Miriam E. Tucker

ST. LOUIS — Convincing your diabetic patients to stop consuming caffeine could significantly reduce their postprandial glucose levels and possibly improve their overall metabolic control, Richard S. Surwit, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

It has long been known that caffeine increases blood pressure, heart rate, and levels of stress (also known as “counterregulatory”) hormones, which in turn are associated with reduced insulin sensitivity. In two placebo-controlled studies designed to look specifically at the impact of oral caffeine on carbohydrate metabolism in regular coffee drinkers with type 2 diabetes, Dr. Surwit and his associates at Duke University, Durham, N.C., have shown that although caffeine does not appear to affect fasting blood glucose levels, it has a major impact on both 2-hour postprandial glucose values and insulin levels. The lead author of both studies was James D. Lane, Ph.D., professor of medical psychology at Duke.

Indeed, the magnitude of the effect is in the range of glucose-lowering medications that are taken before meals, such as nateglinide and acarbose, said Dr. Surwit, professor and chief of the division of medical psychology, and vice chairman of the department of psychiatry and behavioral sciences at Duke.

“If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free. … You can't get that effect without spending a few dollars a day for a pill. Here, you're getting it without adding anything to their regimen, just taking something away,” he remarked.

In the first study, 14 habitual coffee drinkers with type 2 diabetes were given gelatin capsules of either 125 mg of anhydrous caffeine plus dextrose filler or the filler alone on 2 days within a 2-week period. After fasting blood was drawn, they ingested 250 mg of caffeine or placebo in two capsules with water, and another fasting blood sample was taken an hour later. The patients then consumed a liquid meal containing 75 g of carbohydrates (Boost), and additional blood samples were taken at 1 and 2 hours after the meal (Diabetes Care 2004;27:2047–8).

Caffeine did not affect the fasting levels of plasma glucose or insulin, compared with placebo. After the liquid meal, however, glucose levels were 21% higher and insulin levels were 48% higher when the patients had consumed caffeine before the meal, compared with when they hadn't.

The second study was designed to overcome the first study's limitation of using caffeine-containing capsules rather than real coffee or tea, both of which contain numerous organic compounds that might independently affect glucose tolerance positively or negatively. This time, another group of 20 patients with type 2 diabetes who were also regular coffee drinkers were given decaffeinated coffee with or without 250 mg of anhydrous caffeine dissolved into it, roughly equivalent to a 16-ounce mug of regular brewed coffee. This method allowed for precise control of caffeine content and equivalence of other chemical compounds present in coffee—such as magnesium and roasted quinides—that might influence blood sugar levels, said Dr. Surwit, who is also co-director of Duke's Behavioral Endocrinology Clinic.

Again, there was a significant postprandial effect: The mean glucose value following caffeine consumption was 28% higher than it was without caffeine, and the mean insulin values were 19% higher than they were without caffeine (Endocr. Pract. 2007;13:239–43).

Getting patients to quit drinking caffeine may be tricky, but it's not impossible. “It doesn't take more than 3 or 4 days to get people completely off caffeine,” he said.

Dr. Surwit is the author of “The Mind-Body Diabetes Revolution,” which teaches patients methods of reducing stress hormone levels to obtain better glucose control. Information is available at www.richardsurwit.com

'If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free.' DR. SURWIT

ST. LOUIS — Convincing your diabetic patients to stop consuming caffeine could significantly reduce their postprandial glucose levels and possibly improve their overall metabolic control, Richard S. Surwit, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

It has long been known that caffeine increases blood pressure, heart rate, and levels of stress (also known as “counterregulatory”) hormones, which in turn are associated with reduced insulin sensitivity. In two placebo-controlled studies designed to look specifically at the impact of oral caffeine on carbohydrate metabolism in regular coffee drinkers with type 2 diabetes, Dr. Surwit and his associates at Duke University, Durham, N.C., have shown that although caffeine does not appear to affect fasting blood glucose levels, it has a major impact on both 2-hour postprandial glucose values and insulin levels. The lead author of both studies was James D. Lane, Ph.D., professor of medical psychology at Duke.

Indeed, the magnitude of the effect is in the range of glucose-lowering medications that are taken before meals, such as nateglinide and acarbose, said Dr. Surwit, professor and chief of the division of medical psychology, and vice chairman of the department of psychiatry and behavioral sciences at Duke.

“If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free. … You can't get that effect without spending a few dollars a day for a pill. Here, you're getting it without adding anything to their regimen, just taking something away,” he remarked.

In the first study, 14 habitual coffee drinkers with type 2 diabetes were given gelatin capsules of either 125 mg of anhydrous caffeine plus dextrose filler or the filler alone on 2 days within a 2-week period. After fasting blood was drawn, they ingested 250 mg of caffeine or placebo in two capsules with water, and another fasting blood sample was taken an hour later. The patients then consumed a liquid meal containing 75 g of carbohydrates (Boost), and additional blood samples were taken at 1 and 2 hours after the meal (Diabetes Care 2004;27:2047–8).

Caffeine did not affect the fasting levels of plasma glucose or insulin, compared with placebo. After the liquid meal, however, glucose levels were 21% higher and insulin levels were 48% higher when the patients had consumed caffeine before the meal, compared with when they hadn't.

The second study was designed to overcome the first study's limitation of using caffeine-containing capsules rather than real coffee or tea, both of which contain numerous organic compounds that might independently affect glucose tolerance positively or negatively. This time, another group of 20 patients with type 2 diabetes who were also regular coffee drinkers were given decaffeinated coffee with or without 250 mg of anhydrous caffeine dissolved into it, roughly equivalent to a 16-ounce mug of regular brewed coffee. This method allowed for precise control of caffeine content and equivalence of other chemical compounds present in coffee—such as magnesium and roasted quinides—that might influence blood sugar levels, said Dr. Surwit, who is also co-director of Duke's Behavioral Endocrinology Clinic.

Again, there was a significant postprandial effect: The mean glucose value following caffeine consumption was 28% higher than it was without caffeine, and the mean insulin values were 19% higher than they were without caffeine (Endocr. Pract. 2007;13:239–43).

Getting patients to quit drinking caffeine may be tricky, but it's not impossible. “It doesn't take more than 3 or 4 days to get people completely off caffeine,” he said.

Dr. Surwit is the author of “The Mind-Body Diabetes Revolution,” which teaches patients methods of reducing stress hormone levels to obtain better glucose control. Information is available at www.richardsurwit.com

'If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free.' DR. SURWIT

ST. LOUIS — Convincing your diabetic patients to stop consuming caffeine could significantly reduce their postprandial glucose levels and possibly improve their overall metabolic control, Richard S. Surwit, Ph.D., said at the annual meeting of the American Association of Diabetes Educators.

It has long been known that caffeine increases blood pressure, heart rate, and levels of stress (also known as “counterregulatory”) hormones, which in turn are associated with reduced insulin sensitivity. In two placebo-controlled studies designed to look specifically at the impact of oral caffeine on carbohydrate metabolism in regular coffee drinkers with type 2 diabetes, Dr. Surwit and his associates at Duke University, Durham, N.C., have shown that although caffeine does not appear to affect fasting blood glucose levels, it has a major impact on both 2-hour postprandial glucose values and insulin levels. The lead author of both studies was James D. Lane, Ph.D., professor of medical psychology at Duke.

Indeed, the magnitude of the effect is in the range of glucose-lowering medications that are taken before meals, such as nateglinide and acarbose, said Dr. Surwit, professor and chief of the division of medical psychology, and vice chairman of the department of psychiatry and behavioral sciences at Duke.

“If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free. … You can't get that effect without spending a few dollars a day for a pill. Here, you're getting it without adding anything to their regimen, just taking something away,” he remarked.

In the first study, 14 habitual coffee drinkers with type 2 diabetes were given gelatin capsules of either 125 mg of anhydrous caffeine plus dextrose filler or the filler alone on 2 days within a 2-week period. After fasting blood was drawn, they ingested 250 mg of caffeine or placebo in two capsules with water, and another fasting blood sample was taken an hour later. The patients then consumed a liquid meal containing 75 g of carbohydrates (Boost), and additional blood samples were taken at 1 and 2 hours after the meal (Diabetes Care 2004;27:2047–8).

Caffeine did not affect the fasting levels of plasma glucose or insulin, compared with placebo. After the liquid meal, however, glucose levels were 21% higher and insulin levels were 48% higher when the patients had consumed caffeine before the meal, compared with when they hadn't.

The second study was designed to overcome the first study's limitation of using caffeine-containing capsules rather than real coffee or tea, both of which contain numerous organic compounds that might independently affect glucose tolerance positively or negatively. This time, another group of 20 patients with type 2 diabetes who were also regular coffee drinkers were given decaffeinated coffee with or without 250 mg of anhydrous caffeine dissolved into it, roughly equivalent to a 16-ounce mug of regular brewed coffee. This method allowed for precise control of caffeine content and equivalence of other chemical compounds present in coffee—such as magnesium and roasted quinides—that might influence blood sugar levels, said Dr. Surwit, who is also co-director of Duke's Behavioral Endocrinology Clinic.

Again, there was a significant postprandial effect: The mean glucose value following caffeine consumption was 28% higher than it was without caffeine, and the mean insulin values were 19% higher than they were without caffeine (Endocr. Pract. 2007;13:239–43).

Getting patients to quit drinking caffeine may be tricky, but it's not impossible. “It doesn't take more than 3 or 4 days to get people completely off caffeine,” he said.

Dr. Surwit is the author of “The Mind-Body Diabetes Revolution,” which teaches patients methods of reducing stress hormone levels to obtain better glucose control. Information is available at www.richardsurwit.com

'If you get your patients off caffeine, you can have a 20% improvement in postprandial glucose, for free.' DR. SURWIT

PITTSBURGH — Misdiagnosis of bipolar disorder in the postpartum period may be quite common, Dr. Verinder Sharma and his associates said in a poster presentation at the Seventh International Conference on Bipolar Disorder.

Among 56 women consecutively referred for evaluation of postpartum depression, structured instruments—including the Structured Clinical Interview for DSM-IV—revealed that more than half actually had bipolar disorder. Of those 30 women, 13 had bipolar I disorder, 1 had bipolar II disorder, and 16 had bipolar disorder not otherwise specified, reported Dr. Sharma, a gynecologic psychiatrist at Regional Mental Health Care, London, Ont.

“When people think about postpartum [mental] disorders, they're thinking about the blues, about depression, or psychosis. How many are thinking about postpartum hypomania? There isn't the awareness,” he said in an interview at the meeting, sponsored by the University of Pittsburgh.

Misdiagnosis of bipolar disorder as unipolar depression is a well-documented phenomenon in the psychiatric literature, and a couple of studies have now shown that episodes of hypomania occur in approximately 15% of all postpartum women. Indeed, among women at increased genetic risk, the combination of hormonal changes and sleep deprivation can serve as triggers for a hypomanic or manic episode. “There is no time in a woman's life when the risk of a hypomanic episode is [as] high as the postpartum period,” Dr. Sharma remarked.

Clinically, it may be difficult to distinguish normal feelings of elation from those of abnormal mood elevation. Women should be asked if they have felt as if their minds were racing, whether they have increased energy and increased levels of goal-directed activity—cleaning the house, for example—despite a lack of sleep, or if they have been spending more money than usual.

Anecdotally, Dr. Sharma said, some patients have confided to him about having intense sexual desire during these episodes. “We don't typically elicit these symptoms, but I think they are there,” he commented.

The Mood Disorder Questionnaire has not been validated for the postpartum period, but it can be a valuable assessment tool. There is a caveat: The DSM-IV requires a distinct 4-day period of persistently elevated, expansive, or irritable mood among the diagnostic criteria for hypomania, but in Dr. Sharma's experience those periods tend to be shorter among postpartum women.

“In actual clinical practice, around 2 days is what I'm seeing,” he explained.

It is important to ask women about a family history of mood disorders, particularly of depression, mania, or psychosis. A positive family history for bipolar disorder or psychosis places a woman at extremely high risk for bipolarity during the postpartum period.

Dr. Sharma's study also revealed that bipolarity is not the only psychiatric problem that tends to be missed among postpartum women: Comorbid anxiety disorder also was found in 16 of the 30 women with bipolar disorder (53%) and in 11 of the 26 women (42%) with major depressive disorder. And, while none of the women were found to have current substance abuse problems, a lifetime history of substance abuse disorder was found in five patients in the bipolar group (16%) and four of the unipolar depressed patients (15%).

“[Postpartum] women should also be screened for anxiety disorders and substance use disorders,” Dr. Sharma said.

PITTSBURGH — Misdiagnosis of bipolar disorder in the postpartum period may be quite common, Dr. Verinder Sharma and his associates said in a poster presentation at the Seventh International Conference on Bipolar Disorder.

