Doug Brunk

SAN DIEGO — A community-based education effort to improve foot care among African American males with diabetes in the communities of Charleston and Georgetown, S.C., resulted in a sharp decline in amputation rates, from 79.1 per 1,000 diabetes hospitalizations in 1999 to 31.7 per 1,000 in 2002, Carolyn Jenkins, Dr.P.H., reported at the annual scientific sessions of the American Diabetes Association.

“We often label African American males as hard to reach,” said Dr. Jenkins, professor of nursing at the Medical University of South Carolina College of Nursing, Charleston. “The implications [of this study] are that hard-to-reach [patients] can be reached through family, friends, and community leaders. Volunteers can effectively deliver the message [of proper foot care], and community coalitions can produce outcomes specifically in decreasing amputations.”

In 1999, reducing amputations among African American males was identified as one of the priorities for action as part of the REACH 2010 (Racial and Ethnic Approaches to Community Health): Charleston and Georgetown Diabetes Coalition. Funded by a grant from the Centers for Disease Control and Prevention as a national demonstration project, the coalition's overall goal is to improve foot care and self-management of diabetes for more than 12,000 African Americans in five different health systems in the two communities.

“Our action plan is organized around community-driven educational activities where people live, work, worship, play, and seek health care,” Dr. Jenkins said. “We also focused on health systems change and building a sustainable coalition that can work to maintain the activity after grant funding.”

A key focus of the coalition involves training health professionals, volunteers, and lay educators about proper foot care for adults with diabetes. The coalition includes five African American women who are employed full time as lay educators in their communities, 130 registered nurses who have completed a 2- to 3-day foot care course, and 15 registered nurse wound care specialists.

The lesson for lay educators is called “Check Yourself to Protect Yourself: Take Care of Your Feet.” Dr. Jenkins described the lesson objectives as “standard, focused on taking care of feet, cutting nails, selecting appropriate footwear, checking feet each day using the monofilament, when to notify the health care provider [about concerns], discussing a foot exam with the health [care] provider, and methods for prevention of foot problems.”

Clients receive a book about diabetes self-management (“My Guide to Sugar Diabetes,” available at www.musc.edu/reach

The coalition also enlisted the help of local media by placing ads in newspapers, broadcasting radio talk shows, and airing a 30-minute TV show on foot care that ran 34 times.

Dr. Jenkins reported that between 1999 and 2002, the rate of foot exams among all diabetes patients in the five health care systems improved from 49% to 74%.

Meanwhile, amputations in African American males decreased from 79.1 per 1,000 diabetes hospitalizations in 1999 to 31.7 per 1,000 in 2002.

When African American males who took part in focus groups were asked what made them become more proactive about seeking foot care, they gave comments like “we now know that if we have a foot problem, we don't need to wait for it to get better,” Dr. Jenkins said. “We need to go to our health care providers in 1–2 days.”

When an audience member asked Dr. Jenkins how to win support for such an effort at the community level, she replied, “It's key that we educate policy makers about the problem and show them that we can make a difference. Stay in constant contact with them and share the information and get community members to do the same.”

SAN DIEGO — A community-based education effort to improve foot care among African American males with diabetes in the communities of Charleston and Georgetown, S.C., resulted in a sharp decline in amputation rates, from 79.1 per 1,000 diabetes hospitalizations in 1999 to 31.7 per 1,000 in 2002, Carolyn Jenkins, Dr.P.H., reported at the annual scientific sessions of the American Diabetes Association.

“We often label African American males as hard to reach,” said Dr. Jenkins, professor of nursing at the Medical University of South Carolina College of Nursing, Charleston. “The implications [of this study] are that hard-to-reach [patients] can be reached through family, friends, and community leaders. Volunteers can effectively deliver the message [of proper foot care], and community coalitions can produce outcomes specifically in decreasing amputations.”

In 1999, reducing amputations among African American males was identified as one of the priorities for action as part of the REACH 2010 (Racial and Ethnic Approaches to Community Health): Charleston and Georgetown Diabetes Coalition. Funded by a grant from the Centers for Disease Control and Prevention as a national demonstration project, the coalition's overall goal is to improve foot care and self-management of diabetes for more than 12,000 African Americans in five different health systems in the two communities.

“Our action plan is organized around community-driven educational activities where people live, work, worship, play, and seek health care,” Dr. Jenkins said. “We also focused on health systems change and building a sustainable coalition that can work to maintain the activity after grant funding.”

A key focus of the coalition involves training health professionals, volunteers, and lay educators about proper foot care for adults with diabetes. The coalition includes five African American women who are employed full time as lay educators in their communities, 130 registered nurses who have completed a 2- to 3-day foot care course, and 15 registered nurse wound care specialists.

The lesson for lay educators is called “Check Yourself to Protect Yourself: Take Care of Your Feet.” Dr. Jenkins described the lesson objectives as “standard, focused on taking care of feet, cutting nails, selecting appropriate footwear, checking feet each day using the monofilament, when to notify the health care provider [about concerns], discussing a foot exam with the health [care] provider, and methods for prevention of foot problems.”

Clients receive a book about diabetes self-management (“My Guide to Sugar Diabetes,” available at www.musc.edu/reach

The coalition also enlisted the help of local media by placing ads in newspapers, broadcasting radio talk shows, and airing a 30-minute TV show on foot care that ran 34 times.

Dr. Jenkins reported that between 1999 and 2002, the rate of foot exams among all diabetes patients in the five health care systems improved from 49% to 74%.

Meanwhile, amputations in African American males decreased from 79.1 per 1,000 diabetes hospitalizations in 1999 to 31.7 per 1,000 in 2002.

When African American males who took part in focus groups were asked what made them become more proactive about seeking foot care, they gave comments like “we now know that if we have a foot problem, we don't need to wait for it to get better,” Dr. Jenkins said. “We need to go to our health care providers in 1–2 days.”

When an audience member asked Dr. Jenkins how to win support for such an effort at the community level, she replied, “It's key that we educate policy makers about the problem and show them that we can make a difference. Stay in constant contact with them and share the information and get community members to do the same.”

SAN DIEGO — A community-based education effort to improve foot care among African American males with diabetes in the communities of Charleston and Georgetown, S.C., resulted in a sharp decline in amputation rates, from 79.1 per 1,000 diabetes hospitalizations in 1999 to 31.7 per 1,000 in 2002, Carolyn Jenkins, Dr.P.H., reported at the annual scientific sessions of the American Diabetes Association.

“We often label African American males as hard to reach,” said Dr. Jenkins, professor of nursing at the Medical University of South Carolina College of Nursing, Charleston. “The implications [of this study] are that hard-to-reach [patients] can be reached through family, friends, and community leaders. Volunteers can effectively deliver the message [of proper foot care], and community coalitions can produce outcomes specifically in decreasing amputations.”

In 1999, reducing amputations among African American males was identified as one of the priorities for action as part of the REACH 2010 (Racial and Ethnic Approaches to Community Health): Charleston and Georgetown Diabetes Coalition. Funded by a grant from the Centers for Disease Control and Prevention as a national demonstration project, the coalition's overall goal is to improve foot care and self-management of diabetes for more than 12,000 African Americans in five different health systems in the two communities.

“Our action plan is organized around community-driven educational activities where people live, work, worship, play, and seek health care,” Dr. Jenkins said. “We also focused on health systems change and building a sustainable coalition that can work to maintain the activity after grant funding.”

A key focus of the coalition involves training health professionals, volunteers, and lay educators about proper foot care for adults with diabetes. The coalition includes five African American women who are employed full time as lay educators in their communities, 130 registered nurses who have completed a 2- to 3-day foot care course, and 15 registered nurse wound care specialists.

The lesson for lay educators is called “Check Yourself to Protect Yourself: Take Care of Your Feet.” Dr. Jenkins described the lesson objectives as “standard, focused on taking care of feet, cutting nails, selecting appropriate footwear, checking feet each day using the monofilament, when to notify the health care provider [about concerns], discussing a foot exam with the health [care] provider, and methods for prevention of foot problems.”

Clients receive a book about diabetes self-management (“My Guide to Sugar Diabetes,” available at www.musc.edu/reach

The coalition also enlisted the help of local media by placing ads in newspapers, broadcasting radio talk shows, and airing a 30-minute TV show on foot care that ran 34 times.

Dr. Jenkins reported that between 1999 and 2002, the rate of foot exams among all diabetes patients in the five health care systems improved from 49% to 74%.

Meanwhile, amputations in African American males decreased from 79.1 per 1,000 diabetes hospitalizations in 1999 to 31.7 per 1,000 in 2002.

When African American males who took part in focus groups were asked what made them become more proactive about seeking foot care, they gave comments like “we now know that if we have a foot problem, we don't need to wait for it to get better,” Dr. Jenkins said. “We need to go to our health care providers in 1–2 days.”

When an audience member asked Dr. Jenkins how to win support for such an effort at the community level, she replied, “It's key that we educate policy makers about the problem and show them that we can make a difference. Stay in constant contact with them and share the information and get community members to do the same.”

YOSEMITE, CALIF. – Will my child become a dope fiend?

That's a common question Robert S. McKelvey, M.D., fields from parents of children who are prescribed a class II stimulant for attention-deficit hyperactivity disorder (ADHD).

“The answer is 'no,'” Dr. McKelvey said at a pediatric conference sponsored by Symposia Medicus. “The risk of kids who have properly diagnosed ADHD taking stimulants and becoming dope fiends is no different than [it is for] kids who do not have ADHD. The kids at risk are those who have ADHD” and are not on a prescribed drug treatment. “They have three times the likelihood of developing substance abuse problems,” he said.

Nonstimulant medications are an option for antisocial teens with ADHD, “although, at least in my view, they're not as effective as stimulants,” noted Dr. McKelvey, director of child and adolescent psychiatry at Oregon Health and Science University, Portland. Nonstimulant choices include atomoxetine, bupropion, clonidine, guanfacine, and the tricyclic antidepressants imipramine and nortriptyline.

Another question he commonly fields from parents is the effect of stimulants on children who have a chronic tic disorder such as Tourette's syndrome. “When I was in training, if you had tics, you had a history of tics, or even a family history of tics, we didn't start you on stimulant medication,” he said. “Now there are a couple of studies that show that if you have tics and you take stimulants, it's probably OK as long as the tics don't worsen. In many cases, the tics seem to [decrease in severity].”

