Michele G. Sullivan

CHICAGO — A single 2-g dose of azithromycin cures early syphilis as effectively as injected penicillin G benzathine, Dr. Edward W. Hook III said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

However, Dr. Hook cautioned that the federally sponsored randomized, controlled trial did not include any HIV-positive patients, so its results can't support the use of azithromycin in this population.

“This is the very group in which macrolide-resistant Treponema pallidum mutations have emerged in association with azithromycin treatment,” said Dr. Hook of the University of Alabama at Birmingham. “I would certainly not recommend treating these patients with azithromycin for early syphilis.”

Neither should the drug be used for syphilis in pregnant women. “In light of the history of macrolide treatment failures among pregnant women, I would caution very, very strongly against treating them with azithromycin for syphilis,” Dr. Hook said.

The trial compared the efficacy and safety of 2 g of azithromycin given orally with those of 2.4 million U of penicillin G benzathine in 517 patients with early syphilis. Most of the patients (80%) were in Madagascar; the rest were seen at U.S. clinics.

The patients' mean age was 24 years; 26% had primary syphilis, 46% had secondary syphilis, and 28% had presumed early latent syphilis (a sexual partner in the past 12 months with confirmed syphilis).

Serologic cure rates at 3 months were similar in both groups in the intent-to-treat analysis (74% azithromycin vs. 76% penicillin). At 6 months, the cure rates were still not significantly different (77% azithromycin vs. 78% penicillin). Results at 3 and 6 months in the per-protocol analysis were almost identical, Dr. Hook said. U.S. patients exhibited slightly, but not significantly, higher cure rates than did patients in Madagascar.

Serious adverse events were slightly more common in the penicillin group than they were in the azithromycin group (10 vs. 8, respectively). However, none of these were considered related to the study medication. Nonserious adverse events, especially gastrointestinal distress, were significantly more common among the patients taking azithromycin (61% vs. 46% for penicillin). The most common adverse events were gastrointestinal, with 24% of the azithromycin group experiencing some upset, compared with 7% of the penicillin group. However, only three patients taking azithromycin vomited.

Cutaneous reactions were more common among those taking penicillin (4% vs. 1%), as were administration-related adverse events (10% vs. 5%).

CHICAGO — A single 2-g dose of azithromycin cures early syphilis as effectively as injected penicillin G benzathine, Dr. Edward W. Hook III said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

However, Dr. Hook cautioned that the federally sponsored randomized, controlled trial did not include any HIV-positive patients, so its results can't support the use of azithromycin in this population.

“This is the very group in which macrolide-resistant Treponema pallidum mutations have emerged in association with azithromycin treatment,” said Dr. Hook of the University of Alabama at Birmingham. “I would certainly not recommend treating these patients with azithromycin for early syphilis.”

Neither should the drug be used for syphilis in pregnant women. “In light of the history of macrolide treatment failures among pregnant women, I would caution very, very strongly against treating them with azithromycin for syphilis,” Dr. Hook said.

The trial compared the efficacy and safety of 2 g of azithromycin given orally with those of 2.4 million U of penicillin G benzathine in 517 patients with early syphilis. Most of the patients (80%) were in Madagascar; the rest were seen at U.S. clinics.

The patients' mean age was 24 years; 26% had primary syphilis, 46% had secondary syphilis, and 28% had presumed early latent syphilis (a sexual partner in the past 12 months with confirmed syphilis).

Serologic cure rates at 3 months were similar in both groups in the intent-to-treat analysis (74% azithromycin vs. 76% penicillin). At 6 months, the cure rates were still not significantly different (77% azithromycin vs. 78% penicillin). Results at 3 and 6 months in the per-protocol analysis were almost identical, Dr. Hook said. U.S. patients exhibited slightly, but not significantly, higher cure rates than did patients in Madagascar.

Serious adverse events were slightly more common in the penicillin group than they were in the azithromycin group (10 vs. 8, respectively). However, none of these were considered related to the study medication. Nonserious adverse events, especially gastrointestinal distress, were significantly more common among the patients taking azithromycin (61% vs. 46% for penicillin). The most common adverse events were gastrointestinal, with 24% of the azithromycin group experiencing some upset, compared with 7% of the penicillin group. However, only three patients taking azithromycin vomited.

Cutaneous reactions were more common among those taking penicillin (4% vs. 1%), as were administration-related adverse events (10% vs. 5%).

CHICAGO — A single 2-g dose of azithromycin cures early syphilis as effectively as injected penicillin G benzathine, Dr. Edward W. Hook III said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

However, Dr. Hook cautioned that the federally sponsored randomized, controlled trial did not include any HIV-positive patients, so its results can't support the use of azithromycin in this population.

“This is the very group in which macrolide-resistant Treponema pallidum mutations have emerged in association with azithromycin treatment,” said Dr. Hook of the University of Alabama at Birmingham. “I would certainly not recommend treating these patients with azithromycin for early syphilis.”

Neither should the drug be used for syphilis in pregnant women. “In light of the history of macrolide treatment failures among pregnant women, I would caution very, very strongly against treating them with azithromycin for syphilis,” Dr. Hook said.

The trial compared the efficacy and safety of 2 g of azithromycin given orally with those of 2.4 million U of penicillin G benzathine in 517 patients with early syphilis. Most of the patients (80%) were in Madagascar; the rest were seen at U.S. clinics.

The patients' mean age was 24 years; 26% had primary syphilis, 46% had secondary syphilis, and 28% had presumed early latent syphilis (a sexual partner in the past 12 months with confirmed syphilis).

Serologic cure rates at 3 months were similar in both groups in the intent-to-treat analysis (74% azithromycin vs. 76% penicillin). At 6 months, the cure rates were still not significantly different (77% azithromycin vs. 78% penicillin). Results at 3 and 6 months in the per-protocol analysis were almost identical, Dr. Hook said. U.S. patients exhibited slightly, but not significantly, higher cure rates than did patients in Madagascar.

Serious adverse events were slightly more common in the penicillin group than they were in the azithromycin group (10 vs. 8, respectively). However, none of these were considered related to the study medication. Nonserious adverse events, especially gastrointestinal distress, were significantly more common among the patients taking azithromycin (61% vs. 46% for penicillin). The most common adverse events were gastrointestinal, with 24% of the azithromycin group experiencing some upset, compared with 7% of the penicillin group. However, only three patients taking azithromycin vomited.

Cutaneous reactions were more common among those taking penicillin (4% vs. 1%), as were administration-related adverse events (10% vs. 5%).

CHICAGO — A single 2-g dose of azithromycin cures early syphilis as effectively as injected penicillin G benzathine, Dr. Edward W. Hook III said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

However, Dr. Hook cautioned that the federally sponsored randomized controlled trial did not include any HIV-positive patients, so its results can't support the use of azithromycin in this population.

"This is the very group in which macrolide-resistant Treponema pallidum mutations have emerged in association with azithromycin treatment," said Dr. Hook of the University of Alabama, Birmingham. "I would certainly not recommend treating these patients with azithromycin for early syphilis."

Neither should the drug be used for syphilis in pregnant women. "In light of the history of macrolide treatment failures among pregnant women, I would caution very, very strongly against treating them with azithromycin for syphilis," Dr. Hook said.

The trial compared the efficacy and safety of 2 g of azithromycin given orally with those of 2.4 million U of penicillin G benzathine in 517 patients with early syphilis. Most of the patients (80%) were in Madagascar; the rest were seen at U.S. clinics.

Patients' mean age was 24 years; 26% had primary syphilis, 46% had secondary syphilis, and 28% had presumed early latent syphilis (a sexual partner in the past 12 months with confirmed syphilis).

Serologic cure rates at 3 months were similar in both groups in the intent-to-treat analysis (74% azithromycin vs. 76% penicillin). At 6 months, the cure rates were still not significantly different (77% azithromycin vs. 78% penicillin). Results at 3 and 6 months in the per-protocol analysis were almost identical, Dr. Hook said.

U.S. patients exhibited slightly, but not significantly, higher cure rates than patients in Madagascar.

Serious adverse events were slightly more common in the penicillin group than they were in the azithromycin group (10 vs. 8, respectively). However, none of these was considered related to the study medication. Nonserious adverse events, especially gastrointestinal distress, were significantly more common among the patients taking azithromycin (61% vs. 46% for penicillin).

The most common adverse events were gastrointestinal, with 24% of the azithromycin group and 7% of the penicillin group experiencing some upset. However, only three patients taking azithromycin vomited.

Cutaneous reactions were more common among those taking penicillin (4% vs. 1%), as were administration-related adverse events (10% vs. 5%).

CHICAGO — A single 2-g dose of azithromycin cures early syphilis as effectively as injected penicillin G benzathine, Dr. Edward W. Hook III said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

However, Dr. Hook cautioned that the federally sponsored randomized controlled trial did not include any HIV-positive patients, so its results can't support the use of azithromycin in this population.

"This is the very group in which macrolide-resistant Treponema pallidum mutations have emerged in association with azithromycin treatment," said Dr. Hook of the University of Alabama, Birmingham. "I would certainly not recommend treating these patients with azithromycin for early syphilis."

Neither should the drug be used for syphilis in pregnant women. "In light of the history of macrolide treatment failures among pregnant women, I would caution very, very strongly against treating them with azithromycin for syphilis," Dr. Hook said.

The trial compared the efficacy and safety of 2 g of azithromycin given orally with those of 2.4 million U of penicillin G benzathine in 517 patients with early syphilis. Most of the patients (80%) were in Madagascar; the rest were seen at U.S. clinics.

Patients' mean age was 24 years; 26% had primary syphilis, 46% had secondary syphilis, and 28% had presumed early latent syphilis (a sexual partner in the past 12 months with confirmed syphilis).