Among 56 women consecutively referred for evaluation of postpartum depression, structured instruments—including the Structured Clinical Interview for DSM-IV—revealed that more than half actually had bipolar disorder. Of those 30 women, 13 had bipolar I disorder, 1 had bipolar II disorder, and 16 had bipolar disorder not otherwise specified, reported Dr. Sharma, a gynecologic psychiatrist at Regional Mental Health Care, London, Ont.

“When people think about postpartum [mental] disorders, they're thinking about the blues, about depression, or psychosis. How many are thinking about postpartum hypomania? There isn't the awareness,” he said in an interview at the meeting, sponsored by the University of Pittsburgh.

Misdiagnosis of bipolar disorder as unipolar depression is a well-documented phenomenon in the psychiatric literature, and a couple of studies have now shown that episodes of hypomania occur in approximately 15% of all postpartum women. Indeed, among women at increased genetic risk, the combination of hormonal changes and sleep deprivation can serve as triggers for a hypomanic or manic episode. “There is no time in a woman's life when the risk of a hypomanic episode is [as] high as the postpartum period,” Dr. Sharma remarked.

Clinically, it may be difficult to distinguish normal feelings of elation from those of abnormal mood elevation. Women should be asked if they have felt as if their minds were racing, whether they have increased energy and increased levels of goal-directed activity—cleaning the house, for example—despite a lack of sleep, or if they have been spending more money than usual.

Anecdotally, Dr. Sharma said, some patients have confided to him about having intense sexual desire during these episodes. “We don't typically elicit these symptoms, but I think they are there,” he commented.

The Mood Disorder Questionnaire has not been validated for the postpartum period, but it can be a valuable assessment tool. There is a caveat: The DSM-IV requires a distinct 4-day period of persistently elevated, expansive, or irritable mood among the diagnostic criteria for hypomania, but in Dr. Sharma's experience those periods tend to be shorter among postpartum women.

“In actual clinical practice, around 2 days is what I'm seeing,” he explained.

It is important to ask women about a family history of mood disorders, particularly of depression, mania, or psychosis. A positive family history for bipolar disorder or psychosis places a woman at extremely high risk for bipolarity during the postpartum period.

Dr. Sharma's study also revealed that bipolarity is not the only psychiatric problem that tends to be missed among postpartum women: Comorbid anxiety disorder also was found in 16 of the 30 women with bipolar disorder (53%) and in 11 of the 26 women (42%) with major depressive disorder. And, while none of the women were found to have current substance abuse problems, a lifetime history of substance abuse disorder was found in five patients in the bipolar group (16%) and four of the unipolar depressed patients (15%).

“[Postpartum] women should also be screened for anxiety disorders and substance use disorders,” Dr. Sharma said.

PITTSBURGH — Misdiagnosis of bipolar disorder in the postpartum period may be quite common, Dr. Verinder Sharma and his associates said in a poster presentation at the Seventh International Conference on Bipolar Disorder.

Among 56 women consecutively referred for evaluation of postpartum depression, structured instruments—including the Structured Clinical Interview for DSM-IV—revealed that more than half actually had bipolar disorder. Of those 30 women, 13 had bipolar I disorder, 1 had bipolar II disorder, and 16 had bipolar disorder not otherwise specified, reported Dr. Sharma, a gynecologic psychiatrist at Regional Mental Health Care, London, Ont.

“When people think about postpartum [mental] disorders, they're thinking about the blues, about depression, or psychosis. How many are thinking about postpartum hypomania? There isn't the awareness,” he said in an interview at the meeting, sponsored by the University of Pittsburgh.

Misdiagnosis of bipolar disorder as unipolar depression is a well-documented phenomenon in the psychiatric literature, and a couple of studies have now shown that episodes of hypomania occur in approximately 15% of all postpartum women. Indeed, among women at increased genetic risk, the combination of hormonal changes and sleep deprivation can serve as triggers for a hypomanic or manic episode. “There is no time in a woman's life when the risk of a hypomanic episode is [as] high as the postpartum period,” Dr. Sharma remarked.

Clinically, it may be difficult to distinguish normal feelings of elation from those of abnormal mood elevation. Women should be asked if they have felt as if their minds were racing, whether they have increased energy and increased levels of goal-directed activity—cleaning the house, for example—despite a lack of sleep, or if they have been spending more money than usual.

Anecdotally, Dr. Sharma said, some patients have confided to him about having intense sexual desire during these episodes. “We don't typically elicit these symptoms, but I think they are there,” he commented.

The Mood Disorder Questionnaire has not been validated for the postpartum period, but it can be a valuable assessment tool. There is a caveat: The DSM-IV requires a distinct 4-day period of persistently elevated, expansive, or irritable mood among the diagnostic criteria for hypomania, but in Dr. Sharma's experience those periods tend to be shorter among postpartum women.

“In actual clinical practice, around 2 days is what I'm seeing,” he explained.

It is important to ask women about a family history of mood disorders, particularly of depression, mania, or psychosis. A positive family history for bipolar disorder or psychosis places a woman at extremely high risk for bipolarity during the postpartum period.

Dr. Sharma's study also revealed that bipolarity is not the only psychiatric problem that tends to be missed among postpartum women: Comorbid anxiety disorder also was found in 16 of the 30 women with bipolar disorder (53%) and in 11 of the 26 women (42%) with major depressive disorder. And, while none of the women were found to have current substance abuse problems, a lifetime history of substance abuse disorder was found in five patients in the bipolar group (16%) and four of the unipolar depressed patients (15%).

“[Postpartum] women should also be screened for anxiety disorders and substance use disorders,” Dr. Sharma said.

BALTIMORE — The hepatitis B vaccine does not appear to be associated with an increased risk for rheumatoid arthritis, Dr. Roger P. Baxter and his associates reported at a vaccine research conference sponsored by the National Foundation for Infectious Diseases.

Both acute and chronic arthropathies have been reported in adults vaccinated with the tetanus-diphtheria (Td), hepatitis B (HepB), and measles-mumps-rubella (MMR) vaccines. However, most of the evidence to support or refute a causal relationship between the Td or HepB vaccine and chronic arthritis has come from isolated case reports, uncontrolled observational studies, or studies that lacked sufficient statistical power, said Dr. Baxter, associate director of the Vaccine Study Center at Kaiser Permanente, Oakland, Calif., and his associates.

A case-control analysis designed to overcome the shortcomings of the previous studies included a cohort of continuous enrollees in Northern California Kaiser Permanente's health plan from Jan. 1, 1995, through Dec. 31, 1999, who were aged 15–59 years during Jan. 1, 1997-Dec. 31, 1999.

Individuals who had made clinic visits for rheumatoid arthritis (RA) and other inflammatory conditions prior to their follow-up start date were excluded.

A total of 416 incident cases of RA were identified (based on definitive diagnosis at the time or subsequent assessment by a rheumatologist), and each was matched with three controls based on age and the number of clinic visits made during the year prior to the onset date.

Rates of hepatitis B vaccination among the RA patients were compared with those of controls, with adjustment for sex, age, and exact number of clinic visits. Similar comparisons were made for the tetanus and influenza vaccines.

No statistically significant risk of RA was found for any of the three vaccines. Only 1% of RA patients versus 0.6% of controls had been exposed to the hepatitis B vaccine within 1–90 days of onset of RA symptoms, for an adjusted odds ratio of 1.48.

Within 1–180 days, the percentages were 1.9% with RA versus 0.9% of controls, giving a still insignificant odds ratio of 2.01.

Within 1 year, 2.4% of RA cases and 1.6% of controls had been exposed to the vaccine, again insignificant at 1.42.

In all, only 10 of the 416 RA patients had received the HepB vaccine within 1 year of symptom onset, suggesting that, “If there is an association, these data would imply that hepatitis B vaccine would only contribute to a small minority of cases,” Dr. Baxter and his associates said in their poster.

Results for the other two vaccines were also not significant, with adjusted odds ratios of 0.77–1.06 for tetanus and 0.66–1.11 for influenza.

Health care utilization was higher among those with RA, which was a slight confounder in this study despite the attempt to control for number of visits: Even after adjustment, there was still a significant residual effect for number of visits, with an odds ratio of 1.15.

“Basically, people who get vaccines of all kinds are different from those who don't, and underlying differences may confound the relationship with things like RA. We try to control for these factors by matching and analyses, but still we think there are differences. …

“People who have RA are more likely to be higher utilizers and also more likely to have gotten vaccines than people who don't utilize the system as much,” Dr. Baxter commented in a follow-up interview.

However, he added, although the difference in utilization was statistically significant, it probably wasn't that different clinically.

“We thought initially this was an important confounder. But in the end we found that although they were different, in reality we could adjust for the vast majority of the difference,” he said.

BALTIMORE — The hepatitis B vaccine does not appear to be associated with an increased risk for rheumatoid arthritis, Dr. Roger P. Baxter and his associates reported at a vaccine research conference sponsored by the National Foundation for Infectious Diseases.

Both acute and chronic arthropathies have been reported in adults vaccinated with the tetanus-diphtheria (Td), hepatitis B (HepB), and measles-mumps-rubella (MMR) vaccines. However, most of the evidence to support or refute a causal relationship between the Td or HepB vaccine and chronic arthritis has come from isolated case reports, uncontrolled observational studies, or studies that lacked sufficient statistical power, said Dr. Baxter, associate director of the Vaccine Study Center at Kaiser Permanente, Oakland, Calif., and his associates.

A case-control analysis designed to overcome the shortcomings of the previous studies included a cohort of continuous enrollees in Northern California Kaiser Permanente's health plan from Jan. 1, 1995, through Dec. 31, 1999, who were aged 15–59 years during Jan. 1, 1997-Dec. 31, 1999.

Individuals who had made clinic visits for rheumatoid arthritis (RA) and other inflammatory conditions prior to their follow-up start date were excluded.

A total of 416 incident cases of RA were identified (based on definitive diagnosis at the time or subsequent assessment by a rheumatologist), and each was matched with three controls based on age and the number of clinic visits made during the year prior to the onset date.

Rates of hepatitis B vaccination among the RA patients were compared with those of controls, with adjustment for sex, age, and exact number of clinic visits. Similar comparisons were made for the tetanus and influenza vaccines.

No statistically significant risk of RA was found for any of the three vaccines. Only 1% of RA patients versus 0.6% of controls had been exposed to the hepatitis B vaccine within 1–90 days of onset of RA symptoms, for an adjusted odds ratio of 1.48.

Within 1–180 days, the percentages were 1.9% with RA versus 0.9% of controls, giving a still insignificant odds ratio of 2.01.

Within 1 year, 2.4% of RA cases and 1.6% of controls had been exposed to the vaccine, again insignificant at 1.42.

In all, only 10 of the 416 RA patients had received the HepB vaccine within 1 year of symptom onset, suggesting that, “If there is an association, these data would imply that hepatitis B vaccine would only contribute to a small minority of cases,” Dr. Baxter and his associates said in their poster.

Results for the other two vaccines were also not significant, with adjusted odds ratios of 0.77–1.06 for tetanus and 0.66–1.11 for influenza.

Health care utilization was higher among those with RA, which was a slight confounder in this study despite the attempt to control for number of visits: Even after adjustment, there was still a significant residual effect for number of visits, with an odds ratio of 1.15.

“Basically, people who get vaccines of all kinds are different from those who don't, and underlying differences may confound the relationship with things like RA. We try to control for these factors by matching and analyses, but still we think there are differences. …

“People who have RA are more likely to be higher utilizers and also more likely to have gotten vaccines than people who don't utilize the system as much,” Dr. Baxter commented in a follow-up interview.

However, he added, although the difference in utilization was statistically significant, it probably wasn't that different clinically.

“We thought initially this was an important confounder. But in the end we found that although they were different, in reality we could adjust for the vast majority of the difference,” he said.

BALTIMORE — The hepatitis B vaccine does not appear to be associated with an increased risk for rheumatoid arthritis, Dr. Roger P. Baxter and his associates reported at a vaccine research conference sponsored by the National Foundation for Infectious Diseases.

Both acute and chronic arthropathies have been reported in adults vaccinated with the tetanus-diphtheria (Td), hepatitis B (HepB), and measles-mumps-rubella (MMR) vaccines. However, most of the evidence to support or refute a causal relationship between the Td or HepB vaccine and chronic arthritis has come from isolated case reports, uncontrolled observational studies, or studies that lacked sufficient statistical power, said Dr. Baxter, associate director of the Vaccine Study Center at Kaiser Permanente, Oakland, Calif., and his associates.