Drug preparations in the stimulant class are derived from methylphenidate or dextroamphetamine. Methylphenidate is more widely used in the United States, but Dr. McKelvey noted that both agents are equally effective.

“You can't yet predict response, but it's possible that pharmacogenetics studies will give us a hand on that,” he said. “If one of them doesn't work, you try the other.”

A key point to remember about both agents is that they have very short half-lives. Maximal benefit on behavior occurs in 1–2 hours for agents derived from methylphenidate and 3–4 hours for agents derived from dextroamphetamine.

The sustained-release formulations appear to be as effective as the standard short-term formulations. The doses vary with the individual. There is some thought that academic performance (such as that associated with inattention) may respond to a lower dose than do restlessness and impulsivity, he said.

New, long-acting preparations enable once-daily dosing. These include Concerta, Metadate CD, Adderall XR, MethyPatch, and Focalin.

The most common adverse effect of stimulants is decreased appetite, which occurs in about 80% of children who take them. “The decreased appetite and weight loss can be stunning in some kids,” he remarked. “I've seen some very skeletal-looking little boys, and it can make you quite nervous.”

Long-term stimulant use may result in about a 1-cm decrease in height per year during the first 3 years of use, “but some of that is caught up,” Dr. McKelvey said. “More recent studies suggest there is perhaps a 1-cm decrease [in height] overall if you take stimulants long term.”

Insomnia is another common side effect, “so you tend to give it earlier in the day. You have to monitor heart and blood pressure. The things you're monitoring are height, weight, and blood pressure. It's pretty straightforward, but yearly, I usually check the white blood cell count,” he said.

He also warned against unproven therapies for ADHD, including megavitamins, biofeedback, sensory integration training, and optometric vision training. “There's a lot of malarkey out there.”

YOSEMITE, CALIF. – Will my child become a dope fiend?

That's a common question Robert S. McKelvey, M.D., fields from parents of children who are prescribed a class II stimulant for attention-deficit hyperactivity disorder (ADHD).

“The answer is 'no,'” Dr. McKelvey said at a pediatric conference sponsored by Symposia Medicus. “The risk of kids who have properly diagnosed ADHD taking stimulants and becoming dope fiends is no different than [it is for] kids who do not have ADHD. The kids at risk are those who have ADHD” and are not on a prescribed drug treatment. “They have three times the likelihood of developing substance abuse problems,” he said.

Nonstimulant medications are an option for antisocial teens with ADHD, “although, at least in my view, they're not as effective as stimulants,” noted Dr. McKelvey, director of child and adolescent psychiatry at Oregon Health and Science University, Portland. Nonstimulant choices include atomoxetine, bupropion, clonidine, guanfacine, and the tricyclic antidepressants imipramine and nortriptyline.

Another question he commonly fields from parents is the effect of stimulants on children who have a chronic tic disorder such as Tourette's syndrome. “When I was in training, if you had tics, you had a history of tics, or even a family history of tics, we didn't start you on stimulant medication,” he said. “Now there are a couple of studies that show that if you have tics and you take stimulants, it's probably OK as long as the tics don't worsen. In many cases, the tics seem to [decrease in severity].”

Drug preparations in the stimulant class are derived from methylphenidate or dextroamphetamine. Methylphenidate is more widely used in the United States, but Dr. McKelvey noted that both agents are equally effective.

“You can't yet predict response, but it's possible that pharmacogenetics studies will give us a hand on that,” he said. “If one of them doesn't work, you try the other.”

A key point to remember about both agents is that they have very short half-lives. Maximal benefit on behavior occurs in 1–2 hours for agents derived from methylphenidate and 3–4 hours for agents derived from dextroamphetamine.

The sustained-release formulations appear to be as effective as the standard short-term formulations. The doses vary with the individual. There is some thought that academic performance (such as that associated with inattention) may respond to a lower dose than do restlessness and impulsivity, he said.

New, long-acting preparations enable once-daily dosing. These include Concerta, Metadate CD, Adderall XR, MethyPatch, and Focalin.

The most common adverse effect of stimulants is decreased appetite, which occurs in about 80% of children who take them. “The decreased appetite and weight loss can be stunning in some kids,” he remarked. “I've seen some very skeletal-looking little boys, and it can make you quite nervous.”

Long-term stimulant use may result in about a 1-cm decrease in height per year during the first 3 years of use, “but some of that is caught up,” Dr. McKelvey said. “More recent studies suggest there is perhaps a 1-cm decrease [in height] overall if you take stimulants long term.”

Insomnia is another common side effect, “so you tend to give it earlier in the day. You have to monitor heart and blood pressure. The things you're monitoring are height, weight, and blood pressure. It's pretty straightforward, but yearly, I usually check the white blood cell count,” he said.

He also warned against unproven therapies for ADHD, including megavitamins, biofeedback, sensory integration training, and optometric vision training. “There's a lot of malarkey out there.”

YOSEMITE, CALIF. – Will my child become a dope fiend?

That's a common question Robert S. McKelvey, M.D., fields from parents of children who are prescribed a class II stimulant for attention-deficit hyperactivity disorder (ADHD).

“The answer is 'no,'” Dr. McKelvey said at a pediatric conference sponsored by Symposia Medicus. “The risk of kids who have properly diagnosed ADHD taking stimulants and becoming dope fiends is no different than [it is for] kids who do not have ADHD. The kids at risk are those who have ADHD” and are not on a prescribed drug treatment. “They have three times the likelihood of developing substance abuse problems,” he said.

Nonstimulant medications are an option for antisocial teens with ADHD, “although, at least in my view, they're not as effective as stimulants,” noted Dr. McKelvey, director of child and adolescent psychiatry at Oregon Health and Science University, Portland. Nonstimulant choices include atomoxetine, bupropion, clonidine, guanfacine, and the tricyclic antidepressants imipramine and nortriptyline.

Another question he commonly fields from parents is the effect of stimulants on children who have a chronic tic disorder such as Tourette's syndrome. “When I was in training, if you had tics, you had a history of tics, or even a family history of tics, we didn't start you on stimulant medication,” he said. “Now there are a couple of studies that show that if you have tics and you take stimulants, it's probably OK as long as the tics don't worsen. In many cases, the tics seem to [decrease in severity].”

Drug preparations in the stimulant class are derived from methylphenidate or dextroamphetamine. Methylphenidate is more widely used in the United States, but Dr. McKelvey noted that both agents are equally effective.

“You can't yet predict response, but it's possible that pharmacogenetics studies will give us a hand on that,” he said. “If one of them doesn't work, you try the other.”

A key point to remember about both agents is that they have very short half-lives. Maximal benefit on behavior occurs in 1–2 hours for agents derived from methylphenidate and 3–4 hours for agents derived from dextroamphetamine.

The sustained-release formulations appear to be as effective as the standard short-term formulations. The doses vary with the individual. There is some thought that academic performance (such as that associated with inattention) may respond to a lower dose than do restlessness and impulsivity, he said.

New, long-acting preparations enable once-daily dosing. These include Concerta, Metadate CD, Adderall XR, MethyPatch, and Focalin.

The most common adverse effect of stimulants is decreased appetite, which occurs in about 80% of children who take them. “The decreased appetite and weight loss can be stunning in some kids,” he remarked. “I've seen some very skeletal-looking little boys, and it can make you quite nervous.”

Long-term stimulant use may result in about a 1-cm decrease in height per year during the first 3 years of use, “but some of that is caught up,” Dr. McKelvey said. “More recent studies suggest there is perhaps a 1-cm decrease [in height] overall if you take stimulants long term.”

Insomnia is another common side effect, “so you tend to give it earlier in the day. You have to monitor heart and blood pressure. The things you're monitoring are height, weight, and blood pressure. It's pretty straightforward, but yearly, I usually check the white blood cell count,” he said.

He also warned against unproven therapies for ADHD, including megavitamins, biofeedback, sensory integration training, and optometric vision training. “There's a lot of malarkey out there.”

SAN DIEGO — Most emergency department visits for influenza in the United States are by patients aged 5–49 years who have no other diagnoses, results from a large analysis demonstrated.

The finding underscores the importance of vaccination in this segment of the population, Kimmie Kohlhase McLaurin reported in a poster session at the 100th International Conference of the American Thoracic Society.

“We don't know much about influenza in this age group,” said Ms. McLaurin, a research analyst for MedImmune Inc., which manufactures FluMist, the intranasal vaccine that was approved in 2003 for healthy children and adults aged 5–49 years. “We know a lot more in the young and in the old. That's where our focus has been.”

In a study funded by MedImmune, Ms. McLaurin and her associate, Shelah Leader, Ph.D., analyzed emergency department data from the 1997–2002 National Hospital Ambulatory Medical Care Surveys to identify visits with a primary diagnosis of influenza based on ICD-9 codes 487.0 (influenza with pneumonia), 487.1 (influenza with other respiratory manifestations), and 487.8 (influenza with other manifestations).

More than 1.1 million ED visits for influenza occurred during the 6-year study period. Of these, 69% were by patients aged 5–49 years. Nearly three-quarters of ED visits by this age group (71%) had no secondary diagnoses, and visits were highest among 18–22-year-olds, nonwhites, and females. January was the peak month for visits, followed by February, December, and March.

The most common procedures ordered by clinicians were CBC (35%), chest x-ray (26%), pulse oximetry (19%), and administration of IV fluids (14%). Most visits (84%) resulted in prescriptions for analgesics (43%), cold/flu remedies (30%), and antibiotics (21%).

Reasons for the visit as reported by the patient were fever/chills (47%), cough (33%), myalgia (20%), throat symptoms (17%), flu (14%), vomiting (14%), and headache (12%).

SAN DIEGO — Most emergency department visits for influenza in the United States are by patients aged 5–49 years who have no other diagnoses, results from a large analysis demonstrated.

The finding underscores the importance of vaccination in this segment of the population, Kimmie Kohlhase McLaurin reported in a poster session at the 100th International Conference of the American Thoracic Society.

“We don't know much about influenza in this age group,” said Ms. McLaurin, a research analyst for MedImmune Inc., which manufactures FluMist, the intranasal vaccine that was approved in 2003 for healthy children and adults aged 5–49 years. “We know a lot more in the young and in the old. That's where our focus has been.”

In a study funded by MedImmune, Ms. McLaurin and her associate, Shelah Leader, Ph.D., analyzed emergency department data from the 1997–2002 National Hospital Ambulatory Medical Care Surveys to identify visits with a primary diagnosis of influenza based on ICD-9 codes 487.0 (influenza with pneumonia), 487.1 (influenza with other respiratory manifestations), and 487.8 (influenza with other manifestations).

