Expert Warns of Ominous Signs in Fight Against AIDS

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Expert Warns of Ominous Signs in Fight Against AIDS

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

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

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

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

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

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

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

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

Dr. Jaffe said it cannot be entirely ruled out that abstinence-only education could benefit "very specific groups," but most evidence suggests it is not efficacious.

By contrast, he pointed to condom promotion, shown to be "highly efficacious" in preventing HIV transmission, and needle- and syringe-exchange programs, which demonstrate at least modest evidence of reducing intermediate-level activities with the capacity to spread HIV, as more effective approaches. Condom distribution campaigns are currently being opposed by individuals who believe availability will undermine abstinence-only programs.

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

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

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

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

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

"We are seeing behavior trends in gay men in the United States and Western Europe that are similar to trends in the late 70s," he said.

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

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

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

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

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

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

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

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

Dr. Jaffe said it cannot be entirely ruled out that abstinence-only education could benefit "very specific groups," but most evidence suggests it is not efficacious.

By contrast, he pointed to condom promotion, shown to be "highly efficacious" in preventing HIV transmission, and needle- and syringe-exchange programs, which demonstrate at least modest evidence of reducing intermediate-level activities with the capacity to spread HIV, as more effective approaches. Condom distribution campaigns are currently being opposed by individuals who believe availability will undermine abstinence-only programs.

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

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

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

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

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

"We are seeing behavior trends in gay men in the United States and Western Europe that are similar to trends in the late 70s," he said.

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

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

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

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

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

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

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

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

Dr. Jaffe said it cannot be entirely ruled out that abstinence-only education could benefit "very specific groups," but most evidence suggests it is not efficacious.

By contrast, he pointed to condom promotion, shown to be "highly efficacious" in preventing HIV transmission, and needle- and syringe-exchange programs, which demonstrate at least modest evidence of reducing intermediate-level activities with the capacity to spread HIV, as more effective approaches. Condom distribution campaigns are currently being opposed by individuals who believe availability will undermine abstinence-only programs.

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

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

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

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

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

"We are seeing behavior trends in gay men in the United States and Western Europe that are similar to trends in the late 70s," he said.

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Low CD4 Counts Tied to Nonopportunistic Disease Risks

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Low CD4 Counts Tied to Nonopportunistic Disease Risks

LOS ANGELES — The risk of nonopportunistic diseases in HIV-infected patients increases as CD4 counts fall, and the impact of such diseases overshadows that of opportunistic diseases at CD4 counts above 200 cells/mcL, said Dr. Jason Baker of the University of Minnesota in Minneapolis.

The discovery that rates of nonopportunistic diseases vary according to CD4 counts “starts to build a case that people aren't just … living longer and … dying of other causes,” Dr. Baker said at a press conference following his presentation at the 14th Conference on Retroviruses and Opportunistic Infections.

Rates of liver, renal, and cardiovascular diseases, as well as of non-HIV-related cancers, were all associated with CD4 counts in a group of 1,397 patients followed for at least 5 years after enrollment in a study sponsored by the National Institutes of Health.

Dr. Baker and his associates randomly assigned ART-naive patients to one of three drug regimens and carefully monitored all fatal and nonfatal opportunistic and nonopportunistic events.

Over the 5-year follow-up, there were 266 opportunistic disease events with 89 related deaths and 166 nonopportunistic disease events with 25 deaths.

Nonopportunistic diseases seen in the cohort included cirrhosis and grade 4 transaminitis; myocardial infarctions, strokes, and coronary artery disease requiring intervention; renal insufficiency and end-stage renal disease; and 32 malignancies other than non-Hodgkin's lymphoma or Kaposi's sarcoma, including five cases each of anal, lung, and skin cancers.

Liver disease disproportionately included grade 4 elevated liver enzymes, which may be related to medications. Whether or not this diagnosis was included in the analysis, however, CD4 counts were related to disease events. Both opportunistic and nonopportunistic events were less likely in patients with higher CD4 counts.

“The decline was steeper for opportunistic disease events, but nonopportunistic disease became at least as significant if not more so at higher CD4 levels,” Dr. Baker said at the conference, sponsored by the Foundation for Retrovirology and Human Health.

Above CD4 counts of 200 cells/mcL, mortality and morbidity were higher for nonopportunistic than opportunistic disease, he said.

The univariate hazard ratios for the difference in risk for an incremental increase of 100 cells/mcL in the CD4 count was 0.49 for opportunistic disease and 0.78 for nonopportunistic disease, and remained powerful (0.57 and 0.84, respectively) even after adjustment for age, sex, race, prior AIDS, hepatitis B and C, baseline CD4 and RNA viral load, and latest RNA viral load, Dr. Backer said.

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LOS ANGELES — The risk of nonopportunistic diseases in HIV-infected patients increases as CD4 counts fall, and the impact of such diseases overshadows that of opportunistic diseases at CD4 counts above 200 cells/mcL, said Dr. Jason Baker of the University of Minnesota in Minneapolis.

The discovery that rates of nonopportunistic diseases vary according to CD4 counts “starts to build a case that people aren't just … living longer and … dying of other causes,” Dr. Baker said at a press conference following his presentation at the 14th Conference on Retroviruses and Opportunistic Infections.

Rates of liver, renal, and cardiovascular diseases, as well as of non-HIV-related cancers, were all associated with CD4 counts in a group of 1,397 patients followed for at least 5 years after enrollment in a study sponsored by the National Institutes of Health.

Dr. Baker and his associates randomly assigned ART-naive patients to one of three drug regimens and carefully monitored all fatal and nonfatal opportunistic and nonopportunistic events.

Over the 5-year follow-up, there were 266 opportunistic disease events with 89 related deaths and 166 nonopportunistic disease events with 25 deaths.

Nonopportunistic diseases seen in the cohort included cirrhosis and grade 4 transaminitis; myocardial infarctions, strokes, and coronary artery disease requiring intervention; renal insufficiency and end-stage renal disease; and 32 malignancies other than non-Hodgkin's lymphoma or Kaposi's sarcoma, including five cases each of anal, lung, and skin cancers.

Liver disease disproportionately included grade 4 elevated liver enzymes, which may be related to medications. Whether or not this diagnosis was included in the analysis, however, CD4 counts were related to disease events. Both opportunistic and nonopportunistic events were less likely in patients with higher CD4 counts.

“The decline was steeper for opportunistic disease events, but nonopportunistic disease became at least as significant if not more so at higher CD4 levels,” Dr. Baker said at the conference, sponsored by the Foundation for Retrovirology and Human Health.

Above CD4 counts of 200 cells/mcL, mortality and morbidity were higher for nonopportunistic than opportunistic disease, he said.

The univariate hazard ratios for the difference in risk for an incremental increase of 100 cells/mcL in the CD4 count was 0.49 for opportunistic disease and 0.78 for nonopportunistic disease, and remained powerful (0.57 and 0.84, respectively) even after adjustment for age, sex, race, prior AIDS, hepatitis B and C, baseline CD4 and RNA viral load, and latest RNA viral load, Dr. Backer said.

LOS ANGELES — The risk of nonopportunistic diseases in HIV-infected patients increases as CD4 counts fall, and the impact of such diseases overshadows that of opportunistic diseases at CD4 counts above 200 cells/mcL, said Dr. Jason Baker of the University of Minnesota in Minneapolis.

The discovery that rates of nonopportunistic diseases vary according to CD4 counts “starts to build a case that people aren't just … living longer and … dying of other causes,” Dr. Baker said at a press conference following his presentation at the 14th Conference on Retroviruses and Opportunistic Infections.

Rates of liver, renal, and cardiovascular diseases, as well as of non-HIV-related cancers, were all associated with CD4 counts in a group of 1,397 patients followed for at least 5 years after enrollment in a study sponsored by the National Institutes of Health.

Dr. Baker and his associates randomly assigned ART-naive patients to one of three drug regimens and carefully monitored all fatal and nonfatal opportunistic and nonopportunistic events.

Over the 5-year follow-up, there were 266 opportunistic disease events with 89 related deaths and 166 nonopportunistic disease events with 25 deaths.

Nonopportunistic diseases seen in the cohort included cirrhosis and grade 4 transaminitis; myocardial infarctions, strokes, and coronary artery disease requiring intervention; renal insufficiency and end-stage renal disease; and 32 malignancies other than non-Hodgkin's lymphoma or Kaposi's sarcoma, including five cases each of anal, lung, and skin cancers.

Liver disease disproportionately included grade 4 elevated liver enzymes, which may be related to medications. Whether or not this diagnosis was included in the analysis, however, CD4 counts were related to disease events. Both opportunistic and nonopportunistic events were less likely in patients with higher CD4 counts.

