Carotid Wall Thickness, Coronary Calcium Both Predictive in Elderly

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WASHINGTON — Coronary artery calcification and common carotid wall thickness are similarly predictive of total cardiovascular disease events in elderly community-dwelling adults, Anne B. Newman, M.D., reported at a conference on cardiovascular disease epidemiology and prevention sponsored by the American Heart Association.

Several noninvasive methods that document the extent of vascular disease have been shown to predict cardiovascular events, but these methods have not previously been directly compared in the same population, said Dr. Newman of the division of geriatric medicine at the University of Pittsburgh.

As part of the National Heart, Lung, and Blood Institute's Cardiovascular Health Study, 559 participants with a mean age of 80 years underwent both carotid ultrasound and coronary artery calcium (CAC) scans; 40% of the participants were male and 22% were black. At the time of the scans, clinical cardiovascular disease (CVD) was present in 33%.

A total of 112 events, including 23 myocardial infarctions, 24 cases of angina, 15 strokes, and 13 cases of heart failure, occurred over 4.4 years of follow-up. Death due to CVD occurred in 27 subjects, she reported at the meeting, also sponsored by the National Heart, Lung, and Blood Institute.

Total cardiovascular event rates per 100 person-years increased linearly by quartiles of CAC scores: 2.81 for those with scores of 0–56, 5.08 for scores of 57–332, 6.63 for scores of 333–916, and 7.37 for scores greater than 917. Compared with those in the lowest CAC quartile, the hazard ratio for each subsequent quartile—adjusted for age, sex, and prevalent CVD—were 1.76, 2.28, and 2.31, with the upper two reaching statistical significance.

Common carotid artery (CCA) wall thickness was similarly predictive, with event rates ranging from 2.89 per 100 person-years for those with CCA wall thickness of less than 0.95 mm up to 9.30 for those with CCA thickness of 1.23–3.14 mm. The hazard ratios for the upper three quartiles compared with the lowest were 1.43, 1.86, and 2.94. Again, the upper two were significant, Dr. Newman said.

Similar predictive ability of both CAC and common carotid artery wall thickness were seen when the analysis was repeated for incident cardiovascular disease event rates among the 373 subjects who did not already have CVD at baseline, she said.

Although the internal common carotid artery (ICA) wall thickness was more highly correlated with the coronary artery calcium score than was the common carotid artery wall thickness, the relative risks between ICA wall thickness and mortality were not as strong as for the other two measures. With ICA, even the 1.50 hazard ratio for total cardiovascular disease events between the lowest quartile (less than 1.01 mm) and the highest (2.13–6.15 mm) was not significant.

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WASHINGTON — Coronary artery calcification and common carotid wall thickness are similarly predictive of total cardiovascular disease events in elderly community-dwelling adults, Anne B. Newman, M.D., reported at a conference on cardiovascular disease epidemiology and prevention sponsored by the American Heart Association.

Several noninvasive methods that document the extent of vascular disease have been shown to predict cardiovascular events, but these methods have not previously been directly compared in the same population, said Dr. Newman of the division of geriatric medicine at the University of Pittsburgh.

As part of the National Heart, Lung, and Blood Institute's Cardiovascular Health Study, 559 participants with a mean age of 80 years underwent both carotid ultrasound and coronary artery calcium (CAC) scans; 40% of the participants were male and 22% were black. At the time of the scans, clinical cardiovascular disease (CVD) was present in 33%.

A total of 112 events, including 23 myocardial infarctions, 24 cases of angina, 15 strokes, and 13 cases of heart failure, occurred over 4.4 years of follow-up. Death due to CVD occurred in 27 subjects, she reported at the meeting, also sponsored by the National Heart, Lung, and Blood Institute.

Total cardiovascular event rates per 100 person-years increased linearly by quartiles of CAC scores: 2.81 for those with scores of 0–56, 5.08 for scores of 57–332, 6.63 for scores of 333–916, and 7.37 for scores greater than 917. Compared with those in the lowest CAC quartile, the hazard ratio for each subsequent quartile—adjusted for age, sex, and prevalent CVD—were 1.76, 2.28, and 2.31, with the upper two reaching statistical significance.

Common carotid artery (CCA) wall thickness was similarly predictive, with event rates ranging from 2.89 per 100 person-years for those with CCA wall thickness of less than 0.95 mm up to 9.30 for those with CCA thickness of 1.23–3.14 mm. The hazard ratios for the upper three quartiles compared with the lowest were 1.43, 1.86, and 2.94. Again, the upper two were significant, Dr. Newman said.

Similar predictive ability of both CAC and common carotid artery wall thickness were seen when the analysis was repeated for incident cardiovascular disease event rates among the 373 subjects who did not already have CVD at baseline, she said.

Although the internal common carotid artery (ICA) wall thickness was more highly correlated with the coronary artery calcium score than was the common carotid artery wall thickness, the relative risks between ICA wall thickness and mortality were not as strong as for the other two measures. With ICA, even the 1.50 hazard ratio for total cardiovascular disease events between the lowest quartile (less than 1.01 mm) and the highest (2.13–6.15 mm) was not significant.

WASHINGTON — Coronary artery calcification and common carotid wall thickness are similarly predictive of total cardiovascular disease events in elderly community-dwelling adults, Anne B. Newman, M.D., reported at a conference on cardiovascular disease epidemiology and prevention sponsored by the American Heart Association.

Several noninvasive methods that document the extent of vascular disease have been shown to predict cardiovascular events, but these methods have not previously been directly compared in the same population, said Dr. Newman of the division of geriatric medicine at the University of Pittsburgh.

As part of the National Heart, Lung, and Blood Institute's Cardiovascular Health Study, 559 participants with a mean age of 80 years underwent both carotid ultrasound and coronary artery calcium (CAC) scans; 40% of the participants were male and 22% were black. At the time of the scans, clinical cardiovascular disease (CVD) was present in 33%.

A total of 112 events, including 23 myocardial infarctions, 24 cases of angina, 15 strokes, and 13 cases of heart failure, occurred over 4.4 years of follow-up. Death due to CVD occurred in 27 subjects, she reported at the meeting, also sponsored by the National Heart, Lung, and Blood Institute.

Total cardiovascular event rates per 100 person-years increased linearly by quartiles of CAC scores: 2.81 for those with scores of 0–56, 5.08 for scores of 57–332, 6.63 for scores of 333–916, and 7.37 for scores greater than 917. Compared with those in the lowest CAC quartile, the hazard ratio for each subsequent quartile—adjusted for age, sex, and prevalent CVD—were 1.76, 2.28, and 2.31, with the upper two reaching statistical significance.

Common carotid artery (CCA) wall thickness was similarly predictive, with event rates ranging from 2.89 per 100 person-years for those with CCA wall thickness of less than 0.95 mm up to 9.30 for those with CCA thickness of 1.23–3.14 mm. The hazard ratios for the upper three quartiles compared with the lowest were 1.43, 1.86, and 2.94. Again, the upper two were significant, Dr. Newman said.

Similar predictive ability of both CAC and common carotid artery wall thickness were seen when the analysis was repeated for incident cardiovascular disease event rates among the 373 subjects who did not already have CVD at baseline, she said.

Although the internal common carotid artery (ICA) wall thickness was more highly correlated with the coronary artery calcium score than was the common carotid artery wall thickness, the relative risks between ICA wall thickness and mortality were not as strong as for the other two measures. With ICA, even the 1.50 hazard ratio for total cardiovascular disease events between the lowest quartile (less than 1.01 mm) and the highest (2.13–6.15 mm) was not significant.

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Use of ACE Inhibitors Up in MI Patients, but Could Be Better

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WASHINGTON — Use of ACE inhibitors in patients hospitalized with acute myocardial infarction has increased over the past 15 years, but there is still room for improvement, Chyke A. Doubeni, M.D., said at a conference on cardiovascular disease epidemiology and prevention sponsored by the American Heart Association.

Use of ACE inhibitors (ACEIs) in the early treatment of acute MI has indeed risen since their use was recommended in the 1996 Joint American College of Cardiology/American Heart Association guidelines (J. Am. Coll. Cardiol. 1996;28:1328–428). But results of a large community study suggest that the agents are still underutilized in the elderly, patients with renal disease, those with prior acute MI, and patients who were not using ACEIs prior to hospitalization.

“Clinicians should be vigilant about appropriately considering the use of this therapy in all patients with acute myocardial infarction,” commented Dr. Doubeni of the department of family medicine and community health at the University of Massachusetts, Worcester.

Of a total 7,989 Worcester residents hospitalized between 1990 and 2003 with acute MI at 16 acute care hospitals, 44% (3,545) received ACEIs. But of the 1,733 patients who had already been on ACEI therapy prior to hospitalization, 87% continued to receive it while in the hospital. In contrast, 33% of the 6,256 who had not previously been taking ACEIs were newly initiated on the therapy during hospitalization, Dr. Doubeni reported at the conference, also sponsored by the National Heart, Lung, and Blood Institute.

Patients who were on ACEI prior to the index hospitalization were older (73 years vs. 69 years) and were significantly more likely than were those not previously taking these drugs to have hypertension (73% vs. 69%), diabetes (48% vs. 25%), and/or heart failure (41% vs. 15%). The patient population was mostly white.

Overall, receipt of ACEI therapy in hospitalized MI patients rose from just 23% in 1990 to 34% in 1995, then jumped to 50% in 1997, the year after the ACC/AHA guidelines were published. Although the rate of ACEI use remained unchanged between 1997 and 1999, it rose to 68% by 2003.

But these proportions differed substantially between prior users of ACEIs, in whom use during an MI hospitalization rose from 80% to 93% over the 14 year period, and new users, who accounted for just 15% of MI hospitalizations in 1990 and 57% in 2003.

Comparing 1990–1991 with 2001–2003, ACEI use more than doubled in several other subgroups, including those younger than 55 years and those with left ventricular ejection fractions less than 0.40, he reported.

