Miriam E. Tucker

AMSTERDAM — Women who are obese, have diabetes, or both should be asked about symptoms of urinary incontinence and other pelvic floor disorders.

That is the take-home message from two recent studies, one presented in a poster at the annual meeting of the European Association for the Study of Diabetes (EASD) and the other published in the journal Diabetes Care. Both studies—one a case-control study from a group in Turkey, the other a cross-sectional analysis from the Kaiser Permanente database—demonstrated that urinary incontinence (UI) is more common in women with diabetes, but that a large measure of that association may be due to obesity.

Dr. Pinar Topsever, of the department of family medicine at Kocaeli (Turkey) University, presented data from 954 women seen in her primary care setting, of whom 344 had diabetes (the majority with type 2). The women with diabetes were older (49 vs. 32 years), more overweight (body mass index 28 vs. 25 kg/m

When asked by questionnaire if they experienced “any kind of urinary leakage,” a total of 42% of the women with diabetes responded affirmatively, a “striking figure,” compared with the 14% of controls, Dr. Topsever said during her presentation at the EASD meeting.

After adjustment for confounders such as age, reproductive history, diabetes complications, and other comorbidities, the odds ratio for having UI among the diabetic women remained a significant 2.9. Other independent predictors of UI were body mass index (BMI) greater than 22.5 kg/m

But if you don't ask, women may not tell. In fact, her primary care group had decided to do this study because, “We realized that a lot of female patients in primary care had urinary incontinence but didn't complain about it. [The information] just came out when we were inquiring during our normal doctor-patient conversation.” The study was undertaken because the prevalence of diabetes is high in Turkey—about 8% of the population—and diabetic neuropathy is thought to contribute to UI among people with diabetes, she explained.

The situation appears to be quite similar here in the United States, judging by data from 3,962 female health plan participants surveyed by Jean M. Lawrence, Sc.D., M.P.H., of Kaiser Permanente Southern California, Pasadena, and her associates (Diabetes Care 2007;30:2536–41).

Just as with the Turkish study population, the 393 women with diabetes (10%) were significantly older than the rest of the group (64 vs. 56 years), had higher BMIs (32 vs. 27), and were more parous (3 vs. 2 deliveries). They also were more likely to have had a hysterectomy (38% vs. 27%), and to be black (13% vs. 9%). More than half (56%) of the women with diabetes were obese (BMI of 30 or greater).

On the Epidemiology of Prolapse and Incontinence Questionnaire, which assesses a variety of pelvic floor disorders (Int. Urogynecol. J. Pelvic Floor Dysfunct. 2005:16:272–84), overall prevalences were 15% with stress urinary incontinence, 13% with overactive bladder, 25% with anal incontinence, and 35% reporting any of those four pelvic floor disorders.

Diabetes and obesity both strongly predicted each and all of the pelvic floor disorders, but obesity was a stronger predictor for each. Compared with women who were neither obese nor diabetic—and after adjustment for a long list of confounding factors including age, race/ethnicity, mode of delivery, parity, menopause status, smoking status, and neurologic disease—the odds ratios for having stress urinary incontinence were 3.67 for those who were both obese and diabetic, 2.62 for obese nondiabetic women, and 1.81 for nonobese diabetic women.

For having any pelvic floor disorder, those adjusted odds ratios were 2.62, 1.83, and 1.32, respectively. The risk rankings remained in the same order for overactive bladder (2.97, 2.93, and 1.45) and for anal incontinence (2.09, 1.45, and 1.33), they reported.

There is a significant correlation between BMI and intra-abdominal pressure, suggesting obesity may stress the pelvic floor secondary to a chronic state of increased pressure. And weight loss has been shown to improve incontinence in obese women, the researchers noted.

AMSTERDAM — Women who are obese, have diabetes, or both should be asked about symptoms of urinary incontinence and other pelvic floor disorders.

That is the take-home message from two recent studies, one presented in a poster at the annual meeting of the European Association for the Study of Diabetes (EASD) and the other published in the journal Diabetes Care. Both studies—one a case-control study from a group in Turkey, the other a cross-sectional analysis from the Kaiser Permanente database—demonstrated that urinary incontinence (UI) is more common in women with diabetes, but that a large measure of that association may be due to obesity.

Dr. Pinar Topsever, of the department of family medicine at Kocaeli (Turkey) University, presented data from 954 women seen in her primary care setting, of whom 344 had diabetes (the majority with type 2). The women with diabetes were older (49 vs. 32 years), more overweight (body mass index 28 vs. 25 kg/m

When asked by questionnaire if they experienced “any kind of urinary leakage,” a total of 42% of the women with diabetes responded affirmatively, a “striking figure,” compared with the 14% of controls, Dr. Topsever said during her presentation at the EASD meeting.

After adjustment for confounders such as age, reproductive history, diabetes complications, and other comorbidities, the odds ratio for having UI among the diabetic women remained a significant 2.9. Other independent predictors of UI were body mass index (BMI) greater than 22.5 kg/m

But if you don't ask, women may not tell. In fact, her primary care group had decided to do this study because, “We realized that a lot of female patients in primary care had urinary incontinence but didn't complain about it. [The information] just came out when we were inquiring during our normal doctor-patient conversation.” The study was undertaken because the prevalence of diabetes is high in Turkey—about 8% of the population—and diabetic neuropathy is thought to contribute to UI among people with diabetes, she explained.

The situation appears to be quite similar here in the United States, judging by data from 3,962 female health plan participants surveyed by Jean M. Lawrence, Sc.D., M.P.H., of Kaiser Permanente Southern California, Pasadena, and her associates (Diabetes Care 2007;30:2536–41).

Just as with the Turkish study population, the 393 women with diabetes (10%) were significantly older than the rest of the group (64 vs. 56 years), had higher BMIs (32 vs. 27), and were more parous (3 vs. 2 deliveries). They also were more likely to have had a hysterectomy (38% vs. 27%), and to be black (13% vs. 9%). More than half (56%) of the women with diabetes were obese (BMI of 30 or greater).

On the Epidemiology of Prolapse and Incontinence Questionnaire, which assesses a variety of pelvic floor disorders (Int. Urogynecol. J. Pelvic Floor Dysfunct. 2005:16:272–84), overall prevalences were 15% with stress urinary incontinence, 13% with overactive bladder, 25% with anal incontinence, and 35% reporting any of those four pelvic floor disorders.

Diabetes and obesity both strongly predicted each and all of the pelvic floor disorders, but obesity was a stronger predictor for each. Compared with women who were neither obese nor diabetic—and after adjustment for a long list of confounding factors including age, race/ethnicity, mode of delivery, parity, menopause status, smoking status, and neurologic disease—the odds ratios for having stress urinary incontinence were 3.67 for those who were both obese and diabetic, 2.62 for obese nondiabetic women, and 1.81 for nonobese diabetic women.

For having any pelvic floor disorder, those adjusted odds ratios were 2.62, 1.83, and 1.32, respectively. The risk rankings remained in the same order for overactive bladder (2.97, 2.93, and 1.45) and for anal incontinence (2.09, 1.45, and 1.33), they reported.

There is a significant correlation between BMI and intra-abdominal pressure, suggesting obesity may stress the pelvic floor secondary to a chronic state of increased pressure. And weight loss has been shown to improve incontinence in obese women, the researchers noted.

AMSTERDAM — Women who are obese, have diabetes, or both should be asked about symptoms of urinary incontinence and other pelvic floor disorders.

That is the take-home message from two recent studies, one presented in a poster at the annual meeting of the European Association for the Study of Diabetes (EASD) and the other published in the journal Diabetes Care. Both studies—one a case-control study from a group in Turkey, the other a cross-sectional analysis from the Kaiser Permanente database—demonstrated that urinary incontinence (UI) is more common in women with diabetes, but that a large measure of that association may be due to obesity.

Dr. Pinar Topsever, of the department of family medicine at Kocaeli (Turkey) University, presented data from 954 women seen in her primary care setting, of whom 344 had diabetes (the majority with type 2). The women with diabetes were older (49 vs. 32 years), more overweight (body mass index 28 vs. 25 kg/m

When asked by questionnaire if they experienced “any kind of urinary leakage,” a total of 42% of the women with diabetes responded affirmatively, a “striking figure,” compared with the 14% of controls, Dr. Topsever said during her presentation at the EASD meeting.

After adjustment for confounders such as age, reproductive history, diabetes complications, and other comorbidities, the odds ratio for having UI among the diabetic women remained a significant 2.9. Other independent predictors of UI were body mass index (BMI) greater than 22.5 kg/m

But if you don't ask, women may not tell. In fact, her primary care group had decided to do this study because, “We realized that a lot of female patients in primary care had urinary incontinence but didn't complain about it. [The information] just came out when we were inquiring during our normal doctor-patient conversation.” The study was undertaken because the prevalence of diabetes is high in Turkey—about 8% of the population—and diabetic neuropathy is thought to contribute to UI among people with diabetes, she explained.

The situation appears to be quite similar here in the United States, judging by data from 3,962 female health plan participants surveyed by Jean M. Lawrence, Sc.D., M.P.H., of Kaiser Permanente Southern California, Pasadena, and her associates (Diabetes Care 2007;30:2536–41).

Just as with the Turkish study population, the 393 women with diabetes (10%) were significantly older than the rest of the group (64 vs. 56 years), had higher BMIs (32 vs. 27), and were more parous (3 vs. 2 deliveries). They also were more likely to have had a hysterectomy (38% vs. 27%), and to be black (13% vs. 9%). More than half (56%) of the women with diabetes were obese (BMI of 30 or greater).

On the Epidemiology of Prolapse and Incontinence Questionnaire, which assesses a variety of pelvic floor disorders (Int. Urogynecol. J. Pelvic Floor Dysfunct. 2005:16:272–84), overall prevalences were 15% with stress urinary incontinence, 13% with overactive bladder, 25% with anal incontinence, and 35% reporting any of those four pelvic floor disorders.

Diabetes and obesity both strongly predicted each and all of the pelvic floor disorders, but obesity was a stronger predictor for each. Compared with women who were neither obese nor diabetic—and after adjustment for a long list of confounding factors including age, race/ethnicity, mode of delivery, parity, menopause status, smoking status, and neurologic disease—the odds ratios for having stress urinary incontinence were 3.67 for those who were both obese and diabetic, 2.62 for obese nondiabetic women, and 1.81 for nonobese diabetic women.

For having any pelvic floor disorder, those adjusted odds ratios were 2.62, 1.83, and 1.32, respectively. The risk rankings remained in the same order for overactive bladder (2.97, 2.93, and 1.45) and for anal incontinence (2.09, 1.45, and 1.33), they reported.

There is a significant correlation between BMI and intra-abdominal pressure, suggesting obesity may stress the pelvic floor secondary to a chronic state of increased pressure. And weight loss has been shown to improve incontinence in obese women, the researchers noted.

In light of new information regarding thiazolidinediones, the American Diabetes Association and the European Association for the Study of Diabetes have updated their diabetes treatment guidelines to urge “greater caution” in the use of TZDs, particularly in patients with heart failure.