“The decline was steeper for opportunistic disease events, but nonopportunistic disease became at least as significant if not more so at higher CD4 levels,” Dr. Baker said at the conference, sponsored by the Foundation for Retrovirology and Human Health.

Above CD4 counts of 200 cells/mcL, mortality and morbidity were higher for nonopportunistic than opportunistic disease, he said.

The univariate hazard ratios for the difference in risk for an incremental increase of 100 cells/mcL in the CD4 count was 0.49 for opportunistic disease and 0.78 for nonopportunistic disease, and remained powerful (0.57 and 0.84, respectively) even after adjustment for age, sex, race, prior AIDS, hepatitis B and C, baseline CD4 and RNA viral load, and latest RNA viral load, Dr. Backer said.

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Better Strategies Need Funds in Fight Against AIDS

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Better Strategies Need Funds in Fight Against AIDS

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

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

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

“The need for treatment is critical, but I agree with my colleague [WHO director of HIV/AIDS] Dr. Kevin de Kock that we are not going to be able to treat our way out of this epidemic,” added Dr. Jaffe, who singled out federal funding for abstinence-only education as an example of a strategy based on beliefs rather than science.

A “very comprehensive” study in press in the Cochrane Review, for example, reviewed eight published randomized controlled trials of abstinence-only programs, compared with standard sex education or safe-sex programs, involving 13,191 American youths. With a median follow-up of 12 months, none of the abstinence-only programs demonstrated a significant decline in self-reported sexual activity or any biological outcome such as pregnancy or diagnosis with a sexually transmitted disease (STD), compared with the other approaches, said Dr. Jaffe at the conference, sponsored by the Foundation for Retrovirology and Human Health.

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

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

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

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

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

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

“We are seeing behavior trends in gay men in the United States and Western Europe that are similar to trends in the late 70s, years just before tens of thousands of young men were about to lose their lives,” he said.

He urged activists and community leaders to “step forward” and policy makers “to use science rather than moral judgment, religious beliefs, or wishful thinking to guide our strategies.”

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

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

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

“The need for treatment is critical, but I agree with my colleague [WHO director of HIV/AIDS] Dr. Kevin de Kock that we are not going to be able to treat our way out of this epidemic,” added Dr. Jaffe, who singled out federal funding for abstinence-only education as an example of a strategy based on beliefs rather than science.

A “very comprehensive” study in press in the Cochrane Review, for example, reviewed eight published randomized controlled trials of abstinence-only programs, compared with standard sex education or safe-sex programs, involving 13,191 American youths. With a median follow-up of 12 months, none of the abstinence-only programs demonstrated a significant decline in self-reported sexual activity or any biological outcome such as pregnancy or diagnosis with a sexually transmitted disease (STD), compared with the other approaches, said Dr. Jaffe at the conference, sponsored by the Foundation for Retrovirology and Human Health.

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

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

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

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

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

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

“We are seeing behavior trends in gay men in the United States and Western Europe that are similar to trends in the late 70s, years just before tens of thousands of young men were about to lose their lives,” he said.

He urged activists and community leaders to “step forward” and policy makers “to use science rather than moral judgment, religious beliefs, or wishful thinking to guide our strategies.”

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

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

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

“The need for treatment is critical, but I agree with my colleague [WHO director of HIV/AIDS] Dr. Kevin de Kock that we are not going to be able to treat our way out of this epidemic,” added Dr. Jaffe, who singled out federal funding for abstinence-only education as an example of a strategy based on beliefs rather than science.

A “very comprehensive” study in press in the Cochrane Review, for example, reviewed eight published randomized controlled trials of abstinence-only programs, compared with standard sex education or safe-sex programs, involving 13,191 American youths. With a median follow-up of 12 months, none of the abstinence-only programs demonstrated a significant decline in self-reported sexual activity or any biological outcome such as pregnancy or diagnosis with a sexually transmitted disease (STD), compared with the other approaches, said Dr. Jaffe at the conference, sponsored by the Foundation for Retrovirology and Human Health.

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

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

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

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

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

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

“We are seeing behavior trends in gay men in the United States and Western Europe that are similar to trends in the late 70s, years just before tens of thousands of young men were about to lose their lives,” he said.

He urged activists and community leaders to “step forward” and policy makers “to use science rather than moral judgment, religious beliefs, or wishful thinking to guide our strategies.”

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New PCI Safety Standards at Odds With Guidelines : Controversy has greeted the release of standards for performing PCI without on-site surgical backup.

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New PCI Safety Standards at Odds With Guidelines : Controversy has greeted the release of standards for performing PCI without on-site surgical backup.

The Society for Cardiovascular Angiography and Interventions took the dramatic step in early February of introducing “best practice” recommendations for physicians and institutions offering percutaneous coronary intervention without on-site surgical backup, a move that failed to gain the support of the American Heart Association or the American College of Cardiology.

Current guidelines endorsed by all three organizations in November 2005 classified elective percutaneous coronary intervention (PCI) without on-site cardiac surgery a Class III indication, meaning it is considered “not useful/effective and in some cases may be harmful” (Circulation 2006;113:156–75).

Primary PCI without surgical backup was ranked in the 2005 ACC/AHA/SCAI guideline update as a Class IIb indication, for which there is conflicting evidence and/or divergence of opinion and the absence of well-established suggestions of usefulness or efficacy.

Pragmatism was the driving force behind the SCAI's decision to issue structured safety recommendations for the controversial practice, said Dr. Gregory J. Dehmer, president of SCAI, at a press teleconference.

He insisted that the SCAI was “not in any way promoting PCI without surgical backup,” and maintained that the group still stands behind the joint guidelines of 2005, but he said it was time to establish quality standards for an increasingly common practice.

“The reality is that despite the guidelines, this practice is going on in this country and it's growing,” said Dr. Dehmer, professor of medicine at Texas A&M University, College Station, and director of cardiology at the Scott & White Clinic in Temple, Tex.

An SCAI Web survey completed in July found that primary PCI programs without on-site surgical backup exist in 40 states. Elective PCI without on-site surgical backup is being performed in 28 states.

Around the world, the practice is also increasing, said Dr. Dehmer, with 35 of 39 developed countries reporting the performance of PCI without on-site cardiac surgery backup.

“We want to be sure that if this is being done, it is being done with the highest quality,” Dr. Dehmer said during the teleconference.

The SCAI consensus statement, which was developed by a nine-member international committee and endorsed by many international cardiology societies, recommends that PCI programs without on-site cardiac surgery should meet certain standards, including the following:

▸ Institutional case volumes of at least 200 PCIs a year.

▸ Thresholds for interventional cardiologists, including career case volumes of more than 500 PCIs and annual case volumes of more than 100 PCIs, including at least 18 primary PCIs per year.

▸ A “strong recommendation” that interventional cardiologists performing PCI without surgical backup be board certified in interventional cardiology.

▸ Independent review of outcomes, comparing institutions and cardiologists against state or national benchmark standards for success rates and complications.

▸ “Rigorous clinical and angiographic selection criteria” of patients to minimize the risk of complications.

▸ Appropriate equipment, staffing, and training surrounding PCI; a “close alliance” with cardiovascular surgeons; and formalized, tested procedures for emergency transport of patients at the first sign of a complication.

Both the ACC and the AHA pointedly declined to endorse the SCAI's document.

Dr. Steven Nissen, president of the ACC, said the college was concerned that the endorsement of best-practice recommendations would lead to promotion of PCI without surgical backup and “contradict our own guidelines.”

“When we say it's Class III, we're telling people that it shouldn't be done. I don't see how you can have it both ways: It's not indicated but here's how you do it,” said Dr. Nissen, medical director of the Cleveland Clinic Cardiovascular Coordinating Center, in an interview.

Dr. Raymond J. Gibbons, president of the AHA, concurred with that view.

“We have existing guidelines that attempt to discourage angioplasty without surgical backup. The SCAI statement is inconsistent with those guidelines,” he said in an interview.

“The consistency of our statements is critical to their credibility,” said Dr. Gibbons, professor of cardiology at the Mayo Medical School, Rochester, Minn.

An executive summary of the SCAI document acknowledged that PCI without surgical backup is “a polarizing and emotional issue for many individuals both within and external to the interventional community.”

However, the SCAI report contends that burgeoning growth of the practice, coupled with a decline in cardiac surgical services at many hospitals, suggests that on-site surgical capability during PCI will be increasingly difficult to achieve.

The safety rate of PCI is high and improving, with urgent cardiac surgery required in 3–6 cases per 1,000 at high-volume hospitals, according to SCAI data sheets.