More than 1.1 million ED visits for influenza occurred during the 6-year study period. Of these, 69% were by patients aged 5–49 years. Nearly three-quarters of ED visits by this age group (71%) had no secondary diagnoses, and visits were highest among 18–22-year-olds, nonwhites, and females. January was the peak month for visits, followed by February, December, and March.

The most common procedures ordered by clinicians were CBC (35%), chest x-ray (26%), pulse oximetry (19%), and administration of IV fluids (14%). Most visits (84%) resulted in prescriptions for analgesics (43%), cold/flu remedies (30%), and antibiotics (21%).

Reasons for the visit as reported by the patient were fever/chills (47%), cough (33%), myalgia (20%), throat symptoms (17%), flu (14%), vomiting (14%), and headache (12%).

SAN DIEGO — Most emergency department visits for influenza in the United States are by patients aged 5–49 years who have no other diagnoses, results from a large analysis demonstrated.

The finding underscores the importance of vaccination in this segment of the population, Kimmie Kohlhase McLaurin reported in a poster session at the 100th International Conference of the American Thoracic Society.

“We don't know much about influenza in this age group,” said Ms. McLaurin, a research analyst for MedImmune Inc., which manufactures FluMist, the intranasal vaccine that was approved in 2003 for healthy children and adults aged 5–49 years. “We know a lot more in the young and in the old. That's where our focus has been.”

In a study funded by MedImmune, Ms. McLaurin and her associate, Shelah Leader, Ph.D., analyzed emergency department data from the 1997–2002 National Hospital Ambulatory Medical Care Surveys to identify visits with a primary diagnosis of influenza based on ICD-9 codes 487.0 (influenza with pneumonia), 487.1 (influenza with other respiratory manifestations), and 487.8 (influenza with other manifestations).

More than 1.1 million ED visits for influenza occurred during the 6-year study period. Of these, 69% were by patients aged 5–49 years. Nearly three-quarters of ED visits by this age group (71%) had no secondary diagnoses, and visits were highest among 18–22-year-olds, nonwhites, and females. January was the peak month for visits, followed by February, December, and March.

The most common procedures ordered by clinicians were CBC (35%), chest x-ray (26%), pulse oximetry (19%), and administration of IV fluids (14%). Most visits (84%) resulted in prescriptions for analgesics (43%), cold/flu remedies (30%), and antibiotics (21%).

Reasons for the visit as reported by the patient were fever/chills (47%), cough (33%), myalgia (20%), throat symptoms (17%), flu (14%), vomiting (14%), and headache (12%).

SAN DIEGO — Postmenopausal women with newly diagnosed diabetes were more likely to have had a history of breast cancer before their diagnosis than were women without diabetes, results from a large cross-sectional Canadian study showed.

Although the finding supports the hypothesis that breast cancer risk is increased in the prediabetes phase, “there are limitations to our study,” Lorraine Lipscombe, M.D., said at the annual scientific sessions of the American Diabetes Association.

“Given the cross-sectional design, we cannot exclude the possibility of reverse causality in that breast cancer or its treatment actually increased the risk of diabetes,” said Dr. Lipscombe of the division of endocrinology at the University of Toronto. “However, there have been no studies in the literature to support this possibility, and there's no known ration- ale whereby this association might occur.”

A more realistic possibility, she offered, “is that breast cancer increases the opportunity for diabetes diagnosis, representing a detection bias. We also couldn't exclude confounding variables as a possible explanation. We were not able to adjust for other breast cancer risk factors such as family history, reproductive factors, and obesity.”

For the study, which she said is the first of its kind, Dr. Lipscombe and her associates used government health care databases from the province of Ontario to identify women aged 55–79 years who were diagnosed with diabetes from 1994 to 2002 and compare them with their peers without diabetes. They used a breast cancer registry to identify breast cancer cases in Ontario women from 1964 to the present.

From 1994 to 2002, there were 82,390 women in Ontario with newly diagnosed diabetes and 411,950 women without diabetes. “The average age was about 65, but the women with diabetes were a little bit older and were more likely to reside in a lower-income neighborhood,” she said.

The investigators identified prior breast cancers in 3,071 women with newly diagnosed diabetes (3.7%) and in 12,709 women without diabetes (3.1%). The mean time from breast cancer diagnosis to index date was about 8 years.

The unadjusted rates of prior breast cancer were 22% higher among women with newly diagnosed diabetes than among women without diabetes, for an odds ratio of 1.22.

When the investigators adjusted for age, income, and number of primary care visits, the association remained significant. The adjusted rates of prior breast cancer were 13% higher among women with newly diagnosed diabetes than among others, for an odds ratio of 1.13.

“Our results support other studies that have shown a small increase in breast cancer incidence after a diagnosis of diabetes,” Dr. Lipscombe said. “It also lends support to the temporal relationship between insulin resistance and breast cancer. Our results also suggest this risk may be greater in the prediabetes phase. However, further prospective studies will be required.”

The Canadian Diabetes Association funded the study.

SAN DIEGO — Postmenopausal women with newly diagnosed diabetes were more likely to have had a history of breast cancer before their diagnosis than were women without diabetes, results from a large cross-sectional Canadian study showed.

Although the finding supports the hypothesis that breast cancer risk is increased in the prediabetes phase, “there are limitations to our study,” Lorraine Lipscombe, M.D., said at the annual scientific sessions of the American Diabetes Association.

“Given the cross-sectional design, we cannot exclude the possibility of reverse causality in that breast cancer or its treatment actually increased the risk of diabetes,” said Dr. Lipscombe of the division of endocrinology at the University of Toronto. “However, there have been no studies in the literature to support this possibility, and there's no known ration- ale whereby this association might occur.”

A more realistic possibility, she offered, “is that breast cancer increases the opportunity for diabetes diagnosis, representing a detection bias. We also couldn't exclude confounding variables as a possible explanation. We were not able to adjust for other breast cancer risk factors such as family history, reproductive factors, and obesity.”

For the study, which she said is the first of its kind, Dr. Lipscombe and her associates used government health care databases from the province of Ontario to identify women aged 55–79 years who were diagnosed with diabetes from 1994 to 2002 and compare them with their peers without diabetes. They used a breast cancer registry to identify breast cancer cases in Ontario women from 1964 to the present.

From 1994 to 2002, there were 82,390 women in Ontario with newly diagnosed diabetes and 411,950 women without diabetes. “The average age was about 65, but the women with diabetes were a little bit older and were more likely to reside in a lower-income neighborhood,” she said.

The investigators identified prior breast cancers in 3,071 women with newly diagnosed diabetes (3.7%) and in 12,709 women without diabetes (3.1%). The mean time from breast cancer diagnosis to index date was about 8 years.

The unadjusted rates of prior breast cancer were 22% higher among women with newly diagnosed diabetes than among women without diabetes, for an odds ratio of 1.22.

When the investigators adjusted for age, income, and number of primary care visits, the association remained significant. The adjusted rates of prior breast cancer were 13% higher among women with newly diagnosed diabetes than among others, for an odds ratio of 1.13.

“Our results support other studies that have shown a small increase in breast cancer incidence after a diagnosis of diabetes,” Dr. Lipscombe said. “It also lends support to the temporal relationship between insulin resistance and breast cancer. Our results also suggest this risk may be greater in the prediabetes phase. However, further prospective studies will be required.”

The Canadian Diabetes Association funded the study.

SAN DIEGO — Postmenopausal women with newly diagnosed diabetes were more likely to have had a history of breast cancer before their diagnosis than were women without diabetes, results from a large cross-sectional Canadian study showed.

Although the finding supports the hypothesis that breast cancer risk is increased in the prediabetes phase, “there are limitations to our study,” Lorraine Lipscombe, M.D., said at the annual scientific sessions of the American Diabetes Association.

“Given the cross-sectional design, we cannot exclude the possibility of reverse causality in that breast cancer or its treatment actually increased the risk of diabetes,” said Dr. Lipscombe of the division of endocrinology at the University of Toronto. “However, there have been no studies in the literature to support this possibility, and there's no known ration- ale whereby this association might occur.”

A more realistic possibility, she offered, “is that breast cancer increases the opportunity for diabetes diagnosis, representing a detection bias. We also couldn't exclude confounding variables as a possible explanation. We were not able to adjust for other breast cancer risk factors such as family history, reproductive factors, and obesity.”

For the study, which she said is the first of its kind, Dr. Lipscombe and her associates used government health care databases from the province of Ontario to identify women aged 55–79 years who were diagnosed with diabetes from 1994 to 2002 and compare them with their peers without diabetes. They used a breast cancer registry to identify breast cancer cases in Ontario women from 1964 to the present.

From 1994 to 2002, there were 82,390 women in Ontario with newly diagnosed diabetes and 411,950 women without diabetes. “The average age was about 65, but the women with diabetes were a little bit older and were more likely to reside in a lower-income neighborhood,” she said.

The investigators identified prior breast cancers in 3,071 women with newly diagnosed diabetes (3.7%) and in 12,709 women without diabetes (3.1%). The mean time from breast cancer diagnosis to index date was about 8 years.

The unadjusted rates of prior breast cancer were 22% higher among women with newly diagnosed diabetes than among women without diabetes, for an odds ratio of 1.22.

When the investigators adjusted for age, income, and number of primary care visits, the association remained significant. The adjusted rates of prior breast cancer were 13% higher among women with newly diagnosed diabetes than among others, for an odds ratio of 1.13.

“Our results support other studies that have shown a small increase in breast cancer incidence after a diagnosis of diabetes,” Dr. Lipscombe said. “It also lends support to the temporal relationship between insulin resistance and breast cancer. Our results also suggest this risk may be greater in the prediabetes phase. However, further prospective studies will be required.”

The Canadian Diabetes Association funded the study.

SAN DIEGO — Biochemical coronary heart disease risk markers differ between young black women born in the United States and those born in other countries, Errol Davis, Ph.D., reported in a poster session at a meeting sponsored by the American Society for Nutritional Sciences.

The finding suggests that physicians “should not assume that all black individuals have the same level of risk in developing coronary heart disease,” Dr. Davis, a postdoctoral fellow in the department of dietetics and nutrition at Florida International University, Miami, told this newspaper. “Health care professionals designing or managing programs to reduce coronary heart disease in ethnic populations should respond to the specific needs of the different groups within this same race for more effective outcomes.”