A case-control analysis designed to overcome the shortcomings of the previous studies included a cohort of continuous enrollees in Northern California Kaiser Permanente's health plan from Jan. 1, 1995, through Dec. 31, 1999, who were aged 15–59 years during Jan. 1, 1997-Dec. 31, 1999.

Individuals who had made clinic visits for rheumatoid arthritis (RA) and other inflammatory conditions prior to their follow-up start date were excluded.

A total of 416 incident cases of RA were identified (based on definitive diagnosis at the time or subsequent assessment by a rheumatologist), and each was matched with three controls based on age and the number of clinic visits made during the year prior to the onset date.

Rates of hepatitis B vaccination among the RA patients were compared with those of controls, with adjustment for sex, age, and exact number of clinic visits. Similar comparisons were made for the tetanus and influenza vaccines.

No statistically significant risk of RA was found for any of the three vaccines. Only 1% of RA patients versus 0.6% of controls had been exposed to the hepatitis B vaccine within 1–90 days of onset of RA symptoms, for an adjusted odds ratio of 1.48.

Within 1–180 days, the percentages were 1.9% with RA versus 0.9% of controls, giving a still insignificant odds ratio of 2.01.

Within 1 year, 2.4% of RA cases and 1.6% of controls had been exposed to the vaccine, again insignificant at 1.42.

In all, only 10 of the 416 RA patients had received the HepB vaccine within 1 year of symptom onset, suggesting that, “If there is an association, these data would imply that hepatitis B vaccine would only contribute to a small minority of cases,” Dr. Baxter and his associates said in their poster.

Results for the other two vaccines were also not significant, with adjusted odds ratios of 0.77–1.06 for tetanus and 0.66–1.11 for influenza.

Health care utilization was higher among those with RA, which was a slight confounder in this study despite the attempt to control for number of visits: Even after adjustment, there was still a significant residual effect for number of visits, with an odds ratio of 1.15.

“Basically, people who get vaccines of all kinds are different from those who don't, and underlying differences may confound the relationship with things like RA. We try to control for these factors by matching and analyses, but still we think there are differences. …

“People who have RA are more likely to be higher utilizers and also more likely to have gotten vaccines than people who don't utilize the system as much,” Dr. Baxter commented in a follow-up interview.

However, he added, although the difference in utilization was statistically significant, it probably wasn't that different clinically.

“We thought initially this was an important confounder. But in the end we found that although they were different, in reality we could adjust for the vast majority of the difference,” he said.

BALTIMORE — Inflammation appears to underlie the increased risk for insulin resistance, metabolic syndrome, and cardiovascular morbidity in patients with rheumatoid arthritis, Dr. Joan M. Bathon said at a conference on rheumatic diseases sponsored by the Johns Hopkins University.

In addition to tightly controlling inflammation in RA patients, she advised physicians to “think about insulin resistance and metabolic syndrome in your patients with RA, and encourage them to lose weight, exercise, and eat less. This may also reduce insulin resistance.”

Cardiovascular disease (CVD) is the largest contributor to the 1.28- to 3-fold increase in the Standardized Mortality Ratio in patients with RA, and to their 5- to 10-year reduced life span. Although overt CVD risk factors such as hypertension, diabetes, hypercholesterolemia, and body mass index do not appear to be elevated in RA patients, there is evidence that more subtle but nonetheless risky factors associated with CVD are increased in RA patients, particularly insulin resistance.

Inflammation and obesity both predispose to insulin resistance, and insulin resistance in turn is a potent risk factor for myocardial infarctions and stroke, she said.

Data suggest that RA patients have an increased prevalence of insulin resistance even in the absence of diabetes, more proatherogenic lipid profiles including reduced levels of HDL cholesterol, an increased percentage of body fat even in the absence of overall obesity, and higher rates of the metabolic syndrome, an inflammatory condition in the general population.

“Are CV risk factors more prevalent in RA patients? Not by clinical definitions. But, using some of these alternative definitions, the answer is yes,” said Dr. Bathon, professor of medicine and director of the arthritis center at Johns Hopkins University, Baltimore.

Aside from systemic inflammation, factors such as drug toxicity also may contribute to the increased CVD risk in RA patients: Steroids are atherogenic, cyclo- oxygenase 2 inhibitors cause thrombosis, methotrexate is associated with hyperhomocysteinemia, and anti-tumor necrosis factor agents can cause congestive heart failure. RA might also be associated with increased thrombotic tendency, and patients with the disease often are less active, leading to cardiac deconditioning.

Current theory is that inflammatory cytokines such as tumor necrosis factor (TNF) and interleukin-6 (IL-6) explain the increased risk of CVD in RA patients. Both can induce insulin resistance—thus, inflammation could promote atherosclerosis, in part through its link with atherogenic metabolic pathways. Studies researching treatment with a TNF inhibitor, which temporarily or partially improves insulin resistance, dyslipidemia, and endothelial dysfunction, also support the theory, Dr. Bathon said.

Abdominal, and especially visceral, obesity also is linked to insulin resistance. Visceral adiposity, as opposed to subcutaneous fat, is thought to increase the proinflammatory milieu via the same cytokines, also leading to endothelial dysfunction, insulin resistance, and atherosclerosis.

Dr. Bathon and her associates at the university analyzed the body composition of 84 RA patients (58 men, 26 women) using total body dual-energy x-ray absorptiometry scanning. The group had a mean age of 61 years, and 89% of patients were white. About one-third each were classified as normal weight, overweight, and obese.

In the women, body fat percentage (BFP) was about 15% greater than that predicted from norms for age, race, and gender, a statistically significant increase. The mean increase in BFP was comparable across BMI strata. This increase was confirmed more recently in studies comparing RA patients with contemporaneous matched controls. In men with RA, however, BFP was not significantly greater than in controls.

“Women with RA classified as 'normal weight' have proportionally similar increases in BFP as those classified as overweight or obese, suggesting that RA patients may be at greater risk for disorders associated with increased adiposity than would be expected by their BMI values alone,” Dr. Bathon noted.

Inflammation and increased fat mass may work together to promote insulin resistance and CVD in RApatients, so a coordinated program to reduce inflammation and control weight will likely be the most successful approach to reducing the prevalence of insulin resistance, she said.

BALTIMORE — Inflammation appears to underlie the increased risk for insulin resistance, metabolic syndrome, and cardiovascular morbidity in patients with rheumatoid arthritis, Dr. Joan M. Bathon said at a conference on rheumatic diseases sponsored by the Johns Hopkins University.

In addition to tightly controlling inflammation in RA patients, she advised physicians to “think about insulin resistance and metabolic syndrome in your patients with RA, and encourage them to lose weight, exercise, and eat less. This may also reduce insulin resistance.”

Cardiovascular disease (CVD) is the largest contributor to the 1.28- to 3-fold increase in the Standardized Mortality Ratio in patients with RA, and to their 5- to 10-year reduced life span. Although overt CVD risk factors such as hypertension, diabetes, hypercholesterolemia, and body mass index do not appear to be elevated in RA patients, there is evidence that more subtle but nonetheless risky factors associated with CVD are increased in RA patients, particularly insulin resistance.

Inflammation and obesity both predispose to insulin resistance, and insulin resistance in turn is a potent risk factor for myocardial infarctions and stroke, she said.

Data suggest that RA patients have an increased prevalence of insulin resistance even in the absence of diabetes, more proatherogenic lipid profiles including reduced levels of HDL cholesterol, an increased percentage of body fat even in the absence of overall obesity, and higher rates of the metabolic syndrome, an inflammatory condition in the general population.

“Are CV risk factors more prevalent in RA patients? Not by clinical definitions. But, using some of these alternative definitions, the answer is yes,” said Dr. Bathon, professor of medicine and director of the arthritis center at Johns Hopkins University, Baltimore.

Aside from systemic inflammation, factors such as drug toxicity also may contribute to the increased CVD risk in RA patients: Steroids are atherogenic, cyclo- oxygenase 2 inhibitors cause thrombosis, methotrexate is associated with hyperhomocysteinemia, and anti-tumor necrosis factor agents can cause congestive heart failure. RA might also be associated with increased thrombotic tendency, and patients with the disease often are less active, leading to cardiac deconditioning.

Current theory is that inflammatory cytokines such as tumor necrosis factor (TNF) and interleukin-6 (IL-6) explain the increased risk of CVD in RA patients. Both can induce insulin resistance—thus, inflammation could promote atherosclerosis, in part through its link with atherogenic metabolic pathways. Studies researching treatment with a TNF inhibitor, which temporarily or partially improves insulin resistance, dyslipidemia, and endothelial dysfunction, also support the theory, Dr. Bathon said.

Abdominal, and especially visceral, obesity also is linked to insulin resistance. Visceral adiposity, as opposed to subcutaneous fat, is thought to increase the proinflammatory milieu via the same cytokines, also leading to endothelial dysfunction, insulin resistance, and atherosclerosis.

Dr. Bathon and her associates at the university analyzed the body composition of 84 RA patients (58 men, 26 women) using total body dual-energy x-ray absorptiometry scanning. The group had a mean age of 61 years, and 89% of patients were white. About one-third each were classified as normal weight, overweight, and obese.

In the women, body fat percentage (BFP) was about 15% greater than that predicted from norms for age, race, and gender, a statistically significant increase. The mean increase in BFP was comparable across BMI strata. This increase was confirmed more recently in studies comparing RA patients with contemporaneous matched controls. In men with RA, however, BFP was not significantly greater than in controls.

“Women with RA classified as 'normal weight' have proportionally similar increases in BFP as those classified as overweight or obese, suggesting that RA patients may be at greater risk for disorders associated with increased adiposity than would be expected by their BMI values alone,” Dr. Bathon noted.

Inflammation and increased fat mass may work together to promote insulin resistance and CVD in RApatients, so a coordinated program to reduce inflammation and control weight will likely be the most successful approach to reducing the prevalence of insulin resistance, she said.

BALTIMORE — Inflammation appears to underlie the increased risk for insulin resistance, metabolic syndrome, and cardiovascular morbidity in patients with rheumatoid arthritis, Dr. Joan M. Bathon said at a conference on rheumatic diseases sponsored by the Johns Hopkins University.

In addition to tightly controlling inflammation in RA patients, she advised physicians to “think about insulin resistance and metabolic syndrome in your patients with RA, and encourage them to lose weight, exercise, and eat less. This may also reduce insulin resistance.”

Cardiovascular disease (CVD) is the largest contributor to the 1.28- to 3-fold increase in the Standardized Mortality Ratio in patients with RA, and to their 5- to 10-year reduced life span. Although overt CVD risk factors such as hypertension, diabetes, hypercholesterolemia, and body mass index do not appear to be elevated in RA patients, there is evidence that more subtle but nonetheless risky factors associated with CVD are increased in RA patients, particularly insulin resistance.

Inflammation and obesity both predispose to insulin resistance, and insulin resistance in turn is a potent risk factor for myocardial infarctions and stroke, she said.

Data suggest that RA patients have an increased prevalence of insulin resistance even in the absence of diabetes, more proatherogenic lipid profiles including reduced levels of HDL cholesterol, an increased percentage of body fat even in the absence of overall obesity, and higher rates of the metabolic syndrome, an inflammatory condition in the general population.

“Are CV risk factors more prevalent in RA patients? Not by clinical definitions. But, using some of these alternative definitions, the answer is yes,” said Dr. Bathon, professor of medicine and director of the arthritis center at Johns Hopkins University, Baltimore.

Aside from systemic inflammation, factors such as drug toxicity also may contribute to the increased CVD risk in RA patients: Steroids are atherogenic, cyclo- oxygenase 2 inhibitors cause thrombosis, methotrexate is associated with hyperhomocysteinemia, and anti-tumor necrosis factor agents can cause congestive heart failure. RA might also be associated with increased thrombotic tendency, and patients with the disease often are less active, leading to cardiac deconditioning.

Current theory is that inflammatory cytokines such as tumor necrosis factor (TNF) and interleukin-6 (IL-6) explain the increased risk of CVD in RA patients. Both can induce insulin resistance—thus, inflammation could promote atherosclerosis, in part through its link with atherogenic metabolic pathways. Studies researching treatment with a TNF inhibitor, which temporarily or partially improves insulin resistance, dyslipidemia, and endothelial dysfunction, also support the theory, Dr. Bathon said.

Abdominal, and especially visceral, obesity also is linked to insulin resistance. Visceral adiposity, as opposed to subcutaneous fat, is thought to increase the proinflammatory milieu via the same cytokines, also leading to endothelial dysfunction, insulin resistance, and atherosclerosis.

Dr. Bathon and her associates at the university analyzed the body composition of 84 RA patients (58 men, 26 women) using total body dual-energy x-ray absorptiometry scanning. The group had a mean age of 61 years, and 89% of patients were white. About one-third each were classified as normal weight, overweight, and obese.