Patients with diabetes, anterior acute MI, left ventricular dysfunction, and heart failure were significantly more likely to receive ACEIs during the entire study period, while there were no differences with regard to age or gender. Patients who had a history of renal disease were only about half as likely (adjusted odds ratio 0.55) to receive ACEI treatment. This is of concern, given recent data suggesting that the agents are protective in patients who have chronic kidney disease (Circulation 2004;110:3667–73).

During the hospitalization, patients who were also on aspirin or β-blockers and those undergoing cardiac catheterizations or percutaneous coronary intervention were all more likely to receive ACEIs, while those undergoing coronary artery bypass grafting and those receiving calcium channel blockers were less likely to have received them.

Overall, 8% of patients receiving ACEI therapy died while in the hospital, compared with 16% of those not on ACEIs. This survival benefit remained after the investigators factored in age, gender, medical history, characteristics of the incident MI, in-hospital complications, and study year. Similar though somewhat attenuated benefits were observed when the analysis was repeated in patients surviving beyond 24 hours of hospitalization, and remained for all subgroups examined.

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WASHINGTON — Use of ACE inhibitors in patients hospitalized with acute myocardial infarction has increased over the past 15 years, but there is still room for improvement, Chyke A. Doubeni, M.D., said at a conference on cardiovascular disease epidemiology and prevention sponsored by the American Heart Association.

Use of ACE inhibitors (ACEIs) in the early treatment of acute MI has indeed risen since their use was recommended in the 1996 Joint American College of Cardiology/American Heart Association guidelines (J. Am. Coll. Cardiol. 1996;28:1328–428). But results of a large community study suggest that the agents are still underutilized in the elderly, patients with renal disease, those with prior acute MI, and patients who were not using ACEIs prior to hospitalization.

“Clinicians should be vigilant about appropriately considering the use of this therapy in all patients with acute myocardial infarction,” commented Dr. Doubeni of the department of family medicine and community health at the University of Massachusetts, Worcester.

Of a total 7,989 Worcester residents hospitalized between 1990 and 2003 with acute MI at 16 acute care hospitals, 44% (3,545) received ACEIs. But of the 1,733 patients who had already been on ACEI therapy prior to hospitalization, 87% continued to receive it while in the hospital. In contrast, 33% of the 6,256 who had not previously been taking ACEIs were newly initiated on the therapy during hospitalization, Dr. Doubeni reported at the conference, also sponsored by the National Heart, Lung, and Blood Institute.

Patients who were on ACEI prior to the index hospitalization were older (73 years vs. 69 years) and were significantly more likely than were those not previously taking these drugs to have hypertension (73% vs. 69%), diabetes (48% vs. 25%), and/or heart failure (41% vs. 15%). The patient population was mostly white.

Overall, receipt of ACEI therapy in hospitalized MI patients rose from just 23% in 1990 to 34% in 1995, then jumped to 50% in 1997, the year after the ACC/AHA guidelines were published. Although the rate of ACEI use remained unchanged between 1997 and 1999, it rose to 68% by 2003.

But these proportions differed substantially between prior users of ACEIs, in whom use during an MI hospitalization rose from 80% to 93% over the 14 year period, and new users, who accounted for just 15% of MI hospitalizations in 1990 and 57% in 2003.

Comparing 1990–1991 with 2001–2003, ACEI use more than doubled in several other subgroups, including those younger than 55 years and those with left ventricular ejection fractions less than 0.40, he reported.

Patients with diabetes, anterior acute MI, left ventricular dysfunction, and heart failure were significantly more likely to receive ACEIs during the entire study period, while there were no differences with regard to age or gender. Patients who had a history of renal disease were only about half as likely (adjusted odds ratio 0.55) to receive ACEI treatment. This is of concern, given recent data suggesting that the agents are protective in patients who have chronic kidney disease (Circulation 2004;110:3667–73).

During the hospitalization, patients who were also on aspirin or β-blockers and those undergoing cardiac catheterizations or percutaneous coronary intervention were all more likely to receive ACEIs, while those undergoing coronary artery bypass grafting and those receiving calcium channel blockers were less likely to have received them.

Overall, 8% of patients receiving ACEI therapy died while in the hospital, compared with 16% of those not on ACEIs. This survival benefit remained after the investigators factored in age, gender, medical history, characteristics of the incident MI, in-hospital complications, and study year. Similar though somewhat attenuated benefits were observed when the analysis was repeated in patients surviving beyond 24 hours of hospitalization, and remained for all subgroups examined.

WASHINGTON — Use of ACE inhibitors in patients hospitalized with acute myocardial infarction has increased over the past 15 years, but there is still room for improvement, Chyke A. Doubeni, M.D., said at a conference on cardiovascular disease epidemiology and prevention sponsored by the American Heart Association.

Use of ACE inhibitors (ACEIs) in the early treatment of acute MI has indeed risen since their use was recommended in the 1996 Joint American College of Cardiology/American Heart Association guidelines (J. Am. Coll. Cardiol. 1996;28:1328–428). But results of a large community study suggest that the agents are still underutilized in the elderly, patients with renal disease, those with prior acute MI, and patients who were not using ACEIs prior to hospitalization.

“Clinicians should be vigilant about appropriately considering the use of this therapy in all patients with acute myocardial infarction,” commented Dr. Doubeni of the department of family medicine and community health at the University of Massachusetts, Worcester.

Of a total 7,989 Worcester residents hospitalized between 1990 and 2003 with acute MI at 16 acute care hospitals, 44% (3,545) received ACEIs. But of the 1,733 patients who had already been on ACEI therapy prior to hospitalization, 87% continued to receive it while in the hospital. In contrast, 33% of the 6,256 who had not previously been taking ACEIs were newly initiated on the therapy during hospitalization, Dr. Doubeni reported at the conference, also sponsored by the National Heart, Lung, and Blood Institute.

Patients who were on ACEI prior to the index hospitalization were older (73 years vs. 69 years) and were significantly more likely than were those not previously taking these drugs to have hypertension (73% vs. 69%), diabetes (48% vs. 25%), and/or heart failure (41% vs. 15%). The patient population was mostly white.

Overall, receipt of ACEI therapy in hospitalized MI patients rose from just 23% in 1990 to 34% in 1995, then jumped to 50% in 1997, the year after the ACC/AHA guidelines were published. Although the rate of ACEI use remained unchanged between 1997 and 1999, it rose to 68% by 2003.

But these proportions differed substantially between prior users of ACEIs, in whom use during an MI hospitalization rose from 80% to 93% over the 14 year period, and new users, who accounted for just 15% of MI hospitalizations in 1990 and 57% in 2003.

Comparing 1990–1991 with 2001–2003, ACEI use more than doubled in several other subgroups, including those younger than 55 years and those with left ventricular ejection fractions less than 0.40, he reported.

Patients with diabetes, anterior acute MI, left ventricular dysfunction, and heart failure were significantly more likely to receive ACEIs during the entire study period, while there were no differences with regard to age or gender. Patients who had a history of renal disease were only about half as likely (adjusted odds ratio 0.55) to receive ACEI treatment. This is of concern, given recent data suggesting that the agents are protective in patients who have chronic kidney disease (Circulation 2004;110:3667–73).

During the hospitalization, patients who were also on aspirin or β-blockers and those undergoing cardiac catheterizations or percutaneous coronary intervention were all more likely to receive ACEIs, while those undergoing coronary artery bypass grafting and those receiving calcium channel blockers were less likely to have received them.

Overall, 8% of patients receiving ACEI therapy died while in the hospital, compared with 16% of those not on ACEIs. This survival benefit remained after the investigators factored in age, gender, medical history, characteristics of the incident MI, in-hospital complications, and study year. Similar though somewhat attenuated benefits were observed when the analysis was repeated in patients surviving beyond 24 hours of hospitalization, and remained for all subgroups examined.

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Suboptimal Vitamin D Levels Often Overlooked in Osteoporosis Patients

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WASHINGTON — More than half of North American women receiving treatment for osteoporosis have suboptimal serum vitamin D levels, Anne E. de Papp, M.D., and her associates reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

Inadequate vitamin D concentrations can lead to alterations in calcium and phosphate homeostasis, secondary hypoparathyroidism, bone loss, osteoporosis, and an increased risk of fractures.

Yet data from a cross-sectional study of 1,536 postmenopausal women seen at 61 North American sites suggest that the problem is often overlooked in patients being treated for osteoporosis, said Dr. de Papp, of Merck & Co. Inc., West Point, Pa., and her associates.

The patients had a mean age of 71 years (range, 47–103 years) and a mean body mass index (BMI) of 26.4 kg/m

Vitamin D supplementation at a dosage of 400 IU/day or more was reported by 59.5% of the women, while the rest were taking less.

For the entire group, the mean serum level of the active vitamin D metabolite 25-hydroxyvitamin D was 30.4 ng/mL. Most of the women (52%) had levels below 30 ng/mL, considered the minimum concentration necessary to maintain optimal serum parathyroid hormone levels (Osteoporos Int. 1997;7:439–43), while 36% had 25-hydroxyvitamin D levels below 25 ng/mL, and 18% were below 20 ng/mL, the investigators reported.

Suboptimal 25-hydroxyvitamin D concentrations were found in 63% of women taking less than 400 IU/day of vitamin D, compared with 45% of those receiving 400 IU or more per day.

The study was funded by Merck.

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WASHINGTON — More than half of North American women receiving treatment for osteoporosis have suboptimal serum vitamin D levels, Anne E. de Papp, M.D., and her associates reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

Inadequate vitamin D concentrations can lead to alterations in calcium and phosphate homeostasis, secondary hypoparathyroidism, bone loss, osteoporosis, and an increased risk of fractures.

Yet data from a cross-sectional study of 1,536 postmenopausal women seen at 61 North American sites suggest that the problem is often overlooked in patients being treated for osteoporosis, said Dr. de Papp, of Merck & Co. Inc., West Point, Pa., and her associates.