However, they did not fundamentally change last year's original consensus algorithm, which included the thiazolidinediones as one of three possible choices—along with insulin and sulfonylureas—in patients who do not achieve hemoglobin A_1c (HbA_1c) levels below 7% with the first-line therapies of lifestyle modification and metformin (Diabetes Care 2006;29:1963–72; Diabetologia 2006;49:1711–21).

The update, due to be published in January 2008 in both Diabetes Care and Diabetologia, also included information about sitagliptin, which was not yet approved by the Food and Drug Administration at the time the original document was written. As monotherapy, sitagliptin is expected to decrease HbA_1c by 0.5%–0.8%. It has the advantage of being weight neutral, but it also has disadvantages, including limited experience and high cost, according to the ADA/EASD panel of seven authors led by Dr. David M. Nathan, director of the Diabetes Center at Massachusetts General Hospital and professor of medicine at Harvard Medical School, Boston.

But TZDs were the main topic of the update, deemed necessary because of the enormous amount of attention that the class of drugs received during 2007, beginning with the widely publicized meta-analysis by Dr. Steven E. Nissen concluding that rosiglitazone was associated with a significant increase in the risk of myocardial infarction (N. Engl. J. Med. 2007;356:2457–71). At least four additional meta-analyses—including one from the manufacturer and one by the FDA—also called into question the safety of rosiglitazone with regard to the risk of MI, with a putative 30%–40% relative increase in risk.

However, another meta-analysis of essentially the same data found no significant increased risk of cardiovascular mortality for either rosiglitazone or pioglitazone (Lancet 2007;370:1129–36), while the interim analysis from the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study revealed no significant effect on MI but did confirm the risk for heart failure (N. Engl. J. Med. 2007;357:28–38). Meanwhile, yet another meta-analysis suggested a protective effect for pioglitazone (JAMA 2007;298:1180–8).

In addition to the MI concern with rosiglitazone, the previously recognized risk of fluid retention and heart failure that occurs with both rosiglitazone and pioglitazone has now been quantified as approximately twofold. This information is included in a “black box” warning on the labels for both TZDs. Both drugs have also been associated with an increased risk for fractures, particularly in women. The majority of these were in the distal upper or lower limb, not the classic sites of osteoporotic fractures.

Despite these developments, the ADA/EASD panel concluded that the data on MI for both drugs are not definitive, and that the increased risk of heart failure or fractures is not “of a magnitude to warrant their removal as one of the possible second-step medications in our algorithm,” particularly since they do have at least one advantage over either insulin or sulfonylureas: They are far less likely to cause hypoglycemia. Thus, the panel opted to compromise by urging clinicians to consider carefully whether to use TZDs versus insulin or sulfonylureas, as well as to consider what is known about the differences between the two available TZDs.

“We are mindful of the importance of not changing this consensus guideline in the absence of definitive or compelling new data. Future updates are planned to consider further revisions of the algorithm, guided by the evidence base and clinical experience with the newer classes of glucose-lowering medication,” Dr. Nathan and the other panel members wrote.

In light of new information regarding thiazolidinediones, the American Diabetes Association and the European Association for the Study of Diabetes have updated their diabetes treatment guidelines to urge “greater caution” in the use of TZDs, particularly in patients with heart failure.

However, they did not fundamentally change last year's original consensus algorithm, which included the thiazolidinediones as one of three possible choices—along with insulin and sulfonylureas—in patients who do not achieve hemoglobin A_1c (HbA_1c) levels below 7% with the first-line therapies of lifestyle modification and metformin (Diabetes Care 2006;29:1963–72; Diabetologia 2006;49:1711–21).

The update, due to be published in January 2008 in both Diabetes Care and Diabetologia, also included information about sitagliptin, which was not yet approved by the Food and Drug Administration at the time the original document was written. As monotherapy, sitagliptin is expected to decrease HbA_1c by 0.5%–0.8%. It has the advantage of being weight neutral, but it also has disadvantages, including limited experience and high cost, according to the ADA/EASD panel of seven authors led by Dr. David M. Nathan, director of the Diabetes Center at Massachusetts General Hospital and professor of medicine at Harvard Medical School, Boston.

But TZDs were the main topic of the update, deemed necessary because of the enormous amount of attention that the class of drugs received during 2007, beginning with the widely publicized meta-analysis by Dr. Steven E. Nissen concluding that rosiglitazone was associated with a significant increase in the risk of myocardial infarction (N. Engl. J. Med. 2007;356:2457–71). At least four additional meta-analyses—including one from the manufacturer and one by the FDA—also called into question the safety of rosiglitazone with regard to the risk of MI, with a putative 30%–40% relative increase in risk.

However, another meta-analysis of essentially the same data found no significant increased risk of cardiovascular mortality for either rosiglitazone or pioglitazone (Lancet 2007;370:1129–36), while the interim analysis from the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study revealed no significant effect on MI but did confirm the risk for heart failure (N. Engl. J. Med. 2007;357:28–38). Meanwhile, yet another meta-analysis suggested a protective effect for pioglitazone (JAMA 2007;298:1180–8).

In addition to the MI concern with rosiglitazone, the previously recognized risk of fluid retention and heart failure that occurs with both rosiglitazone and pioglitazone has now been quantified as approximately twofold. This information is included in a “black box” warning on the labels for both TZDs. Both drugs have also been associated with an increased risk for fractures, particularly in women. The majority of these were in the distal upper or lower limb, not the classic sites of osteoporotic fractures.

Despite these developments, the ADA/EASD panel concluded that the data on MI for both drugs are not definitive, and that the increased risk of heart failure or fractures is not “of a magnitude to warrant their removal as one of the possible second-step medications in our algorithm,” particularly since they do have at least one advantage over either insulin or sulfonylureas: They are far less likely to cause hypoglycemia. Thus, the panel opted to compromise by urging clinicians to consider carefully whether to use TZDs versus insulin or sulfonylureas, as well as to consider what is known about the differences between the two available TZDs.

“We are mindful of the importance of not changing this consensus guideline in the absence of definitive or compelling new data. Future updates are planned to consider further revisions of the algorithm, guided by the evidence base and clinical experience with the newer classes of glucose-lowering medication,” Dr. Nathan and the other panel members wrote.

In light of new information regarding thiazolidinediones, the American Diabetes Association and the European Association for the Study of Diabetes have updated their diabetes treatment guidelines to urge “greater caution” in the use of TZDs, particularly in patients with heart failure.

However, they did not fundamentally change last year's original consensus algorithm, which included the thiazolidinediones as one of three possible choices—along with insulin and sulfonylureas—in patients who do not achieve hemoglobin A_1c (HbA_1c) levels below 7% with the first-line therapies of lifestyle modification and metformin (Diabetes Care 2006;29:1963–72; Diabetologia 2006;49:1711–21).

The update, due to be published in January 2008 in both Diabetes Care and Diabetologia, also included information about sitagliptin, which was not yet approved by the Food and Drug Administration at the time the original document was written. As monotherapy, sitagliptin is expected to decrease HbA_1c by 0.5%–0.8%. It has the advantage of being weight neutral, but it also has disadvantages, including limited experience and high cost, according to the ADA/EASD panel of seven authors led by Dr. David M. Nathan, director of the Diabetes Center at Massachusetts General Hospital and professor of medicine at Harvard Medical School, Boston.

But TZDs were the main topic of the update, deemed necessary because of the enormous amount of attention that the class of drugs received during 2007, beginning with the widely publicized meta-analysis by Dr. Steven E. Nissen concluding that rosiglitazone was associated with a significant increase in the risk of myocardial infarction (N. Engl. J. Med. 2007;356:2457–71). At least four additional meta-analyses—including one from the manufacturer and one by the FDA—also called into question the safety of rosiglitazone with regard to the risk of MI, with a putative 30%–40% relative increase in risk.

However, another meta-analysis of essentially the same data found no significant increased risk of cardiovascular mortality for either rosiglitazone or pioglitazone (Lancet 2007;370:1129–36), while the interim analysis from the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD) study revealed no significant effect on MI but did confirm the risk for heart failure (N. Engl. J. Med. 2007;357:28–38). Meanwhile, yet another meta-analysis suggested a protective effect for pioglitazone (JAMA 2007;298:1180–8).

In addition to the MI concern with rosiglitazone, the previously recognized risk of fluid retention and heart failure that occurs with both rosiglitazone and pioglitazone has now been quantified as approximately twofold. This information is included in a “black box” warning on the labels for both TZDs. Both drugs have also been associated with an increased risk for fractures, particularly in women. The majority of these were in the distal upper or lower limb, not the classic sites of osteoporotic fractures.

Despite these developments, the ADA/EASD panel concluded that the data on MI for both drugs are not definitive, and that the increased risk of heart failure or fractures is not “of a magnitude to warrant their removal as one of the possible second-step medications in our algorithm,” particularly since they do have at least one advantage over either insulin or sulfonylureas: They are far less likely to cause hypoglycemia. Thus, the panel opted to compromise by urging clinicians to consider carefully whether to use TZDs versus insulin or sulfonylureas, as well as to consider what is known about the differences between the two available TZDs.

“We are mindful of the importance of not changing this consensus guideline in the absence of definitive or compelling new data. Future updates are planned to consider further revisions of the algorithm, guided by the evidence base and clinical experience with the newer classes of glucose-lowering medication,” Dr. Nathan and the other panel members wrote.

Cardiovascular disease affected approximately 6 million diabetic adults aged 35 years and older in the United States in 2005, according to the Centers for Disease Control and Prevention.

Reseachers at the CDC analyzed data from the National Health Interview Survey on the prevalence of heart disease, stroke, and other cardiovascular diseases among persons with diabetes during 1997–2005. In that period, the age-adjusted prevalence of diagnosed diabetes in the United States increased 43%, from 3.7% in 1997 to 5.3% in 2005, according to the report (MMWR 2007;56:1129–32).

During 1997–2005, the annual number of survey respondents aged 35 and older who reported having both diabetes and CVD ranged from approximately 3,700 to 6,800 (out of a total of 31,000–36,000). Although the prevalence of individuals with both disorders did increase overall by 36% during the study period, the age-adjusted overall prevalence actually decreased by 11%, from 37% to 32.5%. The drop indicates that the number of people diagnosed with diabetes during that time exceeded the number with both diabetes and CVD, the report explained.

Broken down by age group, the age-specific prevalence of self-reported CVD among those aged 35–64 years with diabetes decreased by 14%, from 31% in 1997 to 27% in 2005, while the prevalence did not change significantly over time in older groups (from 46% to 51% in individuals aged 65–74 and from 53% to 57% among those aged 75 and older).

Overall during the study period, the age-adjusted prevalence of CVD was higher among men than women, higher among whites than blacks, and higher among non-Hispanics than Hispanics. The age-adjusted prevalence decreased significantly in women (by 11%) but not in men, and in blacks (by 25%) but not in whites. It also decreased significantly among non-Hispanics (by 12%), while there was no clear trend among Hispanics, the CDC said.

The decrease in self-reported CVD prevalence among diagnosed diabetic patients may relate to the fact that the median duration of diabetes has declined significantly overall, the report noted.

Cardiovascular disease affected approximately 6 million diabetic adults aged 35 years and older in the United States in 2005, according to the Centers for Disease Control and Prevention.

