Miriam E. Tucker

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.

AMSTERDAM — Initiation of moderate daily alcohol consumption among patients with type 2 diabetes results in decreased fasting plasma glucose levels, particularly among patients with worse control at baseline, Iris Shai, Ph.D., reported at the annual meeting of the European Association for the Study of Diabetes.

Alcohol may inhibit hepatic glucose production—as does metformin—and also has been associated with beneficial cardiovascular effects. A recent meta-analysis of observational studies suggested that moderate alcohol consumption is associated with a reduced risk of coronary heart disease mortality among patients with type 2 diabetes, and that the beneficial association is greater than among nondiabetics (Diabetologia 2006;49:648-52).

But although several short-term intervention studies have found a decrease in fasting plasma glucose (FPG) levels in diabetic patients with moderate alcohol intake, other studies have not, said Dr. Shai, of the Ben-Gurion University of the Negev, Beer-Sheva, Israel.

A randomized, controlled intervention study to investigate the association was jointly sponsored by the Israeli Diabetes Research Group; Harvard University; the Tishbi Estate Winery, Israel; and Admiral Imports, Cedar Grove, N.J. A total of 109 initially nondrinking (defined as one drink or less per week) patients with type 2 diabetes aged 40-75 years were randomized to either 150 cc of wine (13 g alcohol, 100 kcal) or the same amount of nonalcoholic diet malt beer (0 g alcohol, 30 kcal) during dinner, both served in the same standard measured glass. The wine group could choose either dry red (merlot) or white (sauvignon blanc), said Dr. Shai, who is also a registered dietician.

Participants met with the nurse study coordinator eight times during the trial and with physicians and dieticians at weeks 1, 7, and 12. All study participants received individual dietary counseling, including identical nutritional strategies to achieve glycemic control without aiming for dramatic weight loss. Both groups were instructed to reduce their carbohydrate intake at breakfast and/or lunch but not at dinner, the wine group by 100 kcal and the controls by 30 kcal. Prior to each visit, the subjects filled in 3-day diaries of their food and drink consumption.

A total of 201 patients were screened, of whom 126 were eligible, 109 were randomized, and 91 completed the study. Dropouts were higher among the control group (26% vs. 12% of the intervention group). “Most were disappointed not to be assigned to the wine group,” Dr. Shai said. The dropouts had significantly higher baseline FPG levels, she noted.

At baseline, the 61 men and 48 women who were randomized ranged in age from 41 to 74 years, had an average FPG of 144.5 mg/dL, a hemoglobin A1c (HbA1c) level of 7.39%, blood pressure of 133.7/76.5 mm Hg, and body mass index of 30.1 kg/m

In contrast to the FPG, there were nonsignificant increases in 2-hour postmeal glucose levels, based on an average of self-measurements. Within the alcohol group, there were significant decreases in HbA1c (from 7.37% to 7.07%), LDL cholesterol (96.65 to 85.11 mg/dL), and waist circumference, but not in HDL cholesterol. These changes did not differ significantly between the two groups, however, she said. (HbA1c values dropped slightly in the controls, from 7.08% to 6.84%.)

Liver function biomarkers—including bilirubin, alkaline phosphatases, ALT, and AST—did not change significantly at 12 weeks in either group, although there was a “hint” of an increase in ALT (from 23.17 to 32.92 U/L) and AST (21.15 to 30.47 U/L) in the intervention group. In a long list of side effects to choose from, both groups reported feeling more “calm” after the study. The only effect checked off significantly more often by the alcohol group was an improved ability to fall asleep, Dr. Shai said.

At 6 months after the beginning of the study (3 months after its termination), 61% of the alcohol group thought that the alcohol was beneficial to them, and 49% were continuing to drink alcohol in moderation, ranging from one drink a week to one a day.

AMSTERDAM — Initiation of moderate daily alcohol consumption among patients with type 2 diabetes results in decreased fasting plasma glucose levels, particularly among patients with worse control at baseline, Iris Shai, Ph.D., reported at the annual meeting of the European Association for the Study of Diabetes.

Alcohol may inhibit hepatic glucose production—as does metformin—and also has been associated with beneficial cardiovascular effects. A recent meta-analysis of observational studies suggested that moderate alcohol consumption is associated with a reduced risk of coronary heart disease mortality among patients with type 2 diabetes, and that the beneficial association is greater than among nondiabetics (Diabetologia 2006;49:648-52).

But although several short-term intervention studies have found a decrease in fasting plasma glucose (FPG) levels in diabetic patients with moderate alcohol intake, other studies have not, said Dr. Shai, of the Ben-Gurion University of the Negev, Beer-Sheva, Israel.

A randomized, controlled intervention study to investigate the association was jointly sponsored by the Israeli Diabetes Research Group; Harvard University; the Tishbi Estate Winery, Israel; and Admiral Imports, Cedar Grove, N.J. A total of 109 initially nondrinking (defined as one drink or less per week) patients with type 2 diabetes aged 40-75 years were randomized to either 150 cc of wine (13 g alcohol, 100 kcal) or the same amount of nonalcoholic diet malt beer (0 g alcohol, 30 kcal) during dinner, both served in the same standard measured glass. The wine group could choose either dry red (merlot) or white (sauvignon blanc), said Dr. Shai, who is also a registered dietician.

Participants met with the nurse study coordinator eight times during the trial and with physicians and dieticians at weeks 1, 7, and 12. All study participants received individual dietary counseling, including identical nutritional strategies to achieve glycemic control without aiming for dramatic weight loss. Both groups were instructed to reduce their carbohydrate intake at breakfast and/or lunch but not at dinner, the wine group by 100 kcal and the controls by 30 kcal. Prior to each visit, the subjects filled in 3-day diaries of their food and drink consumption.

A total of 201 patients were screened, of whom 126 were eligible, 109 were randomized, and 91 completed the study. Dropouts were higher among the control group (26% vs. 12% of the intervention group). “Most were disappointed not to be assigned to the wine group,” Dr. Shai said. The dropouts had significantly higher baseline FPG levels, she noted.

At baseline, the 61 men and 48 women who were randomized ranged in age from 41 to 74 years, had an average FPG of 144.5 mg/dL, a hemoglobin A1c (HbA1c) level of 7.39%, blood pressure of 133.7/76.5 mm Hg, and body mass index of 30.1 kg/m

In contrast to the FPG, there were nonsignificant increases in 2-hour postmeal glucose levels, based on an average of self-measurements. Within the alcohol group, there were significant decreases in HbA1c (from 7.37% to 7.07%), LDL cholesterol (96.65 to 85.11 mg/dL), and waist circumference, but not in HDL cholesterol. These changes did not differ significantly between the two groups, however, she said. (HbA1c values dropped slightly in the controls, from 7.08% to 6.84%.)

Liver function biomarkers—including bilirubin, alkaline phosphatases, ALT, and AST—did not change significantly at 12 weeks in either group, although there was a “hint” of an increase in ALT (from 23.17 to 32.92 U/L) and AST (21.15 to 30.47 U/L) in the intervention group. In a long list of side effects to choose from, both groups reported feeling more “calm” after the study. The only effect checked off significantly more often by the alcohol group was an improved ability to fall asleep, Dr. Shai said.

At 6 months after the beginning of the study (3 months after its termination), 61% of the alcohol group thought that the alcohol was beneficial to them, and 49% were continuing to drink alcohol in moderation, ranging from one drink a week to one a day.

AMSTERDAM — Initiation of moderate daily alcohol consumption among patients with type 2 diabetes results in decreased fasting plasma glucose levels, particularly among patients with worse control at baseline, Iris Shai, Ph.D., reported at the annual meeting of the European Association for the Study of Diabetes.

Alcohol may inhibit hepatic glucose production—as does metformin—and also has been associated with beneficial cardiovascular effects. A recent meta-analysis of observational studies suggested that moderate alcohol consumption is associated with a reduced risk of coronary heart disease mortality among patients with type 2 diabetes, and that the beneficial association is greater than among nondiabetics (Diabetologia 2006;49:648-52).

