Online Registry Is Broadening Autism Research

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Since its launch earlier this year, the first online autism registry in the United States has garnered a diverse group of participants and a treasured commodity.

Among the more than 14,000 registrants to the Interactive Autism Network (IAN), there are six sets of triplets, 44 sets of identical twins, and 162 sets of fraternal twins.

“Twins are a cherished resource for understanding autism because they help you get at the issue of environmental versus genetic factors,” Dr. Paul Law, director of the network, said in an interview. “If identical twins aren't the same, then presumably there is some environmental factor that is determining that difference.”

Preliminary data show that the concordance rate of autism among identical twins registered with IAN is about 80%–85%, which falls within the range identified in previous autism twin studies. Concordance rates are in the upper 20% range for fraternal twins. Typically, concordance has been reported around 10% for fraternal twins, prompting the IAN staff to invite experts to look at why this may be, Dr. Law said. The registry was launched in April.

Another statistic of interest to researchers is the growing number of families IAN is attracting who are new to autism research. Among the 250 families that participated as pilot registrants, 80% had never participated in any autism research.

That number has risen to 86% among current registrants, and is expected to reach 90% as news of the project reaches more affected families.

The ability to reach new participants is a result in part of the time and travel constraints that are overcome by Internet participation. Families have registered from all 50 states and the District of Columbia, as well as such exotic locations as Guam, American Samoa, the Marshall Islands, and Palau.

But the success also speaks to the often underestimated desire of families of children with autism spectrum disorders to be part of the solution, Dr. Law said.

What also has become evident in the short history of IAN is the need to register adults with autism spectrum disorders. Registration is now limited to infants and children aged 18 years and younger, as a result of logistical constraints such as competency, guardianship, and the reliability of self-reported data. The IAN staff, based at Baltimore's Kennedy Krieger Institute, is now working with experts in adult autism to overcome these obstacles.

“It's critical, because the one thing the mother wants to know when they come to me as a provider and the baby is 18 months old is what that child is going to look like at 22 or 24 years of age, and we have few information sources to answer that,” Dr. Law said.

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Since its launch earlier this year, the first online autism registry in the United States has garnered a diverse group of participants and a treasured commodity.

Among the more than 14,000 registrants to the Interactive Autism Network (IAN), there are six sets of triplets, 44 sets of identical twins, and 162 sets of fraternal twins.

“Twins are a cherished resource for understanding autism because they help you get at the issue of environmental versus genetic factors,” Dr. Paul Law, director of the network, said in an interview. “If identical twins aren't the same, then presumably there is some environmental factor that is determining that difference.”

Preliminary data show that the concordance rate of autism among identical twins registered with IAN is about 80%–85%, which falls within the range identified in previous autism twin studies. Concordance rates are in the upper 20% range for fraternal twins. Typically, concordance has been reported around 10% for fraternal twins, prompting the IAN staff to invite experts to look at why this may be, Dr. Law said. The registry was launched in April.

Another statistic of interest to researchers is the growing number of families IAN is attracting who are new to autism research. Among the 250 families that participated as pilot registrants, 80% had never participated in any autism research.

That number has risen to 86% among current registrants, and is expected to reach 90% as news of the project reaches more affected families.

The ability to reach new participants is a result in part of the time and travel constraints that are overcome by Internet participation. Families have registered from all 50 states and the District of Columbia, as well as such exotic locations as Guam, American Samoa, the Marshall Islands, and Palau.

But the success also speaks to the often underestimated desire of families of children with autism spectrum disorders to be part of the solution, Dr. Law said.

What also has become evident in the short history of IAN is the need to register adults with autism spectrum disorders. Registration is now limited to infants and children aged 18 years and younger, as a result of logistical constraints such as competency, guardianship, and the reliability of self-reported data. The IAN staff, based at Baltimore's Kennedy Krieger Institute, is now working with experts in adult autism to overcome these obstacles.

“It's critical, because the one thing the mother wants to know when they come to me as a provider and the baby is 18 months old is what that child is going to look like at 22 or 24 years of age, and we have few information sources to answer that,” Dr. Law said.

Since its launch earlier this year, the first online autism registry in the United States has garnered a diverse group of participants and a treasured commodity.

Among the more than 14,000 registrants to the Interactive Autism Network (IAN), there are six sets of triplets, 44 sets of identical twins, and 162 sets of fraternal twins.

“Twins are a cherished resource for understanding autism because they help you get at the issue of environmental versus genetic factors,” Dr. Paul Law, director of the network, said in an interview. “If identical twins aren't the same, then presumably there is some environmental factor that is determining that difference.”

Preliminary data show that the concordance rate of autism among identical twins registered with IAN is about 80%–85%, which falls within the range identified in previous autism twin studies. Concordance rates are in the upper 20% range for fraternal twins. Typically, concordance has been reported around 10% for fraternal twins, prompting the IAN staff to invite experts to look at why this may be, Dr. Law said. The registry was launched in April.

Another statistic of interest to researchers is the growing number of families IAN is attracting who are new to autism research. Among the 250 families that participated as pilot registrants, 80% had never participated in any autism research.

That number has risen to 86% among current registrants, and is expected to reach 90% as news of the project reaches more affected families.

The ability to reach new participants is a result in part of the time and travel constraints that are overcome by Internet participation. Families have registered from all 50 states and the District of Columbia, as well as such exotic locations as Guam, American Samoa, the Marshall Islands, and Palau.

But the success also speaks to the often underestimated desire of families of children with autism spectrum disorders to be part of the solution, Dr. Law said.

What also has become evident in the short history of IAN is the need to register adults with autism spectrum disorders. Registration is now limited to infants and children aged 18 years and younger, as a result of logistical constraints such as competency, guardianship, and the reliability of self-reported data. The IAN staff, based at Baltimore's Kennedy Krieger Institute, is now working with experts in adult autism to overcome these obstacles.

“It's critical, because the one thing the mother wants to know when they come to me as a provider and the baby is 18 months old is what that child is going to look like at 22 or 24 years of age, and we have few information sources to answer that,” Dr. Law said.

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Combo Drug Lowers Refractory HT

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CHICAGO — Nearly three-fourths of patients with uncontrolled hypertension on monotherapy achieved national blood pressure targets on a fixed-dose combination of amlodipine and valsartan that will soon be available, Dr. Joseph L. Izzo Jr. reported at the annual meeting of the American Society of Hypertension.

Two different formulations of Novartis' single-tablet combination drug, which will be marketed as Exforge, were evaluated in a double-blind, multicenter study that randomized 443 patients to amlodipine 5 mg/valsartan 160 mg and 451 patients to amlodipine 10 mg/valsartan 160 mg.

After 8 weeks, hydrochlorothiazide (HCTZ) could be added, first at 12.5 mg and then at 25 mg.

The majority of the patients, including 145 (16%) of whom had type 2 diabetes, had been previously treated with a β-blocker, angiotensin receptor antagonist, ACE inhibitor, calcium channel blocker, or diuretic.

At admission, their mean age was 58 years and their mean blood pressure was 150/90 mm Hg, said Dr. Izzo, who has received research support and is a consultant for Novartis, which sponsored the study. More than 90% of the patients were white.

The study's primary end point was the proportion of patients after 8 and 16 weeks who had reached a blood pressure of 140/90 mm Hg or 130/80 mm Hg for those with diabetes—the currently recommended dual BP targets in the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7).

In an intent-to-treat analysis at week 16, 322 of 440 patients (73%) on the 5-mg/160-mg dose and 338 of 449 patients (75%) on the 10-mg/160-mg dose achieved the dual JNC7 targets, the investigators reported.

Among those with diabetes, 25 of the 61 patients (41%) on the low-dose combination and 27 of the 59 patients (46%) on the high-dose combination reached a BP of less than 130 mm Hg.

Switching patients to the combination therapy resulted in an average additional 20-mm Hg drop in systolic BP, compared with reductions seen with their previous medications.

“Obviously those are pretty good responses when one looks at the control rates in the United States, which are just about half these control rates,” Dr. Izzo, a professor of medicine at the State University of New York at Buffalo, said at a press briefing.

Blood pressure control rates were similar when stratified by prior medication, age, or ethnicity.

There was little increased response after 8 weeks that could be attributed to the addition of HCTZ therapy.

There was an incremental response with the amlodipine 10-mg dose. But the incremental response was smaller than expected, meaning that the 5-mg/160-mg dosage is effective, Dr. Izzo said.

Adverse events were similar between groups, although the incidence of edema was higher in patients taking the 10-mg/160-mg dose than in those taking the lower dose (25% vs. 8%).

Exforge was approved by the Food and Drug Administration this summer. It is indicated for the treatment of hypertension in patients whose blood pressure has not been adequately controlled with a calcium channel blocker or angiotensin II receptor blocker alone.

The pills will be available in four strengths: 5 mg amlodipine/60 mg valsartan, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg. Exforge has been launched by Novartis in select European countries.

The products will be available in the United States no earlier than Sept. 25 of this year, the FDA specified in a December 2006 letter to Novartis, because amlodipine (Norvasc, Pfizer Inc.) remains under patent protection until then.

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CHICAGO — Nearly three-fourths of patients with uncontrolled hypertension on monotherapy achieved national blood pressure targets on a fixed-dose combination of amlodipine and valsartan that will soon be available, Dr. Joseph L. Izzo Jr. reported at the annual meeting of the American Society of Hypertension.

Two different formulations of Novartis' single-tablet combination drug, which will be marketed as Exforge, were evaluated in a double-blind, multicenter study that randomized 443 patients to amlodipine 5 mg/valsartan 160 mg and 451 patients to amlodipine 10 mg/valsartan 160 mg.

After 8 weeks, hydrochlorothiazide (HCTZ) could be added, first at 12.5 mg and then at 25 mg.

The majority of the patients, including 145 (16%) of whom had type 2 diabetes, had been previously treated with a β-blocker, angiotensin receptor antagonist, ACE inhibitor, calcium channel blocker, or diuretic.