Reseachers at the CDC analyzed data from the National Health Interview Survey on the prevalence of heart disease, stroke, and other cardiovascular diseases among persons with diabetes during 1997–2005. In that period, the age-adjusted prevalence of diagnosed diabetes in the United States increased 43%, from 3.7% in 1997 to 5.3% in 2005, according to the report (MMWR 2007;56:1129–32).

During 1997–2005, the annual number of survey respondents aged 35 and older who reported having both diabetes and CVD ranged from approximately 3,700 to 6,800 (out of a total of 31,000–36,000). Although the prevalence of individuals with both disorders did increase overall by 36% during the study period, the age-adjusted overall prevalence actually decreased by 11%, from 37% to 32.5%. The drop indicates that the number of people diagnosed with diabetes during that time exceeded the number with both diabetes and CVD, the report explained.

Broken down by age group, the age-specific prevalence of self-reported CVD among those aged 35–64 years with diabetes decreased by 14%, from 31% in 1997 to 27% in 2005, while the prevalence did not change significantly over time in older groups (from 46% to 51% in individuals aged 65–74 and from 53% to 57% among those aged 75 and older).

Overall during the study period, the age-adjusted prevalence of CVD was higher among men than women, higher among whites than blacks, and higher among non-Hispanics than Hispanics. The age-adjusted prevalence decreased significantly in women (by 11%) but not in men, and in blacks (by 25%) but not in whites. It also decreased significantly among non-Hispanics (by 12%), while there was no clear trend among Hispanics, the CDC said.

The decrease in self-reported CVD prevalence among diagnosed diabetic patients may relate to the fact that the median duration of diabetes has declined significantly overall, the report noted.

Cardiovascular disease affected approximately 6 million diabetic adults aged 35 years and older in the United States in 2005, according to the Centers for Disease Control and Prevention.

Reseachers at the CDC analyzed data from the National Health Interview Survey on the prevalence of heart disease, stroke, and other cardiovascular diseases among persons with diabetes during 1997–2005. In that period, the age-adjusted prevalence of diagnosed diabetes in the United States increased 43%, from 3.7% in 1997 to 5.3% in 2005, according to the report (MMWR 2007;56:1129–32).

During 1997–2005, the annual number of survey respondents aged 35 and older who reported having both diabetes and CVD ranged from approximately 3,700 to 6,800 (out of a total of 31,000–36,000). Although the prevalence of individuals with both disorders did increase overall by 36% during the study period, the age-adjusted overall prevalence actually decreased by 11%, from 37% to 32.5%. The drop indicates that the number of people diagnosed with diabetes during that time exceeded the number with both diabetes and CVD, the report explained.

Broken down by age group, the age-specific prevalence of self-reported CVD among those aged 35–64 years with diabetes decreased by 14%, from 31% in 1997 to 27% in 2005, while the prevalence did not change significantly over time in older groups (from 46% to 51% in individuals aged 65–74 and from 53% to 57% among those aged 75 and older).

Overall during the study period, the age-adjusted prevalence of CVD was higher among men than women, higher among whites than blacks, and higher among non-Hispanics than Hispanics. The age-adjusted prevalence decreased significantly in women (by 11%) but not in men, and in blacks (by 25%) but not in whites. It also decreased significantly among non-Hispanics (by 12%), while there was no clear trend among Hispanics, the CDC said.

The decrease in self-reported CVD prevalence among diagnosed diabetic patients may relate to the fact that the median duration of diabetes has declined significantly overall, the report noted.

AMSTERDAM — Direct medical costs for diabetic ketoacidosis in children and adolescents in the United States totaled approximately $258 million in 2006, Dr. Arleta Rewers and Dr. Marian Rewers reported in a poster at the annual meeting of the European Association for the Study of Diabetes.

The figure, which breaks down to about $73 million for cases occurring at the onset of diabetes and $185 million for already established cases, represents an increase of approximately 40% from 1995, when the total cost was $184 million ($48 million for new-onset diabetes patients and $136 million for established diabetes patients), said Dr. Arleta Rewers, a pediatric emergency physician, and Dr. Marian Rewers, a pediatric endocrinologist, both at the Children's Hospital, Denver, and the University of Colorado at Denver.

Those overall U.S. data were extrapolated from the 1,093 validated cases of diabetic ketoacidosis (DKA) among 777 patients seen at the Children's Hospital, Denver, during 1995–2006. The median age at DKA was 12.0 years (range 0–19 years).

Slightly more than half (55%) were female. Overall, 23% of patients were treated in the emergency department, 12% were in the observation unit (staying less than 24 hours), and 65% were hospitalized for a median of 1 day (range 1–61 days).

Total direct medical costs, including hospital charges and professional fees, were 67% higher for patients at the onset of diabetes (which was when 49% of all DKA events occurred) than for patients with established diabetes, with a median of $10,890 versus $8,010 for the entire 11-year period.

Two-thirds (66%) of the patients had private or HMO insurance, 27% had government insurance or indigent coverage, and 7% were uninsured.

Among those with new-onset diabetes, having indigent coverage or no insurance predicted a nearly fourfold higher cost of DKA treatment, after adjustment for gender, ethnicity, and age.

In contrast, there was no relationship between insurance status and the cost of DKA among patients with established diabetes, the two researchers reported.

After adjustment for inflation, the median direct cost of DKA treatment increased 20% from 1995–1996 ($8,836) to 2005–2006 ($10,551).

The cost extrapolations to the entire U.S. population were based on four sets of data: a previous study suggesting that the prevalence of DKA in newly diagnosed youth is approximately 25.5% (Pediatric News, August 2005, p. 7; Family Practice News, Nov. 1, 2005, p. 27); another finding that the incidence of DKA in patients with established diabetes is 8 per 100 patients per year; estimates of the prevalence and incidence of diabetes among youth from the SEARCH for Diabetes in Youth study database; and U.S. census population data.

The reason that DKA is more costly in newly diagnosed cases—especially those with suboptimal insurance—is likely because of more severe presentation and lower family resources for transition to outpatient management, the researchers said.

AMSTERDAM — Direct medical costs for diabetic ketoacidosis in children and adolescents in the United States totaled approximately $258 million in 2006, Dr. Arleta Rewers and Dr. Marian Rewers reported in a poster at the annual meeting of the European Association for the Study of Diabetes.

The figure, which breaks down to about $73 million for cases occurring at the onset of diabetes and $185 million for already established cases, represents an increase of approximately 40% from 1995, when the total cost was $184 million ($48 million for new-onset diabetes patients and $136 million for established diabetes patients), said Dr. Arleta Rewers, a pediatric emergency physician, and Dr. Marian Rewers, a pediatric endocrinologist, both at the Children's Hospital, Denver, and the University of Colorado at Denver.

Those overall U.S. data were extrapolated from the 1,093 validated cases of diabetic ketoacidosis (DKA) among 777 patients seen at the Children's Hospital, Denver, during 1995–2006. The median age at DKA was 12.0 years (range 0–19 years).

Slightly more than half (55%) were female. Overall, 23% of patients were treated in the emergency department, 12% were in the observation unit (staying less than 24 hours), and 65% were hospitalized for a median of 1 day (range 1–61 days).

Total direct medical costs, including hospital charges and professional fees, were 67% higher for patients at the onset of diabetes (which was when 49% of all DKA events occurred) than for patients with established diabetes, with a median of $10,890 versus $8,010 for the entire 11-year period.

Two-thirds (66%) of the patients had private or HMO insurance, 27% had government insurance or indigent coverage, and 7% were uninsured.

Among those with new-onset diabetes, having indigent coverage or no insurance predicted a nearly fourfold higher cost of DKA treatment, after adjustment for gender, ethnicity, and age.

In contrast, there was no relationship between insurance status and the cost of DKA among patients with established diabetes, the two researchers reported.

After adjustment for inflation, the median direct cost of DKA treatment increased 20% from 1995–1996 ($8,836) to 2005–2006 ($10,551).

The cost extrapolations to the entire U.S. population were based on four sets of data: a previous study suggesting that the prevalence of DKA in newly diagnosed youth is approximately 25.5% (Pediatric News, August 2005, p. 7; Family Practice News, Nov. 1, 2005, p. 27); another finding that the incidence of DKA in patients with established diabetes is 8 per 100 patients per year; estimates of the prevalence and incidence of diabetes among youth from the SEARCH for Diabetes in Youth study database; and U.S. census population data.

The reason that DKA is more costly in newly diagnosed cases—especially those with suboptimal insurance—is likely because of more severe presentation and lower family resources for transition to outpatient management, the researchers said.

AMSTERDAM — Direct medical costs for diabetic ketoacidosis in children and adolescents in the United States totaled approximately $258 million in 2006, Dr. Arleta Rewers and Dr. Marian Rewers reported in a poster at the annual meeting of the European Association for the Study of Diabetes.

The figure, which breaks down to about $73 million for cases occurring at the onset of diabetes and $185 million for already established cases, represents an increase of approximately 40% from 1995, when the total cost was $184 million ($48 million for new-onset diabetes patients and $136 million for established diabetes patients), said Dr. Arleta Rewers, a pediatric emergency physician, and Dr. Marian Rewers, a pediatric endocrinologist, both at the Children's Hospital, Denver, and the University of Colorado at Denver.

Those overall U.S. data were extrapolated from the 1,093 validated cases of diabetic ketoacidosis (DKA) among 777 patients seen at the Children's Hospital, Denver, during 1995–2006. The median age at DKA was 12.0 years (range 0–19 years).

Slightly more than half (55%) were female. Overall, 23% of patients were treated in the emergency department, 12% were in the observation unit (staying less than 24 hours), and 65% were hospitalized for a median of 1 day (range 1–61 days).

Total direct medical costs, including hospital charges and professional fees, were 67% higher for patients at the onset of diabetes (which was when 49% of all DKA events occurred) than for patients with established diabetes, with a median of $10,890 versus $8,010 for the entire 11-year period.

Two-thirds (66%) of the patients had private or HMO insurance, 27% had government insurance or indigent coverage, and 7% were uninsured.

Among those with new-onset diabetes, having indigent coverage or no insurance predicted a nearly fourfold higher cost of DKA treatment, after adjustment for gender, ethnicity, and age.

In contrast, there was no relationship between insurance status and the cost of DKA among patients with established diabetes, the two researchers reported.

After adjustment for inflation, the median direct cost of DKA treatment increased 20% from 1995–1996 ($8,836) to 2005–2006 ($10,551).

The cost extrapolations to the entire U.S. population were based on four sets of data: a previous study suggesting that the prevalence of DKA in newly diagnosed youth is approximately 25.5% (Pediatric News, August 2005, p. 7; Family Practice News, Nov. 1, 2005, p. 27); another finding that the incidence of DKA in patients with established diabetes is 8 per 100 patients per year; estimates of the prevalence and incidence of diabetes among youth from the SEARCH for Diabetes in Youth study database; and U.S. census population data.

The reason that DKA is more costly in newly diagnosed cases—especially those with suboptimal insurance—is likely because of more severe presentation and lower family resources for transition to outpatient management, the researchers said.