In a cross-sectional study conducted with his associate Fatma Huffman, Ph.D., Dr. Davis analyzed the blood lipids and levels of high-sensitivity C-reactive protein (hs-CRP) in 35 foreign-born Afro Caribbean American women living in the United States for fewer than 10 years, 32 Afro Caribbean women born in the United States, and 31 African American women. The women ranged in age from 18 to 40 years.

The investigators observed no significant differences among the three groups in terms of mean total cholesterol, LDL cholesterol, and HDL cholesterol. However, the mean hs-CRP levels were significantly lower in foreign-born Afro Caribbean American women and Afro Caribbean women born in the United States, compared with levels in African American women (1 mg/L, 1.1 mg/L, and 2.4 mg/L, respectively).

In addition, elevated hs-CRP levels defined as greater than 3 mg/L were observed in 10% of foreign-born Afro Caribbean American women, 7.4% of Afro Caribbean women born in the United States, and 30% of African American women.

“We were not totally surprised by the results,” Dr. Davis said. “South Florida is a cultural melting pot due to its ethnically diverse population. We previously observed differences in behavioral habits between foreign-born and U.S.-born individuals of African ancestry. There are data indicating that the death rate due to coronary heart disease in foreign-born individuals was lower than that of their U.S.-born counterparts. It was our theory that biochemical differences with respect to coronary heart disease would also exist. However, there was no evidence in the literature for this assumption. Hence, the importance of our research.” He added that because the study was small and its participants were from a university setting, the findings may not be generalizable to all black women.

SAN DIEGO — Biochemical coronary heart disease risk markers differ between young black women born in the United States and those born in other countries, Errol Davis, Ph.D., reported in a poster session at a meeting sponsored by the American Society for Nutritional Sciences.

The finding suggests that physicians “should not assume that all black individuals have the same level of risk in developing coronary heart disease,” Dr. Davis, a postdoctoral fellow in the department of dietetics and nutrition at Florida International University, Miami, told this newspaper. “Health care professionals designing or managing programs to reduce coronary heart disease in ethnic populations should respond to the specific needs of the different groups within this same race for more effective outcomes.”

In a cross-sectional study conducted with his associate Fatma Huffman, Ph.D., Dr. Davis analyzed the blood lipids and levels of high-sensitivity C-reactive protein (hs-CRP) in 35 foreign-born Afro Caribbean American women living in the United States for fewer than 10 years, 32 Afro Caribbean women born in the United States, and 31 African American women. The women ranged in age from 18 to 40 years.

The investigators observed no significant differences among the three groups in terms of mean total cholesterol, LDL cholesterol, and HDL cholesterol. However, the mean hs-CRP levels were significantly lower in foreign-born Afro Caribbean American women and Afro Caribbean women born in the United States, compared with levels in African American women (1 mg/L, 1.1 mg/L, and 2.4 mg/L, respectively).

In addition, elevated hs-CRP levels defined as greater than 3 mg/L were observed in 10% of foreign-born Afro Caribbean American women, 7.4% of Afro Caribbean women born in the United States, and 30% of African American women.

“We were not totally surprised by the results,” Dr. Davis said. “South Florida is a cultural melting pot due to its ethnically diverse population. We previously observed differences in behavioral habits between foreign-born and U.S.-born individuals of African ancestry. There are data indicating that the death rate due to coronary heart disease in foreign-born individuals was lower than that of their U.S.-born counterparts. It was our theory that biochemical differences with respect to coronary heart disease would also exist. However, there was no evidence in the literature for this assumption. Hence, the importance of our research.” He added that because the study was small and its participants were from a university setting, the findings may not be generalizable to all black women.

SAN DIEGO — Biochemical coronary heart disease risk markers differ between young black women born in the United States and those born in other countries, Errol Davis, Ph.D., reported in a poster session at a meeting sponsored by the American Society for Nutritional Sciences.

The finding suggests that physicians “should not assume that all black individuals have the same level of risk in developing coronary heart disease,” Dr. Davis, a postdoctoral fellow in the department of dietetics and nutrition at Florida International University, Miami, told this newspaper. “Health care professionals designing or managing programs to reduce coronary heart disease in ethnic populations should respond to the specific needs of the different groups within this same race for more effective outcomes.”

In a cross-sectional study conducted with his associate Fatma Huffman, Ph.D., Dr. Davis analyzed the blood lipids and levels of high-sensitivity C-reactive protein (hs-CRP) in 35 foreign-born Afro Caribbean American women living in the United States for fewer than 10 years, 32 Afro Caribbean women born in the United States, and 31 African American women. The women ranged in age from 18 to 40 years.

The investigators observed no significant differences among the three groups in terms of mean total cholesterol, LDL cholesterol, and HDL cholesterol. However, the mean hs-CRP levels were significantly lower in foreign-born Afro Caribbean American women and Afro Caribbean women born in the United States, compared with levels in African American women (1 mg/L, 1.1 mg/L, and 2.4 mg/L, respectively).

In addition, elevated hs-CRP levels defined as greater than 3 mg/L were observed in 10% of foreign-born Afro Caribbean American women, 7.4% of Afro Caribbean women born in the United States, and 30% of African American women.

“We were not totally surprised by the results,” Dr. Davis said. “South Florida is a cultural melting pot due to its ethnically diverse population. We previously observed differences in behavioral habits between foreign-born and U.S.-born individuals of African ancestry. There are data indicating that the death rate due to coronary heart disease in foreign-born individuals was lower than that of their U.S.-born counterparts. It was our theory that biochemical differences with respect to coronary heart disease would also exist. However, there was no evidence in the literature for this assumption. Hence, the importance of our research.” He added that because the study was small and its participants were from a university setting, the findings may not be generalizable to all black women.

SAN DIEGO — With no medical therapy, patients with stage C and D heart failure face a 2-year mortality risk of 35%, Lee Goldberg, M.D., said at the 100th International Conference of the American Thoracic Society.

But clinicians can reduce the 2-year mortality in this population of patients by 12%–24% if they treat patients with the available medical therapies.

“The number needed to treat to save one life is four patients,” said Dr. Goldberg of the heart failure/transplant program at the University of Pennsylvania Health System, Philadelphia.

“So it's extremely cost effective to treat heart failure patients. Many of the medical therapies we have are underutilized—especially in patients who are less symptomatic,” Dr. Goldberg said.

He reviewed the following treatments, commonly used in patients with stage C and D heart failure:

▸ Diuretics. Although there are no clinical trial data proving their efficacy in this patient population, diuretics are the most commonly prescribed drugs for patients with advanced heart failure.

“But we know from epidemiologic data that diuretics don't change the natural history of heart failure,” Dr. Goldberg said. “Morbidity and mortality after taking them doesn't change very much.”

Loop diuretics are the most commonly used type, although many centers use thiazide diuretics in combination to augment the effects of loop diuretics.

“I would titrate to signs and symptoms of volume overload,” he advised. “Many disease management programs have action plans of sliding-scale diuretics to help patients control their volume status. It keeps them out of the hospital and keeps them safe, but it doesn't prolong their life, and it doesn't change the [heart] remodeling process.”

The symptomatic benefits of diuretics occur more rapidly than those of other drugs, and diuretics are the only class of drugs that adequately control chronic fluid retention. Adverse effects may include volume depletion and renal insufficiency. Metabolic effects may include electrolyte imbalance, hyperuricemia, and hyperglycemia.

There are lingering questions about this approach, however: Will newer agents replace the loop diuretics? Which are the best combinations? “These questions still need to be studied,” he said.

▸ ACE inhibitors. There are “buckets of data” on the use of these agents in advanced heart failure. ACE inhibitors interfere with the renin-angiotensin system and enhance the action of kinins. “They alleviate symptoms, reduce death, and reduce hospitalizations,” Dr. Goldberg said. “So they hit all three of our goals [in treating these patients]: heart remodeling, symptoms, and mortality.”

These drugs are typically given to all patients with systolic dysfunction. “A lot of people believe they should also be used in diastolic dysfunction, but we don't have good data for that yet,” he said.

Adverse effects may include hypotension, azotemia, hyperkalemia, cough, and angioedema. Unanswered questions include whether there is a class effect. “The answer is probably yes,” he said. Also, it is not known whether there is a significant interaction with aspirin. “Most of us are comfortable using both aspirin and ACE inhibitors,” said Dr. Goldberg, also of the University of Pennsylvania.

▸ β-Blockers. These drugs inhibit the adverse effects of the sympathetic system, and they delay and reverse heart remodeling. “The No. 1 way to increase the ejection fraction in patients with heart failure is to actually put them on a β-blocker,” Dr. Goldberg said.

β-Blockers are currently given to all patients with systolic heart failure in the absence of fluid overload. Adverse effects may include hypotension, bradycardia, and worsening heart failure.

The ideal target dose for β-blockers has not been determined. This is one remaining question about this class of drugs. “There is probably not a class effect,” he said. “It appears that the long-acting β-blockers and nonselective β-blockers may have an advantage over the shorter-acting and selective ones.”

▸ Angiotensin II receptor blockers. These drugs block the effect of angiotensin II at the receptor site. They delay heart remodeling and reduce symptoms, and they have been shown to reduce hospitalizations and deaths.

ARBs are currently given to patients who can't tolerate ACE inhibitors—specifically, the side effects of angioedema and cough.

The Valsartan Heart Failure Trial (Val-HeFT) and the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) trial showed some improvement in the efficacy of ARBs when used with ACE inhibitors. However, patients in the Val-HeFT trial who took ARBs with an ACE inhibitor and a β-blocker had worse outcomes. This association was not found in the CHARM trial.

Adverse effects may include hypotension, azotemia, hyperkalemia, and cough.

Will ARBs ever replace ACE inhibitors? That's a key question about this class of drugs, Dr. Goldberg said.

▸ Digoxin. This drug has no impact on mortality, but it does appear to improve symptoms. Dr. Goldberg cautioned that digoxin carries a high risk of renal insufficiency and an increased risk of drug interactions. “Therefore, we limit the use of digoxin only to patients with symptomatic heart failure,” he said.

He recommends using the lowest possible dose of the drug and maintaining drug levels below 1.0 ng/mL.

A recent study of heart failure patients found that digoxin had no effect on quality of life, compared with placebo, in terms of perceived health, physical functioning, depression, anxiety, anger, and the 6-minute walk test (J. Card. Fail. 2003;9:4–12).

▸ Aldosterone antagonists. Trials of these agents show improved mortality for class IIIB or class IV patients, but not in heart failure patients with less severe disease, Dr. Goldberg said.

