine at Stony Brook (N.Y.) University.

The 3.75% imiquimod cream has Food and Drug Administration approval to treat actinic keratoses. Graceway is waiting FDA approval of the 3.75% cream to treat external genital warts, Dr. Baker said in a later interview.

The mean age of study participants was 33 years, the mean duration of disease was 5.6 years, the mean wart count was 7.9, and the mean total wart area was 166.3 mm

In the intent to treat analysis, Dr. Baker reported that initial complete clearance of all external genital warts was achieved in 14% of the placebo group, 28% of the imiquimod 2.5% group, and 37% of the imiquimod 3.75% group. Per-protocol results were similar (16%, 35%, and 43%, respectively).

Of the women who achieved initial complete clearance and entered the 12-week follow-up, complete clearance was sustained in 100% of the placebo group, 60% of the imiquimod 2.5% group, and 65% of the imiquimod 3.75% group.

In terms of safety, 0.9% of women in the placebo group, 1% of women in the imiquimod 2.5% group, and 2% of the women imiquimod 3.75% group discontinued the study early due to safety-related reasons.

The 3.75% formulation 'fulfills a need for a shorter and simpler imiquimod treatment.'

Source DR. BAKER

Major Finding: Investigative formulations of 2.5% and 3.75% imiquimod cream applied daily for up to 8 weeks for the treatment of external genital warts in women yielded complete clearance rates of 28% and 37%, respectively, compared with 14% in women using placebo cream.

Data Source: Two combined phase III studies of 534 women who were treated at 37 sites in the United States.

Disclosures: Dr. Baker disclosed that he is a research consultant for Graceway Pharmaceuticals.

SANTA FE, N.M. — Imiquimod 2.5% and 3.75% creams applied daily for up to 8 weeks were both well tolerated and more efficacious, compared with placebo, in treating external genital warts in women, results from two combined randomized studies showed.

In particular, the 3.75% formulation “fulfills a need for a shorter and simpler imiquimod treatment for external genital warts and provides a clinically meaningful benefit with respect to complete clearance of all baseline and new warts and a rapid reduction in wart counts, with an acceptable safety profile,” Dr. David A. Baker said at the meeting.

Imiquimod 5% cream is approved to treat external genital warts and actinic keratoses. This formulation has been shown to be safe and effective, but Dr. Baker noted that the efficacy end points “were based on the analysis of baseline target warts only, and the compliance with three times per week dosing frequency up to 16-week treatment duration may be difficult for some patients to follow.”

In two identical phase III studies, Dr. Baker and his associates randomized 534 women to placebo, imiquimod 2.5% cream, or imiquimod 3.75% cream for the treatment of genital warts. Graceway Pharmaceuticals, which manufactures imiquimod, developed the formulations “to allow daily dosing to treat external genital warts as well as actinic keratoses,” said Dr. Baker, professor of obstetrics, gynecology, and reproductive medicine at Stony Brook (N.Y.) University.

The 3.75% imiquimod cream has Food and Drug Administration approval to treat actinic keratoses. Graceway is waiting FDA approval of the 3.75% cream to treat external genital warts, Dr. Baker said in a later interview.

The mean age of study participants was 33 years, the mean duration of disease was 5.6 years, the mean wart count was 7.9, and the mean total wart area was 166.3 mm

In the intent to treat analysis, Dr. Baker reported that initial complete clearance of all external genital warts was achieved in 14% of the placebo group, 28% of the imiquimod 2.5% group, and 37% of the imiquimod 3.75% group. Per-protocol results were similar (16%, 35%, and 43%, respectively).

Of the women who achieved initial complete clearance and entered the 12-week follow-up, complete clearance was sustained in 100% of the placebo group, 60% of the imiquimod 2.5% group, and 65% of the imiquimod 3.75% group.

In terms of safety, 0.9% of women in the placebo group, 1% of women in the imiquimod 2.5% group, and 2% of the women imiquimod 3.75% group discontinued the study early due to safety-related reasons.

The 3.75% formulation 'fulfills a need for a shorter and simpler imiquimod treatment.'

Source DR. BAKER

Major Finding: Investigative formulations of 2.5% and 3.75% imiquimod cream applied daily for up to 8 weeks for the treatment of external genital warts in women yielded complete clearance rates of 28% and 37%, respectively, compared with 14% in women using placebo cream.

Data Source: Two combined phase III studies of 534 women who were treated at 37 sites in the United States.

Disclosures: Dr. Baker disclosed that he is a research consultant for Graceway Pharmaceuticals.

SANTA FE, N.M. — Imiquimod 2.5% and 3.75% creams applied daily for up to 8 weeks were both well tolerated and more efficacious, compared with placebo, in treating external genital warts in women, results from two combined randomized studies showed.

In particular, the 3.75% formulation “fulfills a need for a shorter and simpler imiquimod treatment for external genital warts and provides a clinically meaningful benefit with respect to complete clearance of all baseline and new warts and a rapid reduction in wart counts, with an acceptable safety profile,” Dr. David A. Baker said at the meeting.

Imiquimod 5% cream is approved to treat external genital warts and actinic keratoses. This formulation has been shown to be safe and effective, but Dr. Baker noted that the efficacy end points “were based on the analysis of baseline target warts only, and the compliance with three times per week dosing frequency up to 16-week treatment duration may be difficult for some patients to follow.”

In two identical phase III studies, Dr. Baker and his associates randomized 534 women to placebo, imiquimod 2.5% cream, or imiquimod 3.75% cream for the treatment of genital warts. Graceway Pharmaceuticals, which manufactures imiquimod, developed the formulations “to allow daily dosing to treat external genital warts as well as actinic keratoses,” said Dr. Baker, professor of obstetrics, gynecology, and reproductive medicine at Stony Brook (N.Y.) University.

The 3.75% imiquimod cream has Food and Drug Administration approval to treat actinic keratoses. Graceway is waiting FDA approval of the 3.75% cream to treat external genital warts, Dr. Baker said in a later interview.

The mean age of study participants was 33 years, the mean duration of disease was 5.6 years, the mean wart count was 7.9, and the mean total wart area was 166.3 mm

In the intent to treat analysis, Dr. Baker reported that initial complete clearance of all external genital warts was achieved in 14% of the placebo group, 28% of the imiquimod 2.5% group, and 37% of the imiquimod 3.75% group. Per-protocol results were similar (16%, 35%, and 43%, respectively).

Of the women who achieved initial complete clearance and entered the 12-week follow-up, complete clearance was sustained in 100% of the placebo group, 60% of the imiquimod 2.5% group, and 65% of the imiquimod 3.75% group.

In terms of safety, 0.9% of women in the placebo group, 1% of women in the imiquimod 2.5% group, and 2% of the women imiquimod 3.75% group discontinued the study early due to safety-related reasons.

The 3.75% formulation 'fulfills a need for a shorter and simpler imiquimod treatment.'

Source DR. BAKER

Major Finding: The mean level of plasma serotonin was 2.4 ng/mL in normal patients, 4.1 ng/mL in patients with compensated systolic heart failure, and 11.8 ng/mL in patients with decompensated systolic heart failure.

Data Source: A study of 112 patients at the Albert Einstein College of Medicine, New York.

Disclosures: The researchers said that they had no relevant financial disclosures to make.

SAN DIEGO — Plasma levels of serotonin were significantly elevated in patients with decompensated systolic heart failure, compared with patients in the compensated state and with normal controls, according to a single-center study.

