Miriam E. Tucker

WASHINGTON — Single-day famciclovir therapy was similar in safety and efficacy to a 3-day course of valacylovir in the first head-to-head comparison of the two oral medications for the treatment of recurrent genital herpes.

Previous data showed that, when taken within 6 hours of symptom onset, single-day famciclovir (Famvir, 1,000 mg b.i.d.) increased the proportion of patients with aborted episodes from 13% to 23%, and reduced healing time and duration of symptoms by 2 days, compared with placebo (Clin Infect Dis 2006;42:8–13).

Now, the findings of a multicenter, randomized, double-blind, parallel group study of 751 adults with recurrent genital herpes suggest that single-day famciclovir is as safe and effective as 3-day valacyclovir (Valtrex, 500 mg b.i.d.), Dr. Stephen Tyring said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Patients were at least 18 years of age and had experienced at least 4 outbreaks of lesions on the external genitalia or anogenital area in the preceding 12 months, with positive herpes simplex virus serology. About two-thirds were female, and most had used suppressive therapy in the previous 12 months. Of the 1,179 patients who were randomized, 751 initiated the study medication within 6 hours of their next recurrence and were included in the analysis.

The proportion of patients with aborted lesions in the intent-to-treat population was 32.7% among the 370 famciclovir patients and 33.6% among the 381 valacyclovir patients. Time to healing of nonaborted lesions was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir, an insignificant difference. There were also no differences in time to resolution of burning, pain, tingling, itching, tenderness, or all symptoms together, said Dr. Tyring of the Center for Clinical Studies at Texas Medical Center, Houston.

Adverse events were reported in about one-fifth of each group, with drug-related events reported in 11% with famciclovir and 9% with valacyclovir. Headache was the most common adverse event, reported in 8% with famciclovir and 4% with valacyclovir.

Dr. Tyring receives research funding and is on the speakers bureau for Novartis, manufacturer of Famvir, and GlaxoSmithKline, manufacturer of Valtrex.

Time to lesion healing was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir. DR. TYRING

WASHINGTON — Single-day famciclovir therapy was similar in safety and efficacy to a 3-day course of valacylovir in the first head-to-head comparison of the two oral medications for the treatment of recurrent genital herpes.

Previous data showed that, when taken within 6 hours of symptom onset, single-day famciclovir (Famvir, 1,000 mg b.i.d.) increased the proportion of patients with aborted episodes from 13% to 23%, and reduced healing time and duration of symptoms by 2 days, compared with placebo (Clin Infect Dis 2006;42:8–13).

Now, the findings of a multicenter, randomized, double-blind, parallel group study of 751 adults with recurrent genital herpes suggest that single-day famciclovir is as safe and effective as 3-day valacyclovir (Valtrex, 500 mg b.i.d.), Dr. Stephen Tyring said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Patients were at least 18 years of age and had experienced at least 4 outbreaks of lesions on the external genitalia or anogenital area in the preceding 12 months, with positive herpes simplex virus serology. About two-thirds were female, and most had used suppressive therapy in the previous 12 months. Of the 1,179 patients who were randomized, 751 initiated the study medication within 6 hours of their next recurrence and were included in the analysis.

The proportion of patients with aborted lesions in the intent-to-treat population was 32.7% among the 370 famciclovir patients and 33.6% among the 381 valacyclovir patients. Time to healing of nonaborted lesions was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir, an insignificant difference. There were also no differences in time to resolution of burning, pain, tingling, itching, tenderness, or all symptoms together, said Dr. Tyring of the Center for Clinical Studies at Texas Medical Center, Houston.

Adverse events were reported in about one-fifth of each group, with drug-related events reported in 11% with famciclovir and 9% with valacyclovir. Headache was the most common adverse event, reported in 8% with famciclovir and 4% with valacyclovir.

Dr. Tyring receives research funding and is on the speakers bureau for Novartis, manufacturer of Famvir, and GlaxoSmithKline, manufacturer of Valtrex.

Time to lesion healing was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir. DR. TYRING

WASHINGTON — Single-day famciclovir therapy was similar in safety and efficacy to a 3-day course of valacylovir in the first head-to-head comparison of the two oral medications for the treatment of recurrent genital herpes.

Previous data showed that, when taken within 6 hours of symptom onset, single-day famciclovir (Famvir, 1,000 mg b.i.d.) increased the proportion of patients with aborted episodes from 13% to 23%, and reduced healing time and duration of symptoms by 2 days, compared with placebo (Clin Infect Dis 2006;42:8–13).

Now, the findings of a multicenter, randomized, double-blind, parallel group study of 751 adults with recurrent genital herpes suggest that single-day famciclovir is as safe and effective as 3-day valacyclovir (Valtrex, 500 mg b.i.d.), Dr. Stephen Tyring said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Patients were at least 18 years of age and had experienced at least 4 outbreaks of lesions on the external genitalia or anogenital area in the preceding 12 months, with positive herpes simplex virus serology. About two-thirds were female, and most had used suppressive therapy in the previous 12 months. Of the 1,179 patients who were randomized, 751 initiated the study medication within 6 hours of their next recurrence and were included in the analysis.

The proportion of patients with aborted lesions in the intent-to-treat population was 32.7% among the 370 famciclovir patients and 33.6% among the 381 valacyclovir patients. Time to healing of nonaborted lesions was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir, an insignificant difference. There were also no differences in time to resolution of burning, pain, tingling, itching, tenderness, or all symptoms together, said Dr. Tyring of the Center for Clinical Studies at Texas Medical Center, Houston.

Adverse events were reported in about one-fifth of each group, with drug-related events reported in 11% with famciclovir and 9% with valacyclovir. Headache was the most common adverse event, reported in 8% with famciclovir and 4% with valacyclovir.

Dr. Tyring receives research funding and is on the speakers bureau for Novartis, manufacturer of Famvir, and GlaxoSmithKline, manufacturer of Valtrex.

Time to lesion healing was 4.25 days with single-day famciclovir and 4.08 days with 3-day valacyclovir. DR. TYRING

WASHINGTON — High rates of both overall and subclinical viral shedding continue even beyond 10 years among people with genital herpes simplex virus type 2 infection, suggesting that there is a continued risk of transmission to sexual partners long after initial infection.

The findings, from a study of 377 healthy adults with a history of symptomatic herpes simplex virus type 2 (HSV-2) infection, "have implications for long-term management of transmission and treatment of clinical recurrences, including long-term use of antiviral medications for clinical suppression and condom use to reduce transmission to partners," Dr. Warren Phipps said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Previous studies suggest that rates of HSV-2 shedding during the first year of infection range from 9% to 40% of days sampled using polymerase chain reaction (PCR), and that clinical recurrences are common, with a median of about four outbreaks per year. Subclinical shedding during the first year is estimated to represent about 50% of days of reactivation. Much less is known about the natural history of genital herpes beyond the first year, and the available data conflict as to whether viral shedding decreases with time, noted Dr. Phipps of the University of Washington and the Fred Hutchinson Cancer Research Center, Seattle.

The study population included participants in several prospective observational studies, some of them funded by GlaxoSmithKline, conducted at two clinics from 1992 to 2008. Subjects collected swabs on at least 30 consecutive days from perianal, vulvar, cervical, penile, and/or urethral sites. They also kept symptom diaries in which they recorded the appearance of genital lesions. The swabs were tested for HSV-2 using PCR, with a positive sample defined as greater than or equal to 150 copies/mL of HSV-2 DNA from any site.

The 377 subjects had a mean age of 39 years (range 20–76 years), were 62% female, and were 89% white. The entire group collected swabs in a total of 439 sessions with a mean of 64 days per session, for a total of 28,252 swab days. Participants were grouped as having had "less than 1 year," "1–9 years," and "10 or more years" since their initial episode.

Time since initial genital herpes episode was associated with reductions in both total and subclinical HSV-2 shedding, from 26% of sampled days within 1 year, to 16% at 1–9 years, to 14% at 10 years and beyond for total shedding, and from 19% to 8% to 4% of sampled days, respectively, for subclinical shedding. The appearance of clinical lesions dropped insignificantly with time, from 11% to 10% to 7% of sampled days for the three groups, respectively. "Although shedding was reduced, it is important to note that rates still remained high even beyond 10 years or more from the initial clinical episode," Dr. Phipps commented.

Race had a significant impact on the change in reactivation rates over time, with nonwhites having much higher rates than whites within the first year (65% vs. 26%) but dropping to a much lower level at 1–9 years (7% vs. 18%) and at 10 or more years (4% vs. 16%). Rates of subclinical shedding also decreased to a greater degree with time in blacks vs. whites.

Small but significant decreases were seen in HSV-2 DNA copy numbers over time, from 4.8 to 4.6 log10 copies/mL between the less than 1 year and 10 years or greater groups. "It is important to note that although there is no known 'infectivity threshold,' it is generally thought that virus is infectious at greater than 3 log10 copies/mL, so these titers remain in presumed infectious range remote from initial infection," he said.

Duration of any reactivation and subclinical reactivation episodes did not change over time, but the duration of clinical episodes did decrease significantly, from a median of 8.5 days within 1 year, to 5.8 days at 1–9 years, to 5.0 days at 10 years and beyond. Dr. Phipps said that he had no financial disclosures.

WASHINGTON — High rates of both overall and subclinical viral shedding continue even beyond 10 years among people with genital herpes simplex virus type 2 infection, suggesting that there is a continued risk of transmission to sexual partners long after initial infection.

The findings, from a study of 377 healthy adults with a history of symptomatic herpes simplex virus type 2 (HSV-2) infection, "have implications for long-term management of transmission and treatment of clinical recurrences, including long-term use of antiviral medications for clinical suppression and condom use to reduce transmission to partners," Dr. Warren Phipps said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Previous studies suggest that rates of HSV-2 shedding during the first year of infection range from 9% to 40% of days sampled using polymerase chain reaction (PCR), and that clinical recurrences are common, with a median of about four outbreaks per year. Subclinical shedding during the first year is estimated to represent about 50% of days of reactivation. Much less is known about the natural history of genital herpes beyond the first year, and the available data conflict as to whether viral shedding decreases with time, noted Dr. Phipps of the University of Washington and the Fred Hutchinson Cancer Research Center, Seattle.

The study population included participants in several prospective observational studies, some of them funded by GlaxoSmithKline, conducted at two clinics from 1992 to 2008. Subjects collected swabs on at least 30 consecutive days from perianal, vulvar, cervical, penile, and/or urethral sites. They also kept symptom diaries in which they recorded the appearance of genital lesions. The swabs were tested for HSV-2 using PCR, with a positive sample defined as greater than or equal to 150 copies/mL of HSV-2 DNA from any site.

The 377 subjects had a mean age of 39 years (range 20–76 years), were 62% female, and were 89% white. The entire group collected swabs in a total of 439 sessions with a mean of 64 days per session, for a total of 28,252 swab days. Participants were grouped as having had "less than 1 year," "1–9 years," and "10 or more years" since their initial episode.

Time since initial genital herpes episode was associated with reductions in both total and subclinical HSV-2 shedding, from 26% of sampled days within 1 year, to 16% at 1–9 years, to 14% at 10 years and beyond for total shedding, and from 19% to 8% to 4% of sampled days, respectively, for subclinical shedding. The appearance of clinical lesions dropped insignificantly with time, from 11% to 10% to 7% of sampled days for the three groups, respectively. "Although shedding was reduced, it is important to note that rates still remained high even beyond 10 years or more from the initial clinical episode," Dr. Phipps commented.

Race had a significant impact on the change in reactivation rates over time, with nonwhites having much higher rates than whites within the first year (65% vs. 26%) but dropping to a much lower level at 1–9 years (7% vs. 18%) and at 10 or more years (4% vs. 16%). Rates of subclinical shedding also decreased to a greater degree with time in blacks vs. whites.

Small but significant decreases were seen in HSV-2 DNA copy numbers over time, from 4.8 to 4.6 log10 copies/mL between the less than 1 year and 10 years or greater groups. "It is important to note that although there is no known 'infectivity threshold,' it is generally thought that virus is infectious at greater than 3 log10 copies/mL, so these titers remain in presumed infectious range remote from initial infection," he said.

Duration of any reactivation and subclinical reactivation episodes did not change over time, but the duration of clinical episodes did decrease significantly, from a median of 8.5 days within 1 year, to 5.8 days at 1–9 years, to 5.0 days at 10 years and beyond. Dr. Phipps said that he had no financial disclosures.