AMSTERDAM — In type 1 diabetic patients with diabetic nephropathy, 40 mg/day of lisinopril appears to be the ideal dose for renoprotection, Dr. Katrine J. Schjoedt said in a poster presentation at the annual meeting of the European Association for the Study of Diabetes.

Angiotensin converting enzyme inhibitors such as lisinopril are considered first-line agents for renoprotection in patients with type 1 diabetes who have nephropathy, because these drugs reduce albuminuria in addition to lowering blood pressure. The currently recommended 20 mg/day dose of lisinopril is based on the drug's blood pressure-lowering effect; the optimal dose for renoprotection has not been established, said Dr. Schjoedt of the Steno Diabetes Center, Gentofte, Denmark.

To evaluate whether additional renoprotective effects could be obtained with higher doses of lisinopril, 56 type 1 diabetic patients with diabetic nephropathy were taken off all ongoing antihypertensive therapy and put on fixed doses (median 60 mg/day) of slow-release furosemide for the entire study. After a 2-month washout period, the patients were randomized to receive 20, 40, or 60 mg/day of lisinopril for 2 months.

The 49 patients who completed the trial had a mean age of 49 years and a diabetes duration of 33 years; two-thirds of them were men. At baseline, they had a mean blood pressure of 142/74 mm Hg, a mean urinary albumin excretion rate of 362 mg/24 hours, and a mean estimated glomerular filtration rate of 75 mL/min per 1.73 m

The mean urinary albumin excretion rate fell by 71% from baseline with 40 mg lisinopril, by 70% with 60 mg, and by 63% with 20 mg. All of the reductions from baseline were significant. The 40-mg group and the 60-mg group both had significant reductions in urinary albumin excretion rate, compared with the 20-mg group, but the difference between the 60-mg and 40-mg groups was not significant.

“High [40 mg] doses of lisinopril offer additional renoprotection in comparison to the currently recommended dose [20 mg]. Ultrahigh [60 mg] doses do not offer any further beneficial effect,” Dr. Schjoedt remarked.

All three dose groups also had significant reductions in blood pressure from baseline: Systolic pressure fell by 10, 13, and 12 mm Hg and diastolic pressure fell by 6, 8, and 7 mm Hg with lisinopril doses of 20, 40, and 60 mg/day, respectively. In addition, there was a dose-dependent reduction in estimated glomerular filtration rate, from 75 mL/min per 1.73 m

Adverse events leading to study dropout were an increase in plasma creatinine in two patients (one on the 20-mg dose and one on the 60-mg dose), high blood pressure in one patient in the 60-mg group, mild dizziness in two patients (on 40 mg and 60 mg), mild diarrhea in one (on 40 mg), and restless legs in one (on 20 mg). There were dose-dependent decreases in hemoglobin (down to 7.8 mmol/L with the 60- and 40-mg doses, compared with 8.3 mmol/L at baseline), and a significant increase in hemoglobin A_1c in the 60-mg group (rising to 8.9%, compared with 8.6% at baseline).

Nonetheless, Dr. Schjoedt concluded, “high doses of lisinopril are generally well tolerated and safe.”

High doses of lisinopril offer additional renoprotection. Ultrahigh doses offer no additional benefit. DR. SCHJOEDT

AMSTERDAM — In type 1 diabetic patients with diabetic nephropathy, 40 mg/day of lisinopril appears to be the ideal dose for renoprotection, Dr. Katrine J. Schjoedt said in a poster presentation at the annual meeting of the European Association for the Study of Diabetes.

Angiotensin converting enzyme inhibitors such as lisinopril are considered first-line agents for renoprotection in patients with type 1 diabetes who have nephropathy, because these drugs reduce albuminuria in addition to lowering blood pressure. The currently recommended 20 mg/day dose of lisinopril is based on the drug's blood pressure-lowering effect; the optimal dose for renoprotection has not been established, said Dr. Schjoedt of the Steno Diabetes Center, Gentofte, Denmark.

To evaluate whether additional renoprotective effects could be obtained with higher doses of lisinopril, 56 type 1 diabetic patients with diabetic nephropathy were taken off all ongoing antihypertensive therapy and put on fixed doses (median 60 mg/day) of slow-release furosemide for the entire study. After a 2-month washout period, the patients were randomized to receive 20, 40, or 60 mg/day of lisinopril for 2 months.

The 49 patients who completed the trial had a mean age of 49 years and a diabetes duration of 33 years; two-thirds of them were men. At baseline, they had a mean blood pressure of 142/74 mm Hg, a mean urinary albumin excretion rate of 362 mg/24 hours, and a mean estimated glomerular filtration rate of 75 mL/min per 1.73 m

The mean urinary albumin excretion rate fell by 71% from baseline with 40 mg lisinopril, by 70% with 60 mg, and by 63% with 20 mg. All of the reductions from baseline were significant. The 40-mg group and the 60-mg group both had significant reductions in urinary albumin excretion rate, compared with the 20-mg group, but the difference between the 60-mg and 40-mg groups was not significant.

“High [40 mg] doses of lisinopril offer additional renoprotection in comparison to the currently recommended dose [20 mg]. Ultrahigh [60 mg] doses do not offer any further beneficial effect,” Dr. Schjoedt remarked.

All three dose groups also had significant reductions in blood pressure from baseline: Systolic pressure fell by 10, 13, and 12 mm Hg and diastolic pressure fell by 6, 8, and 7 mm Hg with lisinopril doses of 20, 40, and 60 mg/day, respectively. In addition, there was a dose-dependent reduction in estimated glomerular filtration rate, from 75 mL/min per 1.73 m

Adverse events leading to study dropout were an increase in plasma creatinine in two patients (one on the 20-mg dose and one on the 60-mg dose), high blood pressure in one patient in the 60-mg group, mild dizziness in two patients (on 40 mg and 60 mg), mild diarrhea in one (on 40 mg), and restless legs in one (on 20 mg). There were dose-dependent decreases in hemoglobin (down to 7.8 mmol/L with the 60- and 40-mg doses, compared with 8.3 mmol/L at baseline), and a significant increase in hemoglobin A_1c in the 60-mg group (rising to 8.9%, compared with 8.6% at baseline).

Nonetheless, Dr. Schjoedt concluded, “high doses of lisinopril are generally well tolerated and safe.”

High doses of lisinopril offer additional renoprotection. Ultrahigh doses offer no additional benefit. DR. SCHJOEDT

AMSTERDAM — In type 1 diabetic patients with diabetic nephropathy, 40 mg/day of lisinopril appears to be the ideal dose for renoprotection, Dr. Katrine J. Schjoedt said in a poster presentation at the annual meeting of the European Association for the Study of Diabetes.

Angiotensin converting enzyme inhibitors such as lisinopril are considered first-line agents for renoprotection in patients with type 1 diabetes who have nephropathy, because these drugs reduce albuminuria in addition to lowering blood pressure. The currently recommended 20 mg/day dose of lisinopril is based on the drug's blood pressure-lowering effect; the optimal dose for renoprotection has not been established, said Dr. Schjoedt of the Steno Diabetes Center, Gentofte, Denmark.

To evaluate whether additional renoprotective effects could be obtained with higher doses of lisinopril, 56 type 1 diabetic patients with diabetic nephropathy were taken off all ongoing antihypertensive therapy and put on fixed doses (median 60 mg/day) of slow-release furosemide for the entire study. After a 2-month washout period, the patients were randomized to receive 20, 40, or 60 mg/day of lisinopril for 2 months.

The 49 patients who completed the trial had a mean age of 49 years and a diabetes duration of 33 years; two-thirds of them were men. At baseline, they had a mean blood pressure of 142/74 mm Hg, a mean urinary albumin excretion rate of 362 mg/24 hours, and a mean estimated glomerular filtration rate of 75 mL/min per 1.73 m

The mean urinary albumin excretion rate fell by 71% from baseline with 40 mg lisinopril, by 70% with 60 mg, and by 63% with 20 mg. All of the reductions from baseline were significant. The 40-mg group and the 60-mg group both had significant reductions in urinary albumin excretion rate, compared with the 20-mg group, but the difference between the 60-mg and 40-mg groups was not significant.

“High [40 mg] doses of lisinopril offer additional renoprotection in comparison to the currently recommended dose [20 mg]. Ultrahigh [60 mg] doses do not offer any further beneficial effect,” Dr. Schjoedt remarked.

All three dose groups also had significant reductions in blood pressure from baseline: Systolic pressure fell by 10, 13, and 12 mm Hg and diastolic pressure fell by 6, 8, and 7 mm Hg with lisinopril doses of 20, 40, and 60 mg/day, respectively. In addition, there was a dose-dependent reduction in estimated glomerular filtration rate, from 75 mL/min per 1.73 m

Adverse events leading to study dropout were an increase in plasma creatinine in two patients (one on the 20-mg dose and one on the 60-mg dose), high blood pressure in one patient in the 60-mg group, mild dizziness in two patients (on 40 mg and 60 mg), mild diarrhea in one (on 40 mg), and restless legs in one (on 20 mg). There were dose-dependent decreases in hemoglobin (down to 7.8 mmol/L with the 60- and 40-mg doses, compared with 8.3 mmol/L at baseline), and a significant increase in hemoglobin A_1c in the 60-mg group (rising to 8.9%, compared with 8.6% at baseline).

Nonetheless, Dr. Schjoedt concluded, “high doses of lisinopril are generally well tolerated and safe.”

High doses of lisinopril offer additional renoprotection. Ultrahigh doses offer no additional benefit. DR. SCHJOEDT

AMSTERDAM — Treating all women with previous gestational diabetes mellitus for GDM early in their subsequent pregnancies—without rescreening them—is likely to improve maternal and fetal outcomes, Dr. Christina S. Cotzias said at the annual meeting of the European Association for the Study of Diabetes.

Recurrence rates of GDM range from about 30% to 70%. In general, the heavier and less white the population, the greater the GDM recurrence rate. And among women who do have GDM recurrence, some studies have suggested that glucose intolerance may occur earlier in subsequent pregnancies than in the initial one, said Dr. Cotzias of the department of obstetrics and gynecology at West Middlesex University Hospital, Isleworth, England.

“In a heavy, multiethnic, insulin-resistant population, seeing all women with a history of GDM early in their next pregnancy to start treatment for GDM seems to optimize fetomaternal outcomes. To leave this population until screening is performed could be detrimental for both mother and baby,” she said.

Middlesex hospital's obstetric unit serves a multiethnic community with a large Asian population. More than 70% of the center's GDM population is nonwhite. All pregnant women are asked if they had GDM in a prior pregnancy, and if so, they are immediately referred to a combined obstetric/endocrine clinic, where they receive education and counseling about GDM and its implications, diet and exercise, and self blood glucose monitoring.

Primigravidas and women who do not report having had GDM in a previous pregnancy are selectively screened for GDM based on a list of risk factors. Women identified with risk factors are screened at 28 weeks with a 50-g oral glucose challenge, and if the result is 7.8 mmol/L (140 mg/dL) or greater, a formal 75-g oral glucose tolerance test is done. If the fasting glucose at the time of the test is above 6 mmol/L (108 mg/dL) or if the 2-hour value is greater than 9 mmol/L (162 mg/dL), the patient then receives the GDM education and counseling. Insulin therapy is initiated if the patient's glucose values exceed 6 mmol/L (108 mg/dL) fasting and 8 mmol/L (144 mg/dL) at 2 hours postprandial with lifestyle modification alone. Women who receive insulin therapy are delivered between 38 and 40 weeks' gestation, Dr. Cotzias noted.