But although several short-term intervention studies have found a decrease in fasting plasma glucose (FPG) levels in diabetic patients with moderate alcohol intake, other studies have not, said Dr. Shai, of the Ben-Gurion University of the Negev, Beer-Sheva, Israel.

A randomized, controlled intervention study to investigate the association was jointly sponsored by the Israeli Diabetes Research Group; Harvard University; the Tishbi Estate Winery, Israel; and Admiral Imports, Cedar Grove, N.J. A total of 109 initially nondrinking (defined as one drink or less per week) patients with type 2 diabetes aged 40-75 years were randomized to either 150 cc of wine (13 g alcohol, 100 kcal) or the same amount of nonalcoholic diet malt beer (0 g alcohol, 30 kcal) during dinner, both served in the same standard measured glass. The wine group could choose either dry red (merlot) or white (sauvignon blanc), said Dr. Shai, who is also a registered dietician.

Participants met with the nurse study coordinator eight times during the trial and with physicians and dieticians at weeks 1, 7, and 12. All study participants received individual dietary counseling, including identical nutritional strategies to achieve glycemic control without aiming for dramatic weight loss. Both groups were instructed to reduce their carbohydrate intake at breakfast and/or lunch but not at dinner, the wine group by 100 kcal and the controls by 30 kcal. Prior to each visit, the subjects filled in 3-day diaries of their food and drink consumption.

A total of 201 patients were screened, of whom 126 were eligible, 109 were randomized, and 91 completed the study. Dropouts were higher among the control group (26% vs. 12% of the intervention group). “Most were disappointed not to be assigned to the wine group,” Dr. Shai said. The dropouts had significantly higher baseline FPG levels, she noted.

At baseline, the 61 men and 48 women who were randomized ranged in age from 41 to 74 years, had an average FPG of 144.5 mg/dL, a hemoglobin A1c (HbA1c) level of 7.39%, blood pressure of 133.7/76.5 mm Hg, and body mass index of 30.1 kg/m

In contrast to the FPG, there were nonsignificant increases in 2-hour postmeal glucose levels, based on an average of self-measurements. Within the alcohol group, there were significant decreases in HbA1c (from 7.37% to 7.07%), LDL cholesterol (96.65 to 85.11 mg/dL), and waist circumference, but not in HDL cholesterol. These changes did not differ significantly between the two groups, however, she said. (HbA1c values dropped slightly in the controls, from 7.08% to 6.84%.)

Liver function biomarkers—including bilirubin, alkaline phosphatases, ALT, and AST—did not change significantly at 12 weeks in either group, although there was a “hint” of an increase in ALT (from 23.17 to 32.92 U/L) and AST (21.15 to 30.47 U/L) in the intervention group. In a long list of side effects to choose from, both groups reported feeling more “calm” after the study. The only effect checked off significantly more often by the alcohol group was an improved ability to fall asleep, Dr. Shai said.

At 6 months after the beginning of the study (3 months after its termination), 61% of the alcohol group thought that the alcohol was beneficial to them, and 49% were continuing to drink alcohol in moderation, ranging from one drink a week to one a day.

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 diabetic ketoacidosis 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 insurance or were covered through a health maintenance organization, 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 diabetic ketoacidosis treatment, after adjustment for gender, ethnicity, and age. In contrast, there was no relationship between insurance status and the cost of diabetic ketacidosis among patients with established diabetes, the two researchers reported.

After adjustment for inflation, the median direct cost of diabetic ketoacidosis treatment increased 20% from 1995-96 ($8,836) to 2005-06 ($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 diabetic ketoacidosis in newly diagnosed youth is approximately 25.5%; another finding that the incidence of diabetic ketoacidosis 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 diabetic ketoacidosis 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 diabetic ketoacidosis 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 insurance or were covered through a health maintenance organization, 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 diabetic ketoacidosis treatment, after adjustment for gender, ethnicity, and age. In contrast, there was no relationship between insurance status and the cost of diabetic ketacidosis among patients with established diabetes, the two researchers reported.

After adjustment for inflation, the median direct cost of diabetic ketoacidosis treatment increased 20% from 1995-96 ($8,836) to 2005-06 ($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 diabetic ketoacidosis in newly diagnosed youth is approximately 25.5%; another finding that the incidence of diabetic ketoacidosis 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 diabetic ketoacidosis 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 diabetic ketoacidosis 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 insurance or were covered through a health maintenance organization, 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 diabetic ketoacidosis treatment, after adjustment for gender, ethnicity, and age. In contrast, there was no relationship between insurance status and the cost of diabetic ketacidosis among patients with established diabetes, the two researchers reported.

After adjustment for inflation, the median direct cost of diabetic ketoacidosis treatment increased 20% from 1995-96 ($8,836) to 2005-06 ($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 diabetic ketoacidosis in newly diagnosed youth is approximately 25.5%; another finding that the incidence of diabetic ketoacidosis 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 diabetic ketoacidosis 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 — Seeing and presumptively treating all women with previous gestational diabetes mellitus 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 in subsequent pregnancies among women who had the condition in a previous pregnancy range from about 30% to 70%, depending on the population studied. In general, the heavier and less Caucasian 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 obstetrics/gynecology department 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 high Asian prevalence. More than 70% of the center's GDM population is non-Caucasian. 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 long list of risk factors, including family history of diabetes, maternal obesity (body mass index greater than 30 kg/m

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 38–40 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 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. 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. “I extrapolate the findings to suggest that if I left these women until 28 weeks' gestation and then started [treatment], I would have missed the boat and had worse outcomes. I can't prove it, but that's what the data suggest,” Dr. Cotzias said.

To leave this population until screening is done may be detrimental for both mother and baby. DR. COTZIAS

ELSEVIER GLOBAL MEDICAL NEWS

AMSTERDAM — Seeing and presumptively treating all women with previous gestational diabetes mellitus 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 in subsequent pregnancies among women who had the condition in a previous pregnancy range from about 30% to 70%, depending on the population studied. In general, the heavier and less Caucasian 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 obstetrics/gynecology department 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 high Asian prevalence. More than 70% of the center's GDM population is non-Caucasian. 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 long list of risk factors, including family history of diabetes, maternal obesity (body mass index greater than 30 kg/m

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 38–40 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 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. 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. “I extrapolate the findings to suggest that if I left these women until 28 weeks' gestation and then started [treatment], I would have missed the boat and had worse outcomes. I can't prove it, but that's what the data suggest,” Dr. Cotzias said.

To leave this population until screening is done may be detrimental for both mother and baby. DR. COTZIAS

ELSEVIER GLOBAL MEDICAL NEWS

AMSTERDAM — Seeing and presumptively treating all women with previous gestational diabetes mellitus 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 in subsequent pregnancies among women who had the condition in a previous pregnancy range from about 30% to 70%, depending on the population studied. In general, the heavier and less Caucasian 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 obstetrics/gynecology department 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 high Asian prevalence. More than 70% of the center's GDM population is non-Caucasian. 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 long list of risk factors, including family history of diabetes, maternal obesity (body mass index greater than 30 kg/m

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 38–40 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 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. 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. “I extrapolate the findings to suggest that if I left these women until 28 weeks' gestation and then started [treatment], I would have missed the boat and had worse outcomes. I can't prove it, but that's what the data suggest,” Dr. Cotzias said.

To leave this population until screening is done may be detrimental for both mother and baby. DR. COTZIAS

ELSEVIER GLOBAL MEDICAL NEWS

WASHINGTON — The everolimus-eluting stent Xience V produced a clinically significant 43% reduction in major adverse cardiac events, compared with the paclitaxel-eluting Taxus at 1 year, Dr. Gregg W. Stone reported at the annual Transcatheter Cardiovascular Therapeutics conference, sponsored by the Cardiovascular Research Foundation.

That major secondary end point finding comes from Abbott Laboratory's 5-year SPIRIT III trial of 1002 patients randomized 2:1 to receive either the Xience V or the Taxus stents. This is the first time a drug-eluting stent system has shown a statistically significant improvement in event-free survival, compared with another FDA-approved drug-eluting stent in a pivotal randomized clinical trial, noted Dr. Stone of Columbia University and director of the Cardiovascular Research Foundation, New York.