WASHINGTON — High rates of both overall and subclinical viral shedding continue even beyond 10 years among people with genital herpes simplex virus type 2 infection, suggesting that there is a continued risk of transmission to sexual partners long after initial infection.

The findings, from a study of 377 healthy adults with a history of symptomatic herpes simplex virus type 2 (HSV-2) infection, "have implications for long-term management of transmission and treatment of clinical recurrences, including long-term use of antiviral medications for clinical suppression and condom use to reduce transmission to partners," Dr. Warren Phipps said at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Previous studies suggest that rates of HSV-2 shedding during the first year of infection range from 9% to 40% of days sampled using polymerase chain reaction (PCR), and that clinical recurrences are common, with a median of about four outbreaks per year. Subclinical shedding during the first year is estimated to represent about 50% of days of reactivation. Much less is known about the natural history of genital herpes beyond the first year, and the available data conflict as to whether viral shedding decreases with time, noted Dr. Phipps of the University of Washington and the Fred Hutchinson Cancer Research Center, Seattle.

The study population included participants in several prospective observational studies, some of them funded by GlaxoSmithKline, conducted at two clinics from 1992 to 2008. Subjects collected swabs on at least 30 consecutive days from perianal, vulvar, cervical, penile, and/or urethral sites. They also kept symptom diaries in which they recorded the appearance of genital lesions. The swabs were tested for HSV-2 using PCR, with a positive sample defined as greater than or equal to 150 copies/mL of HSV-2 DNA from any site.

The 377 subjects had a mean age of 39 years (range 20–76 years), were 62% female, and were 89% white. The entire group collected swabs in a total of 439 sessions with a mean of 64 days per session, for a total of 28,252 swab days. Participants were grouped as having had "less than 1 year," "1–9 years," and "10 or more years" since their initial episode.

Time since initial genital herpes episode was associated with reductions in both total and subclinical HSV-2 shedding, from 26% of sampled days within 1 year, to 16% at 1–9 years, to 14% at 10 years and beyond for total shedding, and from 19% to 8% to 4% of sampled days, respectively, for subclinical shedding. The appearance of clinical lesions dropped insignificantly with time, from 11% to 10% to 7% of sampled days for the three groups, respectively. "Although shedding was reduced, it is important to note that rates still remained high even beyond 10 years or more from the initial clinical episode," Dr. Phipps commented.

Race had a significant impact on the change in reactivation rates over time, with nonwhites having much higher rates than whites within the first year (65% vs. 26%) but dropping to a much lower level at 1–9 years (7% vs. 18%) and at 10 or more years (4% vs. 16%). Rates of subclinical shedding also decreased to a greater degree with time in blacks vs. whites.

Small but significant decreases were seen in HSV-2 DNA copy numbers over time, from 4.8 to 4.6 log10 copies/mL between the less than 1 year and 10 years or greater groups. "It is important to note that although there is no known 'infectivity threshold,' it is generally thought that virus is infectious at greater than 3 log10 copies/mL, so these titers remain in presumed infectious range remote from initial infection," he said.

Duration of any reactivation and subclinical reactivation episodes did not change over time, but the duration of clinical episodes did decrease significantly, from a median of 8.5 days within 1 year, to 5.8 days at 1–9 years, to 5.0 days at 10 years and beyond. Dr. Phipps said that he had no financial disclosures.

WASHINGTON — Use of real-time polymerase chain reaction to screen for group B Streptococcus in the delivery room could reduce the use of intrapartum antibiotics by more than half, compared with antenatal screening alone, the findings of a single-center study of 232 pregnant women suggest.

Current CDC guidelines call for vaginal and rectal swabs at 35–37 weeks' gestation and for all women with cultures positive for group B Streptococcus (GBS) to receive intravenous antibiotic prophylaxis during labor and delivery (MMWR 2002;51[RR11]:1–22). This practice has greatly reduced the rates of neonatal sepsis in the United States, but it is imperfect. Women whose status is unknown at the time of labor also must receive prophylaxis, resulting in overtreatment, while cultures can fail to detect GBS in women who are lightly colonized, resulting in failure to treat.

Rapid testing at the time of delivery using real-time polymerase chain reaction (RT-PCR) has the potential to solve these problems, Dr. Stefan Gerber and his associates said in a poster presentation at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Of 232 women presenting for vaginal birth at University Center Hospital, Lausanne (Switzerland) in an 8-month span, 19% (44) had positive GBS cultures at 35–37 weeks, 65% (152) had negative cultures, and 16% (36) had unknown GBS status at the time of delivery. Per the guidelines, 34% of the women (80) received prophylactic antibiotics during labor, but treatment was completed (at least two doses or at least 4 hours of intravenous antibiotics) in just 21% (17).

Lower vaginal and rectal swabs were obtained in all the women in the delivery room, and GBS detection was performed by both culture and RT-PCR, using Cepheid's Xpert GBS test, which runs on the GeneXpert System, a fully automated molecular testing system. Results were available in 75 minutes (compared with 2 days for cultures). By RT-PCR, just 15% (35) of the women were GBS positive, suggesting that 19% (45) of the women had received unnecessary prophylaxis, Dr. Gerber and his associates at the hospital reported.

Of the 35 PCR-positive women, 7 had negative cultures—presumably because they were only lightly colonized—and therefore would not have received antibiotics under the antenatal screening guidelines.

All 35 PCR-positive women received prophylaxis but just 7 (22%) completed it.

Since further work-up of the newborn is required when the mother doesn't receive complete antimicrobial prophylaxis, RT-PCR could potentially represent a significant cost saving. An ongoing study is investigating the cost-effectiveness of the approach, Dr. Gerber said in an interview.

Moreover, unlike cultures, which must be performed by technicians, the RT-PCR was performed by the midwives themselves. The technology could also be used by labor and delivery nurses or obstetricians, Dr. Gerber said in an interview.

Dr. Gerber stated that he had no financial ties to Cepheid. The company provided the equipment for the study, but no additional funding.

Most insurance plans cover the Xpert GBS test, which was approved by the Food and Drug Administration in 2006. It is categorized as “moderate complexity” by the FDA, meaning that non-laboratory health care professionals such as physicians and nurses can run the test, a Cepheid spokesman said in an interview.

The spokesman declined to say how many Xpert GBS tests are currently in use, but he did say that as of the last quarter of 2008, there were 848 GeneExpert Systems installed worldwide, capable of running the GBS test.

WASHINGTON — Use of real-time polymerase chain reaction to screen for group B Streptococcus in the delivery room could reduce the use of intrapartum antibiotics by more than half, compared with antenatal screening alone, the findings of a single-center study of 232 pregnant women suggest.

Current CDC guidelines call for vaginal and rectal swabs at 35–37 weeks' gestation and for all women with cultures positive for group B Streptococcus (GBS) to receive intravenous antibiotic prophylaxis during labor and delivery (MMWR 2002;51[RR11]:1–22). This practice has greatly reduced the rates of neonatal sepsis in the United States, but it is imperfect. Women whose status is unknown at the time of labor also must receive prophylaxis, resulting in overtreatment, while cultures can fail to detect GBS in women who are lightly colonized, resulting in failure to treat.

Rapid testing at the time of delivery using real-time polymerase chain reaction (RT-PCR) has the potential to solve these problems, Dr. Stefan Gerber and his associates said in a poster presentation at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Of 232 women presenting for vaginal birth at University Center Hospital, Lausanne (Switzerland) in an 8-month span, 19% (44) had positive GBS cultures at 35–37 weeks, 65% (152) had negative cultures, and 16% (36) had unknown GBS status at the time of delivery. Per the guidelines, 34% of the women (80) received prophylactic antibiotics during labor, but treatment was completed (at least two doses or at least 4 hours of intravenous antibiotics) in just 21% (17).

Lower vaginal and rectal swabs were obtained in all the women in the delivery room, and GBS detection was performed by both culture and RT-PCR, using Cepheid's Xpert GBS test, which runs on the GeneXpert System, a fully automated molecular testing system. Results were available in 75 minutes (compared with 2 days for cultures). By RT-PCR, just 15% (35) of the women were GBS positive, suggesting that 19% (45) of the women had received unnecessary prophylaxis, Dr. Gerber and his associates at the hospital reported.

Of the 35 PCR-positive women, 7 had negative cultures—presumably because they were only lightly colonized—and therefore would not have received antibiotics under the antenatal screening guidelines.

All 35 PCR-positive women received prophylaxis but just 7 (22%) completed it.

Since further work-up of the newborn is required when the mother doesn't receive complete antimicrobial prophylaxis, RT-PCR could potentially represent a significant cost saving. An ongoing study is investigating the cost-effectiveness of the approach, Dr. Gerber said in an interview.

Moreover, unlike cultures, which must be performed by technicians, the RT-PCR was performed by the midwives themselves. The technology could also be used by labor and delivery nurses or obstetricians, Dr. Gerber said in an interview.

Dr. Gerber stated that he had no financial ties to Cepheid. The company provided the equipment for the study, but no additional funding.

Most insurance plans cover the Xpert GBS test, which was approved by the Food and Drug Administration in 2006. It is categorized as “moderate complexity” by the FDA, meaning that non-laboratory health care professionals such as physicians and nurses can run the test, a Cepheid spokesman said in an interview.

The spokesman declined to say how many Xpert GBS tests are currently in use, but he did say that as of the last quarter of 2008, there were 848 GeneExpert Systems installed worldwide, capable of running the GBS test.

WASHINGTON — Use of real-time polymerase chain reaction to screen for group B Streptococcus in the delivery room could reduce the use of intrapartum antibiotics by more than half, compared with antenatal screening alone, the findings of a single-center study of 232 pregnant women suggest.

Current CDC guidelines call for vaginal and rectal swabs at 35–37 weeks' gestation and for all women with cultures positive for group B Streptococcus (GBS) to receive intravenous antibiotic prophylaxis during labor and delivery (MMWR 2002;51[RR11]:1–22). This practice has greatly reduced the rates of neonatal sepsis in the United States, but it is imperfect. Women whose status is unknown at the time of labor also must receive prophylaxis, resulting in overtreatment, while cultures can fail to detect GBS in women who are lightly colonized, resulting in failure to treat.

Rapid testing at the time of delivery using real-time polymerase chain reaction (RT-PCR) has the potential to solve these problems, Dr. Stefan Gerber and his associates said in a poster presentation at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

Of 232 women presenting for vaginal birth at University Center Hospital, Lausanne (Switzerland) in an 8-month span, 19% (44) had positive GBS cultures at 35–37 weeks, 65% (152) had negative cultures, and 16% (36) had unknown GBS status at the time of delivery. Per the guidelines, 34% of the women (80) received prophylactic antibiotics during labor, but treatment was completed (at least two doses or at least 4 hours of intravenous antibiotics) in just 21% (17).

Lower vaginal and rectal swabs were obtained in all the women in the delivery room, and GBS detection was performed by both culture and RT-PCR, using Cepheid's Xpert GBS test, which runs on the GeneXpert System, a fully automated molecular testing system. Results were available in 75 minutes (compared with 2 days for cultures). By RT-PCR, just 15% (35) of the women were GBS positive, suggesting that 19% (45) of the women had received unnecessary prophylaxis, Dr. Gerber and his associates at the hospital reported.

Of the 35 PCR-positive women, 7 had negative cultures—presumably because they were only lightly colonized—and therefore would not have received antibiotics under the antenatal screening guidelines.

All 35 PCR-positive women received prophylaxis but just 7 (22%) completed it.

Since further work-up of the newborn is required when the mother doesn't receive complete antimicrobial prophylaxis, RT-PCR could potentially represent a significant cost saving. An ongoing study is investigating the cost-effectiveness of the approach, Dr. Gerber said in an interview.

Moreover, unlike cultures, which must be performed by technicians, the RT-PCR was performed by the midwives themselves. The technology could also be used by labor and delivery nurses or obstetricians, Dr. Gerber said in an interview.

Dr. Gerber stated that he had no financial ties to Cepheid. The company provided the equipment for the study, but no additional funding.

Most insurance plans cover the Xpert GBS test, which was approved by the Food and Drug Administration in 2006. It is categorized as “moderate complexity” by the FDA, meaning that non-laboratory health care professionals such as physicians and nurses can run the test, a Cepheid spokesman said in an interview.

The spokesman declined to say how many Xpert GBS tests are currently in use, but he did say that as of the last quarter of 2008, there were 848 GeneExpert Systems installed worldwide, capable of running the GBS test.