A retrospective case note analysis was performed for 419 women who were treated for GDM at Middlesex Hospital during 2000–2005, of whom 123 (29%) had GDM in a prior pregnancy and 296 (71%) did not. Those with previous GDM were significantly older (median age 34 years vs. 32 years), and heavier (BMI 29 vs. 27), but there were no differences in ethnicity between the groups, both of which were approximately one-half Asian, one-quarter white, and about one-fifth black; the remainder were other ethnicities.

Hemoglobin A_1c levels were significantly higher among the women with previous GDM: 27% were at or above 7%, compared with just 15% among those newly diagnosed with GDM. The women with previous GDM were seen in the obstetric/endocrine clinic sooner in their pregnancies than were those without the history (median 16 vs. 32 weeks). They were much more likely to require insulin therapy (67% vs. 47%), and to be started on insulin sooner (25 vs. 34 weeks' gestation).

Importantly, of the 82 women in the previous GDM group who required insulin, nearly two-thirds (48, or 59%) needed it prior to 28 weeks' gestation, the time of routine GDM screening. “If we waited to screen those women, we would miss nearly 60% of those who need insulin before 28 weeks,” Dr. Cotzias noted.

Exactly half of each group had spontaneous vaginal delivery; cesarean section rates also did not differ significantly in the two groups (44% of those with previous GDM and 40% of those without). There were no significant differences between the two groups in any neonatal outcome, including shoulder dystocia, stillbirth, neonatal abnormality, or birth weight.

Of the women who came back for follow-up after delivery, 23% of 66 with previous GDM and 22% of the 188 without—an insignificant difference—had abnormal glucose tolerance test results.

'If we waited to screen those women, we would miss nearly 60% of those who need insulin before 28 weeks.' DR. COTZIAS

AMSTERDAM — Treating all women with previous gestational diabetes mellitus for GDM early in their subsequent pregnancies—without rescreening them—is likely to improve maternal and fetal outcomes, Dr. Christina S. Cotzias said at the annual meeting of the European Association for the Study of Diabetes.

Recurrence rates of GDM range from about 30% to 70%. In general, the heavier and less white the population, the greater the GDM recurrence rate. And among women who do have GDM recurrence, some studies have suggested that glucose intolerance may occur earlier in subsequent pregnancies than in the initial one, said Dr. Cotzias of the department of obstetrics and gynecology at West Middlesex University Hospital, Isleworth, England.

“In a heavy, multiethnic, insulin-resistant population, seeing all women with a history of GDM early in their next pregnancy to start treatment for GDM seems to optimize fetomaternal outcomes. To leave this population until screening is performed could be detrimental for both mother and baby,” she said.

Middlesex hospital's obstetric unit serves a multiethnic community with a large Asian population. More than 70% of the center's GDM population is nonwhite. All pregnant women are asked if they had GDM in a prior pregnancy, and if so, they are immediately referred to a combined obstetric/endocrine clinic, where they receive education and counseling about GDM and its implications, diet and exercise, and self blood glucose monitoring.

Primigravidas and women who do not report having had GDM in a previous pregnancy are selectively screened for GDM based on a list of risk factors. Women identified with risk factors are screened at 28 weeks with a 50-g oral glucose challenge, and if the result is 7.8 mmol/L (140 mg/dL) or greater, a formal 75-g oral glucose tolerance test is done. If the fasting glucose at the time of the test is above 6 mmol/L (108 mg/dL) or if the 2-hour value is greater than 9 mmol/L (162 mg/dL), the patient then receives the GDM education and counseling. Insulin therapy is initiated if the patient's glucose values exceed 6 mmol/L (108 mg/dL) fasting and 8 mmol/L (144 mg/dL) at 2 hours postprandial with lifestyle modification alone. Women who receive insulin therapy are delivered between 38 and 40 weeks' gestation, Dr. Cotzias noted.

A retrospective case note analysis was performed for 419 women who were treated for GDM at Middlesex Hospital during 2000–2005, of whom 123 (29%) had GDM in a prior pregnancy and 296 (71%) did not. Those with previous GDM were significantly older (median age 34 years vs. 32 years), and heavier (BMI 29 vs. 27), but there were no differences in ethnicity between the groups, both of which were approximately one-half Asian, one-quarter white, and about one-fifth black; the remainder were other ethnicities.

Hemoglobin A_1c levels were significantly higher among the women with previous GDM: 27% were at or above 7%, compared with just 15% among those newly diagnosed with GDM. The women with previous GDM were seen in the obstetric/endocrine clinic sooner in their pregnancies than were those without the history (median 16 vs. 32 weeks). They were much more likely to require insulin therapy (67% vs. 47%), and to be started on insulin sooner (25 vs. 34 weeks' gestation).

Importantly, of the 82 women in the previous GDM group who required insulin, nearly two-thirds (48, or 59%) needed it prior to 28 weeks' gestation, the time of routine GDM screening. “If we waited to screen those women, we would miss nearly 60% of those who need insulin before 28 weeks,” Dr. Cotzias noted.

Exactly half of each group had spontaneous vaginal delivery; cesarean section rates also did not differ significantly in the two groups (44% of those with previous GDM and 40% of those without). There were no significant differences between the two groups in any neonatal outcome, including shoulder dystocia, stillbirth, neonatal abnormality, or birth weight.

Of the women who came back for follow-up after delivery, 23% of 66 with previous GDM and 22% of the 188 without—an insignificant difference—had abnormal glucose tolerance test results.

'If we waited to screen those women, we would miss nearly 60% of those who need insulin before 28 weeks.' DR. COTZIAS

AMSTERDAM — Treating all women with previous gestational diabetes mellitus for GDM early in their subsequent pregnancies—without rescreening them—is likely to improve maternal and fetal outcomes, Dr. Christina S. Cotzias said at the annual meeting of the European Association for the Study of Diabetes.

Recurrence rates of GDM range from about 30% to 70%. In general, the heavier and less white the population, the greater the GDM recurrence rate. And among women who do have GDM recurrence, some studies have suggested that glucose intolerance may occur earlier in subsequent pregnancies than in the initial one, said Dr. Cotzias of the department of obstetrics and gynecology at West Middlesex University Hospital, Isleworth, England.

“In a heavy, multiethnic, insulin-resistant population, seeing all women with a history of GDM early in their next pregnancy to start treatment for GDM seems to optimize fetomaternal outcomes. To leave this population until screening is performed could be detrimental for both mother and baby,” she said.

Middlesex hospital's obstetric unit serves a multiethnic community with a large Asian population. More than 70% of the center's GDM population is nonwhite. All pregnant women are asked if they had GDM in a prior pregnancy, and if so, they are immediately referred to a combined obstetric/endocrine clinic, where they receive education and counseling about GDM and its implications, diet and exercise, and self blood glucose monitoring.

Primigravidas and women who do not report having had GDM in a previous pregnancy are selectively screened for GDM based on a list of risk factors. Women identified with risk factors are screened at 28 weeks with a 50-g oral glucose challenge, and if the result is 7.8 mmol/L (140 mg/dL) or greater, a formal 75-g oral glucose tolerance test is done. If the fasting glucose at the time of the test is above 6 mmol/L (108 mg/dL) or if the 2-hour value is greater than 9 mmol/L (162 mg/dL), the patient then receives the GDM education and counseling. Insulin therapy is initiated if the patient's glucose values exceed 6 mmol/L (108 mg/dL) fasting and 8 mmol/L (144 mg/dL) at 2 hours postprandial with lifestyle modification alone. Women who receive insulin therapy are delivered between 38 and 40 weeks' gestation, Dr. Cotzias noted.

A retrospective case note analysis was performed for 419 women who were treated for GDM at Middlesex Hospital during 2000–2005, of whom 123 (29%) had GDM in a prior pregnancy and 296 (71%) did not. Those with previous GDM were significantly older (median age 34 years vs. 32 years), and heavier (BMI 29 vs. 27), but there were no differences in ethnicity between the groups, both of which were approximately one-half Asian, one-quarter white, and about one-fifth black; the remainder were other ethnicities.

Hemoglobin A_1c levels were significantly higher among the women with previous GDM: 27% were at or above 7%, compared with just 15% among those newly diagnosed with GDM. The women with previous GDM were seen in the obstetric/endocrine clinic sooner in their pregnancies than were those without the history (median 16 vs. 32 weeks). They were much more likely to require insulin therapy (67% vs. 47%), and to be started on insulin sooner (25 vs. 34 weeks' gestation).

Importantly, of the 82 women in the previous GDM group who required insulin, nearly two-thirds (48, or 59%) needed it prior to 28 weeks' gestation, the time of routine GDM screening. “If we waited to screen those women, we would miss nearly 60% of those who need insulin before 28 weeks,” Dr. Cotzias noted.

Exactly half of each group had spontaneous vaginal delivery; cesarean section rates also did not differ significantly in the two groups (44% of those with previous GDM and 40% of those without). There were no significant differences between the two groups in any neonatal outcome, including shoulder dystocia, stillbirth, neonatal abnormality, or birth weight.

Of the women who came back for follow-up after delivery, 23% of 66 with previous GDM and 22% of the 188 without—an insignificant difference—had abnormal glucose tolerance test results.

'If we waited to screen those women, we would miss nearly 60% of those who need insulin before 28 weeks.' DR. COTZIAS

AMSTERDAM — A novel gastric electrical stimulation device can potentially improve glucose levels and induce weight loss in obese patients with type 2 diabetes on oral antihyperglycemic therapy, Dr. Christoph Rosak said in a poster presentation at the annual meeting of the European Association for the Study of Diabetes.

The implantable device, called the Tantalus system, is manufactured by MetaCure Ltd. It has met marketing requirements in Europe (CE marking) and is indicated for the treatment of both type 2 diabetes and obesity (defined as a body mass index of 30–50 kg/m

The Tantalus system comprises a pulse generator and bipolar leads that are implanted laparoscopically in the antrum and fundus of the stomach. When food intake occurs, the system delivers nonexcitatory electrical stimulation to the gastric wall, thereby increasing the amplitude of the contractions and allowing the vagal nerve to send a signal to the brain, triggering earlier satiety. Previous data suggested that the device could safely produce clinically significant weight loss and reduce blood pressure in morbidly obese individuals at 1 year (Obes. Surg. 2006;16:627–34).

In the current phase II open-label study, 24 obese patients with type 2 diabetes were implanted with the Tantalus. Subjects included 9 men and 15 women, with a mean BMI of 41.7. In all, 7 patients used insulin; the other 17 took oral antihyperglycemic medication. The 16 patients on oral diabetes drugs who completed a 1-year follow-up showed a significant mean weight loss of 5.5 kg and reductions in waist circumference, Dr. Rosak, of Krankenhaus Sachsenhausen, Frankfurt, Germany, said during the poster presentation.