The Xience V has been licensed in Europe and parts of Asia since 2006, and currently awaits approval from the Food and Drug Administration. Abbott anticipates its licensure in the first half of 2008, a company statement said.

Earlier this year at the American College of Cardiology meeting, Dr. Stone presented data showing that Xience produced a statistically significant reduction of 50%, compared with Taxus, in in-segment late loss, the primary end point of the SPIRIT III. Now, at 1 year, rates of target vessel failure (TVF) (cardiac death, MI, or ischemia-driven target vessel revascularization) were 8.3% with Xience versus 10.8% for Taxus, a 25% difference representing a nonsignificant trend in that major secondary end point.

However, the 43% difference between the two stents in major adverse cardiac events (MACE)—5.8% for Xience vs. 9.9% with Taxus—was highly significant, and, Dr. Stone believes, is more important than TVF in terms of analyzing the performance of the two stents. While the TVF includes factors such as side vessel branches and discordant lesions, the MACE outcome “is much more specific to stenting itself.”

There were no differences in cardiac death (0.8% for Xience and 0.9% for Taxus) at 1 year, and MI rates—2.6% for Xience, 3.7% for Taxus—did not differ significantly. Ischemia-driven target lesion revascularization accounted for the majority of the MACE difference, with rates of 3.3% with Xience and 5.6% with Taxus, a “strong trend” difference of 41%. The 5.6% for Taxus “is a good number, but Xience was better,” remarked Dr. Stone, who is a consultant for both Abbott Vascular and Taxus manufacturer Boston Scientific.

Thrombosis rates at 1 year were low in both groups, 0.8% for Xience and 0.6% for Taxus. No differences in thrombosis rates were seen when the figures were broken down according to those occurring at 30 days or sooner versus beyond 30 days.

Subgroup analyses of the 8-month late loss were consistent across most parameters, including the angiographic cohort of 501 patients, gender, single or dual vessel treated, and lesion length. One exception was by age, with the greatest reduction occurring in late loss among those aged at least 63 years, compared with those younger. “This was a significant difference. I don't know why,” Dr. Stone commented.

Another somewhat surprising subgroup finding was that the Xience worked better in nondiabetics than in the diabetic population, the opposite of what has been seen in previous studies. There were, however, only 280 diabetics in SPIRIT III. “Again, you have to be cautious with subgroups,” he remarked, “because the study wasn't powered to show those differences.”

Indeed, the ongoing SPIRIT IV trial is designed to examine that issue. The single-blind, randomized, multicenter study will enroll 3,900 patients for the treatment of up to three de novo native coronary lesions. The primary end point is TVF at 270 days, and, like SPIRIT III, patients will be followed out to 5 years. “We'll be looking at subgroups,” Dr. Stone said.

WASHINGTON — The everolimus-eluting stent Xience V produced a clinically significant 43% reduction in major adverse cardiac events, compared with the paclitaxel-eluting Taxus at 1 year, Dr. Gregg W. Stone reported at the annual Transcatheter Cardiovascular Therapeutics conference, sponsored by the Cardiovascular Research Foundation.

That major secondary end point finding comes from Abbott Laboratory's 5-year SPIRIT III trial of 1002 patients randomized 2:1 to receive either the Xience V or the Taxus stents. This is the first time a drug-eluting stent system has shown a statistically significant improvement in event-free survival, compared with another FDA-approved drug-eluting stent in a pivotal randomized clinical trial, noted Dr. Stone of Columbia University and director of the Cardiovascular Research Foundation, New York.

The Xience V has been licensed in Europe and parts of Asia since 2006, and currently awaits approval from the Food and Drug Administration. Abbott anticipates its licensure in the first half of 2008, a company statement said.

Earlier this year at the American College of Cardiology meeting, Dr. Stone presented data showing that Xience produced a statistically significant reduction of 50%, compared with Taxus, in in-segment late loss, the primary end point of the SPIRIT III. Now, at 1 year, rates of target vessel failure (TVF) (cardiac death, MI, or ischemia-driven target vessel revascularization) were 8.3% with Xience versus 10.8% for Taxus, a 25% difference representing a nonsignificant trend in that major secondary end point.

However, the 43% difference between the two stents in major adverse cardiac events (MACE)—5.8% for Xience vs. 9.9% with Taxus—was highly significant, and, Dr. Stone believes, is more important than TVF in terms of analyzing the performance of the two stents. While the TVF includes factors such as side vessel branches and discordant lesions, the MACE outcome “is much more specific to stenting itself.”

There were no differences in cardiac death (0.8% for Xience and 0.9% for Taxus) at 1 year, and MI rates—2.6% for Xience, 3.7% for Taxus—did not differ significantly. Ischemia-driven target lesion revascularization accounted for the majority of the MACE difference, with rates of 3.3% with Xience and 5.6% with Taxus, a “strong trend” difference of 41%. The 5.6% for Taxus “is a good number, but Xience was better,” remarked Dr. Stone, who is a consultant for both Abbott Vascular and Taxus manufacturer Boston Scientific.

Thrombosis rates at 1 year were low in both groups, 0.8% for Xience and 0.6% for Taxus. No differences in thrombosis rates were seen when the figures were broken down according to those occurring at 30 days or sooner versus beyond 30 days.

Subgroup analyses of the 8-month late loss were consistent across most parameters, including the angiographic cohort of 501 patients, gender, single or dual vessel treated, and lesion length. One exception was by age, with the greatest reduction occurring in late loss among those aged at least 63 years, compared with those younger. “This was a significant difference. I don't know why,” Dr. Stone commented.

Another somewhat surprising subgroup finding was that the Xience worked better in nondiabetics than in the diabetic population, the opposite of what has been seen in previous studies. There were, however, only 280 diabetics in SPIRIT III. “Again, you have to be cautious with subgroups,” he remarked, “because the study wasn't powered to show those differences.”

Indeed, the ongoing SPIRIT IV trial is designed to examine that issue. The single-blind, randomized, multicenter study will enroll 3,900 patients for the treatment of up to three de novo native coronary lesions. The primary end point is TVF at 270 days, and, like SPIRIT III, patients will be followed out to 5 years. “We'll be looking at subgroups,” Dr. Stone said.

WASHINGTON — The everolimus-eluting stent Xience V produced a clinically significant 43% reduction in major adverse cardiac events, compared with the paclitaxel-eluting Taxus at 1 year, Dr. Gregg W. Stone reported at the annual Transcatheter Cardiovascular Therapeutics conference, sponsored by the Cardiovascular Research Foundation.

That major secondary end point finding comes from Abbott Laboratory's 5-year SPIRIT III trial of 1002 patients randomized 2:1 to receive either the Xience V or the Taxus stents. This is the first time a drug-eluting stent system has shown a statistically significant improvement in event-free survival, compared with another FDA-approved drug-eluting stent in a pivotal randomized clinical trial, noted Dr. Stone of Columbia University and director of the Cardiovascular Research Foundation, New York.

The Xience V has been licensed in Europe and parts of Asia since 2006, and currently awaits approval from the Food and Drug Administration. Abbott anticipates its licensure in the first half of 2008, a company statement said.

Earlier this year at the American College of Cardiology meeting, Dr. Stone presented data showing that Xience produced a statistically significant reduction of 50%, compared with Taxus, in in-segment late loss, the primary end point of the SPIRIT III. Now, at 1 year, rates of target vessel failure (TVF) (cardiac death, MI, or ischemia-driven target vessel revascularization) were 8.3% with Xience versus 10.8% for Taxus, a 25% difference representing a nonsignificant trend in that major secondary end point.

However, the 43% difference between the two stents in major adverse cardiac events (MACE)—5.8% for Xience vs. 9.9% with Taxus—was highly significant, and, Dr. Stone believes, is more important than TVF in terms of analyzing the performance of the two stents. While the TVF includes factors such as side vessel branches and discordant lesions, the MACE outcome “is much more specific to stenting itself.”