Many small, retrospective studies have concluded that PCI can be performed safely and with a very low rate of complications at individual institutions.

 

 

The “fly in the ointment” came in a 2004 study of 1,121 hospitals. The study found that there were higher mortality rates among nonprimary PCI cases performed in hospitals without surgical backup, especially those that performed a small number of the procedures each year, said Dr. Michael Cowley, professor of medicine at Virginia Commonwealth University, Richmond, during a January conference in Snowmass, Colo., sponsored by SCAI and the ACC (JAMA 2004;292:1961–8).

Dr. Dehmer said in his press briefing that the safety issue will become clearer with the first large randomized trial comparing PCI rates at hospitals with and without surgical backup.

That trial, the Atlantic Cardiovascular Patient Outcomes Research Team Elective Angioplasty Study (CPORT), will enroll 18,000 patients.

In the meantime, the SCAI safety guidelines “focus on the goal of providing the best possible care to patients who require PCI, regardless of the setting.”

“Ensuring that all PCI programs meet appropriate performance metrics is likely to save more lives than requiring all PCI programs have on-site surgery,” noted the society's executive summary.

The summary acknowledged there is “clearly a potential for unnecessary or inappropriate PCI program development in the same geographic area.”

In addition, it stressed that such actions driven by financial or market gain are “strongly discouraged.”

In his President's Page to members, Dr. Dehmer said that “it was the belief of the Society that remaining silent in the face of this growing practice simply avoided the issue, and would not be the correct course.”

He also said cardiologists may need a “dose of reality” in recognizing that some patients may place a higher priority on “personal rather than medical considerations” when it comes to moving to a different facility for PCI.

“Having a surgeon on-site and just waiting for a failed PCI may be ideal, but it is not a realistic solution for the foreseeable future,” he wrote.

Finally, Dr. Dehmer said a larger message “not meant to be hidden” within the document is that ideal quality standards are not being met at every institution or by every interventional cardiologist.

“The message is QUALITY and promoting quality among all PCI facilities,” he told members in his president's message online.

The SCAI report, as well as the president's message, are available online at www.scai.org

ELSEVIER GLOBAL MEDICAL NEWS

“Despite the guidelines, this practice is going on in this country and it's growing,” SCAI President Gregory J. Dehmer said. Scott & White Clinic

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The Society for Cardiovascular Angiography and Interventions took the dramatic step in early February of introducing “best practice” recommendations for physicians and institutions offering percutaneous coronary intervention without on-site surgical backup, a move that failed to gain the support of the American Heart Association or the American College of Cardiology.

Current guidelines endorsed by all three organizations in November 2005 classified elective percutaneous coronary intervention (PCI) without on-site cardiac surgery a Class III indication, meaning it is considered “not useful/effective and in some cases may be harmful” (Circulation 2006;113:156–75).

Primary PCI without surgical backup was ranked in the 2005 ACC/AHA/SCAI guideline update as a Class IIb indication, for which there is conflicting evidence and/or divergence of opinion and the absence of well-established suggestions of usefulness or efficacy.

Pragmatism was the driving force behind the SCAI's decision to issue structured safety recommendations for the controversial practice, said Dr. Gregory J. Dehmer, president of SCAI, at a press teleconference.

He insisted that the SCAI was “not in any way promoting PCI without surgical backup,” and maintained that the group still stands behind the joint guidelines of 2005, but he said it was time to establish quality standards for an increasingly common practice.

“The reality is that despite the guidelines, this practice is going on in this country and it's growing,” said Dr. Dehmer, professor of medicine at Texas A&M University, College Station, and director of cardiology at the Scott & White Clinic in Temple, Tex.

An SCAI Web survey completed in July found that primary PCI programs without on-site surgical backup exist in 40 states. Elective PCI without on-site surgical backup is being performed in 28 states.

Around the world, the practice is also increasing, said Dr. Dehmer, with 35 of 39 developed countries reporting the performance of PCI without on-site cardiac surgery backup.

“We want to be sure that if this is being done, it is being done with the highest quality,” Dr. Dehmer said during the teleconference.

The SCAI consensus statement, which was developed by a nine-member international committee and endorsed by many international cardiology societies, recommends that PCI programs without on-site cardiac surgery should meet certain standards, including the following:

▸ Institutional case volumes of at least 200 PCIs a year.

▸ Thresholds for interventional cardiologists, including career case volumes of more than 500 PCIs and annual case volumes of more than 100 PCIs, including at least 18 primary PCIs per year.

▸ A “strong recommendation” that interventional cardiologists performing PCI without surgical backup be board certified in interventional cardiology.

▸ Independent review of outcomes, comparing institutions and cardiologists against state or national benchmark standards for success rates and complications.

▸ “Rigorous clinical and angiographic selection criteria” of patients to minimize the risk of complications.

▸ Appropriate equipment, staffing, and training surrounding PCI; a “close alliance” with cardiovascular surgeons; and formalized, tested procedures for emergency transport of patients at the first sign of a complication.

Both the ACC and the AHA pointedly declined to endorse the SCAI's document.

Dr. Steven Nissen, president of the ACC, said the college was concerned that the endorsement of best-practice recommendations would lead to promotion of PCI without surgical backup and “contradict our own guidelines.”

“When we say it's Class III, we're telling people that it shouldn't be done. I don't see how you can have it both ways: It's not indicated but here's how you do it,” said Dr. Nissen, medical director of the Cleveland Clinic Cardiovascular Coordinating Center, in an interview.

Dr. Raymond J. Gibbons, president of the AHA, concurred with that view.

“We have existing guidelines that attempt to discourage angioplasty without surgical backup. The SCAI statement is inconsistent with those guidelines,” he said in an interview.

“The consistency of our statements is critical to their credibility,” said Dr. Gibbons, professor of cardiology at the Mayo Medical School, Rochester, Minn.

An executive summary of the SCAI document acknowledged that PCI without surgical backup is “a polarizing and emotional issue for many individuals both within and external to the interventional community.”

However, the SCAI report contends that burgeoning growth of the practice, coupled with a decline in cardiac surgical services at many hospitals, suggests that on-site surgical capability during PCI will be increasingly difficult to achieve.

The safety rate of PCI is high and improving, with urgent cardiac surgery required in 3–6 cases per 1,000 at high-volume hospitals, according to SCAI data sheets.

Many small, retrospective studies have concluded that PCI can be performed safely and with a very low rate of complications at individual institutions.

 

 

The “fly in the ointment” came in a 2004 study of 1,121 hospitals. The study found that there were higher mortality rates among nonprimary PCI cases performed in hospitals without surgical backup, especially those that performed a small number of the procedures each year, said Dr. Michael Cowley, professor of medicine at Virginia Commonwealth University, Richmond, during a January conference in Snowmass, Colo., sponsored by SCAI and the ACC (JAMA 2004;292:1961–8).

Dr. Dehmer said in his press briefing that the safety issue will become clearer with the first large randomized trial comparing PCI rates at hospitals with and without surgical backup.

That trial, the Atlantic Cardiovascular Patient Outcomes Research Team Elective Angioplasty Study (CPORT), will enroll 18,000 patients.

In the meantime, the SCAI safety guidelines “focus on the goal of providing the best possible care to patients who require PCI, regardless of the setting.”

“Ensuring that all PCI programs meet appropriate performance metrics is likely to save more lives than requiring all PCI programs have on-site surgery,” noted the society's executive summary.

The summary acknowledged there is “clearly a potential for unnecessary or inappropriate PCI program development in the same geographic area.”

In addition, it stressed that such actions driven by financial or market gain are “strongly discouraged.”

In his President's Page to members, Dr. Dehmer said that “it was the belief of the Society that remaining silent in the face of this growing practice simply avoided the issue, and would not be the correct course.”

He also said cardiologists may need a “dose of reality” in recognizing that some patients may place a higher priority on “personal rather than medical considerations” when it comes to moving to a different facility for PCI.

“Having a surgeon on-site and just waiting for a failed PCI may be ideal, but it is not a realistic solution for the foreseeable future,” he wrote.

Finally, Dr. Dehmer said a larger message “not meant to be hidden” within the document is that ideal quality standards are not being met at every institution or by every interventional cardiologist.

“The message is QUALITY and promoting quality among all PCI facilities,” he told members in his president's message online.

The SCAI report, as well as the president's message, are available online at www.scai.org

ELSEVIER GLOBAL MEDICAL NEWS

“Despite the guidelines, this practice is going on in this country and it's growing,” SCAI President Gregory J. Dehmer said. Scott & White Clinic

The Society for Cardiovascular Angiography and Interventions took the dramatic step in early February of introducing “best practice” recommendations for physicians and institutions offering percutaneous coronary intervention without on-site surgical backup, a move that failed to gain the support of the American Heart Association or the American College of Cardiology.