A subset of eight patients who were initially not well controlled (hemoglobin A_1c greater than 7%) on stable oral medications had a significant decrease in mean HbA_1c from 8.34% to 7.44%, and a drop in fasting plasma glucose from 206 mg/dL to 158 mg/dL. Available data on self glucose monitoring showed a significant decrease in 2-hour postprandial levels from 176 mg/dL to 141 mg/dL. The other eight patients on oral agents either changed their medication regime during treatment or had been well controlled initially, Dr. Rosak said.

In contrast, the four insulin-treated subjects who completed the 1-year study showed no significant changes in HbA_1c or weight. It's not clear why insulin-treated patients don't respond as well to the Tantalus, but one theory is that exogenous insulin may interfere with the vagal signal, he said.

Dr. Harold Lebovitz, professor of medicine at the State University of New York Downstate Medical Center, Brooklyn, and a consultant to MetaCure, said the Tantalus could “improve glycemic control with an associated weight loss in type 2 diabetic patients inadequately controlled on combinations of oral agents.”

It may also work in insulin-treated patients, he said, noting that some of the insulin-treated patients in the study were adjusting their premeal bolus doses, which would have masked the device's effect. “The meaningful data were the results in the patients on oral agents since their medication doses were kept constant” he said.

Patients on insulin don't respond as well to the device [because] exogenous insulin may interfere with the vagal signal. DR. ROSAK

ELSEVIER GLOBAL MEDICAL NEWS

AMSTERDAM — A novel gastric electrical stimulation device can potentially improve glucose levels and induce weight loss in obese patients with type 2 diabetes on oral antihyperglycemic therapy, Dr. Christoph Rosak said in a poster presentation at the annual meeting of the European Association for the Study of Diabetes.

The implantable device, called the Tantalus system, is manufactured by MetaCure Ltd. It has met marketing requirements in Europe (CE marking) and is indicated for the treatment of both type 2 diabetes and obesity (defined as a body mass index of 30–50 kg/m

The Tantalus system comprises a pulse generator and bipolar leads that are implanted laparoscopically in the antrum and fundus of the stomach. When food intake occurs, the system delivers nonexcitatory electrical stimulation to the gastric wall, thereby increasing the amplitude of the contractions and allowing the vagal nerve to send a signal to the brain, triggering earlier satiety. Previous data suggested that the device could safely produce clinically significant weight loss and reduce blood pressure in morbidly obese individuals at 1 year (Obes. Surg. 2006;16:627–34).

In the current phase II open-label study, 24 obese patients with type 2 diabetes were implanted with the Tantalus. Subjects included 9 men and 15 women, with a mean BMI of 41.7. In all, 7 patients used insulin; the other 17 took oral antihyperglycemic medication. The 16 patients on oral diabetes drugs who completed a 1-year follow-up showed a significant mean weight loss of 5.5 kg and reductions in waist circumference, Dr. Rosak, of Krankenhaus Sachsenhausen, Frankfurt, Germany, said during the poster presentation.

A subset of eight patients who were initially not well controlled (hemoglobin A_1c greater than 7%) on stable oral medications had a significant decrease in mean HbA_1c from 8.34% to 7.44%, and a drop in fasting plasma glucose from 206 mg/dL to 158 mg/dL. Available data on self glucose monitoring showed a significant decrease in 2-hour postprandial levels from 176 mg/dL to 141 mg/dL. The other eight patients on oral agents either changed their medication regime during treatment or had been well controlled initially, Dr. Rosak said.

In contrast, the four insulin-treated subjects who completed the 1-year study showed no significant changes in HbA_1c or weight. It's not clear why insulin-treated patients don't respond as well to the Tantalus, but one theory is that exogenous insulin may interfere with the vagal signal, he said.

Dr. Harold Lebovitz, professor of medicine at the State University of New York Downstate Medical Center, Brooklyn, and a consultant to MetaCure, said the Tantalus could “improve glycemic control with an associated weight loss in type 2 diabetic patients inadequately controlled on combinations of oral agents.”

It may also work in insulin-treated patients, he said, noting that some of the insulin-treated patients in the study were adjusting their premeal bolus doses, which would have masked the device's effect. “The meaningful data were the results in the patients on oral agents since their medication doses were kept constant” he said.

Patients on insulin don't respond as well to the device [because] exogenous insulin may interfere with the vagal signal. DR. ROSAK

ELSEVIER GLOBAL MEDICAL NEWS

AMSTERDAM — A novel gastric electrical stimulation device can potentially improve glucose levels and induce weight loss in obese patients with type 2 diabetes on oral antihyperglycemic therapy, Dr. Christoph Rosak said in a poster presentation at the annual meeting of the European Association for the Study of Diabetes.

The implantable device, called the Tantalus system, is manufactured by MetaCure Ltd. It has met marketing requirements in Europe (CE marking) and is indicated for the treatment of both type 2 diabetes and obesity (defined as a body mass index of 30–50 kg/m

The Tantalus system comprises a pulse generator and bipolar leads that are implanted laparoscopically in the antrum and fundus of the stomach. When food intake occurs, the system delivers nonexcitatory electrical stimulation to the gastric wall, thereby increasing the amplitude of the contractions and allowing the vagal nerve to send a signal to the brain, triggering earlier satiety. Previous data suggested that the device could safely produce clinically significant weight loss and reduce blood pressure in morbidly obese individuals at 1 year (Obes. Surg. 2006;16:627–34).

In the current phase II open-label study, 24 obese patients with type 2 diabetes were implanted with the Tantalus. Subjects included 9 men and 15 women, with a mean BMI of 41.7. In all, 7 patients used insulin; the other 17 took oral antihyperglycemic medication. The 16 patients on oral diabetes drugs who completed a 1-year follow-up showed a significant mean weight loss of 5.5 kg and reductions in waist circumference, Dr. Rosak, of Krankenhaus Sachsenhausen, Frankfurt, Germany, said during the poster presentation.

A subset of eight patients who were initially not well controlled (hemoglobin A_1c greater than 7%) on stable oral medications had a significant decrease in mean HbA_1c from 8.34% to 7.44%, and a drop in fasting plasma glucose from 206 mg/dL to 158 mg/dL. Available data on self glucose monitoring showed a significant decrease in 2-hour postprandial levels from 176 mg/dL to 141 mg/dL. The other eight patients on oral agents either changed their medication regime during treatment or had been well controlled initially, Dr. Rosak said.

In contrast, the four insulin-treated subjects who completed the 1-year study showed no significant changes in HbA_1c or weight. It's not clear why insulin-treated patients don't respond as well to the Tantalus, but one theory is that exogenous insulin may interfere with the vagal signal, he said.

Dr. Harold Lebovitz, professor of medicine at the State University of New York Downstate Medical Center, Brooklyn, and a consultant to MetaCure, said the Tantalus could “improve glycemic control with an associated weight loss in type 2 diabetic patients inadequately controlled on combinations of oral agents.”

It may also work in insulin-treated patients, he said, noting that some of the insulin-treated patients in the study were adjusting their premeal bolus doses, which would have masked the device's effect. “The meaningful data were the results in the patients on oral agents since their medication doses were kept constant” he said.

Patients on insulin don't respond as well to the device [because] exogenous insulin may interfere with the vagal signal. DR. ROSAK

ELSEVIER GLOBAL MEDICAL NEWS

Cardiovascular disease affected approximately 6 million diabetic adults aged 35 years and older in the United States in 2005, according to the Centers for Disease Control and Prevention.

Reseachers at the CDC analyzed data from the National Health Interview Survey on the prevalence of heart disease, stroke, and other cardiovascular diseases among persons with diabetes during 1997–2005. In that period, the age-adjusted prevalence of diagnosed diabetes in the United States increased 43%, from 3.7% in 1997 to 5.3% in 2005, according to the report (MMWR 2007;56:1129–32).

During 1997–2005, the annual number of survey respondents aged 35 and older who reported having both diabetes and CVD ranged from approximately 3,700 to 6,800 (out of a total of 31,000–36,000). Although the prevalence of individuals with both disorders did increase overall by 36% during the study period, the age-adjusted overall prevalence actually decreased by 11%, from 37% to 32.5%. The drop indicates that the number of people diagnosed with diabetes during that time exceeded the number with both diabetes and CVD, the report explained.

Broken down by age group, the age-specific prevalence of self-reported CVD among those aged 35–64 years with diabetes decreased by 14%, from 31% in 1997 to 27% in 2005, while the prevalence did not change significantly over time in older groups (from 46% to 51% in individuals aged 65–74 and from 53%–57% among those aged 75 and older).

Overall during the study period, the age-adjusted prevalence of CVD was higher among men than women, higher among whites than blacks, and higher among non-Hispanics than Hispanics. The age-adjusted prevalence decreased significantly in women (by 11%) but not in men, and in blacks (by 25%) but not in whites. It also decreased significantly among non-Hispanics (by 12%), while there was no clear trend among Hispanics, according to the CDC.

The decrease in self-reported CVD prevalence among diagnosed diabetic patients may relate to the fact that the median duration of diabetes has declined significantly overall. Also, decreases in risk factors such as total cholesterol level, blood pressure, and smoking may contribute, along with the increased use of preventive medications such as statins and aspirin, the report noted.

Cardiovascular disease affected approximately 6 million diabetic adults aged 35 years and older in the United States in 2005, according to the Centers for Disease Control and Prevention.

Reseachers at the CDC analyzed data from the National Health Interview Survey on the prevalence of heart disease, stroke, and other cardiovascular diseases among persons with diabetes during 1997–2005. In that period, the age-adjusted prevalence of diagnosed diabetes in the United States increased 43%, from 3.7% in 1997 to 5.3% in 2005, according to the report (MMWR 2007;56:1129–32).

During 1997–2005, the annual number of survey respondents aged 35 and older who reported having both diabetes and CVD ranged from approximately 3,700 to 6,800 (out of a total of 31,000–36,000). Although the prevalence of individuals with both disorders did increase overall by 36% during the study period, the age-adjusted overall prevalence actually decreased by 11%, from 37% to 32.5%. The drop indicates that the number of people diagnosed with diabetes during that time exceeded the number with both diabetes and CVD, the report explained.

Broken down by age group, the age-specific prevalence of self-reported CVD among those aged 35–64 years with diabetes decreased by 14%, from 31% in 1997 to 27% in 2005, while the prevalence did not change significantly over time in older groups (from 46% to 51% in individuals aged 65–74 and from 53%–57% among those aged 75 and older).

Overall during the study period, the age-adjusted prevalence of CVD was higher among men than women, higher among whites than blacks, and higher among non-Hispanics than Hispanics. The age-adjusted prevalence decreased significantly in women (by 11%) but not in men, and in blacks (by 25%) but not in whites. It also decreased significantly among non-Hispanics (by 12%), while there was no clear trend among Hispanics, according to the CDC.

The decrease in self-reported CVD prevalence among diagnosed diabetic patients may relate to the fact that the median duration of diabetes has declined significantly overall. Also, decreases in risk factors such as total cholesterol level, blood pressure, and smoking may contribute, along with the increased use of preventive medications such as statins and aspirin, the report noted.

Cardiovascular disease affected approximately 6 million diabetic adults aged 35 years and older in the United States in 2005, according to the Centers for Disease Control and Prevention.