Serologic cure rates at 3 months were similar in both groups in the intent-to-treat analysis (74% azithromycin vs. 76% penicillin). At 6 months, the cure rates were still not significantly different (77% azithromycin vs. 78% penicillin). Results at 3 and 6 months in the per-protocol analysis were almost identical, Dr. Hook said.

U.S. patients exhibited slightly, but not significantly, higher cure rates than patients in Madagascar.

Serious adverse events were slightly more common in the penicillin group than they were in the azithromycin group (10 vs. 8, respectively). However, none of these was considered related to the study medication. Nonserious adverse events, especially gastrointestinal distress, were significantly more common among the patients taking azithromycin (61% vs. 46% for penicillin).

The most common adverse events were gastrointestinal, with 24% of the azithromycin group and 7% of the penicillin group experiencing some upset. However, only three patients taking azithromycin vomited.

Cutaneous reactions were more common among those taking penicillin (4% vs. 1%), as were administration-related adverse events (10% vs. 5%).

CHICAGO — A single 2-g dose of azithromycin cures early syphilis as effectively as injected penicillin G benzathine, Dr. Edward W. Hook III said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

However, Dr. Hook cautioned that the federally sponsored randomized controlled trial did not include any HIV-positive patients, so its results can't support the use of azithromycin in this population.

"This is the very group in which macrolide-resistant Treponema pallidum mutations have emerged in association with azithromycin treatment," said Dr. Hook of the University of Alabama, Birmingham. "I would certainly not recommend treating these patients with azithromycin for early syphilis."

Neither should the drug be used for syphilis in pregnant women. "In light of the history of macrolide treatment failures among pregnant women, I would caution very, very strongly against treating them with azithromycin for syphilis," Dr. Hook said.

The trial compared the efficacy and safety of 2 g of azithromycin given orally with those of 2.4 million U of penicillin G benzathine in 517 patients with early syphilis. Most of the patients (80%) were in Madagascar; the rest were seen at U.S. clinics.

Patients' mean age was 24 years; 26% had primary syphilis, 46% had secondary syphilis, and 28% had presumed early latent syphilis (a sexual partner in the past 12 months with confirmed syphilis).

Serologic cure rates at 3 months were similar in both groups in the intent-to-treat analysis (74% azithromycin vs. 76% penicillin). At 6 months, the cure rates were still not significantly different (77% azithromycin vs. 78% penicillin). Results at 3 and 6 months in the per-protocol analysis were almost identical, Dr. Hook said.

U.S. patients exhibited slightly, but not significantly, higher cure rates than patients in Madagascar.

Serious adverse events were slightly more common in the penicillin group than they were in the azithromycin group (10 vs. 8, respectively). However, none of these was considered related to the study medication. Nonserious adverse events, especially gastrointestinal distress, were significantly more common among the patients taking azithromycin (61% vs. 46% for penicillin).

The most common adverse events were gastrointestinal, with 24% of the azithromycin group and 7% of the penicillin group experiencing some upset. However, only three patients taking azithromycin vomited.

Cutaneous reactions were more common among those taking penicillin (4% vs. 1%), as were administration-related adverse events (10% vs. 5%).

CHICAGO — Azithromycin-resistant strains of Treponema pallidum continue to emerge in San Francisco, despite cessation of the drug's use for syphilis treatment and prophylaxis, and for the treatment of nongonococcal urethritis in gay men.

The city's 5% resistance rate jumped to 40% in 2003, just a year after the San Francisco Department of Public Health began using the drug prophylactically in the sex partners of gay men with symptomatic syphilis, Dr. Kenneth Katz said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

During this time, azithromycin also was used to treat both syphilis and nongonococcal urethritis in gay men who were allergic to penicillin. But despite a 2004 decision to stop using the drug for any syphilis treatment, resistance has risen linearly each year, to a high of 77% in 2006, said Dr. Katz, a public health official with the CDC and the San Francisco Department of Public Health.

In 1998, gay men made up only 20% of the syphilis cases in San Francisco. By early 2002, that proportion had risen to 90%, said Dr. Katz. The increase spurred the city's health department to launch an aggressive program aimed at decreasing the spread of the disease. "Part of our response was to treat the sex partners of symptomatic patients with a single 1-g dose of azithromycin. Symptomatic patients who were allergic to penicillin were treated with a single 2-g dose."

The protocol began in July 2002. Soon after, "we began to notice treatment failures in patients with primary or incubating syphilis who had been treated with azithromycin," he said. Azithromycin kills microbes by binding at the ribosome to inhibit protein synthesis. Some strains of T. pallidum had developed a mutation that inhibited this ribosomal binding.

In September 2004, the city's health department ceased using azithromycin for any syphilis treatment. But a case-control study showed that the resistant mutation was associated with any azithromycin use within 30 days prior to the syphilis diagnosis. Therefore, Dr. Katz said, the azithromycin ban was extended; in 2005, its use was discontinued in nongonococcal urethritis in gay men.

Despite these precautions, azithromycin resistance has continued to increase, he said. The department conducted a polymerase chain reaction assay on samples from 39 positive lesions in 2005 and 2006. Almost all cases (36) were in gay men. Of the 17 lesions sampled in 2005, 13 (76%) contained the resistant strain. In 2006, 17 (77%) contained the strain.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Azithromycin-resistant strains of Treponema pallidum continue to emerge in San Francisco, despite cessation of the drug's use for syphilis treatment and prophylaxis, and for the treatment of nongonococcal urethritis in gay men.

The city's 5% resistance rate jumped to 40% in 2003, just a year after the San Francisco Department of Public Health began using the drug prophylactically in the sex partners of gay men with symptomatic syphilis, Dr. Kenneth Katz said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

During this time, azithromycin also was used to treat both syphilis and nongonococcal urethritis in gay men who were allergic to penicillin. But despite a 2004 decision to stop using the drug for any syphilis treatment, resistance has risen linearly each year, to a high of 77% in 2006, said Dr. Katz, a public health official with the CDC and the San Francisco Department of Public Health.

In 1998, gay men made up only 20% of the syphilis cases in San Francisco. By early 2002, that proportion had risen to 90%, said Dr. Katz. The increase spurred the city's health department to launch an aggressive program aimed at decreasing the spread of the disease. "Part of our response was to treat the sex partners of symptomatic patients with a single 1-g dose of azithromycin. Symptomatic patients who were allergic to penicillin were treated with a single 2-g dose."

The protocol began in July 2002. Soon after, "we began to notice treatment failures in patients with primary or incubating syphilis who had been treated with azithromycin," he said. Azithromycin kills microbes by binding at the ribosome to inhibit protein synthesis. Some strains of T. pallidum had developed a mutation that inhibited this ribosomal binding.

In September 2004, the city's health department ceased using azithromycin for any syphilis treatment. But a case-control study showed that the resistant mutation was associated with any azithromycin use within 30 days prior to the syphilis diagnosis. Therefore, Dr. Katz said, the azithromycin ban was extended; in 2005, its use was discontinued in nongonococcal urethritis in gay men.

Despite these precautions, azithromycin resistance has continued to increase, he said. The department conducted a polymerase chain reaction assay on samples from 39 positive lesions in 2005 and 2006. Almost all cases (36) were in gay men. Of the 17 lesions sampled in 2005, 13 (76%) contained the resistant strain. In 2006, 17 (77%) contained the strain.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Azithromycin-resistant strains of Treponema pallidum continue to emerge in San Francisco, despite cessation of the drug's use for syphilis treatment and prophylaxis, and for the treatment of nongonococcal urethritis in gay men.

The city's 5% resistance rate jumped to 40% in 2003, just a year after the San Francisco Department of Public Health began using the drug prophylactically in the sex partners of gay men with symptomatic syphilis, Dr. Kenneth Katz said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

During this time, azithromycin also was used to treat both syphilis and nongonococcal urethritis in gay men who were allergic to penicillin. But despite a 2004 decision to stop using the drug for any syphilis treatment, resistance has risen linearly each year, to a high of 77% in 2006, said Dr. Katz, a public health official with the CDC and the San Francisco Department of Public Health.

In 1998, gay men made up only 20% of the syphilis cases in San Francisco. By early 2002, that proportion had risen to 90%, said Dr. Katz. The increase spurred the city's health department to launch an aggressive program aimed at decreasing the spread of the disease. "Part of our response was to treat the sex partners of symptomatic patients with a single 1-g dose of azithromycin. Symptomatic patients who were allergic to penicillin were treated with a single 2-g dose."

The protocol began in July 2002. Soon after, "we began to notice treatment failures in patients with primary or incubating syphilis who had been treated with azithromycin," he said. Azithromycin kills microbes by binding at the ribosome to inhibit protein synthesis. Some strains of T. pallidum had developed a mutation that inhibited this ribosomal binding.

In September 2004, the city's health department ceased using azithromycin for any syphilis treatment. But a case-control study showed that the resistant mutation was associated with any azithromycin use within 30 days prior to the syphilis diagnosis. Therefore, Dr. Katz said, the azithromycin ban was extended; in 2005, its use was discontinued in nongonococcal urethritis in gay men.

Despite these precautions, azithromycin resistance has continued to increase, he said. The department conducted a polymerase chain reaction assay on samples from 39 positive lesions in 2005 and 2006. Almost all cases (36) were in gay men. Of the 17 lesions sampled in 2005, 13 (76%) contained the resistant strain. In 2006, 17 (77%) contained the strain.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Safety concerns and lack of efficacy continue to dash researchers' hopes of a vaginal microbicide that would protect women from sexually transmitted diseases and HIV.

"In the last year, we have had some major, huge disappointments," Dr. Jeanne Marrazzo said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. "It has proven very, very difficult to deliver a broad-spectrum microbicide while preserving safety and protecting the integrity of the vaginal mucosa as well as the vaginal flora."