The finding suggests that serotonin has an active role in the progression of heart failure, researchers led by Dr. Ahmed M. Selim reported during a poster session at the annual meeting of the Heart Failure Society of America.

“More studies should be done to test the sensitivity, specificity, and prognostic value of serotonin as a marker for congestive heart failure and also to investigate the therapeutic benefits of the medications affecting this pathway,” wrote the researchers from the department of cardiology at Albert Einstein College of Medicine, New York.

They noted that, while the relationship between heart failure and the serotoninergic system has been established in previous research, fluctuations in serotonin levels during the course of the disease and its correlation with exacerbation of heart failure have never been tested.

Dr. Selim, a heart failure research fellow, and his associates collected plasma serotonin levels from 29 patients who were admitted with decompensated heart failure, 61 patients with stable heart failure, and 22 normal controls. They excluded patients receiving medications affecting serotonin receptors and those with pulmonary hypertension. All heart failure patients were on stable doses of heart failure medications and had left-ventricular ejections fractions of 40% or less, while normal controls had a mean ejection fraction of 59%.

Overall, the mean age of patients was 55 years, and 62% were male.

The researchers reported that the mean serotonin level in the control group was 2.4 ng/mL, vs. 4.1 ng/mL in the compensated group and 11.8 ng/mL in the decompensated group. This was independent of age, race, renal function, diabetes, and hypertension. “All results were highly significant,” the researchers wrote.

Dr. Selim and his associates stated that they had no relevant financial disclosures to make.

Major Finding: The mean level of plasma serotonin was 2.4 ng/mL in normal patients, 4.1 ng/mL in patients with compensated systolic heart failure, and 11.8 ng/mL in patients with decompensated systolic heart failure.

Data Source: A study of 112 patients at the Albert Einstein College of Medicine, New York.

Disclosures: The researchers said that they had no relevant financial disclosures to make.

SAN DIEGO — Plasma levels of serotonin were significantly elevated in patients with decompensated systolic heart failure, compared with patients in the compensated state and with normal controls, according to a single-center study.

The finding suggests that serotonin has an active role in the progression of heart failure, researchers led by Dr. Ahmed M. Selim reported during a poster session at the annual meeting of the Heart Failure Society of America.

“More studies should be done to test the sensitivity, specificity, and prognostic value of serotonin as a marker for congestive heart failure and also to investigate the therapeutic benefits of the medications affecting this pathway,” wrote the researchers from the department of cardiology at Albert Einstein College of Medicine, New York.

They noted that, while the relationship between heart failure and the serotoninergic system has been established in previous research, fluctuations in serotonin levels during the course of the disease and its correlation with exacerbation of heart failure have never been tested.

Dr. Selim, a heart failure research fellow, and his associates collected plasma serotonin levels from 29 patients who were admitted with decompensated heart failure, 61 patients with stable heart failure, and 22 normal controls. They excluded patients receiving medications affecting serotonin receptors and those with pulmonary hypertension. All heart failure patients were on stable doses of heart failure medications and had left-ventricular ejections fractions of 40% or less, while normal controls had a mean ejection fraction of 59%.

Overall, the mean age of patients was 55 years, and 62% were male.

The researchers reported that the mean serotonin level in the control group was 2.4 ng/mL, vs. 4.1 ng/mL in the compensated group and 11.8 ng/mL in the decompensated group. This was independent of age, race, renal function, diabetes, and hypertension. “All results were highly significant,” the researchers wrote.

Dr. Selim and his associates stated that they had no relevant financial disclosures to make.

Major Finding: The mean level of plasma serotonin was 2.4 ng/mL in normal patients, 4.1 ng/mL in patients with compensated systolic heart failure, and 11.8 ng/mL in patients with decompensated systolic heart failure.

Data Source: A study of 112 patients at the Albert Einstein College of Medicine, New York.

Disclosures: The researchers said that they had no relevant financial disclosures to make.

SAN DIEGO — Plasma levels of serotonin were significantly elevated in patients with decompensated systolic heart failure, compared with patients in the compensated state and with normal controls, according to a single-center study.

The finding suggests that serotonin has an active role in the progression of heart failure, researchers led by Dr. Ahmed M. Selim reported during a poster session at the annual meeting of the Heart Failure Society of America.

“More studies should be done to test the sensitivity, specificity, and prognostic value of serotonin as a marker for congestive heart failure and also to investigate the therapeutic benefits of the medications affecting this pathway,” wrote the researchers from the department of cardiology at Albert Einstein College of Medicine, New York.

They noted that, while the relationship between heart failure and the serotoninergic system has been established in previous research, fluctuations in serotonin levels during the course of the disease and its correlation with exacerbation of heart failure have never been tested.

Dr. Selim, a heart failure research fellow, and his associates collected plasma serotonin levels from 29 patients who were admitted with decompensated heart failure, 61 patients with stable heart failure, and 22 normal controls. They excluded patients receiving medications affecting serotonin receptors and those with pulmonary hypertension. All heart failure patients were on stable doses of heart failure medications and had left-ventricular ejections fractions of 40% or less, while normal controls had a mean ejection fraction of 59%.

Overall, the mean age of patients was 55 years, and 62% were male.

The researchers reported that the mean serotonin level in the control group was 2.4 ng/mL, vs. 4.1 ng/mL in the compensated group and 11.8 ng/mL in the decompensated group. This was independent of age, race, renal function, diabetes, and hypertension. “All results were highly significant,” the researchers wrote.

Dr. Selim and his associates stated that they had no relevant financial disclosures to make.

Major Finding: Most patients with olfactory reference syndrome (85%) have concurrent major depressive disorder, and 44% have sought nonpsychiatric medical treatment for their perceived odor.

Data Source: A study of 20 patients with olfactory reference syndrome.

Disclosures: Dr. Phillips disclosed that she has received grant and research support from the American Foundation for Suicide Prevention and the National Institute of Mental Health.

Patients with olfactory reference syndrome have high rates of clinical depression and other comorbid psychiatric disorders, and nearly half of them do not seek psychiatric treatment for their perceived order.

Those are key findings from a small, novel study discussed during a press briefing sponsored by the American Psychiatric Association.

Olfactory reference syndrome (ORS) is a preoccupation with the belief that one emits a foul or offensive body odor that is not perceived by other people, said lead study investigator Dr. Katharine A. Phillips, of the department of psychiatry at Rhode Island Hospital/Brown University, Providence.

The few reports about ORS that have been published in the last century “suggest that it is clinically important,” she said. “Patients suffer tremendously as a result of this false belief, and they appear to be very impaired in terms of their functioning and to have high rates of suicidality.”

In an effort to better understand the clinical features of ORS, the researchers used semistructured measurement tools to assess 20 patients with the syndrome, including the Structured Clinical Interview for DSM-IV (SCID) to assess comorbidity, the Brown Assessment of Beliefs Scale to assess insight/delusionality and referential thinking, and a slightly modified version of the Yale-Brown Obsessive Compulsive Scale to assess ORS severity. The mean age of patients was 33 years, 60% were female, and the mean age of onset was 16 years.

Patients reported being preoccupied with their perceived body odor for 3-8 hours per day, mostly the mouth (75%), armpits (60%), and genitals (35%). Bad breath was the most common odor description reported (75%), followed by sweat (65%).

Most patients (85%) reported being completely convinced that their belief about the odor was accurate, and 77% reported thinking “that other people take special notice of them in a negative way because they smell so bad,” Dr. Phillips said. In addition, 85% of patients reported that they actually smelled the odor (an olfactory hallucination).