The role of these drugs with β-blockers is not well defined, and they are contraindicated if patients are on both an ACE inhibitor and an ARB due to a risk of hyperkalemia.

▸ Nitrates. The Vasodilator-Heart Failure Trial (V-HeFT) demonstrated that nitrates in combination with hydralazine are not as effective as ACE inhibitors, yet they are better than placebo.

The African-American Heart Failure Trial (A-HeFT) showed that nitrates and hydralazine improved mortality when used with ACE inhibitors and β-blockers, but their value when added to traditional therapy is unknown in other racial groups.

SAN DIEGO — With no medical therapy, patients with stage C and D heart failure face a 2-year mortality risk of 35%, Lee Goldberg, M.D., said at the 100th International Conference of the American Thoracic Society.

But clinicians can reduce the 2-year mortality in this population of patients by 12%–24% if they treat patients with the available medical therapies.

“The number needed to treat to save one life is four patients,” said Dr. Goldberg of the heart failure/transplant program at the University of Pennsylvania Health System, Philadelphia.

“So it's extremely cost effective to treat heart failure patients. Many of the medical therapies we have are underutilized—especially in patients who are less symptomatic,” Dr. Goldberg said.

He reviewed the following treatments, commonly used in patients with stage C and D heart failure:

▸ Diuretics. Although there are no clinical trial data proving their efficacy in this patient population, diuretics are the most commonly prescribed drugs for patients with advanced heart failure.

“But we know from epidemiologic data that diuretics don't change the natural history of heart failure,” Dr. Goldberg said. “Morbidity and mortality after taking them doesn't change very much.”

Loop diuretics are the most commonly used type, although many centers use thiazide diuretics in combination to augment the effects of loop diuretics.

“I would titrate to signs and symptoms of volume overload,” he advised. “Many disease management programs have action plans of sliding-scale diuretics to help patients control their volume status. It keeps them out of the hospital and keeps them safe, but it doesn't prolong their life, and it doesn't change the [heart] remodeling process.”

The symptomatic benefits of diuretics occur more rapidly than those of other drugs, and diuretics are the only class of drugs that adequately control chronic fluid retention. Adverse effects may include volume depletion and renal insufficiency. Metabolic effects may include electrolyte imbalance, hyperuricemia, and hyperglycemia.

There are lingering questions about this approach, however: Will newer agents replace the loop diuretics? Which are the best combinations? “These questions still need to be studied,” he said.

▸ ACE inhibitors. There are “buckets of data” on the use of these agents in advanced heart failure. ACE inhibitors interfere with the renin-angiotensin system and enhance the action of kinins. “They alleviate symptoms, reduce death, and reduce hospitalizations,” Dr. Goldberg said. “So they hit all three of our goals [in treating these patients]: heart remodeling, symptoms, and mortality.”

These drugs are typically given to all patients with systolic dysfunction. “A lot of people believe they should also be used in diastolic dysfunction, but we don't have good data for that yet,” he said.

Adverse effects may include hypotension, azotemia, hyperkalemia, cough, and angioedema. Unanswered questions include whether there is a class effect. “The answer is probably yes,” he said. Also, it is not known whether there is a significant interaction with aspirin. “Most of us are comfortable using both aspirin and ACE inhibitors,” said Dr. Goldberg, also of the University of Pennsylvania.

▸ β-Blockers. These drugs inhibit the adverse effects of the sympathetic system, and they delay and reverse heart remodeling. “The No. 1 way to increase the ejection fraction in patients with heart failure is to actually put them on a β-blocker,” Dr. Goldberg said.

β-Blockers are currently given to all patients with systolic heart failure in the absence of fluid overload. Adverse effects may include hypotension, bradycardia, and worsening heart failure.

The ideal target dose for β-blockers has not been determined. This is one remaining question about this class of drugs. “There is probably not a class effect,” he said. “It appears that the long-acting β-blockers and nonselective β-blockers may have an advantage over the shorter-acting and selective ones.”

▸ Angiotensin II receptor blockers. These drugs block the effect of angiotensin II at the receptor site. They delay heart remodeling and reduce symptoms, and they have been shown to reduce hospitalizations and deaths.

ARBs are currently given to patients who can't tolerate ACE inhibitors—specifically, the side effects of angioedema and cough.

The Valsartan Heart Failure Trial (Val-HeFT) and the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) trial showed some improvement in the efficacy of ARBs when used with ACE inhibitors. However, patients in the Val-HeFT trial who took ARBs with an ACE inhibitor and a β-blocker had worse outcomes. This association was not found in the CHARM trial.

Adverse effects may include hypotension, azotemia, hyperkalemia, and cough.

Will ARBs ever replace ACE inhibitors? That's a key question about this class of drugs, Dr. Goldberg said.

▸ Digoxin. This drug has no impact on mortality, but it does appear to improve symptoms. Dr. Goldberg cautioned that digoxin carries a high risk of renal insufficiency and an increased risk of drug interactions. “Therefore, we limit the use of digoxin only to patients with symptomatic heart failure,” he said.

He recommends using the lowest possible dose of the drug and maintaining drug levels below 1.0 ng/mL.

A recent study of heart failure patients found that digoxin had no effect on quality of life, compared with placebo, in terms of perceived health, physical functioning, depression, anxiety, anger, and the 6-minute walk test (J. Card. Fail. 2003;9:4–12).

▸ Aldosterone antagonists. Trials of these agents show improved mortality for class IIIB or class IV patients, but not in heart failure patients with less severe disease, Dr. Goldberg said.

The role of these drugs with β-blockers is not well defined, and they are contraindicated if patients are on both an ACE inhibitor and an ARB due to a risk of hyperkalemia.

▸ Nitrates. The Vasodilator-Heart Failure Trial (V-HeFT) demonstrated that nitrates in combination with hydralazine are not as effective as ACE inhibitors, yet they are better than placebo.

The African-American Heart Failure Trial (A-HeFT) showed that nitrates and hydralazine improved mortality when used with ACE inhibitors and β-blockers, but their value when added to traditional therapy is unknown in other racial groups.

SAN DIEGO — With no medical therapy, patients with stage C and D heart failure face a 2-year mortality risk of 35%, Lee Goldberg, M.D., said at the 100th International Conference of the American Thoracic Society.

But clinicians can reduce the 2-year mortality in this population of patients by 12%–24% if they treat patients with the available medical therapies.

“The number needed to treat to save one life is four patients,” said Dr. Goldberg of the heart failure/transplant program at the University of Pennsylvania Health System, Philadelphia.

“So it's extremely cost effective to treat heart failure patients. Many of the medical therapies we have are underutilized—especially in patients who are less symptomatic,” Dr. Goldberg said.

He reviewed the following treatments, commonly used in patients with stage C and D heart failure:

▸ Diuretics. Although there are no clinical trial data proving their efficacy in this patient population, diuretics are the most commonly prescribed drugs for patients with advanced heart failure.

“But we know from epidemiologic data that diuretics don't change the natural history of heart failure,” Dr. Goldberg said. “Morbidity and mortality after taking them doesn't change very much.”

Loop diuretics are the most commonly used type, although many centers use thiazide diuretics in combination to augment the effects of loop diuretics.

“I would titrate to signs and symptoms of volume overload,” he advised. “Many disease management programs have action plans of sliding-scale diuretics to help patients control their volume status. It keeps them out of the hospital and keeps them safe, but it doesn't prolong their life, and it doesn't change the [heart] remodeling process.”

The symptomatic benefits of diuretics occur more rapidly than those of other drugs, and diuretics are the only class of drugs that adequately control chronic fluid retention. Adverse effects may include volume depletion and renal insufficiency. Metabolic effects may include electrolyte imbalance, hyperuricemia, and hyperglycemia.

There are lingering questions about this approach, however: Will newer agents replace the loop diuretics? Which are the best combinations? “These questions still need to be studied,” he said.

▸ ACE inhibitors. There are “buckets of data” on the use of these agents in advanced heart failure. ACE inhibitors interfere with the renin-angiotensin system and enhance the action of kinins. “They alleviate symptoms, reduce death, and reduce hospitalizations,” Dr. Goldberg said. “So they hit all three of our goals [in treating these patients]: heart remodeling, symptoms, and mortality.”

These drugs are typically given to all patients with systolic dysfunction. “A lot of people believe they should also be used in diastolic dysfunction, but we don't have good data for that yet,” he said.

Adverse effects may include hypotension, azotemia, hyperkalemia, cough, and angioedema. Unanswered questions include whether there is a class effect. “The answer is probably yes,” he said. Also, it is not known whether there is a significant interaction with aspirin. “Most of us are comfortable using both aspirin and ACE inhibitors,” said Dr. Goldberg, also of the University of Pennsylvania.

▸ β-Blockers. These drugs inhibit the adverse effects of the sympathetic system, and they delay and reverse heart remodeling. “The No. 1 way to increase the ejection fraction in patients with heart failure is to actually put them on a β-blocker,” Dr. Goldberg said.

β-Blockers are currently given to all patients with systolic heart failure in the absence of fluid overload. Adverse effects may include hypotension, bradycardia, and worsening heart failure.

The ideal target dose for β-blockers has not been determined. This is one remaining question about this class of drugs. “There is probably not a class effect,” he said. “It appears that the long-acting β-blockers and nonselective β-blockers may have an advantage over the shorter-acting and selective ones.”

▸ Angiotensin II receptor blockers. These drugs block the effect of angiotensin II at the receptor site. They delay heart remodeling and reduce symptoms, and they have been shown to reduce hospitalizations and deaths.

ARBs are currently given to patients who can't tolerate ACE inhibitors—specifically, the side effects of angioedema and cough.

The Valsartan Heart Failure Trial (Val-HeFT) and the Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity (CHARM) trial showed some improvement in the efficacy of ARBs when used with ACE inhibitors. However, patients in the Val-HeFT trial who took ARBs with an ACE inhibitor and a β-blocker had worse outcomes. This association was not found in the CHARM trial.

Adverse effects may include hypotension, azotemia, hyperkalemia, and cough.

Will ARBs ever replace ACE inhibitors? That's a key question about this class of drugs, Dr. Goldberg said.

▸ Digoxin. This drug has no impact on mortality, but it does appear to improve symptoms. Dr. Goldberg cautioned that digoxin carries a high risk of renal insufficiency and an increased risk of drug interactions. “Therefore, we limit the use of digoxin only to patients with symptomatic heart failure,” he said.