The last 24 months have seen the closure of four highly anticipated studies—one of them when the data safety and monitoring committee actually found an increased risk of HIV among women taking the active product.

Two phase III studies involved cellulose sulfate, a topical microbicide gel, said Dr. Marrazzo, an infectious disease specialist at the University of Washington, Seattle. The trials, which comprised 2,600 women, were being conducted in Africa and India.

The first study, sponsored by CONRAD—an organization established jointly by the U.S. Agency for International Development and Eastern Virginia Medical School, Norfolk—was halted in January 2007 because of a higher number of HIV infections in the active group, compared with the placebo group. In light of those findings, Family Health International, a nonprofit international public health agency in North Carolina, halted its own cellulose sulfate trial.

Family Health research had suffered a previous setback in 2006, when it closed its trial of Savvy gel, a vaginal microbicide tested in a phase II randomized, controlled trial of 2,150 women in Nigeria. After slightly fewer than half the expected number of HIV infections was observed, the investigators saw no evidence that the product was effective in preventing infections.

A similar disappointment occurred at a microbicide research meeting in New Delhi in February, when the Population Council, an international nonprofit research institution, released negative data on its phase III, randomized controlled trial of Carraguard. The seaweed-based vaginal gel was being tested as an HIV and STD preventative.

That trial enrolled 6,200 women in South Africa, and investigators found that although the product was safe, it was not effective for preventing HIV infections; 134 new infections occurred in the experimental arm, compared with 151 new infections in the placebo arm.

Three studies are ongoing, she noted. The National Institute of Allergy and Infectious Diseases is studying BufferGel, a gel designed to maintain vaginal acidity at a level that deactivates HIV particles, and PRO 2000/5, a gel that inhibits viral entry into susceptible cells. Both of these agents will be tested in seven sites (one in the United States and six in Africa). The patient cohort of 3,100 will be followed for up to 30 months.

The U.K. Microbicide Development Program is also looking at PRO 2000/5 in a larger study of 9,600 women. Results are expected in 2009 or 2010.

Because of the disappointing results with microbicides and increased pressure to find a prophylactic approach to HIV infection, researchers are now focusing much more attention on vaginal antiretrovirals, especially tenofovir, Dr. Marrazzo said. "This is exciting, but also scary because some women who use these drugs prophylactically will contract HIV, and there is a possibility that they will then show early treatment resistance to tenofovir, which is the backbone of antiretroviral therapy."

A gel containing 1% tenofovir is getting the most attention. "Some data presented at the New Delhi meeting showed that it was very safe, had no local inflammatory response, and doesn't change the vaginal microflora. It is absorbed, however, and so there are questions about later resistance," she said.

The National Institutes of Health are now launching the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study. VOICE will enroll 4,200 women at 10 African sites. The women will be randomized to active compounds or placebo in one of three arms: once-daily oral tenofovir, a daily two-drug oral antiretroviral regimen, or once-daily 1% tenofovir vaginal gel.

Dr. Marrazzo did not report any financial conflicts of interest.

CHICAGO — Safety concerns and lack of efficacy continue to dash researchers' hopes of a vaginal microbicide that would protect women from sexually transmitted diseases and HIV.

"In the last year, we have had some major, huge disappointments," Dr. Jeanne Marrazzo said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. "It has proven very, very difficult to deliver a broad-spectrum microbicide while preserving safety and protecting the integrity of the vaginal mucosa as well as the vaginal flora."

The last 24 months have seen the closure of four highly anticipated studies—one of them when the data safety and monitoring committee actually found an increased risk of HIV among women taking the active product.

Two phase III studies involved cellulose sulfate, a topical microbicide gel, said Dr. Marrazzo, an infectious disease specialist at the University of Washington, Seattle. The trials, which comprised 2,600 women, were being conducted in Africa and India.

The first study, sponsored by CONRAD—an organization established jointly by the U.S. Agency for International Development and Eastern Virginia Medical School, Norfolk—was halted in January 2007 because of a higher number of HIV infections in the active group, compared with the placebo group. In light of those findings, Family Health International, a nonprofit international public health agency in North Carolina, halted its own cellulose sulfate trial.

Family Health research had suffered a previous setback in 2006, when it closed its trial of Savvy gel, a vaginal microbicide tested in a phase II randomized, controlled trial of 2,150 women in Nigeria. After slightly fewer than half the expected number of HIV infections was observed, the investigators saw no evidence that the product was effective in preventing infections.

A similar disappointment occurred at a microbicide research meeting in New Delhi in February, when the Population Council, an international nonprofit research institution, released negative data on its phase III, randomized controlled trial of Carraguard. The seaweed-based vaginal gel was being tested as an HIV and STD preventative.

That trial enrolled 6,200 women in South Africa, and investigators found that although the product was safe, it was not effective for preventing HIV infections; 134 new infections occurred in the experimental arm, compared with 151 new infections in the placebo arm.

Three studies are ongoing, she noted. The National Institute of Allergy and Infectious Diseases is studying BufferGel, a gel designed to maintain vaginal acidity at a level that deactivates HIV particles, and PRO 2000/5, a gel that inhibits viral entry into susceptible cells. Both of these agents will be tested in seven sites (one in the United States and six in Africa). The patient cohort of 3,100 will be followed for up to 30 months.

The U.K. Microbicide Development Program is also looking at PRO 2000/5 in a larger study of 9,600 women. Results are expected in 2009 or 2010.

Because of the disappointing results with microbicides and increased pressure to find a prophylactic approach to HIV infection, researchers are now focusing much more attention on vaginal antiretrovirals, especially tenofovir, Dr. Marrazzo said. "This is exciting, but also scary because some women who use these drugs prophylactically will contract HIV, and there is a possibility that they will then show early treatment resistance to tenofovir, which is the backbone of antiretroviral therapy."

A gel containing 1% tenofovir is getting the most attention. "Some data presented at the New Delhi meeting showed that it was very safe, had no local inflammatory response, and doesn't change the vaginal microflora. It is absorbed, however, and so there are questions about later resistance," she said.

The National Institutes of Health are now launching the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study. VOICE will enroll 4,200 women at 10 African sites. The women will be randomized to active compounds or placebo in one of three arms: once-daily oral tenofovir, a daily two-drug oral antiretroviral regimen, or once-daily 1% tenofovir vaginal gel.

Dr. Marrazzo did not report any financial conflicts of interest.

CHICAGO — Safety concerns and lack of efficacy continue to dash researchers' hopes of a vaginal microbicide that would protect women from sexually transmitted diseases and HIV.

"In the last year, we have had some major, huge disappointments," Dr. Jeanne Marrazzo said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. "It has proven very, very difficult to deliver a broad-spectrum microbicide while preserving safety and protecting the integrity of the vaginal mucosa as well as the vaginal flora."

The last 24 months have seen the closure of four highly anticipated studies—one of them when the data safety and monitoring committee actually found an increased risk of HIV among women taking the active product.

Two phase III studies involved cellulose sulfate, a topical microbicide gel, said Dr. Marrazzo, an infectious disease specialist at the University of Washington, Seattle. The trials, which comprised 2,600 women, were being conducted in Africa and India.

The first study, sponsored by CONRAD—an organization established jointly by the U.S. Agency for International Development and Eastern Virginia Medical School, Norfolk—was halted in January 2007 because of a higher number of HIV infections in the active group, compared with the placebo group. In light of those findings, Family Health International, a nonprofit international public health agency in North Carolina, halted its own cellulose sulfate trial.

Family Health research had suffered a previous setback in 2006, when it closed its trial of Savvy gel, a vaginal microbicide tested in a phase II randomized, controlled trial of 2,150 women in Nigeria. After slightly fewer than half the expected number of HIV infections was observed, the investigators saw no evidence that the product was effective in preventing infections.

A similar disappointment occurred at a microbicide research meeting in New Delhi in February, when the Population Council, an international nonprofit research institution, released negative data on its phase III, randomized controlled trial of Carraguard. The seaweed-based vaginal gel was being tested as an HIV and STD preventative.

That trial enrolled 6,200 women in South Africa, and investigators found that although the product was safe, it was not effective for preventing HIV infections; 134 new infections occurred in the experimental arm, compared with 151 new infections in the placebo arm.

Three studies are ongoing, she noted. The National Institute of Allergy and Infectious Diseases is studying BufferGel, a gel designed to maintain vaginal acidity at a level that deactivates HIV particles, and PRO 2000/5, a gel that inhibits viral entry into susceptible cells. Both of these agents will be tested in seven sites (one in the United States and six in Africa). The patient cohort of 3,100 will be followed for up to 30 months.

The U.K. Microbicide Development Program is also looking at PRO 2000/5 in a larger study of 9,600 women. Results are expected in 2009 or 2010.

Because of the disappointing results with microbicides and increased pressure to find a prophylactic approach to HIV infection, researchers are now focusing much more attention on vaginal antiretrovirals, especially tenofovir, Dr. Marrazzo said. "This is exciting, but also scary because some women who use these drugs prophylactically will contract HIV, and there is a possibility that they will then show early treatment resistance to tenofovir, which is the backbone of antiretroviral therapy."

A gel containing 1% tenofovir is getting the most attention. "Some data presented at the New Delhi meeting showed that it was very safe, had no local inflammatory response, and doesn't change the vaginal microflora. It is absorbed, however, and so there are questions about later resistance," she said.

The National Institutes of Health are now launching the VOICE (Vaginal and Oral Interventions to Control the Epidemic) study. VOICE will enroll 4,200 women at 10 African sites. The women will be randomized to active compounds or placebo in one of three arms: once-daily oral tenofovir, a daily two-drug oral antiretroviral regimen, or once-daily 1% tenofovir vaginal gel.

Dr. Marrazzo did not report any financial conflicts of interest.