All of the patients reported practicing repetitive behaviors in an effort to camouflage the perceived odor, mostly with perfume or scented powder (90%), chewing gum (60%), deodorant (55%), and mints (55%).

“Some patients actually drank perfume,” she said. “Some of them constantly chewed gum, ate mints, or reapplied deodorant over and over throughout the day [and] used prescription strength mouthwashes frequently. Some patients showered for hours a day, using an entire bar of soap, trying to remove the odor they perceived.”

In addition, 74% reported that ORS symptoms led to avoidance of social interactions “because they felt so ashamed,” she said. “They worried that other people thought badly of them because they felt they stank.”

More than a third of the patients (40%) said that symptoms were so bad that they were housebound for at least 1 week. “They didn't leave the house at all because they felt too embarrassed [or] ashamed,” she said.

More than two-thirds of the patients (68%) had a history of suicidal ideation, 32% had attempted suicide, and 53% had been hospitalized in a psychiatric unit. The most common lifetime comorbid disorder was major depressive disorder (85%), followed by social phobia (65%), and substance use disorders (50%).

Dr. Phillips also reported that 44% of patients had sought nonpsychiatric medical treatment for the perceived odor. “They went to dentists if they thought they had bad breath, [to] dermatologists if they thought they had smelly sweat,” she said. “One participant in our study had their tonsils removed because they thought their tonsils were causing their breath to be bad.”

About one-third of patients received nonpsychiatric treatment for the perceived odor “but in no case did this treatment diminish the worry about the perceived body odor.”

Dr. Phillips concluded her remarks by noting that ORS “appears to be very under-recognized, and we certainly need more research on this area of study.”

The study also was presented during a poster session at the APA's annual meeting in New Orleans.

Patients 'appear to be very impaired in terms of their functioning and to have high rates of suicidality.'

Source DR. PHILLIPS

Major Finding: Most patients with olfactory reference syndrome (85%) have concurrent major depressive disorder, and 44% have sought nonpsychiatric medical treatment for their perceived odor.

Data Source: A study of 20 patients with olfactory reference syndrome.

Disclosures: Dr. Phillips disclosed that she has received grant and research support from the American Foundation for Suicide Prevention and the National Institute of Mental Health.

Patients with olfactory reference syndrome have high rates of clinical depression and other comorbid psychiatric disorders, and nearly half of them do not seek psychiatric treatment for their perceived order.

Those are key findings from a small, novel study discussed during a press briefing sponsored by the American Psychiatric Association.

Olfactory reference syndrome (ORS) is a preoccupation with the belief that one emits a foul or offensive body odor that is not perceived by other people, said lead study investigator Dr. Katharine A. Phillips, of the department of psychiatry at Rhode Island Hospital/Brown University, Providence.

The few reports about ORS that have been published in the last century “suggest that it is clinically important,” she said. “Patients suffer tremendously as a result of this false belief, and they appear to be very impaired in terms of their functioning and to have high rates of suicidality.”

In an effort to better understand the clinical features of ORS, the researchers used semistructured measurement tools to assess 20 patients with the syndrome, including the Structured Clinical Interview for DSM-IV (SCID) to assess comorbidity, the Brown Assessment of Beliefs Scale to assess insight/delusionality and referential thinking, and a slightly modified version of the Yale-Brown Obsessive Compulsive Scale to assess ORS severity. The mean age of patients was 33 years, 60% were female, and the mean age of onset was 16 years.

Patients reported being preoccupied with their perceived body odor for 3-8 hours per day, mostly the mouth (75%), armpits (60%), and genitals (35%). Bad breath was the most common odor description reported (75%), followed by sweat (65%).

Most patients (85%) reported being completely convinced that their belief about the odor was accurate, and 77% reported thinking “that other people take special notice of them in a negative way because they smell so bad,” Dr. Phillips said. In addition, 85% of patients reported that they actually smelled the odor (an olfactory hallucination).

All of the patients reported practicing repetitive behaviors in an effort to camouflage the perceived odor, mostly with perfume or scented powder (90%), chewing gum (60%), deodorant (55%), and mints (55%).

“Some patients actually drank perfume,” she said. “Some of them constantly chewed gum, ate mints, or reapplied deodorant over and over throughout the day [and] used prescription strength mouthwashes frequently. Some patients showered for hours a day, using an entire bar of soap, trying to remove the odor they perceived.”

In addition, 74% reported that ORS symptoms led to avoidance of social interactions “because they felt so ashamed,” she said. “They worried that other people thought badly of them because they felt they stank.”

More than a third of the patients (40%) said that symptoms were so bad that they were housebound for at least 1 week. “They didn't leave the house at all because they felt too embarrassed [or] ashamed,” she said.

More than two-thirds of the patients (68%) had a history of suicidal ideation, 32% had attempted suicide, and 53% had been hospitalized in a psychiatric unit. The most common lifetime comorbid disorder was major depressive disorder (85%), followed by social phobia (65%), and substance use disorders (50%).

Dr. Phillips also reported that 44% of patients had sought nonpsychiatric medical treatment for the perceived odor. “They went to dentists if they thought they had bad breath, [to] dermatologists if they thought they had smelly sweat,” she said. “One participant in our study had their tonsils removed because they thought their tonsils were causing their breath to be bad.”

About one-third of patients received nonpsychiatric treatment for the perceived odor “but in no case did this treatment diminish the worry about the perceived body odor.”

Dr. Phillips concluded her remarks by noting that ORS “appears to be very under-recognized, and we certainly need more research on this area of study.”

The study also was presented during a poster session at the APA's annual meeting in New Orleans.

Patients 'appear to be very impaired in terms of their functioning and to have high rates of suicidality.'

Source DR. PHILLIPS

Major Finding: Most patients with olfactory reference syndrome (85%) have concurrent major depressive disorder, and 44% have sought nonpsychiatric medical treatment for their perceived odor.

Data Source: A study of 20 patients with olfactory reference syndrome.

Disclosures: Dr. Phillips disclosed that she has received grant and research support from the American Foundation for Suicide Prevention and the National Institute of Mental Health.

Patients with olfactory reference syndrome have high rates of clinical depression and other comorbid psychiatric disorders, and nearly half of them do not seek psychiatric treatment for their perceived order.

Those are key findings from a small, novel study discussed during a press briefing sponsored by the American Psychiatric Association.

Olfactory reference syndrome (ORS) is a preoccupation with the belief that one emits a foul or offensive body odor that is not perceived by other people, said lead study investigator Dr. Katharine A. Phillips, of the department of psychiatry at Rhode Island Hospital/Brown University, Providence.

The few reports about ORS that have been published in the last century “suggest that it is clinically important,” she said. “Patients suffer tremendously as a result of this false belief, and they appear to be very impaired in terms of their functioning and to have high rates of suicidality.”

In an effort to better understand the clinical features of ORS, the researchers used semistructured measurement tools to assess 20 patients with the syndrome, including the Structured Clinical Interview for DSM-IV (SCID) to assess comorbidity, the Brown Assessment of Beliefs Scale to assess insight/delusionality and referential thinking, and a slightly modified version of the Yale-Brown Obsessive Compulsive Scale to assess ORS severity. The mean age of patients was 33 years, 60% were female, and the mean age of onset was 16 years.

Patients reported being preoccupied with their perceived body odor for 3-8 hours per day, mostly the mouth (75%), armpits (60%), and genitals (35%). Bad breath was the most common odor description reported (75%), followed by sweat (65%).