At admission, their mean age was 58 years and their mean blood pressure was 150/90 mm Hg, said Dr. Izzo, who has received research support and is a consultant for Novartis, which sponsored the study. More than 90% of the patients were white.

The study's primary end point was the proportion of patients after 8 and 16 weeks who had reached a blood pressure of 140/90 mm Hg or 130/80 mm Hg for those with diabetes—the currently recommended dual BP targets in the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7).

In an intent-to-treat analysis at week 16, 322 of 440 patients (73%) on the 5-mg/160-mg dose and 338 of 449 patients (75%) on the 10-mg/160-mg dose achieved the dual JNC7 targets, the investigators reported.

Among those with diabetes, 25 of the 61 patients (41%) on the low-dose combination and 27 of the 59 patients (46%) on the high-dose combination reached a BP of less than 130 mm Hg.

Switching patients to the combination therapy resulted in an average additional 20-mm Hg drop in systolic BP, compared with reductions seen with their previous medications.

“Obviously those are pretty good responses when one looks at the control rates in the United States, which are just about half these control rates,” Dr. Izzo, a professor of medicine at the State University of New York at Buffalo, said at a press briefing.

Blood pressure control rates were similar when stratified by prior medication, age, or ethnicity.

There was little increased response after 8 weeks that could be attributed to the addition of HCTZ therapy.

There was an incremental response with the amlodipine 10-mg dose. But the incremental response was smaller than expected, meaning that the 5-mg/160-mg dosage is effective, Dr. Izzo said.

Adverse events were similar between groups, although the incidence of edema was higher in patients taking the 10-mg/160-mg dose than in those taking the lower dose (25% vs. 8%).

Exforge was approved by the Food and Drug Administration this summer. It is indicated for the treatment of hypertension in patients whose blood pressure has not been adequately controlled with a calcium channel blocker or angiotensin II receptor blocker alone.

The pills will be available in four strengths: 5 mg amlodipine/60 mg valsartan, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg. Exforge has been launched by Novartis in select European countries.

The products will be available in the United States no earlier than Sept. 25 of this year, the FDA specified in a December 2006 letter to Novartis, because amlodipine (Norvasc, Pfizer Inc.) remains under patent protection until then.

CHICAGO — Nearly three-fourths of patients with uncontrolled hypertension on monotherapy achieved national blood pressure targets on a fixed-dose combination of amlodipine and valsartan that will soon be available, Dr. Joseph L. Izzo Jr. reported at the annual meeting of the American Society of Hypertension.

Two different formulations of Novartis' single-tablet combination drug, which will be marketed as Exforge, were evaluated in a double-blind, multicenter study that randomized 443 patients to amlodipine 5 mg/valsartan 160 mg and 451 patients to amlodipine 10 mg/valsartan 160 mg.

After 8 weeks, hydrochlorothiazide (HCTZ) could be added, first at 12.5 mg and then at 25 mg.

The majority of the patients, including 145 (16%) of whom had type 2 diabetes, had been previously treated with a β-blocker, angiotensin receptor antagonist, ACE inhibitor, calcium channel blocker, or diuretic.

At admission, their mean age was 58 years and their mean blood pressure was 150/90 mm Hg, said Dr. Izzo, who has received research support and is a consultant for Novartis, which sponsored the study. More than 90% of the patients were white.

The study's primary end point was the proportion of patients after 8 and 16 weeks who had reached a blood pressure of 140/90 mm Hg or 130/80 mm Hg for those with diabetes—the currently recommended dual BP targets in the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC7).

In an intent-to-treat analysis at week 16, 322 of 440 patients (73%) on the 5-mg/160-mg dose and 338 of 449 patients (75%) on the 10-mg/160-mg dose achieved the dual JNC7 targets, the investigators reported.

Among those with diabetes, 25 of the 61 patients (41%) on the low-dose combination and 27 of the 59 patients (46%) on the high-dose combination reached a BP of less than 130 mm Hg.

Switching patients to the combination therapy resulted in an average additional 20-mm Hg drop in systolic BP, compared with reductions seen with their previous medications.

“Obviously those are pretty good responses when one looks at the control rates in the United States, which are just about half these control rates,” Dr. Izzo, a professor of medicine at the State University of New York at Buffalo, said at a press briefing.

Blood pressure control rates were similar when stratified by prior medication, age, or ethnicity.

There was little increased response after 8 weeks that could be attributed to the addition of HCTZ therapy.

There was an incremental response with the amlodipine 10-mg dose. But the incremental response was smaller than expected, meaning that the 5-mg/160-mg dosage is effective, Dr. Izzo said.

Adverse events were similar between groups, although the incidence of edema was higher in patients taking the 10-mg/160-mg dose than in those taking the lower dose (25% vs. 8%).

Exforge was approved by the Food and Drug Administration this summer. It is indicated for the treatment of hypertension in patients whose blood pressure has not been adequately controlled with a calcium channel blocker or angiotensin II receptor blocker alone.

The pills will be available in four strengths: 5 mg amlodipine/60 mg valsartan, 10 mg/160 mg, 5 mg/320 mg, and 10 mg/320 mg. Exforge has been launched by Novartis in select European countries.

The products will be available in the United States no earlier than Sept. 25 of this year, the FDA specified in a December 2006 letter to Novartis, because amlodipine (Norvasc, Pfizer Inc.) remains under patent protection until then.

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Deficit of Vitamin D, Dark Skin Underlie Reemergence of Rickets

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NEW ORLEANS — Nutritional rickets caused by vitamin D deficiency persists, in part because the risk factors may not be fully appreciated, Dr. Arlette Soros and colleagues reported in a poster at the Southern regional meeting of the American Federation for Medical Research.

They have encountered nearly a dozen cases in the last decade at Children's Hospital in New Orleans, and have documented four representative cases. The children, aged 3 months to 3 years, shared similar risk factors of having been breast-fed without any vitamin D supplementation, limited sun exposure, and darker skin.

Breast milk typically contains a vitamin D concentration of 25 IU or less per liter, which falls far short of the daily recommended minimum intake of 200 IU per day for infants, said Dr. Soros, a pediatrician with the division of endocrinology at Louisiana State University, New Orleans.

“It's wrong to think that a baby will get all the nutrients it needs from breast milk, and not give vitamin D supplementation” she said in an interview. “They may appear healthy, but there is a deficiency going on.”

In addition, synthesis of vitamin D from ultraviolet sunlight is decreased in darker skin pigmentation.

Three of the children were African American, and one was Arabic. They presented with tetany, bony deformities such as bowed legs, widening of wrists and ankles, and rachitic rosary.

All of the children had low serum total calcium (range 6.1–7.8 mg/dL) and ionized calcium levels (range 2.2- 4.3 mg/dL); relatively low normal serum phosphorus levels (range 4.3–6.1 mg/dL), and elevated alkaline phosphatase levels (range 391–1,158 U/L). They also had low serum 25-hydroxy vitamin D (range 5.0–21 ng/mL), high parathyroid hormone levels (range 143–454 pg/mL), and relatively high 1,25-dihydroxy vitamin D levels (range 93–195 pg/mL). Renal and liver functions were normal.

After a single dose of intravenous calcium, ergocalciferol, or calcitriol, all of the children had complete or near-complete resolution of their symptoms. “[One boy] was up running the next day,” Dr. Soros said. “This is very preventable.”

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NEW ORLEANS — Nutritional rickets caused by vitamin D deficiency persists, in part because the risk factors may not be fully appreciated, Dr. Arlette Soros and colleagues reported in a poster at the Southern regional meeting of the American Federation for Medical Research.

They have encountered nearly a dozen cases in the last decade at Children's Hospital in New Orleans, and have documented four representative cases. The children, aged 3 months to 3 years, shared similar risk factors of having been breast-fed without any vitamin D supplementation, limited sun exposure, and darker skin.

Breast milk typically contains a vitamin D concentration of 25 IU or less per liter, which falls far short of the daily recommended minimum intake of 200 IU per day for infants, said Dr. Soros, a pediatrician with the division of endocrinology at Louisiana State University, New Orleans.

“It's wrong to think that a baby will get all the nutrients it needs from breast milk, and not give vitamin D supplementation” she said in an interview. “They may appear healthy, but there is a deficiency going on.”

In addition, synthesis of vitamin D from ultraviolet sunlight is decreased in darker skin pigmentation.

Three of the children were African American, and one was Arabic. They presented with tetany, bony deformities such as bowed legs, widening of wrists and ankles, and rachitic rosary.

All of the children had low serum total calcium (range 6.1–7.8 mg/dL) and ionized calcium levels (range 2.2- 4.3 mg/dL); relatively low normal serum phosphorus levels (range 4.3–6.1 mg/dL), and elevated alkaline phosphatase levels (range 391–1,158 U/L). They also had low serum 25-hydroxy vitamin D (range 5.0–21 ng/mL), high parathyroid hormone levels (range 143–454 pg/mL), and relatively high 1,25-dihydroxy vitamin D levels (range 93–195 pg/mL). Renal and liver functions were normal.

After a single dose of intravenous calcium, ergocalciferol, or calcitriol, all of the children had complete or near-complete resolution of their symptoms. “[One boy] was up running the next day,” Dr. Soros said. “This is very preventable.”

NEW ORLEANS — Nutritional rickets caused by vitamin D deficiency persists, in part because the risk factors may not be fully appreciated, Dr. Arlette Soros and colleagues reported in a poster at the Southern regional meeting of the American Federation for Medical Research.

They have encountered nearly a dozen cases in the last decade at Children's Hospital in New Orleans, and have documented four representative cases. The children, aged 3 months to 3 years, shared similar risk factors of having been breast-fed without any vitamin D supplementation, limited sun exposure, and darker skin.

Breast milk typically contains a vitamin D concentration of 25 IU or less per liter, which falls far short of the daily recommended minimum intake of 200 IU per day for infants, said Dr. Soros, a pediatrician with the division of endocrinology at Louisiana State University, New Orleans.

“It's wrong to think that a baby will get all the nutrients it needs from breast milk, and not give vitamin D supplementation” she said in an interview. “They may appear healthy, but there is a deficiency going on.”