Current guidelines endorsed by all three organizations in November 2005 classified elective percutaneous coronary intervention (PCI) without on-site cardiac surgery a Class III indication, meaning it is considered “not useful/effective and in some cases may be harmful” (Circulation 2006;113:156–75).

Primary PCI without surgical backup was ranked in the 2005 ACC/AHA/SCAI guideline update as a Class IIb indication, for which there is conflicting evidence and/or divergence of opinion and the absence of well-established suggestions of usefulness or efficacy.

Pragmatism was the driving force behind the SCAI's decision to issue structured safety recommendations for the controversial practice, said Dr. Gregory J. Dehmer, president of SCAI, at a press teleconference.

He insisted that the SCAI was “not in any way promoting PCI without surgical backup,” and maintained that the group still stands behind the joint guidelines of 2005, but he said it was time to establish quality standards for an increasingly common practice.

“The reality is that despite the guidelines, this practice is going on in this country and it's growing,” said Dr. Dehmer, professor of medicine at Texas A&M University, College Station, and director of cardiology at the Scott & White Clinic in Temple, Tex.

An SCAI Web survey completed in July found that primary PCI programs without on-site surgical backup exist in 40 states. Elective PCI without on-site surgical backup is being performed in 28 states.

Around the world, the practice is also increasing, said Dr. Dehmer, with 35 of 39 developed countries reporting the performance of PCI without on-site cardiac surgery backup.

“We want to be sure that if this is being done, it is being done with the highest quality,” Dr. Dehmer said during the teleconference.

The SCAI consensus statement, which was developed by a nine-member international committee and endorsed by many international cardiology societies, recommends that PCI programs without on-site cardiac surgery should meet certain standards, including the following:

▸ Institutional case volumes of at least 200 PCIs a year.

▸ Thresholds for interventional cardiologists, including career case volumes of more than 500 PCIs and annual case volumes of more than 100 PCIs, including at least 18 primary PCIs per year.

▸ A “strong recommendation” that interventional cardiologists performing PCI without surgical backup be board certified in interventional cardiology.

▸ Independent review of outcomes, comparing institutions and cardiologists against state or national benchmark standards for success rates and complications.

▸ “Rigorous clinical and angiographic selection criteria” of patients to minimize the risk of complications.

▸ Appropriate equipment, staffing, and training surrounding PCI; a “close alliance” with cardiovascular surgeons; and formalized, tested procedures for emergency transport of patients at the first sign of a complication.

Both the ACC and the AHA pointedly declined to endorse the SCAI's document.

Dr. Steven Nissen, president of the ACC, said the college was concerned that the endorsement of best-practice recommendations would lead to promotion of PCI without surgical backup and “contradict our own guidelines.”

“When we say it's Class III, we're telling people that it shouldn't be done. I don't see how you can have it both ways: It's not indicated but here's how you do it,” said Dr. Nissen, medical director of the Cleveland Clinic Cardiovascular Coordinating Center, in an interview.

Dr. Raymond J. Gibbons, president of the AHA, concurred with that view.

“We have existing guidelines that attempt to discourage angioplasty without surgical backup. The SCAI statement is inconsistent with those guidelines,” he said in an interview.

“The consistency of our statements is critical to their credibility,” said Dr. Gibbons, professor of cardiology at the Mayo Medical School, Rochester, Minn.

An executive summary of the SCAI document acknowledged that PCI without surgical backup is “a polarizing and emotional issue for many individuals both within and external to the interventional community.”

However, the SCAI report contends that burgeoning growth of the practice, coupled with a decline in cardiac surgical services at many hospitals, suggests that on-site surgical capability during PCI will be increasingly difficult to achieve.

The safety rate of PCI is high and improving, with urgent cardiac surgery required in 3–6 cases per 1,000 at high-volume hospitals, according to SCAI data sheets.

Many small, retrospective studies have concluded that PCI can be performed safely and with a very low rate of complications at individual institutions.

 

 

The “fly in the ointment” came in a 2004 study of 1,121 hospitals. The study found that there were higher mortality rates among nonprimary PCI cases performed in hospitals without surgical backup, especially those that performed a small number of the procedures each year, said Dr. Michael Cowley, professor of medicine at Virginia Commonwealth University, Richmond, during a January conference in Snowmass, Colo., sponsored by SCAI and the ACC (JAMA 2004;292:1961–8).

Dr. Dehmer said in his press briefing that the safety issue will become clearer with the first large randomized trial comparing PCI rates at hospitals with and without surgical backup.

That trial, the Atlantic Cardiovascular Patient Outcomes Research Team Elective Angioplasty Study (CPORT), will enroll 18,000 patients.

In the meantime, the SCAI safety guidelines “focus on the goal of providing the best possible care to patients who require PCI, regardless of the setting.”

“Ensuring that all PCI programs meet appropriate performance metrics is likely to save more lives than requiring all PCI programs have on-site surgery,” noted the society's executive summary.

The summary acknowledged there is “clearly a potential for unnecessary or inappropriate PCI program development in the same geographic area.”

In addition, it stressed that such actions driven by financial or market gain are “strongly discouraged.”

In his President's Page to members, Dr. Dehmer said that “it was the belief of the Society that remaining silent in the face of this growing practice simply avoided the issue, and would not be the correct course.”

He also said cardiologists may need a “dose of reality” in recognizing that some patients may place a higher priority on “personal rather than medical considerations” when it comes to moving to a different facility for PCI.

“Having a surgeon on-site and just waiting for a failed PCI may be ideal, but it is not a realistic solution for the foreseeable future,” he wrote.

Finally, Dr. Dehmer said a larger message “not meant to be hidden” within the document is that ideal quality standards are not being met at every institution or by every interventional cardiologist.

“The message is QUALITY and promoting quality among all PCI facilities,” he told members in his president's message online.

The SCAI report, as well as the president's message, are available online at www.scai.org

ELSEVIER GLOBAL MEDICAL NEWS

“Despite the guidelines, this practice is going on in this country and it's growing,” SCAI President Gregory J. Dehmer said. Scott & White Clinic

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Ranolazine Doesn't Need BP Reduction to Work

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Ranolazine Doesn't Need BP Reduction to Work

SNOWMASS, COLO. — A year-old drug believed to inhibit ischemia through a novel mechanism may prove useful for angina patients whose symptoms are not relieved by revascularization or other agents, Dr. C. Richard Conti said at a conference sponsored by the Society for Cardiovascular Angiography and Interventions.

Ranolazine, approved in early 2006, is thought to block the late sodium current that results from a decreased oxygen supply to the heart, thereby reducing the sodium-dependent calcium overload that acts as a key player in the development of ischemia, explained Dr. Conti at the meeting, which was cosponsored by the American Academy of Cardiology.

It is the first major advance in antianginal therapy since calcium channel blockers, he noted.

Ranolazine's unusual mechanism translates into important clinical information, because its antianginal and anti-ischemic effects do not depend on reductions in heart rate or blood pressure.

“All of the other drugs do,” said Dr. Conti, eminent scholar and professor of cardiology at the University of Florida, Gainesville.

In clinical trials, patients experienced minimal changes in mean heart rate (less than 2 beats/min) and systolic blood pressure (less than 3 mm Hg). In patients with severe renal impairment, ranolazine did increase blood pressure by 10–15 mm Hg, so “you need to be careful” and monitor blood pressure regularly.

Dr. Conti said the “important trial that everyone knows about” was the Combination Assessment of Ranolazine in Stable Angina (CARISA), in which ranolazine significantly improved exercise duration and angina onset at trough and peak dose, as well as reducing angina frequency by 36% and nitroglycerine use by 43%.

The more recent, less well known Efficacy of Ranolazine in Chronic Angina (ERICA) trial was launched at the behest of the FDA and conducted mostly in Eastern European countries.

Among 565 subjects who had a mean of more than 6 angina attacks per week at baseline, angina frequency was reduced to 3.3 attacks per week in those randomly assigned to receive 1,000 mg twice daily of ranolazine, compared with 4.3 in those receiving placebo, a 23% reduction in frequency over placebo. Patients in both groups received 10 mg of amlodipine daily and were permitted to use long-acting and sublingual nitrates as needed.

The ERICA trial also found a 25% reduction in nitroglycerine use among ranolazine users, compared with those receiving placebo.

Dr. Conti pointed out that a dose-related increase in QT intervals has been observed in patients taking ranolazine: “Not way up, but they go up.”