There were no differences in cardiac death (0.8% for Xience and 0.9% for Taxus) at 1 year, and MI rates—2.6% for Xience, 3.7% for Taxus—did not differ significantly. Ischemia-driven target lesion revascularization accounted for the majority of the MACE difference, with rates of 3.3% with Xience and 5.6% with Taxus, a “strong trend” difference of 41%. The 5.6% for Taxus “is a good number, but Xience was better,” remarked Dr. Stone, who is a consultant for both Abbott Vascular and Taxus manufacturer Boston Scientific.

Thrombosis rates at 1 year were low in both groups, 0.8% for Xience and 0.6% for Taxus. No differences in thrombosis rates were seen when the figures were broken down according to those occurring at 30 days or sooner versus beyond 30 days.

Subgroup analyses of the 8-month late loss were consistent across most parameters, including the angiographic cohort of 501 patients, gender, single or dual vessel treated, and lesion length. One exception was by age, with the greatest reduction occurring in late loss among those aged at least 63 years, compared with those younger. “This was a significant difference. I don't know why,” Dr. Stone commented.

Another somewhat surprising subgroup finding was that the Xience worked better in nondiabetics than in the diabetic population, the opposite of what has been seen in previous studies. There were, however, only 280 diabetics in SPIRIT III. “Again, you have to be cautious with subgroups,” he remarked, “because the study wasn't powered to show those differences.”

Indeed, the ongoing SPIRIT IV trial is designed to examine that issue. The single-blind, randomized, multicenter study will enroll 3,900 patients for the treatment of up to three de novo native coronary lesions. The primary end point is TVF at 270 days, and, like SPIRIT III, patients will be followed out to 5 years. “We'll be looking at subgroups,” Dr. Stone said.

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 than among those without, but that a large measure of that association may be explained by 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 (49.3 vs. 32.3 years), more overweight (body mass index 27.9 vs. 24.9 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

Findings were similar from a study of 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 (64.4 vs. 55.8 years), had higher BMIs (32.1 vs. 26.9), and were more parous (2.6 vs. 2.1 deliveries). They also were more likely to have had a hysterectomy (37.9% vs. 26.9%), and to be black (13.4% vs. 9.2%). 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 (PFDs).

Diabetes and obesity both strongly predicted each and all of the PFDs, 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, hormone use, menopause status, smoking status, and neurologic disease—the odds ratios for having stress urinary incontinence was 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 PFD, those adjusted odds ratios were 2.62, 1.83, and 1.32, respectively.

ELSEVIER GLOBAL MEDICAL NEWS

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 than among those without, but that a large measure of that association may be explained by 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 (49.3 vs. 32.3 years), more overweight (body mass index 27.9 vs. 24.9 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

Findings were similar from a study of 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 (64.4 vs. 55.8 years), had higher BMIs (32.1 vs. 26.9), and were more parous (2.6 vs. 2.1 deliveries). They also were more likely to have had a hysterectomy (37.9% vs. 26.9%), and to be black (13.4% vs. 9.2%). 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 (PFDs).

Diabetes and obesity both strongly predicted each and all of the PFDs, 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, hormone use, menopause status, smoking status, and neurologic disease—the odds ratios for having stress urinary incontinence was 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 PFD, those adjusted odds ratios were 2.62, 1.83, and 1.32, respectively.

ELSEVIER GLOBAL MEDICAL NEWS

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 than among those without, but that a large measure of that association may be explained by 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 (49.3 vs. 32.3 years), more overweight (body mass index 27.9 vs. 24.9 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

Findings were similar from a study of 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 (64.4 vs. 55.8 years), had higher BMIs (32.1 vs. 26.9), and were more parous (2.6 vs. 2.1 deliveries). They also were more likely to have had a hysterectomy (37.9% vs. 26.9%), and to be black (13.4% vs. 9.2%). 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 (PFDs).

Diabetes and obesity both strongly predicted each and all of the PFDs, 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, hormone use, menopause status, smoking status, and neurologic disease—the odds ratios for having stress urinary incontinence was 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 PFD, those adjusted odds ratios were 2.62, 1.83, and 1.32, respectively.

ELSEVIER GLOBAL MEDICAL NEWS

The glucose-lowering drug pramlintide will now be available in pens, but not for patients not using premeal bolus insulin.

Last month the Food and Drug Administration said Amylin could begin marketing the SymlinPen 60 and the SymlinPen 120 pen-injector devices for administering pramlintide injection, currently sold in vials. The pens are expected to be available by December 2007, the firm said.

Dosing had been an issue with the vials due to confusion with insulin syringes, which are not marked in microgram units. But the SymlinPen 60 delivers fixed doses of 15, 30, 45, or 60 mcg; the SymlinPen 120 delivers only 60- and 120-mcg doses.

The agency also issued a “Not Approvable” letter for those using only basal insulin without concurrent mealtime (bolus) insulin. Supporting data included results from a 16-week, double-blind, placebo-controlled study of 212 patients with type 2 diabetes who used glargine (basal) insulin with or without oral antidiabetic agents, but who did not use premeal insulin (Diabetes Care 2007 Aug. 13 [Epub ahead of print]). In those completing the study, hemoglobin A_1c reductions from baseline were greater in the 87 on pramlintide (7.8%, from 8.5%), compared with the 91 on placebo (8.1%, from 8.5%), said Dr. Matthew Riddle, of Oregon Health and Science University, Portland, and associates. An FDA spokeswoman said the agency does not discuss its nonapprovable actions.

The glucose-lowering drug pramlintide will now be available in pens, but not for patients not using premeal bolus insulin.

Last month the Food and Drug Administration said Amylin could begin marketing the SymlinPen 60 and the SymlinPen 120 pen-injector devices for administering pramlintide injection, currently sold in vials. The pens are expected to be available by December 2007, the firm said.

Dosing had been an issue with the vials due to confusion with insulin syringes, which are not marked in microgram units. But the SymlinPen 60 delivers fixed doses of 15, 30, 45, or 60 mcg; the SymlinPen 120 delivers only 60- and 120-mcg doses.

The agency also issued a “Not Approvable” letter for those using only basal insulin without concurrent mealtime (bolus) insulin. Supporting data included results from a 16-week, double-blind, placebo-controlled study of 212 patients with type 2 diabetes who used glargine (basal) insulin with or without oral antidiabetic agents, but who did not use premeal insulin (Diabetes Care 2007 Aug. 13 [Epub ahead of print]). In those completing the study, hemoglobin A_1c reductions from baseline were greater in the 87 on pramlintide (7.8%, from 8.5%), compared with the 91 on placebo (8.1%, from 8.5%), said Dr. Matthew Riddle, of Oregon Health and Science University, Portland, and associates. An FDA spokeswoman said the agency does not discuss its nonapprovable actions.

The glucose-lowering drug pramlintide will now be available in pens, but not for patients not using premeal bolus insulin.

Last month the Food and Drug Administration said Amylin could begin marketing the SymlinPen 60 and the SymlinPen 120 pen-injector devices for administering pramlintide injection, currently sold in vials. The pens are expected to be available by December 2007, the firm said.

Dosing had been an issue with the vials due to confusion with insulin syringes, which are not marked in microgram units. But the SymlinPen 60 delivers fixed doses of 15, 30, 45, or 60 mcg; the SymlinPen 120 delivers only 60- and 120-mcg doses.

The agency also issued a “Not Approvable” letter for those using only basal insulin without concurrent mealtime (bolus) insulin. Supporting data included results from a 16-week, double-blind, placebo-controlled study of 212 patients with type 2 diabetes who used glargine (basal) insulin with or without oral antidiabetic agents, but who did not use premeal insulin (Diabetes Care 2007 Aug. 13 [Epub ahead of print]). In those completing the study, hemoglobin A_1c reductions from baseline were greater in the 87 on pramlintide (7.8%, from 8.5%), compared with the 91 on placebo (8.1%, from 8.5%), said Dr. Matthew Riddle, of Oregon Health and Science University, Portland, and associates. An FDA spokeswoman said the agency does not discuss its nonapprovable actions.