The patients had a mean age of 71 years (range, 47–103 years) and a mean body mass index (BMI) of 26.4 kg/m

Vitamin D supplementation at a dosage of 400 IU/day or more was reported by 59.5% of the women, while the rest were taking less.

For the entire group, the mean serum level of the active vitamin D metabolite 25-hydroxyvitamin D was 30.4 ng/mL. Most of the women (52%) had levels below 30 ng/mL, considered the minimum concentration necessary to maintain optimal serum parathyroid hormone levels (Osteoporos Int. 1997;7:439–43), while 36% had 25-hydroxyvitamin D levels below 25 ng/mL, and 18% were below 20 ng/mL, the investigators reported.

Suboptimal 25-hydroxyvitamin D concentrations were found in 63% of women taking less than 400 IU/day of vitamin D, compared with 45% of those receiving 400 IU or more per day.

The study was funded by Merck.

WASHINGTON — More than half of North American women receiving treatment for osteoporosis have suboptimal serum vitamin D levels, Anne E. de Papp, M.D., and her associates reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

Inadequate vitamin D concentrations can lead to alterations in calcium and phosphate homeostasis, secondary hypoparathyroidism, bone loss, osteoporosis, and an increased risk of fractures.

Yet data from a cross-sectional study of 1,536 postmenopausal women seen at 61 North American sites suggest that the problem is often overlooked in patients being treated for osteoporosis, said Dr. de Papp, of Merck & Co. Inc., West Point, Pa., and her associates.

The patients had a mean age of 71 years (range, 47–103 years) and a mean body mass index (BMI) of 26.4 kg/m

Vitamin D supplementation at a dosage of 400 IU/day or more was reported by 59.5% of the women, while the rest were taking less.

For the entire group, the mean serum level of the active vitamin D metabolite 25-hydroxyvitamin D was 30.4 ng/mL. Most of the women (52%) had levels below 30 ng/mL, considered the minimum concentration necessary to maintain optimal serum parathyroid hormone levels (Osteoporos Int. 1997;7:439–43), while 36% had 25-hydroxyvitamin D levels below 25 ng/mL, and 18% were below 20 ng/mL, the investigators reported.

Suboptimal 25-hydroxyvitamin D concentrations were found in 63% of women taking less than 400 IU/day of vitamin D, compared with 45% of those receiving 400 IU or more per day.

The study was funded by Merck.

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New Cutoff Value Identifies More Vitamin D Deficiency

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WASHINGTON — A serum 25-hydroxyvitamin D level below 30 ng/mL appears to define vitamin D deficiency, Paraskevi Sapountzi, M.D., reported at the annual meeting of the American Association of Clinical Endocrinologists.

Vitamin D deficiency, which is highly prevalent among patients with osteoporosis, can lead to a poor response to therapy. But recent reports of assay variability have led to confusion about interpretation of the metabolite 25(OH)D levels, and not enough data are available to guide clinicians regarding when to initiate vitamin D therapy, said Dr. Sapountzi, of Loyola University, Chicago.

In a retrospective analysis of 143 female and 20 male patients who had been evaluated for low bone mass at the university's Osteoporosis and Metabolic Bone Disease Center, the patients had a mean age of 62.5 years, a mean 25(OH)D level of 29.8 ng/mL, a mean parathyroid hormone (PTH) level of 61.7 pg/mL, a mean urine calcium level of 215.7 mg/24 hours, and a mean spine T score of −1.9. None of the subjects were on vitamin D therapy or had primary hyperparathyroidism, she said.

Initially, vitamin D insufficiency was defined as a 25(OH)D level of less than 20 ng/mL, based on the lab's reference range and data from one study suggesting that this was the cutoff below which the risk for secondary hyperparathyroidism increases. With that definition, 26.4% of the 163 patients had vitamin D insufficiency.

The 25(OH)D level was significantly correlated with PTH and with urinary calcium, with the difference between the means of PTH above and below a 25(OH)D level of 30 ng/mL being significant. At 35 ng/mL, the significance was lost. Using the new cutoff of 30 ng/mL for vitamin D deficiency raised the prevalence among the subjects to 48%, Dr. Sapountzi reported.

A 25(OH)D level of 30 ng/mL also showed significant differences in the urinary calcium levels of patients with 25(OH)D above and below that threshold.

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WASHINGTON — A serum 25-hydroxyvitamin D level below 30 ng/mL appears to define vitamin D deficiency, Paraskevi Sapountzi, M.D., reported at the annual meeting of the American Association of Clinical Endocrinologists.

Vitamin D deficiency, which is highly prevalent among patients with osteoporosis, can lead to a poor response to therapy. But recent reports of assay variability have led to confusion about interpretation of the metabolite 25(OH)D levels, and not enough data are available to guide clinicians regarding when to initiate vitamin D therapy, said Dr. Sapountzi, of Loyola University, Chicago.

In a retrospective analysis of 143 female and 20 male patients who had been evaluated for low bone mass at the university's Osteoporosis and Metabolic Bone Disease Center, the patients had a mean age of 62.5 years, a mean 25(OH)D level of 29.8 ng/mL, a mean parathyroid hormone (PTH) level of 61.7 pg/mL, a mean urine calcium level of 215.7 mg/24 hours, and a mean spine T score of −1.9. None of the subjects were on vitamin D therapy or had primary hyperparathyroidism, she said.

Initially, vitamin D insufficiency was defined as a 25(OH)D level of less than 20 ng/mL, based on the lab's reference range and data from one study suggesting that this was the cutoff below which the risk for secondary hyperparathyroidism increases. With that definition, 26.4% of the 163 patients had vitamin D insufficiency.

The 25(OH)D level was significantly correlated with PTH and with urinary calcium, with the difference between the means of PTH above and below a 25(OH)D level of 30 ng/mL being significant. At 35 ng/mL, the significance was lost. Using the new cutoff of 30 ng/mL for vitamin D deficiency raised the prevalence among the subjects to 48%, Dr. Sapountzi reported.

A 25(OH)D level of 30 ng/mL also showed significant differences in the urinary calcium levels of patients with 25(OH)D above and below that threshold.

WASHINGTON — A serum 25-hydroxyvitamin D level below 30 ng/mL appears to define vitamin D deficiency, Paraskevi Sapountzi, M.D., reported at the annual meeting of the American Association of Clinical Endocrinologists.

Vitamin D deficiency, which is highly prevalent among patients with osteoporosis, can lead to a poor response to therapy. But recent reports of assay variability have led to confusion about interpretation of the metabolite 25(OH)D levels, and not enough data are available to guide clinicians regarding when to initiate vitamin D therapy, said Dr. Sapountzi, of Loyola University, Chicago.

In a retrospective analysis of 143 female and 20 male patients who had been evaluated for low bone mass at the university's Osteoporosis and Metabolic Bone Disease Center, the patients had a mean age of 62.5 years, a mean 25(OH)D level of 29.8 ng/mL, a mean parathyroid hormone (PTH) level of 61.7 pg/mL, a mean urine calcium level of 215.7 mg/24 hours, and a mean spine T score of −1.9. None of the subjects were on vitamin D therapy or had primary hyperparathyroidism, she said.

Initially, vitamin D insufficiency was defined as a 25(OH)D level of less than 20 ng/mL, based on the lab's reference range and data from one study suggesting that this was the cutoff below which the risk for secondary hyperparathyroidism increases. With that definition, 26.4% of the 163 patients had vitamin D insufficiency.

The 25(OH)D level was significantly correlated with PTH and with urinary calcium, with the difference between the means of PTH above and below a 25(OH)D level of 30 ng/mL being significant. At 35 ng/mL, the significance was lost. Using the new cutoff of 30 ng/mL for vitamin D deficiency raised the prevalence among the subjects to 48%, Dr. Sapountzi reported.

A 25(OH)D level of 30 ng/mL also showed significant differences in the urinary calcium levels of patients with 25(OH)D above and below that threshold.

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Surveyed Rheums Diagnose, Treat Osteoporosis Aggressively

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WASHINGTON — Endocrinologists and rheumatologists are the most aggressive specialists when it comes to the screening, diagnosis, and treatment of osteoporosis, Tiffany Karas, M.D., and her associates reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

Of 122 physicians who responded to an electronic survey, there were 27 geriatricians, 25 endocrinologists, 23 obstetrician/gynecologists, 20 rheumatologists, 19 primary care physicians, and 8 orthopedic surgeons. In screening for osteoporosis, 94% of the entire group said they would order a dual-energy x-ray absorptiometry (DXA) scan for a patient with two or more risk factors, said Dr. Karas and her associates, of Loyola University Medical Center, Maywood, Ill.

The risk factors most likely to prompt DXA scanning were height loss (93%), chronic prednisone use (89%), and menopause (86.6%). Among the risk factors least likely to prompt DXA were low testosterone (60%) and vertebral deformities (74%) in an elderly male patient. In general, all physicians surveyed were much less likely to order DXA for men with indications than for women. “This is one area where continuing education about osteoporosis may improve patient care,” the investigators noted.

Endocrinologists and rheumatologists were more likely to order DXA given any risk factor or patient scenario than were the other specialties, while orthopedic surgeons were the least likely. Rheumatologists were the most likely to initiate treatment in patients, followed by endocrinologists, geriatricians, primary care physicians, and ob.gyns.

Alendronate and risedronate were deemed the most efficacious treatments by more than 98% of all physicians, while calcium/vitamin D and calcitonin were thought to be the least efficacious. Overall, patients were more likely to be screened, diagnosed, and treated for osteoporosis by female physicians who had been in practice more than 6 years and who practice in urban, academic settings, Dr. Karas and her associates reported.

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WASHINGTON — Endocrinologists and rheumatologists are the most aggressive specialists when it comes to the screening, diagnosis, and treatment of osteoporosis, Tiffany Karas, M.D., and her associates reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

Of 122 physicians who responded to an electronic survey, there were 27 geriatricians, 25 endocrinologists, 23 obstetrician/gynecologists, 20 rheumatologists, 19 primary care physicians, and 8 orthopedic surgeons. In screening for osteoporosis, 94% of the entire group said they would order a dual-energy x-ray absorptiometry (DXA) scan for a patient with two or more risk factors, said Dr. Karas and her associates, of Loyola University Medical Center, Maywood, Ill.