In the ERICA trial, the mean change in QT intervals, in milliseconds, was -2.3 in patients taking placebo, 1.9 in patients taking 500 mg twice-daily ranolazine, and 5.4 in those taking 1,000 mg twice-daily ranolazine, with standard deviations of 15.6, 20.6, and 14.7, respectively.

“I suspect that if you go to 1,500 or 2,000 mg twice daily, it'll even go further,” he said, adding that he does not believe doses higher than 1,000 mg twice daily should be used.

No incidents of torsades de pointes-type arrhythmias have been reported in patients taking ranolazine, but the grave complication has been associated with other drugs that prolong the QT interval, and the same could occur with ranolazine.

Dr. Conti reserves the agent for patients who have not achieved adequate symptom control with other drugs, and he obtains baseline and follow-up electrocardiograms.

“How often? I think it's a matter of clinical judgment,” he said.

Another important point is that ranolazine is metabolized by CYP3A, contraindicating its use with other drugs that are potent or moderately potent inhibitors of that enzyme, including diltiazem, verapamil, ketoconazole and other azole antifungals, macrolide antibiotics, HIV protease inhibitors, and grapefruit products.

For the same reason, doses of simvastatin, digoxin, and drugs that are mainly metabolized by CYP2D6 may need to be reduced if given to patients also taking ranolazine, said Dr. Conti.

Dr. Conti disclosed that he serves on the speakers' bureau for CV Therapeutics, maker of ranolazine, marketed under the name Ranexa.

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SNOWMASS, COLO. — A year-old drug believed to inhibit ischemia through a novel mechanism may prove useful for angina patients whose symptoms are not relieved by revascularization or other agents, Dr. C. Richard Conti said at a conference sponsored by the Society for Cardiovascular Angiography and Interventions.

Ranolazine, approved in early 2006, is thought to block the late sodium current that results from a decreased oxygen supply to the heart, thereby reducing the sodium-dependent calcium overload that acts as a key player in the development of ischemia, explained Dr. Conti at the meeting, which was cosponsored by the American Academy of Cardiology.

It is the first major advance in antianginal therapy since calcium channel blockers, he noted.

Ranolazine's unusual mechanism translates into important clinical information, because its antianginal and anti-ischemic effects do not depend on reductions in heart rate or blood pressure.

“All of the other drugs do,” said Dr. Conti, eminent scholar and professor of cardiology at the University of Florida, Gainesville.

In clinical trials, patients experienced minimal changes in mean heart rate (less than 2 beats/min) and systolic blood pressure (less than 3 mm Hg). In patients with severe renal impairment, ranolazine did increase blood pressure by 10–15 mm Hg, so “you need to be careful” and monitor blood pressure regularly.

Dr. Conti said the “important trial that everyone knows about” was the Combination Assessment of Ranolazine in Stable Angina (CARISA), in which ranolazine significantly improved exercise duration and angina onset at trough and peak dose, as well as reducing angina frequency by 36% and nitroglycerine use by 43%.

The more recent, less well known Efficacy of Ranolazine in Chronic Angina (ERICA) trial was launched at the behest of the FDA and conducted mostly in Eastern European countries.

Among 565 subjects who had a mean of more than 6 angina attacks per week at baseline, angina frequency was reduced to 3.3 attacks per week in those randomly assigned to receive 1,000 mg twice daily of ranolazine, compared with 4.3 in those receiving placebo, a 23% reduction in frequency over placebo. Patients in both groups received 10 mg of amlodipine daily and were permitted to use long-acting and sublingual nitrates as needed.

The ERICA trial also found a 25% reduction in nitroglycerine use among ranolazine users, compared with those receiving placebo.

Dr. Conti pointed out that a dose-related increase in QT intervals has been observed in patients taking ranolazine: “Not way up, but they go up.”

In the ERICA trial, the mean change in QT intervals, in milliseconds, was -2.3 in patients taking placebo, 1.9 in patients taking 500 mg twice-daily ranolazine, and 5.4 in those taking 1,000 mg twice-daily ranolazine, with standard deviations of 15.6, 20.6, and 14.7, respectively.

“I suspect that if you go to 1,500 or 2,000 mg twice daily, it'll even go further,” he said, adding that he does not believe doses higher than 1,000 mg twice daily should be used.

No incidents of torsades de pointes-type arrhythmias have been reported in patients taking ranolazine, but the grave complication has been associated with other drugs that prolong the QT interval, and the same could occur with ranolazine.

Dr. Conti reserves the agent for patients who have not achieved adequate symptom control with other drugs, and he obtains baseline and follow-up electrocardiograms.

“How often? I think it's a matter of clinical judgment,” he said.

Another important point is that ranolazine is metabolized by CYP3A, contraindicating its use with other drugs that are potent or moderately potent inhibitors of that enzyme, including diltiazem, verapamil, ketoconazole and other azole antifungals, macrolide antibiotics, HIV protease inhibitors, and grapefruit products.

For the same reason, doses of simvastatin, digoxin, and drugs that are mainly metabolized by CYP2D6 may need to be reduced if given to patients also taking ranolazine, said Dr. Conti.

Dr. Conti disclosed that he serves on the speakers' bureau for CV Therapeutics, maker of ranolazine, marketed under the name Ranexa.

SNOWMASS, COLO. — A year-old drug believed to inhibit ischemia through a novel mechanism may prove useful for angina patients whose symptoms are not relieved by revascularization or other agents, Dr. C. Richard Conti said at a conference sponsored by the Society for Cardiovascular Angiography and Interventions.

Ranolazine, approved in early 2006, is thought to block the late sodium current that results from a decreased oxygen supply to the heart, thereby reducing the sodium-dependent calcium overload that acts as a key player in the development of ischemia, explained Dr. Conti at the meeting, which was cosponsored by the American Academy of Cardiology.

It is the first major advance in antianginal therapy since calcium channel blockers, he noted.

Ranolazine's unusual mechanism translates into important clinical information, because its antianginal and anti-ischemic effects do not depend on reductions in heart rate or blood pressure.

“All of the other drugs do,” said Dr. Conti, eminent scholar and professor of cardiology at the University of Florida, Gainesville.

In clinical trials, patients experienced minimal changes in mean heart rate (less than 2 beats/min) and systolic blood pressure (less than 3 mm Hg). In patients with severe renal impairment, ranolazine did increase blood pressure by 10–15 mm Hg, so “you need to be careful” and monitor blood pressure regularly.

Dr. Conti said the “important trial that everyone knows about” was the Combination Assessment of Ranolazine in Stable Angina (CARISA), in which ranolazine significantly improved exercise duration and angina onset at trough and peak dose, as well as reducing angina frequency by 36% and nitroglycerine use by 43%.

The more recent, less well known Efficacy of Ranolazine in Chronic Angina (ERICA) trial was launched at the behest of the FDA and conducted mostly in Eastern European countries.

Among 565 subjects who had a mean of more than 6 angina attacks per week at baseline, angina frequency was reduced to 3.3 attacks per week in those randomly assigned to receive 1,000 mg twice daily of ranolazine, compared with 4.3 in those receiving placebo, a 23% reduction in frequency over placebo. Patients in both groups received 10 mg of amlodipine daily and were permitted to use long-acting and sublingual nitrates as needed.

The ERICA trial also found a 25% reduction in nitroglycerine use among ranolazine users, compared with those receiving placebo.

Dr. Conti pointed out that a dose-related increase in QT intervals has been observed in patients taking ranolazine: “Not way up, but they go up.”

In the ERICA trial, the mean change in QT intervals, in milliseconds, was -2.3 in patients taking placebo, 1.9 in patients taking 500 mg twice-daily ranolazine, and 5.4 in those taking 1,000 mg twice-daily ranolazine, with standard deviations of 15.6, 20.6, and 14.7, respectively.

“I suspect that if you go to 1,500 or 2,000 mg twice daily, it'll even go further,” he said, adding that he does not believe doses higher than 1,000 mg twice daily should be used.

No incidents of torsades de pointes-type arrhythmias have been reported in patients taking ranolazine, but the grave complication has been associated with other drugs that prolong the QT interval, and the same could occur with ranolazine.

Dr. Conti reserves the agent for patients who have not achieved adequate symptom control with other drugs, and he obtains baseline and follow-up electrocardiograms.

“How often? I think it's a matter of clinical judgment,” he said.

Another important point is that ranolazine is metabolized by CYP3A, contraindicating its use with other drugs that are potent or moderately potent inhibitors of that enzyme, including diltiazem, verapamil, ketoconazole and other azole antifungals, macrolide antibiotics, HIV protease inhibitors, and grapefruit products.