AMSTERDAM — Patients with type 1 diabetes often underestimate the amount of carbohydrates in their meals, Dr. Guido Freckmann reported at the annual meeting of the European Association for the Study of Diabetes.

The ability to accurately estimate the carbohydrate content is key to a patient's efficacy in making appropriate therapy decisions with insulin pump or basal-bolus insulin injection regimens. It is therefore of concern that underestimation by about 25% was typical in this study of 74 such patients, with warm meals and large meals presenting even greater potential for error, said Dr. Freckmann, of the Institute for Diabetes Technology in Ulm, Germany.

The study included 38 men and 36 women with a mean age of 44 years and mean diabetes duration of 21 years. Their mean hemoglobin A_1c level was 7.2%. Twenty-six were on multiple daily injections and 48 were on insulin pump therapy.

Patients were given 24 different test meals—11 warm and 13 cold—in random order, including 8 breakfasts, 8 lunches, and 8 dinners ranging in carbohydrate content from 55 g to 164 g. Among the meals were a breakfast of rye bread, roll, margarine, ham sausage, Camembert, and yogurt containing 82 g of carbohydrate; a pizza lunch including mozzarella, basil, olive oil, and fruit, adding up to 138 g of carbs; and a dinner of baguette, tomato, mozzarella, and olive oil totaling 101 g of carbs.

Patients estimated the carbohydrate content of the meals to be a median of 75% compared with the actual content; estimates ranged from 53% to 127%. Warm meals prompted even more carb underestimation than cold (72% vs. 77%), and large meals were underestimated to a greater degree than were smaller meals, Dr. Freckmann reported.

Possible reasons include the fact that patients often don't count the carbs of vegetables and other low-carb items. It's also possible that some patients might compensate for the underestimate by adapting their individual insulin-to-carb ratio, thereby giving themselves sufficient insulin doses despite the carb underestimate, he said.

On the positive side, the degree of correct estimation was significantly improved—from 73% to 83%—among 35 patients who received training in carb counting.

AMSTERDAM — Patients with type 1 diabetes often underestimate the amount of carbohydrates in their meals, Dr. Guido Freckmann reported at the annual meeting of the European Association for the Study of Diabetes.

The ability to accurately estimate the carbohydrate content is key to a patient's efficacy in making appropriate therapy decisions with insulin pump or basal-bolus insulin injection regimens. It is therefore of concern that underestimation by about 25% was typical in this study of 74 such patients, with warm meals and large meals presenting even greater potential for error, said Dr. Freckmann, of the Institute for Diabetes Technology in Ulm, Germany.

The study included 38 men and 36 women with a mean age of 44 years and mean diabetes duration of 21 years. Their mean hemoglobin A_1c level was 7.2%. Twenty-six were on multiple daily injections and 48 were on insulin pump therapy.

Patients were given 24 different test meals—11 warm and 13 cold—in random order, including 8 breakfasts, 8 lunches, and 8 dinners ranging in carbohydrate content from 55 g to 164 g. Among the meals were a breakfast of rye bread, roll, margarine, ham sausage, Camembert, and yogurt containing 82 g of carbohydrate; a pizza lunch including mozzarella, basil, olive oil, and fruit, adding up to 138 g of carbs; and a dinner of baguette, tomato, mozzarella, and olive oil totaling 101 g of carbs.

Patients estimated the carbohydrate content of the meals to be a median of 75% compared with the actual content; estimates ranged from 53% to 127%. Warm meals prompted even more carb underestimation than cold (72% vs. 77%), and large meals were underestimated to a greater degree than were smaller meals, Dr. Freckmann reported.

Possible reasons include the fact that patients often don't count the carbs of vegetables and other low-carb items. It's also possible that some patients might compensate for the underestimate by adapting their individual insulin-to-carb ratio, thereby giving themselves sufficient insulin doses despite the carb underestimate, he said.

On the positive side, the degree of correct estimation was significantly improved—from 73% to 83%—among 35 patients who received training in carb counting.

AMSTERDAM — Patients with type 1 diabetes often underestimate the amount of carbohydrates in their meals, Dr. Guido Freckmann reported at the annual meeting of the European Association for the Study of Diabetes.

The ability to accurately estimate the carbohydrate content is key to a patient's efficacy in making appropriate therapy decisions with insulin pump or basal-bolus insulin injection regimens. It is therefore of concern that underestimation by about 25% was typical in this study of 74 such patients, with warm meals and large meals presenting even greater potential for error, said Dr. Freckmann, of the Institute for Diabetes Technology in Ulm, Germany.

The study included 38 men and 36 women with a mean age of 44 years and mean diabetes duration of 21 years. Their mean hemoglobin A_1c level was 7.2%. Twenty-six were on multiple daily injections and 48 were on insulin pump therapy.

Patients were given 24 different test meals—11 warm and 13 cold—in random order, including 8 breakfasts, 8 lunches, and 8 dinners ranging in carbohydrate content from 55 g to 164 g. Among the meals were a breakfast of rye bread, roll, margarine, ham sausage, Camembert, and yogurt containing 82 g of carbohydrate; a pizza lunch including mozzarella, basil, olive oil, and fruit, adding up to 138 g of carbs; and a dinner of baguette, tomato, mozzarella, and olive oil totaling 101 g of carbs.

Patients estimated the carbohydrate content of the meals to be a median of 75% compared with the actual content; estimates ranged from 53% to 127%. Warm meals prompted even more carb underestimation than cold (72% vs. 77%), and large meals were underestimated to a greater degree than were smaller meals, Dr. Freckmann reported.

Possible reasons include the fact that patients often don't count the carbs of vegetables and other low-carb items. It's also possible that some patients might compensate for the underestimate by adapting their individual insulin-to-carb ratio, thereby giving themselves sufficient insulin doses despite the carb underestimate, he said.

On the positive side, the degree of correct estimation was significantly improved—from 73% to 83%—among 35 patients who received training in carb counting.

AMSTERDAM — Data from an international trial have yielded a formula that accurately converts hemoglobin A_1c values to an estimated average blood glucose.

The results of the A_1c-Derived Average Glucose (ADAG) study, comprising 4 months' worth of glucose data from 643 diabetic and nondiabetic subjects from 10 centers around the world, provided this “simple, linear” equation to obtain glucose values in mmol/L: (1.583 × HbA_1c) - 2.52. Thus, when multiplied by 18 to get the value in the American units mg/dL, a hemoglobin A_1c of 6% is converted to approximately 126 mg/dL, 7% is converted to 155 mg/dL, and 8% is converted to 182 mg/dL.

“The results are even better than we expected or could have hoped for. There's a linear correlation between the HbA_1c and the calculated mean glucose over a wide range of A_1c values. … The results should apply to the majority of patients with diabetes,” study leader Dr. Robert Heine of Vrije University, Amsterdam, said at a press briefing held during the annual meeting of the European Association for the Study of Diabetes (EASD), where the study results were presented later that day at a special symposium.

No need to pull out your calculator for every diabetic patient, though. In August, a joint consensus statement from the EASD, the American Diabetes Association (ADA), the International Diabetes Federation, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Diabetes Federation advised that—pending the results from the ADAG study—clinical laboratories begin reporting both the HbA_1c percentage and the ADAG, along with a third number, the “true” HbA_1c value expressed in mmol/mol (Clin Chem. 2007;53:1562–4 and Diabetes Care 2007;30:2399–400).

Clinically, these developments provide an opportunity for physicians to begin shifting discussions with diabetic patients away from hemoglobin A_1c and toward average glucose, two representatives from the ADA said at the briefing. “The clinician has the choice to use one, two, or three values when communicating with the patient. The diabetes organizations would encourage physicians to use the estimated average glucose,” said Richard Kahn, Ph.D., ADA's chief scientific officer.