In the women, body fat percentage (BFP) was about 15% greater than that predicted from norms for age, race, and gender, a statistically significant increase. The mean increase in BFP was comparable across BMI strata. This increase was confirmed more recently in studies comparing RA patients with contemporaneous matched controls. In men with RA, however, BFP was not significantly greater than in controls.

“Women with RA classified as 'normal weight' have proportionally similar increases in BFP as those classified as overweight or obese, suggesting that RA patients may be at greater risk for disorders associated with increased adiposity than would be expected by their BMI values alone,” Dr. Bathon noted.

Inflammation and increased fat mass may work together to promote insulin resistance and CVD in RApatients, so a coordinated program to reduce inflammation and control weight will likely be the most successful approach to reducing the prevalence of insulin resistance, she said.

ST. LOUIS — Teaching type 2 diabetes patients about how to take care of themselves isn't enough; they need to be motivated to follow through, according to results of a survey of 3,867 patients.

Yet discussions with patients remain primarily educational rather than motivational. “There is a huge gap between knowledge and behavior. We, as educators, have to get away from simple knowledge, or we have to target our audiences better,” Debbra D. Bazata, R.D., a certified diabetes educator at St. Luke's South Primary Care, Overland Park, Kan., said in an interview held at the annual meeting of the American Association of Diabetes Educators.

In a poster that was coauthored by Dr. Andrew J Green, who is with an endocrinology practice in Overland Park, the two also advised that “physicians and other health care professionals should negotiate with their patients in setting weight, exercise, and medication goals with specified timelines.”

The survey asked a series of questions related to knowledge, attitudes, and behaviors pertaining to diabetes, exercise, and eating. Respondents had a mean age of 60.2 years; 58% were women, 85% were white, and 64% had at least some college education. Nearly two-thirds (62%) were obese, with a mean body mass index (kg/m

A majority had been advised to change their lifestyle habits, with 56% receiving recommendations to change their diet and 63% being urged to exercise more. And they displayed healthy attitudes, with 87% agreeing that “obesity can aggravate or contribute to the onset of other chronic diseases,” whereas 78% said that they tried to make healthy food choices. Only 17% agreed with the statement “I prefer taking medications for my health problems rather than changing my lifestyle.”

Most respondents were knowledgeable about diabetes, with only 22% agreeing that “type 2 diabetes is not as serious as type 1 diabetes.” They were a high-utilizing group, making an average of 11 total health care visits in the past year. Of those, a mean of 3.8 visits per year were to endocrinologists, and 4.0 were to a nutritionist/dietician/health educator.

They also reported a mean of 17.1 visits per year for rehabilitation/physical therapy, and 8.2 visits for psychiatric care, along with 4.9 visits per year for primary care/general practice, Ms. Bazata and Dr. Green reported.

Yet despite all that knowledge and access to care, only 26% said they exercised regularly and only 21% had performed vigorous activity in the past 7 days. Only 33% followed a prescribed eating plan. And although 70% tried to lose weight, only 34% actually maintained a desired weight.

During the interview, Ms. Bazata acknowledged that these findings can't necessarily be extrapolated to groups other than the predominantly older, white, female population that responded to the survey.

However, “we learned a little about this target audience. They know what to do, they know they should [do it], and they even want to…. But they aren't.”

The questionnaire was part of the 5-year longitudinal Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD), sponsored by AstraZeneca Pharmaceuticals L.P.

ST. LOUIS — Teaching type 2 diabetes patients about how to take care of themselves isn't enough; they need to be motivated to follow through, according to results of a survey of 3,867 patients.

Yet discussions with patients remain primarily educational rather than motivational. “There is a huge gap between knowledge and behavior. We, as educators, have to get away from simple knowledge, or we have to target our audiences better,” Debbra D. Bazata, R.D., a certified diabetes educator at St. Luke's South Primary Care, Overland Park, Kan., said in an interview held at the annual meeting of the American Association of Diabetes Educators.

In a poster that was coauthored by Dr. Andrew J Green, who is with an endocrinology practice in Overland Park, the two also advised that “physicians and other health care professionals should negotiate with their patients in setting weight, exercise, and medication goals with specified timelines.”

The survey asked a series of questions related to knowledge, attitudes, and behaviors pertaining to diabetes, exercise, and eating. Respondents had a mean age of 60.2 years; 58% were women, 85% were white, and 64% had at least some college education. Nearly two-thirds (62%) were obese, with a mean body mass index (kg/m

A majority had been advised to change their lifestyle habits, with 56% receiving recommendations to change their diet and 63% being urged to exercise more. And they displayed healthy attitudes, with 87% agreeing that “obesity can aggravate or contribute to the onset of other chronic diseases,” whereas 78% said that they tried to make healthy food choices. Only 17% agreed with the statement “I prefer taking medications for my health problems rather than changing my lifestyle.”

Most respondents were knowledgeable about diabetes, with only 22% agreeing that “type 2 diabetes is not as serious as type 1 diabetes.” They were a high-utilizing group, making an average of 11 total health care visits in the past year. Of those, a mean of 3.8 visits per year were to endocrinologists, and 4.0 were to a nutritionist/dietician/health educator.

They also reported a mean of 17.1 visits per year for rehabilitation/physical therapy, and 8.2 visits for psychiatric care, along with 4.9 visits per year for primary care/general practice, Ms. Bazata and Dr. Green reported.

Yet despite all that knowledge and access to care, only 26% said they exercised regularly and only 21% had performed vigorous activity in the past 7 days. Only 33% followed a prescribed eating plan. And although 70% tried to lose weight, only 34% actually maintained a desired weight.

During the interview, Ms. Bazata acknowledged that these findings can't necessarily be extrapolated to groups other than the predominantly older, white, female population that responded to the survey.

However, “we learned a little about this target audience. They know what to do, they know they should [do it], and they even want to…. But they aren't.”

The questionnaire was part of the 5-year longitudinal Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD), sponsored by AstraZeneca Pharmaceuticals L.P.

ST. LOUIS — Teaching type 2 diabetes patients about how to take care of themselves isn't enough; they need to be motivated to follow through, according to results of a survey of 3,867 patients.

Yet discussions with patients remain primarily educational rather than motivational. “There is a huge gap between knowledge and behavior. We, as educators, have to get away from simple knowledge, or we have to target our audiences better,” Debbra D. Bazata, R.D., a certified diabetes educator at St. Luke's South Primary Care, Overland Park, Kan., said in an interview held at the annual meeting of the American Association of Diabetes Educators.

In a poster that was coauthored by Dr. Andrew J Green, who is with an endocrinology practice in Overland Park, the two also advised that “physicians and other health care professionals should negotiate with their patients in setting weight, exercise, and medication goals with specified timelines.”

The survey asked a series of questions related to knowledge, attitudes, and behaviors pertaining to diabetes, exercise, and eating. Respondents had a mean age of 60.2 years; 58% were women, 85% were white, and 64% had at least some college education. Nearly two-thirds (62%) were obese, with a mean body mass index (kg/m

A majority had been advised to change their lifestyle habits, with 56% receiving recommendations to change their diet and 63% being urged to exercise more. And they displayed healthy attitudes, with 87% agreeing that “obesity can aggravate or contribute to the onset of other chronic diseases,” whereas 78% said that they tried to make healthy food choices. Only 17% agreed with the statement “I prefer taking medications for my health problems rather than changing my lifestyle.”

Most respondents were knowledgeable about diabetes, with only 22% agreeing that “type 2 diabetes is not as serious as type 1 diabetes.” They were a high-utilizing group, making an average of 11 total health care visits in the past year. Of those, a mean of 3.8 visits per year were to endocrinologists, and 4.0 were to a nutritionist/dietician/health educator.

They also reported a mean of 17.1 visits per year for rehabilitation/physical therapy, and 8.2 visits for psychiatric care, along with 4.9 visits per year for primary care/general practice, Ms. Bazata and Dr. Green reported.

Yet despite all that knowledge and access to care, only 26% said they exercised regularly and only 21% had performed vigorous activity in the past 7 days. Only 33% followed a prescribed eating plan. And although 70% tried to lose weight, only 34% actually maintained a desired weight.

During the interview, Ms. Bazata acknowledged that these findings can't necessarily be extrapolated to groups other than the predominantly older, white, female population that responded to the survey.

However, “we learned a little about this target audience. They know what to do, they know they should [do it], and they even want to…. But they aren't.”

The questionnaire was part of the 5-year longitudinal Study to Help Improve Early Evaluation and Management of Risk Factors Leading to Diabetes (SHIELD), sponsored by AstraZeneca Pharmaceuticals L.P.

ST. LOUIS — Diabetes education programs are struggling to achieve financial viability, according to results from a large national survey of diabetes educators.

In addition, such providers hail from a diverse range of professional backgrounds and practice in as many different types of settings.

The American Association of Diabetes Educators' (AADE) National Practice Survey was launched in 2005 with the aim of laying the groundwork for creating evidence-based practices, Mary M. Austin and Malinda Peeples explained in a joint presentation at the association's annual meeting.

The challenge is to define core elements of successful diabetes education programs and to standardize them in a way that will still allow providers to use their creativity and customize their programs, said Ms. Peeples, a certified diabetes educator and immediate past president of the AADE.

Earlier National Practice Survey (NPS) results have been published (Diabetes Educ. 2007;33:424-33), but the 2007 data, which are currently being analyzed by a health economist, are significant because they are the first to illustrate trends, noted Ms. Austin, who also is a certified diabetes educator and past president of the AADE.

From 2005 to 2007, there was an increase in the number of programs serving multiple locations (38% to 43%, respectively), with a corresponding decrease in the proportion serving a single location (62% to 57%). In 2007, 26% of the programs were serving 2 locations, and 24% were serving more than 10 locations. These findings are not surprising because there have been reimbursement initiatives that encourage programs to serve multiple sites, Ms. Peeples said.

Hospital outpatient settings were the most common venues for delivery of diabetes education (33%), followed by hospital inpatient settings (15%), and physician's offices (12%). Beyond those, there was a range of venues, including health system ambulatory clinics (5%), community education centers (4%), offices run by self-employed/independent educators (3%), and work site health clinics (2%). At least some of the respondents worked in each of the 17 types of settings listed in the survey, and 9% listed their setting as “other.”

Equally diverse was the list of disciplines from which diabetes educators emerge. Registered nurses topped the list at 51%, a significant increase from 45% in 2005. Registered dieticians were second, at 33%, also significantly up from 30% in 2005. Pharmacists dropped from 4% in 2005 to 3% in 2007. Those numbers closely reflect the entire AADE membership, Ms. Peeples said.

But also on the list in small proportions were professionals such as exercise physiologists, social workers, psychologists, and physicians (primary care and endocrinologists). A majority (79%) had earned a CDE credential, whereas only a small percentage (3%) had a board certification in advanced diabetes management. Sixty-two percent worked full-time (66% in 2005) and 37% part-time (34% in 2005).

The programs were divided almost equally among urban, suburban, and rural settings. “This is important when you hear about how rural areas are underserved. … We're already there. We just need to understand better how we can maximize the efforts of educators in some of those areas,” Ms. Peeples said.

Of concern was the fact that most of the programs reported just 4–20 patient visits a week. “We need to get more data on staff/patient ratios. Some educators may be seeing as few as four patients a week. If that's the case, then there's a real challenge to financial viability,” she remarked.

The results highlighted an area for improvement in the proportion of visits for newly diagnosed patients, which remained at about 45% throughout the 3 years since the last survey.

Only half of all patients with diabetes in the United States are currently meeting recommended diabetes management goals. Ms. Peebles suggested that diabetes educators have an opportunity to improve diabetes care by seeing patients on an ongoing basis and not just when they're newly diagnosed. “There may be limits in terms of reimbursement, but these data allow us to talk about these issues,” she said.

Results also showed that payment sources for diabetes education included 29% from Medicare, 18% from managed care (HMO, PPO, or IPA), 16% from private (indemnity) insurance, and 9% from Medicaid.

Of concern was the finding that only about 10% of the 484 program managers reported that their programs were operating at a profit, which was down from 14% in 2005. At the same time, 44% of programs were operating at a loss, compared with 42% in 2005. Also worrisome was that 15% of program managers in 2007 (16% in 2005) said they didn't know whether their programs were making a profit, operating at cost, or losing money.

The survey also tried to correlate profitability with the number of patient visits. The data were not easy to interpret. In general, it seemed that the small proportion of programs (0.3%, or 17) that had more than 5,000 patient visits a year were the most likely to be making a profit, but even then only 18% were doing so. Of programs with 2,001–5,000 patient visits a year, 10% were making a profit; 48% were operating at a loss, Ms. Austin reported.