CHICAGO — Only 27% of women requesting emergency contraception received screening for chlamydia and gonorrhea, and of those who were screened, 12% were positive for at least one infection, according to the findings of a study conducted in 10 New York City-based sexual health clinics.

“Emergency contraception [EC] visits represent an important opportunity to improve STD testing and treatment. … Screening more women who request emergency contraception should be a high priority,” said the study's lead investigator, Shoshanna Handel, a public health official with the Centers for Disease Control and Prevention and the New York City Department of Health and Mental Hygiene.

Clinic visit data from a 19-month period were analyzed. A total of 3,758 women made 4,657 requests for EC. For 66% of these women, EC was the main reason for the visit, Ms. Handel said at a conference on STD prevention sponsored by the CDC.

The patients' median age was 21 years, but 12% of the requests came from women under 18 years, who are unable to buy EC without a prescription. More than 75% of the requests came from women aged 25 years and under, precisely the group for which the CDC recommends annual chlamydia and gonorrhea screening. Overall, 27% of the EC visits included testing; 11% of these patients tested positive for chlamydia and 2% for gonorrhea. Women aged 25 and younger were significantly more likely to test positive (14% vs. 7%).

When the visits were separated into EC-only requests and visits comprising EC and other services, there was a significant difference in how often screening was offered. “At the EC-only visits, 4% of women were screened. But at the EC-plus visits, 71% were screened,” Ms. Handel said.

After reviewing the analysis, the New York City STD clinics changed their screening policy for women seeking EC. “Our previous protocol stressed expedited EC access. Now we offer chlamydia and gonorrhea screening as a package with emergency contraception,” she said.

CHICAGO — Only 27% of women requesting emergency contraception received screening for chlamydia and gonorrhea, and of those who were screened, 12% were positive for at least one infection, according to the findings of a study conducted in 10 New York City-based sexual health clinics.

“Emergency contraception [EC] visits represent an important opportunity to improve STD testing and treatment. … Screening more women who request emergency contraception should be a high priority,” said the study's lead investigator, Shoshanna Handel, a public health official with the Centers for Disease Control and Prevention and the New York City Department of Health and Mental Hygiene.

Clinic visit data from a 19-month period were analyzed. A total of 3,758 women made 4,657 requests for EC. For 66% of these women, EC was the main reason for the visit, Ms. Handel said at a conference on STD prevention sponsored by the CDC.

The patients' median age was 21 years, but 12% of the requests came from women under 18 years, who are unable to buy EC without a prescription. More than 75% of the requests came from women aged 25 years and under, precisely the group for which the CDC recommends annual chlamydia and gonorrhea screening. Overall, 27% of the EC visits included testing; 11% of these patients tested positive for chlamydia and 2% for gonorrhea. Women aged 25 and younger were significantly more likely to test positive (14% vs. 7%).

When the visits were separated into EC-only requests and visits comprising EC and other services, there was a significant difference in how often screening was offered. “At the EC-only visits, 4% of women were screened. But at the EC-plus visits, 71% were screened,” Ms. Handel said.

After reviewing the analysis, the New York City STD clinics changed their screening policy for women seeking EC. “Our previous protocol stressed expedited EC access. Now we offer chlamydia and gonorrhea screening as a package with emergency contraception,” she said.

CHICAGO — Only 27% of women requesting emergency contraception received screening for chlamydia and gonorrhea, and of those who were screened, 12% were positive for at least one infection, according to the findings of a study conducted in 10 New York City-based sexual health clinics.

“Emergency contraception [EC] visits represent an important opportunity to improve STD testing and treatment. … Screening more women who request emergency contraception should be a high priority,” said the study's lead investigator, Shoshanna Handel, a public health official with the Centers for Disease Control and Prevention and the New York City Department of Health and Mental Hygiene.

Clinic visit data from a 19-month period were analyzed. A total of 3,758 women made 4,657 requests for EC. For 66% of these women, EC was the main reason for the visit, Ms. Handel said at a conference on STD prevention sponsored by the CDC.

The patients' median age was 21 years, but 12% of the requests came from women under 18 years, who are unable to buy EC without a prescription. More than 75% of the requests came from women aged 25 years and under, precisely the group for which the CDC recommends annual chlamydia and gonorrhea screening. Overall, 27% of the EC visits included testing; 11% of these patients tested positive for chlamydia and 2% for gonorrhea. Women aged 25 and younger were significantly more likely to test positive (14% vs. 7%).

When the visits were separated into EC-only requests and visits comprising EC and other services, there was a significant difference in how often screening was offered. “At the EC-only visits, 4% of women were screened. But at the EC-plus visits, 71% were screened,” Ms. Handel said.

After reviewing the analysis, the New York City STD clinics changed their screening policy for women seeking EC. “Our previous protocol stressed expedited EC access. Now we offer chlamydia and gonorrhea screening as a package with emergency contraception,” she said.

CHICAGO — Safety concerns and lack of efficacy continue to dash researchers' hopes of a vaginal microbicide that would protect women from sexually transmitted diseases and HIV.

“In the last year, we have had some major, huge disappointments,” Dr. Jeanne Marrazzo said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. “It has proven very, very difficult to deliver a broad-spectrum microbicide while preserving safety and protecting the integrity of the vaginal mucosa as well as the vaginal flora.”

The last 24 months have seen the closure of four highly anticipated studies—one of them when the data safety and monitoring committee actually found an increased risk of HIV among women taking the active product.

Two phase III studies involved cellulose sulfate, a topical microbicide gel, said Dr. Marrazzo, an infectious disease specialist at the University of Washington, Seattle. The trials, which comprised 2,600 women, were being conducted in Africa and India.

The first study, sponsored by CONRAD—an organization established jointly by the U.S. Agency for International Development and Eastern Virginia Medical School, Norfolk—was halted in January 2007 because of a higher number of HIV infections in the active group, compared with the placebo group. In light of those findings, Family Health International, a nonprofit international public health agency in North Carolina, halted its own cellulose sulfate trial.

Family Health research had suffered a previous setback in 2006, when it closed its trial of Savvy gel, a vaginal microbicide tested in a phase II randomized, controlled trial of 2,150 women in Nigeria. After slightly fewer than half the expected number of HIV infections was observed, the investigators saw no evidence that the product was effective in preventing infections.

A similar disappointment occurred at a microbicide research meeting in New Delhi in February, when the Population Council, an international nonprofit research institution, released negative data on its phase III, randomized controlled trial of Carraguard. The seaweed-based vaginal gel was being tested as an HIV and STD preventative. That trial enrolled 6,200 women in South Africa, and investigators found that although the product was safe, it was not effective for preventing HIV infections; 134 new infections occurred in the experimental arm, compared with 151 new infections in the placebo arm.

Three studies are ongoing, she noted. The National Institute of Allergy and Infectious Diseases is studying BufferGel, a gel designed to maintain vaginal acidity at a level that deactivates HIV particles, and PRO 2000/5, a gel that inhibits viral entry into susceptible cells. Both of these agents will be tested in seven sites (one U.S. and six African sites). The patient cohort of 3,100 will be followed for up to 30 months. “We hope to have results by the end of this year or early 2009,” Dr. Marrazzo said.

The U.K. Microbicide Development Program is also looking at PRO 2000/5 in a larger study of 9,600 women. Results are expected in 2009 or 2010.

Because of the disappointing results with microbicides and pressure to find a prophylactic approach to HIV infection, researchers are now focusing much more attention on vaginal antiretrovirals, especially tenofovir, Dr. Marrazzo said. “This is exciting, but also scary because some women who use these drugs prophylactically will contract HIV, and there is a possibility that they will then show early treatment resistance to tenofovir, which is the backbone of antiretroviral therapy.”

A 1% tenofovir gel is getting the most attention, she said. “Some data presented at the New Delhi meeting showed that it was very safe, had no local inflammatory response, and doesn't change the vaginal microflora. It is absorbed, however, and so there are questions about later resistance.”

Dr. Marrazzo did not report any financial conflicts of interest.

CHICAGO — Safety concerns and lack of efficacy continue to dash researchers' hopes of a vaginal microbicide that would protect women from sexually transmitted diseases and HIV.

“In the last year, we have had some major, huge disappointments,” Dr. Jeanne Marrazzo said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. “It has proven very, very difficult to deliver a broad-spectrum microbicide while preserving safety and protecting the integrity of the vaginal mucosa as well as the vaginal flora.”

The last 24 months have seen the closure of four highly anticipated studies—one of them when the data safety and monitoring committee actually found an increased risk of HIV among women taking the active product.

Two phase III studies involved cellulose sulfate, a topical microbicide gel, said Dr. Marrazzo, an infectious disease specialist at the University of Washington, Seattle. The trials, which comprised 2,600 women, were being conducted in Africa and India.

The first study, sponsored by CONRAD—an organization established jointly by the U.S. Agency for International Development and Eastern Virginia Medical School, Norfolk—was halted in January 2007 because of a higher number of HIV infections in the active group, compared with the placebo group. In light of those findings, Family Health International, a nonprofit international public health agency in North Carolina, halted its own cellulose sulfate trial.

Family Health research had suffered a previous setback in 2006, when it closed its trial of Savvy gel, a vaginal microbicide tested in a phase II randomized, controlled trial of 2,150 women in Nigeria. After slightly fewer than half the expected number of HIV infections was observed, the investigators saw no evidence that the product was effective in preventing infections.

A similar disappointment occurred at a microbicide research meeting in New Delhi in February, when the Population Council, an international nonprofit research institution, released negative data on its phase III, randomized controlled trial of Carraguard. The seaweed-based vaginal gel was being tested as an HIV and STD preventative. That trial enrolled 6,200 women in South Africa, and investigators found that although the product was safe, it was not effective for preventing HIV infections; 134 new infections occurred in the experimental arm, compared with 151 new infections in the placebo arm.