In addition, synthesis of vitamin D from ultraviolet sunlight is decreased in darker skin pigmentation.

Three of the children were African American, and one was Arabic. They presented with tetany, bony deformities such as bowed legs, widening of wrists and ankles, and rachitic rosary.

All of the children had low serum total calcium (range 6.1–7.8 mg/dL) and ionized calcium levels (range 2.2- 4.3 mg/dL); relatively low normal serum phosphorus levels (range 4.3–6.1 mg/dL), and elevated alkaline phosphatase levels (range 391–1,158 U/L). They also had low serum 25-hydroxy vitamin D (range 5.0–21 ng/mL), high parathyroid hormone levels (range 143–454 pg/mL), and relatively high 1,25-dihydroxy vitamin D levels (range 93–195 pg/mL). Renal and liver functions were normal.

After a single dose of intravenous calcium, ergocalciferol, or calcitriol, all of the children had complete or near-complete resolution of their symptoms. “[One boy] was up running the next day,” Dr. Soros said. “This is very preventable.”

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Education Tool Helps Diabetics Focus on Self-Management

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CHICAGO — Health care professionals are trying a new tack to better engage patients in the self-management of their disease.

The American Diabetes Association (ADA) and Healthy Interactions Inc. are launching an initiative centered on a series of visual aids called U.S. Diabetes Conversation Maps. The 3-by-5-foot “maps,” which depict symbolic images that can be used as conversation starters to help small groups explore a variety of diabetes-related facts and issues, are designed to be used in conjunction with a structured series of questions and activities.

The aim is for the maps to shift diabetes education from a one-way lecture to an interactive discussion that increases patients' ability to understand and manage their illness, said diabetes educator Martha M. Funnell, R.N., past president of health care and education for the ADA, and member of the ADA team that helped develop the content for the maps.

“One of the reasons I'm so excited about these maps is they provide an opportunity to be truly patient centered in our delivery of education,” Ms. Funnell said at a press briefing during the annual scientific sessions of the ADA, where the initiative was unveiled.

About 150 training sessions are planned for 2007, with a goal to have more than 10,000 health care professionals incorporate the maps into their diabetes education programs within the next 3 years.

The U.S. Diabetes Conversation Maps initially are being promoted to the 2,800 ADA-recognized education programs, but also will be available to other health care professionals conducting group education including physicians and pharmacists. The five Conversation Maps will be provided free to those who complete the 3-hour training program, thanks to corporate sponsorship from Merck & Co., Peter Gorman, president of Healthy Interactions, said at the press briefing.

The five maps—diabetes overview, healthy eating, blood glucose monitoring, natural course of diabetes, and gestational diabetes—are designed for either type 1 or type 2 diabetes. They contain up-to-date clinical content, and address a wide range of topics, from food and exercise to ways to talk more effectively about the emotional and behavioral component of the disease.

Each map comes with a guide and a set of questions that the facilitator uses as a framework to lead the discussion. For example, the first question patients are asked when using the diabetes overview map is to explain their understanding of what diabetes is and the difference between the two types of diabetes. For women using the gestational diabetes map, much of the discussion centers on diet and exercise plans, as well as on what to expect after childbirth and with subsequent pregnancies.

“A lot of people don't even believe they have diabetes,” Mr. Gorman said in an interview. “So we have a lot of conversations and activities that get them to look at their assumptions and [whether] those assumptions are correct. It's through those questions and answers that they come to their own conclusions and [to] conclusions they are willing to act on.”

All patients are asked to identify near- and long-term goals and to write out an action plan detailing how they will engage their health care team and family to support their accomplishment of those goals. “People can talk about things they want to do, but until they take an active step of writing things down, it doesn't get done,” Mr. Gorman said. The action plan also provides educators with something concrete to follow up on at the next session.

A similar approach to diabetes education was introduced last year in Canada, and preliminary data showed high satisfaction among both patients and educators. At one pilot site with an already well-established diabetes education program, the patient return rate increased 15% between the first and second education sessions, and by 50% between the second and third sessions, Mr. Gorman said.

The company has not evaluated how effective the Canadian maps have been in improving outcomes such as reaching target hemoglobin A1c levels or medication compliance. A protocol is under development in the United States to evaluate such outcomes in the future, Mr. Gorman said.

Michael Weiss, past chair of the ADA board and member of the ADA content team, said the only education he received in 1984 when diagnosed with type 1 diabetes was a single session devoted to how the pancreas works. “This is the validation that patients have a seat at the table. To my knowledge, this is the only educational product developed by physicians and patients working together.”

The Diabetes Conversation Maps can help facilitate discussion about diabetes-related topics in small groups of patients. Healthy Interactions Inc.

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CHICAGO — Health care professionals are trying a new tack to better engage patients in the self-management of their disease.

The American Diabetes Association (ADA) and Healthy Interactions Inc. are launching an initiative centered on a series of visual aids called U.S. Diabetes Conversation Maps. The 3-by-5-foot “maps,” which depict symbolic images that can be used as conversation starters to help small groups explore a variety of diabetes-related facts and issues, are designed to be used in conjunction with a structured series of questions and activities.

The aim is for the maps to shift diabetes education from a one-way lecture to an interactive discussion that increases patients' ability to understand and manage their illness, said diabetes educator Martha M. Funnell, R.N., past president of health care and education for the ADA, and member of the ADA team that helped develop the content for the maps.

“One of the reasons I'm so excited about these maps is they provide an opportunity to be truly patient centered in our delivery of education,” Ms. Funnell said at a press briefing during the annual scientific sessions of the ADA, where the initiative was unveiled.

About 150 training sessions are planned for 2007, with a goal to have more than 10,000 health care professionals incorporate the maps into their diabetes education programs within the next 3 years.

The U.S. Diabetes Conversation Maps initially are being promoted to the 2,800 ADA-recognized education programs, but also will be available to other health care professionals conducting group education including physicians and pharmacists. The five Conversation Maps will be provided free to those who complete the 3-hour training program, thanks to corporate sponsorship from Merck & Co., Peter Gorman, president of Healthy Interactions, said at the press briefing.

The five maps—diabetes overview, healthy eating, blood glucose monitoring, natural course of diabetes, and gestational diabetes—are designed for either type 1 or type 2 diabetes. They contain up-to-date clinical content, and address a wide range of topics, from food and exercise to ways to talk more effectively about the emotional and behavioral component of the disease.

Each map comes with a guide and a set of questions that the facilitator uses as a framework to lead the discussion. For example, the first question patients are asked when using the diabetes overview map is to explain their understanding of what diabetes is and the difference between the two types of diabetes. For women using the gestational diabetes map, much of the discussion centers on diet and exercise plans, as well as on what to expect after childbirth and with subsequent pregnancies.

“A lot of people don't even believe they have diabetes,” Mr. Gorman said in an interview. “So we have a lot of conversations and activities that get them to look at their assumptions and [whether] those assumptions are correct. It's through those questions and answers that they come to their own conclusions and [to] conclusions they are willing to act on.”

All patients are asked to identify near- and long-term goals and to write out an action plan detailing how they will engage their health care team and family to support their accomplishment of those goals. “People can talk about things they want to do, but until they take an active step of writing things down, it doesn't get done,” Mr. Gorman said. The action plan also provides educators with something concrete to follow up on at the next session.

A similar approach to diabetes education was introduced last year in Canada, and preliminary data showed high satisfaction among both patients and educators. At one pilot site with an already well-established diabetes education program, the patient return rate increased 15% between the first and second education sessions, and by 50% between the second and third sessions, Mr. Gorman said.

The company has not evaluated how effective the Canadian maps have been in improving outcomes such as reaching target hemoglobin A1c levels or medication compliance. A protocol is under development in the United States to evaluate such outcomes in the future, Mr. Gorman said.

Michael Weiss, past chair of the ADA board and member of the ADA content team, said the only education he received in 1984 when diagnosed with type 1 diabetes was a single session devoted to how the pancreas works. “This is the validation that patients have a seat at the table. To my knowledge, this is the only educational product developed by physicians and patients working together.”

The Diabetes Conversation Maps can help facilitate discussion about diabetes-related topics in small groups of patients. Healthy Interactions Inc.

CHICAGO — Health care professionals are trying a new tack to better engage patients in the self-management of their disease.

The American Diabetes Association (ADA) and Healthy Interactions Inc. are launching an initiative centered on a series of visual aids called U.S. Diabetes Conversation Maps. The 3-by-5-foot “maps,” which depict symbolic images that can be used as conversation starters to help small groups explore a variety of diabetes-related facts and issues, are designed to be used in conjunction with a structured series of questions and activities.

The aim is for the maps to shift diabetes education from a one-way lecture to an interactive discussion that increases patients' ability to understand and manage their illness, said diabetes educator Martha M. Funnell, R.N., past president of health care and education for the ADA, and member of the ADA team that helped develop the content for the maps.

“One of the reasons I'm so excited about these maps is they provide an opportunity to be truly patient centered in our delivery of education,” Ms. Funnell said at a press briefing during the annual scientific sessions of the ADA, where the initiative was unveiled.

About 150 training sessions are planned for 2007, with a goal to have more than 10,000 health care professionals incorporate the maps into their diabetes education programs within the next 3 years.

The U.S. Diabetes Conversation Maps initially are being promoted to the 2,800 ADA-recognized education programs, but also will be available to other health care professionals conducting group education including physicians and pharmacists. The five Conversation Maps will be provided free to those who complete the 3-hour training program, thanks to corporate sponsorship from Merck & Co., Peter Gorman, president of Healthy Interactions, said at the press briefing.

The five maps—diabetes overview, healthy eating, blood glucose monitoring, natural course of diabetes, and gestational diabetes—are designed for either type 1 or type 2 diabetes. They contain up-to-date clinical content, and address a wide range of topics, from food and exercise to ways to talk more effectively about the emotional and behavioral component of the disease.