The risk factors most likely to prompt DXA scanning were height loss (93%), chronic prednisone use (89%), and menopause (86.6%). Among the risk factors least likely to prompt DXA were low testosterone (60%) and vertebral deformities (74%) in an elderly male patient. In general, all physicians surveyed were much less likely to order DXA for men with indications than for women. “This is one area where continuing education about osteoporosis may improve patient care,” the investigators noted.

Endocrinologists and rheumatologists were more likely to order DXA given any risk factor or patient scenario than were the other specialties, while orthopedic surgeons were the least likely. Rheumatologists were the most likely to initiate treatment in patients, followed by endocrinologists, geriatricians, primary care physicians, and ob.gyns.

Alendronate and risedronate were deemed the most efficacious treatments by more than 98% of all physicians, while calcium/vitamin D and calcitonin were thought to be the least efficacious. Overall, patients were more likely to be screened, diagnosed, and treated for osteoporosis by female physicians who had been in practice more than 6 years and who practice in urban, academic settings, Dr. Karas and her associates reported.

WASHINGTON — Endocrinologists and rheumatologists are the most aggressive specialists when it comes to the screening, diagnosis, and treatment of osteoporosis, Tiffany Karas, M.D., and her associates reported in a poster at the annual meeting of the American Association of Clinical Endocrinologists.

Of 122 physicians who responded to an electronic survey, there were 27 geriatricians, 25 endocrinologists, 23 obstetrician/gynecologists, 20 rheumatologists, 19 primary care physicians, and 8 orthopedic surgeons. In screening for osteoporosis, 94% of the entire group said they would order a dual-energy x-ray absorptiometry (DXA) scan for a patient with two or more risk factors, said Dr. Karas and her associates, of Loyola University Medical Center, Maywood, Ill.

The risk factors most likely to prompt DXA scanning were height loss (93%), chronic prednisone use (89%), and menopause (86.6%). Among the risk factors least likely to prompt DXA were low testosterone (60%) and vertebral deformities (74%) in an elderly male patient. In general, all physicians surveyed were much less likely to order DXA for men with indications than for women. “This is one area where continuing education about osteoporosis may improve patient care,” the investigators noted.

Endocrinologists and rheumatologists were more likely to order DXA given any risk factor or patient scenario than were the other specialties, while orthopedic surgeons were the least likely. Rheumatologists were the most likely to initiate treatment in patients, followed by endocrinologists, geriatricians, primary care physicians, and ob.gyns.

Alendronate and risedronate were deemed the most efficacious treatments by more than 98% of all physicians, while calcium/vitamin D and calcitonin were thought to be the least efficacious. Overall, patients were more likely to be screened, diagnosed, and treated for osteoporosis by female physicians who had been in practice more than 6 years and who practice in urban, academic settings, Dr. Karas and her associates reported.

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Test for Hepatitis A in Likely Candidates Only

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Testing for hepatitis A infection should be reserved for patients who have symptoms consistent with the diagnosis or who have had recent exposure to a person known to be infected with hepatitis A, the Centers for Disease Control and Prevention said.

Specifically, IgM anti-hepatitis A virus (HAV) testing should not be done routinely to screen people who have liver function test abnormalities or who are suspected of having hepatitis C, the CDC said (MMWR 2005;54:453–6).

After receiving multiple reports of positive IgM anti-HAV test results in individuals who did not have clinical illness consistent with HAV infection, the CDC investigated the clinical and epidemiologic characteristics of these cases for the first time. The findings of the CDC investigation suggest that these people are unlikely to have the illness unless they have been exposed recently to someone with acute HAV infection.

The findings also indicate that their contacts are unlikely to require immunoprophylaxis. Therefore, testing these individuals only serves to lower the predictive value of the IgM anti-HAV test.

In Connecticut, the state health department investigated 127 positive IgM anti-HAV test results; 108 of the individuals had clinical illness consistent with hepatitis A infection. Of the other 19 persons (aged 28–88 years), 3 had elevated alanine aminotransferase (ALT) concentrations and 3 had a previous report of a positive IgM anti-HAV test result but did not have illness that met the case definition at that time either.

Among 10 such people in Alaska (aged 9–77 years), 7 had abnormal ALT concentrations, suggesting the presence of liver injury or disease. However, six did not have an illness with acute onset, while the seventh had an acute illness traced to acetaminophen toxicity. The other three were asymptomatic. One person previously had a positive IgM anti-HAV test.

In a third investigation involving six U.S. counties with demographic compositions representative of the U.S. population, 140 persons were reported to have a positive IgM anti-HAV test result. Of those, 62% (87) did not have an illness consistent with the case definition, while 38% (53) did.

The 87 persons who did not have illness meeting the case definition were significantly older and more likely to be female (this was also the case in Connecticut). Of 31 for whom serum samples were available for repeat testing at the CDC, 2 tested positive for IgM anti-HAV. Of 25 specimens tested for HAV nucleic acid, 1 (4%), from a 77-year-old man, had detectable HAV RNA. In contrast, 34 of 51 specimens from persons with both clinical and laboratory evidence of HAV infection had detectable HAV RNA. A repeat test of the 77-year-old man's specimen was negative for IgM anti-HAV, suggesting that his RNA test was a false positive, the CDC said.

A positive IgM anti-HAV test in a person without typical symptoms of hepatitis A infection might indicate asymptomatic acute HAV infection, previous HAV infection with prolonged presence of IgM anti-HAV, or a false-positive test result.

The findings from these reports suggest that in older adults, the most likely explanations are either a false-positive result or the outcome of HAV infection that occurred months to years before, rather than more recent infection requiring consideration of postexposure immunoprophylaxis for contacts.

Published guidelines for the work-up of abnormal liver enzyme tests do not include IgM anti-HAV testing, yet physicians may be tempted to order a multitest “hepatitis panel” offered by some laboratories at a cheaper price than the individual tests, James Hadler, M.D., state epidemiologist in the Connecticut Department of Public Health in Hartford, told this newspaper.

“It is this kind of reflex bargain basement testing that may result in getting back false-positive results,” Dr. Hadler said.

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Testing for hepatitis A infection should be reserved for patients who have symptoms consistent with the diagnosis or who have had recent exposure to a person known to be infected with hepatitis A, the Centers for Disease Control and Prevention said.

Specifically, IgM anti-hepatitis A virus (HAV) testing should not be done routinely to screen people who have liver function test abnormalities or who are suspected of having hepatitis C, the CDC said (MMWR 2005;54:453–6).

After receiving multiple reports of positive IgM anti-HAV test results in individuals who did not have clinical illness consistent with HAV infection, the CDC investigated the clinical and epidemiologic characteristics of these cases for the first time. The findings of the CDC investigation suggest that these people are unlikely to have the illness unless they have been exposed recently to someone with acute HAV infection.

The findings also indicate that their contacts are unlikely to require immunoprophylaxis. Therefore, testing these individuals only serves to lower the predictive value of the IgM anti-HAV test.

In Connecticut, the state health department investigated 127 positive IgM anti-HAV test results; 108 of the individuals had clinical illness consistent with hepatitis A infection. Of the other 19 persons (aged 28–88 years), 3 had elevated alanine aminotransferase (ALT) concentrations and 3 had a previous report of a positive IgM anti-HAV test result but did not have illness that met the case definition at that time either.

Among 10 such people in Alaska (aged 9–77 years), 7 had abnormal ALT concentrations, suggesting the presence of liver injury or disease. However, six did not have an illness with acute onset, while the seventh had an acute illness traced to acetaminophen toxicity. The other three were asymptomatic. One person previously had a positive IgM anti-HAV test.

In a third investigation involving six U.S. counties with demographic compositions representative of the U.S. population, 140 persons were reported to have a positive IgM anti-HAV test result. Of those, 62% (87) did not have an illness consistent with the case definition, while 38% (53) did.

The 87 persons who did not have illness meeting the case definition were significantly older and more likely to be female (this was also the case in Connecticut). Of 31 for whom serum samples were available for repeat testing at the CDC, 2 tested positive for IgM anti-HAV. Of 25 specimens tested for HAV nucleic acid, 1 (4%), from a 77-year-old man, had detectable HAV RNA. In contrast, 34 of 51 specimens from persons with both clinical and laboratory evidence of HAV infection had detectable HAV RNA. A repeat test of the 77-year-old man's specimen was negative for IgM anti-HAV, suggesting that his RNA test was a false positive, the CDC said.

A positive IgM anti-HAV test in a person without typical symptoms of hepatitis A infection might indicate asymptomatic acute HAV infection, previous HAV infection with prolonged presence of IgM anti-HAV, or a false-positive test result.

The findings from these reports suggest that in older adults, the most likely explanations are either a false-positive result or the outcome of HAV infection that occurred months to years before, rather than more recent infection requiring consideration of postexposure immunoprophylaxis for contacts.

Published guidelines for the work-up of abnormal liver enzyme tests do not include IgM anti-HAV testing, yet physicians may be tempted to order a multitest “hepatitis panel” offered by some laboratories at a cheaper price than the individual tests, James Hadler, M.D., state epidemiologist in the Connecticut Department of Public Health in Hartford, told this newspaper.

“It is this kind of reflex bargain basement testing that may result in getting back false-positive results,” Dr. Hadler said.

Testing for hepatitis A infection should be reserved for patients who have symptoms consistent with the diagnosis or who have had recent exposure to a person known to be infected with hepatitis A, the Centers for Disease Control and Prevention said.

Specifically, IgM anti-hepatitis A virus (HAV) testing should not be done routinely to screen people who have liver function test abnormalities or who are suspected of having hepatitis C, the CDC said (MMWR 2005;54:453–6).