Three studies are ongoing, she noted. The National Institute of Allergy and Infectious Diseases is studying BufferGel, a gel designed to maintain vaginal acidity at a level that deactivates HIV particles, and PRO 2000/5, a gel that inhibits viral entry into susceptible cells. Both of these agents will be tested in seven sites (one U.S. and six African sites). The patient cohort of 3,100 will be followed for up to 30 months. “We hope to have results by the end of this year or early 2009,” Dr. Marrazzo said.

The U.K. Microbicide Development Program is also looking at PRO 2000/5 in a larger study of 9,600 women. Results are expected in 2009 or 2010.

Because of the disappointing results with microbicides and pressure to find a prophylactic approach to HIV infection, researchers are now focusing much more attention on vaginal antiretrovirals, especially tenofovir, Dr. Marrazzo said. “This is exciting, but also scary because some women who use these drugs prophylactically will contract HIV, and there is a possibility that they will then show early treatment resistance to tenofovir, which is the backbone of antiretroviral therapy.”

A 1% tenofovir gel is getting the most attention, she said. “Some data presented at the New Delhi meeting showed that it was very safe, had no local inflammatory response, and doesn't change the vaginal microflora. It is absorbed, however, and so there are questions about later resistance.”

Dr. Marrazzo did not report any financial conflicts of interest.

CHICAGO — Safety concerns and lack of efficacy continue to dash researchers' hopes of a vaginal microbicide that would protect women from sexually transmitted diseases and HIV.

“In the last year, we have had some major, huge disappointments,” Dr. Jeanne Marrazzo said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention. “It has proven very, very difficult to deliver a broad-spectrum microbicide while preserving safety and protecting the integrity of the vaginal mucosa as well as the vaginal flora.”

The last 24 months have seen the closure of four highly anticipated studies—one of them when the data safety and monitoring committee actually found an increased risk of HIV among women taking the active product.

Two phase III studies involved cellulose sulfate, a topical microbicide gel, said Dr. Marrazzo, an infectious disease specialist at the University of Washington, Seattle. The trials, which comprised 2,600 women, were being conducted in Africa and India.

The first study, sponsored by CONRAD—an organization established jointly by the U.S. Agency for International Development and Eastern Virginia Medical School, Norfolk—was halted in January 2007 because of a higher number of HIV infections in the active group, compared with the placebo group. In light of those findings, Family Health International, a nonprofit international public health agency in North Carolina, halted its own cellulose sulfate trial.

Family Health research had suffered a previous setback in 2006, when it closed its trial of Savvy gel, a vaginal microbicide tested in a phase II randomized, controlled trial of 2,150 women in Nigeria. After slightly fewer than half the expected number of HIV infections was observed, the investigators saw no evidence that the product was effective in preventing infections.

A similar disappointment occurred at a microbicide research meeting in New Delhi in February, when the Population Council, an international nonprofit research institution, released negative data on its phase III, randomized controlled trial of Carraguard. The seaweed-based vaginal gel was being tested as an HIV and STD preventative. That trial enrolled 6,200 women in South Africa, and investigators found that although the product was safe, it was not effective for preventing HIV infections; 134 new infections occurred in the experimental arm, compared with 151 new infections in the placebo arm.

Three studies are ongoing, she noted. The National Institute of Allergy and Infectious Diseases is studying BufferGel, a gel designed to maintain vaginal acidity at a level that deactivates HIV particles, and PRO 2000/5, a gel that inhibits viral entry into susceptible cells. Both of these agents will be tested in seven sites (one U.S. and six African sites). The patient cohort of 3,100 will be followed for up to 30 months. “We hope to have results by the end of this year or early 2009,” Dr. Marrazzo said.

The U.K. Microbicide Development Program is also looking at PRO 2000/5 in a larger study of 9,600 women. Results are expected in 2009 or 2010.

Because of the disappointing results with microbicides and pressure to find a prophylactic approach to HIV infection, researchers are now focusing much more attention on vaginal antiretrovirals, especially tenofovir, Dr. Marrazzo said. “This is exciting, but also scary because some women who use these drugs prophylactically will contract HIV, and there is a possibility that they will then show early treatment resistance to tenofovir, which is the backbone of antiretroviral therapy.”

A 1% tenofovir gel is getting the most attention, she said. “Some data presented at the New Delhi meeting showed that it was very safe, had no local inflammatory response, and doesn't change the vaginal microflora. It is absorbed, however, and so there are questions about later resistance.”

Dr. Marrazzo did not report any financial conflicts of interest.

CHICAGO — Young women with pelvic inflammatory disease are more likely than older women to test positive for chlamydia and gonococcal infections, Dr. Joan Chow of the California Department of Public Health reported.

Although the overall prevalence of chlamydia was only 12%, 21% of women younger than 20 years tested positive for the infection, compared with 16% of women aged 21–25 years, and just 5% of those older than 25 years. Gonococcal infections also were significantly more common in the youngest women, Dr. Chow said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

“The significantly higher chlamydia and gonococcal prevalence among younger cases of PID [pelvic inflammatory disease] suggests that the etiology of PID in women older than 25 may be different than it is in younger women. This is consistent with the very low levels of cervical chlamydia and gonococci that we consistently observe among older women in national and local prevalent monitoring data.”

Dr. Chow's cross-sectional analysis drew on two sources of data: paid claims from California's Family Planning, Access, Care, and Treatment (FPACT) program, which serves low-income women, and linked test data from Quest Diagnostics, which account for about 18% of all chlamydia testing in the program.

Of the 381 women with PID included in the analysis, 22% were younger than 20 years, 29% were aged 21–25 years, and the rest were older than 25 years. More than half (56%) were Hispanic, 28% were white, and 5% were black. Other racial groups made up the remainder of the patient population.

Chlamydia prevalence was highest in the youngest women (21%). Among those aged 21–25 years, prevalence was 16%, dropping to 5% in those older than 25 years.

In a comparator group of 333,000 FPACT patients without PID, chlamydia prevalence was 6% in those younger than 20 years, 5% in the 21- to 25-year-olds, and 2% in those older than 25 years.

Gonorrhea prevalence also was highest in those younger than 20 years (4%) in the group with PID. Prevalence was 2% in the 21- to 25-year-olds and 1% in those older than 25 years.

In the comparator group without PID, gonorrhea prevalence was less than 1% in each age group.

The findings stress the importance of following national guidelines for annual screening in women younger than 25 years, Dr. Chow said at the meeting.

“While chlamydia screening has increased since the release of the recommendations, screening is still only reaching about 50% of sexually active young women,” she noted.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Young women with pelvic inflammatory disease are more likely than older women to test positive for chlamydia and gonococcal infections, Dr. Joan Chow of the California Department of Public Health reported.

Although the overall prevalence of chlamydia was only 12%, 21% of women younger than 20 years tested positive for the infection, compared with 16% of women aged 21–25 years, and just 5% of those older than 25 years. Gonococcal infections also were significantly more common in the youngest women, Dr. Chow said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

“The significantly higher chlamydia and gonococcal prevalence among younger cases of PID [pelvic inflammatory disease] suggests that the etiology of PID in women older than 25 may be different than it is in younger women. This is consistent with the very low levels of cervical chlamydia and gonococci that we consistently observe among older women in national and local prevalent monitoring data.”

Dr. Chow's cross-sectional analysis drew on two sources of data: paid claims from California's Family Planning, Access, Care, and Treatment (FPACT) program, which serves low-income women, and linked test data from Quest Diagnostics, which account for about 18% of all chlamydia testing in the program.

Of the 381 women with PID included in the analysis, 22% were younger than 20 years, 29% were aged 21–25 years, and the rest were older than 25 years. More than half (56%) were Hispanic, 28% were white, and 5% were black. Other racial groups made up the remainder of the patient population.

Chlamydia prevalence was highest in the youngest women (21%). Among those aged 21–25 years, prevalence was 16%, dropping to 5% in those older than 25 years.

In a comparator group of 333,000 FPACT patients without PID, chlamydia prevalence was 6% in those younger than 20 years, 5% in the 21- to 25-year-olds, and 2% in those older than 25 years.

Gonorrhea prevalence also was highest in those younger than 20 years (4%) in the group with PID. Prevalence was 2% in the 21- to 25-year-olds and 1% in those older than 25 years.

In the comparator group without PID, gonorrhea prevalence was less than 1% in each age group.

The findings stress the importance of following national guidelines for annual screening in women younger than 25 years, Dr. Chow said at the meeting.

“While chlamydia screening has increased since the release of the recommendations, screening is still only reaching about 50% of sexually active young women,” she noted.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Young women with pelvic inflammatory disease are more likely than older women to test positive for chlamydia and gonococcal infections, Dr. Joan Chow of the California Department of Public Health reported.

Although the overall prevalence of chlamydia was only 12%, 21% of women younger than 20 years tested positive for the infection, compared with 16% of women aged 21–25 years, and just 5% of those older than 25 years. Gonococcal infections also were significantly more common in the youngest women, Dr. Chow said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

“The significantly higher chlamydia and gonococcal prevalence among younger cases of PID [pelvic inflammatory disease] suggests that the etiology of PID in women older than 25 may be different than it is in younger women. This is consistent with the very low levels of cervical chlamydia and gonococci that we consistently observe among older women in national and local prevalent monitoring data.”

Dr. Chow's cross-sectional analysis drew on two sources of data: paid claims from California's Family Planning, Access, Care, and Treatment (FPACT) program, which serves low-income women, and linked test data from Quest Diagnostics, which account for about 18% of all chlamydia testing in the program.

Of the 381 women with PID included in the analysis, 22% were younger than 20 years, 29% were aged 21–25 years, and the rest were older than 25 years. More than half (56%) were Hispanic, 28% were white, and 5% were black. Other racial groups made up the remainder of the patient population.