Most patients (85%) reported being completely convinced that their belief about the odor was accurate, and 77% reported thinking “that other people take special notice of them in a negative way because they smell so bad,” Dr. Phillips said. In addition, 85% of patients reported that they actually smelled the odor (an olfactory hallucination).

All of the patients reported practicing repetitive behaviors in an effort to camouflage the perceived odor, mostly with perfume or scented powder (90%), chewing gum (60%), deodorant (55%), and mints (55%).

“Some patients actually drank perfume,” she said. “Some of them constantly chewed gum, ate mints, or reapplied deodorant over and over throughout the day [and] used prescription strength mouthwashes frequently. Some patients showered for hours a day, using an entire bar of soap, trying to remove the odor they perceived.”

In addition, 74% reported that ORS symptoms led to avoidance of social interactions “because they felt so ashamed,” she said. “They worried that other people thought badly of them because they felt they stank.”

More than a third of the patients (40%) said that symptoms were so bad that they were housebound for at least 1 week. “They didn't leave the house at all because they felt too embarrassed [or] ashamed,” she said.

More than two-thirds of the patients (68%) had a history of suicidal ideation, 32% had attempted suicide, and 53% had been hospitalized in a psychiatric unit. The most common lifetime comorbid disorder was major depressive disorder (85%), followed by social phobia (65%), and substance use disorders (50%).

Dr. Phillips also reported that 44% of patients had sought nonpsychiatric medical treatment for the perceived odor. “They went to dentists if they thought they had bad breath, [to] dermatologists if they thought they had smelly sweat,” she said. “One participant in our study had their tonsils removed because they thought their tonsils were causing their breath to be bad.”

About one-third of patients received nonpsychiatric treatment for the perceived odor “but in no case did this treatment diminish the worry about the perceived body odor.”

Dr. Phillips concluded her remarks by noting that ORS “appears to be very under-recognized, and we certainly need more research on this area of study.”

The study also was presented during a poster session at the APA's annual meeting in New Orleans.

Patients 'appear to be very impaired in terms of their functioning and to have high rates of suicidality.'

Source DR. PHILLIPS

SAN DIEGO – Plasma levels of serotonin were significantly elevated in patients with decompensated systolic heart failure, compared with patients in the compensated state and with normal controls, according to a single-center study.

The finding suggests that that serotonin has an active role in the progression of heart failure, researchers led by Dr. Ahmed M. Selim reported Sept. 15 during a poster session at the annual meeting of the Heart Failure Society of America.

“More studies should be done to test the sensitivity, specificity, and prognostic value of serotonin as a marker for congestive heart failure and also to investigate the therapeutic benefits of the medications affecting this pathway,” wrote the researchers from the department of cardiology at Albert Einstein College of Medicine, New York.

They noted that, while the relationship between heart failure and the serotoninergic system has been established in previous research, fluctuations in serotonin levels during the course of the disease and its correlation with exacerbation of heart failure have never been tested.

Dr. Selim, a heart failure research fellow, and his associates collected plasma serotonin levels from 29 patients who were admitted with decompensated heart failure, 61 patients with stable heart failure, and 22 normal controls. They excluded patients receiving medications affecting serotonin receptors and those with pulmonary hypertension. All heart failure patients were on stable doses of heart failure medications and had left-ventricular ejections fractions of 40% or less, while normal controls had a mean ejection fraction of 59%.

Overall, the mean age of patients was 55 years, and 62% were male.

The researchers reported that the mean serotonin level in the control group was 2.4 ng/mL, compared with 4.1 ng/mL in the compensated group and 11.8 ng/mL in the decompensated group. This was independent of age, race, renal function, diabetes mellitus, and hypertension. “All results were highly significant,” the researchers wrote.

Dr. Selim and his associates stated that they had no relevant financial disclosures to make.

SAN DIEGO – Plasma levels of serotonin were significantly elevated in patients with decompensated systolic heart failure, compared with patients in the compensated state and with normal controls, according to a single-center study.

The finding suggests that that serotonin has an active role in the progression of heart failure, researchers led by Dr. Ahmed M. Selim reported Sept. 15 during a poster session at the annual meeting of the Heart Failure Society of America.

“More studies should be done to test the sensitivity, specificity, and prognostic value of serotonin as a marker for congestive heart failure and also to investigate the therapeutic benefits of the medications affecting this pathway,” wrote the researchers from the department of cardiology at Albert Einstein College of Medicine, New York.

They noted that, while the relationship between heart failure and the serotoninergic system has been established in previous research, fluctuations in serotonin levels during the course of the disease and its correlation with exacerbation of heart failure have never been tested.

Dr. Selim, a heart failure research fellow, and his associates collected plasma serotonin levels from 29 patients who were admitted with decompensated heart failure, 61 patients with stable heart failure, and 22 normal controls. They excluded patients receiving medications affecting serotonin receptors and those with pulmonary hypertension. All heart failure patients were on stable doses of heart failure medications and had left-ventricular ejections fractions of 40% or less, while normal controls had a mean ejection fraction of 59%.

Overall, the mean age of patients was 55 years, and 62% were male.

The researchers reported that the mean serotonin level in the control group was 2.4 ng/mL, compared with 4.1 ng/mL in the compensated group and 11.8 ng/mL in the decompensated group. This was independent of age, race, renal function, diabetes mellitus, and hypertension. “All results were highly significant,” the researchers wrote.

Dr. Selim and his associates stated that they had no relevant financial disclosures to make.

SAN DIEGO – Plasma levels of serotonin were significantly elevated in patients with decompensated systolic heart failure, compared with patients in the compensated state and with normal controls, according to a single-center study.

The finding suggests that that serotonin has an active role in the progression of heart failure, researchers led by Dr. Ahmed M. Selim reported Sept. 15 during a poster session at the annual meeting of the Heart Failure Society of America.

“More studies should be done to test the sensitivity, specificity, and prognostic value of serotonin as a marker for congestive heart failure and also to investigate the therapeutic benefits of the medications affecting this pathway,” wrote the researchers from the department of cardiology at Albert Einstein College of Medicine, New York.

They noted that, while the relationship between heart failure and the serotoninergic system has been established in previous research, fluctuations in serotonin levels during the course of the disease and its correlation with exacerbation of heart failure have never been tested.

Dr. Selim, a heart failure research fellow, and his associates collected plasma serotonin levels from 29 patients who were admitted with decompensated heart failure, 61 patients with stable heart failure, and 22 normal controls. They excluded patients receiving medications affecting serotonin receptors and those with pulmonary hypertension. All heart failure patients were on stable doses of heart failure medications and had left-ventricular ejections fractions of 40% or less, while normal controls had a mean ejection fraction of 59%.

Overall, the mean age of patients was 55 years, and 62% were male.

The researchers reported that the mean serotonin level in the control group was 2.4 ng/mL, compared with 4.1 ng/mL in the compensated group and 11.8 ng/mL in the decompensated group. This was independent of age, race, renal function, diabetes mellitus, and hypertension. “All results were highly significant,” the researchers wrote.

Dr. Selim and his associates stated that they had no relevant financial disclosures to make.

SAN DIEGO – Plasma levels of serotonin were significantly elevated in patients with decompensated systolic heart failure, compared with patients in the compensated state and with normal controls, according to a single-center study.

The finding suggests that that serotonin has an active role in the progression of heart failure, researchers led by Dr. Ahmed M. Selim reported Sept. 15 during a poster session at the annual meeting of the Heart Failure Society of America.