After receiving multiple reports of positive IgM anti-HAV test results in individuals who did not have clinical illness consistent with HAV infection, the CDC investigated the clinical and epidemiologic characteristics of these cases for the first time. The findings of the CDC investigation suggest that these people are unlikely to have the illness unless they have been exposed recently to someone with acute HAV infection.

The findings also indicate that their contacts are unlikely to require immunoprophylaxis. Therefore, testing these individuals only serves to lower the predictive value of the IgM anti-HAV test.

In Connecticut, the state health department investigated 127 positive IgM anti-HAV test results; 108 of the individuals had clinical illness consistent with hepatitis A infection. Of the other 19 persons (aged 28–88 years), 3 had elevated alanine aminotransferase (ALT) concentrations and 3 had a previous report of a positive IgM anti-HAV test result but did not have illness that met the case definition at that time either.

Among 10 such people in Alaska (aged 9–77 years), 7 had abnormal ALT concentrations, suggesting the presence of liver injury or disease. However, six did not have an illness with acute onset, while the seventh had an acute illness traced to acetaminophen toxicity. The other three were asymptomatic. One person previously had a positive IgM anti-HAV test.

In a third investigation involving six U.S. counties with demographic compositions representative of the U.S. population, 140 persons were reported to have a positive IgM anti-HAV test result. Of those, 62% (87) did not have an illness consistent with the case definition, while 38% (53) did.

The 87 persons who did not have illness meeting the case definition were significantly older and more likely to be female (this was also the case in Connecticut). Of 31 for whom serum samples were available for repeat testing at the CDC, 2 tested positive for IgM anti-HAV. Of 25 specimens tested for HAV nucleic acid, 1 (4%), from a 77-year-old man, had detectable HAV RNA. In contrast, 34 of 51 specimens from persons with both clinical and laboratory evidence of HAV infection had detectable HAV RNA. A repeat test of the 77-year-old man's specimen was negative for IgM anti-HAV, suggesting that his RNA test was a false positive, the CDC said.

A positive IgM anti-HAV test in a person without typical symptoms of hepatitis A infection might indicate asymptomatic acute HAV infection, previous HAV infection with prolonged presence of IgM anti-HAV, or a false-positive test result.

The findings from these reports suggest that in older adults, the most likely explanations are either a false-positive result or the outcome of HAV infection that occurred months to years before, rather than more recent infection requiring consideration of postexposure immunoprophylaxis for contacts.

Published guidelines for the work-up of abnormal liver enzyme tests do not include IgM anti-HAV testing, yet physicians may be tempted to order a multitest “hepatitis panel” offered by some laboratories at a cheaper price than the individual tests, James Hadler, M.D., state epidemiologist in the Connecticut Department of Public Health in Hartford, told this newspaper.

“It is this kind of reflex bargain basement testing that may result in getting back false-positive results,” Dr. Hadler said.

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Most Should Get Birth Dose Against Hepatitis B : ACIP recommendation says waiting to vaccinate infants weighing more than 2 kg should be 'rare.'

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ATLANTA — The birth dose of hepatitis B vaccine is now the standard of care, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted at its meeting.

Although giving newborns their first dose of hepatitis B vaccine prior to discharge has already been deemed the “preferred” practice by the CDC, the American Academy of Family Physicians, and the American Academy of Pediatrics, the groups have allowed providers the alternative of administering during the first 2 months of age if the mother is hepatitis B surface antigen (HBsAg) negative.

Now ACIP has updated its recommendation—pending approval by the CDC—to say that withholding of the birth dose in a medically stable infant weighing 2,000 g or more at birth should be “rare” and must be documented in the infant's medical chart, along with the laboratory report confirming the mother's antigen-negative status. Both AAFP and AAP will consider endorsing the new policy, their ACIP liaisons told FAMILY PRACTICE NEWS.

“Core to the ACIP recommendations is having standing orders, which the [AAP's Committee on Infectious Diseases] supports as long as there is some physician discretion,” said Margaret Rennels, M.D., AAP's co-liaison to ACIP.

Eric E. Mast, M.D., chief of the prevention branch in the CDC's Division of Viral Hepatitis, said that implementation of the infant immunization series beginning in 1991 has resulted in a 93% reduction in hepatitis B incidence in persons younger than 20 years. “We've been very successful in preventing infections in children and adolescents, but there are still gaps in the perinatal hepatitis B-prevention program,” he said.

In particular, only about 50% of expected infants born to HBsAg-positive mothers are identified for case management, which has been shown to increase successful completion of postexposure immunization. In addition, there have been numerous documented incidences of failure to test women with unknown HBsAg status at the time of delivery and failure to administer appropriate immunoprophylaxis to infants.

Giving the first dose of hepatitis B vaccine soon after birth to all infants weighing 2,000 g or more should minimize the risk for infection because of errors in maternal HBsAg testing or reporting or from exposure to persons with chronic HBV infection in the household and can increase the likelihood of completing the vaccine series, he explained.

Still, some panel members expressed discomfort with the idea of removing a degree of provider autonomy, while others wanted to remove the “opt out” clause altogether. In the end, the committee opted for the compromise language to require documentation for “rare” deferrals.

“This sets a high bar of things to consider. The chart record is critical. … It emphasizes that the birth dose is the standard of care,” said panel member Guthrie S. Birkhead, M.D., director of the Center for Community Health, New York State Department of Health, Albany.

Fellow ACIP member Janet R. Gilsdorf, director of pediatric infectious diseases at the University of Michigan, Ann Arbor, agreed. “What I want is for every child in America to get that birth dose.”

Also included in the recommendation is a call for delivery hospitals to implement standing orders for review of maternal HBsAg test results for all pregnant women at the time of delivery and for women to be tested if the result was not documented. Immunoprophylaxis should be administered to all infants born to women who are HbsAg positive and to those with unknown status, and both the maternal test results and the infant hepatitis B vaccination status should be documented in the infant's medical record.

Standing orders should also address the management of infants weighing less than 2,000 g at birth, including ensuring initiation of postexposure immunization of infants born to HBsAg-positive mothers and to mothers who were not screened, and documenting the maternal HBsAg test results on the infant's medical record.

In other votes pertaining to hepatitis B vaccination, ACIP said providers should review immunization records for all children aged 11–12 years and those born in hepatitis B-endemic countries, including all of Asia, the Pacific Islands, and Africa. Hepatitis B vaccine should be offered to all such individuals not previously vaccinated.

Foreign-born HBsAg-positive persons are expected to be an increasing source of transmission—in 2001–2002, 42% of verified hepatitis B cases among children born after 1991 were born outside the United States (MMWR 2004;53:1015–8). The number of people coming into the United States with HBV infection is 10 times greater than the number currently becoming infected here, Dr. Mast noted.

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ATLANTA — The birth dose of hepatitis B vaccine is now the standard of care, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted at its meeting.

Although giving newborns their first dose of hepatitis B vaccine prior to discharge has already been deemed the “preferred” practice by the CDC, the American Academy of Family Physicians, and the American Academy of Pediatrics, the groups have allowed providers the alternative of administering during the first 2 months of age if the mother is hepatitis B surface antigen (HBsAg) negative.

Now ACIP has updated its recommendation—pending approval by the CDC—to say that withholding of the birth dose in a medically stable infant weighing 2,000 g or more at birth should be “rare” and must be documented in the infant's medical chart, along with the laboratory report confirming the mother's antigen-negative status. Both AAFP and AAP will consider endorsing the new policy, their ACIP liaisons told FAMILY PRACTICE NEWS.

“Core to the ACIP recommendations is having standing orders, which the [AAP's Committee on Infectious Diseases] supports as long as there is some physician discretion,” said Margaret Rennels, M.D., AAP's co-liaison to ACIP.

Eric E. Mast, M.D., chief of the prevention branch in the CDC's Division of Viral Hepatitis, said that implementation of the infant immunization series beginning in 1991 has resulted in a 93% reduction in hepatitis B incidence in persons younger than 20 years. “We've been very successful in preventing infections in children and adolescents, but there are still gaps in the perinatal hepatitis B-prevention program,” he said.

In particular, only about 50% of expected infants born to HBsAg-positive mothers are identified for case management, which has been shown to increase successful completion of postexposure immunization. In addition, there have been numerous documented incidences of failure to test women with unknown HBsAg status at the time of delivery and failure to administer appropriate immunoprophylaxis to infants.

Giving the first dose of hepatitis B vaccine soon after birth to all infants weighing 2,000 g or more should minimize the risk for infection because of errors in maternal HBsAg testing or reporting or from exposure to persons with chronic HBV infection in the household and can increase the likelihood of completing the vaccine series, he explained.

Still, some panel members expressed discomfort with the idea of removing a degree of provider autonomy, while others wanted to remove the “opt out” clause altogether. In the end, the committee opted for the compromise language to require documentation for “rare” deferrals.

“This sets a high bar of things to consider. The chart record is critical. … It emphasizes that the birth dose is the standard of care,” said panel member Guthrie S. Birkhead, M.D., director of the Center for Community Health, New York State Department of Health, Albany.

Fellow ACIP member Janet R. Gilsdorf, director of pediatric infectious diseases at the University of Michigan, Ann Arbor, agreed. “What I want is for every child in America to get that birth dose.”

Also included in the recommendation is a call for delivery hospitals to implement standing orders for review of maternal HBsAg test results for all pregnant women at the time of delivery and for women to be tested if the result was not documented. Immunoprophylaxis should be administered to all infants born to women who are HbsAg positive and to those with unknown status, and both the maternal test results and the infant hepatitis B vaccination status should be documented in the infant's medical record.

Standing orders should also address the management of infants weighing less than 2,000 g at birth, including ensuring initiation of postexposure immunization of infants born to HBsAg-positive mothers and to mothers who were not screened, and documenting the maternal HBsAg test results on the infant's medical record.