ROME — Treatment of polycystic ovary syndrome with exenatide plus metformin was more effective than either medication alone in improving menstrual cycle frequency and in ameliorating hormonal and metabolic derangements, a study has found.

The study findings were presented at the annual meeting of the European Association for the Study of Diabetes by Dr. Ted Okerson of Amylin Pharmaceuticals Inc. on behalf of the scheduled presenter, Dr. Rajat Bhushan of the Metabolic Center of Louisiana Research Foundation, Baton Rouge, who was unable to attend the meeting because of a hurricane. Dr. Karen Elkind-Hirsch of the same institution was the principal author of the study, which was published in the Journal of Clinical Endocrinology and Metabolism (2008;93:2670-8).

Metformin has been shown to reduce insulin resistance and androgen levels while increasing ovulation in women with polycystic ovary syndrome (PCOS). However, metformin does not alter insulin secretion. Exenatide (Byetta), used to treat type 2 diabetes, has been shown to restore first- and second-phase insulin secretion, which is attenuated in women with PCOS, as well as promote weight loss, thereby potentially further improving insulin sensitivity, Dr. Okerson said.

An open-label, prospective 24-week pilot study of 60 obese oligo-ovulatory women with PCOS was funded by a grant from Amylin Pharmaceuticals and Eli Lilly & Co. In the study, 40 white and 20 African American women with PCOS were randomized to receive either 1,000 mg metformin twice daily, exenatide 10 mcg twice daily, or a combination of the two, for 24 weeks. All were aged 18-40, with a body mass index above 27 kg/m

Menstrual cycle frequency, the primary study end point, was significantly increased in all treatment groups at 24 weeks and to a significantly greater degree with the combination, compared with metformin alone. The proportion of normal cycles in the group increased from a mean of 22% at baseline to 57% with exenatide alone, from 21% to 49% with metformin alone, and from 29% to 83% with both drugs. Ovulatory rates also improved with all three regimens, but significantly more so with the combination. Ovulation occurred in 12 of the combination patients (86%), compared with 7 who received exenatide alone (50%) and 4 (29%) with metformin alone.

Body weight changes were significant in both groups receiving exenatide, but not in those receiving metformin alone. At 24 weeks, mean weight loss was 6 kg in the combination group and 3.2 kg with exenatide alone, vs. just 1.6 kg with metformin alone. Similar reductions were seen in body mass index. Abdominal girth diminished slightly in both exenatide groups but increased slightly between weeks 12 and 24 among the metformin-alone patients, Dr. Okerson reported.

Total testosterone was significantly decreased from baseline in all treatment groups, by 10.2 ng/dL with exenatide alone, 3.6 ng/dL with metformin alone, and 18.4 ng/dL with the combination. The free androgen index was significantly more reduced with the combination, compared with metformin alone but not compared with exenatide alone. Levels of sex hormone-binding globulin were increased, but not significantly, with all treatments, while levels of dehydroepiandrosterone sulfate and thyroid-stimulating hormone were not significantly altered in any group.

Insulin sensitivity improved significantly with all treatments, and was significantly higher in the combination group than in the metformin group at 24 weeks. After therapy, the calculated mean insulin secretion sensitivity index was 516 with combination therapy, 395 with exenatide alone, and 232 with metformin alone. Total cholesterol and triglycerides decreased significantly with combination therapy vs. metformin monotherapy, which did not consistently improve those levels, while HDL and LDL cholesterol levels did not change significantly with treatment. Adiponectin levels increased significantly with all treatments, while other inflammatory markers did not change.

ROME — Treatment of polycystic ovary syndrome with exenatide plus metformin was more effective than either medication alone in improving menstrual cycle frequency and in ameliorating hormonal and metabolic derangements, a study has found.

The study findings were presented at the annual meeting of the European Association for the Study of Diabetes by Dr. Ted Okerson of Amylin Pharmaceuticals Inc. on behalf of the scheduled presenter, Dr. Rajat Bhushan of the Metabolic Center of Louisiana Research Foundation, Baton Rouge, who was unable to attend the meeting because of a hurricane. Dr. Karen Elkind-Hirsch of the same institution was the principal author of the study, which was published in the Journal of Clinical Endocrinology and Metabolism (2008;93:2670-8).

Metformin has been shown to reduce insulin resistance and androgen levels while increasing ovulation in women with polycystic ovary syndrome (PCOS). However, metformin does not alter insulin secretion. Exenatide (Byetta), used to treat type 2 diabetes, has been shown to restore first- and second-phase insulin secretion, which is attenuated in women with PCOS, as well as promote weight loss, thereby potentially further improving insulin sensitivity, Dr. Okerson said.

An open-label, prospective 24-week pilot study of 60 obese oligo-ovulatory women with PCOS was funded by a grant from Amylin Pharmaceuticals and Eli Lilly & Co. In the study, 40 white and 20 African American women with PCOS were randomized to receive either 1,000 mg metformin twice daily, exenatide 10 mcg twice daily, or a combination of the two, for 24 weeks. All were aged 18-40, with a body mass index above 27 kg/m

Menstrual cycle frequency, the primary study end point, was significantly increased in all treatment groups at 24 weeks and to a significantly greater degree with the combination, compared with metformin alone. The proportion of normal cycles in the group increased from a mean of 22% at baseline to 57% with exenatide alone, from 21% to 49% with metformin alone, and from 29% to 83% with both drugs. Ovulatory rates also improved with all three regimens, but significantly more so with the combination. Ovulation occurred in 12 of the combination patients (86%), compared with 7 who received exenatide alone (50%) and 4 (29%) with metformin alone.

Body weight changes were significant in both groups receiving exenatide, but not in those receiving metformin alone. At 24 weeks, mean weight loss was 6 kg in the combination group and 3.2 kg with exenatide alone, vs. just 1.6 kg with metformin alone. Similar reductions were seen in body mass index. Abdominal girth diminished slightly in both exenatide groups but increased slightly between weeks 12 and 24 among the metformin-alone patients, Dr. Okerson reported.

Total testosterone was significantly decreased from baseline in all treatment groups, by 10.2 ng/dL with exenatide alone, 3.6 ng/dL with metformin alone, and 18.4 ng/dL with the combination. The free androgen index was significantly more reduced with the combination, compared with metformin alone but not compared with exenatide alone. Levels of sex hormone-binding globulin were increased, but not significantly, with all treatments, while levels of dehydroepiandrosterone sulfate and thyroid-stimulating hormone were not significantly altered in any group.

Insulin sensitivity improved significantly with all treatments, and was significantly higher in the combination group than in the metformin group at 24 weeks. After therapy, the calculated mean insulin secretion sensitivity index was 516 with combination therapy, 395 with exenatide alone, and 232 with metformin alone. Total cholesterol and triglycerides decreased significantly with combination therapy vs. metformin monotherapy, which did not consistently improve those levels, while HDL and LDL cholesterol levels did not change significantly with treatment. Adiponectin levels increased significantly with all treatments, while other inflammatory markers did not change.

ROME — Treatment of polycystic ovary syndrome with exenatide plus metformin was more effective than either medication alone in improving menstrual cycle frequency and in ameliorating hormonal and metabolic derangements, a study has found.

The study findings were presented at the annual meeting of the European Association for the Study of Diabetes by Dr. Ted Okerson of Amylin Pharmaceuticals Inc. on behalf of the scheduled presenter, Dr. Rajat Bhushan of the Metabolic Center of Louisiana Research Foundation, Baton Rouge, who was unable to attend the meeting because of a hurricane. Dr. Karen Elkind-Hirsch of the same institution was the principal author of the study, which was published in the Journal of Clinical Endocrinology and Metabolism (2008;93:2670-8).

Metformin has been shown to reduce insulin resistance and androgen levels while increasing ovulation in women with polycystic ovary syndrome (PCOS). However, metformin does not alter insulin secretion. Exenatide (Byetta), used to treat type 2 diabetes, has been shown to restore first- and second-phase insulin secretion, which is attenuated in women with PCOS, as well as promote weight loss, thereby potentially further improving insulin sensitivity, Dr. Okerson said.

An open-label, prospective 24-week pilot study of 60 obese oligo-ovulatory women with PCOS was funded by a grant from Amylin Pharmaceuticals and Eli Lilly & Co. In the study, 40 white and 20 African American women with PCOS were randomized to receive either 1,000 mg metformin twice daily, exenatide 10 mcg twice daily, or a combination of the two, for 24 weeks. All were aged 18-40, with a body mass index above 27 kg/m

Menstrual cycle frequency, the primary study end point, was significantly increased in all treatment groups at 24 weeks and to a significantly greater degree with the combination, compared with metformin alone. The proportion of normal cycles in the group increased from a mean of 22% at baseline to 57% with exenatide alone, from 21% to 49% with metformin alone, and from 29% to 83% with both drugs. Ovulatory rates also improved with all three regimens, but significantly more so with the combination. Ovulation occurred in 12 of the combination patients (86%), compared with 7 who received exenatide alone (50%) and 4 (29%) with metformin alone.

Body weight changes were significant in both groups receiving exenatide, but not in those receiving metformin alone. At 24 weeks, mean weight loss was 6 kg in the combination group and 3.2 kg with exenatide alone, vs. just 1.6 kg with metformin alone. Similar reductions were seen in body mass index. Abdominal girth diminished slightly in both exenatide groups but increased slightly between weeks 12 and 24 among the metformin-alone patients, Dr. Okerson reported.

Total testosterone was significantly decreased from baseline in all treatment groups, by 10.2 ng/dL with exenatide alone, 3.6 ng/dL with metformin alone, and 18.4 ng/dL with the combination. The free androgen index was significantly more reduced with the combination, compared with metformin alone but not compared with exenatide alone. Levels of sex hormone-binding globulin were increased, but not significantly, with all treatments, while levels of dehydroepiandrosterone sulfate and thyroid-stimulating hormone were not significantly altered in any group.

Insulin sensitivity improved significantly with all treatments, and was significantly higher in the combination group than in the metformin group at 24 weeks. After therapy, the calculated mean insulin secretion sensitivity index was 516 with combination therapy, 395 with exenatide alone, and 232 with metformin alone. Total cholesterol and triglycerides decreased significantly with combination therapy vs. metformin monotherapy, which did not consistently improve those levels, while HDL and LDL cholesterol levels did not change significantly with treatment. Adiponectin levels increased significantly with all treatments, while other inflammatory markers did not change.

Eye involvement is a core element of new recommendations on the management of Behçet disease from the European League Against Rheumatism.

The recommendations were developed by a EULAR task force of the Standing Committee for Clinical Affairs, which included nine rheumatologists, three ophthalmologists, one internist, one dermatologist, and one neurologist. Members were from six European countries plus Tunisia and Korea. A patient representative also participated. The lead author was Dr. Gulen Hatemi, of the division of rheumatology at the Cerrahpasa Medical School, Istanbul (Turkey) University.

Among the recommendations:

▸ Any patient with BD and inflammatory eye disease affecting the posterior segment should be on a treatment regime that includes azathioprine and systemic corticosteroids. Azathioprine is widely accepted as the initial agent for ocular involvement. Local and systemic corticosteroids rapidly suppress the inflammation but potential side effects, including cataracts and glaucoma, cause concern.

▸ Patients with severe eye disease, defined as more than a drop of more than two lines in visual acuity on a 10/10 scale and/or retinal disease (retinal vasculitis or macular involvement) should receive either cyclosporine A or infliximab in combination with azathioprine and corticosteroids. Alternatively, interferon-α (INF-α) with or without corticosteroids could be used.

Each of the nine recommendations was voted on both by the group as a whole and by individual members who were experts in each field. While recommendations related to the eye, skin/mucosa, and arthritis were mainly evidence based, those pertaining to vascular disease, neurologic, and gastrointestinal involvement were based largely on expert opinion and uncontrolled evidence from open trials and observational studies.

“The need for further properly designed controlled clinical trials is apparent,” Dr. Hatemi wrote in the December issue of Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2008;67:1656–62).

Further recommendations held:

▸ There is no firm evidence to guide the management of major vessel disease in BD. For acute deep vein thrombosis in BD, agents such as corticosteroids, azathioprine, cyclophosphamide, or cyclosporine A are recommended. Cyclophosphamide and corticosteroids are recommended for the management of pulmonary and peripheral arterial aneurysms.

▸ Similarly, there are no controlled data—and no evidence of benefit from uncontrolled experience—with anticoagulants, antiplatelet, or antifibrinolytic agents in the management of deep vein thrombosis or for the use of anticoagulation for the arterial lesions of BD.