He recommends using the lowest possible dose of the drug and maintaining drug levels below 1.0 ng/mL.

A recent study of heart failure patients found that digoxin had no effect on quality of life, compared with placebo, in terms of perceived health, physical functioning, depression, anxiety, anger, and the 6-minute walk test (J. Card. Fail. 2003;9:4–12).

▸ Aldosterone antagonists. Trials of these agents show improved mortality for class IIIB or class IV patients, but not in heart failure patients with less severe disease, Dr. Goldberg said.

The role of these drugs with β-blockers is not well defined, and they are contraindicated if patients are on both an ACE inhibitor and an ARB due to a risk of hyperkalemia.

▸ Nitrates. The Vasodilator-Heart Failure Trial (V-HeFT) demonstrated that nitrates in combination with hydralazine are not as effective as ACE inhibitors, yet they are better than placebo.

The African-American Heart Failure Trial (A-HeFT) showed that nitrates and hydralazine improved mortality when used with ACE inhibitors and β-blockers, but their value when added to traditional therapy is unknown in other racial groups.

SAN DIEGO — It pays to be proactive about preventing diabetes.

Data from a 9-year study of adults enrolled in a large HMO showed that annual health care costs for people with the highest prediabetic glucose levels were about 32% higher than costs for those who had normal blood glucose levels, Gregory A. Nichols, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

“Our data show that the American Diabetes Association's new lower cut point for impaired fasting glucose of 100 mg/dL identifies a set of patients with higher medical costs, greater cardiovascular disease, and more metabolic syndrome than normoglycemic patients,” said Dr. Nichols, of the Kaiser Permanente Center for Health Research, Portland, Ore. From a cost standpoint, he added, “if diabetes prevention can truly be achieved, the attention to and treatment of hyperglycemia at a level earlier than diabetes might be warranted, and maybe the earlier, the better.”

In a study funded by the National Institute of Diabetes and Digestive and Kidney Diseases, Dr. Nichols and his associate, Jonathan B. Brown, Ph.D., identified 28,335 members of Kaiser Permanente Northwest between January 1994 and December 2003 who had at least two fasting plasma glucose levels between 100 and 125 mg/dL but did not have diagnosed diabetes. The researchers matched these subjects with other HMO members of the same age and gender who had fasting plasma glucose levels below 100 mg/dL.

The investigators divided the subjects with elevated fasting glucose into two stages of prediabetes that represented the ADA's 2003 and 1997 cut points for impaired fasting glucose. They defined stage 1 prediabetes as 100–109 mg/dL, which represents the current ADA cut point. Stage 2 prediabetes was defined as 110–125 mg/dL, representing the old ADA cut point.

All subjects were then followed until one of the following events occurred: A subsequent blood test classified them as having a higher stage of prediabetes, they received an oral agent for diabetes indicating diagnosis of the disease, they terminated from the health plan, or they reached the end of the study on Dec. 31, 2003. The duration of follow-up averaged about 4.5 years. Most subjects remained in a single stage of prediabetes, but 3,281 progressed.

The investigators calculated inpatient, outpatient, pharmaceutical, and total costs incurred during subjects' individual observation periods. Dr. Nichols reported that the annual age- and gender-adjusted medical costs were $4,357 for patients with normal blood glucose levels, $4,617 for those with stage 1 prediabetes, and $4,966 for those with stage 2 prediabetes.

When patients who later progressed to impaired levels of fasting glucose or diabetes were removed from the analysis, the cost differences were even more marked. In this analysis, annual costs were only $3,799 for those with normal blood glucose levels, $4,580 for those with stage 1 prediabetes, and $4,960 for those with stage 2 prediabetes. This yielded a 32% difference in cost between those with normal blood glucose levels and those with stage 2 prediabetes.

The investigators also observed a higher prevalence of cardiovascular disease among patients with stages 1 and 2 prediabetes. “In addition, components of the metabolic syndrome—higher blood pressure, lower HDL, higher triglycerides, and higher body mass index—were all associated with increasing glucose stage,” Dr. Nichols said.

SAN DIEGO — It pays to be proactive about preventing diabetes.

Data from a 9-year study of adults enrolled in a large HMO showed that annual health care costs for people with the highest prediabetic glucose levels were about 32% higher than costs for those who had normal blood glucose levels, Gregory A. Nichols, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

“Our data show that the American Diabetes Association's new lower cut point for impaired fasting glucose of 100 mg/dL identifies a set of patients with higher medical costs, greater cardiovascular disease, and more metabolic syndrome than normoglycemic patients,” said Dr. Nichols, of the Kaiser Permanente Center for Health Research, Portland, Ore. From a cost standpoint, he added, “if diabetes prevention can truly be achieved, the attention to and treatment of hyperglycemia at a level earlier than diabetes might be warranted, and maybe the earlier, the better.”

In a study funded by the National Institute of Diabetes and Digestive and Kidney Diseases, Dr. Nichols and his associate, Jonathan B. Brown, Ph.D., identified 28,335 members of Kaiser Permanente Northwest between January 1994 and December 2003 who had at least two fasting plasma glucose levels between 100 and 125 mg/dL but did not have diagnosed diabetes. The researchers matched these subjects with other HMO members of the same age and gender who had fasting plasma glucose levels below 100 mg/dL.

The investigators divided the subjects with elevated fasting glucose into two stages of prediabetes that represented the ADA's 2003 and 1997 cut points for impaired fasting glucose. They defined stage 1 prediabetes as 100–109 mg/dL, which represents the current ADA cut point. Stage 2 prediabetes was defined as 110–125 mg/dL, representing the old ADA cut point.

All subjects were then followed until one of the following events occurred: A subsequent blood test classified them as having a higher stage of prediabetes, they received an oral agent for diabetes indicating diagnosis of the disease, they terminated from the health plan, or they reached the end of the study on Dec. 31, 2003. The duration of follow-up averaged about 4.5 years. Most subjects remained in a single stage of prediabetes, but 3,281 progressed.

The investigators calculated inpatient, outpatient, pharmaceutical, and total costs incurred during subjects' individual observation periods. Dr. Nichols reported that the annual age- and gender-adjusted medical costs were $4,357 for patients with normal blood glucose levels, $4,617 for those with stage 1 prediabetes, and $4,966 for those with stage 2 prediabetes.

When patients who later progressed to impaired levels of fasting glucose or diabetes were removed from the analysis, the cost differences were even more marked. In this analysis, annual costs were only $3,799 for those with normal blood glucose levels, $4,580 for those with stage 1 prediabetes, and $4,960 for those with stage 2 prediabetes. This yielded a 32% difference in cost between those with normal blood glucose levels and those with stage 2 prediabetes.

The investigators also observed a higher prevalence of cardiovascular disease among patients with stages 1 and 2 prediabetes. “In addition, components of the metabolic syndrome—higher blood pressure, lower HDL, higher triglycerides, and higher body mass index—were all associated with increasing glucose stage,” Dr. Nichols said.

SAN DIEGO — It pays to be proactive about preventing diabetes.

Data from a 9-year study of adults enrolled in a large HMO showed that annual health care costs for people with the highest prediabetic glucose levels were about 32% higher than costs for those who had normal blood glucose levels, Gregory A. Nichols, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

“Our data show that the American Diabetes Association's new lower cut point for impaired fasting glucose of 100 mg/dL identifies a set of patients with higher medical costs, greater cardiovascular disease, and more metabolic syndrome than normoglycemic patients,” said Dr. Nichols, of the Kaiser Permanente Center for Health Research, Portland, Ore. From a cost standpoint, he added, “if diabetes prevention can truly be achieved, the attention to and treatment of hyperglycemia at a level earlier than diabetes might be warranted, and maybe the earlier, the better.”

In a study funded by the National Institute of Diabetes and Digestive and Kidney Diseases, Dr. Nichols and his associate, Jonathan B. Brown, Ph.D., identified 28,335 members of Kaiser Permanente Northwest between January 1994 and December 2003 who had at least two fasting plasma glucose levels between 100 and 125 mg/dL but did not have diagnosed diabetes. The researchers matched these subjects with other HMO members of the same age and gender who had fasting plasma glucose levels below 100 mg/dL.

The investigators divided the subjects with elevated fasting glucose into two stages of prediabetes that represented the ADA's 2003 and 1997 cut points for impaired fasting glucose. They defined stage 1 prediabetes as 100–109 mg/dL, which represents the current ADA cut point. Stage 2 prediabetes was defined as 110–125 mg/dL, representing the old ADA cut point.

All subjects were then followed until one of the following events occurred: A subsequent blood test classified them as having a higher stage of prediabetes, they received an oral agent for diabetes indicating diagnosis of the disease, they terminated from the health plan, or they reached the end of the study on Dec. 31, 2003. The duration of follow-up averaged about 4.5 years. Most subjects remained in a single stage of prediabetes, but 3,281 progressed.

The investigators calculated inpatient, outpatient, pharmaceutical, and total costs incurred during subjects' individual observation periods. Dr. Nichols reported that the annual age- and gender-adjusted medical costs were $4,357 for patients with normal blood glucose levels, $4,617 for those with stage 1 prediabetes, and $4,966 for those with stage 2 prediabetes.

When patients who later progressed to impaired levels of fasting glucose or diabetes were removed from the analysis, the cost differences were even more marked. In this analysis, annual costs were only $3,799 for those with normal blood glucose levels, $4,580 for those with stage 1 prediabetes, and $4,960 for those with stage 2 prediabetes. This yielded a 32% difference in cost between those with normal blood glucose levels and those with stage 2 prediabetes.

The investigators also observed a higher prevalence of cardiovascular disease among patients with stages 1 and 2 prediabetes. “In addition, components of the metabolic syndrome—higher blood pressure, lower HDL, higher triglycerides, and higher body mass index—were all associated with increasing glucose stage,” Dr. Nichols said.

SAN DIEGO — An intensive intervention conducted by a nurse case manager and community health worker over 18 months helped reduce visits to the emergency department, and possibly hospitalizations, among urban African Americans with type 2 diabetes, Tiffany Gary, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

“This intervention is designed to test a novel approach to improve diabetes care in urban African Americans,” said Dr. Gary of Johns Hopkins University, Baltimore. “The final results from our 24- and 36-month studies will determine the significance.”

She and her associates randomized 542 African Americans with type 2 diabetes to either an intensive intervention group or a minimal intervention group.