“More studies should be done to test the sensitivity, specificity, and prognostic value of serotonin as a marker for congestive heart failure and also to investigate the therapeutic benefits of the medications affecting this pathway,” wrote the researchers from the department of cardiology at Albert Einstein College of Medicine, New York.

They noted that, while the relationship between heart failure and the serotoninergic system has been established in previous research, fluctuations in serotonin levels during the course of the disease and its correlation with exacerbation of heart failure have never been tested.

Dr. Selim, a heart failure research fellow, and his associates collected plasma serotonin levels from 29 patients who were admitted with decompensated heart failure, 61 patients with stable heart failure, and 22 normal controls. They excluded patients receiving medications affecting serotonin receptors and those with pulmonary hypertension. All heart failure patients were on stable doses of heart failure medications and had left-ventricular ejections fractions of 40% or less, while normal controls had a mean ejection fraction of 59%.

Overall, the mean age of patients was 55 years, and 62% were male.

The researchers reported that the mean serotonin level in the control group was 2.4 ng/mL, compared with 4.1 ng/mL in the compensated group and 11.8 ng/mL in the decompensated group. This was independent of age, race, renal function, diabetes mellitus, and hypertension. “All results were highly significant,” the researchers wrote.

Dr. Selim and his associates stated that they had no relevant financial disclosures to make.

SAN DIEGO – Plasma levels of serotonin were significantly elevated in patients with decompensated systolic heart failure, compared with patients in the compensated state and with normal controls, according to a single-center study.

The finding suggests that that serotonin has an active role in the progression of heart failure, researchers led by Dr. Ahmed M. Selim reported Sept. 15 during a poster session at the annual meeting of the Heart Failure Society of America.

“More studies should be done to test the sensitivity, specificity, and prognostic value of serotonin as a marker for congestive heart failure and also to investigate the therapeutic benefits of the medications affecting this pathway,” wrote the researchers from the department of cardiology at Albert Einstein College of Medicine, New York.

They noted that, while the relationship between heart failure and the serotoninergic system has been established in previous research, fluctuations in serotonin levels during the course of the disease and its correlation with exacerbation of heart failure have never been tested.

Dr. Selim, a heart failure research fellow, and his associates collected plasma serotonin levels from 29 patients who were admitted with decompensated heart failure, 61 patients with stable heart failure, and 22 normal controls. They excluded patients receiving medications affecting serotonin receptors and those with pulmonary hypertension. All heart failure patients were on stable doses of heart failure medications and had left-ventricular ejections fractions of 40% or less, while normal controls had a mean ejection fraction of 59%.

Overall, the mean age of patients was 55 years, and 62% were male.

The researchers reported that the mean serotonin level in the control group was 2.4 ng/mL, compared with 4.1 ng/mL in the compensated group and 11.8 ng/mL in the decompensated group. This was independent of age, race, renal function, diabetes mellitus, and hypertension. “All results were highly significant,” the researchers wrote.

Dr. Selim and his associates stated that they had no relevant financial disclosures to make.

SAN DIEGO – Plasma levels of serotonin were significantly elevated in patients with decompensated systolic heart failure, compared with patients in the compensated state and with normal controls, according to a single-center study.

The finding suggests that that serotonin has an active role in the progression of heart failure, researchers led by Dr. Ahmed M. Selim reported Sept. 15 during a poster session at the annual meeting of the Heart Failure Society of America.

“More studies should be done to test the sensitivity, specificity, and prognostic value of serotonin as a marker for congestive heart failure and also to investigate the therapeutic benefits of the medications affecting this pathway,” wrote the researchers from the department of cardiology at Albert Einstein College of Medicine, New York.

They noted that, while the relationship between heart failure and the serotoninergic system has been established in previous research, fluctuations in serotonin levels during the course of the disease and its correlation with exacerbation of heart failure have never been tested.

Dr. Selim, a heart failure research fellow, and his associates collected plasma serotonin levels from 29 patients who were admitted with decompensated heart failure, 61 patients with stable heart failure, and 22 normal controls. They excluded patients receiving medications affecting serotonin receptors and those with pulmonary hypertension. All heart failure patients were on stable doses of heart failure medications and had left-ventricular ejections fractions of 40% or less, while normal controls had a mean ejection fraction of 59%.

Overall, the mean age of patients was 55 years, and 62% were male.

The researchers reported that the mean serotonin level in the control group was 2.4 ng/mL, compared with 4.1 ng/mL in the compensated group and 11.8 ng/mL in the decompensated group. This was independent of age, race, renal function, diabetes mellitus, and hypertension. “All results were highly significant,” the researchers wrote.

Dr. Selim and his associates stated that they had no relevant financial disclosures to make.

SAN DIEGO – Adults with decreased levels of serum 25-hydroxy vitamin D are significantly more likely to die from heart failure or die prematurely, compared with adults who have normal serum levels of vitamin D, results from a large analysis found.

“This may be additional justification for a study of vitamin D supplementation in appropriate patients to determine if there is causality and if this is a treatable condition,” Dr. Howard J. Eisen said Sept. 14 at the annual meeting of the Heart Failure Society of America.

In a study led by his associate, Dr. Longjian Liu of the department of epidemiology and biostatistics at Drexel University School of Public Health, Philadelphia, the researchers reviewed data from 13,131 individuals (6,130 men and 7,001 women) aged 35 and older who were enrolled in the prospective cohort of the Third National Health and Nutrition Examination Survey (NHANES III) from 1988 to 1994 and followed for mortality through the year 2000. At baseline, a radioimmunoassay kit was used to measure the serum vitamin D level of each study participant.

Vitamin D deficiency was defined as having a serum level below 20 ng/mL, while vitamin D insufficiency was defined as having a serum level ranging from 20 to 29 ng/mL. Normal levels were defined as 30 ng/mL or greater, said Dr. Eisen of the department of medicine at Drexel University, Philadelphia.

Premature death was defined as death before age 75 years. The researchers used Cox proportional hazards regression analysis to examine the association between serum levels of vitamin D and mortality risk.

Dr. Eisen reported that more than 60% of African American study participants were vitamin D deficient, compared with 20% of whites and about 40% of Hispanics. “This might be yet another explanation for the high prevalence of heart failure [among African Americans],” he said.

During an average follow-up period of 8 years, there were 3,266 deaths among the 13,131 participants (24.9%), including 101 heart failure deaths (0.8%). Of the total deaths, there were 1,066 premature deaths (33%). Death from cardiovascular disease accounted for as many as 34% of the total premature deaths.

The rate of vitamin D deficiency among heart failure deaths was 37%, compared with 26% among non-heart failure–related deaths, a difference that was statistically significant.

After the researchers adjusted for age, gender, race, and baseline medical conditions, study participants with vitamin D deficiency were 3.4 times more likely to die from heart failure, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 2 times more likely to die from heart failure, compared with those who had normal vitamin D levels.

In addition, study participants with vitamin D deficiency were 1.45 times more likely to die prematurely, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 1.14 times more likely to die prematurely, compared with those who had normal vitamin D levels.

Dr. Eisen said that that neither he nor his associates had any relevant financial disclosures to make.

SAN DIEGO – Adults with decreased levels of serum 25-hydroxy vitamin D are significantly more likely to die from heart failure or die prematurely, compared with adults who have normal serum levels of vitamin D, results from a large analysis found.

“This may be additional justification for a study of vitamin D supplementation in appropriate patients to determine if there is causality and if this is a treatable condition,” Dr. Howard J. Eisen said Sept. 14 at the annual meeting of the Heart Failure Society of America.