▸ There is no evidence-based treatment that can be recommended for the management of gastrointestinal involvement of BD. Agents such as sulfasalazine, corticosteroids, azathioprine, tumor necrosis factor-α (TNF-α) antagonists, and thalidomide should be tried first before moving to surgery, except in emergencies.

▸ Arthritis can be managed with colchicine in most BD patients.

▸ There are no controlled data to guide the management of central nervous system involvement in BD. For parenchymal involvement, agents to be tried may include corticosteroids, INF-α, azathioprine, cyclophosphamide, methotrexate, and TNF-α antagonists. For dural sinus thrombosis, corticosteroids are recommended.

▸ Cyclosporine A should not be used in BD patients with central nervous system involvement unless necessary for intraocular inflammation.

▸ The decision to treat skin and mucosa involvement will depend on the perceived severity by the physician and the patient. Mucocutaneous involvement should be treated according to the dominant or codominant lesions present:

Topical measures, such as local corticosteroids, should be the first line of treatment for isolated oral and genital ulcers.

Acne-like lesions are usually of cosmetic concern only. Thus, topical measures as used in acne vulgaris are sufficient.

Colchicine should be preferred when the dominant lesion is erythema nodosum. Leg ulcers in BD might have different causes. Azathioprine, INF-α and TNF-α antagonists may be considered in resistant cases.

The work was financially supported by EULAR, with no competing interests.

Eye involvement is a core element of new recommendations on the management of Behçet disease from the European League Against Rheumatism.

The recommendations were developed by a EULAR task force of the Standing Committee for Clinical Affairs, which included nine rheumatologists, three ophthalmologists, one internist, one dermatologist, and one neurologist. Members were from six European countries plus Tunisia and Korea. A patient representative also participated. The lead author was Dr. Gulen Hatemi, of the division of rheumatology at the Cerrahpasa Medical School, Istanbul (Turkey) University.

Among the recommendations:

▸ Any patient with BD and inflammatory eye disease affecting the posterior segment should be on a treatment regime that includes azathioprine and systemic corticosteroids. Azathioprine is widely accepted as the initial agent for ocular involvement. Local and systemic corticosteroids rapidly suppress the inflammation but potential side effects, including cataracts and glaucoma, cause concern.

▸ Patients with severe eye disease, defined as more than a drop of more than two lines in visual acuity on a 10/10 scale and/or retinal disease (retinal vasculitis or macular involvement) should receive either cyclosporine A or infliximab in combination with azathioprine and corticosteroids. Alternatively, interferon-α (INF-α) with or without corticosteroids could be used.

Each of the nine recommendations was voted on both by the group as a whole and by individual members who were experts in each field. While recommendations related to the eye, skin/mucosa, and arthritis were mainly evidence based, those pertaining to vascular disease, neurologic, and gastrointestinal involvement were based largely on expert opinion and uncontrolled evidence from open trials and observational studies.

“The need for further properly designed controlled clinical trials is apparent,” Dr. Hatemi wrote in the December issue of Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2008;67:1656–62).

Further recommendations held:

▸ There is no firm evidence to guide the management of major vessel disease in BD. For acute deep vein thrombosis in BD, agents such as corticosteroids, azathioprine, cyclophosphamide, or cyclosporine A are recommended. Cyclophosphamide and corticosteroids are recommended for the management of pulmonary and peripheral arterial aneurysms.

▸ Similarly, there are no controlled data—and no evidence of benefit from uncontrolled experience—with anticoagulants, antiplatelet, or antifibrinolytic agents in the management of deep vein thrombosis or for the use of anticoagulation for the arterial lesions of BD.

▸ There is no evidence-based treatment that can be recommended for the management of gastrointestinal involvement of BD. Agents such as sulfasalazine, corticosteroids, azathioprine, tumor necrosis factor-α (TNF-α) antagonists, and thalidomide should be tried first before moving to surgery, except in emergencies.

▸ Arthritis can be managed with colchicine in most BD patients.

▸ There are no controlled data to guide the management of central nervous system involvement in BD. For parenchymal involvement, agents to be tried may include corticosteroids, INF-α, azathioprine, cyclophosphamide, methotrexate, and TNF-α antagonists. For dural sinus thrombosis, corticosteroids are recommended.

▸ Cyclosporine A should not be used in BD patients with central nervous system involvement unless necessary for intraocular inflammation.

▸ The decision to treat skin and mucosa involvement will depend on the perceived severity by the physician and the patient. Mucocutaneous involvement should be treated according to the dominant or codominant lesions present:

Topical measures, such as local corticosteroids, should be the first line of treatment for isolated oral and genital ulcers.

Acne-like lesions are usually of cosmetic concern only. Thus, topical measures as used in acne vulgaris are sufficient.

Colchicine should be preferred when the dominant lesion is erythema nodosum. Leg ulcers in BD might have different causes. Azathioprine, INF-α and TNF-α antagonists may be considered in resistant cases.

The work was financially supported by EULAR, with no competing interests.

Eye involvement is a core element of new recommendations on the management of Behçet disease from the European League Against Rheumatism.

The recommendations were developed by a EULAR task force of the Standing Committee for Clinical Affairs, which included nine rheumatologists, three ophthalmologists, one internist, one dermatologist, and one neurologist. Members were from six European countries plus Tunisia and Korea. A patient representative also participated. The lead author was Dr. Gulen Hatemi, of the division of rheumatology at the Cerrahpasa Medical School, Istanbul (Turkey) University.

Among the recommendations:

▸ Any patient with BD and inflammatory eye disease affecting the posterior segment should be on a treatment regime that includes azathioprine and systemic corticosteroids. Azathioprine is widely accepted as the initial agent for ocular involvement. Local and systemic corticosteroids rapidly suppress the inflammation but potential side effects, including cataracts and glaucoma, cause concern.

▸ Patients with severe eye disease, defined as more than a drop of more than two lines in visual acuity on a 10/10 scale and/or retinal disease (retinal vasculitis or macular involvement) should receive either cyclosporine A or infliximab in combination with azathioprine and corticosteroids. Alternatively, interferon-α (INF-α) with or without corticosteroids could be used.

Each of the nine recommendations was voted on both by the group as a whole and by individual members who were experts in each field. While recommendations related to the eye, skin/mucosa, and arthritis were mainly evidence based, those pertaining to vascular disease, neurologic, and gastrointestinal involvement were based largely on expert opinion and uncontrolled evidence from open trials and observational studies.

“The need for further properly designed controlled clinical trials is apparent,” Dr. Hatemi wrote in the December issue of Annals of the Rheumatic Diseases (Ann. Rheum. Dis. 2008;67:1656–62).

Further recommendations held:

▸ There is no firm evidence to guide the management of major vessel disease in BD. For acute deep vein thrombosis in BD, agents such as corticosteroids, azathioprine, cyclophosphamide, or cyclosporine A are recommended. Cyclophosphamide and corticosteroids are recommended for the management of pulmonary and peripheral arterial aneurysms.

▸ Similarly, there are no controlled data—and no evidence of benefit from uncontrolled experience—with anticoagulants, antiplatelet, or antifibrinolytic agents in the management of deep vein thrombosis or for the use of anticoagulation for the arterial lesions of BD.

▸ There is no evidence-based treatment that can be recommended for the management of gastrointestinal involvement of BD. Agents such as sulfasalazine, corticosteroids, azathioprine, tumor necrosis factor-α (TNF-α) antagonists, and thalidomide should be tried first before moving to surgery, except in emergencies.

▸ Arthritis can be managed with colchicine in most BD patients.

▸ There are no controlled data to guide the management of central nervous system involvement in BD. For parenchymal involvement, agents to be tried may include corticosteroids, INF-α, azathioprine, cyclophosphamide, methotrexate, and TNF-α antagonists. For dural sinus thrombosis, corticosteroids are recommended.

▸ Cyclosporine A should not be used in BD patients with central nervous system involvement unless necessary for intraocular inflammation.

▸ The decision to treat skin and mucosa involvement will depend on the perceived severity by the physician and the patient. Mucocutaneous involvement should be treated according to the dominant or codominant lesions present:

Topical measures, such as local corticosteroids, should be the first line of treatment for isolated oral and genital ulcers.

Acne-like lesions are usually of cosmetic concern only. Thus, topical measures as used in acne vulgaris are sufficient.

Colchicine should be preferred when the dominant lesion is erythema nodosum. Leg ulcers in BD might have different causes. Azathioprine, INF-α and TNF-α antagonists may be considered in resistant cases.

The work was financially supported by EULAR, with no competing interests.

WASHINGTON — What is a safe, drug-free, and effective method for treating obesity and its comorbidities in patients with diabetes or those who are at risk for it? Tell them to try prepackaged, nutritionally balanced, and calorie-controlled meal replacements.

“Meal replacements are considered state-of-the-art dietary treatment for overweight and obesity. They produce double the weight loss of traditional weight loss plans and they improve long-term maintenance,” Anne Daly said at the annual meeting of the American Association of Diabetes Educators.

The benefits extend beyond weight loss, with data showing improved metabolic outcomes in patients with diabetes and other cardiovascular risk factors, said Ms. Daly, a certified diabetes educator and registered dietitian who is cofounder of the Springfield (Ill.) Diabetes and Endocrine Center.

Meal replacements have been used in several major clinical trials sponsored by the National Institutes of Health, including the Diabetes Prevention Program (DPP), Action for Diabetes in Health (Look AHEAD), and Reach Out to Enhance Wellness in Older Survivors (RENEW). Meal replacement is also mentioned in the 2007 Nutrition Position Paper of the American Diabetes Association, and is supported by the American Dietetic Association's Evidence Analysis Library, which cites eight randomized clinical trials in which patients who replaced between one and three meals a day lost 2.5–3.0 kg more than those who followed traditional low-calorie diets, about 7% from baseline.

A “meal replacement” is any prepackaged food product—such as shakes, soups, puddings, entrees, or snack bars—that is portion controlled, calorie controlled, and high nutrition. They are used to replace an entire meal or snack with the aim of reducing calorie intake and promoting weight loss. Typically, they contain about 150–300 calories, 10–45 g carbohydrate, 10–20 g protein, and 3–9 g fat per serving. With certain meal plans, patients are encouraged to supplement the packaged foods with fresh fruits and vegetables (within prescribed carbohydrate limits for diabetic patients).

Ms. Daly's facility has had a 20-year relationship with a Boston-based company called Health Management Resources (HMR), which provides weight-loss management program services in addition to shelf-stable packaged foods that patients can buy on-site (www.hmrprogram.com

However, she said, “This is not a sales pitch for HMR. Everything I say is applicable to anything out there that is a meal replacement. Try them all, taste them, and see which ones you and your patients like.” Examples of well-known meal-replacement brands available in stores include Lean Cuisine, Healthy Choice, and Slimfast, while commercial weight-loss programs that sell packaged foods, such as Jenny Craig and Medifast, also fall under the heading.

Meal replacements provide a simple way to structure meal planning, with no calorie “mysteries.” They achieve both portion control and predictable weight loss, while decreasing “decision anxiety” among patients who are uncertain about what they should and shouldn't eat. “Patients do better when you tell them what to do, rather than what not to do,” Ms. Daly said.

Full meal replacement can be less costly for patients than what they're already spending on food. The U.S. Department of Agriculture estimates that the average American spends about $101 per week on food, while the HMR regimens range in cost from $73 to $92 per week.

And that's not counting the savings in medical costs. In a 12-week study of 75 patients with type 2 diabetes treated with oral agents only (of whom 57 completed the study), those randomized to receive one of two meal-replacement regimens lost more weight (6.4% and 6.7% vs. 4.9% of total body weight) than did those who followed a traditional exchange diet plan. Fasting glucose, total cholesterol, and LDL cholesterol levels were all significantly reduced among the meal-replacement patients as well (Obes. Res. 2001;9 [suppl. 4]:341S-7).

In a more recent study of 118 patients who each lost more than 100 pounds using meal replacements and increased physical activity, medications for comorbidities were discontinued in 66% at a cost savings of $100/month per patient. The patients, whose weight loss averaged 61 kg in 44 weeks, maintained a 30-kg weight loss at 5 years by continuing to replace at least one meal and one snack per day, while they were allowed unlimited fruits and vegetables (Am. J. Clin. Nutr. 2007;86:301–7).

Data from HMR on 1,000 patients show similar results. Over a 2-year period, patients lost an average of 43 pounds, with a 14% reduction in total cholesterol/HDL cholesterol level, 25% in triglycerides, and 10% in fasting glucose. Systolic blood pressures dropped an average of 8 mm Hg, and diastolic by 6 mm Hg. Approximately 21% of patients came off at least one medication.