Reseachers at the CDC analyzed data from the National Health Interview Survey on the prevalence of heart disease, stroke, and other cardiovascular diseases among persons with diabetes during 1997–2005. In that period, the age-adjusted prevalence of diagnosed diabetes in the United States increased 43%, from 3.7% in 1997 to 5.3% in 2005, according to the report (MMWR 2007;56:1129–32).

During 1997–2005, the annual number of survey respondents aged 35 and older who reported having both diabetes and CVD ranged from approximately 3,700 to 6,800 (out of a total of 31,000–36,000). Although the prevalence of individuals with both disorders did increase overall by 36% during the study period, the age-adjusted overall prevalence actually decreased by 11%, from 37% to 32.5%. The drop indicates that the number of people diagnosed with diabetes during that time exceeded the number with both diabetes and CVD, the report explained.

Broken down by age group, the age-specific prevalence of self-reported CVD among those aged 35–64 years with diabetes decreased by 14%, from 31% in 1997 to 27% in 2005, while the prevalence did not change significantly over time in older groups (from 46% to 51% in individuals aged 65–74 and from 53%–57% among those aged 75 and older).

Overall during the study period, the age-adjusted prevalence of CVD was higher among men than women, higher among whites than blacks, and higher among non-Hispanics than Hispanics. The age-adjusted prevalence decreased significantly in women (by 11%) but not in men, and in blacks (by 25%) but not in whites. It also decreased significantly among non-Hispanics (by 12%), while there was no clear trend among Hispanics, according to the CDC.

The decrease in self-reported CVD prevalence among diagnosed diabetic patients may relate to the fact that the median duration of diabetes has declined significantly overall. Also, decreases in risk factors such as total cholesterol level, blood pressure, and smoking may contribute, along with the increased use of preventive medications such as statins and aspirin, the report noted.

Nearly two-thirds of adults with diabetes in the United States perform self-monitoring of blood glucose at least daily, the Centers for Disease Control and Prevention reported.

The data come from the Behavioral Risk Factor Surveillance System, which surveys samples of more than 100,000 adults aged 18 years and older on a yearly basis. In 2006, 63% of respondents reported self-monitoring of blood glucose at least daily, compared with just 41% in 1997. Among those treated with insulin, the proportion rose to 87%, both figures exceeding the Healthy People 2010 national objective of 61%, the CDC said (MMWR 2007;56:1133–7).

Rates increased among all age groups from 1997 to 2006, from 44% to 66% for those aged 18–44 years, 43% to 62% among 45- to 64-year-olds, and from 37% to 66% among those aged 65–74 years.

The following factors were significantly positive associations with performing daily self-monitoring of blood glucose: having a high school education, compared with less education (adjusted odds ratio 1.4); having health insurance coverage (1.4); using oral medication only (2.7); using insulin only (11.0), or using both insulin and oral medication (7.8), compared with not using any medication. In addition, having annual physician visits was associated with an adjusted odds ratio ranging from 1.5 for 1–2 visits a year to 2.6 for 11 or more visits a year. Having ever taken a diabetes education course also significantly increased the odds of daily self-monitoring. By contrast, being male was associated with decreased odds of performing daily blood glucose monitoring (0.7).

Studies on the efficacy of daily blood glucose monitoring for patients with type 2 diabetes not treated with insulin remain inconclusive.

ELSEVIER GLOBAL MEDICAL NEWS

Nearly two-thirds of adults with diabetes in the United States perform self-monitoring of blood glucose at least daily, the Centers for Disease Control and Prevention reported.

The data come from the Behavioral Risk Factor Surveillance System, which surveys samples of more than 100,000 adults aged 18 years and older on a yearly basis. In 2006, 63% of respondents reported self-monitoring of blood glucose at least daily, compared with just 41% in 1997. Among those treated with insulin, the proportion rose to 87%, both figures exceeding the Healthy People 2010 national objective of 61%, the CDC said (MMWR 2007;56:1133–7).

Rates increased among all age groups from 1997 to 2006, from 44% to 66% for those aged 18–44 years, 43% to 62% among 45- to 64-year-olds, and from 37% to 66% among those aged 65–74 years.

The following factors were significantly positive associations with performing daily self-monitoring of blood glucose: having a high school education, compared with less education (adjusted odds ratio 1.4); having health insurance coverage (1.4); using oral medication only (2.7); using insulin only (11.0), or using both insulin and oral medication (7.8), compared with not using any medication. In addition, having annual physician visits was associated with an adjusted odds ratio ranging from 1.5 for 1–2 visits a year to 2.6 for 11 or more visits a year. Having ever taken a diabetes education course also significantly increased the odds of daily self-monitoring. By contrast, being male was associated with decreased odds of performing daily blood glucose monitoring (0.7).

Studies on the efficacy of daily blood glucose monitoring for patients with type 2 diabetes not treated with insulin remain inconclusive.

ELSEVIER GLOBAL MEDICAL NEWS

Nearly two-thirds of adults with diabetes in the United States perform self-monitoring of blood glucose at least daily, the Centers for Disease Control and Prevention reported.

The data come from the Behavioral Risk Factor Surveillance System, which surveys samples of more than 100,000 adults aged 18 years and older on a yearly basis. In 2006, 63% of respondents reported self-monitoring of blood glucose at least daily, compared with just 41% in 1997. Among those treated with insulin, the proportion rose to 87%, both figures exceeding the Healthy People 2010 national objective of 61%, the CDC said (MMWR 2007;56:1133–7).

Rates increased among all age groups from 1997 to 2006, from 44% to 66% for those aged 18–44 years, 43% to 62% among 45- to 64-year-olds, and from 37% to 66% among those aged 65–74 years.

The following factors were significantly positive associations with performing daily self-monitoring of blood glucose: having a high school education, compared with less education (adjusted odds ratio 1.4); having health insurance coverage (1.4); using oral medication only (2.7); using insulin only (11.0), or using both insulin and oral medication (7.8), compared with not using any medication. In addition, having annual physician visits was associated with an adjusted odds ratio ranging from 1.5 for 1–2 visits a year to 2.6 for 11 or more visits a year. Having ever taken a diabetes education course also significantly increased the odds of daily self-monitoring. By contrast, being male was associated with decreased odds of performing daily blood glucose monitoring (0.7).

Studies on the efficacy of daily blood glucose monitoring for patients with type 2 diabetes not treated with insulin remain inconclusive.

ELSEVIER GLOBAL MEDICAL NEWS

The question of whether all asymptomatic diabetic patients should be routinely screened for coronary artery disease—and if so, how—is still open, according to a consensus statement from the American Diabetes Association.

“Although the CAD-asymptomatic patient with diabetes is by definition at least at intermediate risk for cardiovascular disease events, it is difficult to support routine CAD screening for these patients,” the ADA document stated. “As previous recommendations for stratifying diabetic patients based upon the number of risk factors have not proven effective, the question remains whether there are individuals with diabetes in whom coronary artery imaging would seem particularly appropriate” (Diabetes Care 2007;30:2729–36).

Until more data become available, “we recommend testing for atherosclerosis or ischemia, perhaps with cardiac [computed tomography] as the initial test, be reserved for those in whom medical treatment goals cannot be met and for selected individuals in whom there is strong clinical suspicion of very high risk CAD,” said a six-member panel chaired by Dr. Jeroen J. Bax, of the department of cardiology at Leiden (the Netherlands) University Medical Center.

The new document updates the last ADA statement on the subject, published in 1998. Then, the advice was to base the decision to screen patients on risk-factor burden, baseline electrocardiogram findings, and whether there was clinical evidence of vascular disease at other sites. But the authors acknowledged their positions were based primarily on opinion, because few well-controlled clinical trial data were available at that time (Diabetes Care 1998;21:1551–9).

Since then, there has been greatly increased recognition of the prevalence and impact of CAD in people with diabetes. More is known about the role of inflammatory risk markers, and the benefit of primary and secondary cardiovascular disease risk factor modification on cardiac outcomes has been proven in several prospective interventional trials. Evidence has accumulated regarding newer CAD diagnostic tools, such as CT angiography, coronary artery calcium scoring, and cardiac magnetic resonance imaging. But, so far, there are not sufficient data to provide a “robust evidence-based recommendation” for CAD testing in diabetic patients, the panel said.

At the same time, studies that have looked specifically at asymptomatic type 2 diabetes patients have not supported the 1998 recommendation to screen only those patients with two or more risk factors, they noted. Based on these issues, the panel addressed the following four questions:

▸ Which patients with diabetes are at increased risk for adverse cardiovascular outcomes and should be screened? The goal of screening would be to identify a group of patients with high cardiac risk in whom outcomes might be improved through more aggressive risk-factor modification, medical surveillance, or revascularization. Among asymptomatic patients, potentially predictive clinical features include other atherosclerotic vascular disease; microalbuminuria and other chronic kidney disease; abnormal resting electrocardiogram; autonomic neuropathy; retinopathy; hyperglycemia; age older than 65 years and male gender; and the presence of multiple cardiac risk factors.

However, at least two trials have found that such risk factors do not always predict which patients will have abnormal screening tests. For example, the DIAD (Detection of Ischemia in Asymptomatic Diabetics) study showed that basing the decision to screen on clinical features alone would fail to identify 41% of patients with silent ischemia (Diabetes Care 2004;27:1954–61).

▸ What are the implications of an early diagnosis of coronary ischemia or atherosclerosis? Noninvasive imaging techniques are now available that can help define the degree of atherosclerosis and estimate the degree of narrowing in individual lesions.

However, the benefit of such images is not clear in a patient who receives aggressive medical risk-factor reduction therapy, which is already recommended for patients with diabetes. Presumably, the idea of using imaging is to identify asymptomatic patients with more extensive disease, in whom further testing would be indicated to identify those with significant inducible myocardial ischemia who might in turn then undergo coronary angiography and subsequent revascularization.

But although some data suggest that patients with ischemia involving 10% or more of the left ventricle have a better outcome after revascularization than do those on medical therapy alone, other data—such as those from the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) study, in which one-third of the 2,287 patients had diabetes—have cast doubt on the superiority of revascularization over medical treatment (Am. Heart J. 2006;151:1173–9).

▸ What tests, or sequence of tests, should be considered? With what frequencies should testing be done? The 1998 panel recommended that exercise ECG be used to screen patients believed to be at high risk, followed by imaging only in patients with abnormal resting ECGs. Since then, studies have demonstrated the prognostic value of cardiac CT in asymptomatic patients, including those with diabetes.

Thus, although prospective trial data are still lacking, if “in the judgment of the clinician, an asymptomatic patient is a candidate for CAD testing, it is reasonable to apply cardiac CT for detection of coronary artery calcification, using either electron beam or multislice technology, as the first step,” the panel recommended.

Several studies have suggested that a coronary calcium score of 400 or greater is associated with a high likelihood of inducible ischemia, including one study that looked specifically at asymptomatic patients with diabetes (Eur. Heart J. 2006;27:713–21).

Thus, if coronary calcium testing is performed, it “appears reasonable” to proceed with further testing in diabetes patients with coronary calcium scores greater than 400. Such further testing could be done with single photon emission tomography to assess myocardial perfusion, or with stress echocardiography to assess ischemic wall motion abnormalities, the panel said.