“We're trying to [determine] whether it's size or number of visits that makes a difference in terms of profitability. Right now we're having a difficult time figuring it all out, but it looks like nobody is really operating at full profit with no loss. Everyone's operating at some loss, but once you get over 5,000 [patients a year], you're losing less than everyone else.”

Another worrisome trend was a slight downturn in the amount of clinical data collected and reported since 2005, with 12% of programs not collecting any outcome measures.

In 2007, the survey was mailed to 10,865 AADE members. The 30% return rate was a significant increase from the 21% of 9,322 members who responded in 2005. Educators from every state in the union responded, with the greatest numbers from Texas, California, New York, Illinois, Ohio, and Florida. Ms. Peeples acknowledged that a limitation of the survey was that it was sent only to AADE members.

Most (92%) of the 2007 respondents reported they are currently “providing, supervising, or coordinating” diabetes patient education. A total of 73% described their role as “diabetes educator,” and 28% described it as “diabetes program manager/director/coordinator.”

The survey consisted of 33 questions on program structure, 7 questions on process (interventions, program services, and activity), and 8 questions pertaining to outcomes. A diabetes education program was defined as “any structured, organized delivery of diabetes education occurring in any practice setting.”

ST. LOUIS — Diabetes education programs are struggling to achieve financial viability, according to results from a large national survey of diabetes educators.

In addition, such providers hail from a diverse range of professional backgrounds and practice in as many different types of settings.

The American Association of Diabetes Educators' (AADE) National Practice Survey was launched in 2005 with the aim of laying the groundwork for creating evidence-based practices, Mary M. Austin and Malinda Peeples explained in a joint presentation at the association's annual meeting.

The challenge is to define core elements of successful diabetes education programs and to standardize them in a way that will still allow providers to use their creativity and customize their programs, said Ms. Peeples, a certified diabetes educator and immediate past president of the AADE.

Earlier National Practice Survey (NPS) results have been published (Diabetes Educ. 2007;33:424-33), but the 2007 data, which are currently being analyzed by a health economist, are significant because they are the first to illustrate trends, noted Ms. Austin, who also is a certified diabetes educator and past president of the AADE.

From 2005 to 2007, there was an increase in the number of programs serving multiple locations (38% to 43%, respectively), with a corresponding decrease in the proportion serving a single location (62% to 57%). In 2007, 26% of the programs were serving 2 locations, and 24% were serving more than 10 locations. These findings are not surprising because there have been reimbursement initiatives that encourage programs to serve multiple sites, Ms. Peeples said.

Hospital outpatient settings were the most common venues for delivery of diabetes education (33%), followed by hospital inpatient settings (15%), and physician's offices (12%). Beyond those, there was a range of venues, including health system ambulatory clinics (5%), community education centers (4%), offices run by self-employed/independent educators (3%), and work site health clinics (2%). At least some of the respondents worked in each of the 17 types of settings listed in the survey, and 9% listed their setting as “other.”

Equally diverse was the list of disciplines from which diabetes educators emerge. Registered nurses topped the list at 51%, a significant increase from 45% in 2005. Registered dieticians were second, at 33%, also significantly up from 30% in 2005. Pharmacists dropped from 4% in 2005 to 3% in 2007. Those numbers closely reflect the entire AADE membership, Ms. Peeples said.

But also on the list in small proportions were professionals such as exercise physiologists, social workers, psychologists, and physicians (primary care and endocrinologists). A majority (79%) had earned a CDE credential, whereas only a small percentage (3%) had a board certification in advanced diabetes management. Sixty-two percent worked full-time (66% in 2005) and 37% part-time (34% in 2005).

The programs were divided almost equally among urban, suburban, and rural settings. “This is important when you hear about how rural areas are underserved. … We're already there. We just need to understand better how we can maximize the efforts of educators in some of those areas,” Ms. Peeples said.

Of concern was the fact that most of the programs reported just 4–20 patient visits a week. “We need to get more data on staff/patient ratios. Some educators may be seeing as few as four patients a week. If that's the case, then there's a real challenge to financial viability,” she remarked.

The results highlighted an area for improvement in the proportion of visits for newly diagnosed patients, which remained at about 45% throughout the 3 years since the last survey.

Only half of all patients with diabetes in the United States are currently meeting recommended diabetes management goals. Ms. Peebles suggested that diabetes educators have an opportunity to improve diabetes care by seeing patients on an ongoing basis and not just when they're newly diagnosed. “There may be limits in terms of reimbursement, but these data allow us to talk about these issues,” she said.

Results also showed that payment sources for diabetes education included 29% from Medicare, 18% from managed care (HMO, PPO, or IPA), 16% from private (indemnity) insurance, and 9% from Medicaid.

Of concern was the finding that only about 10% of the 484 program managers reported that their programs were operating at a profit, which was down from 14% in 2005. At the same time, 44% of programs were operating at a loss, compared with 42% in 2005. Also worrisome was that 15% of program managers in 2007 (16% in 2005) said they didn't know whether their programs were making a profit, operating at cost, or losing money.

The survey also tried to correlate profitability with the number of patient visits. The data were not easy to interpret. In general, it seemed that the small proportion of programs (0.3%, or 17) that had more than 5,000 patient visits a year were the most likely to be making a profit, but even then only 18% were doing so. Of programs with 2,001–5,000 patient visits a year, 10% were making a profit; 48% were operating at a loss, Ms. Austin reported.

“We're trying to [determine] whether it's size or number of visits that makes a difference in terms of profitability. Right now we're having a difficult time figuring it all out, but it looks like nobody is really operating at full profit with no loss. Everyone's operating at some loss, but once you get over 5,000 [patients a year], you're losing less than everyone else.”

Another worrisome trend was a slight downturn in the amount of clinical data collected and reported since 2005, with 12% of programs not collecting any outcome measures.

In 2007, the survey was mailed to 10,865 AADE members. The 30% return rate was a significant increase from the 21% of 9,322 members who responded in 2005. Educators from every state in the union responded, with the greatest numbers from Texas, California, New York, Illinois, Ohio, and Florida. Ms. Peeples acknowledged that a limitation of the survey was that it was sent only to AADE members.

Most (92%) of the 2007 respondents reported they are currently “providing, supervising, or coordinating” diabetes patient education. A total of 73% described their role as “diabetes educator,” and 28% described it as “diabetes program manager/director/coordinator.”

The survey consisted of 33 questions on program structure, 7 questions on process (interventions, program services, and activity), and 8 questions pertaining to outcomes. A diabetes education program was defined as “any structured, organized delivery of diabetes education occurring in any practice setting.”

ST. LOUIS — Diabetes education programs are struggling to achieve financial viability, according to results from a large national survey of diabetes educators.

In addition, such providers hail from a diverse range of professional backgrounds and practice in as many different types of settings.

The American Association of Diabetes Educators' (AADE) National Practice Survey was launched in 2005 with the aim of laying the groundwork for creating evidence-based practices, Mary M. Austin and Malinda Peeples explained in a joint presentation at the association's annual meeting.

The challenge is to define core elements of successful diabetes education programs and to standardize them in a way that will still allow providers to use their creativity and customize their programs, said Ms. Peeples, a certified diabetes educator and immediate past president of the AADE.

Earlier National Practice Survey (NPS) results have been published (Diabetes Educ. 2007;33:424-33), but the 2007 data, which are currently being analyzed by a health economist, are significant because they are the first to illustrate trends, noted Ms. Austin, who also is a certified diabetes educator and past president of the AADE.

From 2005 to 2007, there was an increase in the number of programs serving multiple locations (38% to 43%, respectively), with a corresponding decrease in the proportion serving a single location (62% to 57%). In 2007, 26% of the programs were serving 2 locations, and 24% were serving more than 10 locations. These findings are not surprising because there have been reimbursement initiatives that encourage programs to serve multiple sites, Ms. Peeples said.

Hospital outpatient settings were the most common venues for delivery of diabetes education (33%), followed by hospital inpatient settings (15%), and physician's offices (12%). Beyond those, there was a range of venues, including health system ambulatory clinics (5%), community education centers (4%), offices run by self-employed/independent educators (3%), and work site health clinics (2%). At least some of the respondents worked in each of the 17 types of settings listed in the survey, and 9% listed their setting as “other.”

Equally diverse was the list of disciplines from which diabetes educators emerge. Registered nurses topped the list at 51%, a significant increase from 45% in 2005. Registered dieticians were second, at 33%, also significantly up from 30% in 2005. Pharmacists dropped from 4% in 2005 to 3% in 2007. Those numbers closely reflect the entire AADE membership, Ms. Peeples said.

But also on the list in small proportions were professionals such as exercise physiologists, social workers, psychologists, and physicians (primary care and endocrinologists). A majority (79%) had earned a CDE credential, whereas only a small percentage (3%) had a board certification in advanced diabetes management. Sixty-two percent worked full-time (66% in 2005) and 37% part-time (34% in 2005).

The programs were divided almost equally among urban, suburban, and rural settings. “This is important when you hear about how rural areas are underserved. … We're already there. We just need to understand better how we can maximize the efforts of educators in some of those areas,” Ms. Peeples said.

Of concern was the fact that most of the programs reported just 4–20 patient visits a week. “We need to get more data on staff/patient ratios. Some educators may be seeing as few as four patients a week. If that's the case, then there's a real challenge to financial viability,” she remarked.

The results highlighted an area for improvement in the proportion of visits for newly diagnosed patients, which remained at about 45% throughout the 3 years since the last survey.

Only half of all patients with diabetes in the United States are currently meeting recommended diabetes management goals. Ms. Peebles suggested that diabetes educators have an opportunity to improve diabetes care by seeing patients on an ongoing basis and not just when they're newly diagnosed. “There may be limits in terms of reimbursement, but these data allow us to talk about these issues,” she said.

Results also showed that payment sources for diabetes education included 29% from Medicare, 18% from managed care (HMO, PPO, or IPA), 16% from private (indemnity) insurance, and 9% from Medicaid.

Of concern was the finding that only about 10% of the 484 program managers reported that their programs were operating at a profit, which was down from 14% in 2005. At the same time, 44% of programs were operating at a loss, compared with 42% in 2005. Also worrisome was that 15% of program managers in 2007 (16% in 2005) said they didn't know whether their programs were making a profit, operating at cost, or losing money.

The survey also tried to correlate profitability with the number of patient visits. The data were not easy to interpret. In general, it seemed that the small proportion of programs (0.3%, or 17) that had more than 5,000 patient visits a year were the most likely to be making a profit, but even then only 18% were doing so. Of programs with 2,001–5,000 patient visits a year, 10% were making a profit; 48% were operating at a loss, Ms. Austin reported.

“We're trying to [determine] whether it's size or number of visits that makes a difference in terms of profitability. Right now we're having a difficult time figuring it all out, but it looks like nobody is really operating at full profit with no loss. Everyone's operating at some loss, but once you get over 5,000 [patients a year], you're losing less than everyone else.”

Another worrisome trend was a slight downturn in the amount of clinical data collected and reported since 2005, with 12% of programs not collecting any outcome measures.

In 2007, the survey was mailed to 10,865 AADE members. The 30% return rate was a significant increase from the 21% of 9,322 members who responded in 2005. Educators from every state in the union responded, with the greatest numbers from Texas, California, New York, Illinois, Ohio, and Florida. Ms. Peeples acknowledged that a limitation of the survey was that it was sent only to AADE members.

Most (92%) of the 2007 respondents reported they are currently “providing, supervising, or coordinating” diabetes patient education. A total of 73% described their role as “diabetes educator,” and 28% described it as “diabetes program manager/director/coordinator.”

The survey consisted of 33 questions on program structure, 7 questions on process (interventions, program services, and activity), and 8 questions pertaining to outcomes. A diabetes education program was defined as “any structured, organized delivery of diabetes education occurring in any practice setting.”

CHICAGO — Findings from a recent study suggest that the combined real-time continuous glucose monitor/insulin pump system reduces glycemic variability and improves glucose control in selected insulin pump users with type 1 diabetes, Dr. Irl B. Hirsch reported at the annual scientific sessions of the American Diabetes Association.

A significant finding of the 6-month study was that the benefits of real-time continuous glucose monitoring (RT-CGM) were realized only in patients who wore the sensor device consistently, said Dr. Hirsch, professor of medicine and medical director of the Diabetes Care Center at the University of Washington, Seattle.

In the study, 138 adolescents and adults with poorly controlled type 1 diabetes (defined as having a hemoglobin A_1c of 7.5% or greater) despite 6 months or more of insulin pump therapy were randomized to either wear the combined pump/RT-CGM device (MiniMed Paradigm 722 System) and to perform self-monitoring of blood glucose (SMBG) four or more times a day, or to perform SMBG while wearing the MiniMed pump by itself. All insulin adjustments were based on SMBG values. Clinical staff contacted the patients on a weekly or biweekly basis throughout the study period. The study was funded by Medtronic, maker of the devices.