For the same reason, doses of simvastatin, digoxin, and drugs that are mainly metabolized by CYP2D6 may need to be reduced if given to patients also taking ranolazine, said Dr. Conti.

Dr. Conti disclosed that he serves on the speakers' bureau for CV Therapeutics, maker of ranolazine, marketed under the name Ranexa.

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Essence of Ethical Marketing: Underpromise and Overdeliver

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LAS VEGAS — An ethical cosmetic practice should always "underpromise and overdeliver," said Dr. Michael A.C. Kane, a plastic surgeon in private practice in New York, at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

"Before" and "after" photographs, patients' testimonials, and catchy phrases such as "a facelift in a syringe" can all be misleading to the point of being unethical, Dr. Kane warned meeting attendees during his presentation.

"Computer imaging is the most dishonest of all," Dr. Kane maintained.

Most practices that utilize computer-imaging technology require patients to sign a statement saying that they understand "they're not going to look like that," he said. "Then why show it to them?"

Ethical marketing should feature realistic and representative results, Dr. Kane said.

Photographs should not be cherry-picked images from one's best results over a career, but should depict real results in consecutive patients undergoing similar procedures.

Patients should not be given a time-machine-type prediction of their results, such as "You'll look 10 years younger," because this promise can't be consistently delivered.

Superlative phrases used to characterize procedures or combination treatments often "way, way overpromise," Dr. Kane commented.

"Does anyone really think eight syringes of Restylane and Botox are the same as a face-lift?" he asked.

As tempting as it is to entice patients with general statements suggesting that they will see dramatic results with minimally invasive treatments, it's misleading to make such blanket claims.

"Some people need the whole enchilada," he said.

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LAS VEGAS — An ethical cosmetic practice should always "underpromise and overdeliver," said Dr. Michael A.C. Kane, a plastic surgeon in private practice in New York, at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

"Before" and "after" photographs, patients' testimonials, and catchy phrases such as "a facelift in a syringe" can all be misleading to the point of being unethical, Dr. Kane warned meeting attendees during his presentation.

"Computer imaging is the most dishonest of all," Dr. Kane maintained.

Most practices that utilize computer-imaging technology require patients to sign a statement saying that they understand "they're not going to look like that," he said. "Then why show it to them?"

Ethical marketing should feature realistic and representative results, Dr. Kane said.

Photographs should not be cherry-picked images from one's best results over a career, but should depict real results in consecutive patients undergoing similar procedures.

Patients should not be given a time-machine-type prediction of their results, such as "You'll look 10 years younger," because this promise can't be consistently delivered.

Superlative phrases used to characterize procedures or combination treatments often "way, way overpromise," Dr. Kane commented.

"Does anyone really think eight syringes of Restylane and Botox are the same as a face-lift?" he asked.

As tempting as it is to entice patients with general statements suggesting that they will see dramatic results with minimally invasive treatments, it's misleading to make such blanket claims.

"Some people need the whole enchilada," he said.

LAS VEGAS — An ethical cosmetic practice should always "underpromise and overdeliver," said Dr. Michael A.C. Kane, a plastic surgeon in private practice in New York, at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery.

"Before" and "after" photographs, patients' testimonials, and catchy phrases such as "a facelift in a syringe" can all be misleading to the point of being unethical, Dr. Kane warned meeting attendees during his presentation.

"Computer imaging is the most dishonest of all," Dr. Kane maintained.

Most practices that utilize computer-imaging technology require patients to sign a statement saying that they understand "they're not going to look like that," he said. "Then why show it to them?"

Ethical marketing should feature realistic and representative results, Dr. Kane said.

Photographs should not be cherry-picked images from one's best results over a career, but should depict real results in consecutive patients undergoing similar procedures.

Patients should not be given a time-machine-type prediction of their results, such as "You'll look 10 years younger," because this promise can't be consistently delivered.

Superlative phrases used to characterize procedures or combination treatments often "way, way overpromise," Dr. Kane commented.

"Does anyone really think eight syringes of Restylane and Botox are the same as a face-lift?" he asked.

As tempting as it is to entice patients with general statements suggesting that they will see dramatic results with minimally invasive treatments, it's misleading to make such blanket claims.

"Some people need the whole enchilada," he said.

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Surgeon: Don't Scrimp On Initial Equipment

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LAS VEGAS — The most critical investments one should make in a new surgical practice are a quality surgical table, a top-of-the-line surgical light, and excellent surgical instruments, Dr. James M. Spencer said at the annual meeting of the American Society of Cosmetic Dermatology & Aesthetic Surgery.

"There are a lot of places in life to cut corners. Don't do it here," said Dr. Spencer, a dermatologist in private practice in St. Petersburg, Fla.

A dermatologic surgeon who only intends to do facial work might be well served by a top-flight procedure chair, such as those used by otolaryngologists.

However, Dr. Spencer prefers a high-quality surgical table and an adjustable, ceiling-mounted surgical light.

"Don't be cheap here," he reiterated.

Every surgeon has his or her favorite piece of equipment, and Dr. Spencer is no exception.

"The smartest thing I ever bought in my whole life was an Ellman Surgitron [electrosurgery unit]," he said.

Dr. Spencer noted that he has no financial interest in the Ellman Surgitron company or the recommended product.

Making a foray into surgical practice should be a careful and well-thought-out career move, cautioned Dr. Spencer, who serves on the clinical faculty of the Mount Sinai School of Medicine in New York.

"Why would another doctor refer to you because you took a weekend course?" he asked.

He advises doing a procedural dermatology fellowship, writing papers, doing research, and then, with some expertise to offer, arranging to do a grand rounds lecture at the local community hospital.

Dr. Spencer said young dermatologic surgeons are wise to take Medicare so that they can begin to build a referral practice for patients with skin cancer.

Family physicians often perform skin biopsies, but have a choice about where to send their patients for excisions and repairs.

"Get to know them," he suggested.

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LAS VEGAS — The most critical investments one should make in a new surgical practice are a quality surgical table, a top-of-the-line surgical light, and excellent surgical instruments, Dr. James M. Spencer said at the annual meeting of the American Society of Cosmetic Dermatology & Aesthetic Surgery.

"There are a lot of places in life to cut corners. Don't do it here," said Dr. Spencer, a dermatologist in private practice in St. Petersburg, Fla.

A dermatologic surgeon who only intends to do facial work might be well served by a top-flight procedure chair, such as those used by otolaryngologists.

However, Dr. Spencer prefers a high-quality surgical table and an adjustable, ceiling-mounted surgical light.

"Don't be cheap here," he reiterated.

Every surgeon has his or her favorite piece of equipment, and Dr. Spencer is no exception.

"The smartest thing I ever bought in my whole life was an Ellman Surgitron [electrosurgery unit]," he said.

Dr. Spencer noted that he has no financial interest in the Ellman Surgitron company or the recommended product.

Making a foray into surgical practice should be a careful and well-thought-out career move, cautioned Dr. Spencer, who serves on the clinical faculty of the Mount Sinai School of Medicine in New York.

"Why would another doctor refer to you because you took a weekend course?" he asked.

He advises doing a procedural dermatology fellowship, writing papers, doing research, and then, with some expertise to offer, arranging to do a grand rounds lecture at the local community hospital.

Dr. Spencer said young dermatologic surgeons are wise to take Medicare so that they can begin to build a referral practice for patients with skin cancer.

Family physicians often perform skin biopsies, but have a choice about where to send their patients for excisions and repairs.

"Get to know them," he suggested.

LAS VEGAS — The most critical investments one should make in a new surgical practice are a quality surgical table, a top-of-the-line surgical light, and excellent surgical instruments, Dr. James M. Spencer said at the annual meeting of the American Society of Cosmetic Dermatology & Aesthetic Surgery.

"There are a lot of places in life to cut corners. Don't do it here," said Dr. Spencer, a dermatologist in private practice in St. Petersburg, Fla.

A dermatologic surgeon who only intends to do facial work might be well served by a top-flight procedure chair, such as those used by otolaryngologists.

However, Dr. Spencer prefers a high-quality surgical table and an adjustable, ceiling-mounted surgical light.

"Don't be cheap here," he reiterated.

Every surgeon has his or her favorite piece of equipment, and Dr. Spencer is no exception.

"The smartest thing I ever bought in my whole life was an Ellman Surgitron [electrosurgery unit]," he said.

Dr. Spencer noted that he has no financial interest in the Ellman Surgitron company or the recommended product.

Making a foray into surgical practice should be a careful and well-thought-out career move, cautioned Dr. Spencer, who serves on the clinical faculty of the Mount Sinai School of Medicine in New York.

"Why would another doctor refer to you because you took a weekend course?" he asked.