In other votes pertaining to hepatitis B vaccination, ACIP said providers should review immunization records for all children aged 11–12 years and those born in hepatitis B-endemic countries, including all of Asia, the Pacific Islands, and Africa. Hepatitis B vaccine should be offered to all such individuals not previously vaccinated.

Foreign-born HBsAg-positive persons are expected to be an increasing source of transmission—in 2001–2002, 42% of verified hepatitis B cases among children born after 1991 were born outside the United States (MMWR 2004;53:1015–8). The number of people coming into the United States with HBV infection is 10 times greater than the number currently becoming infected here, Dr. Mast noted.

ATLANTA — The birth dose of hepatitis B vaccine is now the standard of care, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention voted at its meeting.

Although giving newborns their first dose of hepatitis B vaccine prior to discharge has already been deemed the “preferred” practice by the CDC, the American Academy of Family Physicians, and the American Academy of Pediatrics, the groups have allowed providers the alternative of administering during the first 2 months of age if the mother is hepatitis B surface antigen (HBsAg) negative.

Now ACIP has updated its recommendation—pending approval by the CDC—to say that withholding of the birth dose in a medically stable infant weighing 2,000 g or more at birth should be “rare” and must be documented in the infant's medical chart, along with the laboratory report confirming the mother's antigen-negative status. Both AAFP and AAP will consider endorsing the new policy, their ACIP liaisons told FAMILY PRACTICE NEWS.

“Core to the ACIP recommendations is having standing orders, which the [AAP's Committee on Infectious Diseases] supports as long as there is some physician discretion,” said Margaret Rennels, M.D., AAP's co-liaison to ACIP.

Eric E. Mast, M.D., chief of the prevention branch in the CDC's Division of Viral Hepatitis, said that implementation of the infant immunization series beginning in 1991 has resulted in a 93% reduction in hepatitis B incidence in persons younger than 20 years. “We've been very successful in preventing infections in children and adolescents, but there are still gaps in the perinatal hepatitis B-prevention program,” he said.

In particular, only about 50% of expected infants born to HBsAg-positive mothers are identified for case management, which has been shown to increase successful completion of postexposure immunization. In addition, there have been numerous documented incidences of failure to test women with unknown HBsAg status at the time of delivery and failure to administer appropriate immunoprophylaxis to infants.

Giving the first dose of hepatitis B vaccine soon after birth to all infants weighing 2,000 g or more should minimize the risk for infection because of errors in maternal HBsAg testing or reporting or from exposure to persons with chronic HBV infection in the household and can increase the likelihood of completing the vaccine series, he explained.

Still, some panel members expressed discomfort with the idea of removing a degree of provider autonomy, while others wanted to remove the “opt out” clause altogether. In the end, the committee opted for the compromise language to require documentation for “rare” deferrals.

“This sets a high bar of things to consider. The chart record is critical. … It emphasizes that the birth dose is the standard of care,” said panel member Guthrie S. Birkhead, M.D., director of the Center for Community Health, New York State Department of Health, Albany.

Fellow ACIP member Janet R. Gilsdorf, director of pediatric infectious diseases at the University of Michigan, Ann Arbor, agreed. “What I want is for every child in America to get that birth dose.”

Also included in the recommendation is a call for delivery hospitals to implement standing orders for review of maternal HBsAg test results for all pregnant women at the time of delivery and for women to be tested if the result was not documented. Immunoprophylaxis should be administered to all infants born to women who are HbsAg positive and to those with unknown status, and both the maternal test results and the infant hepatitis B vaccination status should be documented in the infant's medical record.

Standing orders should also address the management of infants weighing less than 2,000 g at birth, including ensuring initiation of postexposure immunization of infants born to HBsAg-positive mothers and to mothers who were not screened, and documenting the maternal HBsAg test results on the infant's medical record.

In other votes pertaining to hepatitis B vaccination, ACIP said providers should review immunization records for all children aged 11–12 years and those born in hepatitis B-endemic countries, including all of Asia, the Pacific Islands, and Africa. Hepatitis B vaccine should be offered to all such individuals not previously vaccinated.

Foreign-born HBsAg-positive persons are expected to be an increasing source of transmission—in 2001–2002, 42% of verified hepatitis B cases among children born after 1991 were born outside the United States (MMWR 2004;53:1015–8). The number of people coming into the United States with HBV infection is 10 times greater than the number currently becoming infected here, Dr. Mast noted.

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2 Adult Diabetes Drugs Appear Safe in Children

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SAN DIEGO — Two oral glucose-lowering agents that are commonly used in adults with type 2 diabetes appeared safe and effective in children in two industry-funded studies presented at the annual scientific sessions of the American Diabetes Association.

Although the prevalence of type 2 diabetes among children is increasing, only one oral drug (metformin) is currently approved for pediatric use (ages 10–16 years).

Michael Gottschalk, M.D., head of endocrinology at the University of California, San Diego, presented data on a 26-week, randomized, single-blind study comparing the safety and efficacy of glimepiride (Amaryl) with metformin in 263 children aged 9–17 years with type 2 diabetes who were inadequately controlled (hemoglobin A1c 7.1%–12.0%) on diet and exercise alone or failed oral monotherapy (HbA1c greater than 7.5% for 3 or more months).

After a 2-week run-in period, 132 of the children were randomized to receive glimepiride at a starting dose of 1 mg/day, which was then titrated to 2 mg, 4 mg, and 8 mg at 4-week intervals to achieve a fasting glucose level of less than 126 mg/dL. The other 131 children received 500 mg metformin twice daily and were titrated up only once—to 1,000 mg twice daily—if their mean self-monitored blood glucose values exceeded 126 mg/dL at 12 weeks.

The two groups were similar at baseline, with a mean age of 13.8 years. About one-third were male, and nearly one-fourth were African American. About 40% were Hispanic. Body mass indexes were 31.57 kg/m2 in the glimepiride group and 31.60 for metformin. Their mean HbA1c values were 8.52% and 8.54%, respectively.

By 24 weeks, the proportion of patients achieving good control, defined as an HbA1c below 7%, were also similar: 42% with glimepiride and 48% with metformin. Lipid parameters also did not differ between the two treatment groups, Dr. Gottschalk reported.

At 24 weeks, the glimepiride patients gained an average of 2.2 kg while the metformin group gained just 0.7 kg. That difference was significant.

Safety was analyzed for the initial cohort of 284 subjects (142 in each group). Rates of headache, diarrhea, and nausea were low, and occurred more frequently in the metformin group. The incidences of hypoglycemia (blood glucose less than 50 mg/dL) were reported in 4.9% of the glimepiride group compared with 4.2% of the metformin group, with one severe hypoglycemic event requiring assistance occurring in each group. These differences were not significant, Dr. Gottschalk said.

The data on rosiglitazone (GlaxoSmithKline's Avandia) were presented in a poster by Guissou Dabiri, a clinical pharmacologist with the company in King of Prussia, Pa., and her associates.

A total of 208 children aged 8–17 years with type 2 diabetes entered a 4-week run-in period, and 200 were randomized to either rosiglitazone 2 mg twice daily or metformin 500 mg twice daily. Both were titrated up as necessary—twice daily rosiglitazone to 4 mg or metformin to 1,000 mg—to achieve a fasting plasma glucose value less than 126 mg/dL.

Fifty-five percent of the 97 who received rosiglitazone and half of the 98 patients randomized to receive metformin had been treated with diet only, while the rest had been on oral monotherapy. Both groups had diabetes a little over 1 year, and neither was in good control at baseline—the rosiglitazone group had a mean HbA1c of 7.88% and the metformin group had a mean HbA1c of 8.17. This difference—which had not been present at screening—was statistically significant, probably due to the higher proportion in the rosiglitazone group who had received prior therapy, Dr. Dabiri and her associates noted.

At week 24, reductions in HbA1c from baseline were 0.25% among the rosiglitazone patients and 0.55% in the metformin group.

Compared with screening, the reductions were 0.5% in both groups. Median HbA1c values at 24 weeks were 7% for rosiglitazone and 7.1% for metformin. The proportion achieving HbA1c values of 7% or less were 51.5% of rosiglitazone and 48% for metformin, while 42.7% and 43.9%, respectively, achieved fasting plasma glucose levels of 126 mg/dL or below.

Adverse events occurred in a total of 61.6% of rosiglitazone patients and 59.4% of metformin subjects. As expected, the incidences of nausea, vomiting, and diarrhea were higher with metformin than with rosiglitazone (8.9%–12.9% vs. 1.0%–4.0%). Edema occurred in one rosiglitazone patient and in none of the metformin group. Incidences of hypoglycemia were similar (4.0% in the rosiglitazone group, 5.0% in the metformin group). The rosiglitazone group gained a mean of 3 kg at 24 weeks. No effects on serum lipid parameters were seen in either group, the investigators said.

 

 

In April, the FDA rejected GlaxoSmithKline's request for a pediatric indication for rosiglitazone, citing concern about statistical limitations with regard to efficacy and certain adverse effects of rosiglitazone therapy. However, GlaxoSmithKline continues to work with the FDA in pursuit of the pediatric indication, according to the company.

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SAN DIEGO — Two oral glucose-lowering agents that are commonly used in adults with type 2 diabetes appeared safe and effective in children in two industry-funded studies presented at the annual scientific sessions of the American Diabetes Association.

Although the prevalence of type 2 diabetes among children is increasing, only one oral drug (metformin) is currently approved for pediatric use (ages 10–16 years).

Michael Gottschalk, M.D., head of endocrinology at the University of California, San Diego, presented data on a 26-week, randomized, single-blind study comparing the safety and efficacy of glimepiride (Amaryl) with metformin in 263 children aged 9–17 years with type 2 diabetes who were inadequately controlled (hemoglobin A1c 7.1%–12.0%) on diet and exercise alone or failed oral monotherapy (HbA1c greater than 7.5% for 3 or more months).