The group was 90% white, nearly two-thirds female, and had a mean diabetes duration of 18 years. There were 40 adolescents with a mean age of 14 years, and 98 adults with a mean age of 41 years. Mean hemoglobin A_1c (HbA_1c) levels did not differ between the two groups at baseline.

At 13 weeks, mean HbA_1c levels had dropped significantly and to a nearly identical degree in both groups, from 8.4% to 7.8% in the controls and from 8.5% to 7.7% in the CGM group. There were no further significant drops in either group, and by week 26, both groups had a mean HbA_1c of 7.8%. However, the proportion reaching the HbA_1c target of less than 7% was significantly greater in the CGM patients, at 38%, compared with 19% of the controls. Similar results were seen when the adults were analyzed separately.

Among the adolescents, only the CGM group had a significant drop in HbA_1c from baseline, from 8.8% to 8.0% at 26 weeks, with 35% reaching an HbA_1c below 7%, compared with just 9% of controls, said Dr. Hirsch.

Differences in the amount of hypoglycemia—but not hyperglycemia—could help explain why the proportion dropping below 7.0% between the two groups was significantly different, whereas the overall HbA_1c values were not. Although there were no differences in the time and amplitude of exposure (in mg/dL per minute) for hyperglycemia between the two groups, the controls spent significantly more time at glucose levels below 70 mg/dL than did the CGM group (0.8 vs. 0.3 mg/dL per minute), suggesting that they had more glucose variability.

Compliance strongly predicted the results among the CGM patients. With “compliance” defined as wearing the sensor 6 days a week (meaning it was possible to be more than 100% compliant) HbA_1c levels patients with 100% or greater compliance dropped from 8.6% at baseline to 7.7% at 26 weeks. Those with 80%–100% compliance dropped similarly, from 8.4% to 7.7%, as did those with 60%–80% compliance, 8.2% to 7.5%. All of those reductions were significant. However, when compliance dropped below 60%, mean HbA_1c actually rose slightly (but not significantly), from 9.5% to 9.6%. In the teens, only those with 80%–100% compliance had a significant drop in HbA_1c, by 1 percentage point from baseline.

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CHICAGO — Findings from a recent study suggest that the combined real-time continuous glucose monitor/insulin pump system reduces glycemic variability and improves glucose control in selected insulin pump users with type 1 diabetes, Dr. Irl B. Hirsch reported at the annual scientific sessions of the American Diabetes Association.

A significant finding of the 6-month study was that the benefits of real-time continuous glucose monitoring (RT-CGM) were realized only in patients who wore the sensor device consistently, said Dr. Hirsch, professor of medicine and medical director of the Diabetes Care Center at the University of Washington, Seattle.

In the study, 138 adolescents and adults with poorly controlled type 1 diabetes (defined as having a hemoglobin A_1c of 7.5% or greater) despite 6 months or more of insulin pump therapy were randomized to either wear the combined pump/RT-CGM device (MiniMed Paradigm 722 System) and to perform self-monitoring of blood glucose (SMBG) four or more times a day, or to perform SMBG while wearing the MiniMed pump by itself. All insulin adjustments were based on SMBG values. Clinical staff contacted the patients on a weekly or biweekly basis throughout the study period. The study was funded by Medtronic, maker of the devices.

The group was 90% white, nearly two-thirds female, and had a mean diabetes duration of 18 years. There were 40 adolescents with a mean age of 14 years, and 98 adults with a mean age of 41 years. Mean hemoglobin A_1c (HbA_1c) levels did not differ between the two groups at baseline.

At 13 weeks, mean HbA_1c levels had dropped significantly and to a nearly identical degree in both groups, from 8.4% to 7.8% in the controls and from 8.5% to 7.7% in the CGM group. There were no further significant drops in either group, and by week 26, both groups had a mean HbA_1c of 7.8%. However, the proportion reaching the HbA_1c target of less than 7% was significantly greater in the CGM patients, at 38%, compared with 19% of the controls. Similar results were seen when the adults were analyzed separately.

Among the adolescents, only the CGM group had a significant drop in HbA_1c from baseline, from 8.8% to 8.0% at 26 weeks, with 35% reaching an HbA_1c below 7%, compared with just 9% of controls, said Dr. Hirsch.

Differences in the amount of hypoglycemia—but not hyperglycemia—could help explain why the proportion dropping below 7.0% between the two groups was significantly different, whereas the overall HbA_1c values were not. Although there were no differences in the time and amplitude of exposure (in mg/dL per minute) for hyperglycemia between the two groups, the controls spent significantly more time at glucose levels below 70 mg/dL than did the CGM group (0.8 vs. 0.3 mg/dL per minute), suggesting that they had more glucose variability.

Compliance strongly predicted the results among the CGM patients. With “compliance” defined as wearing the sensor 6 days a week (meaning it was possible to be more than 100% compliant) HbA_1c levels patients with 100% or greater compliance dropped from 8.6% at baseline to 7.7% at 26 weeks. Those with 80%–100% compliance dropped similarly, from 8.4% to 7.7%, as did those with 60%–80% compliance, 8.2% to 7.5%. All of those reductions were significant. However, when compliance dropped below 60%, mean HbA_1c actually rose slightly (but not significantly), from 9.5% to 9.6%. In the teens, only those with 80%–100% compliance had a significant drop in HbA_1c, by 1 percentage point from baseline.

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Findings from a recent study suggest that the combined real-time continuous glucose monitor/insulin pump system reduces glycemic variability and improves glucose control in selected insulin pump users with type 1 diabetes, Dr. Irl B. Hirsch reported at the annual scientific sessions of the American Diabetes Association.

A significant finding of the 6-month study was that the benefits of real-time continuous glucose monitoring (RT-CGM) were realized only in patients who wore the sensor device consistently, said Dr. Hirsch, professor of medicine and medical director of the Diabetes Care Center at the University of Washington, Seattle.

In the study, 138 adolescents and adults with poorly controlled type 1 diabetes (defined as having a hemoglobin A_1c of 7.5% or greater) despite 6 months or more of insulin pump therapy were randomized to either wear the combined pump/RT-CGM device (MiniMed Paradigm 722 System) and to perform self-monitoring of blood glucose (SMBG) four or more times a day, or to perform SMBG while wearing the MiniMed pump by itself. All insulin adjustments were based on SMBG values. Clinical staff contacted the patients on a weekly or biweekly basis throughout the study period. The study was funded by Medtronic, maker of the devices.

The group was 90% white, nearly two-thirds female, and had a mean diabetes duration of 18 years. There were 40 adolescents with a mean age of 14 years, and 98 adults with a mean age of 41 years. Mean hemoglobin A_1c (HbA_1c) levels did not differ between the two groups at baseline.

At 13 weeks, mean HbA_1c levels had dropped significantly and to a nearly identical degree in both groups, from 8.4% to 7.8% in the controls and from 8.5% to 7.7% in the CGM group. There were no further significant drops in either group, and by week 26, both groups had a mean HbA_1c of 7.8%. However, the proportion reaching the HbA_1c target of less than 7% was significantly greater in the CGM patients, at 38%, compared with 19% of the controls. Similar results were seen when the adults were analyzed separately.

Among the adolescents, only the CGM group had a significant drop in HbA_1c from baseline, from 8.8% to 8.0% at 26 weeks, with 35% reaching an HbA_1c below 7%, compared with just 9% of controls, said Dr. Hirsch.

Differences in the amount of hypoglycemia—but not hyperglycemia—could help explain why the proportion dropping below 7.0% between the two groups was significantly different, whereas the overall HbA_1c values were not. Although there were no differences in the time and amplitude of exposure (in mg/dL per minute) for hyperglycemia between the two groups, the controls spent significantly more time at glucose levels below 70 mg/dL than did the CGM group (0.8 vs. 0.3 mg/dL per minute), suggesting that they had more glucose variability.

Compliance strongly predicted the results among the CGM patients. With “compliance” defined as wearing the sensor 6 days a week (meaning it was possible to be more than 100% compliant) HbA_1c levels patients with 100% or greater compliance dropped from 8.6% at baseline to 7.7% at 26 weeks. Those with 80%–100% compliance dropped similarly, from 8.4% to 7.7%, as did those with 60%–80% compliance, 8.2% to 7.5%. All of those reductions were significant. However, when compliance dropped below 60%, mean HbA_1c actually rose slightly (but not significantly), from 9.5% to 9.6%. In the teens, only those with 80%–100% compliance had a significant drop in HbA_1c, by 1 percentage point from baseline.

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CHICAGO — Intensive lipid lowering with high-dose atorvastatin significantly reduced the incidence of major cardiovascular events in coronary patients who have both type 2 diabetes and chronic kidney disease, Dr. James Shepherd reported at the annual scientific sessions of the American Diabetes Association.

In a new subanalysis of diabetic patients in the Pfizer-funded Treating to New Targets (TNT) study, “Individuals got greater benefit in relative terms and far greater benefit in absolute terms if they had the combination of diabetes and renal disease, because they had much greater risk to begin with,” said Dr. Shepherd, professor and head of pathological biochemistry at the Royal Infirmary and the University of Glasgow (Scotland).

The main finding of the TNT study of 10,001 patients with stable coronary heart disease was a 22% reduction in the risk of major cardiovascular events with the use of 80 mg of atorvastatin per day relative to 10 mg/day at a median follow-up of 5 years (N. Engl. J. Med. 2005;352:1425–35). A subsequent subanalysis of the 1,501 diabetic patients in that study showed a 25% event reduction with 80 mg versus 10 mg (Diabetes Care 2006;29:1220–6). However, another study of 1,255 patients who had type 2 diabetes and end-stage renal disease (ESRD) and were undergoing hemodialysis showed no cardiovascular benefit of 20 mg of atorvastatin per day, compared with placebo (N. Engl. J. Med. 2005; 353:238–48).

To further investigate the potential role of atorvastatin treatment in patients with both diabetes and kidney disease, Dr. Shepherd and his associates analyzed the TNT outcomes of 1,431 of the diabetic patients in the study for whom renal data were available. There were 546 patients with chronic kidney disease (CKD)—defined as having an estimated glomerular filtration (eGFR) rate of less than 60 mL/min per 1.73 m

At baseline, those with CKD had greater cardiovascular morbidity than those without, including higher systolic blood pressure (136.1 vs. 133.6 mm Hg); a greater proportion had a history of hypertension (76% vs. 67%), as well as higher rates of peripheral vascular disease, coronary bypass grafting, and congestive heart failure. There were also more women in the CKD group (42% vs. 18%). The 80-mg dose of atorvastatin lowered LDL cholesterol equally in both groups, from about 98 mg/dL at baseline to 75 mg/dL at follow-up, Dr. Shepherd reported.

Major cardiovascular events (coronary heart disease death, nonfatal myocardial infarction, resuscitation after cardiac arrest, fatal or nonfatal stroke) occurred in 13.4% of the diabetics with normal GFR and 17.4% of those with both diabetes and CKD. (The rates were 7.8% among those without diabetes or CKD and 10% for the nondiabetics with CKD.) Compared with 10 mg of atorvastatin, the 80-mg dose reduced the relative risk of major cardiovascular events by 35% in the diabetic patients with CKD, compared with just 10% among the diabetics without CKD. “Those with the greatest risk got the greatest benefit from intensive intervention with atorvastatin,” Dr. Shepherd commented.

The drug was well tolerated overall, with no evidence of myopathy. “The high dose of atorvastatin created no penalty with regard to side effects,” he noted.

When asked by an audience member why atorvastatin did not benefit the patients with ESRD in the earlier study, Dr. Shepherd responded, “I think it's a function of the degree of kidney compromise. If you have patients with ESRD on dialysis, you're asking far too much of a drug to reverse that. But you can see a reversal if you have compromise but still-viable glomerular filtration rates.”

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CHICAGO — Intensive lipid lowering with high-dose atorvastatin significantly reduced the incidence of major cardiovascular events in coronary patients who have both type 2 diabetes and chronic kidney disease, Dr. James Shepherd reported at the annual scientific sessions of the American Diabetes Association.

In a new subanalysis of diabetic patients in the Pfizer-funded Treating to New Targets (TNT) study, “Individuals got greater benefit in relative terms and far greater benefit in absolute terms if they had the combination of diabetes and renal disease, because they had much greater risk to begin with,” said Dr. Shepherd, professor and head of pathological biochemistry at the Royal Infirmary and the University of Glasgow (Scotland).