Participants in the minimal intervention group received reminders every 6 months about preventive screenings in the form of mailings and phone calls from a lay health educator with a high school education.

Participants in the intensive intervention group received individualized care from a nurse case manager and a community health worker. The nurse case manager saw the patients in the clinic yearly, Dr. Gary said.

“She used algorithms and intervention action plans that were standardized and evidence based,” she added.

The nurse case manager also provided written feedback to the primary care physicians, as well as verbal feedback, e-mails, and pages as necessary.

The community health workers were high school graduates who were native to the communities of Baltimore. “They saw the participants in their homes and in the community,” Dr. Gary said. “They also implemented standarized algorithms and action plans. However, their focus was to hone in on the family environment and social support.”

Current estimates suggest that the yearly cost of the program is about $608 per patient, but data are still being analyzed.

The study was carried out in six primary care clinics affiliated with a managed care organization in Baltimore. It remains to be seen whether the intervention is cost effective and could be used in other settings and patient populations, Dr. Gary noted.

Participants in both interventions attended a baseline and follow-up interview, where the investigators obtained data on demographics, health care use and behaviors, and clinical characteristics. They also obtained data on diabetes-related emergency department visits and hospitalizations.

At baseline, participants had a mean age of 58 years and most (74%) were female. About one-third (35%) had annual household incomes of less than $7,500 per year, and 33% were married.

More than half (57%) had hemoglobin A_1c levels higher than 7%; 73% had blood pressure readings greater than 130/80 mm Hg, and 77% had HDL cholesterol levels that exceeded 40 mg/dL.

In addition, 39% reported at least one visit to the emergency department within the past year, and 23% reported having a diabetes-related hospitalization within the past year.

At 18 months, no significant differences were seen between the two intervention groups in terms of hemoglobin A_1c levels, blood pressure, or lipids.

However, those who participated in the intensive intervention group had significantly fewer visits to the emergency department, compared with their counterparts in the minimal intervention group, which translated into a rate ratio of 0.78.

A trend toward fewer hospitalizations was also seen among those who participated in the intensive intervention group, compared with their counterparts in the minimal intervention group, but the rate ratio of 0.84 did not reach statistical significance.

SAN DIEGO — An intensive intervention conducted by a nurse case manager and community health worker over 18 months helped reduce visits to the emergency department, and possibly hospitalizations, among urban African Americans with type 2 diabetes, Tiffany Gary, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

“This intervention is designed to test a novel approach to improve diabetes care in urban African Americans,” said Dr. Gary of Johns Hopkins University, Baltimore. “The final results from our 24- and 36-month studies will determine the significance.”

She and her associates randomized 542 African Americans with type 2 diabetes to either an intensive intervention group or a minimal intervention group.

Participants in the minimal intervention group received reminders every 6 months about preventive screenings in the form of mailings and phone calls from a lay health educator with a high school education.

Participants in the intensive intervention group received individualized care from a nurse case manager and a community health worker. The nurse case manager saw the patients in the clinic yearly, Dr. Gary said.

“She used algorithms and intervention action plans that were standardized and evidence based,” she added.

The nurse case manager also provided written feedback to the primary care physicians, as well as verbal feedback, e-mails, and pages as necessary.

The community health workers were high school graduates who were native to the communities of Baltimore. “They saw the participants in their homes and in the community,” Dr. Gary said. “They also implemented standarized algorithms and action plans. However, their focus was to hone in on the family environment and social support.”

Current estimates suggest that the yearly cost of the program is about $608 per patient, but data are still being analyzed.

The study was carried out in six primary care clinics affiliated with a managed care organization in Baltimore. It remains to be seen whether the intervention is cost effective and could be used in other settings and patient populations, Dr. Gary noted.

Participants in both interventions attended a baseline and follow-up interview, where the investigators obtained data on demographics, health care use and behaviors, and clinical characteristics. They also obtained data on diabetes-related emergency department visits and hospitalizations.

At baseline, participants had a mean age of 58 years and most (74%) were female. About one-third (35%) had annual household incomes of less than $7,500 per year, and 33% were married.

More than half (57%) had hemoglobin A_1c levels higher than 7%; 73% had blood pressure readings greater than 130/80 mm Hg, and 77% had HDL cholesterol levels that exceeded 40 mg/dL.

In addition, 39% reported at least one visit to the emergency department within the past year, and 23% reported having a diabetes-related hospitalization within the past year.

At 18 months, no significant differences were seen between the two intervention groups in terms of hemoglobin A_1c levels, blood pressure, or lipids.

However, those who participated in the intensive intervention group had significantly fewer visits to the emergency department, compared with their counterparts in the minimal intervention group, which translated into a rate ratio of 0.78.

A trend toward fewer hospitalizations was also seen among those who participated in the intensive intervention group, compared with their counterparts in the minimal intervention group, but the rate ratio of 0.84 did not reach statistical significance.

SAN DIEGO — An intensive intervention conducted by a nurse case manager and community health worker over 18 months helped reduce visits to the emergency department, and possibly hospitalizations, among urban African Americans with type 2 diabetes, Tiffany Gary, Ph.D., reported at the annual scientific sessions of the American Diabetes Association.

“This intervention is designed to test a novel approach to improve diabetes care in urban African Americans,” said Dr. Gary of Johns Hopkins University, Baltimore. “The final results from our 24- and 36-month studies will determine the significance.”

She and her associates randomized 542 African Americans with type 2 diabetes to either an intensive intervention group or a minimal intervention group.

Participants in the minimal intervention group received reminders every 6 months about preventive screenings in the form of mailings and phone calls from a lay health educator with a high school education.

Participants in the intensive intervention group received individualized care from a nurse case manager and a community health worker. The nurse case manager saw the patients in the clinic yearly, Dr. Gary said.

“She used algorithms and intervention action plans that were standardized and evidence based,” she added.

The nurse case manager also provided written feedback to the primary care physicians, as well as verbal feedback, e-mails, and pages as necessary.

The community health workers were high school graduates who were native to the communities of Baltimore. “They saw the participants in their homes and in the community,” Dr. Gary said. “They also implemented standarized algorithms and action plans. However, their focus was to hone in on the family environment and social support.”

Current estimates suggest that the yearly cost of the program is about $608 per patient, but data are still being analyzed.

The study was carried out in six primary care clinics affiliated with a managed care organization in Baltimore. It remains to be seen whether the intervention is cost effective and could be used in other settings and patient populations, Dr. Gary noted.

Participants in both interventions attended a baseline and follow-up interview, where the investigators obtained data on demographics, health care use and behaviors, and clinical characteristics. They also obtained data on diabetes-related emergency department visits and hospitalizations.

At baseline, participants had a mean age of 58 years and most (74%) were female. About one-third (35%) had annual household incomes of less than $7,500 per year, and 33% were married.

More than half (57%) had hemoglobin A_1c levels higher than 7%; 73% had blood pressure readings greater than 130/80 mm Hg, and 77% had HDL cholesterol levels that exceeded 40 mg/dL.

In addition, 39% reported at least one visit to the emergency department within the past year, and 23% reported having a diabetes-related hospitalization within the past year.

At 18 months, no significant differences were seen between the two intervention groups in terms of hemoglobin A_1c levels, blood pressure, or lipids.

However, those who participated in the intensive intervention group had significantly fewer visits to the emergency department, compared with their counterparts in the minimal intervention group, which translated into a rate ratio of 0.78.

A trend toward fewer hospitalizations was also seen among those who participated in the intensive intervention group, compared with their counterparts in the minimal intervention group, but the rate ratio of 0.84 did not reach statistical significance.

SAN DIEGO — Ruboxistaurin, a specific protein kinase C beta inhibitor, had favorable effects on albuminuria and renal function in patients with diabetic nephropathy, according to results from the first human trial of the drug.

“Ruboxistaurin is a promising novel therapy that may improve upon established therapies for diabetic nephropathy,” Katherine R. Tuttle, M.D., said at the annual scientific sessions of the American Diabetes Association.

A lot of data show “that diabetic nephropathy, even in advanced stages, is potentially reversible. Perhaps this builds that bit of evidence. Large-scale trials should be performed to confirm its effectiveness and safety.”

Developed by Eli Lilly & Co., ruboxistaurin is the first of the specific protein kinase C beta inhibitors being investigated for the treatment of diabetic peripheral neuropathy, diabetic retinopathy, and diabetic nephropathy.

In a year-long multicenter, randomized, double-blind trial funded by Lilly, Dr. Tuttle and her associates randomized 123 subjects to receive ruboxistaurin 32 mg/day or placebo. Study participants who were taking ACE inhibitors, angiotensin receptor blockers, or both remained on the drugs for the entire trial.

Over the course of 12 months, investigators at 17 sites in the United States obtained periodic measurements of the participants' urinary albumin/creatinine ratio (ACR), blood pressure, estimated glomerular filtration rate (GFR), and hemoglobin A_1c levels.

By month 12, the mean ACR had decreased by 24% among subjects in the ruboxistaurin group but had not changed in the placebo group, reported Dr. Tuttle of Providence Medical Research Center and The Heart Institute of Spokane, Washington.

The change in urinary ACR in the ruboxistaurin group appeared as early as 1 month into the study and was maintained over the 12-month trial. The mean estimated GFR declined by a mean of 4.8 mL/min per year in the placebo group but did not change significantly in the ruboxistaurin group.

Blood pressure and hemoglobin A_1c levels did not differ significantly between the two groups over the study period.

The most frequently reported adverse event was hypertension, which required intervention in 8% of subjects in the placebo group, compared with none in the ruboxistaurin group.

Dr. Tuttle, who is a paid consultant to Lilly, noted that it will take “at least several hundred if not more” subjects per treatment arm to confirm the findings in a future trial.

Diabetic nephropathy develops in about 40% of people with type 2 diabetes and is responsible for 40%–50% of incident end-stage renal disease in the United States.

SAN DIEGO — Ruboxistaurin, a specific protein kinase C beta inhibitor, had favorable effects on albuminuria and renal function in patients with diabetic nephropathy, according to results from the first human trial of the drug.

“Ruboxistaurin is a promising novel therapy that may improve upon established therapies for diabetic nephropathy,” Katherine R. Tuttle, M.D., said at the annual scientific sessions of the American Diabetes Association.

A lot of data show “that diabetic nephropathy, even in advanced stages, is potentially reversible. Perhaps this builds that bit of evidence. Large-scale trials should be performed to confirm its effectiveness and safety.”