Meal replacements provide a simple way to structure meal planning, with no calorie 'mysteries.' MS. DALY

WASHINGTON — What is a safe, drug-free, and effective method for treating obesity and its comorbidities in patients with diabetes or those who are at risk for it? Tell them to try prepackaged, nutritionally balanced, and calorie-controlled meal replacements.

“Meal replacements are considered state-of-the-art dietary treatment for overweight and obesity. They produce double the weight loss of traditional weight loss plans and they improve long-term maintenance,” Anne Daly said at the annual meeting of the American Association of Diabetes Educators.

The benefits extend beyond weight loss, with data showing improved metabolic outcomes in patients with diabetes and other cardiovascular risk factors, said Ms. Daly, a certified diabetes educator and registered dietitian who is cofounder of the Springfield (Ill.) Diabetes and Endocrine Center.

Meal replacements have been used in several major clinical trials sponsored by the National Institutes of Health, including the Diabetes Prevention Program (DPP), Action for Diabetes in Health (Look AHEAD), and Reach Out to Enhance Wellness in Older Survivors (RENEW). Meal replacement is also mentioned in the 2007 Nutrition Position Paper of the American Diabetes Association, and is supported by the American Dietetic Association's Evidence Analysis Library, which cites eight randomized clinical trials in which patients who replaced between one and three meals a day lost 2.5–3.0 kg more than those who followed traditional low-calorie diets, about 7% from baseline.

A “meal replacement” is any prepackaged food product—such as shakes, soups, puddings, entrees, or snack bars—that is portion controlled, calorie controlled, and high nutrition. They are used to replace an entire meal or snack with the aim of reducing calorie intake and promoting weight loss. Typically, they contain about 150–300 calories, 10–45 g carbohydrate, 10–20 g protein, and 3–9 g fat per serving. With certain meal plans, patients are encouraged to supplement the packaged foods with fresh fruits and vegetables (within prescribed carbohydrate limits for diabetic patients).

Ms. Daly's facility has had a 20-year relationship with a Boston-based company called Health Management Resources (HMR), which provides weight-loss management program services in addition to shelf-stable packaged foods that patients can buy on-site (www.hmrprogram.com

However, she said, “This is not a sales pitch for HMR. Everything I say is applicable to anything out there that is a meal replacement. Try them all, taste them, and see which ones you and your patients like.” Examples of well-known meal-replacement brands available in stores include Lean Cuisine, Healthy Choice, and Slimfast, while commercial weight-loss programs that sell packaged foods, such as Jenny Craig and Medifast, also fall under the heading.

Meal replacements provide a simple way to structure meal planning, with no calorie “mysteries.” They achieve both portion control and predictable weight loss, while decreasing “decision anxiety” among patients who are uncertain about what they should and shouldn't eat. “Patients do better when you tell them what to do, rather than what not to do,” Ms. Daly said.

Full meal replacement can be less costly for patients than what they're already spending on food. The U.S. Department of Agriculture estimates that the average American spends about $101 per week on food, while the HMR regimens range in cost from $73 to $92 per week.

And that's not counting the savings in medical costs. In a 12-week study of 75 patients with type 2 diabetes treated with oral agents only (of whom 57 completed the study), those randomized to receive one of two meal-replacement regimens lost more weight (6.4% and 6.7% vs. 4.9% of total body weight) than did those who followed a traditional exchange diet plan. Fasting glucose, total cholesterol, and LDL cholesterol levels were all significantly reduced among the meal-replacement patients as well (Obes. Res. 2001;9 [suppl. 4]:341S-7).

In a more recent study of 118 patients who each lost more than 100 pounds using meal replacements and increased physical activity, medications for comorbidities were discontinued in 66% at a cost savings of $100/month per patient. The patients, whose weight loss averaged 61 kg in 44 weeks, maintained a 30-kg weight loss at 5 years by continuing to replace at least one meal and one snack per day, while they were allowed unlimited fruits and vegetables (Am. J. Clin. Nutr. 2007;86:301–7).

Data from HMR on 1,000 patients show similar results. Over a 2-year period, patients lost an average of 43 pounds, with a 14% reduction in total cholesterol/HDL cholesterol level, 25% in triglycerides, and 10% in fasting glucose. Systolic blood pressures dropped an average of 8 mm Hg, and diastolic by 6 mm Hg. Approximately 21% of patients came off at least one medication.

Meal replacements provide a simple way to structure meal planning, with no calorie 'mysteries.' MS. DALY

WASHINGTON — What is a safe, drug-free, and effective method for treating obesity and its comorbidities in patients with diabetes or those who are at risk for it? Tell them to try prepackaged, nutritionally balanced, and calorie-controlled meal replacements.

“Meal replacements are considered state-of-the-art dietary treatment for overweight and obesity. They produce double the weight loss of traditional weight loss plans and they improve long-term maintenance,” Anne Daly said at the annual meeting of the American Association of Diabetes Educators.

The benefits extend beyond weight loss, with data showing improved metabolic outcomes in patients with diabetes and other cardiovascular risk factors, said Ms. Daly, a certified diabetes educator and registered dietitian who is cofounder of the Springfield (Ill.) Diabetes and Endocrine Center.

Meal replacements have been used in several major clinical trials sponsored by the National Institutes of Health, including the Diabetes Prevention Program (DPP), Action for Diabetes in Health (Look AHEAD), and Reach Out to Enhance Wellness in Older Survivors (RENEW). Meal replacement is also mentioned in the 2007 Nutrition Position Paper of the American Diabetes Association, and is supported by the American Dietetic Association's Evidence Analysis Library, which cites eight randomized clinical trials in which patients who replaced between one and three meals a day lost 2.5–3.0 kg more than those who followed traditional low-calorie diets, about 7% from baseline.

A “meal replacement” is any prepackaged food product—such as shakes, soups, puddings, entrees, or snack bars—that is portion controlled, calorie controlled, and high nutrition. They are used to replace an entire meal or snack with the aim of reducing calorie intake and promoting weight loss. Typically, they contain about 150–300 calories, 10–45 g carbohydrate, 10–20 g protein, and 3–9 g fat per serving. With certain meal plans, patients are encouraged to supplement the packaged foods with fresh fruits and vegetables (within prescribed carbohydrate limits for diabetic patients).

Ms. Daly's facility has had a 20-year relationship with a Boston-based company called Health Management Resources (HMR), which provides weight-loss management program services in addition to shelf-stable packaged foods that patients can buy on-site (www.hmrprogram.com

However, she said, “This is not a sales pitch for HMR. Everything I say is applicable to anything out there that is a meal replacement. Try them all, taste them, and see which ones you and your patients like.” Examples of well-known meal-replacement brands available in stores include Lean Cuisine, Healthy Choice, and Slimfast, while commercial weight-loss programs that sell packaged foods, such as Jenny Craig and Medifast, also fall under the heading.

Meal replacements provide a simple way to structure meal planning, with no calorie “mysteries.” They achieve both portion control and predictable weight loss, while decreasing “decision anxiety” among patients who are uncertain about what they should and shouldn't eat. “Patients do better when you tell them what to do, rather than what not to do,” Ms. Daly said.

Full meal replacement can be less costly for patients than what they're already spending on food. The U.S. Department of Agriculture estimates that the average American spends about $101 per week on food, while the HMR regimens range in cost from $73 to $92 per week.

And that's not counting the savings in medical costs. In a 12-week study of 75 patients with type 2 diabetes treated with oral agents only (of whom 57 completed the study), those randomized to receive one of two meal-replacement regimens lost more weight (6.4% and 6.7% vs. 4.9% of total body weight) than did those who followed a traditional exchange diet plan. Fasting glucose, total cholesterol, and LDL cholesterol levels were all significantly reduced among the meal-replacement patients as well (Obes. Res. 2001;9 [suppl. 4]:341S-7).

In a more recent study of 118 patients who each lost more than 100 pounds using meal replacements and increased physical activity, medications for comorbidities were discontinued in 66% at a cost savings of $100/month per patient. The patients, whose weight loss averaged 61 kg in 44 weeks, maintained a 30-kg weight loss at 5 years by continuing to replace at least one meal and one snack per day, while they were allowed unlimited fruits and vegetables (Am. J. Clin. Nutr. 2007;86:301–7).

Data from HMR on 1,000 patients show similar results. Over a 2-year period, patients lost an average of 43 pounds, with a 14% reduction in total cholesterol/HDL cholesterol level, 25% in triglycerides, and 10% in fasting glucose. Systolic blood pressures dropped an average of 8 mm Hg, and diastolic by 6 mm Hg. Approximately 21% of patients came off at least one medication.

Meal replacements provide a simple way to structure meal planning, with no calorie 'mysteries.' MS. DALY

WASHINGTON — A single-use bacteriophage amplification test kit was able to accurately identify Staphylococcus aureus and determine whether it was methicillin sensitive or resistant within 5 hours in a study of clinical bacteremia isolates.

The findings suggest that it is possible not only to slash the diagnostic time for bacteremia—from 2–3 days to 5 hours—but also to obtain rapid results that will guide treatment and prevent overuse of broad-spectrum antibiotics, Dr. J. Drew Smith said in an interview during a poster presentation at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

The test, made by MicroPhage Inc., uses bacteriophage amplification technology, which detects proteins produced by viruses that are selected to amplify in response to S. aureus. Blood culture samples are mixed in two separate tubes and placed in an incubator for 5 hours. The tubes are removed and six drops of each sample are applied to dipstick-type detectors similar to those used in home pregnancy tests. One tube determines if the sample contains S. aureus; the other determines if the bacteria are antibiotic resistant or susceptible, explained Dr. Smith, director of research and development at MicroPhage.

In a panel of 120 S. aureus clinical isolates and 120 closely related nonpathogenic coagulase-negative staphylococci, the identity test for S. aureus had a sensitivity of 93% and a specificity of 96%. Among the strains identified as S. aureus, methicillin susceptibility was determined with 99% sensitivity and 99% specificity. Only 1.8% of samples were falsely identified as methicillin-resistant S. aureus (MRSA) and no samples were falsely identified as methicillin sensitive (MSSA), Dr. Smith and his associates reported.

Current polymerase chain reaction (PCR) technology allows for rapid detection of MRSA but doesn't accurately determine susceptibility. With the bacteriophage test, a result indicating MSSA allows for the patient to be safely switched from empiric vancomycin to nafcillin or another conventional β-lactam antibiotic, which are more effective against S. aureus than is vancomycin and can reduce mortality by 30%–50% if the organism is susceptible. The PCR test gives too many false positives for MSSA to be used for this purpose, Dr. Smith said in the interview.

Bacteriophage amplification technology also could be used to prospectively screen patients for MRSA carriage.

In a separate study presented in another poster, nasal swabs were collected from preoperative and ICU patients and were streaked on agar plates for MRSA detection. The swabs were then transferred to MicroPhage tubes, incubated for 7–24 hours, and read in the same way as was done for the bacteremia test. This time, 32 samples were read at 7 and 24 hours and 77 were read at 12–18 hours and again at 18–24 hours. (More time is needed for nasal swabs than blood cultures because fewer bacteria are present, Dr. Smith explained.)

Sensitivity for detecting MRSA nasal carriage was just 33% at 7 hours, but improved to 92% at 12–18 hours and 100% by 18–24 hours. There was little loss of specificity, which began at 100% at 7 hours and dropped to 98% at 12–18 and 18–24 hours. Positive predictive value was 100% at 7 hours, dropping to 88% by 18–24 hours whereas negative predictive value rose from 94% at 7 hours to 100% at 18–24 hours.

Lab personnel were trained to use the test in less than half an hour, it required no specialized or dedicated equipment, and it can be “adapted to a variety of testing and reporting schedules,” the authors said.

MicroPhage is hoping to market both uses for the technology to community hospitals and to offer the nasal tests to outpatient settings such as nursing homes. Clinical testing will begin in early 2009, and the company hopes to obtain licensure from the Food and Drug Administration by late 2009 or early 2010, Dr. Smith said.

WASHINGTON — A single-use bacteriophage amplification test kit was able to accurately identify Staphylococcus aureus and determine whether it was methicillin sensitive or resistant within 5 hours in a study of clinical bacteremia isolates.