In a study led by his associate, Dr. Longjian Liu of the department of epidemiology and biostatistics at Drexel University School of Public Health, Philadelphia, the researchers reviewed data from 13,131 individuals (6,130 men and 7,001 women) aged 35 and older who were enrolled in the prospective cohort of the Third National Health and Nutrition Examination Survey (NHANES III) from 1988 to 1994 and followed for mortality through the year 2000. At baseline, a radioimmunoassay kit was used to measure the serum vitamin D level of each study participant.

Vitamin D deficiency was defined as having a serum level below 20 ng/mL, while vitamin D insufficiency was defined as having a serum level ranging from 20 to 29 ng/mL. Normal levels were defined as 30 ng/mL or greater, said Dr. Eisen of the department of medicine at Drexel University, Philadelphia.

Premature death was defined as death before age 75 years. The researchers used Cox proportional hazards regression analysis to examine the association between serum levels of vitamin D and mortality risk.

Dr. Eisen reported that more than 60% of African American study participants were vitamin D deficient, compared with 20% of whites and about 40% of Hispanics. “This might be yet another explanation for the high prevalence of heart failure [among African Americans],” he said.

During an average follow-up period of 8 years, there were 3,266 deaths among the 13,131 participants (24.9%), including 101 heart failure deaths (0.8%). Of the total deaths, there were 1,066 premature deaths (33%). Death from cardiovascular disease accounted for as many as 34% of the total premature deaths.

The rate of vitamin D deficiency among heart failure deaths was 37%, compared with 26% among non-heart failure–related deaths, a difference that was statistically significant.

After the researchers adjusted for age, gender, race, and baseline medical conditions, study participants with vitamin D deficiency were 3.4 times more likely to die from heart failure, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 2 times more likely to die from heart failure, compared with those who had normal vitamin D levels.

In addition, study participants with vitamin D deficiency were 1.45 times more likely to die prematurely, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 1.14 times more likely to die prematurely, compared with those who had normal vitamin D levels.

Dr. Eisen said that that neither he nor his associates had any relevant financial disclosures to make.

SAN DIEGO – Adults with decreased levels of serum 25-hydroxy vitamin D are significantly more likely to die from heart failure or die prematurely, compared with adults who have normal serum levels of vitamin D, results from a large analysis found.

“This may be additional justification for a study of vitamin D supplementation in appropriate patients to determine if there is causality and if this is a treatable condition,” Dr. Howard J. Eisen said Sept. 14 at the annual meeting of the Heart Failure Society of America.

In a study led by his associate, Dr. Longjian Liu of the department of epidemiology and biostatistics at Drexel University School of Public Health, Philadelphia, the researchers reviewed data from 13,131 individuals (6,130 men and 7,001 women) aged 35 and older who were enrolled in the prospective cohort of the Third National Health and Nutrition Examination Survey (NHANES III) from 1988 to 1994 and followed for mortality through the year 2000. At baseline, a radioimmunoassay kit was used to measure the serum vitamin D level of each study participant.

Vitamin D deficiency was defined as having a serum level below 20 ng/mL, while vitamin D insufficiency was defined as having a serum level ranging from 20 to 29 ng/mL. Normal levels were defined as 30 ng/mL or greater, said Dr. Eisen of the department of medicine at Drexel University, Philadelphia.

Premature death was defined as death before age 75 years. The researchers used Cox proportional hazards regression analysis to examine the association between serum levels of vitamin D and mortality risk.

Dr. Eisen reported that more than 60% of African American study participants were vitamin D deficient, compared with 20% of whites and about 40% of Hispanics. “This might be yet another explanation for the high prevalence of heart failure [among African Americans],” he said.

During an average follow-up period of 8 years, there were 3,266 deaths among the 13,131 participants (24.9%), including 101 heart failure deaths (0.8%). Of the total deaths, there were 1,066 premature deaths (33%). Death from cardiovascular disease accounted for as many as 34% of the total premature deaths.

The rate of vitamin D deficiency among heart failure deaths was 37%, compared with 26% among non-heart failure–related deaths, a difference that was statistically significant.

After the researchers adjusted for age, gender, race, and baseline medical conditions, study participants with vitamin D deficiency were 3.4 times more likely to die from heart failure, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 2 times more likely to die from heart failure, compared with those who had normal vitamin D levels.

In addition, study participants with vitamin D deficiency were 1.45 times more likely to die prematurely, compared with those who had normal vitamin D levels, while those with vitamin D insufficiency were 1.14 times more likely to die prematurely, compared with those who had normal vitamin D levels.

Dr. Eisen said that that neither he nor his associates had any relevant financial disclosures to make.

SANTA FE, N.M. — Treatment of bacterial vaginitis with tinidazole at 500 mg twice a day for 7 days was not significantly more efficacious than the standard dose of metronidazole, results from a single-center study demonstrated.

“BV is extremely common and has associated complications, but the therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV,” Dr. Jane R. Schwebke said at the meeting. “Tinidazole was licensed in the U.S. for BV based on a placebo-controlled study, so we really have no data to compare the efficacy of tinidazole for the treatment of BV … with metronidazole.”

In what she described as the first study of its kind, Dr. Schwebke and her associates randomized 593 women with symptomatic BV who attended an STD clinic in Birmingham, Ala., over 4 years to one of three regimens: metronidazole 500 mg b.i.d. for 7 days, tinidazole 500 mg b.i.d. for 7 days, or tinidazole 1 g b.i.d. for 7 days. The researchers conducted follow-up visits at 14 and 28 days and then monthly for two additional visits. Cure was defined as a Nugent score of less than 7 among any of the treatment groups.

The mean age of the study participants was 28 years and most (92%) were black. Dr. Schwebke, professor of medicine at the University of Alabama, Birmingham, reported that there were no statistically significant differences between the cure rates at the day-14 visit or at the day-28 visit among any of the treatment groups.

Cure rates at the day 14 visit for the metronidazole, tinidazole 1 g b.i.d., and tinidazole 500 mg b.i.d. were 82%, 73%, and 73%, respectively, while the cure rates at the day 28 visit were 64%, 68%, and 62%.

“Interestingly, neither baseline Nugent score, consistent use of condoms, sex with a new partner, nor sex with multiple partners were associated with treatment outcome,” Dr. Schwebke said. “However, women who engaged in sex during the study were more likely to have BV at follow-up, which has been a consistent finding among most studies of late.”

The side effect profiles were similar among treatment groups, with the most common side effects being yeast infections, nausea/vomiting, and a bad taste in the mouth.

The study was funded by the National Institute of Allergy and Infectious Diseases. Mission Pharmacal Co. provided the tinidazole.

Dr. Schwebke said that she had no relevant financial conflicts.

'The therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV.'

Source DR. SCHWEBKE

SANTA FE, N.M. — Treatment of bacterial vaginitis with tinidazole at 500 mg twice a day for 7 days was not significantly more efficacious than the standard dose of metronidazole, results from a single-center study demonstrated.

“BV is extremely common and has associated complications, but the therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV,” Dr. Jane R. Schwebke said at the meeting. “Tinidazole was licensed in the U.S. for BV based on a placebo-controlled study, so we really have no data to compare the efficacy of tinidazole for the treatment of BV … with metronidazole.”