Each map comes with a guide and a set of questions that the facilitator uses as a framework to lead the discussion. For example, the first question patients are asked when using the diabetes overview map is to explain their understanding of what diabetes is and the difference between the two types of diabetes. For women using the gestational diabetes map, much of the discussion centers on diet and exercise plans, as well as on what to expect after childbirth and with subsequent pregnancies.

“A lot of people don't even believe they have diabetes,” Mr. Gorman said in an interview. “So we have a lot of conversations and activities that get them to look at their assumptions and [whether] those assumptions are correct. It's through those questions and answers that they come to their own conclusions and [to] conclusions they are willing to act on.”

All patients are asked to identify near- and long-term goals and to write out an action plan detailing how they will engage their health care team and family to support their accomplishment of those goals. “People can talk about things they want to do, but until they take an active step of writing things down, it doesn't get done,” Mr. Gorman said. The action plan also provides educators with something concrete to follow up on at the next session.

A similar approach to diabetes education was introduced last year in Canada, and preliminary data showed high satisfaction among both patients and educators. At one pilot site with an already well-established diabetes education program, the patient return rate increased 15% between the first and second education sessions, and by 50% between the second and third sessions, Mr. Gorman said.

The company has not evaluated how effective the Canadian maps have been in improving outcomes such as reaching target hemoglobin A1c levels or medication compliance. A protocol is under development in the United States to evaluate such outcomes in the future, Mr. Gorman said.

Michael Weiss, past chair of the ADA board and member of the ADA content team, said the only education he received in 1984 when diagnosed with type 1 diabetes was a single session devoted to how the pancreas works. “This is the validation that patients have a seat at the table. To my knowledge, this is the only educational product developed by physicians and patients working together.”

The Diabetes Conversation Maps can help facilitate discussion about diabetes-related topics in small groups of patients. Healthy Interactions Inc.

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Some Find Prescribing Chlorthalidone Is Not as Easy as ABC

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CHICAGO — The diuretic chlorthalidone is being underused in patients with hypertension, despite its superior efficacy—and the reason may be as simple as the lack of a convenient abbreviation for it, according to Dr. William J. Elliot.

Studies support the efficacy of chlorthalidone in reducing hypertension, yet the diuretic hydrochlorothiazide remains favored in clinical practice. One theory is that chlorthalidone is associated with more hypokalemia than hydrochlorothiazide.

But Dr. Elliott, a preventive medicine professor at Chicago's Rush University Medical Center, suggests chlorthalidone has fallen out of favor because, unlike hydrochlorothiazide, which is easily abbreviated as HCTZ, there is no standard abbreviation for chlorthalidone. “It has to be written out, all 14 letters of it,” he said at a press briefing at the annual meeting of the America Society of Hypertension.

Dr. Elliott cited several studies favoring chlorthalidone, including a recent blinded randomized head-to-head comparison (Hypertension 2006;47:352–8) that showed a greater reduction in 24-hour mean systolic blood pressure at 8 weeks in patients receiving chlorthalidone 25 mg/day, compared with those receiving HCTZ 50 mg/day (−12.4 mm Hg vs. −7.4 mm Hg, respectively). The greater reduction with chlorthalidone, at half the dose, was thought to be primarily because of its effect on nighttime mean systolic blood pressure, which fell 13.5 mm Hg for chlorthalidone, compared with 6.4 mm Hg for HCTZ.

In the Multiple Risk Factor Intervention Trial (Circulation 1990;82:1616–28), patients who received HCTZ had 44% more coronary heart disease and 16% more deaths after 5 years of follow-up, compared with control patients cared for in the community by primary care physicians. Conversely, there was 58% less coronary heart disease and 41% fewer deaths in patients treated with chlorthalidone, compared with referred-care controls, Dr. Elliott said.

More recently, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial found fewer cardiovascular events with chlorthalidone than with an angiotensin-converting enzyme inhibitor, and the second Australian National Blood Pressure study found an inhibitor to be superior to HCTZ at reducing combined mortality and morbidity in men, but not women.

“We ought to be putting HCTZ on the list of 'do not use' abbreviations because it is an inferior product and ought to be replaced in general practice by chlorthalidone,” he said.

Cost is not a factor in the argument, because both drugs are generically available, said Dr. Elliott, who disclosed possible conflicts of interest with Pfizer Inc., Novartis Pharmaceuticals Corp., Astra-Zeneca, Kos Pharmaceuticals Co., Abbott Laboratories, and KV Pharmaceutical.

He recommends low-dose chlorthalidone 12.5 mg because of its better efficacy and longer duration of action. He uses diuretics in hypertensive patients with chronic kidney disease, diabetes mellitus, or at high risk of heart failure, but typically switches patients with severe late-stage kidney disease to loop diuretics taken twice daily.

Dr. John Flack, of Wayne State University, in Detroit, told reporters he agreed with Dr. Elliott's recommendation to use chlorthalidone over HCTZ. “It would help if a pharmaceutical company had the courage to break the trend of simply putting HCTZ with everything. They seem reluctant to do it.”

HCTZ is part of several fixed-dose combination drugs, but chlorthalidone is available in only three combination products: clonidine (Clorpres), reserpine (Regroton), and atenolol (Tenoretic), Dr. Elliott explained.

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CHICAGO — The diuretic chlorthalidone is being underused in patients with hypertension, despite its superior efficacy—and the reason may be as simple as the lack of a convenient abbreviation for it, according to Dr. William J. Elliot.

Studies support the efficacy of chlorthalidone in reducing hypertension, yet the diuretic hydrochlorothiazide remains favored in clinical practice. One theory is that chlorthalidone is associated with more hypokalemia than hydrochlorothiazide.

But Dr. Elliott, a preventive medicine professor at Chicago's Rush University Medical Center, suggests chlorthalidone has fallen out of favor because, unlike hydrochlorothiazide, which is easily abbreviated as HCTZ, there is no standard abbreviation for chlorthalidone. “It has to be written out, all 14 letters of it,” he said at a press briefing at the annual meeting of the America Society of Hypertension.

Dr. Elliott cited several studies favoring chlorthalidone, including a recent blinded randomized head-to-head comparison (Hypertension 2006;47:352–8) that showed a greater reduction in 24-hour mean systolic blood pressure at 8 weeks in patients receiving chlorthalidone 25 mg/day, compared with those receiving HCTZ 50 mg/day (−12.4 mm Hg vs. −7.4 mm Hg, respectively). The greater reduction with chlorthalidone, at half the dose, was thought to be primarily because of its effect on nighttime mean systolic blood pressure, which fell 13.5 mm Hg for chlorthalidone, compared with 6.4 mm Hg for HCTZ.

In the Multiple Risk Factor Intervention Trial (Circulation 1990;82:1616–28), patients who received HCTZ had 44% more coronary heart disease and 16% more deaths after 5 years of follow-up, compared with control patients cared for in the community by primary care physicians. Conversely, there was 58% less coronary heart disease and 41% fewer deaths in patients treated with chlorthalidone, compared with referred-care controls, Dr. Elliott said.

More recently, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial found fewer cardiovascular events with chlorthalidone than with an angiotensin-converting enzyme inhibitor, and the second Australian National Blood Pressure study found an inhibitor to be superior to HCTZ at reducing combined mortality and morbidity in men, but not women.

“We ought to be putting HCTZ on the list of 'do not use' abbreviations because it is an inferior product and ought to be replaced in general practice by chlorthalidone,” he said.

Cost is not a factor in the argument, because both drugs are generically available, said Dr. Elliott, who disclosed possible conflicts of interest with Pfizer Inc., Novartis Pharmaceuticals Corp., Astra-Zeneca, Kos Pharmaceuticals Co., Abbott Laboratories, and KV Pharmaceutical.

He recommends low-dose chlorthalidone 12.5 mg because of its better efficacy and longer duration of action. He uses diuretics in hypertensive patients with chronic kidney disease, diabetes mellitus, or at high risk of heart failure, but typically switches patients with severe late-stage kidney disease to loop diuretics taken twice daily.

Dr. John Flack, of Wayne State University, in Detroit, told reporters he agreed with Dr. Elliott's recommendation to use chlorthalidone over HCTZ. “It would help if a pharmaceutical company had the courage to break the trend of simply putting HCTZ with everything. They seem reluctant to do it.”

HCTZ is part of several fixed-dose combination drugs, but chlorthalidone is available in only three combination products: clonidine (Clorpres), reserpine (Regroton), and atenolol (Tenoretic), Dr. Elliott explained.

CHICAGO — The diuretic chlorthalidone is being underused in patients with hypertension, despite its superior efficacy—and the reason may be as simple as the lack of a convenient abbreviation for it, according to Dr. William J. Elliot.

Studies support the efficacy of chlorthalidone in reducing hypertension, yet the diuretic hydrochlorothiazide remains favored in clinical practice. One theory is that chlorthalidone is associated with more hypokalemia than hydrochlorothiazide.

But Dr. Elliott, a preventive medicine professor at Chicago's Rush University Medical Center, suggests chlorthalidone has fallen out of favor because, unlike hydrochlorothiazide, which is easily abbreviated as HCTZ, there is no standard abbreviation for chlorthalidone. “It has to be written out, all 14 letters of it,” he said at a press briefing at the annual meeting of the America Society of Hypertension.

Dr. Elliott cited several studies favoring chlorthalidone, including a recent blinded randomized head-to-head comparison (Hypertension 2006;47:352–8) that showed a greater reduction in 24-hour mean systolic blood pressure at 8 weeks in patients receiving chlorthalidone 25 mg/day, compared with those receiving HCTZ 50 mg/day (−12.4 mm Hg vs. −7.4 mm Hg, respectively). The greater reduction with chlorthalidone, at half the dose, was thought to be primarily because of its effect on nighttime mean systolic blood pressure, which fell 13.5 mm Hg for chlorthalidone, compared with 6.4 mm Hg for HCTZ.

In the Multiple Risk Factor Intervention Trial (Circulation 1990;82:1616–28), patients who received HCTZ had 44% more coronary heart disease and 16% more deaths after 5 years of follow-up, compared with control patients cared for in the community by primary care physicians. Conversely, there was 58% less coronary heart disease and 41% fewer deaths in patients treated with chlorthalidone, compared with referred-care controls, Dr. Elliott said.