The findings suggest that it is possible not only to slash the diagnostic time for bacteremia—from 2–3 days to 5 hours—but also to obtain rapid results that will guide treatment and prevent overuse of broad-spectrum antibiotics, Dr. J. Drew Smith said in an interview during a poster presentation at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

The test, made by MicroPhage Inc., uses bacteriophage amplification technology, which detects proteins produced by viruses that are selected to amplify in response to S. aureus. Blood culture samples are mixed in two separate tubes and placed in an incubator for 5 hours. The tubes are removed and six drops of each sample are applied to dipstick-type detectors similar to those used in home pregnancy tests. One tube determines if the sample contains S. aureus; the other determines if the bacteria are antibiotic resistant or susceptible, explained Dr. Smith, director of research and development at MicroPhage.

In a panel of 120 S. aureus clinical isolates and 120 closely related nonpathogenic coagulase-negative staphylococci, the identity test for S. aureus had a sensitivity of 93% and a specificity of 96%. Among the strains identified as S. aureus, methicillin susceptibility was determined with 99% sensitivity and 99% specificity. Only 1.8% of samples were falsely identified as methicillin-resistant S. aureus (MRSA) and no samples were falsely identified as methicillin sensitive (MSSA), Dr. Smith and his associates reported.

Current polymerase chain reaction (PCR) technology allows for rapid detection of MRSA but doesn't accurately determine susceptibility. With the bacteriophage test, a result indicating MSSA allows for the patient to be safely switched from empiric vancomycin to nafcillin or another conventional β-lactam antibiotic, which are more effective against S. aureus than is vancomycin and can reduce mortality by 30%–50% if the organism is susceptible. The PCR test gives too many false positives for MSSA to be used for this purpose, Dr. Smith said in the interview.

Bacteriophage amplification technology also could be used to prospectively screen patients for MRSA carriage.

In a separate study presented in another poster, nasal swabs were collected from preoperative and ICU patients and were streaked on agar plates for MRSA detection. The swabs were then transferred to MicroPhage tubes, incubated for 7–24 hours, and read in the same way as was done for the bacteremia test. This time, 32 samples were read at 7 and 24 hours and 77 were read at 12–18 hours and again at 18–24 hours. (More time is needed for nasal swabs than blood cultures because fewer bacteria are present, Dr. Smith explained.)

Sensitivity for detecting MRSA nasal carriage was just 33% at 7 hours, but improved to 92% at 12–18 hours and 100% by 18–24 hours. There was little loss of specificity, which began at 100% at 7 hours and dropped to 98% at 12–18 and 18–24 hours. Positive predictive value was 100% at 7 hours, dropping to 88% by 18–24 hours whereas negative predictive value rose from 94% at 7 hours to 100% at 18–24 hours.

Lab personnel were trained to use the test in less than half an hour, it required no specialized or dedicated equipment, and it can be “adapted to a variety of testing and reporting schedules,” the authors said.

MicroPhage is hoping to market both uses for the technology to community hospitals and to offer the nasal tests to outpatient settings such as nursing homes. Clinical testing will begin in early 2009, and the company hopes to obtain licensure from the Food and Drug Administration by late 2009 or early 2010, Dr. Smith said.

WASHINGTON — A single-use bacteriophage amplification test kit was able to accurately identify Staphylococcus aureus and determine whether it was methicillin sensitive or resistant within 5 hours in a study of clinical bacteremia isolates.

The findings suggest that it is possible not only to slash the diagnostic time for bacteremia—from 2–3 days to 5 hours—but also to obtain rapid results that will guide treatment and prevent overuse of broad-spectrum antibiotics, Dr. J. Drew Smith said in an interview during a poster presentation at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy and the annual meeting of the Infectious Diseases Society of America.

The test, made by MicroPhage Inc., uses bacteriophage amplification technology, which detects proteins produced by viruses that are selected to amplify in response to S. aureus. Blood culture samples are mixed in two separate tubes and placed in an incubator for 5 hours. The tubes are removed and six drops of each sample are applied to dipstick-type detectors similar to those used in home pregnancy tests. One tube determines if the sample contains S. aureus; the other determines if the bacteria are antibiotic resistant or susceptible, explained Dr. Smith, director of research and development at MicroPhage.

In a panel of 120 S. aureus clinical isolates and 120 closely related nonpathogenic coagulase-negative staphylococci, the identity test for S. aureus had a sensitivity of 93% and a specificity of 96%. Among the strains identified as S. aureus, methicillin susceptibility was determined with 99% sensitivity and 99% specificity. Only 1.8% of samples were falsely identified as methicillin-resistant S. aureus (MRSA) and no samples were falsely identified as methicillin sensitive (MSSA), Dr. Smith and his associates reported.

Current polymerase chain reaction (PCR) technology allows for rapid detection of MRSA but doesn't accurately determine susceptibility. With the bacteriophage test, a result indicating MSSA allows for the patient to be safely switched from empiric vancomycin to nafcillin or another conventional β-lactam antibiotic, which are more effective against S. aureus than is vancomycin and can reduce mortality by 30%–50% if the organism is susceptible. The PCR test gives too many false positives for MSSA to be used for this purpose, Dr. Smith said in the interview.

Bacteriophage amplification technology also could be used to prospectively screen patients for MRSA carriage.

In a separate study presented in another poster, nasal swabs were collected from preoperative and ICU patients and were streaked on agar plates for MRSA detection. The swabs were then transferred to MicroPhage tubes, incubated for 7–24 hours, and read in the same way as was done for the bacteremia test. This time, 32 samples were read at 7 and 24 hours and 77 were read at 12–18 hours and again at 18–24 hours. (More time is needed for nasal swabs than blood cultures because fewer bacteria are present, Dr. Smith explained.)

Sensitivity for detecting MRSA nasal carriage was just 33% at 7 hours, but improved to 92% at 12–18 hours and 100% by 18–24 hours. There was little loss of specificity, which began at 100% at 7 hours and dropped to 98% at 12–18 and 18–24 hours. Positive predictive value was 100% at 7 hours, dropping to 88% by 18–24 hours whereas negative predictive value rose from 94% at 7 hours to 100% at 18–24 hours.

Lab personnel were trained to use the test in less than half an hour, it required no specialized or dedicated equipment, and it can be “adapted to a variety of testing and reporting schedules,” the authors said.

MicroPhage is hoping to market both uses for the technology to community hospitals and to offer the nasal tests to outpatient settings such as nursing homes. Clinical testing will begin in early 2009, and the company hopes to obtain licensure from the Food and Drug Administration by late 2009 or early 2010, Dr. Smith said.

ROME — Youth with type 2 diabetes had an average of nearly three cardiovascular risk factors each, compared with just one in healthy controls in an analysis of 295 participants in a large, multicenter, U.S. case-control study.

The data come from 106 patients with type 2 diabetes and 189 healthy controls (matched for age, sex, and race/ethnicity) recruited by primary care providers at two sites (Colorado and South Carolina) of the six participating in the federally funded SEARCH for Diabetes in Youth, a study designed to investigate the prevalence and characteristics of diabetes in individuals aged younger than 20 years.

The current analysis, one of the first to focus on cardiovascular (CV) risk in this population, also showed that not all the risk factors could be accounted for by increased obesity and/or hyperglycemia.

The data appear to “support the statement that early prevention and treatment strategies [to reduce] the prevalence of cardiovascular risk factors in youth with type 2 diabetes mellitus are urgently needed,” Dr. Dana Dabelea said at the annual meeting of the European Association for the Study of Diabetes.

The participants were aged 10–22 years, with a mean of 16 years for the diabetic group and 14 years for the controls—a statistically significant difference, despite attempts to age-match. Duration of diabetes in the type 2 group was 1.5 years. Females comprised 69% of the diabetic group and 60% of controls, not significantly different, said Dr. Dabelea, director of the epidemiology PhD program at the University of Colorado, Denver, and a principal investigator at the Colorado site.

The type 2 group was significantly more likely than were the controls to be African American (55% vs. 29%, respectively) and less likely to be non-Hispanic white (28% vs. 54%). Body mass index was significantly greater in the youth with diabetes (35 vs. 24 kg/m

Consumption of saturated fat as a percent of total daily calories was slightly higher in the type 2 group, and the amount of daily physical activity was lower, but these were not statistically significant.

Highly statistically significant differences between the groups were seen in the proportions who had hypertension (27% in the type 2 group vs. 5% of controls), were on medication (5% of controls), had low HDL cholesterol (25% vs. 5%, respectively), and high triglycerides (27% vs. 6%).

Also highly significantly different were the proportions who were obese, defined as 95th percentile or greater BMI for age and sex (86% in the type 2 group vs. 26% of controls) and those with a large waist circumference, defined as 90th percentile or greater for age and sex (82% vs. 22%).

Elevated albumin/creatinine ratio of 30 mcg/mg or greater was present in 17% of the type 2 group, compared with 7% of controls, of borderline significance. Proportions of those with high LDL cholesterol and who were current smokers were not significantly different, she said.

Nearly half (45%) of the controls had none of these CV risk factors, compared with 3% of those with type 2 diabetes. In type 2 patients, 60% had three or more risk factors, compared with 13% of the nondiabetic controls. Those with type 2 diabetes had a mean of 2.9 CV risk factors each, compared with 1 for the controls.

In a series of multiple linear regression models, adjustment for differences in obesity accounted for the differences between the type 2 group and the controls in HDL cholesterol, systolic blood pressure, and adiponectin, while adjustment for hemoglobin A_1c between the groups accounted for the differences in apolipoprotein B and LDL particle size. Adjustment for obesity and HbA_1c accounted for the difference in triglycerides. But levels of the inflammatory markers fibrinogen and IL-6 remained significantly different between the two groups, even after adjustment for obesity and hemoglobin A_1c, Dr. Dabelea said.

ROME — Youth with type 2 diabetes had an average of nearly three cardiovascular risk factors each, compared with just one in healthy controls in an analysis of 295 participants in a large, multicenter, U.S. case-control study.

The data come from 106 patients with type 2 diabetes and 189 healthy controls (matched for age, sex, and race/ethnicity) recruited by primary care providers at two sites (Colorado and South Carolina) of the six participating in the federally funded SEARCH for Diabetes in Youth, a study designed to investigate the prevalence and characteristics of diabetes in individuals aged younger than 20 years.

The current analysis, one of the first to focus on cardiovascular (CV) risk in this population, also showed that not all the risk factors could be accounted for by increased obesity and/or hyperglycemia.

The data appear to “support the statement that early prevention and treatment strategies [to reduce] the prevalence of cardiovascular risk factors in youth with type 2 diabetes mellitus are urgently needed,” Dr. Dana Dabelea said at the annual meeting of the European Association for the Study of Diabetes.

The participants were aged 10–22 years, with a mean of 16 years for the diabetic group and 14 years for the controls—a statistically significant difference, despite attempts to age-match. Duration of diabetes in the type 2 group was 1.5 years. Females comprised 69% of the diabetic group and 60% of controls, not significantly different, said Dr. Dabelea, director of the epidemiology PhD program at the University of Colorado, Denver, and a principal investigator at the Colorado site.

The type 2 group was significantly more likely than were the controls to be African American (55% vs. 29%, respectively) and less likely to be non-Hispanic white (28% vs. 54%). Body mass index was significantly greater in the youth with diabetes (35 vs. 24 kg/m

Consumption of saturated fat as a percent of total daily calories was slightly higher in the type 2 group, and the amount of daily physical activity was lower, but these were not statistically significant.

Highly statistically significant differences between the groups were seen in the proportions who had hypertension (27% in the type 2 group vs. 5% of controls), were on medication (5% of controls), had low HDL cholesterol (25% vs. 5%, respectively), and high triglycerides (27% vs. 6%).

Also highly significantly different were the proportions who were obese, defined as 95th percentile or greater BMI for age and sex (86% in the type 2 group vs. 26% of controls) and those with a large waist circumference, defined as 90th percentile or greater for age and sex (82% vs. 22%).

Elevated albumin/creatinine ratio of 30 mcg/mg or greater was present in 17% of the type 2 group, compared with 7% of controls, of borderline significance. Proportions of those with high LDL cholesterol and who were current smokers were not significantly different, she said.

Nearly half (45%) of the controls had none of these CV risk factors, compared with 3% of those with type 2 diabetes. In type 2 patients, 60% had three or more risk factors, compared with 13% of the nondiabetic controls. Those with type 2 diabetes had a mean of 2.9 CV risk factors each, compared with 1 for the controls.