After a 2-week run-in period, 132 of the children were randomized to receive glimepiride at a starting dose of 1 mg/day, which was then titrated to 2 mg, 4 mg, and 8 mg at 4-week intervals to achieve a fasting glucose level of less than 126 mg/dL. The other 131 children received 500 mg metformin twice daily and were titrated up only once—to 1,000 mg twice daily—if their mean self-monitored blood glucose values exceeded 126 mg/dL at 12 weeks.

The two groups were similar at baseline, with a mean age of 13.8 years. About one-third were male, and nearly one-fourth were African American. About 40% were Hispanic. Body mass indexes were 31.57 kg/m2 in the glimepiride group and 31.60 for metformin. Their mean HbA1c values were 8.52% and 8.54%, respectively.

By 24 weeks, the proportion of patients achieving good control, defined as an HbA1c below 7%, were also similar: 42% with glimepiride and 48% with metformin. Lipid parameters also did not differ between the two treatment groups, Dr. Gottschalk reported.

At 24 weeks, the glimepiride patients gained an average of 2.2 kg while the metformin group gained just 0.7 kg. That difference was significant.

Safety was analyzed for the initial cohort of 284 subjects (142 in each group). Rates of headache, diarrhea, and nausea were low, and occurred more frequently in the metformin group. The incidences of hypoglycemia (blood glucose less than 50 mg/dL) were reported in 4.9% of the glimepiride group compared with 4.2% of the metformin group, with one severe hypoglycemic event requiring assistance occurring in each group. These differences were not significant, Dr. Gottschalk said.

The data on rosiglitazone (GlaxoSmithKline's Avandia) were presented in a poster by Guissou Dabiri, a clinical pharmacologist with the company in King of Prussia, Pa., and her associates.

A total of 208 children aged 8–17 years with type 2 diabetes entered a 4-week run-in period, and 200 were randomized to either rosiglitazone 2 mg twice daily or metformin 500 mg twice daily. Both were titrated up as necessary—twice daily rosiglitazone to 4 mg or metformin to 1,000 mg—to achieve a fasting plasma glucose value less than 126 mg/dL.

Fifty-five percent of the 97 who received rosiglitazone and half of the 98 patients randomized to receive metformin had been treated with diet only, while the rest had been on oral monotherapy. Both groups had diabetes a little over 1 year, and neither was in good control at baseline—the rosiglitazone group had a mean HbA1c of 7.88% and the metformin group had a mean HbA1c of 8.17. This difference—which had not been present at screening—was statistically significant, probably due to the higher proportion in the rosiglitazone group who had received prior therapy, Dr. Dabiri and her associates noted.

At week 24, reductions in HbA1c from baseline were 0.25% among the rosiglitazone patients and 0.55% in the metformin group.

Compared with screening, the reductions were 0.5% in both groups. Median HbA1c values at 24 weeks were 7% for rosiglitazone and 7.1% for metformin. The proportion achieving HbA1c values of 7% or less were 51.5% of rosiglitazone and 48% for metformin, while 42.7% and 43.9%, respectively, achieved fasting plasma glucose levels of 126 mg/dL or below.

Adverse events occurred in a total of 61.6% of rosiglitazone patients and 59.4% of metformin subjects. As expected, the incidences of nausea, vomiting, and diarrhea were higher with metformin than with rosiglitazone (8.9%–12.9% vs. 1.0%–4.0%). Edema occurred in one rosiglitazone patient and in none of the metformin group. Incidences of hypoglycemia were similar (4.0% in the rosiglitazone group, 5.0% in the metformin group). The rosiglitazone group gained a mean of 3 kg at 24 weeks. No effects on serum lipid parameters were seen in either group, the investigators said.

 

 

In April, the FDA rejected GlaxoSmithKline's request for a pediatric indication for rosiglitazone, citing concern about statistical limitations with regard to efficacy and certain adverse effects of rosiglitazone therapy. However, GlaxoSmithKline continues to work with the FDA in pursuit of the pediatric indication, according to the company.

SAN DIEGO — Two oral glucose-lowering agents that are commonly used in adults with type 2 diabetes appeared safe and effective in children in two industry-funded studies presented at the annual scientific sessions of the American Diabetes Association.

Although the prevalence of type 2 diabetes among children is increasing, only one oral drug (metformin) is currently approved for pediatric use (ages 10–16 years).

Michael Gottschalk, M.D., head of endocrinology at the University of California, San Diego, presented data on a 26-week, randomized, single-blind study comparing the safety and efficacy of glimepiride (Amaryl) with metformin in 263 children aged 9–17 years with type 2 diabetes who were inadequately controlled (hemoglobin A1c 7.1%–12.0%) on diet and exercise alone or failed oral monotherapy (HbA1c greater than 7.5% for 3 or more months).

After a 2-week run-in period, 132 of the children were randomized to receive glimepiride at a starting dose of 1 mg/day, which was then titrated to 2 mg, 4 mg, and 8 mg at 4-week intervals to achieve a fasting glucose level of less than 126 mg/dL. The other 131 children received 500 mg metformin twice daily and were titrated up only once—to 1,000 mg twice daily—if their mean self-monitored blood glucose values exceeded 126 mg/dL at 12 weeks.

The two groups were similar at baseline, with a mean age of 13.8 years. About one-third were male, and nearly one-fourth were African American. About 40% were Hispanic. Body mass indexes were 31.57 kg/m2 in the glimepiride group and 31.60 for metformin. Their mean HbA1c values were 8.52% and 8.54%, respectively.

By 24 weeks, the proportion of patients achieving good control, defined as an HbA1c below 7%, were also similar: 42% with glimepiride and 48% with metformin. Lipid parameters also did not differ between the two treatment groups, Dr. Gottschalk reported.

At 24 weeks, the glimepiride patients gained an average of 2.2 kg while the metformin group gained just 0.7 kg. That difference was significant.

Safety was analyzed for the initial cohort of 284 subjects (142 in each group). Rates of headache, diarrhea, and nausea were low, and occurred more frequently in the metformin group. The incidences of hypoglycemia (blood glucose less than 50 mg/dL) were reported in 4.9% of the glimepiride group compared with 4.2% of the metformin group, with one severe hypoglycemic event requiring assistance occurring in each group. These differences were not significant, Dr. Gottschalk said.

The data on rosiglitazone (GlaxoSmithKline's Avandia) were presented in a poster by Guissou Dabiri, a clinical pharmacologist with the company in King of Prussia, Pa., and her associates.

A total of 208 children aged 8–17 years with type 2 diabetes entered a 4-week run-in period, and 200 were randomized to either rosiglitazone 2 mg twice daily or metformin 500 mg twice daily. Both were titrated up as necessary—twice daily rosiglitazone to 4 mg or metformin to 1,000 mg—to achieve a fasting plasma glucose value less than 126 mg/dL.

Fifty-five percent of the 97 who received rosiglitazone and half of the 98 patients randomized to receive metformin had been treated with diet only, while the rest had been on oral monotherapy. Both groups had diabetes a little over 1 year, and neither was in good control at baseline—the rosiglitazone group had a mean HbA1c of 7.88% and the metformin group had a mean HbA1c of 8.17. This difference—which had not been present at screening—was statistically significant, probably due to the higher proportion in the rosiglitazone group who had received prior therapy, Dr. Dabiri and her associates noted.

At week 24, reductions in HbA1c from baseline were 0.25% among the rosiglitazone patients and 0.55% in the metformin group.

Compared with screening, the reductions were 0.5% in both groups. Median HbA1c values at 24 weeks were 7% for rosiglitazone and 7.1% for metformin. The proportion achieving HbA1c values of 7% or less were 51.5% of rosiglitazone and 48% for metformin, while 42.7% and 43.9%, respectively, achieved fasting plasma glucose levels of 126 mg/dL or below.

Adverse events occurred in a total of 61.6% of rosiglitazone patients and 59.4% of metformin subjects. As expected, the incidences of nausea, vomiting, and diarrhea were higher with metformin than with rosiglitazone (8.9%–12.9% vs. 1.0%–4.0%). Edema occurred in one rosiglitazone patient and in none of the metformin group. Incidences of hypoglycemia were similar (4.0% in the rosiglitazone group, 5.0% in the metformin group). The rosiglitazone group gained a mean of 3 kg at 24 weeks. No effects on serum lipid parameters were seen in either group, the investigators said.

 

 

In April, the FDA rejected GlaxoSmithKline's request for a pediatric indication for rosiglitazone, citing concern about statistical limitations with regard to efficacy and certain adverse effects of rosiglitazone therapy. However, GlaxoSmithKline continues to work with the FDA in pursuit of the pediatric indication, according to the company.

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Depression Tied to Poor Adherence to Cardiac Rx : Results of two studies show that use of aspirinand β-blockers was lower in depressed patients.

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VANCOUVER, B.C. – Depressed patients with coronary artery disease are less likely to take prescribed medications than are those who are not depressed, Karina W. Davidson, Ph.D., and Mary Whooley, M.D., reported in separate presentations at the annual meeting of the American Psychosomatic Society.

The findings from two large trials both suggest that medication nonadherence is one possible mechanism by which depression adversely impacts cardiovascular disease outcome, the investigators said.

Dr. Davidson, of Columbia University, New York, reported her findings from the Coronary Psychosocial Evaluation Study, funded by the National Heart, Lung, and Blood Institute. Unlike previous adherence studies that have relied on patient self-reports, this one employed the Medication Event Monitoring System, in which an electronic device is stored in the cap of a pill bottle that records the date and time the container is opened.

The study involved 65 patients with acute coronary syndrome (ST- and non-ST-elevation myocardial infarction or unstable angina) who were prescribed a daily dose of either 81 mg or 325 mg of aspirin and were given a 90-day supply upon hospital discharge. Pill data were downloaded at 1-month and 3-month follow-up visits.

A total of 29 patients were considered nondepressed, having scored 0–4 on the Beck Depression Inventory (BDI) at baseline (in the hospital 1 week after the initial cardiac event). Another 17 patients who scored 10 or greater on the BDI at baseline but subsequently dropped below a score of 10 at 3 months were classified as “remittent depressed,” while the remaining 19 patients who scored 10 or above on the BDI at both baseline and 3 months were classified as persistently depressed.