More recently, the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial found fewer cardiovascular events with chlorthalidone than with an angiotensin-converting enzyme inhibitor, and the second Australian National Blood Pressure study found an inhibitor to be superior to HCTZ at reducing combined mortality and morbidity in men, but not women.

“We ought to be putting HCTZ on the list of 'do not use' abbreviations because it is an inferior product and ought to be replaced in general practice by chlorthalidone,” he said.

Cost is not a factor in the argument, because both drugs are generically available, said Dr. Elliott, who disclosed possible conflicts of interest with Pfizer Inc., Novartis Pharmaceuticals Corp., Astra-Zeneca, Kos Pharmaceuticals Co., Abbott Laboratories, and KV Pharmaceutical.

He recommends low-dose chlorthalidone 12.5 mg because of its better efficacy and longer duration of action. He uses diuretics in hypertensive patients with chronic kidney disease, diabetes mellitus, or at high risk of heart failure, but typically switches patients with severe late-stage kidney disease to loop diuretics taken twice daily.

Dr. John Flack, of Wayne State University, in Detroit, told reporters he agreed with Dr. Elliott's recommendation to use chlorthalidone over HCTZ. “It would help if a pharmaceutical company had the courage to break the trend of simply putting HCTZ with everything. They seem reluctant to do it.”

HCTZ is part of several fixed-dose combination drugs, but chlorthalidone is available in only three combination products: clonidine (Clorpres), reserpine (Regroton), and atenolol (Tenoretic), Dr. Elliott explained.

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Cancer Follow-Up Could Shift to Primary Care

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CHICAGO — Primary care physicians are willing to assume a greater role in providing comprehensive care to adult cancer survivors, new data suggest.

Of 330 community-based primary care physicians surveyed in Canada, 40% said they would be willing to assume exclusive care of patients immediately or within 1 year after completion of active treatment for breast, prostate, and colorectal cancer. One-third of physicians in the cross-sectional survey said they would do so for lymphoma patients.

Physicians located farther from cancer specialists were willing to accept earlier exclusive care of breast-, prostate-, and colorectal-cancer survivors, but not lymphoma survivors. For all four cancer sites, physicians already providing care were significantly more likely to provide earlier exclusive care, according to results presented in a poster at the annual meeting of the American Society of Clinical Oncology.

The majority of physicians (69%) worked in a group practice, with 42% practicing in cities, 21% in suburbs, and 37% in rural areas or small towns. The average time to the closest cancer center was 58 minutes (median 30 minutes).

Follow-up care was defined as “well” routine cancer follow-up, and care after active treatment including surgery, chemotherapy, or radiation was complete and presumably curative.

Some Canadian oncology programs are starting to move toward discharging patients who are expected to do well or who are long-time survivors, lead investigator Dr. Lisa Del Giudice noted in an interview.

Shifting care back to primary care physicians would make more efficient use of specialist care resources. However, more information was needed about the attitudes of primary care physicians and their willingness to provide exclusive care. There are national and cancer organization guidelines regarding when to perform specific tests, but those guidelines don't address who should provide follow-up care, said Dr. Del Guidice of the University of Toronto and the Sunnybrook Health Sciences Centre.

Primary care physicians reported that the most useful tool in assuming patient care would be a standardized letter from oncologists that addresses the individual patient's needs. This was followed by printed guidelines, expedited re-referral to specialists, and telephone or mail advice from the specialist. More medical or support staff and pamphlets ranked at the bottom of the list.

Most respondents selected share care as their preferred model of routine care, and two-thirds of physicians reported they should be involved at an earlier stage in follow-up.

Primary care physicians were confident in their abilities, with two-thirds reporting they have the skills necessary to provide routine follow-up care. Just 37% agreed that specialists were more efficient at detecting occurrences than primary care physicians. More than half (55%) of respondents reported that specialist clinics were overcrowded.

A majority (80%) of physicians felt they were more appropriate providers than specialists for addressing psychosocial support issues, Dr. Del Giudice and associates reported.

Although having primary care physicians provide follow-up cancer care could be cost effective, there are obstacles. Among respondents, 72% felt patients expect cancer follow-up from specialists, and only 23% believed that patients would rather go to their primary care physician for that care. And 40% believed patients would not be adequately assured with follow-up from their primary care physician.

A randomized trial is planned to evaluate patient acceptance, and a second trial will examine administrative data to determine current practices and trends in follow-up cancer care in Canada, Dr. Del Giudice said.

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CHICAGO — Primary care physicians are willing to assume a greater role in providing comprehensive care to adult cancer survivors, new data suggest.

Of 330 community-based primary care physicians surveyed in Canada, 40% said they would be willing to assume exclusive care of patients immediately or within 1 year after completion of active treatment for breast, prostate, and colorectal cancer. One-third of physicians in the cross-sectional survey said they would do so for lymphoma patients.

Physicians located farther from cancer specialists were willing to accept earlier exclusive care of breast-, prostate-, and colorectal-cancer survivors, but not lymphoma survivors. For all four cancer sites, physicians already providing care were significantly more likely to provide earlier exclusive care, according to results presented in a poster at the annual meeting of the American Society of Clinical Oncology.

The majority of physicians (69%) worked in a group practice, with 42% practicing in cities, 21% in suburbs, and 37% in rural areas or small towns. The average time to the closest cancer center was 58 minutes (median 30 minutes).

Follow-up care was defined as “well” routine cancer follow-up, and care after active treatment including surgery, chemotherapy, or radiation was complete and presumably curative.

Some Canadian oncology programs are starting to move toward discharging patients who are expected to do well or who are long-time survivors, lead investigator Dr. Lisa Del Giudice noted in an interview.

Shifting care back to primary care physicians would make more efficient use of specialist care resources. However, more information was needed about the attitudes of primary care physicians and their willingness to provide exclusive care. There are national and cancer organization guidelines regarding when to perform specific tests, but those guidelines don't address who should provide follow-up care, said Dr. Del Guidice of the University of Toronto and the Sunnybrook Health Sciences Centre.

Primary care physicians reported that the most useful tool in assuming patient care would be a standardized letter from oncologists that addresses the individual patient's needs. This was followed by printed guidelines, expedited re-referral to specialists, and telephone or mail advice from the specialist. More medical or support staff and pamphlets ranked at the bottom of the list.

Most respondents selected share care as their preferred model of routine care, and two-thirds of physicians reported they should be involved at an earlier stage in follow-up.

Primary care physicians were confident in their abilities, with two-thirds reporting they have the skills necessary to provide routine follow-up care. Just 37% agreed that specialists were more efficient at detecting occurrences than primary care physicians. More than half (55%) of respondents reported that specialist clinics were overcrowded.

A majority (80%) of physicians felt they were more appropriate providers than specialists for addressing psychosocial support issues, Dr. Del Giudice and associates reported.

Although having primary care physicians provide follow-up cancer care could be cost effective, there are obstacles. Among respondents, 72% felt patients expect cancer follow-up from specialists, and only 23% believed that patients would rather go to their primary care physician for that care. And 40% believed patients would not be adequately assured with follow-up from their primary care physician.

A randomized trial is planned to evaluate patient acceptance, and a second trial will examine administrative data to determine current practices and trends in follow-up cancer care in Canada, Dr. Del Giudice said.

CHICAGO — Primary care physicians are willing to assume a greater role in providing comprehensive care to adult cancer survivors, new data suggest.

Of 330 community-based primary care physicians surveyed in Canada, 40% said they would be willing to assume exclusive care of patients immediately or within 1 year after completion of active treatment for breast, prostate, and colorectal cancer. One-third of physicians in the cross-sectional survey said they would do so for lymphoma patients.

Physicians located farther from cancer specialists were willing to accept earlier exclusive care of breast-, prostate-, and colorectal-cancer survivors, but not lymphoma survivors. For all four cancer sites, physicians already providing care were significantly more likely to provide earlier exclusive care, according to results presented in a poster at the annual meeting of the American Society of Clinical Oncology.

The majority of physicians (69%) worked in a group practice, with 42% practicing in cities, 21% in suburbs, and 37% in rural areas or small towns. The average time to the closest cancer center was 58 minutes (median 30 minutes).

Follow-up care was defined as “well” routine cancer follow-up, and care after active treatment including surgery, chemotherapy, or radiation was complete and presumably curative.

Some Canadian oncology programs are starting to move toward discharging patients who are expected to do well or who are long-time survivors, lead investigator Dr. Lisa Del Giudice noted in an interview.

Shifting care back to primary care physicians would make more efficient use of specialist care resources. However, more information was needed about the attitudes of primary care physicians and their willingness to provide exclusive care. There are national and cancer organization guidelines regarding when to perform specific tests, but those guidelines don't address who should provide follow-up care, said Dr. Del Guidice of the University of Toronto and the Sunnybrook Health Sciences Centre.

Primary care physicians reported that the most useful tool in assuming patient care would be a standardized letter from oncologists that addresses the individual patient's needs. This was followed by printed guidelines, expedited re-referral to specialists, and telephone or mail advice from the specialist. More medical or support staff and pamphlets ranked at the bottom of the list.

Most respondents selected share care as their preferred model of routine care, and two-thirds of physicians reported they should be involved at an earlier stage in follow-up.

Primary care physicians were confident in their abilities, with two-thirds reporting they have the skills necessary to provide routine follow-up care. Just 37% agreed that specialists were more efficient at detecting occurrences than primary care physicians. More than half (55%) of respondents reported that specialist clinics were overcrowded.

A majority (80%) of physicians felt they were more appropriate providers than specialists for addressing psychosocial support issues, Dr. Del Giudice and associates reported.

Although having primary care physicians provide follow-up cancer care could be cost effective, there are obstacles. Among respondents, 72% felt patients expect cancer follow-up from specialists, and only 23% believed that patients would rather go to their primary care physician for that care. And 40% believed patients would not be adequately assured with follow-up from their primary care physician.