Chlamydia prevalence was highest in the youngest women (21%). Among those aged 21–25 years, prevalence was 16%, dropping to 5% in those older than 25 years.

In a comparator group of 333,000 FPACT patients without PID, chlamydia prevalence was 6% in those younger than 20 years, 5% in the 21- to 25-year-olds, and 2% in those older than 25 years.

Gonorrhea prevalence also was highest in those younger than 20 years (4%) in the group with PID. Prevalence was 2% in the 21- to 25-year-olds and 1% in those older than 25 years.

In the comparator group without PID, gonorrhea prevalence was less than 1% in each age group.

The findings stress the importance of following national guidelines for annual screening in women younger than 25 years, Dr. Chow said at the meeting.

“While chlamydia screening has increased since the release of the recommendations, screening is still only reaching about 50% of sexually active young women,” she noted.

ELSEVIER GLOBAL MEDICAL NEWS

About two-thirds of minority patients referred for colonoscopy by a primary care physician completed the procedure if they were guided along the way by a patient navigator, according to the findings of an observational study.

The use of a patient navigator also enhanced compliance with the bowel preparation process and increased patient satisfaction with the procedure, reported Dr. Lee Ann Chen of the Mount Sinai School of Medicine, New York, and her coinvestigators.

Patient navigation is part of the facility's ongoing efforts to increase screening colonoscopy by decreasing organizational barriers, the authors said. This effort began with an open-access referral program, in which primary care physicians were able to refer patients directly for the procedure, bypassing evaluation by a gastroenterologist.

“This decreases the number of appointments a patient must complete before obtaining a screening colonoscopy and shortens the time to screening colonoscopy … open access can increase the number of screening colonoscopies and enhance neoplasm detection,” they wrote.

To further increase screening rates, they added a bilingual (Spanish/English) female health educator as a patient navigator. She received specialized training on colonoscopy and guided each referred patient through the process. This involved gathering medical information, scheduling the colonoscopy, explaining the bowel prep process, frequently reminding patients of their appointment by phone and mail, and even personally meeting with patients who were fearful of the procedure.

The authors presented results from 532 patients who had used the services of a patient navigator. Their mean age was 56 years; 79% were female. Hispanic patients made up 55% of the group; 31% were black; the rest were other ethnic groups.

Overall, 353 (66%) completed their colonoscopy. Reasons for noncompletion among the remaining 179 patients were the desire to speak in detail with their physician before the procedure (14) and refusal to undergo the procedure (52). Forty-seven patients never returned the navigator's phone calls, 14 rescheduled their colonoscopies more than four times, and 52 did not show up for their scheduled colonoscopies twice.

Women were 31% more likely to complete the colonoscopy than men. Of the completers, 60% were Hispanic and 28% were black. Hispanic patients were 67% more likely than were blacks to complete the colonoscopy, while Hispanic women were 50% more likely to complete the colonoscopy than Hispanic men were. There were no significant gender differences among black patients.

Bowel prep information was available for 330 patients who completed the procedure. Of these, 9% of the bowel preparations were rated as excellent, 34% were very good, 48% were good, 4% were fair, and 5% were poor. The facility's historical percentage of poor preps was 12%.

Overall, 34% of patients had a polyp or mass removed and biopsied. Among the 58 patients with an adenoma, 12% had villous histology, 12% had an adenoma larger than 1 cm, and 5% had an adenoma with high-grade dysplasia or cancer. Two patients had an advanced adenoma. Both patients underwent surgical resection with no residual cancer at the polypectomy site or in the regional lymph nodes.

A subset of patients (196) completed a patient satisfaction survey. Most (84%) said their primary care physician adequately explained the reason for their screening colonoscopy, but that figure rose to 92% after contact with the patient navigator. Likewise, 86% said they were extremely satisfied with their primary care physician's explanation of the bowel prep, but that number rose to 99% after contact with the navigator. A high percentage (87%) said the navigator was able to calm their preprocedure fears, and 66% said they would not have completed the colonoscopy without the navigator's attention.

About two-thirds of minority patients referred for colonoscopy by a primary care physician completed the procedure if they were guided along the way by a patient navigator, according to the findings of an observational study.

The use of a patient navigator also enhanced compliance with the bowel preparation process and increased patient satisfaction with the procedure, reported Dr. Lee Ann Chen of the Mount Sinai School of Medicine, New York, and her coinvestigators.

Patient navigation is part of the facility's ongoing efforts to increase screening colonoscopy by decreasing organizational barriers, the authors said. This effort began with an open-access referral program, in which primary care physicians were able to refer patients directly for the procedure, bypassing evaluation by a gastroenterologist.

“This decreases the number of appointments a patient must complete before obtaining a screening colonoscopy and shortens the time to screening colonoscopy … open access can increase the number of screening colonoscopies and enhance neoplasm detection,” they wrote.

To further increase screening rates, they added a bilingual (Spanish/English) female health educator as a patient navigator. She received specialized training on colonoscopy and guided each referred patient through the process. This involved gathering medical information, scheduling the colonoscopy, explaining the bowel prep process, frequently reminding patients of their appointment by phone and mail, and even personally meeting with patients who were fearful of the procedure.

The authors presented results from 532 patients who had used the services of a patient navigator. Their mean age was 56 years; 79% were female. Hispanic patients made up 55% of the group; 31% were black; the rest were other ethnic groups.

Overall, 353 (66%) completed their colonoscopy. Reasons for noncompletion among the remaining 179 patients were the desire to speak in detail with their physician before the procedure (14) and refusal to undergo the procedure (52). Forty-seven patients never returned the navigator's phone calls, 14 rescheduled their colonoscopies more than four times, and 52 did not show up for their scheduled colonoscopies twice.

Women were 31% more likely to complete the colonoscopy than men. Of the completers, 60% were Hispanic and 28% were black. Hispanic patients were 67% more likely than were blacks to complete the colonoscopy, while Hispanic women were 50% more likely to complete the colonoscopy than Hispanic men were. There were no significant gender differences among black patients.

Bowel prep information was available for 330 patients who completed the procedure. Of these, 9% of the bowel preparations were rated as excellent, 34% were very good, 48% were good, 4% were fair, and 5% were poor. The facility's historical percentage of poor preps was 12%.

Overall, 34% of patients had a polyp or mass removed and biopsied. Among the 58 patients with an adenoma, 12% had villous histology, 12% had an adenoma larger than 1 cm, and 5% had an adenoma with high-grade dysplasia or cancer. Two patients had an advanced adenoma. Both patients underwent surgical resection with no residual cancer at the polypectomy site or in the regional lymph nodes.

A subset of patients (196) completed a patient satisfaction survey. Most (84%) said their primary care physician adequately explained the reason for their screening colonoscopy, but that figure rose to 92% after contact with the patient navigator. Likewise, 86% said they were extremely satisfied with their primary care physician's explanation of the bowel prep, but that number rose to 99% after contact with the navigator. A high percentage (87%) said the navigator was able to calm their preprocedure fears, and 66% said they would not have completed the colonoscopy without the navigator's attention.

About two-thirds of minority patients referred for colonoscopy by a primary care physician completed the procedure if they were guided along the way by a patient navigator, according to the findings of an observational study.

The use of a patient navigator also enhanced compliance with the bowel preparation process and increased patient satisfaction with the procedure, reported Dr. Lee Ann Chen of the Mount Sinai School of Medicine, New York, and her coinvestigators.

Patient navigation is part of the facility's ongoing efforts to increase screening colonoscopy by decreasing organizational barriers, the authors said. This effort began with an open-access referral program, in which primary care physicians were able to refer patients directly for the procedure, bypassing evaluation by a gastroenterologist.

“This decreases the number of appointments a patient must complete before obtaining a screening colonoscopy and shortens the time to screening colonoscopy … open access can increase the number of screening colonoscopies and enhance neoplasm detection,” they wrote.

To further increase screening rates, they added a bilingual (Spanish/English) female health educator as a patient navigator. She received specialized training on colonoscopy and guided each referred patient through the process. This involved gathering medical information, scheduling the colonoscopy, explaining the bowel prep process, frequently reminding patients of their appointment by phone and mail, and even personally meeting with patients who were fearful of the procedure.

The authors presented results from 532 patients who had used the services of a patient navigator. Their mean age was 56 years; 79% were female. Hispanic patients made up 55% of the group; 31% were black; the rest were other ethnic groups.

Overall, 353 (66%) completed their colonoscopy. Reasons for noncompletion among the remaining 179 patients were the desire to speak in detail with their physician before the procedure (14) and refusal to undergo the procedure (52). Forty-seven patients never returned the navigator's phone calls, 14 rescheduled their colonoscopies more than four times, and 52 did not show up for their scheduled colonoscopies twice.

Women were 31% more likely to complete the colonoscopy than men. Of the completers, 60% were Hispanic and 28% were black. Hispanic patients were 67% more likely than were blacks to complete the colonoscopy, while Hispanic women were 50% more likely to complete the colonoscopy than Hispanic men were. There were no significant gender differences among black patients.

Bowel prep information was available for 330 patients who completed the procedure. Of these, 9% of the bowel preparations were rated as excellent, 34% were very good, 48% were good, 4% were fair, and 5% were poor. The facility's historical percentage of poor preps was 12%.

Overall, 34% of patients had a polyp or mass removed and biopsied. Among the 58 patients with an adenoma, 12% had villous histology, 12% had an adenoma larger than 1 cm, and 5% had an adenoma with high-grade dysplasia or cancer. Two patients had an advanced adenoma. Both patients underwent surgical resection with no residual cancer at the polypectomy site or in the regional lymph nodes.