▸ What further research is needed to evaluate the effectiveness of these recommendations? As a first step, the development and testing of improved risk prediction models against data available from national registries would be particularly helpful in capturing general population risk data, Dr. Bax and his associates said.

In the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) study, patients with type 2 diabetes and documented CAD have been randomized to immediate revascularization combined with aggressive medical management, or a program of aggressive medical management with delayed or no revascularization. This study will provide important insight to assist in the development of strategies for the treatment of asymptomatic patients.

The question of whether all asymptomatic diabetic patients should be routinely screened for coronary artery disease—and if so, how—is still open, according to a consensus statement from the American Diabetes Association.

“Although the CAD-asymptomatic patient with diabetes is by definition at least at intermediate risk for cardiovascular disease events, it is difficult to support routine CAD screening for these patients,” the ADA document stated. “As previous recommendations for stratifying diabetic patients based upon the number of risk factors have not proven effective, the question remains whether there are individuals with diabetes in whom coronary artery imaging would seem particularly appropriate” (Diabetes Care 2007;30:2729–36).

Until more data become available, “we recommend testing for atherosclerosis or ischemia, perhaps with cardiac [computed tomography] as the initial test, be reserved for those in whom medical treatment goals cannot be met and for selected individuals in whom there is strong clinical suspicion of very high risk CAD,” said a six-member panel chaired by Dr. Jeroen J. Bax, of the department of cardiology at Leiden (the Netherlands) University Medical Center.

The new document updates the last ADA statement on the subject, published in 1998. Then, the advice was to base the decision to screen patients on risk-factor burden, baseline electrocardiogram findings, and whether there was clinical evidence of vascular disease at other sites. But the authors acknowledged their positions were based primarily on opinion, because few well-controlled clinical trial data were available at that time (Diabetes Care 1998;21:1551–9).

Since then, there has been greatly increased recognition of the prevalence and impact of CAD in people with diabetes. More is known about the role of inflammatory risk markers, and the benefit of primary and secondary cardiovascular disease risk factor modification on cardiac outcomes has been proven in several prospective interventional trials. Evidence has accumulated regarding newer CAD diagnostic tools, such as CT angiography, coronary artery calcium scoring, and cardiac magnetic resonance imaging. But, so far, there are not sufficient data to provide a “robust evidence-based recommendation” for CAD testing in diabetic patients, the panel said.

At the same time, studies that have looked specifically at asymptomatic type 2 diabetes patients have not supported the 1998 recommendation to screen only those patients with two or more risk factors, they noted. Based on these issues, the panel addressed the following four questions:

▸ Which patients with diabetes are at increased risk for adverse cardiovascular outcomes and should be screened? The goal of screening would be to identify a group of patients with high cardiac risk in whom outcomes might be improved through more aggressive risk-factor modification, medical surveillance, or revascularization. Among asymptomatic patients, potentially predictive clinical features include other atherosclerotic vascular disease; microalbuminuria and other chronic kidney disease; abnormal resting electrocardiogram; autonomic neuropathy; retinopathy; hyperglycemia; age older than 65 years and male gender; and the presence of multiple cardiac risk factors.

However, at least two trials have found that such risk factors do not always predict which patients will have abnormal screening tests. For example, the DIAD (Detection of Ischemia in Asymptomatic Diabetics) study showed that basing the decision to screen on clinical features alone would fail to identify 41% of patients with silent ischemia (Diabetes Care 2004;27:1954–61).

▸ What are the implications of an early diagnosis of coronary ischemia or atherosclerosis? Noninvasive imaging techniques are now available that can help define the degree of atherosclerosis and estimate the degree of narrowing in individual lesions.

However, the benefit of such images is not clear in a patient who receives aggressive medical risk-factor reduction therapy, which is already recommended for patients with diabetes. Presumably, the idea of using imaging is to identify asymptomatic patients with more extensive disease, in whom further testing would be indicated to identify those with significant inducible myocardial ischemia who might in turn then undergo coronary angiography and subsequent revascularization.

But although some data suggest that patients with ischemia involving 10% or more of the left ventricle have a better outcome after revascularization than do those on medical therapy alone, other data—such as those from the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) study, in which one-third of the 2,287 patients had diabetes—have cast doubt on the superiority of revascularization over medical treatment (Am. Heart J. 2006;151:1173–9).

▸ What tests, or sequence of tests, should be considered? With what frequencies should testing be done? The 1998 panel recommended that exercise ECG be used to screen patients believed to be at high risk, followed by imaging only in patients with abnormal resting ECGs. Since then, studies have demonstrated the prognostic value of cardiac CT in asymptomatic patients, including those with diabetes.

Thus, although prospective trial data are still lacking, if “in the judgment of the clinician, an asymptomatic patient is a candidate for CAD testing, it is reasonable to apply cardiac CT for detection of coronary artery calcification, using either electron beam or multislice technology, as the first step,” the panel recommended.

Several studies have suggested that a coronary calcium score of 400 or greater is associated with a high likelihood of inducible ischemia, including one study that looked specifically at asymptomatic patients with diabetes (Eur. Heart J. 2006;27:713–21).

Thus, if coronary calcium testing is performed, it “appears reasonable” to proceed with further testing in diabetes patients with coronary calcium scores greater than 400. Such further testing could be done with single photon emission tomography to assess myocardial perfusion, or with stress echocardiography to assess ischemic wall motion abnormalities, the panel said.

▸ What further research is needed to evaluate the effectiveness of these recommendations? As a first step, the development and testing of improved risk prediction models against data available from national registries would be particularly helpful in capturing general population risk data, Dr. Bax and his associates said.

In the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) study, patients with type 2 diabetes and documented CAD have been randomized to immediate revascularization combined with aggressive medical management, or a program of aggressive medical management with delayed or no revascularization. This study will provide important insight to assist in the development of strategies for the treatment of asymptomatic patients.

The question of whether all asymptomatic diabetic patients should be routinely screened for coronary artery disease—and if so, how—is still open, according to a consensus statement from the American Diabetes Association.

“Although the CAD-asymptomatic patient with diabetes is by definition at least at intermediate risk for cardiovascular disease events, it is difficult to support routine CAD screening for these patients,” the ADA document stated. “As previous recommendations for stratifying diabetic patients based upon the number of risk factors have not proven effective, the question remains whether there are individuals with diabetes in whom coronary artery imaging would seem particularly appropriate” (Diabetes Care 2007;30:2729–36).

Until more data become available, “we recommend testing for atherosclerosis or ischemia, perhaps with cardiac [computed tomography] as the initial test, be reserved for those in whom medical treatment goals cannot be met and for selected individuals in whom there is strong clinical suspicion of very high risk CAD,” said a six-member panel chaired by Dr. Jeroen J. Bax, of the department of cardiology at Leiden (the Netherlands) University Medical Center.

The new document updates the last ADA statement on the subject, published in 1998. Then, the advice was to base the decision to screen patients on risk-factor burden, baseline electrocardiogram findings, and whether there was clinical evidence of vascular disease at other sites. But the authors acknowledged their positions were based primarily on opinion, because few well-controlled clinical trial data were available at that time (Diabetes Care 1998;21:1551–9).

Since then, there has been greatly increased recognition of the prevalence and impact of CAD in people with diabetes. More is known about the role of inflammatory risk markers, and the benefit of primary and secondary cardiovascular disease risk factor modification on cardiac outcomes has been proven in several prospective interventional trials. Evidence has accumulated regarding newer CAD diagnostic tools, such as CT angiography, coronary artery calcium scoring, and cardiac magnetic resonance imaging. But, so far, there are not sufficient data to provide a “robust evidence-based recommendation” for CAD testing in diabetic patients, the panel said.

At the same time, studies that have looked specifically at asymptomatic type 2 diabetes patients have not supported the 1998 recommendation to screen only those patients with two or more risk factors, they noted. Based on these issues, the panel addressed the following four questions:

▸ Which patients with diabetes are at increased risk for adverse cardiovascular outcomes and should be screened? The goal of screening would be to identify a group of patients with high cardiac risk in whom outcomes might be improved through more aggressive risk-factor modification, medical surveillance, or revascularization. Among asymptomatic patients, potentially predictive clinical features include other atherosclerotic vascular disease; microalbuminuria and other chronic kidney disease; abnormal resting electrocardiogram; autonomic neuropathy; retinopathy; hyperglycemia; age older than 65 years and male gender; and the presence of multiple cardiac risk factors.

However, at least two trials have found that such risk factors do not always predict which patients will have abnormal screening tests. For example, the DIAD (Detection of Ischemia in Asymptomatic Diabetics) study showed that basing the decision to screen on clinical features alone would fail to identify 41% of patients with silent ischemia (Diabetes Care 2004;27:1954–61).

▸ What are the implications of an early diagnosis of coronary ischemia or atherosclerosis? Noninvasive imaging techniques are now available that can help define the degree of atherosclerosis and estimate the degree of narrowing in individual lesions.

However, the benefit of such images is not clear in a patient who receives aggressive medical risk-factor reduction therapy, which is already recommended for patients with diabetes. Presumably, the idea of using imaging is to identify asymptomatic patients with more extensive disease, in whom further testing would be indicated to identify those with significant inducible myocardial ischemia who might in turn then undergo coronary angiography and subsequent revascularization.

But although some data suggest that patients with ischemia involving 10% or more of the left ventricle have a better outcome after revascularization than do those on medical therapy alone, other data—such as those from the COURAGE (Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation) study, in which one-third of the 2,287 patients had diabetes—have cast doubt on the superiority of revascularization over medical treatment (Am. Heart J. 2006;151:1173–9).

▸ What tests, or sequence of tests, should be considered? With what frequencies should testing be done? The 1998 panel recommended that exercise ECG be used to screen patients believed to be at high risk, followed by imaging only in patients with abnormal resting ECGs. Since then, studies have demonstrated the prognostic value of cardiac CT in asymptomatic patients, including those with diabetes.

Thus, although prospective trial data are still lacking, if “in the judgment of the clinician, an asymptomatic patient is a candidate for CAD testing, it is reasonable to apply cardiac CT for detection of coronary artery calcification, using either electron beam or multislice technology, as the first step,” the panel recommended.

Several studies have suggested that a coronary calcium score of 400 or greater is associated with a high likelihood of inducible ischemia, including one study that looked specifically at asymptomatic patients with diabetes (Eur. Heart J. 2006;27:713–21).

Thus, if coronary calcium testing is performed, it “appears reasonable” to proceed with further testing in diabetes patients with coronary calcium scores greater than 400. Such further testing could be done with single photon emission tomography to assess myocardial perfusion, or with stress echocardiography to assess ischemic wall motion abnormalities, the panel said.

▸ What further research is needed to evaluate the effectiveness of these recommendations? As a first step, the development and testing of improved risk prediction models against data available from national registries would be particularly helpful in capturing general population risk data, Dr. Bax and his associates said.

In the BARI 2D (Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes) study, patients with type 2 diabetes and documented CAD have been randomized to immediate revascularization combined with aggressive medical management, or a program of aggressive medical management with delayed or no revascularization. This study will provide important insight to assist in the development of strategies for the treatment of asymptomatic patients.