The main finding of the TNT study of 10,001 patients with stable coronary heart disease was a 22% reduction in the risk of major cardiovascular events with the use of 80 mg of atorvastatin per day relative to 10 mg/day at a median follow-up of 5 years (N. Engl. J. Med. 2005;352:1425–35). A subsequent subanalysis of the 1,501 diabetic patients in that study showed a 25% event reduction with 80 mg versus 10 mg (Diabetes Care 2006;29:1220–6). However, another study of 1,255 patients who had type 2 diabetes and end-stage renal disease (ESRD) and were undergoing hemodialysis showed no cardiovascular benefit of 20 mg of atorvastatin per day, compared with placebo (N. Engl. J. Med. 2005; 353:238–48).

To further investigate the potential role of atorvastatin treatment in patients with both diabetes and kidney disease, Dr. Shepherd and his associates analyzed the TNT outcomes of 1,431 of the diabetic patients in the study for whom renal data were available. There were 546 patients with chronic kidney disease (CKD)—defined as having an estimated glomerular filtration (eGFR) rate of less than 60 mL/min per 1.73 m

At baseline, those with CKD had greater cardiovascular morbidity than those without, including higher systolic blood pressure (136.1 vs. 133.6 mm Hg); a greater proportion had a history of hypertension (76% vs. 67%), as well as higher rates of peripheral vascular disease, coronary bypass grafting, and congestive heart failure. There were also more women in the CKD group (42% vs. 18%). The 80-mg dose of atorvastatin lowered LDL cholesterol equally in both groups, from about 98 mg/dL at baseline to 75 mg/dL at follow-up, Dr. Shepherd reported.

Major cardiovascular events (coronary heart disease death, nonfatal myocardial infarction, resuscitation after cardiac arrest, fatal or nonfatal stroke) occurred in 13.4% of the diabetics with normal GFR and 17.4% of those with both diabetes and CKD. (The rates were 7.8% among those without diabetes or CKD and 10% for the nondiabetics with CKD.) Compared with 10 mg of atorvastatin, the 80-mg dose reduced the relative risk of major cardiovascular events by 35% in the diabetic patients with CKD, compared with just 10% among the diabetics without CKD. “Those with the greatest risk got the greatest benefit from intensive intervention with atorvastatin,” Dr. Shepherd commented.

The drug was well tolerated overall, with no evidence of myopathy. “The high dose of atorvastatin created no penalty with regard to side effects,” he noted.

When asked by an audience member why atorvastatin did not benefit the patients with ESRD in the earlier study, Dr. Shepherd responded, “I think it's a function of the degree of kidney compromise. If you have patients with ESRD on dialysis, you're asking far too much of a drug to reverse that. But you can see a reversal if you have compromise but still-viable glomerular filtration rates.”

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Intensive lipid lowering with high-dose atorvastatin significantly reduced the incidence of major cardiovascular events in coronary patients who have both type 2 diabetes and chronic kidney disease, Dr. James Shepherd reported at the annual scientific sessions of the American Diabetes Association.

In a new subanalysis of diabetic patients in the Pfizer-funded Treating to New Targets (TNT) study, “Individuals got greater benefit in relative terms and far greater benefit in absolute terms if they had the combination of diabetes and renal disease, because they had much greater risk to begin with,” said Dr. Shepherd, professor and head of pathological biochemistry at the Royal Infirmary and the University of Glasgow (Scotland).

The main finding of the TNT study of 10,001 patients with stable coronary heart disease was a 22% reduction in the risk of major cardiovascular events with the use of 80 mg of atorvastatin per day relative to 10 mg/day at a median follow-up of 5 years (N. Engl. J. Med. 2005;352:1425–35). A subsequent subanalysis of the 1,501 diabetic patients in that study showed a 25% event reduction with 80 mg versus 10 mg (Diabetes Care 2006;29:1220–6). However, another study of 1,255 patients who had type 2 diabetes and end-stage renal disease (ESRD) and were undergoing hemodialysis showed no cardiovascular benefit of 20 mg of atorvastatin per day, compared with placebo (N. Engl. J. Med. 2005; 353:238–48).

To further investigate the potential role of atorvastatin treatment in patients with both diabetes and kidney disease, Dr. Shepherd and his associates analyzed the TNT outcomes of 1,431 of the diabetic patients in the study for whom renal data were available. There were 546 patients with chronic kidney disease (CKD)—defined as having an estimated glomerular filtration (eGFR) rate of less than 60 mL/min per 1.73 m

At baseline, those with CKD had greater cardiovascular morbidity than those without, including higher systolic blood pressure (136.1 vs. 133.6 mm Hg); a greater proportion had a history of hypertension (76% vs. 67%), as well as higher rates of peripheral vascular disease, coronary bypass grafting, and congestive heart failure. There were also more women in the CKD group (42% vs. 18%). The 80-mg dose of atorvastatin lowered LDL cholesterol equally in both groups, from about 98 mg/dL at baseline to 75 mg/dL at follow-up, Dr. Shepherd reported.

Major cardiovascular events (coronary heart disease death, nonfatal myocardial infarction, resuscitation after cardiac arrest, fatal or nonfatal stroke) occurred in 13.4% of the diabetics with normal GFR and 17.4% of those with both diabetes and CKD. (The rates were 7.8% among those without diabetes or CKD and 10% for the nondiabetics with CKD.) Compared with 10 mg of atorvastatin, the 80-mg dose reduced the relative risk of major cardiovascular events by 35% in the diabetic patients with CKD, compared with just 10% among the diabetics without CKD. “Those with the greatest risk got the greatest benefit from intensive intervention with atorvastatin,” Dr. Shepherd commented.

The drug was well tolerated overall, with no evidence of myopathy. “The high dose of atorvastatin created no penalty with regard to side effects,” he noted.

When asked by an audience member why atorvastatin did not benefit the patients with ESRD in the earlier study, Dr. Shepherd responded, “I think it's a function of the degree of kidney compromise. If you have patients with ESRD on dialysis, you're asking far too much of a drug to reverse that. But you can see a reversal if you have compromise but still-viable glomerular filtration rates.”

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BALTIMORE — A new understanding of the “anemia of inflammation” may help point the way to new treatments in the future, but in the meantime it illustrates why iron supplementation doesn't raise hemoglobin levels in patients with rheumatoid arthritis and other inflammatory diseases, Dr. Joan Bathon said at a conference on rheumatic diseases sponsored by the Johns Hopkins University.

Formerly known as “anemia of chronic diseases” because it is commonly seen in inflammatory diseases such as rheumatoid arthritis (RA) as well as in chronic infections and some cancers, the condition is now known by the term “anemia of inflammation,” which better reflects its etiology. It is not the result of bleeding, hemolysis, nutritional deficit (vitamin B₁₂, folate, iron), or a marrow disorder, said Dr. Bathon, professor of medicine at Johns Hopkins, Baltimore.

Lacking an understanding of the underlying etiology, health care providers will often give these patients iron supplementation. However, “we know that iron treatment does not really alleviate this anemia,” she said.

Anemia is extremely common among RA patients. In a study comparing 2,120 consecutive RA patients (contributing 26,221 hemoglobin determinations) with 3,843 patients who had noninflammatory rheumatic disorders (7,251 hemoglobin determinations) seen between 1974 and 2004 in a clinical practice setting, the prevalence of chronic anemia was 35.3% when a hemoglobin cutoff of less than 12 g/dL was used. Hemoglobin levels were consistently lower among the RA patients than among those with noninflammatory conditions, by a mean of 0.8 g/dL.

Those data, reported at the 2005 American College of Rheumatology meeting by Dr. Frederick Wolfe of the National Data Bank for Rheumatic Diseases, Wichita, Kan., suggest that “more than one-third of patients with RA are anemic, if you use a broad definition,” Dr. Bathon said.

That study also found that among the RA patients, lower hemoglobin was associated with high disease activity; C-reactive protein levels were strongly predictive of anemia; and quality of life was reduced by 5.5% among the patients with anemia after adjustment for age and gender.

In general, patients with anemia of inflammation have decreased total circulating iron levels and binding capacity, yet their total body iron (ferritin) stores are increased. At the same time, erythropoietin production is blunted, as is the response to endogenous erythropoietin. Red blood cell survival is modestly decreased. “Exogenous iron and/or exogenous erythropoietin do not fully resolve the anemia,” she said.

Although iron is essential for oxygen transport and other vital functions, it also generates free radicals that can lead to oxidative damage, manifesting in conditions such as atherosclerosis, diabetes, or cancer. But humans can't eliminate excess iron. Therefore, uptake from the gastrointestinal tract is tightly regulated and efficiently recycled. “No matter how much you give orally, there's only a limited amount the body can pick up,” Dr. Bathon explained.

Recently, a small peptide hormone called hepcidin was identified as the principal regulator of systemic iron homeostasis. Synthesized in the liver, hepcidin inhibits the intestinal absorption of iron and suppresses release of iron from macrophage and hepatocyte stores.

Measurement of hepcidin levels is now being investigated as a possible diagnostic tool for various iron disorders.

BALTIMORE — A new understanding of the “anemia of inflammation” may help point the way to new treatments in the future, but in the meantime it illustrates why iron supplementation doesn't raise hemoglobin levels in patients with rheumatoid arthritis and other inflammatory diseases, Dr. Joan Bathon said at a conference on rheumatic diseases sponsored by the Johns Hopkins University.

Formerly known as “anemia of chronic diseases” because it is commonly seen in inflammatory diseases such as rheumatoid arthritis (RA) as well as in chronic infections and some cancers, the condition is now known by the term “anemia of inflammation,” which better reflects its etiology. It is not the result of bleeding, hemolysis, nutritional deficit (vitamin B₁₂, folate, iron), or a marrow disorder, said Dr. Bathon, professor of medicine at Johns Hopkins, Baltimore.

Lacking an understanding of the underlying etiology, health care providers will often give these patients iron supplementation. However, “we know that iron treatment does not really alleviate this anemia,” she said.

Anemia is extremely common among RA patients. In a study comparing 2,120 consecutive RA patients (contributing 26,221 hemoglobin determinations) with 3,843 patients who had noninflammatory rheumatic disorders (7,251 hemoglobin determinations) seen between 1974 and 2004 in a clinical practice setting, the prevalence of chronic anemia was 35.3% when a hemoglobin cutoff of less than 12 g/dL was used. Hemoglobin levels were consistently lower among the RA patients than among those with noninflammatory conditions, by a mean of 0.8 g/dL.

Those data, reported at the 2005 American College of Rheumatology meeting by Dr. Frederick Wolfe of the National Data Bank for Rheumatic Diseases, Wichita, Kan., suggest that “more than one-third of patients with RA are anemic, if you use a broad definition,” Dr. Bathon said.

That study also found that among the RA patients, lower hemoglobin was associated with high disease activity; C-reactive protein levels were strongly predictive of anemia; and quality of life was reduced by 5.5% among the patients with anemia after adjustment for age and gender.

In general, patients with anemia of inflammation have decreased total circulating iron levels and binding capacity, yet their total body iron (ferritin) stores are increased. At the same time, erythropoietin production is blunted, as is the response to endogenous erythropoietin. Red blood cell survival is modestly decreased. “Exogenous iron and/or exogenous erythropoietin do not fully resolve the anemia,” she said.

Although iron is essential for oxygen transport and other vital functions, it also generates free radicals that can lead to oxidative damage, manifesting in conditions such as atherosclerosis, diabetes, or cancer. But humans can't eliminate excess iron. Therefore, uptake from the gastrointestinal tract is tightly regulated and efficiently recycled. “No matter how much you give orally, there's only a limited amount the body can pick up,” Dr. Bathon explained.

Recently, a small peptide hormone called hepcidin was identified as the principal regulator of systemic iron homeostasis. Synthesized in the liver, hepcidin inhibits the intestinal absorption of iron and suppresses release of iron from macrophage and hepatocyte stores.

Measurement of hepcidin levels is now being investigated as a possible diagnostic tool for various iron disorders.

BALTIMORE — A new understanding of the “anemia of inflammation” may help point the way to new treatments in the future, but in the meantime it illustrates why iron supplementation doesn't raise hemoglobin levels in patients with rheumatoid arthritis and other inflammatory diseases, Dr. Joan Bathon said at a conference on rheumatic diseases sponsored by the Johns Hopkins University.

Formerly known as “anemia of chronic diseases” because it is commonly seen in inflammatory diseases such as rheumatoid arthritis (RA) as well as in chronic infections and some cancers, the condition is now known by the term “anemia of inflammation,” which better reflects its etiology. It is not the result of bleeding, hemolysis, nutritional deficit (vitamin B₁₂, folate, iron), or a marrow disorder, said Dr. Bathon, professor of medicine at Johns Hopkins, Baltimore.