A randomized trial is planned to evaluate patient acceptance, and a second trial will examine administrative data to determine current practices and trends in follow-up cancer care in Canada, Dr. Del Giudice said.

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HBV Seen in 9% of Asian Immigrants

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KANSAS CITY, MO. — Almost 1 in 10 foreign-born Asian Americans is chronically infected with hepatitis B virus, according to data from the largest study of hepatitis B infection in Asian Americans to date.

Free serological screening conducted from 2001 to 2006 in 3,163 Asian American adults living in the San Francisco Bay area revealed that 283 (9%) were chronically infected with hepatitis B.

Two-thirds (65%) of those chronically infected were unaware that they were infected, Steven Lin, Ellen Chang, Sc.D., and Dr. Samuel So reported in a poster presentation at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

Blood samples were collected by venipuncture and were tested for both hepatitis B surface antigen (HBsAg) and surface antibody (HBsAb), or for HBsAg alone.

The volunteer sample included participants from China (1,016), East Asia excluding China (1,072), Southeast Asia/Pacific Islands (298), the United States (153), other Asian countries (15), and unknown/missing locations (609). The mean age of the participants was 53 years (range, 18–101).

Participants who were born in East Asia, Southeast Asia, or the Pacific Islands were about 20 times more likely to be chronically infected than were those born in the United States (10.7% HBsAg-positive vs. 0.7%, respectively).

Infection rates for each group were as follows: 113 (11%) from China, 103 (9.6%) from East Asia excluding China, 40 (13.4%) from Southeast Asia/Pacific Islands, 1 (0.7%) from the United States, 0 from other Asian countries, and 26 (4.3%) from unknown/missing locations, the investigators said.

Of the 1,523 individuals who were tested for HBsAb, 682 (45%) lacked protective antibodies against HBV and were susceptible to future infection, reported Mr. Lin, a medical student at Stanford (Calif.) University, and his colleagues from Stanford's Asian Liver Center.

Only 381 participants (12%) reported having been vaccinated against HBV. Of these, 20 (5.2%) were found to be chronically infected with HBV. Surprisingly, U.S.-born Asian Americans had a higher risk of being unprotected than did their China-born counterparts (47% vs. 42%).

In December 2006, the CDC published a comprehensive immunization strategy for increasing hepatitis B vaccination coverage among adults, who in 2005 accounted for 95% of an estimated 51,000 new hepatitis B infections in the United States. HBV infection is associated with a 25% risk of death if left unmonitored or untreated. Asian Americans are more than twice as likely to die from liver cancer as their white counterparts are, because of their high prevalence of chronic HBV infection.

“Given the serious medical implications of this study, a strong public health response is needed,” the authors concluded. “In support of the newly released Centers for Disease Control and Prevention recommendations, we call for all foreign-born Asian American adults to be screened for HBV—regardless of their vaccination status.”

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KANSAS CITY, MO. — Almost 1 in 10 foreign-born Asian Americans is chronically infected with hepatitis B virus, according to data from the largest study of hepatitis B infection in Asian Americans to date.

Free serological screening conducted from 2001 to 2006 in 3,163 Asian American adults living in the San Francisco Bay area revealed that 283 (9%) were chronically infected with hepatitis B.

Two-thirds (65%) of those chronically infected were unaware that they were infected, Steven Lin, Ellen Chang, Sc.D., and Dr. Samuel So reported in a poster presentation at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

Blood samples were collected by venipuncture and were tested for both hepatitis B surface antigen (HBsAg) and surface antibody (HBsAb), or for HBsAg alone.

The volunteer sample included participants from China (1,016), East Asia excluding China (1,072), Southeast Asia/Pacific Islands (298), the United States (153), other Asian countries (15), and unknown/missing locations (609). The mean age of the participants was 53 years (range, 18–101).

Participants who were born in East Asia, Southeast Asia, or the Pacific Islands were about 20 times more likely to be chronically infected than were those born in the United States (10.7% HBsAg-positive vs. 0.7%, respectively).

Infection rates for each group were as follows: 113 (11%) from China, 103 (9.6%) from East Asia excluding China, 40 (13.4%) from Southeast Asia/Pacific Islands, 1 (0.7%) from the United States, 0 from other Asian countries, and 26 (4.3%) from unknown/missing locations, the investigators said.

Of the 1,523 individuals who were tested for HBsAb, 682 (45%) lacked protective antibodies against HBV and were susceptible to future infection, reported Mr. Lin, a medical student at Stanford (Calif.) University, and his colleagues from Stanford's Asian Liver Center.

Only 381 participants (12%) reported having been vaccinated against HBV. Of these, 20 (5.2%) were found to be chronically infected with HBV. Surprisingly, U.S.-born Asian Americans had a higher risk of being unprotected than did their China-born counterparts (47% vs. 42%).

In December 2006, the CDC published a comprehensive immunization strategy for increasing hepatitis B vaccination coverage among adults, who in 2005 accounted for 95% of an estimated 51,000 new hepatitis B infections in the United States. HBV infection is associated with a 25% risk of death if left unmonitored or untreated. Asian Americans are more than twice as likely to die from liver cancer as their white counterparts are, because of their high prevalence of chronic HBV infection.

“Given the serious medical implications of this study, a strong public health response is needed,” the authors concluded. “In support of the newly released Centers for Disease Control and Prevention recommendations, we call for all foreign-born Asian American adults to be screened for HBV—regardless of their vaccination status.”

KANSAS CITY, MO. — Almost 1 in 10 foreign-born Asian Americans is chronically infected with hepatitis B virus, according to data from the largest study of hepatitis B infection in Asian Americans to date.

Free serological screening conducted from 2001 to 2006 in 3,163 Asian American adults living in the San Francisco Bay area revealed that 283 (9%) were chronically infected with hepatitis B.

Two-thirds (65%) of those chronically infected were unaware that they were infected, Steven Lin, Ellen Chang, Sc.D., and Dr. Samuel So reported in a poster presentation at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

Blood samples were collected by venipuncture and were tested for both hepatitis B surface antigen (HBsAg) and surface antibody (HBsAb), or for HBsAg alone.

The volunteer sample included participants from China (1,016), East Asia excluding China (1,072), Southeast Asia/Pacific Islands (298), the United States (153), other Asian countries (15), and unknown/missing locations (609). The mean age of the participants was 53 years (range, 18–101).

Participants who were born in East Asia, Southeast Asia, or the Pacific Islands were about 20 times more likely to be chronically infected than were those born in the United States (10.7% HBsAg-positive vs. 0.7%, respectively).

Infection rates for each group were as follows: 113 (11%) from China, 103 (9.6%) from East Asia excluding China, 40 (13.4%) from Southeast Asia/Pacific Islands, 1 (0.7%) from the United States, 0 from other Asian countries, and 26 (4.3%) from unknown/missing locations, the investigators said.

Of the 1,523 individuals who were tested for HBsAb, 682 (45%) lacked protective antibodies against HBV and were susceptible to future infection, reported Mr. Lin, a medical student at Stanford (Calif.) University, and his colleagues from Stanford's Asian Liver Center.

Only 381 participants (12%) reported having been vaccinated against HBV. Of these, 20 (5.2%) were found to be chronically infected with HBV. Surprisingly, U.S.-born Asian Americans had a higher risk of being unprotected than did their China-born counterparts (47% vs. 42%).

In December 2006, the CDC published a comprehensive immunization strategy for increasing hepatitis B vaccination coverage among adults, who in 2005 accounted for 95% of an estimated 51,000 new hepatitis B infections in the United States. HBV infection is associated with a 25% risk of death if left unmonitored or untreated. Asian Americans are more than twice as likely to die from liver cancer as their white counterparts are, because of their high prevalence of chronic HBV infection.

“Given the serious medical implications of this study, a strong public health response is needed,” the authors concluded. “In support of the newly released Centers for Disease Control and Prevention recommendations, we call for all foreign-born Asian American adults to be screened for HBV—regardless of their vaccination status.”

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CA125 Plus Ultrasound May Flag Early Ovarian Ca

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CA125 Plus Ultrasound May Flag Early Ovarian Ca

CHICAGO – Frequent serum CA125 testing in tandem with transvaginal sonography may be an effective screening method to detect ovarian cancer early in women at increased risk of the disease.

When serial CA125 levels were analyzed using the previously established risk of ovarian cancer algorithm (ROCA), the overall specificity was 99.7% and positive predictive value was 13% among 2,343 high-risk women. The prospective pilot study included women with a BRCA mutation, who are known to have a 20%-40% increased lifetime risk of ovarian cancer.

The results are encouraging because no proven strategy exists for this high-risk group, but larger studies are needed to validate the findings, Steven J. Skates, Ph.D., reported at the annual meeting of the American Society of Clinical Oncology.

“Serial CA125 testing essentially establishes a baseline value for each woman that personalizes the interpretation of each new CA125 result to determine if ultrasound is indicated at a particular time,” Dr. Skates said in an interview. “The hope is that the serial approach will increase the sensitivity of CA125 testing without loss of specificity. The ROCA has previously shown greater positive predictive value and sensitivity than a single CA125 test in screening healthy postmenopausal women for ovarian cancer (J. Clin. Oncol. 2005;23:7919-26).

The current study defined high-risk women as those with a BRCA1 or BRCA2 mutation or first- or second-degree relatives with a BRCA mutation or multiple breast or ovarian cancers, or women of Ashkenazi heritage and at least one first-degree or two second-degree relatives with breast or ovarian cancer. Women with a prior diagnosis of ovarian cancer were excluded.

Participants underwent CA125 testing every 3 months, and the risk of having ovarian cancer was recalculated after each test based on the CA125 profile. Women with a greater than 1% risk were referred to ultrasound, and those with a greater than 10% risk to a gynecologic oncologist.

Between July 2001 and September 2006, a total of 19,549 CA125 tests were performed, totaling 6,284 women-years of screening. The average number of CA125 tests performed was three per year. Of 628 referrals made to ultrasound, 414 were performed, resulting in 38 women (9%) undergoing study-indicated surgeries.