In what she described as the first study of its kind, Dr. Schwebke and her associates randomized 593 women with symptomatic BV who attended an STD clinic in Birmingham, Ala., over 4 years to one of three regimens: metronidazole 500 mg b.i.d. for 7 days, tinidazole 500 mg b.i.d. for 7 days, or tinidazole 1 g b.i.d. for 7 days. The researchers conducted follow-up visits at 14 and 28 days and then monthly for two additional visits. Cure was defined as a Nugent score of less than 7 among any of the treatment groups.

The mean age of the study participants was 28 years and most (92%) were black. Dr. Schwebke, professor of medicine at the University of Alabama, Birmingham, reported that there were no statistically significant differences between the cure rates at the day-14 visit or at the day-28 visit among any of the treatment groups.

Cure rates at the day 14 visit for the metronidazole, tinidazole 1 g b.i.d., and tinidazole 500 mg b.i.d. were 82%, 73%, and 73%, respectively, while the cure rates at the day 28 visit were 64%, 68%, and 62%.

“Interestingly, neither baseline Nugent score, consistent use of condoms, sex with a new partner, nor sex with multiple partners were associated with treatment outcome,” Dr. Schwebke said. “However, women who engaged in sex during the study were more likely to have BV at follow-up, which has been a consistent finding among most studies of late.”

The side effect profiles were similar among treatment groups, with the most common side effects being yeast infections, nausea/vomiting, and a bad taste in the mouth.

The study was funded by the National Institute of Allergy and Infectious Diseases. Mission Pharmacal Co. provided the tinidazole.

Dr. Schwebke said that she had no relevant financial conflicts.

'The therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV.'

Source DR. SCHWEBKE

SANTA FE, N.M. — Treatment of bacterial vaginitis with tinidazole at 500 mg twice a day for 7 days was not significantly more efficacious than the standard dose of metronidazole, results from a single-center study demonstrated.

“BV is extremely common and has associated complications, but the therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV,” Dr. Jane R. Schwebke said at the meeting. “Tinidazole was licensed in the U.S. for BV based on a placebo-controlled study, so we really have no data to compare the efficacy of tinidazole for the treatment of BV … with metronidazole.”

In what she described as the first study of its kind, Dr. Schwebke and her associates randomized 593 women with symptomatic BV who attended an STD clinic in Birmingham, Ala., over 4 years to one of three regimens: metronidazole 500 mg b.i.d. for 7 days, tinidazole 500 mg b.i.d. for 7 days, or tinidazole 1 g b.i.d. for 7 days. The researchers conducted follow-up visits at 14 and 28 days and then monthly for two additional visits. Cure was defined as a Nugent score of less than 7 among any of the treatment groups.

The mean age of the study participants was 28 years and most (92%) were black. Dr. Schwebke, professor of medicine at the University of Alabama, Birmingham, reported that there were no statistically significant differences between the cure rates at the day-14 visit or at the day-28 visit among any of the treatment groups.

Cure rates at the day 14 visit for the metronidazole, tinidazole 1 g b.i.d., and tinidazole 500 mg b.i.d. were 82%, 73%, and 73%, respectively, while the cure rates at the day 28 visit were 64%, 68%, and 62%.

“Interestingly, neither baseline Nugent score, consistent use of condoms, sex with a new partner, nor sex with multiple partners were associated with treatment outcome,” Dr. Schwebke said. “However, women who engaged in sex during the study were more likely to have BV at follow-up, which has been a consistent finding among most studies of late.”

The side effect profiles were similar among treatment groups, with the most common side effects being yeast infections, nausea/vomiting, and a bad taste in the mouth.

The study was funded by the National Institute of Allergy and Infectious Diseases. Mission Pharmacal Co. provided the tinidazole.

Dr. Schwebke said that she had no relevant financial conflicts.

'The therapeutic options that we have are limited and I think we all get frustrated in trying to treat women with BV.'

Source DR. SCHWEBKE

Major Finding: The use of unrecommended molecular tests for lower genital tract infections increased total molecular test spending by 29%, compared with the cost of recommended molecular tests alone.

Data Source: Laboratory claims from 82,443 patients in a large national insurance database from the year 2008.

Disclosures: Dr. Eckert said that she had no relevant financial conflicts to disclose.

SANTA FE, N.M. — Molecular diagnostic tests appear to be overused for the diagnosis of lower genital tract infections in women, results from an analysis of national practice patterns showed.

In fact, use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommended molecular tests alone.

Vaginitis is a common clinical problem in which accurate diagnosis “can be challenging,” Dr. Linda O'Neal Eckert said during the meeting “In fact, many of us make a living by trying to accurately diagnose challenging cases of vaginitis. The availability of molecular testing for female genital tract infections is definitely increasing. Their use may offer appeal, partly because there's a perception of accuracy when you can get the result back and hope that that might determine the etiology of the symptoms, and also because using these tests does not require a microscope.”

Dr. Eckert of the University of Washington, Seattle, and her associates conducted a cross-sectional study of laboratory claims within a large national insurance database for the year 2008. “This database represents 3.5 million commercially insured patients,” she said. “More than 500 laboratories are in this database, including both commercial and hospital laboratories.”

The researchers used ICD-9 codes to select women who presented for a first evaluation of vaginal and cervical infections, and then identified molecular tests performed to detect infections from laboratory CPT codes billed on the same visit. They used published guidelines (N. Engl. J. Med 2006;355:1244-52; ACOG Practice Bulletin No. 72, May 2006, reaffirmed 2008) to classify molecular tests as either recommended (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, herpes simplex virus) or not recommended (Candida species and subspecies, Gardnerella vaginalis, staphylococcus, streptococcus, enterococcus, cytomegalovirus, and others) for use in this setting.

Of 211,933 women in the database, 82,443 met criteria for inclusion in the study. Of these patients, 61,132 (74%) had recommended tests, 17,934 (22%) had both recommended and nonrecommended tests, and 3,377 (4%) had only nonrecommended tests performed at their initial visits.

The most common molecular test classified as not recommended that was ordered was for the detection of an agent not otherwise specified by amplified DNA probe method. Dr. Eckert reported that this test was performed 15,526 times at an average cost of $21.60 per test, for a total amount spent of $335,290.

The second most common test performed, a direct DNA probe to search for G. vaginalis, was performed 14,698 times at an average cost of $21.30 per test, for a total amount spent of $313,298. The third most common test performed, a direct DNA probe for Candida species and subspecies, was performed 14,630 times at an average cost of $21.37 per test, for a total amount spent of $312,707.

Overall, a total of $6,328,168 was spent on molecular testing, Dr. Eckert said. Of this total, the cost of recommended tests amounted to $4,816,407 (76.1%), whereas the cost of nonrecommended tests amounted to $1,408,270 million (22.3%). The use of nonspecified molecular tests accounted for the remaining 1.6%, or $103,491.

The researchers determined that the average cost of recommended testing was $61 per patient visit, whereas the average cost of additional unrecommended testing was $66 per visit. In the aggregate, use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommend testing alone.

One of the meeting attendees, Dr. Harold C. Wiesenfeld, director of the division of reproductive infectious diseases in the University of Pittsburgh, said that some of his patients who aren't covered by insurance are getting bills approaching $1,400 for vaginitis panels. “There is no data that any clinical outcome is improved based on these tests,” he commented.

Dr. Eckert noted that one of the labs studied accounted for the vast majority of nonrecommended molecular testing. “There is a significant variation that occurs between laboratories for the use of recommended vs. nonrecommended molecular tests,” she said.

The use of unrecommended tests increased total molecular test spending by 29%.

Source DR. ECKERT

Major Finding: The use of unrecommended molecular tests for lower genital tract infections increased total molecular test spending by 29%, compared with the cost of recommended molecular tests alone.