A subset of patients (196) completed a patient satisfaction survey. Most (84%) said their primary care physician adequately explained the reason for their screening colonoscopy, but that figure rose to 92% after contact with the patient navigator. Likewise, 86% said they were extremely satisfied with their primary care physician's explanation of the bowel prep, but that number rose to 99% after contact with the navigator. A high percentage (87%) said the navigator was able to calm their preprocedure fears, and 66% said they would not have completed the colonoscopy without the navigator's attention.

CHICAGO — A cloudy cervical exudate observed on clinical exam is strongly associated with Mycoplasma genitalium infections, especially in women older than 25 years.

The age correlation suggests a different immunologic response to the bacterium in older women, and may partially explain the conflicting literature regarding the association of M. genitalium and cervicitis, Lisa Manhart, Ph.D., said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Manhart and her associates examined M. genitalium infections in 1,038 women aged 14–46 years who attended a public STD clinic from 2000 to 2006. All of the women underwent an external and internal pelvic exam; providers collected urine specimens and cervical swabs, and the women submitted a self-collected vaginal swab. M. genitalium infection was determined by either polymerase chain reaction or transcription-mediated amplification assay.

M. genitalium was detected in 119 women (11%), of whom 5 (4%) were coinfected with gonorrhea and 7 (6%) with chlamydia, said Dr. Manhart of the University of Washington, Seattle.

Women with M. genitalium were significantly younger than those without (24 vs. 27 years), and significantly more likely to be black (57% vs. 35%). They had a significantly younger age at sexual debut (15 vs. 16 years), were more likely to be smokers, and were less likely to be taking oral contraceptives. There were no significant associations with sexual behaviors (other than debut) or with the time since their last sexual encounter.

The incidence of mucopurulent cervicitis was not significantly different between those with and without infection (14% vs. 9%). More than 30 polymorphonuclear neutrophils per high-magnification field were seen in 18% of the infected women and in 14% of the noninfected women—not a significant difference. Cervical mucopus was present in 4% of each group, and 11% of each group had easy cervical bleeding.

The researchers then examined the incidence of mild cervicitis in the women. “[Most] women in both groups had very low levels of polymorphonuclear neutrophils (up to 14 per high-magnification field),” Dr. Manhart said. “However, we did see a significant difference when we looked at the incidence of cloudy cervical discharge. This was present in 22% of the women with M. genitalium infections, but only in 12% of those without the infection.”

This pattern was consistent in a multivariate analysis that adjusted for other known causes of mucopurulent cervicitis and cloudy discharge, including gonorrhea and chlamydia infections and the use of oral contraceptives, Dr. Manhart said.

After adjusting for these factors, women with mucopurulent cervicitis had a modest, but nonsignificant, 60% increased risk of the infection, compared with those without mucopurulent cervicitis. Women with cloudy cervical discharge, however, were twice as likely to have the infection as those without cloudy discharge—a significantly increased risk.

Of eight studies that have examined the association of M. genitalium and cervicitis, four have found a significant association, and four have not, Dr. Manhart said. “The studies that showed an association looked at populations with broad age groups, ranging from 18 years to the mid-40s, while those that showed no relationship were conducted in [younger] populations.”

Given the known associations of cervicitis with chlamydia infection and younger age, they investigated the impact of age on the risk of M. genitalium infection and cervicitis. The association went in the opposite direction of what they expected.

Although the infection was more prevalent in younger women, they were less likely than older women to show an association between M. genitalium and cervicitis. In women younger than 25 years, there was no significant relationship between the infection and either mucopurulent cervicitis or cloudy discharge. But women older than 25 years who had M. genitalium were 2.5 times more likely to have mucopurulent discharge and 2.4 times more likely to have cloudy cervical discharge than women under 25 years.

“This suggests that older women have a different immunologic response to M. genitalium,” Dr. Manhart said, “[but] we can't draw any conclusions about causality.” Dr. Manhart reported no financial disclosures related to the study.

CHICAGO — A cloudy cervical exudate observed on clinical exam is strongly associated with Mycoplasma genitalium infections, especially in women older than 25 years.

The age correlation suggests a different immunologic response to the bacterium in older women, and may partially explain the conflicting literature regarding the association of M. genitalium and cervicitis, Lisa Manhart, Ph.D., said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Manhart and her associates examined M. genitalium infections in 1,038 women aged 14–46 years who attended a public STD clinic from 2000 to 2006. All of the women underwent an external and internal pelvic exam; providers collected urine specimens and cervical swabs, and the women submitted a self-collected vaginal swab. M. genitalium infection was determined by either polymerase chain reaction or transcription-mediated amplification assay.

M. genitalium was detected in 119 women (11%), of whom 5 (4%) were coinfected with gonorrhea and 7 (6%) with chlamydia, said Dr. Manhart of the University of Washington, Seattle.

Women with M. genitalium were significantly younger than those without (24 vs. 27 years), and significantly more likely to be black (57% vs. 35%). They had a significantly younger age at sexual debut (15 vs. 16 years), were more likely to be smokers, and were less likely to be taking oral contraceptives. There were no significant associations with sexual behaviors (other than debut) or with the time since their last sexual encounter.

The incidence of mucopurulent cervicitis was not significantly different between those with and without infection (14% vs. 9%). More than 30 polymorphonuclear neutrophils per high-magnification field were seen in 18% of the infected women and in 14% of the noninfected women—not a significant difference. Cervical mucopus was present in 4% of each group, and 11% of each group had easy cervical bleeding.

The researchers then examined the incidence of mild cervicitis in the women. “[Most] women in both groups had very low levels of polymorphonuclear neutrophils (up to 14 per high-magnification field),” Dr. Manhart said. “However, we did see a significant difference when we looked at the incidence of cloudy cervical discharge. This was present in 22% of the women with M. genitalium infections, but only in 12% of those without the infection.”

This pattern was consistent in a multivariate analysis that adjusted for other known causes of mucopurulent cervicitis and cloudy discharge, including gonorrhea and chlamydia infections and the use of oral contraceptives, Dr. Manhart said.

After adjusting for these factors, women with mucopurulent cervicitis had a modest, but nonsignificant, 60% increased risk of the infection, compared with those without mucopurulent cervicitis. Women with cloudy cervical discharge, however, were twice as likely to have the infection as those without cloudy discharge—a significantly increased risk.

Of eight studies that have examined the association of M. genitalium and cervicitis, four have found a significant association, and four have not, Dr. Manhart said. “The studies that showed an association looked at populations with broad age groups, ranging from 18 years to the mid-40s, while those that showed no relationship were conducted in [younger] populations.”

Given the known associations of cervicitis with chlamydia infection and younger age, they investigated the impact of age on the risk of M. genitalium infection and cervicitis. The association went in the opposite direction of what they expected.

Although the infection was more prevalent in younger women, they were less likely than older women to show an association between M. genitalium and cervicitis. In women younger than 25 years, there was no significant relationship between the infection and either mucopurulent cervicitis or cloudy discharge. But women older than 25 years who had M. genitalium were 2.5 times more likely to have mucopurulent discharge and 2.4 times more likely to have cloudy cervical discharge than women under 25 years.

“This suggests that older women have a different immunologic response to M. genitalium,” Dr. Manhart said, “[but] we can't draw any conclusions about causality.” Dr. Manhart reported no financial disclosures related to the study.

CHICAGO — A cloudy cervical exudate observed on clinical exam is strongly associated with Mycoplasma genitalium infections, especially in women older than 25 years.

The age correlation suggests a different immunologic response to the bacterium in older women, and may partially explain the conflicting literature regarding the association of M. genitalium and cervicitis, Lisa Manhart, Ph.D., said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.

Dr. Manhart and her associates examined M. genitalium infections in 1,038 women aged 14–46 years who attended a public STD clinic from 2000 to 2006. All of the women underwent an external and internal pelvic exam; providers collected urine specimens and cervical swabs, and the women submitted a self-collected vaginal swab. M. genitalium infection was determined by either polymerase chain reaction or transcription-mediated amplification assay.

M. genitalium was detected in 119 women (11%), of whom 5 (4%) were coinfected with gonorrhea and 7 (6%) with chlamydia, said Dr. Manhart of the University of Washington, Seattle.

Women with M. genitalium were significantly younger than those without (24 vs. 27 years), and significantly more likely to be black (57% vs. 35%). They had a significantly younger age at sexual debut (15 vs. 16 years), were more likely to be smokers, and were less likely to be taking oral contraceptives. There were no significant associations with sexual behaviors (other than debut) or with the time since their last sexual encounter.

The incidence of mucopurulent cervicitis was not significantly different between those with and without infection (14% vs. 9%). More than 30 polymorphonuclear neutrophils per high-magnification field were seen in 18% of the infected women and in 14% of the noninfected women—not a significant difference. Cervical mucopus was present in 4% of each group, and 11% of each group had easy cervical bleeding.

The researchers then examined the incidence of mild cervicitis in the women. “[Most] women in both groups had very low levels of polymorphonuclear neutrophils (up to 14 per high-magnification field),” Dr. Manhart said. “However, we did see a significant difference when we looked at the incidence of cloudy cervical discharge. This was present in 22% of the women with M. genitalium infections, but only in 12% of those without the infection.”

This pattern was consistent in a multivariate analysis that adjusted for other known causes of mucopurulent cervicitis and cloudy discharge, including gonorrhea and chlamydia infections and the use of oral contraceptives, Dr. Manhart said.

After adjusting for these factors, women with mucopurulent cervicitis had a modest, but nonsignificant, 60% increased risk of the infection, compared with those without mucopurulent cervicitis. Women with cloudy cervical discharge, however, were twice as likely to have the infection as those without cloudy discharge—a significantly increased risk.

Of eight studies that have examined the association of M. genitalium and cervicitis, four have found a significant association, and four have not, Dr. Manhart said. “The studies that showed an association looked at populations with broad age groups, ranging from 18 years to the mid-40s, while those that showed no relationship were conducted in [younger] populations.”