In a series of multiple linear regression models, adjustment for differences in obesity accounted for the differences between the type 2 group and the controls in HDL cholesterol, systolic blood pressure, and adiponectin, while adjustment for hemoglobin A_1c between the groups accounted for the differences in apolipoprotein B and LDL particle size. Adjustment for obesity and HbA_1c accounted for the difference in triglycerides. But levels of the inflammatory markers fibrinogen and IL-6 remained significantly different between the two groups, even after adjustment for obesity and hemoglobin A_1c, Dr. Dabelea said.

ROME — Youth with type 2 diabetes had an average of nearly three cardiovascular risk factors each, compared with just one in healthy controls in an analysis of 295 participants in a large, multicenter, U.S. case-control study.

The data come from 106 patients with type 2 diabetes and 189 healthy controls (matched for age, sex, and race/ethnicity) recruited by primary care providers at two sites (Colorado and South Carolina) of the six participating in the federally funded SEARCH for Diabetes in Youth, a study designed to investigate the prevalence and characteristics of diabetes in individuals aged younger than 20 years.

The current analysis, one of the first to focus on cardiovascular (CV) risk in this population, also showed that not all the risk factors could be accounted for by increased obesity and/or hyperglycemia.

The data appear to “support the statement that early prevention and treatment strategies [to reduce] the prevalence of cardiovascular risk factors in youth with type 2 diabetes mellitus are urgently needed,” Dr. Dana Dabelea said at the annual meeting of the European Association for the Study of Diabetes.

The participants were aged 10–22 years, with a mean of 16 years for the diabetic group and 14 years for the controls—a statistically significant difference, despite attempts to age-match. Duration of diabetes in the type 2 group was 1.5 years. Females comprised 69% of the diabetic group and 60% of controls, not significantly different, said Dr. Dabelea, director of the epidemiology PhD program at the University of Colorado, Denver, and a principal investigator at the Colorado site.

The type 2 group was significantly more likely than were the controls to be African American (55% vs. 29%, respectively) and less likely to be non-Hispanic white (28% vs. 54%). Body mass index was significantly greater in the youth with diabetes (35 vs. 24 kg/m

Consumption of saturated fat as a percent of total daily calories was slightly higher in the type 2 group, and the amount of daily physical activity was lower, but these were not statistically significant.

Highly statistically significant differences between the groups were seen in the proportions who had hypertension (27% in the type 2 group vs. 5% of controls), were on medication (5% of controls), had low HDL cholesterol (25% vs. 5%, respectively), and high triglycerides (27% vs. 6%).

Also highly significantly different were the proportions who were obese, defined as 95th percentile or greater BMI for age and sex (86% in the type 2 group vs. 26% of controls) and those with a large waist circumference, defined as 90th percentile or greater for age and sex (82% vs. 22%).

Elevated albumin/creatinine ratio of 30 mcg/mg or greater was present in 17% of the type 2 group, compared with 7% of controls, of borderline significance. Proportions of those with high LDL cholesterol and who were current smokers were not significantly different, she said.

Nearly half (45%) of the controls had none of these CV risk factors, compared with 3% of those with type 2 diabetes. In type 2 patients, 60% had three or more risk factors, compared with 13% of the nondiabetic controls. Those with type 2 diabetes had a mean of 2.9 CV risk factors each, compared with 1 for the controls.

In a series of multiple linear regression models, adjustment for differences in obesity accounted for the differences between the type 2 group and the controls in HDL cholesterol, systolic blood pressure, and adiponectin, while adjustment for hemoglobin A_1c between the groups accounted for the differences in apolipoprotein B and LDL particle size. Adjustment for obesity and HbA_1c accounted for the difference in triglycerides. But levels of the inflammatory markers fibrinogen and IL-6 remained significantly different between the two groups, even after adjustment for obesity and hemoglobin A_1c, Dr. Dabelea said.

WASHINGTON — A single-use bacteriophage amplification test kit was able to both accurately identify Staphylococcus aureus and determine whether it was methicillin sensitive or resistant within 5 hours in a study of clinical bacteremia isolates.

The findings suggest that it is possible not only to slash the diagnostic time for bacteremia—from 2–3 days to 5 hours—but also to obtain rapid results that will guide treatment and prevent overuse of broad-spectrum antibiotics, Dr. J. Drew Smith said in an interview during his poster presentation at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the annual meeting of the Infectious Diseases Society of America (IDSA).

The test, made by MicroPhage Inc., uses bacteriophage amplification technology, which detects proteins produced by viruses that are selected to amplify in response to S. aureus. Blood culture samples are mixed in two separate tubes and placed in an incubator for 5 hours. The tubes are removed and six drops of each sample are applied to dipstick-type detectors similar to those used in home pregnancy tests.

One tube determines whether or not the sample contains S. aureus; the other determines whether the bacteria are antibiotic resistant or susceptible, explained Dr. Smith, director of research and development at MicroPhage.

In a panel of 120 S. aureus clinical isolates and 120 closely related nonpathogenic coagulase-negative staphylococci, the identity test for S. aureus had a sensitivity of 93% and a specificity of 96%.

Among the strains identified as S. aureus, methicillin susceptibility was determined with 99% sensitivity and 99% specificity. Only 1.8% of samples were falsely identified as methicillin-resistant S. aureus (MRSA) and no samples were falsely identified as methicillin sensitive (MSSA), Dr. Smith and his associates reported.

Current polymerase chain reaction (PCR) technology allows for rapid detection of MRSA but doesn't accurately determine susceptibility. With the bacteriophage test, a result indicating MSSA allows for the patient to be safely switched from empiric vancomycin to nafcillin or another conventional β-lactam antibiotic, which are more effective against S. aureus than is vancomycin and can reduce mortality by 30%–50% if the organism is susceptible.

The PCR test gives too many false positives for MSSA in order to be used for this purpose, Dr. Smith explained in the interview.

Bacteriophage amplification technology also could be used to prospectively screen patients for MRSA carriage.

In a separate study presented in another poster, nasal swabs were collected from preoperative and ICU patients and were streaked on agar plates for MRSA detection. The swabs were then transferred to MicroPhage tubes, incubated for 7–24 hours, and read in the same way as was done for the bacteremia test. This time, 32 samples were read at 7 and 24 hours and 77 were read at 12–18 hours and again at 18–24 hours. (More time is needed for nasal swabs than blood cultures because fewer bacteria are present, Dr. Smith explained.)

Sensitivity for detecting MRSA nasal carriage was just 33% at 7 hours, but improved to 92% at 12–18 hours and 100% by 18–24 hours. At the same time, there was little loss of specificity, which began at 100% at 7 hours and dropped to 98% only at 12–18 and 18–24 hours. Positive predictive value was 100% at 7 hours, dropping to 88% by 18–24 hours while negative predictive value rose from 94% at 7 hours to 100% at 18–24 hours.

Lab personnel were trained to use the test in less than half an hour, and it required no specialized or dedicated equipment.

Moreover, "the test is flexible with respect to read times, allowing it to be adapted to a variety of testing and reporting schedules," the investigators said.

MicroPhage is hoping to market both uses for the technology to community hospitals and to offer the nasal tests to outpatient settings such as nursing homes or surgicenters.

Clinical testing will begin in early 2009, and the company hopes to obtain licensure from the Food and Drug Administration by late 2009 or early 2010, Dr. Smith said.

WASHINGTON — A single-use bacteriophage amplification test kit was able to both accurately identify Staphylococcus aureus and determine whether it was methicillin sensitive or resistant within 5 hours in a study of clinical bacteremia isolates.

The findings suggest that it is possible not only to slash the diagnostic time for bacteremia—from 2–3 days to 5 hours—but also to obtain rapid results that will guide treatment and prevent overuse of broad-spectrum antibiotics, Dr. J. Drew Smith said in an interview during his poster presentation at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the annual meeting of the Infectious Diseases Society of America (IDSA).

The test, made by MicroPhage Inc., uses bacteriophage amplification technology, which detects proteins produced by viruses that are selected to amplify in response to S. aureus. Blood culture samples are mixed in two separate tubes and placed in an incubator for 5 hours. The tubes are removed and six drops of each sample are applied to dipstick-type detectors similar to those used in home pregnancy tests.

One tube determines whether or not the sample contains S. aureus; the other determines whether the bacteria are antibiotic resistant or susceptible, explained Dr. Smith, director of research and development at MicroPhage.

In a panel of 120 S. aureus clinical isolates and 120 closely related nonpathogenic coagulase-negative staphylococci, the identity test for S. aureus had a sensitivity of 93% and a specificity of 96%.

Among the strains identified as S. aureus, methicillin susceptibility was determined with 99% sensitivity and 99% specificity. Only 1.8% of samples were falsely identified as methicillin-resistant S. aureus (MRSA) and no samples were falsely identified as methicillin sensitive (MSSA), Dr. Smith and his associates reported.

Current polymerase chain reaction (PCR) technology allows for rapid detection of MRSA but doesn't accurately determine susceptibility. With the bacteriophage test, a result indicating MSSA allows for the patient to be safely switched from empiric vancomycin to nafcillin or another conventional β-lactam antibiotic, which are more effective against S. aureus than is vancomycin and can reduce mortality by 30%–50% if the organism is susceptible.

The PCR test gives too many false positives for MSSA in order to be used for this purpose, Dr. Smith explained in the interview.

Bacteriophage amplification technology also could be used to prospectively screen patients for MRSA carriage.

In a separate study presented in another poster, nasal swabs were collected from preoperative and ICU patients and were streaked on agar plates for MRSA detection. The swabs were then transferred to MicroPhage tubes, incubated for 7–24 hours, and read in the same way as was done for the bacteremia test. This time, 32 samples were read at 7 and 24 hours and 77 were read at 12–18 hours and again at 18–24 hours. (More time is needed for nasal swabs than blood cultures because fewer bacteria are present, Dr. Smith explained.)

Sensitivity for detecting MRSA nasal carriage was just 33% at 7 hours, but improved to 92% at 12–18 hours and 100% by 18–24 hours. At the same time, there was little loss of specificity, which began at 100% at 7 hours and dropped to 98% only at 12–18 and 18–24 hours. Positive predictive value was 100% at 7 hours, dropping to 88% by 18–24 hours while negative predictive value rose from 94% at 7 hours to 100% at 18–24 hours.

Lab personnel were trained to use the test in less than half an hour, and it required no specialized or dedicated equipment.

Moreover, "the test is flexible with respect to read times, allowing it to be adapted to a variety of testing and reporting schedules," the investigators said.

MicroPhage is hoping to market both uses for the technology to community hospitals and to offer the nasal tests to outpatient settings such as nursing homes or surgicenters.

Clinical testing will begin in early 2009, and the company hopes to obtain licensure from the Food and Drug Administration by late 2009 or early 2010, Dr. Smith said.

WASHINGTON — A single-use bacteriophage amplification test kit was able to both accurately identify Staphylococcus aureus and determine whether it was methicillin sensitive or resistant within 5 hours in a study of clinical bacteremia isolates.

The findings suggest that it is possible not only to slash the diagnostic time for bacteremia—from 2–3 days to 5 hours—but also to obtain rapid results that will guide treatment and prevent overuse of broad-spectrum antibiotics, Dr. J. Drew Smith said in an interview during his poster presentation at the jointly held annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) and the annual meeting of the Infectious Diseases Society of America (IDSA).

The test, made by MicroPhage Inc., uses bacteriophage amplification technology, which detects proteins produced by viruses that are selected to amplify in response to S. aureus. Blood culture samples are mixed in two separate tubes and placed in an incubator for 5 hours. The tubes are removed and six drops of each sample are applied to dipstick-type detectors similar to those used in home pregnancy tests.

One tube determines whether or not the sample contains S. aureus; the other determines whether the bacteria are antibiotic resistant or susceptible, explained Dr. Smith, director of research and development at MicroPhage.

In a panel of 120 S. aureus clinical isolates and 120 closely related nonpathogenic coagulase-negative staphylococci, the identity test for S. aureus had a sensitivity of 93% and a specificity of 96%.

Among the strains identified as S. aureus, methicillin susceptibility was determined with 99% sensitivity and 99% specificity. Only 1.8% of samples were falsely identified as methicillin-resistant S. aureus (MRSA) and no samples were falsely identified as methicillin sensitive (MSSA), Dr. Smith and his associates reported.

Current polymerase chain reaction (PCR) technology allows for rapid detection of MRSA but doesn't accurately determine susceptibility. With the bacteriophage test, a result indicating MSSA allows for the patient to be safely switched from empiric vancomycin to nafcillin or another conventional β-lactam antibiotic, which are more effective against S. aureus than is vancomycin and can reduce mortality by 30%–50% if the organism is susceptible.