Nine ovarian cancers were identified during screening–three were prevalent (one early stage, two late stage) and six were incident (five early stage, one late stage), reported Dr. Skates, ROCA Screening Study Group, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston.

Three of the incident carcinomas were found on prophylactic oophorectomy in early stage. The ROCA detected two of the three remaining incident cases in early stage, and three of three prevalent cases. Positive predictive value was 5/38 or 13% and sensitivity was 5/6 or 83%. The sample size was too small to determine sensitivity for incident cases. Overall specificity was excellent for the combined strategy at 99.7%, Dr. Skates said.

The positive predictive value of ROCA was higher at 22% in the study of postmenopausal women, but is acceptable at 13% in a group of high-risk women considering prophylactic oophorectomy after childbearing, Dr. Skates said.

The researchers also evaluated other serum biomarkers, and observed that the HE4 and B7-H4 proteins seemed to confirm CA125 levels.

There was high compliance throughout the study, with 84%, 85%, 85%, and 82% of participants returning within 1 month for the first four tests.

A definitive screening study with more than 30 incident cases and possibly additional biomarkers is needed to define sensitivity for longitudinal ROCA for early-stage ovarian cancer, said Dr. Skates, who received grant support from Fujirebo Diagnostics Inc., a cosponsor of the study with the National Cancer Institute.

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CHICAGO – Frequent serum CA125 testing in tandem with transvaginal sonography may be an effective screening method to detect ovarian cancer early in women at increased risk of the disease.

When serial CA125 levels were analyzed using the previously established risk of ovarian cancer algorithm (ROCA), the overall specificity was 99.7% and positive predictive value was 13% among 2,343 high-risk women. The prospective pilot study included women with a BRCA mutation, who are known to have a 20%-40% increased lifetime risk of ovarian cancer.

The results are encouraging because no proven strategy exists for this high-risk group, but larger studies are needed to validate the findings, Steven J. Skates, Ph.D., reported at the annual meeting of the American Society of Clinical Oncology.

“Serial CA125 testing essentially establishes a baseline value for each woman that personalizes the interpretation of each new CA125 result to determine if ultrasound is indicated at a particular time,” Dr. Skates said in an interview. “The hope is that the serial approach will increase the sensitivity of CA125 testing without loss of specificity. The ROCA has previously shown greater positive predictive value and sensitivity than a single CA125 test in screening healthy postmenopausal women for ovarian cancer (J. Clin. Oncol. 2005;23:7919-26).

The current study defined high-risk women as those with a BRCA1 or BRCA2 mutation or first- or second-degree relatives with a BRCA mutation or multiple breast or ovarian cancers, or women of Ashkenazi heritage and at least one first-degree or two second-degree relatives with breast or ovarian cancer. Women with a prior diagnosis of ovarian cancer were excluded.

Participants underwent CA125 testing every 3 months, and the risk of having ovarian cancer was recalculated after each test based on the CA125 profile. Women with a greater than 1% risk were referred to ultrasound, and those with a greater than 10% risk to a gynecologic oncologist.

Between July 2001 and September 2006, a total of 19,549 CA125 tests were performed, totaling 6,284 women-years of screening. The average number of CA125 tests performed was three per year. Of 628 referrals made to ultrasound, 414 were performed, resulting in 38 women (9%) undergoing study-indicated surgeries.

Nine ovarian cancers were identified during screening–three were prevalent (one early stage, two late stage) and six were incident (five early stage, one late stage), reported Dr. Skates, ROCA Screening Study Group, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston.

Three of the incident carcinomas were found on prophylactic oophorectomy in early stage. The ROCA detected two of the three remaining incident cases in early stage, and three of three prevalent cases. Positive predictive value was 5/38 or 13% and sensitivity was 5/6 or 83%. The sample size was too small to determine sensitivity for incident cases. Overall specificity was excellent for the combined strategy at 99.7%, Dr. Skates said.

The positive predictive value of ROCA was higher at 22% in the study of postmenopausal women, but is acceptable at 13% in a group of high-risk women considering prophylactic oophorectomy after childbearing, Dr. Skates said.

The researchers also evaluated other serum biomarkers, and observed that the HE4 and B7-H4 proteins seemed to confirm CA125 levels.

There was high compliance throughout the study, with 84%, 85%, 85%, and 82% of participants returning within 1 month for the first four tests.

A definitive screening study with more than 30 incident cases and possibly additional biomarkers is needed to define sensitivity for longitudinal ROCA for early-stage ovarian cancer, said Dr. Skates, who received grant support from Fujirebo Diagnostics Inc., a cosponsor of the study with the National Cancer Institute.

CHICAGO – Frequent serum CA125 testing in tandem with transvaginal sonography may be an effective screening method to detect ovarian cancer early in women at increased risk of the disease.

When serial CA125 levels were analyzed using the previously established risk of ovarian cancer algorithm (ROCA), the overall specificity was 99.7% and positive predictive value was 13% among 2,343 high-risk women. The prospective pilot study included women with a BRCA mutation, who are known to have a 20%-40% increased lifetime risk of ovarian cancer.

The results are encouraging because no proven strategy exists for this high-risk group, but larger studies are needed to validate the findings, Steven J. Skates, Ph.D., reported at the annual meeting of the American Society of Clinical Oncology.

“Serial CA125 testing essentially establishes a baseline value for each woman that personalizes the interpretation of each new CA125 result to determine if ultrasound is indicated at a particular time,” Dr. Skates said in an interview. “The hope is that the serial approach will increase the sensitivity of CA125 testing without loss of specificity. The ROCA has previously shown greater positive predictive value and sensitivity than a single CA125 test in screening healthy postmenopausal women for ovarian cancer (J. Clin. Oncol. 2005;23:7919-26).

The current study defined high-risk women as those with a BRCA1 or BRCA2 mutation or first- or second-degree relatives with a BRCA mutation or multiple breast or ovarian cancers, or women of Ashkenazi heritage and at least one first-degree or two second-degree relatives with breast or ovarian cancer. Women with a prior diagnosis of ovarian cancer were excluded.

Participants underwent CA125 testing every 3 months, and the risk of having ovarian cancer was recalculated after each test based on the CA125 profile. Women with a greater than 1% risk were referred to ultrasound, and those with a greater than 10% risk to a gynecologic oncologist.

Between July 2001 and September 2006, a total of 19,549 CA125 tests were performed, totaling 6,284 women-years of screening. The average number of CA125 tests performed was three per year. Of 628 referrals made to ultrasound, 414 were performed, resulting in 38 women (9%) undergoing study-indicated surgeries.

Nine ovarian cancers were identified during screening–three were prevalent (one early stage, two late stage) and six were incident (five early stage, one late stage), reported Dr. Skates, ROCA Screening Study Group, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston.

Three of the incident carcinomas were found on prophylactic oophorectomy in early stage. The ROCA detected two of the three remaining incident cases in early stage, and three of three prevalent cases. Positive predictive value was 5/38 or 13% and sensitivity was 5/6 or 83%. The sample size was too small to determine sensitivity for incident cases. Overall specificity was excellent for the combined strategy at 99.7%, Dr. Skates said.

The positive predictive value of ROCA was higher at 22% in the study of postmenopausal women, but is acceptable at 13% in a group of high-risk women considering prophylactic oophorectomy after childbearing, Dr. Skates said.

The researchers also evaluated other serum biomarkers, and observed that the HE4 and B7-H4 proteins seemed to confirm CA125 levels.

There was high compliance throughout the study, with 84%, 85%, 85%, and 82% of participants returning within 1 month for the first four tests.

A definitive screening study with more than 30 incident cases and possibly additional biomarkers is needed to define sensitivity for longitudinal ROCA for early-stage ovarian cancer, said Dr. Skates, who received grant support from Fujirebo Diagnostics Inc., a cosponsor of the study with the National Cancer Institute.

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Valsartan Shown Effective in Young Hypertensive Children

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CHICAGO — Valsartan significantly reduced both systolic and diastolic blood pressure without significant adverse events in the first trial of an angiotensin II receptor blocker in children younger than 6 years.

Valsartan is indicated for the treatment of hypertension and heart failure in adults, but had never been studied in children. In November 2006, the Food and Drug Administration approved safety labeling revisions for valsartan tablets to advise of the risk of fetal and neonatal morbidity when used by pregnant women.

Dr. Joseph Flynn and associates presented preliminary results at the annual meeting of the American Society of Hypertension from a multicenter, placebo-controlled study evaluating three doses of valsartan in 90 children with a mean seated systolic BP of at least the 95th percentile of the National High Blood Pressure Education Program normative BP values for children.

After a 1-week placebo washout screening phase, the children were randomized to low, medium, and high doses of valsartan for 2 weeks (phase 1), and then rerandomized to placebo or valsartan for 2 more weeks (phase 2).

In phase 1, the doses were 5, 20, or 40 mg/day for those children weighing less than 18 kg, and 10, 40, or 80 mg/day for those weighing more than 18 kg. Half of the children stayed on the same dose in phase 2, and half were withdrawn to placebo.

At admission, the children's mean age was 3 years; 60% were boys, and 30% were black. Most children (79%) had hypertension related to renal disease; some (3%) were hypertensive because of heart disease, and 18% because of other causes.

In phase 1, valsartan significantly reduced both systolic and diastolic BP at all three doses, reported Dr. Flynn, who conducted the study while at Children's Hospital at Montefiore, New York, and is now a professor of pediatrics at Children's Hospital and Regional Medical Center, in Seattle. (See box.)

In phase 2, systolic and diastolic BP was significantly lower in children receiving valsartan, compared with those receiving placebo. The mean difference between valsartan and placebo was −4.1 mm Hg for systolic BP and −3.7 mm Hg for diastolic.

“Since many of these children have hypertension due to underlying renal disease, valsartan may be well suited for treatment of hypertension in this age group,” Dr. Flynn said in an interview.

Adverse events, such as cold symptoms, were minor and were similar between the different dose groups, he said. No participants discontinued treatment because of an adverse event.