Lacking an understanding of the underlying etiology, health care providers will often give these patients iron supplementation. However, “we know that iron treatment does not really alleviate this anemia,” she said.

Anemia is extremely common among RA patients. In a study comparing 2,120 consecutive RA patients (contributing 26,221 hemoglobin determinations) with 3,843 patients who had noninflammatory rheumatic disorders (7,251 hemoglobin determinations) seen between 1974 and 2004 in a clinical practice setting, the prevalence of chronic anemia was 35.3% when a hemoglobin cutoff of less than 12 g/dL was used. Hemoglobin levels were consistently lower among the RA patients than among those with noninflammatory conditions, by a mean of 0.8 g/dL.

Those data, reported at the 2005 American College of Rheumatology meeting by Dr. Frederick Wolfe of the National Data Bank for Rheumatic Diseases, Wichita, Kan., suggest that “more than one-third of patients with RA are anemic, if you use a broad definition,” Dr. Bathon said.

That study also found that among the RA patients, lower hemoglobin was associated with high disease activity; C-reactive protein levels were strongly predictive of anemia; and quality of life was reduced by 5.5% among the patients with anemia after adjustment for age and gender.

In general, patients with anemia of inflammation have decreased total circulating iron levels and binding capacity, yet their total body iron (ferritin) stores are increased. At the same time, erythropoietin production is blunted, as is the response to endogenous erythropoietin. Red blood cell survival is modestly decreased. “Exogenous iron and/or exogenous erythropoietin do not fully resolve the anemia,” she said.

Although iron is essential for oxygen transport and other vital functions, it also generates free radicals that can lead to oxidative damage, manifesting in conditions such as atherosclerosis, diabetes, or cancer. But humans can't eliminate excess iron. Therefore, uptake from the gastrointestinal tract is tightly regulated and efficiently recycled. “No matter how much you give orally, there's only a limited amount the body can pick up,” Dr. Bathon explained.

Recently, a small peptide hormone called hepcidin was identified as the principal regulator of systemic iron homeostasis. Synthesized in the liver, hepcidin inhibits the intestinal absorption of iron and suppresses release of iron from macrophage and hepatocyte stores.

Measurement of hepcidin levels is now being investigated as a possible diagnostic tool for various iron disorders.

CHICAGO — Intensive lipid lowering with high-dose atorvastatin significantly reduces the incidence of major cardiovascular events in coronary patients who have both type 2 diabetes and chronic kidney disease, Dr. James Shepherd reported at the annual scientific sessions of the American Diabetes Association.

In a new subanalysis of diabetic patients in the Pfizer-funded Treating to New Targets (TNT) study, “Individuals got greater benefit in relative terms and far greater benefit in absolute terms if they had the combination of diabetes and renal disease, because they had much greater risk to begin with,” said Dr. Shepherd, professor and head of pathological biochemistry at the Royal Infirmary and the University of Glasgow (Scotland).

The main finding of the TNT study of 10,001 patients with stable coronary heart disease was a 22% reduction in the risk of major cardiovascular events with using 80 mg of atorvastatin per day relative to 10 mg/day at a median follow-up of 5 years (N. Engl. J. Med. 2005;352:1425–35). A subsequent sub-analysis of the 1,501 diabetics in that study showed a 25% event reduction with 80 mg versus 10 mg (Diabetes Care 2006;29:1220–6). However, another study of 1,255 patients who had type 2 diabetes and end-stage renal disease (ESRD) and were undergoing hemodialysis showed no cardiovascular benefit of 20 mg of atorvastatin per day, compared with placebo (N. Engl. J. Med. 2005;353:238–48).

To further investigate the potential role of atorvastatin treatment in patients with both diabetes and kidney disease, Dr. Shepherd and his associates analyzed the TNT outcomes of 1,431 of the diabetic patients in the study for whom renal data were available. There were 546 patients with chronic kidney disease (CKD) — defined as having an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m

At baseline, those with CKD had greater cardiovascular morbidity than those without, including higher systolic blood pressure (136.1 vs. 133.6 mm Hg); a greater proportion had a history of hypertension (76% vs. 67%), as well as higher rates of peripheral vascular disease, coronary bypass grafting, and congestive heart failure. There were also more women in the CKD group (42% vs. 18%). The 80-mg dose of atorvastatin lowered LDL equally in both groups, from about 98 mg/dL at baseline to 75 mg/dL at follow-up, Dr. Shepherd reported.

Major cardiovascular events (coronary heart disease death, nonfatal myocardial infarction, resuscitation after cardiac arrest, fatal or nonfatal stroke) occurred in 13.4% of the diabetics with normal GFR and 17.4% for those with both diabetes and CKD. (The rates were 7.8% among those without diabetes or CKD and 10% for the nondiabetics with CKD.) Compared with 10 mg of atorvastatin, the 80-mg dose reduced the relative risk of major cardiovascular events by 35% in the diabetic patients with CKD, compared with just 10% among the diabetics without CKD. “Those patients with the greatest risk got the greatest benefit from intensive intervention with atorvastatin,” Dr. Shepherd commented.

The drug was well tolerated overall, with no evidence of myopathy and less than 1% with elevated liver enzymes. “The high dose of atorvastatin created no penalty with regard to side effects,” he noted.

Although not an end point in the study, improvements in GFR were seen with both atorvastatin doses over the 5 years of the study, but were greater with 80 mg, he said.

When asked by an audience member why atorvastatin did not benefit the patients with ESRD in the earlier study, Dr. Shepherd responded, “I think it's a function of the degree of kidney compromise. If you have patients with ESRD on dialysis, you're asking far too much of a drug to reverse that. But you can see a reversal if you have compromise but still-viable glomerular filtration rates.”

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CHICAGO — Intensive lipid lowering with high-dose atorvastatin significantly reduces the incidence of major cardiovascular events in coronary patients who have both type 2 diabetes and chronic kidney disease, Dr. James Shepherd reported at the annual scientific sessions of the American Diabetes Association.

In a new subanalysis of diabetic patients in the Pfizer-funded Treating to New Targets (TNT) study, “Individuals got greater benefit in relative terms and far greater benefit in absolute terms if they had the combination of diabetes and renal disease, because they had much greater risk to begin with,” said Dr. Shepherd, professor and head of pathological biochemistry at the Royal Infirmary and the University of Glasgow (Scotland).

The main finding of the TNT study of 10,001 patients with stable coronary heart disease was a 22% reduction in the risk of major cardiovascular events with using 80 mg of atorvastatin per day relative to 10 mg/day at a median follow-up of 5 years (N. Engl. J. Med. 2005;352:1425–35). A subsequent sub-analysis of the 1,501 diabetics in that study showed a 25% event reduction with 80 mg versus 10 mg (Diabetes Care 2006;29:1220–6). However, another study of 1,255 patients who had type 2 diabetes and end-stage renal disease (ESRD) and were undergoing hemodialysis showed no cardiovascular benefit of 20 mg of atorvastatin per day, compared with placebo (N. Engl. J. Med. 2005;353:238–48).

To further investigate the potential role of atorvastatin treatment in patients with both diabetes and kidney disease, Dr. Shepherd and his associates analyzed the TNT outcomes of 1,431 of the diabetic patients in the study for whom renal data were available. There were 546 patients with chronic kidney disease (CKD) — defined as having an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m

At baseline, those with CKD had greater cardiovascular morbidity than those without, including higher systolic blood pressure (136.1 vs. 133.6 mm Hg); a greater proportion had a history of hypertension (76% vs. 67%), as well as higher rates of peripheral vascular disease, coronary bypass grafting, and congestive heart failure. There were also more women in the CKD group (42% vs. 18%). The 80-mg dose of atorvastatin lowered LDL equally in both groups, from about 98 mg/dL at baseline to 75 mg/dL at follow-up, Dr. Shepherd reported.

Major cardiovascular events (coronary heart disease death, nonfatal myocardial infarction, resuscitation after cardiac arrest, fatal or nonfatal stroke) occurred in 13.4% of the diabetics with normal GFR and 17.4% for those with both diabetes and CKD. (The rates were 7.8% among those without diabetes or CKD and 10% for the nondiabetics with CKD.) Compared with 10 mg of atorvastatin, the 80-mg dose reduced the relative risk of major cardiovascular events by 35% in the diabetic patients with CKD, compared with just 10% among the diabetics without CKD. “Those patients with the greatest risk got the greatest benefit from intensive intervention with atorvastatin,” Dr. Shepherd commented.

The drug was well tolerated overall, with no evidence of myopathy and less than 1% with elevated liver enzymes. “The high dose of atorvastatin created no penalty with regard to side effects,” he noted.

Although not an end point in the study, improvements in GFR were seen with both atorvastatin doses over the 5 years of the study, but were greater with 80 mg, he said.

When asked by an audience member why atorvastatin did not benefit the patients with ESRD in the earlier study, Dr. Shepherd responded, “I think it's a function of the degree of kidney compromise. If you have patients with ESRD on dialysis, you're asking far too much of a drug to reverse that. But you can see a reversal if you have compromise but still-viable glomerular filtration rates.”

ELSEVIER GLOBAL MEDICAL NEWS

CHICAGO — Intensive lipid lowering with high-dose atorvastatin significantly reduces the incidence of major cardiovascular events in coronary patients who have both type 2 diabetes and chronic kidney disease, Dr. James Shepherd reported at the annual scientific sessions of the American Diabetes Association.

In a new subanalysis of diabetic patients in the Pfizer-funded Treating to New Targets (TNT) study, “Individuals got greater benefit in relative terms and far greater benefit in absolute terms if they had the combination of diabetes and renal disease, because they had much greater risk to begin with,” said Dr. Shepherd, professor and head of pathological biochemistry at the Royal Infirmary and the University of Glasgow (Scotland).

The main finding of the TNT study of 10,001 patients with stable coronary heart disease was a 22% reduction in the risk of major cardiovascular events with using 80 mg of atorvastatin per day relative to 10 mg/day at a median follow-up of 5 years (N. Engl. J. Med. 2005;352:1425–35). A subsequent sub-analysis of the 1,501 diabetics in that study showed a 25% event reduction with 80 mg versus 10 mg (Diabetes Care 2006;29:1220–6). However, another study of 1,255 patients who had type 2 diabetes and end-stage renal disease (ESRD) and were undergoing hemodialysis showed no cardiovascular benefit of 20 mg of atorvastatin per day, compared with placebo (N. Engl. J. Med. 2005;353:238–48).

To further investigate the potential role of atorvastatin treatment in patients with both diabetes and kidney disease, Dr. Shepherd and his associates analyzed the TNT outcomes of 1,431 of the diabetic patients in the study for whom renal data were available. There were 546 patients with chronic kidney disease (CKD) — defined as having an estimated glomerular filtration rate (eGFR) of less than 60 mL/min per 1.73 m

At baseline, those with CKD had greater cardiovascular morbidity than those without, including higher systolic blood pressure (136.1 vs. 133.6 mm Hg); a greater proportion had a history of hypertension (76% vs. 67%), as well as higher rates of peripheral vascular disease, coronary bypass grafting, and congestive heart failure. There were also more women in the CKD group (42% vs. 18%). The 80-mg dose of atorvastatin lowered LDL equally in both groups, from about 98 mg/dL at baseline to 75 mg/dL at follow-up, Dr. Shepherd reported.

Major cardiovascular events (coronary heart disease death, nonfatal myocardial infarction, resuscitation after cardiac arrest, fatal or nonfatal stroke) occurred in 13.4% of the diabetics with normal GFR and 17.4% for those with both diabetes and CKD. (The rates were 7.8% among those without diabetes or CKD and 10% for the nondiabetics with CKD.) Compared with 10 mg of atorvastatin, the 80-mg dose reduced the relative risk of major cardiovascular events by 35% in the diabetic patients with CKD, compared with just 10% among the diabetics without CKD. “Those patients with the greatest risk got the greatest benefit from intensive intervention with atorvastatin,” Dr. Shepherd commented.

The drug was well tolerated overall, with no evidence of myopathy and less than 1% with elevated liver enzymes. “The high dose of atorvastatin created no penalty with regard to side effects,” he noted.

Although not an end point in the study, improvements in GFR were seen with both atorvastatin doses over the 5 years of the study, but were greater with 80 mg, he said.

When asked by an audience member why atorvastatin did not benefit the patients with ESRD in the earlier study, Dr. Shepherd responded, “I think it's a function of the degree of kidney compromise. If you have patients with ESRD on dialysis, you're asking far too much of a drug to reverse that. But you can see a reversal if you have compromise but still-viable glomerular filtration rates.”

ELSEVIER GLOBAL MEDICAL NEWS