The PCR test gives too many false positives for MSSA in order to be used for this purpose, Dr. Smith explained in the interview.

Bacteriophage amplification technology also could be used to prospectively screen patients for MRSA carriage.

In a separate study presented in another poster, nasal swabs were collected from preoperative and ICU patients and were streaked on agar plates for MRSA detection. The swabs were then transferred to MicroPhage tubes, incubated for 7–24 hours, and read in the same way as was done for the bacteremia test. This time, 32 samples were read at 7 and 24 hours and 77 were read at 12–18 hours and again at 18–24 hours. (More time is needed for nasal swabs than blood cultures because fewer bacteria are present, Dr. Smith explained.)

Sensitivity for detecting MRSA nasal carriage was just 33% at 7 hours, but improved to 92% at 12–18 hours and 100% by 18–24 hours. At the same time, there was little loss of specificity, which began at 100% at 7 hours and dropped to 98% only at 12–18 and 18–24 hours. Positive predictive value was 100% at 7 hours, dropping to 88% by 18–24 hours while negative predictive value rose from 94% at 7 hours to 100% at 18–24 hours.

Lab personnel were trained to use the test in less than half an hour, and it required no specialized or dedicated equipment.

Moreover, "the test is flexible with respect to read times, allowing it to be adapted to a variety of testing and reporting schedules," the investigators said.

MicroPhage is hoping to market both uses for the technology to community hospitals and to offer the nasal tests to outpatient settings such as nursing homes or surgicenters.

Clinical testing will begin in early 2009, and the company hopes to obtain licensure from the Food and Drug Administration by late 2009 or early 2010, Dr. Smith said.

BETHESDA, MD. — The Society for Investigative Dermatology has launched an ambitious multiyear, multidisciplinary research agenda focusing on skin disease comorbidities.

Initially, the Co-Morbidities of Skin Disease project will focus on three main areas: dermatotoxicity resulting from the use of cancer drugs; the association between psoriasis and cardiovascular disease; and the psychiatric and psychosocial aspects of dermatologic disease. With time, the SID aims to broaden both the research agenda and, ultimately, the scope of dermatologic practice.

At a “launch conference” sponsored by the SID with support from Abbott Laboratories, Amgen Inc., Centocor Inc., and OSI Pharmaceuticals Inc., participants met for a day and a half to review current knowledge, identify research priorities, and address potential avenues for collaboration and data collection. Over the next 6–9 months, the SID will publish the conference proceedings and post an online database at its comorbidities site, www.sidnetcommunity.org/como.htm

“At the most basic level, we recognize that patients affected by skin disease do not just have skin disease. … We've brought together people from cardiology, psychiatry, government, and industry. We want to develop new research communities,” said Dr. Robert Swerlick, chief of dermatology at Emory University, Atlanta, and director of the dermatology section at the Emory Clinic.

Collaboration is essential, noted conference chair Dr. Lowell A. Goldsmith, professor of dermatology at the University of North Carolina at Chapel Hill. “Dermatology can't do this by itself.”

More than 41 anticancer agents have been identified to cause 52 distinct dermatologic toxicities, which may affect the dose intensity of the antineoplastic regimen in a large proportion of cases. “The effect of this on clinical outcome hasn't been adequately studied … and there is a significant physical and psychosocial discomfort associated with these dermatologic toxicities,” said Dr. Mario E. Lacouture, who works in an interdisciplinary clinic involving dermatology, ophthalmology, and oncology at Northwestern University, Chicago.

Research efforts are focusing on therapies to treat or prevent these eruptions in patients undergoing chemotherapy, including oral tetracycline (Cancer 2008;113:847-53) and oral minocycline plus topical tazarotene (J. Clin. Oncol. 2007;25:5390-6). Currently there are 24 ongoing clinical trials in this area, he said.

The field of psychiatry and dermatology is potentially broader than the others but far less advanced. The literature often quotes the figure of 30% for the proportion of dermatology patients who have psychiatric comorbidities. However, that number has been repeated for decades with very little in the way of definitions or standardized measures, said Dr. Francisco Tausk, a professor in the departments of dermatology and psychiatry at the University of Rochester (N.Y.).

Included in this category are psychiatric diseases that affect the skin, such as delusions of parasitosis, trichotillomania, and skin picking, which can be extreme. The latter two are extremely common, but “we have no data on how prevalent they are or how to treat them,” Dr. Tausk said.

Then there are the skin diseases such as psoriasis, acne, and eczema that can be profoundly affected by psychiatric problems such as stress, depression, and anxiety.

Dr. Joel M. Gelfand, medical director of the clinical studies unit at the University of Pennsylvania, Philadelphia, summarized the current knowledge about the link between psoriasis and cardiovascular disease, his research focus. Data increasingly suggest that psoriasis is a chronic systemic inflammatory disease commonly associated with other conditions such as atherosclerosis and diabetes.

In a cohort study Dr. Gelfand and his associates recently published, patients with severe psoriasis who were seen by general practitioners in the United Kingdom in 1987–2002 had a threefold risk of mortality, compared with controls, even after adjustment for other mortality risk factors. Male patients with psoriasis died 3.5 years younger, and female patients, 4.4 years younger, an excess mortality similar to that of cardiovascular disease (Arch. Dermatol. 2007;143:1493-9).

BETHESDA, MD. — The Society for Investigative Dermatology has launched an ambitious multiyear, multidisciplinary research agenda focusing on skin disease comorbidities.

Initially, the Co-Morbidities of Skin Disease project will focus on three main areas: dermatotoxicity resulting from the use of cancer drugs; the association between psoriasis and cardiovascular disease; and the psychiatric and psychosocial aspects of dermatologic disease. With time, the SID aims to broaden both the research agenda and, ultimately, the scope of dermatologic practice.

At a “launch conference” sponsored by the SID with support from Abbott Laboratories, Amgen Inc., Centocor Inc., and OSI Pharmaceuticals Inc., participants met for a day and a half to review current knowledge, identify research priorities, and address potential avenues for collaboration and data collection. Over the next 6–9 months, the SID will publish the conference proceedings and post an online database at its comorbidities site, www.sidnetcommunity.org/como.htm

“At the most basic level, we recognize that patients affected by skin disease do not just have skin disease. … We've brought together people from cardiology, psychiatry, government, and industry. We want to develop new research communities,” said Dr. Robert Swerlick, chief of dermatology at Emory University, Atlanta, and director of the dermatology section at the Emory Clinic.

Collaboration is essential, noted conference chair Dr. Lowell A. Goldsmith, professor of dermatology at the University of North Carolina at Chapel Hill. “Dermatology can't do this by itself.”

More than 41 anticancer agents have been identified to cause 52 distinct dermatologic toxicities, which may affect the dose intensity of the antineoplastic regimen in a large proportion of cases. “The effect of this on clinical outcome hasn't been adequately studied … and there is a significant physical and psychosocial discomfort associated with these dermatologic toxicities,” said Dr. Mario E. Lacouture, who works in an interdisciplinary clinic involving dermatology, ophthalmology, and oncology at Northwestern University, Chicago.

Research efforts are focusing on therapies to treat or prevent these eruptions in patients undergoing chemotherapy, including oral tetracycline (Cancer 2008;113:847-53) and oral minocycline plus topical tazarotene (J. Clin. Oncol. 2007;25:5390-6). Currently there are 24 ongoing clinical trials in this area, he said.

The field of psychiatry and dermatology is potentially broader than the others but far less advanced. The literature often quotes the figure of 30% for the proportion of dermatology patients who have psychiatric comorbidities. However, that number has been repeated for decades with very little in the way of definitions or standardized measures, said Dr. Francisco Tausk, a professor in the departments of dermatology and psychiatry at the University of Rochester (N.Y.).

Included in this category are psychiatric diseases that affect the skin, such as delusions of parasitosis, trichotillomania, and skin picking, which can be extreme. The latter two are extremely common, but “we have no data on how prevalent they are or how to treat them,” Dr. Tausk said.

Then there are the skin diseases such as psoriasis, acne, and eczema that can be profoundly affected by psychiatric problems such as stress, depression, and anxiety.

Dr. Joel M. Gelfand, medical director of the clinical studies unit at the University of Pennsylvania, Philadelphia, summarized the current knowledge about the link between psoriasis and cardiovascular disease, his research focus. Data increasingly suggest that psoriasis is a chronic systemic inflammatory disease commonly associated with other conditions such as atherosclerosis and diabetes.

In a cohort study Dr. Gelfand and his associates recently published, patients with severe psoriasis who were seen by general practitioners in the United Kingdom in 1987–2002 had a threefold risk of mortality, compared with controls, even after adjustment for other mortality risk factors. Male patients with psoriasis died 3.5 years younger, and female patients, 4.4 years younger, an excess mortality similar to that of cardiovascular disease (Arch. Dermatol. 2007;143:1493-9).

BETHESDA, MD. — The Society for Investigative Dermatology has launched an ambitious multiyear, multidisciplinary research agenda focusing on skin disease comorbidities.

Initially, the Co-Morbidities of Skin Disease project will focus on three main areas: dermatotoxicity resulting from the use of cancer drugs; the association between psoriasis and cardiovascular disease; and the psychiatric and psychosocial aspects of dermatologic disease. With time, the SID aims to broaden both the research agenda and, ultimately, the scope of dermatologic practice.

At a “launch conference” sponsored by the SID with support from Abbott Laboratories, Amgen Inc., Centocor Inc., and OSI Pharmaceuticals Inc., participants met for a day and a half to review current knowledge, identify research priorities, and address potential avenues for collaboration and data collection. Over the next 6–9 months, the SID will publish the conference proceedings and post an online database at its comorbidities site, www.sidnetcommunity.org/como.htm

“At the most basic level, we recognize that patients affected by skin disease do not just have skin disease. … We've brought together people from cardiology, psychiatry, government, and industry. We want to develop new research communities,” said Dr. Robert Swerlick, chief of dermatology at Emory University, Atlanta, and director of the dermatology section at the Emory Clinic.

Collaboration is essential, noted conference chair Dr. Lowell A. Goldsmith, professor of dermatology at the University of North Carolina at Chapel Hill. “Dermatology can't do this by itself.”

More than 41 anticancer agents have been identified to cause 52 distinct dermatologic toxicities, which may affect the dose intensity of the antineoplastic regimen in a large proportion of cases. “The effect of this on clinical outcome hasn't been adequately studied … and there is a significant physical and psychosocial discomfort associated with these dermatologic toxicities,” said Dr. Mario E. Lacouture, who works in an interdisciplinary clinic involving dermatology, ophthalmology, and oncology at Northwestern University, Chicago.

Research efforts are focusing on therapies to treat or prevent these eruptions in patients undergoing chemotherapy, including oral tetracycline (Cancer 2008;113:847-53) and oral minocycline plus topical tazarotene (J. Clin. Oncol. 2007;25:5390-6). Currently there are 24 ongoing clinical trials in this area, he said.

The field of psychiatry and dermatology is potentially broader than the others but far less advanced. The literature often quotes the figure of 30% for the proportion of dermatology patients who have psychiatric comorbidities. However, that number has been repeated for decades with very little in the way of definitions or standardized measures, said Dr. Francisco Tausk, a professor in the departments of dermatology and psychiatry at the University of Rochester (N.Y.).

Included in this category are psychiatric diseases that affect the skin, such as delusions of parasitosis, trichotillomania, and skin picking, which can be extreme. The latter two are extremely common, but “we have no data on how prevalent they are or how to treat them,” Dr. Tausk said.

Then there are the skin diseases such as psoriasis, acne, and eczema that can be profoundly affected by psychiatric problems such as stress, depression, and anxiety.

Dr. Joel M. Gelfand, medical director of the clinical studies unit at the University of Pennsylvania, Philadelphia, summarized the current knowledge about the link between psoriasis and cardiovascular disease, his research focus. Data increasingly suggest that psoriasis is a chronic systemic inflammatory disease commonly associated with other conditions such as atherosclerosis and diabetes.

In a cohort study Dr. Gelfand and his associates recently published, patients with severe psoriasis who were seen by general practitioners in the United Kingdom in 1987–2002 had a threefold risk of mortality, compared with controls, even after adjustment for other mortality risk factors. Male patients with psoriasis died 3.5 years younger, and female patients, 4.4 years younger, an excess mortality similar to that of cardiovascular disease (Arch. Dermatol. 2007;143:1493-9).