The reason, explained ADA president Dr. John Buse, is that “[The HbA_1c] has always been kind of confusing for patients. At home they measure their glucose, then every 3 months they visit the doctor and get something that has the word 'hemoglobin' in it … There's always been a disconnect.” In contrast, “The estimated average glucose is expressed in numbers that people are used to looking at all day every day,” said Dr. Buse, director of the Diabetes Care Center of the division of general medicine and clinical epidemiology at the University of North Carolina at Chapel Hill.

It's not yet clear what will happen with point-of-care HbA_1c machines that many physicians currently have in their offices, but it's likely that the manufacturers can provide some sort of simple software adjustment or Internet link that won't be excessively burdensome or costly, Dr. Kahn noted at the briefing.

The shift to ADAG was initially spurred by the 2002 IFCC publication of a new reference method that measures the concentration of only one molecular species of glycated hemoglobins (the A_1c), as opposed to the mixture that had previously been measured. Recognizing that the IFCC's adoption of the new reference method would cause confusion in the clinical setting, an international working group decided in 2004 to launch the ADAG study. Although there already were data that provided a rough estimate of average glucose from HbA_1c—and indeed, many labs currently report those numbers—they were generated from old studies using infrequent fingerstick monitoring. The ADAG study, in contrast, utilized both frequent fingerstick and continuous glucose monitoring (CGM) to gather “thousands of data points” in order to derive a precise average, Dr. Heine explained.

Dr. Judith Kuenen, who works with Dr. Heine at Vrije University, presented the study data at the symposium. The entire group of 643 patients was about half men and half women. Half had type 1 diabetes, 36% had type 2 diabetes, and the other 14% did not have diabetes. Three-fourths were Caucasian. A total of 38% of participants, including all the nondiabetics, had hemoglobin A_1c values of 4%–6.5%. Another 44% had values between 6.6% and 8.5%, while 18% had HbA_1c levels about 8.5%.

A total of 427 patients had completed the study at the time of the meeting; the addition of the other 216 subjects is not expected to change the results. Of the 427 patients, 224 had type 1 diabetes and 125 had type 2 diabetes; the rest did not have diabetes. They had a mean age of 46 years; 53 were women, and 82% were white.(More minority subjects are among the other 216 patients who had not yet completed the study.) Approximately 2,400 CGM and 300 fingerstick glucose measurements were collected per subject, “an enormous amount of data,” Dr. Kuenen remarked.

Despite such frequent monitoring, HbA_1c levels remained stable in most patients during the course of the study, with only 4% showing improvement of more than 1 percentage point.

The study was supported by grants from several pharmaceutical and glucose monitoring device manufacturers. Among its limitations were the inclusion of only small numbers from various ethnic minority groups, and the lack of any data on children, pregnant women, or patients with renal impairment, Dr. Kuenen noted.

Independent commentator Dr. Philip Home, professor of diabetes medicine at the University of Newcastle-upon-Tyne (England), cautioned that it will take time to transition to using new numbers that don't correlate with a huge amount of published literature on data using the HbA_1c measurement to predict diabetes complications and other important clinical values. “The problem we have as a result of all this is that we have to re-standardize all our guidelines to align with this [ADAG], and that means a bit of re-education.”

AMSTERDAM — Data from an international trial have yielded a formula that accurately converts hemoglobin A_1c values to an estimated average blood glucose.

The results of the A_1c-Derived Average Glucose (ADAG) study, comprising 4 months' worth of glucose data from 643 diabetic and nondiabetic subjects from 10 centers around the world, provided this “simple, linear” equation to obtain glucose values in mmol/L: (1.583 × HbA_1c) - 2.52. Thus, when multiplied by 18 to get the value in the American units mg/dL, a hemoglobin A_1c of 6% is converted to approximately 126 mg/dL, 7% is converted to 155 mg/dL, and 8% is converted to 182 mg/dL.

“The results are even better than we expected or could have hoped for. There's a linear correlation between the HbA_1c and the calculated mean glucose over a wide range of A_1c values. … The results should apply to the majority of patients with diabetes,” study leader Dr. Robert Heine of Vrije University, Amsterdam, said at a press briefing held during the annual meeting of the European Association for the Study of Diabetes (EASD), where the study results were presented later that day at a special symposium.

No need to pull out your calculator for every diabetic patient, though. In August, a joint consensus statement from the EASD, the American Diabetes Association (ADA), the International Diabetes Federation, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Diabetes Federation advised that—pending the results from the ADAG study—clinical laboratories begin reporting both the HbA_1c percentage and the ADAG, along with a third number, the “true” HbA_1c value expressed in mmol/mol (Clin Chem. 2007;53:1562–4 and Diabetes Care 2007;30:2399–400).

Clinically, these developments provide an opportunity for physicians to begin shifting discussions with diabetic patients away from hemoglobin A_1c and toward average glucose, two representatives from the ADA said at the briefing. “The clinician has the choice to use one, two, or three values when communicating with the patient. The diabetes organizations would encourage physicians to use the estimated average glucose,” said Richard Kahn, Ph.D., ADA's chief scientific officer.

The reason, explained ADA president Dr. John Buse, is that “[The HbA_1c] has always been kind of confusing for patients. At home they measure their glucose, then every 3 months they visit the doctor and get something that has the word 'hemoglobin' in it … There's always been a disconnect.” In contrast, “The estimated average glucose is expressed in numbers that people are used to looking at all day every day,” said Dr. Buse, director of the Diabetes Care Center of the division of general medicine and clinical epidemiology at the University of North Carolina at Chapel Hill.

It's not yet clear what will happen with point-of-care HbA_1c machines that many physicians currently have in their offices, but it's likely that the manufacturers can provide some sort of simple software adjustment or Internet link that won't be excessively burdensome or costly, Dr. Kahn noted at the briefing.

The shift to ADAG was initially spurred by the 2002 IFCC publication of a new reference method that measures the concentration of only one molecular species of glycated hemoglobins (the A_1c), as opposed to the mixture that had previously been measured. Recognizing that the IFCC's adoption of the new reference method would cause confusion in the clinical setting, an international working group decided in 2004 to launch the ADAG study. Although there already were data that provided a rough estimate of average glucose from HbA_1c—and indeed, many labs currently report those numbers—they were generated from old studies using infrequent fingerstick monitoring. The ADAG study, in contrast, utilized both frequent fingerstick and continuous glucose monitoring (CGM) to gather “thousands of data points” in order to derive a precise average, Dr. Heine explained.

Dr. Judith Kuenen, who works with Dr. Heine at Vrije University, presented the study data at the symposium. The entire group of 643 patients was about half men and half women. Half had type 1 diabetes, 36% had type 2 diabetes, and the other 14% did not have diabetes. Three-fourths were Caucasian. A total of 38% of participants, including all the nondiabetics, had hemoglobin A_1c values of 4%–6.5%. Another 44% had values between 6.6% and 8.5%, while 18% had HbA_1c levels about 8.5%.

A total of 427 patients had completed the study at the time of the meeting; the addition of the other 216 subjects is not expected to change the results. Of the 427 patients, 224 had type 1 diabetes and 125 had type 2 diabetes; the rest did not have diabetes. They had a mean age of 46 years; 53 were women, and 82% were white.(More minority subjects are among the other 216 patients who had not yet completed the study.) Approximately 2,400 CGM and 300 fingerstick glucose measurements were collected per subject, “an enormous amount of data,” Dr. Kuenen remarked.

Despite such frequent monitoring, HbA_1c levels remained stable in most patients during the course of the study, with only 4% showing improvement of more than 1 percentage point.

The study was supported by grants from several pharmaceutical and glucose monitoring device manufacturers. Among its limitations were the inclusion of only small numbers from various ethnic minority groups, and the lack of any data on children, pregnant women, or patients with renal impairment, Dr. Kuenen noted.

Independent commentator Dr. Philip Home, professor of diabetes medicine at the University of Newcastle-upon-Tyne (England), cautioned that it will take time to transition to using new numbers that don't correlate with a huge amount of published literature on data using the HbA_1c measurement to predict diabetes complications and other important clinical values. “The problem we have as a result of all this is that we have to re-standardize all our guidelines to align with this [ADAG], and that means a bit of re-education.”