Given the known associations of cervicitis with chlamydia infection and younger age, they investigated the impact of age on the risk of M. genitalium infection and cervicitis. The association went in the opposite direction of what they expected.

Although the infection was more prevalent in younger women, they were less likely than older women to show an association between M. genitalium and cervicitis. In women younger than 25 years, there was no significant relationship between the infection and either mucopurulent cervicitis or cloudy discharge. But women older than 25 years who had M. genitalium were 2.5 times more likely to have mucopurulent discharge and 2.4 times more likely to have cloudy cervical discharge than women under 25 years.

“This suggests that older women have a different immunologic response to M. genitalium,” Dr. Manhart said, “[but] we can't draw any conclusions about causality.” Dr. Manhart reported no financial disclosures related to the study.

Children born as a result of in vitro fertilization have significantly higher blood pressure and fasting glucose levels than do those conceived naturally—a finding suggestive of fetal programming during an early developmental window, Dr. Manon Ceelen and colleagues reported.

Although the possible mechanism behind this finding remains unknown, the study “underscores the importance of the continuing worldwide monitoring of postnatal development of IVF children,” Dr. Ceelen and her coauthors wrote in the Journal of Clinical Endocrinology and Metabolism (2008 Feb. 19 [doi:10.1210/jc.2007-2432

Dr. Ceelen and her coauthors of the Free University Medical Center, Amsterdam, compared the cardiometabolic measurements of 225 IVF and 225 naturally conceived children (average age, 12 years). The parents of all the children had been part of a Dutch study on the long-term health effects of hormone stimulation in 26,400 subfertile women. Of this group, 20,000 women received IVF treatment.

Compared with naturally conceived children, those conceived through IVF weighed significantly less on average at birth (3.2 vs. 3.4 kg). In addition, there were significantly more preterm infants among the IVF group (29 vs. 6).

Average systolic blood pressure was significantly higher in IVF children than in the control group (109 mm Hg vs. 105 mm Hg); mean diastolic blood pressure was also significantly higher in the in vitro fertilization group (61 mm Hg vs. 59 mm Hg).

Children born via IVF were twice as likely as those naturally conceived to have a systolic blood pressure of at least 114 mm Hg and to have a diastolic blood pressure of at least 65 mm Hg.

Those in the IVF group had significantly greater average sum of skinfolds measurement (40 mm vs. 37 mm), although there were no significant differences in weight or body mass index between the groups.

Significantly higher mean fasting glucose measurements were seen in the IVF group (5 mmol/L vs. 4.8 mmol/L). IVF children were 2.5 times more likely to have a fasting glucose level of at least 5.2 mmol/L.

These relationships remained significant even after the investigators adjusted for confounders (birth weight, gestational age, sum of skinfolds measurement, parity, and the cause of the mother's subfertility).

Although the differences in blood pressure appear small on an individual level, they could have significant health implications on a population level, the investigators wrote. “A slight increase in blood pressure is associated with a remarkably increased risk of developing cardiovascular disease. … Furthermore, it cannot be excluded that raised blood pressure after in vitro fertilization may be amplified throughout life, as blood pressure is known to track from childhood into adult life.”

The authors could not explain the observed relationships between IVF and cardiometabolic status. Both population and animal studies show a link between prenatal environment and early gestational development. For instance, maternal malnutrition in early pregnancy has been linked to later cardiovascular disease in the offspring.

“Preconceptional undernutrition has been associated with the precocious activation of the hypothalamo-pituitary-adrenal axis,” the authors wrote. This premature activation might be associated with fetal programming effects.

However, they wrote, “it remains to be elucidated whether increased blood pressure among in vitro fertilization children originates from early prenatal life adaptations mediated through neuroendocrineal pathways related to the HPA axis and/or through one of the unidentified mechanisms.”

Children born as a result of in vitro fertilization have significantly higher blood pressure and fasting glucose levels than do those conceived naturally—a finding suggestive of fetal programming during an early developmental window, Dr. Manon Ceelen and colleagues reported.

Although the possible mechanism behind this finding remains unknown, the study “underscores the importance of the continuing worldwide monitoring of postnatal development of IVF children,” Dr. Ceelen and her coauthors wrote in the Journal of Clinical Endocrinology and Metabolism (2008 Feb. 19 [doi:10.1210/jc.2007-2432

Dr. Ceelen and her coauthors of the Free University Medical Center, Amsterdam, compared the cardiometabolic measurements of 225 IVF and 225 naturally conceived children (average age, 12 years). The parents of all the children had been part of a Dutch study on the long-term health effects of hormone stimulation in 26,400 subfertile women. Of this group, 20,000 women received IVF treatment.

Compared with naturally conceived children, those conceived through IVF weighed significantly less on average at birth (3.2 vs. 3.4 kg). In addition, there were significantly more preterm infants among the IVF group (29 vs. 6).

Average systolic blood pressure was significantly higher in IVF children than in the control group (109 mm Hg vs. 105 mm Hg); mean diastolic blood pressure was also significantly higher in the in vitro fertilization group (61 mm Hg vs. 59 mm Hg).

Children born via IVF were twice as likely as those naturally conceived to have a systolic blood pressure of at least 114 mm Hg and to have a diastolic blood pressure of at least 65 mm Hg.

Those in the IVF group had significantly greater average sum of skinfolds measurement (40 mm vs. 37 mm), although there were no significant differences in weight or body mass index between the groups.

Significantly higher mean fasting glucose measurements were seen in the IVF group (5 mmol/L vs. 4.8 mmol/L). IVF children were 2.5 times more likely to have a fasting glucose level of at least 5.2 mmol/L.

These relationships remained significant even after the investigators adjusted for confounders (birth weight, gestational age, sum of skinfolds measurement, parity, and the cause of the mother's subfertility).

Although the differences in blood pressure appear small on an individual level, they could have significant health implications on a population level, the investigators wrote. “A slight increase in blood pressure is associated with a remarkably increased risk of developing cardiovascular disease. … Furthermore, it cannot be excluded that raised blood pressure after in vitro fertilization may be amplified throughout life, as blood pressure is known to track from childhood into adult life.”

The authors could not explain the observed relationships between IVF and cardiometabolic status. Both population and animal studies show a link between prenatal environment and early gestational development. For instance, maternal malnutrition in early pregnancy has been linked to later cardiovascular disease in the offspring.

“Preconceptional undernutrition has been associated with the precocious activation of the hypothalamo-pituitary-adrenal axis,” the authors wrote. This premature activation might be associated with fetal programming effects.

However, they wrote, “it remains to be elucidated whether increased blood pressure among in vitro fertilization children originates from early prenatal life adaptations mediated through neuroendocrineal pathways related to the HPA axis and/or through one of the unidentified mechanisms.”

Children born as a result of in vitro fertilization have significantly higher blood pressure and fasting glucose levels than do those conceived naturally—a finding suggestive of fetal programming during an early developmental window, Dr. Manon Ceelen and colleagues reported.

Although the possible mechanism behind this finding remains unknown, the study “underscores the importance of the continuing worldwide monitoring of postnatal development of IVF children,” Dr. Ceelen and her coauthors wrote in the Journal of Clinical Endocrinology and Metabolism (2008 Feb. 19 [doi:10.1210/jc.2007-2432

Dr. Ceelen and her coauthors of the Free University Medical Center, Amsterdam, compared the cardiometabolic measurements of 225 IVF and 225 naturally conceived children (average age, 12 years). The parents of all the children had been part of a Dutch study on the long-term health effects of hormone stimulation in 26,400 subfertile women. Of this group, 20,000 women received IVF treatment.

Compared with naturally conceived children, those conceived through IVF weighed significantly less on average at birth (3.2 vs. 3.4 kg). In addition, there were significantly more preterm infants among the IVF group (29 vs. 6).

Average systolic blood pressure was significantly higher in IVF children than in the control group (109 mm Hg vs. 105 mm Hg); mean diastolic blood pressure was also significantly higher in the in vitro fertilization group (61 mm Hg vs. 59 mm Hg).

Children born via IVF were twice as likely as those naturally conceived to have a systolic blood pressure of at least 114 mm Hg and to have a diastolic blood pressure of at least 65 mm Hg.

Those in the IVF group had significantly greater average sum of skinfolds measurement (40 mm vs. 37 mm), although there were no significant differences in weight or body mass index between the groups.

Significantly higher mean fasting glucose measurements were seen in the IVF group (5 mmol/L vs. 4.8 mmol/L). IVF children were 2.5 times more likely to have a fasting glucose level of at least 5.2 mmol/L.

These relationships remained significant even after the investigators adjusted for confounders (birth weight, gestational age, sum of skinfolds measurement, parity, and the cause of the mother's subfertility).

Although the differences in blood pressure appear small on an individual level, they could have significant health implications on a population level, the investigators wrote. “A slight increase in blood pressure is associated with a remarkably increased risk of developing cardiovascular disease. … Furthermore, it cannot be excluded that raised blood pressure after in vitro fertilization may be amplified throughout life, as blood pressure is known to track from childhood into adult life.”

The authors could not explain the observed relationships between IVF and cardiometabolic status. Both population and animal studies show a link between prenatal environment and early gestational development. For instance, maternal malnutrition in early pregnancy has been linked to later cardiovascular disease in the offspring.

“Preconceptional undernutrition has been associated with the precocious activation of the hypothalamo-pituitary-adrenal axis,” the authors wrote. This premature activation might be associated with fetal programming effects.

However, they wrote, “it remains to be elucidated whether increased blood pressure among in vitro fertilization children originates from early prenatal life adaptations mediated through neuroendocrineal pathways related to the HPA axis and/or through one of the unidentified mechanisms.”