He advises doing a procedural dermatology fellowship, writing papers, doing research, and then, with some expertise to offer, arranging to do a grand rounds lecture at the local community hospital.

Dr. Spencer said young dermatologic surgeons are wise to take Medicare so that they can begin to build a referral practice for patients with skin cancer.

Family physicians often perform skin biopsies, but have a choice about where to send their patients for excisions and repairs.

"Get to know them," he suggested.

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Botox Put to Innovative Uses in Facial Surgery

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LAS VEGAS — The use of botulinum toxin type A in a dermatologic surgical practice extends far beyond touching up the results of a brow lift or smoothing crow's feet to complement a facial laser procedure.

Surgeons speaking at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery said that they have incorporated botulinum toxin type A (Botox) into many facets of their practice, from stabilizing healing tissue to treating fellow surgeons' sweaty palms.

"Botox is a great adjunct to surgery," said Dr. Steven Dayan, a facial, plastic, and reconstructive surgeon and otolaryngologist in Chicago.

Dr. Dayan injects every patient undergoing a forehead lift with Botox to immobilize the frontalis muscle and prevent scars from being pulled apart. "It helps quite a bit in closing these scars and keeping the area splinted," he said.

Dr. Joel Cohen, a dermatologist and Mohs surgeon in Denver, uses the same immobilizing effect of Botox to hold tissue in place following extensive Mohs cases of the face.

If a nerve is weakened during surgery, Botox can restore symmetry of the face, said Dr. Dayan. He uses it to smooth platysmal bands that remain following a neck lift, to rotate the nasal tip upward when it has become elongated with age, and to raise the corners of the mouth.

He's even used it on surgeons' hands—once they've signed explicit informed-consent agreements—to reduce perspiration in their surgical gloves.

Despite the risks, some surgeons are so concerned that their hands become slippery in their gloves during procedures that they are more than willing to undergo Botox injections, Dr. Dayan said.

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LAS VEGAS — The use of botulinum toxin type A in a dermatologic surgical practice extends far beyond touching up the results of a brow lift or smoothing crow's feet to complement a facial laser procedure.

Surgeons speaking at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery said that they have incorporated botulinum toxin type A (Botox) into many facets of their practice, from stabilizing healing tissue to treating fellow surgeons' sweaty palms.

"Botox is a great adjunct to surgery," said Dr. Steven Dayan, a facial, plastic, and reconstructive surgeon and otolaryngologist in Chicago.

Dr. Dayan injects every patient undergoing a forehead lift with Botox to immobilize the frontalis muscle and prevent scars from being pulled apart. "It helps quite a bit in closing these scars and keeping the area splinted," he said.

Dr. Joel Cohen, a dermatologist and Mohs surgeon in Denver, uses the same immobilizing effect of Botox to hold tissue in place following extensive Mohs cases of the face.

If a nerve is weakened during surgery, Botox can restore symmetry of the face, said Dr. Dayan. He uses it to smooth platysmal bands that remain following a neck lift, to rotate the nasal tip upward when it has become elongated with age, and to raise the corners of the mouth.

He's even used it on surgeons' hands—once they've signed explicit informed-consent agreements—to reduce perspiration in their surgical gloves.

Despite the risks, some surgeons are so concerned that their hands become slippery in their gloves during procedures that they are more than willing to undergo Botox injections, Dr. Dayan said.

LAS VEGAS — The use of botulinum toxin type A in a dermatologic surgical practice extends far beyond touching up the results of a brow lift or smoothing crow's feet to complement a facial laser procedure.

Surgeons speaking at the annual meeting of the American Society of Cosmetic Dermatology and Aesthetic Surgery said that they have incorporated botulinum toxin type A (Botox) into many facets of their practice, from stabilizing healing tissue to treating fellow surgeons' sweaty palms.

"Botox is a great adjunct to surgery," said Dr. Steven Dayan, a facial, plastic, and reconstructive surgeon and otolaryngologist in Chicago.

Dr. Dayan injects every patient undergoing a forehead lift with Botox to immobilize the frontalis muscle and prevent scars from being pulled apart. "It helps quite a bit in closing these scars and keeping the area splinted," he said.

Dr. Joel Cohen, a dermatologist and Mohs surgeon in Denver, uses the same immobilizing effect of Botox to hold tissue in place following extensive Mohs cases of the face.

If a nerve is weakened during surgery, Botox can restore symmetry of the face, said Dr. Dayan. He uses it to smooth platysmal bands that remain following a neck lift, to rotate the nasal tip upward when it has become elongated with age, and to raise the corners of the mouth.

He's even used it on surgeons' hands—once they've signed explicit informed-consent agreements—to reduce perspiration in their surgical gloves.

Despite the risks, some surgeons are so concerned that their hands become slippery in their gloves during procedures that they are more than willing to undergo Botox injections, Dr. Dayan said.

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Tampon Buttress Mimics Pessary in Active Women

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Even very young women—and certainly many older women who lead physically active lives—may leak urine during vigorous exercise, but that does not mean they all need pessaries or surgery to get them on the court or the playing field, Dr. Michael Moen said at a meeting on women's health sponsored by OB.GYN. NEWS.

“For any woman who has stopped exercising due to leaking, the tampon trick is great,” he said.

He instructs such women to use the largest tampon they can comfortably accommodate using lubrication to act as a buttress supporting the urethra, just as a pessary would.

The tampon trick should only be used during the period of time when a woman knows she will be engaged in doing vigorous activity.

“There's nothing wrong with using a tampon and wearing a pad and getting some biker shorts that have some support,” he emphasized.

The point is to work with women until a way is found for them to engage in activities they enjoy, using whatever works for them, he said.

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Even very young women—and certainly many older women who lead physically active lives—may leak urine during vigorous exercise, but that does not mean they all need pessaries or surgery to get them on the court or the playing field, Dr. Michael Moen said at a meeting on women's health sponsored by OB.GYN. NEWS.

“For any woman who has stopped exercising due to leaking, the tampon trick is great,” he said.

He instructs such women to use the largest tampon they can comfortably accommodate using lubrication to act as a buttress supporting the urethra, just as a pessary would.

The tampon trick should only be used during the period of time when a woman knows she will be engaged in doing vigorous activity.

“There's nothing wrong with using a tampon and wearing a pad and getting some biker shorts that have some support,” he emphasized.

The point is to work with women until a way is found for them to engage in activities they enjoy, using whatever works for them, he said.

Even very young women—and certainly many older women who lead physically active lives—may leak urine during vigorous exercise, but that does not mean they all need pessaries or surgery to get them on the court or the playing field, Dr. Michael Moen said at a meeting on women's health sponsored by OB.GYN. NEWS.

“For any woman who has stopped exercising due to leaking, the tampon trick is great,” he said.

He instructs such women to use the largest tampon they can comfortably accommodate using lubrication to act as a buttress supporting the urethra, just as a pessary would.

The tampon trick should only be used during the period of time when a woman knows she will be engaged in doing vigorous activity.

“There's nothing wrong with using a tampon and wearing a pad and getting some biker shorts that have some support,” he emphasized.

The point is to work with women until a way is found for them to engage in activities they enjoy, using whatever works for them, he said.

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Obese Children May Face Heart Failure in Their 20s

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Obese Children May Face Heart Failure in Their 20s

SNOWMASS, COLO. — The complications of type 2 diabetes mellitus are occurring so rapidly in children that cardiologists should brace for seeing congestive heart failure patients dying in their 40s, an endocrinologist predicted at a conference sponsored by the Society for Cardiovascular Angiography and Interventions.

“It doesn't take 15 years for the complications [of pediatric type 2 diabetes] to develop,” stressed Dr. Kathleen Wyne, who serves in the division of endocrinology and metabolism at the University of Texas at Dallas.

About 10 years ago, when obese youth and adolescents began being diagnosed with type 2 diabetes, endocrinologists predicted it would take many years for them to develop hypertension, albuminuria, retinopathy, and cardiovascular complications of the disease because, unlike their adult counterparts, they did not have a decade or more of preceding insulin resistance.

That's turning out to be a false assumption, and children with type 2 diabetes are demonstrating “all of the complications we see in adults,” within 5–6 years of their diagnoses, Dr. Wyne said at the meeting, also sponsored by the American College of Cardiology.

Compared with adolescents who have type 1 diabetes, those with type 2 diabetes have more obesity, overweight, hypertension, high triglycerides, low HDL cholesterol, microalbuminuria, and retinopathy. “Once you start seeing [those symptoms], you know the process has already started, and you need to look for other complications,” said Dr. Wyne.