AMSTERDAM — Data from an international trial have yielded a formula that accurately converts hemoglobin A_1c values to an estimated average blood glucose.

The results of the A_1c-Derived Average Glucose (ADAG) study, comprising 4 months' worth of glucose data from 643 diabetic and nondiabetic subjects from 10 centers around the world, provided this “simple, linear” equation to obtain glucose values in mmol/L: (1.583 × HbA_1c) - 2.52. Thus, when multiplied by 18 to get the value in the American units mg/dL, a hemoglobin A_1c of 6% is converted to approximately 126 mg/dL, 7% is converted to 155 mg/dL, and 8% is converted to 182 mg/dL.

“The results are even better than we expected or could have hoped for. There's a linear correlation between the HbA_1c and the calculated mean glucose over a wide range of A_1c values. … The results should apply to the majority of patients with diabetes,” study leader Dr. Robert Heine of Vrije University, Amsterdam, said at a press briefing held during the annual meeting of the European Association for the Study of Diabetes (EASD), where the study results were presented later that day at a special symposium.

No need to pull out your calculator for every diabetic patient, though. In August, a joint consensus statement from the EASD, the American Diabetes Association (ADA), the International Diabetes Federation, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and the International Diabetes Federation advised that—pending the results from the ADAG study—clinical laboratories begin reporting both the HbA_1c percentage and the ADAG, along with a third number, the “true” HbA_1c value expressed in mmol/mol (Clin Chem. 2007;53:1562–4 and Diabetes Care 2007;30:2399–400).

Clinically, these developments provide an opportunity for physicians to begin shifting discussions with diabetic patients away from hemoglobin A_1c and toward average glucose, two representatives from the ADA said at the briefing. “The clinician has the choice to use one, two, or three values when communicating with the patient. The diabetes organizations would encourage physicians to use the estimated average glucose,” said Richard Kahn, Ph.D., ADA's chief scientific officer.

The reason, explained ADA president Dr. John Buse, is that “[The HbA_1c] has always been kind of confusing for patients. At home they measure their glucose, then every 3 months they visit the doctor and get something that has the word 'hemoglobin' in it … There's always been a disconnect.” In contrast, “The estimated average glucose is expressed in numbers that people are used to looking at all day every day,” said Dr. Buse, director of the Diabetes Care Center of the division of general medicine and clinical epidemiology at the University of North Carolina at Chapel Hill.

It's not yet clear what will happen with point-of-care HbA_1c machines that many physicians currently have in their offices, but it's likely that the manufacturers can provide some sort of simple software adjustment or Internet link that won't be excessively burdensome or costly, Dr. Kahn noted at the briefing.

The shift to ADAG was initially spurred by the 2002 IFCC publication of a new reference method that measures the concentration of only one molecular species of glycated hemoglobins (the A_1c), as opposed to the mixture that had previously been measured. Recognizing that the IFCC's adoption of the new reference method would cause confusion in the clinical setting, an international working group decided in 2004 to launch the ADAG study. Although there already were data that provided a rough estimate of average glucose from HbA_1c—and indeed, many labs currently report those numbers—they were generated from old studies using infrequent fingerstick monitoring. The ADAG study, in contrast, utilized both frequent fingerstick and continuous glucose monitoring (CGM) to gather “thousands of data points” in order to derive a precise average, Dr. Heine explained.

Dr. Judith Kuenen, who works with Dr. Heine at Vrije University, presented the study data at the symposium. The entire group of 643 patients was about half men and half women. Half had type 1 diabetes, 36% had type 2 diabetes, and the other 14% did not have diabetes. Three-fourths were Caucasian. A total of 38% of participants, including all the nondiabetics, had hemoglobin A_1c values of 4%–6.5%. Another 44% had values between 6.6% and 8.5%, while 18% had HbA_1c levels about 8.5%.

A total of 427 patients had completed the study at the time of the meeting; the addition of the other 216 subjects is not expected to change the results. Of the 427 patients, 224 had type 1 diabetes and 125 had type 2 diabetes; the rest did not have diabetes. They had a mean age of 46 years; 53 were women, and 82% were white.(More minority subjects are among the other 216 patients who had not yet completed the study.) Approximately 2,400 CGM and 300 fingerstick glucose measurements were collected per subject, “an enormous amount of data,” Dr. Kuenen remarked.

Despite such frequent monitoring, HbA_1c levels remained stable in most patients during the course of the study, with only 4% showing improvement of more than 1 percentage point.

The study was supported by grants from several pharmaceutical and glucose monitoring device manufacturers. Among its limitations were the inclusion of only small numbers from various ethnic minority groups, and the lack of any data on children, pregnant women, or patients with renal impairment, Dr. Kuenen noted.

Independent commentator Dr. Philip Home, professor of diabetes medicine at the University of Newcastle-upon-Tyne (England), cautioned that it will take time to transition to using new numbers that don't correlate with a huge amount of published literature on data using the HbA_1c measurement to predict diabetes complications and other important clinical values. “The problem we have as a result of all this is that we have to re-standardize all our guidelines to align with this [ADAG], and that means a bit of re-education.”

AMSTERDAM — Initiation of moderate daily alcohol consumption among patients with type 2 diabetes results in decreased fasting plasma glucose levels, particularly among patients with worse control at baseline, Iris Shai, Ph.D., reported at the annual meeting of the European Association for the Study of Diabetes.

Alcohol may inhibit hepatic glucose production—as does the antidiabetic drug metformin—and also has been associated with beneficial cardiovascular effects. A recent meta-analysis of observational studies suggested that moderate alcohol consumption is associated with a reduced risk of coronary heart disease mortality among patients with type 2 diabetes, and that the beneficial association is greater than among nondiabetics (Diabetologia 2006;49:648–52).

But although several short-term intervention studies have found a decrease in fasting plasma glucose (FPG) levels in diabetic patients with moderate alcohol intake, other studies have not, said Dr. Shai, of the Ben-Gurion University of the Negev, Beer-Sheva, Israel.

A randomized, controlled intervention study to investigate the association was jointly sponsored by the Israeli Diabetes Research Group; Harvard University, Boston; the Tishbi Estate Winery, Israel; and Admiral Imports, Cedar Grove, N.J. A total of 109 initially nondrinking (defined as one drink or less per week) patients with type 2 diabetes aged 40–75 years were randomized to either 150 cc of wine (13 g alcohol, 100 kcal) or the same amount of nonalcoholic diet malt beer (0 g alcohol, 30 kcal) during dinner, both served in the same standard measured glass. The wine group could choose either dry red (merlot) or white (sauvignon blanc). Three-fourths chose the red, noted Dr. Shai, who is also a registered dietician.

Participants met with the nurse study coordinator, physicians, and dieticians several times during the trial. All participants received individual dietary counseling, including identical nutritional strategies to achieve glycemic control without aiming for dramatic weight loss. Both groups were instructed to reduce their carbohydrate intake at breakfast and/or lunch but not at dinner, the wine group by 100 kcal and the controls by 30 kcal. Prior to each visit, the subjects filled in 3-day diaries of their food and drink consumption.

Of the 201 patients screened, 126 were eligible, 109 were randomized, and 91 completed the study. Dropouts were higher among the control group (26% vs. 12% of the intervention group). “Most were disappointed not to be assigned to the wine group,” Dr. Shai said. The dropouts had significantly higher baseline FPG levels (167 vs. 140 mg/dL), she noted.

At baseline, the 61 men and 48 women who were randomized ranged in age from 41 to 74 years, had an average FPG of 144.5 mg/dL, a hemoglobin A_1c (HbA_1c) level of 7.39%, blood pressure of 133.7/76.5 mm Hg, and body mass index of 30.1 kg/m

In contrast to the FPG, there were nonsignificant increases in 2-hour postmeal glucose levels, based on an average of self-measurements. Within the alcohol group, there were significant decreases in HbA_1c (from 7.37% to 7.07%), LDL cholesterol (96.65 to 85.11 mg/dL), and waist circumference, but not in HDL cholesterol. These changes did not differ significantly between the two groups, however, she said. (HbA_1c values dropped slightly in the controls, from 7.08% to 6.84%.)