Data Source: Laboratory claims from 82,443 patients in a large national insurance database from the year 2008.

Disclosures: Dr. Eckert said that she had no relevant financial conflicts to disclose.

SANTA FE, N.M. — Molecular diagnostic tests appear to be overused for the diagnosis of lower genital tract infections in women, results from an analysis of national practice patterns showed.

In fact, use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommended molecular tests alone.

Vaginitis is a common clinical problem in which accurate diagnosis “can be challenging,” Dr. Linda O'Neal Eckert said during the meeting “In fact, many of us make a living by trying to accurately diagnose challenging cases of vaginitis. The availability of molecular testing for female genital tract infections is definitely increasing. Their use may offer appeal, partly because there's a perception of accuracy when you can get the result back and hope that that might determine the etiology of the symptoms, and also because using these tests does not require a microscope.”

Dr. Eckert of the University of Washington, Seattle, and her associates conducted a cross-sectional study of laboratory claims within a large national insurance database for the year 2008. “This database represents 3.5 million commercially insured patients,” she said. “More than 500 laboratories are in this database, including both commercial and hospital laboratories.”

The researchers used ICD-9 codes to select women who presented for a first evaluation of vaginal and cervical infections, and then identified molecular tests performed to detect infections from laboratory CPT codes billed on the same visit. They used published guidelines (N. Engl. J. Med 2006;355:1244-52; ACOG Practice Bulletin No. 72, May 2006, reaffirmed 2008) to classify molecular tests as either recommended (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, herpes simplex virus) or not recommended (Candida species and subspecies, Gardnerella vaginalis, staphylococcus, streptococcus, enterococcus, cytomegalovirus, and others) for use in this setting.

Of 211,933 women in the database, 82,443 met criteria for inclusion in the study. Of these patients, 61,132 (74%) had recommended tests, 17,934 (22%) had both recommended and nonrecommended tests, and 3,377 (4%) had only nonrecommended tests performed at their initial visits.

The most common molecular test classified as not recommended that was ordered was for the detection of an agent not otherwise specified by amplified DNA probe method. Dr. Eckert reported that this test was performed 15,526 times at an average cost of $21.60 per test, for a total amount spent of $335,290.

The second most common test performed, a direct DNA probe to search for G. vaginalis, was performed 14,698 times at an average cost of $21.30 per test, for a total amount spent of $313,298. The third most common test performed, a direct DNA probe for Candida species and subspecies, was performed 14,630 times at an average cost of $21.37 per test, for a total amount spent of $312,707.

Overall, a total of $6,328,168 was spent on molecular testing, Dr. Eckert said. Of this total, the cost of recommended tests amounted to $4,816,407 (76.1%), whereas the cost of nonrecommended tests amounted to $1,408,270 million (22.3%). The use of nonspecified molecular tests accounted for the remaining 1.6%, or $103,491.

The researchers determined that the average cost of recommended testing was $61 per patient visit, whereas the average cost of additional unrecommended testing was $66 per visit. In the aggregate, use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommend testing alone.

One of the meeting attendees, Dr. Harold C. Wiesenfeld, director of the division of reproductive infectious diseases in the University of Pittsburgh, said that some of his patients who aren't covered by insurance are getting bills approaching $1,400 for vaginitis panels. “There is no data that any clinical outcome is improved based on these tests,” he commented.

Dr. Eckert noted that one of the labs studied accounted for the vast majority of nonrecommended molecular testing. “There is a significant variation that occurs between laboratories for the use of recommended vs. nonrecommended molecular tests,” she said.

The use of unrecommended tests increased total molecular test spending by 29%.

Source DR. ECKERT

Major Finding: The use of unrecommended molecular tests for lower genital tract infections increased total molecular test spending by 29%, compared with the cost of recommended molecular tests alone.

Data Source: Laboratory claims from 82,443 patients in a large national insurance database from the year 2008.

Disclosures: Dr. Eckert said that she had no relevant financial conflicts to disclose.

SANTA FE, N.M. — Molecular diagnostic tests appear to be overused for the diagnosis of lower genital tract infections in women, results from an analysis of national practice patterns showed.

In fact, use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommended molecular tests alone.

Vaginitis is a common clinical problem in which accurate diagnosis “can be challenging,” Dr. Linda O'Neal Eckert said during the meeting “In fact, many of us make a living by trying to accurately diagnose challenging cases of vaginitis. The availability of molecular testing for female genital tract infections is definitely increasing. Their use may offer appeal, partly because there's a perception of accuracy when you can get the result back and hope that that might determine the etiology of the symptoms, and also because using these tests does not require a microscope.”

Dr. Eckert of the University of Washington, Seattle, and her associates conducted a cross-sectional study of laboratory claims within a large national insurance database for the year 2008. “This database represents 3.5 million commercially insured patients,” she said. “More than 500 laboratories are in this database, including both commercial and hospital laboratories.”

The researchers used ICD-9 codes to select women who presented for a first evaluation of vaginal and cervical infections, and then identified molecular tests performed to detect infections from laboratory CPT codes billed on the same visit. They used published guidelines (N. Engl. J. Med 2006;355:1244-52; ACOG Practice Bulletin No. 72, May 2006, reaffirmed 2008) to classify molecular tests as either recommended (Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, herpes simplex virus) or not recommended (Candida species and subspecies, Gardnerella vaginalis, staphylococcus, streptococcus, enterococcus, cytomegalovirus, and others) for use in this setting.

Of 211,933 women in the database, 82,443 met criteria for inclusion in the study. Of these patients, 61,132 (74%) had recommended tests, 17,934 (22%) had both recommended and nonrecommended tests, and 3,377 (4%) had only nonrecommended tests performed at their initial visits.

The most common molecular test classified as not recommended that was ordered was for the detection of an agent not otherwise specified by amplified DNA probe method. Dr. Eckert reported that this test was performed 15,526 times at an average cost of $21.60 per test, for a total amount spent of $335,290.

The second most common test performed, a direct DNA probe to search for G. vaginalis, was performed 14,698 times at an average cost of $21.30 per test, for a total amount spent of $313,298. The third most common test performed, a direct DNA probe for Candida species and subspecies, was performed 14,630 times at an average cost of $21.37 per test, for a total amount spent of $312,707.

Overall, a total of $6,328,168 was spent on molecular testing, Dr. Eckert said. Of this total, the cost of recommended tests amounted to $4,816,407 (76.1%), whereas the cost of nonrecommended tests amounted to $1,408,270 million (22.3%). The use of nonspecified molecular tests accounted for the remaining 1.6%, or $103,491.

The researchers determined that the average cost of recommended testing was $61 per patient visit, whereas the average cost of additional unrecommended testing was $66 per visit. In the aggregate, use of unrecommended tests increased total molecular test spending by 29%, compared with the cost of recommend testing alone.

One of the meeting attendees, Dr. Harold C. Wiesenfeld, director of the division of reproductive infectious diseases in the University of Pittsburgh, said that some of his patients who aren't covered by insurance are getting bills approaching $1,400 for vaginitis panels. “There is no data that any clinical outcome is improved based on these tests,” he commented.

Dr. Eckert noted that one of the labs studied accounted for the vast majority of nonrecommended molecular testing. “There is a significant variation that occurs between laboratories for the use of recommended vs. nonrecommended molecular tests,” she said.

The use of unrecommended tests increased total molecular test spending by 29%.

Source DR. ECKERT