By putting numbers on the problem, Dr. Wyne reported that in Dallas County alone, children seen in outpatient clinics for obesity, dietary surveillance, abnormal weight gain, or acanthosis nigricans soared from 665 in 2001 to 1,378 in 2005. Diagnoses of type 2 diabetes more than doubled, from 69 to 137.

Texas academic centers are currently seeing 250 children a year with type 2 diabetes, aged 4–16 years. “This is not a disease of kids postpubertal. This goes the full range of kids' [ages],” she said.

If an estimated one-third of adults with diabetes are undiagnosed, then the percentage could be much higher in children, according to Dr. Wyne. Based on obesity rates among the 1 million children in Houston, for example, there could be 5,600 children with “silent” type 2 diabetes in that city alone, she said.

One practical suggestion to prevent cardiovascular catastrophes in young adults is to screen children early and screen them often, using two important risk factors: a family history of diabetes and obesity.

Lifestyle interventions are the first line of therapy of youth and adolescents, just as in adults. Almost always, the whole family is involved in dietary and exercise patterns that put them at risk for diabetes, so interventions must be familywide.

If those steps fail to produce results, Dr. Wyne said she prescribes ACE inhibitors, statins, and angiotensin II receptor blockers (ARBs) to symptomatic teenagers and younger children. “What I don't know [is how to treat] newly diagnosed youth and adolescents who have no complications yet,” she said.

Often, she makes emotional appeals to the parents and grandparents of children who seem destined for the cardiac catheterization laboratory in young adulthood.

“If I've got grandparents in their 40s and 50s with diabetes and heart disease and they have a fat little [grand]kid, I know that kid is heading in that direction,” she said.

County hospitals in Texas are currently seeing patients with congestive heart failure in their 30s, 40s, and 50s, said Dr. Wyne. She's been diagnosing elementary school children with type 2 diabetes for 10 years, and they're been developing complications in 5–6 years.

The math suggests that some of these children will develop heart failure in their 20s and 30s, she said. “A few years ago, it struck me that this is going to be a generation in which parents are burying their children.”

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SNOWMASS, COLO. — The complications of type 2 diabetes mellitus are occurring so rapidly in children that cardiologists should brace for seeing congestive heart failure patients dying in their 40s, an endocrinologist predicted at a conference sponsored by the Society for Cardiovascular Angiography and Interventions.

“It doesn't take 15 years for the complications [of pediatric type 2 diabetes] to develop,” stressed Dr. Kathleen Wyne, who serves in the division of endocrinology and metabolism at the University of Texas at Dallas.

About 10 years ago, when obese youth and adolescents began being diagnosed with type 2 diabetes, endocrinologists predicted it would take many years for them to develop hypertension, albuminuria, retinopathy, and cardiovascular complications of the disease because, unlike their adult counterparts, they did not have a decade or more of preceding insulin resistance.

That's turning out to be a false assumption, and children with type 2 diabetes are demonstrating “all of the complications we see in adults,” within 5–6 years of their diagnoses, Dr. Wyne said at the meeting, also sponsored by the American College of Cardiology.

Compared with adolescents who have type 1 diabetes, those with type 2 diabetes have more obesity, overweight, hypertension, high triglycerides, low HDL cholesterol, microalbuminuria, and retinopathy. “Once you start seeing [those symptoms], you know the process has already started, and you need to look for other complications,” said Dr. Wyne.

By putting numbers on the problem, Dr. Wyne reported that in Dallas County alone, children seen in outpatient clinics for obesity, dietary surveillance, abnormal weight gain, or acanthosis nigricans soared from 665 in 2001 to 1,378 in 2005. Diagnoses of type 2 diabetes more than doubled, from 69 to 137.

Texas academic centers are currently seeing 250 children a year with type 2 diabetes, aged 4–16 years. “This is not a disease of kids postpubertal. This goes the full range of kids' [ages],” she said.

If an estimated one-third of adults with diabetes are undiagnosed, then the percentage could be much higher in children, according to Dr. Wyne. Based on obesity rates among the 1 million children in Houston, for example, there could be 5,600 children with “silent” type 2 diabetes in that city alone, she said.

One practical suggestion to prevent cardiovascular catastrophes in young adults is to screen children early and screen them often, using two important risk factors: a family history of diabetes and obesity.

Lifestyle interventions are the first line of therapy of youth and adolescents, just as in adults. Almost always, the whole family is involved in dietary and exercise patterns that put them at risk for diabetes, so interventions must be familywide.

If those steps fail to produce results, Dr. Wyne said she prescribes ACE inhibitors, statins, and angiotensin II receptor blockers (ARBs) to symptomatic teenagers and younger children. “What I don't know [is how to treat] newly diagnosed youth and adolescents who have no complications yet,” she said.

Often, she makes emotional appeals to the parents and grandparents of children who seem destined for the cardiac catheterization laboratory in young adulthood.

“If I've got grandparents in their 40s and 50s with diabetes and heart disease and they have a fat little [grand]kid, I know that kid is heading in that direction,” she said.

County hospitals in Texas are currently seeing patients with congestive heart failure in their 30s, 40s, and 50s, said Dr. Wyne. She's been diagnosing elementary school children with type 2 diabetes for 10 years, and they're been developing complications in 5–6 years.

The math suggests that some of these children will develop heart failure in their 20s and 30s, she said. “A few years ago, it struck me that this is going to be a generation in which parents are burying their children.”

SNOWMASS, COLO. — The complications of type 2 diabetes mellitus are occurring so rapidly in children that cardiologists should brace for seeing congestive heart failure patients dying in their 40s, an endocrinologist predicted at a conference sponsored by the Society for Cardiovascular Angiography and Interventions.

“It doesn't take 15 years for the complications [of pediatric type 2 diabetes] to develop,” stressed Dr. Kathleen Wyne, who serves in the division of endocrinology and metabolism at the University of Texas at Dallas.

About 10 years ago, when obese youth and adolescents began being diagnosed with type 2 diabetes, endocrinologists predicted it would take many years for them to develop hypertension, albuminuria, retinopathy, and cardiovascular complications of the disease because, unlike their adult counterparts, they did not have a decade or more of preceding insulin resistance.

That's turning out to be a false assumption, and children with type 2 diabetes are demonstrating “all of the complications we see in adults,” within 5–6 years of their diagnoses, Dr. Wyne said at the meeting, also sponsored by the American College of Cardiology.

Compared with adolescents who have type 1 diabetes, those with type 2 diabetes have more obesity, overweight, hypertension, high triglycerides, low HDL cholesterol, microalbuminuria, and retinopathy. “Once you start seeing [those symptoms], you know the process has already started, and you need to look for other complications,” said Dr. Wyne.

By putting numbers on the problem, Dr. Wyne reported that in Dallas County alone, children seen in outpatient clinics for obesity, dietary surveillance, abnormal weight gain, or acanthosis nigricans soared from 665 in 2001 to 1,378 in 2005. Diagnoses of type 2 diabetes more than doubled, from 69 to 137.

Texas academic centers are currently seeing 250 children a year with type 2 diabetes, aged 4–16 years. “This is not a disease of kids postpubertal. This goes the full range of kids' [ages],” she said.

If an estimated one-third of adults with diabetes are undiagnosed, then the percentage could be much higher in children, according to Dr. Wyne. Based on obesity rates among the 1 million children in Houston, for example, there could be 5,600 children with “silent” type 2 diabetes in that city alone, she said.

One practical suggestion to prevent cardiovascular catastrophes in young adults is to screen children early and screen them often, using two important risk factors: a family history of diabetes and obesity.

Lifestyle interventions are the first line of therapy of youth and adolescents, just as in adults. Almost always, the whole family is involved in dietary and exercise patterns that put them at risk for diabetes, so interventions must be familywide.

If those steps fail to produce results, Dr. Wyne said she prescribes ACE inhibitors, statins, and angiotensin II receptor blockers (ARBs) to symptomatic teenagers and younger children. “What I don't know [is how to treat] newly diagnosed youth and adolescents who have no complications yet,” she said.

Often, she makes emotional appeals to the parents and grandparents of children who seem destined for the cardiac catheterization laboratory in young adulthood.

“If I've got grandparents in their 40s and 50s with diabetes and heart disease and they have a fat little [grand]kid, I know that kid is heading in that direction,” she said.

County hospitals in Texas are currently seeing patients with congestive heart failure in their 30s, 40s, and 50s, said Dr. Wyne. She's been diagnosing elementary school children with type 2 diabetes for 10 years, and they're been developing complications in 5–6 years.

The math suggests that some of these children will develop heart failure in their 20s and 30s, she said. “A few years ago, it struck me that this is going to be a generation in which parents are burying their children.”

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