Developed by Eli Lilly & Co., ruboxistaurin is the first of the specific protein kinase C beta inhibitors being investigated for the treatment of diabetic peripheral neuropathy, diabetic retinopathy, and diabetic nephropathy.

In a year-long multicenter, randomized, double-blind trial funded by Lilly, Dr. Tuttle and her associates randomized 123 subjects to receive ruboxistaurin 32 mg/day or placebo. Study participants who were taking ACE inhibitors, angiotensin receptor blockers, or both remained on the drugs for the entire trial.

Over the course of 12 months, investigators at 17 sites in the United States obtained periodic measurements of the participants' urinary albumin/creatinine ratio (ACR), blood pressure, estimated glomerular filtration rate (GFR), and hemoglobin A_1c levels.

By month 12, the mean ACR had decreased by 24% among subjects in the ruboxistaurin group but had not changed in the placebo group, reported Dr. Tuttle of Providence Medical Research Center and The Heart Institute of Spokane, Washington.

The change in urinary ACR in the ruboxistaurin group appeared as early as 1 month into the study and was maintained over the 12-month trial. The mean estimated GFR declined by a mean of 4.8 mL/min per year in the placebo group but did not change significantly in the ruboxistaurin group.

Blood pressure and hemoglobin A_1c levels did not differ significantly between the two groups over the study period.

The most frequently reported adverse event was hypertension, which required intervention in 8% of subjects in the placebo group, compared with none in the ruboxistaurin group.

Dr. Tuttle, who is a paid consultant to Lilly, noted that it will take “at least several hundred if not more” subjects per treatment arm to confirm the findings in a future trial.

Diabetic nephropathy develops in about 40% of people with type 2 diabetes and is responsible for 40%–50% of incident end-stage renal disease in the United States.

SAN DIEGO — Ruboxistaurin, a specific protein kinase C beta inhibitor, had favorable effects on albuminuria and renal function in patients with diabetic nephropathy, according to results from the first human trial of the drug.

“Ruboxistaurin is a promising novel therapy that may improve upon established therapies for diabetic nephropathy,” Katherine R. Tuttle, M.D., said at the annual scientific sessions of the American Diabetes Association.

A lot of data show “that diabetic nephropathy, even in advanced stages, is potentially reversible. Perhaps this builds that bit of evidence. Large-scale trials should be performed to confirm its effectiveness and safety.”

Developed by Eli Lilly & Co., ruboxistaurin is the first of the specific protein kinase C beta inhibitors being investigated for the treatment of diabetic peripheral neuropathy, diabetic retinopathy, and diabetic nephropathy.

In a year-long multicenter, randomized, double-blind trial funded by Lilly, Dr. Tuttle and her associates randomized 123 subjects to receive ruboxistaurin 32 mg/day or placebo. Study participants who were taking ACE inhibitors, angiotensin receptor blockers, or both remained on the drugs for the entire trial.

Over the course of 12 months, investigators at 17 sites in the United States obtained periodic measurements of the participants' urinary albumin/creatinine ratio (ACR), blood pressure, estimated glomerular filtration rate (GFR), and hemoglobin A_1c levels.

By month 12, the mean ACR had decreased by 24% among subjects in the ruboxistaurin group but had not changed in the placebo group, reported Dr. Tuttle of Providence Medical Research Center and The Heart Institute of Spokane, Washington.

The change in urinary ACR in the ruboxistaurin group appeared as early as 1 month into the study and was maintained over the 12-month trial. The mean estimated GFR declined by a mean of 4.8 mL/min per year in the placebo group but did not change significantly in the ruboxistaurin group.

Blood pressure and hemoglobin A_1c levels did not differ significantly between the two groups over the study period.

The most frequently reported adverse event was hypertension, which required intervention in 8% of subjects in the placebo group, compared with none in the ruboxistaurin group.

Dr. Tuttle, who is a paid consultant to Lilly, noted that it will take “at least several hundred if not more” subjects per treatment arm to confirm the findings in a future trial.

Diabetic nephropathy develops in about 40% of people with type 2 diabetes and is responsible for 40%–50% of incident end-stage renal disease in the United States.

SAN DIEGO — Diabetic peripheral neuropathy was the most common microvascular complication among people with diabetes who underwent a comprehensive annual diabetes assessment, Robyn Anderson reported in a poster session at the annual scientific sessions of the American Diabetes Association.

“We expected to see more retinopathy, but this was a fairly healthy population [of people with diabetes],” said Ms. Anderson, an epidemiologist with the International Diabetes Center, Minneapolis.

“These were people coming in for a 3-hour comprehensive diabetes visit, so we recruited from that pool. They were already very motivated patients, to come in and get help.” She also noted that 84% of the patients had type 2 diabetes, “so if there had been a higher prevalence of type 1, it's possible we may have detected more retinopathy.”

In a study led by Mary L. Johnson, a registered nurse at the center, Ms. Anderson and her associates evaluated 206 patients for microvascular complications during their annual diabetes visit. Their mean age was 57 years, more than half (54%) were female, and their average hemoglobin A_1c level was 7.3%.

The investigators collected data on hemoglobin A_1c, lipids, and microalbuminuria, and they also conducted several screenings including the nonmydriatic retinal photo, nerve conduction tests, the Michigan Neuropathy Screening Instrument (MNSI), the vibration detection threshold (VDT), and Neuropathy Total Symptom Score-6.

They defined diabetic peripheral neuropathy as an MNSI score of greater than 2.0 plus either VDT greater than or equal to the 95th percentile or abnormal nerve conduction. Complete data were available for 166 of the 206 patients.

The investigators identified microvascular complications in 48% of patients.

The 10-g microfilament test identified 16% of patients who screened positive for diabetic peripheral neuropathy, yet about twice as many (31%) met the clinical definition of diabetic peripheral neuropathy. At the same time, symptoms of diabetic peripheral neuropathy were observed in 63% of all patients.

Nephropathy was found in 20% of patients and diabetic retinopathy was identified in 11% of patients.

In their poster, the investigators wrote that the observations “support more extensive and systematic screening for diabetic peripheral neuropathy (including both symptoms and clinical exam) in addition to 10-g microfilament exam in diabetes patients with and without known diabetic microvascular complications.”

Eli Lilly & Co. sponsored the study.

SAN DIEGO — Diabetic peripheral neuropathy was the most common microvascular complication among people with diabetes who underwent a comprehensive annual diabetes assessment, Robyn Anderson reported in a poster session at the annual scientific sessions of the American Diabetes Association.

“We expected to see more retinopathy, but this was a fairly healthy population [of people with diabetes],” said Ms. Anderson, an epidemiologist with the International Diabetes Center, Minneapolis.

“These were people coming in for a 3-hour comprehensive diabetes visit, so we recruited from that pool. They were already very motivated patients, to come in and get help.” She also noted that 84% of the patients had type 2 diabetes, “so if there had been a higher prevalence of type 1, it's possible we may have detected more retinopathy.”

In a study led by Mary L. Johnson, a registered nurse at the center, Ms. Anderson and her associates evaluated 206 patients for microvascular complications during their annual diabetes visit. Their mean age was 57 years, more than half (54%) were female, and their average hemoglobin A_1c level was 7.3%.

The investigators collected data on hemoglobin A_1c, lipids, and microalbuminuria, and they also conducted several screenings including the nonmydriatic retinal photo, nerve conduction tests, the Michigan Neuropathy Screening Instrument (MNSI), the vibration detection threshold (VDT), and Neuropathy Total Symptom Score-6.

They defined diabetic peripheral neuropathy as an MNSI score of greater than 2.0 plus either VDT greater than or equal to the 95th percentile or abnormal nerve conduction. Complete data were available for 166 of the 206 patients.

The investigators identified microvascular complications in 48% of patients.

The 10-g microfilament test identified 16% of patients who screened positive for diabetic peripheral neuropathy, yet about twice as many (31%) met the clinical definition of diabetic peripheral neuropathy. At the same time, symptoms of diabetic peripheral neuropathy were observed in 63% of all patients.

Nephropathy was found in 20% of patients and diabetic retinopathy was identified in 11% of patients.

In their poster, the investigators wrote that the observations “support more extensive and systematic screening for diabetic peripheral neuropathy (including both symptoms and clinical exam) in addition to 10-g microfilament exam in diabetes patients with and without known diabetic microvascular complications.”

Eli Lilly & Co. sponsored the study.

SAN DIEGO — Diabetic peripheral neuropathy was the most common microvascular complication among people with diabetes who underwent a comprehensive annual diabetes assessment, Robyn Anderson reported in a poster session at the annual scientific sessions of the American Diabetes Association.

“We expected to see more retinopathy, but this was a fairly healthy population [of people with diabetes],” said Ms. Anderson, an epidemiologist with the International Diabetes Center, Minneapolis.

“These were people coming in for a 3-hour comprehensive diabetes visit, so we recruited from that pool. They were already very motivated patients, to come in and get help.” She also noted that 84% of the patients had type 2 diabetes, “so if there had been a higher prevalence of type 1, it's possible we may have detected more retinopathy.”

In a study led by Mary L. Johnson, a registered nurse at the center, Ms. Anderson and her associates evaluated 206 patients for microvascular complications during their annual diabetes visit. Their mean age was 57 years, more than half (54%) were female, and their average hemoglobin A_1c level was 7.3%.

The investigators collected data on hemoglobin A_1c, lipids, and microalbuminuria, and they also conducted several screenings including the nonmydriatic retinal photo, nerve conduction tests, the Michigan Neuropathy Screening Instrument (MNSI), the vibration detection threshold (VDT), and Neuropathy Total Symptom Score-6.

They defined diabetic peripheral neuropathy as an MNSI score of greater than 2.0 plus either VDT greater than or equal to the 95th percentile or abnormal nerve conduction. Complete data were available for 166 of the 206 patients.

The investigators identified microvascular complications in 48% of patients.

The 10-g microfilament test identified 16% of patients who screened positive for diabetic peripheral neuropathy, yet about twice as many (31%) met the clinical definition of diabetic peripheral neuropathy. At the same time, symptoms of diabetic peripheral neuropathy were observed in 63% of all patients.

Nephropathy was found in 20% of patients and diabetic retinopathy was identified in 11% of patients.

In their poster, the investigators wrote that the observations “support more extensive and systematic screening for diabetic peripheral neuropathy (including both symptoms and clinical exam) in addition to 10-g microfilament exam in diabetes patients with and without known diabetic microvascular complications.”

Eli Lilly & Co. sponsored the study.