At 6 months after the start of the study (3 months after its termination), 61% of the alcohol group thought the alcohol was beneficial to them, and 49% were continuing to drink alcohol in moderation, ranging from one drink a week to one a day.

In response to an audience member's question about red vs. white wine, Dr. Shai said that the group plans to break down the data to see if there was a difference. But, she added, the study was deliberately designed to examine the effects of ethanol per se, rather than those of any particular components that are unique to red wine. She also cautioned that longer intervention studies will be necessary to determine the efficacy and safety of initiating moderate alcohol consumption in people with type 2 diabetes who don't already drink.

AMSTERDAM — Initiation of moderate daily alcohol consumption among patients with type 2 diabetes results in decreased fasting plasma glucose levels, particularly among patients with worse control at baseline, Iris Shai, Ph.D., reported at the annual meeting of the European Association for the Study of Diabetes.

Alcohol may inhibit hepatic glucose production—as does the antidiabetic drug metformin—and also has been associated with beneficial cardiovascular effects. A recent meta-analysis of observational studies suggested that moderate alcohol consumption is associated with a reduced risk of coronary heart disease mortality among patients with type 2 diabetes, and that the beneficial association is greater than among nondiabetics (Diabetologia 2006;49:648–52).

But although several short-term intervention studies have found a decrease in fasting plasma glucose (FPG) levels in diabetic patients with moderate alcohol intake, other studies have not, said Dr. Shai, of the Ben-Gurion University of the Negev, Beer-Sheva, Israel.

A randomized, controlled intervention study to investigate the association was jointly sponsored by the Israeli Diabetes Research Group; Harvard University, Boston; the Tishbi Estate Winery, Israel; and Admiral Imports, Cedar Grove, N.J. A total of 109 initially nondrinking (defined as one drink or less per week) patients with type 2 diabetes aged 40–75 years were randomized to either 150 cc of wine (13 g alcohol, 100 kcal) or the same amount of nonalcoholic diet malt beer (0 g alcohol, 30 kcal) during dinner, both served in the same standard measured glass. The wine group could choose either dry red (merlot) or white (sauvignon blanc). Three-fourths chose the red, noted Dr. Shai, who is also a registered dietician.

Participants met with the nurse study coordinator, physicians, and dieticians several times during the trial. All participants received individual dietary counseling, including identical nutritional strategies to achieve glycemic control without aiming for dramatic weight loss. Both groups were instructed to reduce their carbohydrate intake at breakfast and/or lunch but not at dinner, the wine group by 100 kcal and the controls by 30 kcal. Prior to each visit, the subjects filled in 3-day diaries of their food and drink consumption.

Of the 201 patients screened, 126 were eligible, 109 were randomized, and 91 completed the study. Dropouts were higher among the control group (26% vs. 12% of the intervention group). “Most were disappointed not to be assigned to the wine group,” Dr. Shai said. The dropouts had significantly higher baseline FPG levels (167 vs. 140 mg/dL), she noted.

At baseline, the 61 men and 48 women who were randomized ranged in age from 41 to 74 years, had an average FPG of 144.5 mg/dL, a hemoglobin A_1c (HbA_1c) level of 7.39%, blood pressure of 133.7/76.5 mm Hg, and body mass index of 30.1 kg/m

In contrast to the FPG, there were nonsignificant increases in 2-hour postmeal glucose levels, based on an average of self-measurements. Within the alcohol group, there were significant decreases in HbA_1c (from 7.37% to 7.07%), LDL cholesterol (96.65 to 85.11 mg/dL), and waist circumference, but not in HDL cholesterol. These changes did not differ significantly between the two groups, however, she said. (HbA_1c values dropped slightly in the controls, from 7.08% to 6.84%.)

At 6 months after the start of the study (3 months after its termination), 61% of the alcohol group thought the alcohol was beneficial to them, and 49% were continuing to drink alcohol in moderation, ranging from one drink a week to one a day.

In response to an audience member's question about red vs. white wine, Dr. Shai said that the group plans to break down the data to see if there was a difference. But, she added, the study was deliberately designed to examine the effects of ethanol per se, rather than those of any particular components that are unique to red wine. She also cautioned that longer intervention studies will be necessary to determine the efficacy and safety of initiating moderate alcohol consumption in people with type 2 diabetes who don't already drink.

AMSTERDAM — Initiation of moderate daily alcohol consumption among patients with type 2 diabetes results in decreased fasting plasma glucose levels, particularly among patients with worse control at baseline, Iris Shai, Ph.D., reported at the annual meeting of the European Association for the Study of Diabetes.

Alcohol may inhibit hepatic glucose production—as does the antidiabetic drug metformin—and also has been associated with beneficial cardiovascular effects. A recent meta-analysis of observational studies suggested that moderate alcohol consumption is associated with a reduced risk of coronary heart disease mortality among patients with type 2 diabetes, and that the beneficial association is greater than among nondiabetics (Diabetologia 2006;49:648–52).

But although several short-term intervention studies have found a decrease in fasting plasma glucose (FPG) levels in diabetic patients with moderate alcohol intake, other studies have not, said Dr. Shai, of the Ben-Gurion University of the Negev, Beer-Sheva, Israel.

A randomized, controlled intervention study to investigate the association was jointly sponsored by the Israeli Diabetes Research Group; Harvard University, Boston; the Tishbi Estate Winery, Israel; and Admiral Imports, Cedar Grove, N.J. A total of 109 initially nondrinking (defined as one drink or less per week) patients with type 2 diabetes aged 40–75 years were randomized to either 150 cc of wine (13 g alcohol, 100 kcal) or the same amount of nonalcoholic diet malt beer (0 g alcohol, 30 kcal) during dinner, both served in the same standard measured glass. The wine group could choose either dry red (merlot) or white (sauvignon blanc). Three-fourths chose the red, noted Dr. Shai, who is also a registered dietician.

Participants met with the nurse study coordinator, physicians, and dieticians several times during the trial. All participants received individual dietary counseling, including identical nutritional strategies to achieve glycemic control without aiming for dramatic weight loss. Both groups were instructed to reduce their carbohydrate intake at breakfast and/or lunch but not at dinner, the wine group by 100 kcal and the controls by 30 kcal. Prior to each visit, the subjects filled in 3-day diaries of their food and drink consumption.

Of the 201 patients screened, 126 were eligible, 109 were randomized, and 91 completed the study. Dropouts were higher among the control group (26% vs. 12% of the intervention group). “Most were disappointed not to be assigned to the wine group,” Dr. Shai said. The dropouts had significantly higher baseline FPG levels (167 vs. 140 mg/dL), she noted.

At baseline, the 61 men and 48 women who were randomized ranged in age from 41 to 74 years, had an average FPG of 144.5 mg/dL, a hemoglobin A_1c (HbA_1c) level of 7.39%, blood pressure of 133.7/76.5 mm Hg, and body mass index of 30.1 kg/m

In contrast to the FPG, there were nonsignificant increases in 2-hour postmeal glucose levels, based on an average of self-measurements. Within the alcohol group, there were significant decreases in HbA_1c (from 7.37% to 7.07%), LDL cholesterol (96.65 to 85.11 mg/dL), and waist circumference, but not in HDL cholesterol. These changes did not differ significantly between the two groups, however, she said. (HbA_1c values dropped slightly in the controls, from 7.08% to 6.84%.)

At 6 months after the start of the study (3 months after its termination), 61% of the alcohol group thought the alcohol was beneficial to them, and 49% were continuing to drink alcohol in moderation, ranging from one drink a week to one a day.

In response to an audience member's question about red vs. white wine, Dr. Shai said that the group plans to break down the data to see if there was a difference. But, she added, the study was deliberately designed to examine the effects of ethanol per se, rather than those of any particular components that are unique to red wine. She also cautioned that longer intervention studies will be necessary to determine the efficacy and safety of initiating moderate alcohol consumption in people with type 2 diabetes who don't already drink.