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CHICAGO — Valsartan significantly reduced both systolic and diastolic blood pressure without significant adverse events in the first trial of an angiotensin II receptor blocker in children younger than 6 years.

Valsartan is indicated for the treatment of hypertension and heart failure in adults, but had never been studied in children. In November 2006, the Food and Drug Administration approved safety labeling revisions for valsartan tablets to advise of the risk of fetal and neonatal morbidity when used by pregnant women.

Dr. Joseph Flynn and associates presented preliminary results at the annual meeting of the American Society of Hypertension from a multicenter, placebo-controlled study evaluating three doses of valsartan in 90 children with a mean seated systolic BP of at least the 95th percentile of the National High Blood Pressure Education Program normative BP values for children.

After a 1-week placebo washout screening phase, the children were randomized to low, medium, and high doses of valsartan for 2 weeks (phase 1), and then rerandomized to placebo or valsartan for 2 more weeks (phase 2).

In phase 1, the doses were 5, 20, or 40 mg/day for those children weighing less than 18 kg, and 10, 40, or 80 mg/day for those weighing more than 18 kg. Half of the children stayed on the same dose in phase 2, and half were withdrawn to placebo.

At admission, the children's mean age was 3 years; 60% were boys, and 30% were black. Most children (79%) had hypertension related to renal disease; some (3%) were hypertensive because of heart disease, and 18% because of other causes.

In phase 1, valsartan significantly reduced both systolic and diastolic BP at all three doses, reported Dr. Flynn, who conducted the study while at Children's Hospital at Montefiore, New York, and is now a professor of pediatrics at Children's Hospital and Regional Medical Center, in Seattle. (See box.)

In phase 2, systolic and diastolic BP was significantly lower in children receiving valsartan, compared with those receiving placebo. The mean difference between valsartan and placebo was −4.1 mm Hg for systolic BP and −3.7 mm Hg for diastolic.

“Since many of these children have hypertension due to underlying renal disease, valsartan may be well suited for treatment of hypertension in this age group,” Dr. Flynn said in an interview.

Adverse events, such as cold symptoms, were minor and were similar between the different dose groups, he said. No participants discontinued treatment because of an adverse event.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Valsartan significantly reduced both systolic and diastolic blood pressure without significant adverse events in the first trial of an angiotensin II receptor blocker in children younger than 6 years.

Valsartan is indicated for the treatment of hypertension and heart failure in adults, but had never been studied in children. In November 2006, the Food and Drug Administration approved safety labeling revisions for valsartan tablets to advise of the risk of fetal and neonatal morbidity when used by pregnant women.

Dr. Joseph Flynn and associates presented preliminary results at the annual meeting of the American Society of Hypertension from a multicenter, placebo-controlled study evaluating three doses of valsartan in 90 children with a mean seated systolic BP of at least the 95th percentile of the National High Blood Pressure Education Program normative BP values for children.

After a 1-week placebo washout screening phase, the children were randomized to low, medium, and high doses of valsartan for 2 weeks (phase 1), and then rerandomized to placebo or valsartan for 2 more weeks (phase 2).

In phase 1, the doses were 5, 20, or 40 mg/day for those children weighing less than 18 kg, and 10, 40, or 80 mg/day for those weighing more than 18 kg. Half of the children stayed on the same dose in phase 2, and half were withdrawn to placebo.

At admission, the children's mean age was 3 years; 60% were boys, and 30% were black. Most children (79%) had hypertension related to renal disease; some (3%) were hypertensive because of heart disease, and 18% because of other causes.

In phase 1, valsartan significantly reduced both systolic and diastolic BP at all three doses, reported Dr. Flynn, who conducted the study while at Children's Hospital at Montefiore, New York, and is now a professor of pediatrics at Children's Hospital and Regional Medical Center, in Seattle. (See box.)

In phase 2, systolic and diastolic BP was significantly lower in children receiving valsartan, compared with those receiving placebo. The mean difference between valsartan and placebo was −4.1 mm Hg for systolic BP and −3.7 mm Hg for diastolic.

“Since many of these children have hypertension due to underlying renal disease, valsartan may be well suited for treatment of hypertension in this age group,” Dr. Flynn said in an interview.

Adverse events, such as cold symptoms, were minor and were similar between the different dose groups, he said. No participants discontinued treatment because of an adverse event.

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Losartan Cut Blood Pressures In Obese Hypertensive Patients

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CHICAGO — The angiotensin II blocker losartan, alone or in combination with the diuretic hydrochlorothiazide, appears efficacious in the treatment of obesity-associated hypertension, new data suggest.

Current guidelines—based on the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)—do not specify particular treatments for obesity-related hypertension or for the related metabolic syndrome.

The prominent role of angiotensin II in obesity-induced hypertension, however, suggests the possibility that angiotensin receptor blockade may be useful in its treatment, Dr. Suzanne Oparil said at the annual meeting of the American Society of Hypertension (ASH).

She presented preliminary data from a double-blind trial in which 261 patients from 51 sites were randomized to either placebo or losartan 50 mg/day for 4 weeks, titrated to 100 mg/day. Hydrochlorothiazide 12.5 mg/day was added in the active treatment group at week 8 and titrated to 25 mg/day at week 12.

At admission, the average body mass index was 37 kg/m

In all, 105 patients in each group completed the study, which was sponsored by Merck & Co. Inc., which has provided research support to Dr. Oparil.

Losartan 50 mg reduced the average sitting systolic BP to 140 mm Hg at week 4 and maintained it there through week 8. Adding hydrochlorothiazide to the 100-mg losartan dosage caused significant further reductions to about 133 mm Hg at week 16.

Similarly, losartan 50 mg decreased the average sitting diastolic BP to 90 mm Hg at week 4 through week 8. Add-on hydrochlorothiazide decreased the reading to about 85 mm Hg at week 18.

At week 16, 75% of those on losartan achieved systolic BP control to less than 140 mm Hg, and 77% achieved diastolic control to less than 90 mm Hg. In comparison, control rates on placebo were 18% for systolic BP and 38% for diastolic.

All changes in the losartan group were significantly greater than those in the placebo group for all time points, said Dr. Oparil, president of the ASH and director of the vascular biology and hypertension program at the University of Alabama, Birmingham. The losartan-based treatment regimen had a similar safety and tolerability profile as placebo, she said.

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CHICAGO — The angiotensin II blocker losartan, alone or in combination with the diuretic hydrochlorothiazide, appears efficacious in the treatment of obesity-associated hypertension, new data suggest.

Current guidelines—based on the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)—do not specify particular treatments for obesity-related hypertension or for the related metabolic syndrome.

The prominent role of angiotensin II in obesity-induced hypertension, however, suggests the possibility that angiotensin receptor blockade may be useful in its treatment, Dr. Suzanne Oparil said at the annual meeting of the American Society of Hypertension (ASH).

She presented preliminary data from a double-blind trial in which 261 patients from 51 sites were randomized to either placebo or losartan 50 mg/day for 4 weeks, titrated to 100 mg/day. Hydrochlorothiazide 12.5 mg/day was added in the active treatment group at week 8 and titrated to 25 mg/day at week 12.

At admission, the average body mass index was 37 kg/m

In all, 105 patients in each group completed the study, which was sponsored by Merck & Co. Inc., which has provided research support to Dr. Oparil.

Losartan 50 mg reduced the average sitting systolic BP to 140 mm Hg at week 4 and maintained it there through week 8. Adding hydrochlorothiazide to the 100-mg losartan dosage caused significant further reductions to about 133 mm Hg at week 16.

Similarly, losartan 50 mg decreased the average sitting diastolic BP to 90 mm Hg at week 4 through week 8. Add-on hydrochlorothiazide decreased the reading to about 85 mm Hg at week 18.

At week 16, 75% of those on losartan achieved systolic BP control to less than 140 mm Hg, and 77% achieved diastolic control to less than 90 mm Hg. In comparison, control rates on placebo were 18% for systolic BP and 38% for diastolic.

All changes in the losartan group were significantly greater than those in the placebo group for all time points, said Dr. Oparil, president of the ASH and director of the vascular biology and hypertension program at the University of Alabama, Birmingham. The losartan-based treatment regimen had a similar safety and tolerability profile as placebo, she said.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — The angiotensin II blocker losartan, alone or in combination with the diuretic hydrochlorothiazide, appears efficacious in the treatment of obesity-associated hypertension, new data suggest.

Current guidelines—based on the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)—do not specify particular treatments for obesity-related hypertension or for the related metabolic syndrome.

The prominent role of angiotensin II in obesity-induced hypertension, however, suggests the possibility that angiotensin receptor blockade may be useful in its treatment, Dr. Suzanne Oparil said at the annual meeting of the American Society of Hypertension (ASH).

She presented preliminary data from a double-blind trial in which 261 patients from 51 sites were randomized to either placebo or losartan 50 mg/day for 4 weeks, titrated to 100 mg/day. Hydrochlorothiazide 12.5 mg/day was added in the active treatment group at week 8 and titrated to 25 mg/day at week 12.

At admission, the average body mass index was 37 kg/m

In all, 105 patients in each group completed the study, which was sponsored by Merck & Co. Inc., which has provided research support to Dr. Oparil.

Losartan 50 mg reduced the average sitting systolic BP to 140 mm Hg at week 4 and maintained it there through week 8. Adding hydrochlorothiazide to the 100-mg losartan dosage caused significant further reductions to about 133 mm Hg at week 16.

Similarly, losartan 50 mg decreased the average sitting diastolic BP to 90 mm Hg at week 4 through week 8. Add-on hydrochlorothiazide decreased the reading to about 85 mm Hg at week 18.

At week 16, 75% of those on losartan achieved systolic BP control to less than 140 mm Hg, and 77% achieved diastolic control to less than 90 mm Hg. In comparison, control rates on placebo were 18% for systolic BP and 38% for diastolic.

All changes in the losartan group were significantly greater than those in the placebo group for all time points, said Dr. Oparil, president of the ASH and director of the vascular biology and hypertension program at the University of Alabama, Birmingham. The losartan-based treatment regimen had a similar safety and tolerability profile as placebo, she said.

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