The persistently depressed patients were more likely than were the other two groups to be female and Hispanic, and to have lower levels of education and family income. All three groups were similar with regard to age, race, and current employment, she said.

Adherence–defined as the percentage of days that the correct dose of aspirin was taken–was 67% for the persistently depressed group, compared with 86% for the remittent depressed and 87% for the nondepressed patients. The difference between the persistent and remittent groups was not explained by baseline BDI severity, which differed only slightly (17 persistent vs. 15.06 intermittent, compared with 1.9 in the nondepressed). Reports of side effects to aspirin did not differ between the groups.

“Persistently depressed patients are the ones uniquely not taking their medication,” Dr. Davidson noted, adding that the results are particularly noteworthy given that the aspirin regimen is a once-daily pill. “This is the simplest, easiest medicine for patients to take, [yet] the persistently depressed are taking it two-thirds of the time they're supposed to.”

In the other study, presented by Dr. Whooley, depressed heart disease patients tended to skip prescribed β-blockers.

The cross-sectional data came from the Heart and Soul Study, a cohort investigation of potential mechanisms linking depression and cardiovascular outcomes. Of 1,024 patients with known coronary disease, 940 were taking one or more cardiac medications, including β-blockers, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs), aspirin, and/or statins.

All of the patients had stable disease, with none having had an acute coronary syndrome in the previous 6 months, noted Dr. Whooley, who is with the departments of medicine, epidemiology, and biostatistics at the University of California, San Francisco.

Current major depression–as measured by the Diagnostic Interview Schedule and the Patient Health Questionnaire–was present in 22% (204) of the 940 patients.

Those with depression were younger (62 vs. 69 years), more likely to be female (27% vs. 13%), and to be current smokers (31% vs. 16%). The groups were similar with regard to race, education, proportion with MI (52% depressed/57% nondepressed), and were taking similar numbers of cardiac medications (2.6 depressed/2.8 nondepressed).

Patients were considered adherent if they said they took their medications as prescribed “all” or “nearly all” of the time. Those who took their medications “most,” “about half,” or “less than half” of the time were classified as nonadherent.

Fourteen percent of depressed patients reported nonadherence, compared with 5% of the nondepressed, and the percentage reporting nonadherence increased with the number of depressive symptoms. After adjustment for several factors including race, education, and current angina, depressed patients were more than twice as likely to report not taking their medication as prescribed, Dr. Whooley said.

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VANCOUVER, B.C. – Depressed patients with coronary artery disease are less likely to take prescribed medications than are those who are not depressed, Karina W. Davidson, Ph.D., and Mary Whooley, M.D., reported in separate presentations at the annual meeting of the American Psychosomatic Society.

The findings from two large trials both suggest that medication nonadherence is one possible mechanism by which depression adversely impacts cardiovascular disease outcome, the investigators said.

Dr. Davidson, of Columbia University, New York, reported her findings from the Coronary Psychosocial Evaluation Study, funded by the National Heart, Lung, and Blood Institute. Unlike previous adherence studies that have relied on patient self-reports, this one employed the Medication Event Monitoring System, in which an electronic device is stored in the cap of a pill bottle that records the date and time the container is opened.

The study involved 65 patients with acute coronary syndrome (ST- and non-ST-elevation myocardial infarction or unstable angina) who were prescribed a daily dose of either 81 mg or 325 mg of aspirin and were given a 90-day supply upon hospital discharge. Pill data were downloaded at 1-month and 3-month follow-up visits.

A total of 29 patients were considered nondepressed, having scored 0–4 on the Beck Depression Inventory (BDI) at baseline (in the hospital 1 week after the initial cardiac event). Another 17 patients who scored 10 or greater on the BDI at baseline but subsequently dropped below a score of 10 at 3 months were classified as “remittent depressed,” while the remaining 19 patients who scored 10 or above on the BDI at both baseline and 3 months were classified as persistently depressed.

The persistently depressed patients were more likely than were the other two groups to be female and Hispanic, and to have lower levels of education and family income. All three groups were similar with regard to age, race, and current employment, she said.

Adherence–defined as the percentage of days that the correct dose of aspirin was taken–was 67% for the persistently depressed group, compared with 86% for the remittent depressed and 87% for the nondepressed patients. The difference between the persistent and remittent groups was not explained by baseline BDI severity, which differed only slightly (17 persistent vs. 15.06 intermittent, compared with 1.9 in the nondepressed). Reports of side effects to aspirin did not differ between the groups.

“Persistently depressed patients are the ones uniquely not taking their medication,” Dr. Davidson noted, adding that the results are particularly noteworthy given that the aspirin regimen is a once-daily pill. “This is the simplest, easiest medicine for patients to take, [yet] the persistently depressed are taking it two-thirds of the time they're supposed to.”

In the other study, presented by Dr. Whooley, depressed heart disease patients tended to skip prescribed β-blockers.

The cross-sectional data came from the Heart and Soul Study, a cohort investigation of potential mechanisms linking depression and cardiovascular outcomes. Of 1,024 patients with known coronary disease, 940 were taking one or more cardiac medications, including β-blockers, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs), aspirin, and/or statins.

All of the patients had stable disease, with none having had an acute coronary syndrome in the previous 6 months, noted Dr. Whooley, who is with the departments of medicine, epidemiology, and biostatistics at the University of California, San Francisco.

Current major depression–as measured by the Diagnostic Interview Schedule and the Patient Health Questionnaire–was present in 22% (204) of the 940 patients.

Those with depression were younger (62 vs. 69 years), more likely to be female (27% vs. 13%), and to be current smokers (31% vs. 16%). The groups were similar with regard to race, education, proportion with MI (52% depressed/57% nondepressed), and were taking similar numbers of cardiac medications (2.6 depressed/2.8 nondepressed).

Patients were considered adherent if they said they took their medications as prescribed “all” or “nearly all” of the time. Those who took their medications “most,” “about half,” or “less than half” of the time were classified as nonadherent.

Fourteen percent of depressed patients reported nonadherence, compared with 5% of the nondepressed, and the percentage reporting nonadherence increased with the number of depressive symptoms. After adjustment for several factors including race, education, and current angina, depressed patients were more than twice as likely to report not taking their medication as prescribed, Dr. Whooley said.

VANCOUVER, B.C. – Depressed patients with coronary artery disease are less likely to take prescribed medications than are those who are not depressed, Karina W. Davidson, Ph.D., and Mary Whooley, M.D., reported in separate presentations at the annual meeting of the American Psychosomatic Society.

The findings from two large trials both suggest that medication nonadherence is one possible mechanism by which depression adversely impacts cardiovascular disease outcome, the investigators said.

Dr. Davidson, of Columbia University, New York, reported her findings from the Coronary Psychosocial Evaluation Study, funded by the National Heart, Lung, and Blood Institute. Unlike previous adherence studies that have relied on patient self-reports, this one employed the Medication Event Monitoring System, in which an electronic device is stored in the cap of a pill bottle that records the date and time the container is opened.

The study involved 65 patients with acute coronary syndrome (ST- and non-ST-elevation myocardial infarction or unstable angina) who were prescribed a daily dose of either 81 mg or 325 mg of aspirin and were given a 90-day supply upon hospital discharge. Pill data were downloaded at 1-month and 3-month follow-up visits.

A total of 29 patients were considered nondepressed, having scored 0–4 on the Beck Depression Inventory (BDI) at baseline (in the hospital 1 week after the initial cardiac event). Another 17 patients who scored 10 or greater on the BDI at baseline but subsequently dropped below a score of 10 at 3 months were classified as “remittent depressed,” while the remaining 19 patients who scored 10 or above on the BDI at both baseline and 3 months were classified as persistently depressed.

The persistently depressed patients were more likely than were the other two groups to be female and Hispanic, and to have lower levels of education and family income. All three groups were similar with regard to age, race, and current employment, she said.

Adherence–defined as the percentage of days that the correct dose of aspirin was taken–was 67% for the persistently depressed group, compared with 86% for the remittent depressed and 87% for the nondepressed patients. The difference between the persistent and remittent groups was not explained by baseline BDI severity, which differed only slightly (17 persistent vs. 15.06 intermittent, compared with 1.9 in the nondepressed). Reports of side effects to aspirin did not differ between the groups.

“Persistently depressed patients are the ones uniquely not taking their medication,” Dr. Davidson noted, adding that the results are particularly noteworthy given that the aspirin regimen is a once-daily pill. “This is the simplest, easiest medicine for patients to take, [yet] the persistently depressed are taking it two-thirds of the time they're supposed to.”

In the other study, presented by Dr. Whooley, depressed heart disease patients tended to skip prescribed β-blockers.

The cross-sectional data came from the Heart and Soul Study, a cohort investigation of potential mechanisms linking depression and cardiovascular outcomes. Of 1,024 patients with known coronary disease, 940 were taking one or more cardiac medications, including β-blockers, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs), aspirin, and/or statins.

All of the patients had stable disease, with none having had an acute coronary syndrome in the previous 6 months, noted Dr. Whooley, who is with the departments of medicine, epidemiology, and biostatistics at the University of California, San Francisco.

Current major depression–as measured by the Diagnostic Interview Schedule and the Patient Health Questionnaire–was present in 22% (204) of the 940 patients.

Those with depression were younger (62 vs. 69 years), more likely to be female (27% vs. 13%), and to be current smokers (31% vs. 16%). The groups were similar with regard to race, education, proportion with MI (52% depressed/57% nondepressed), and were taking similar numbers of cardiac medications (2.6 depressed/2.8 nondepressed).

Patients were considered adherent if they said they took their medications as prescribed “all” or “nearly all” of the time. Those who took their medications “most,” “about half,” or “less than half” of the time were classified as nonadherent.

Fourteen percent of depressed patients reported nonadherence, compared with 5% of the nondepressed, and the percentage reporting nonadherence increased with the number of depressive symptoms. After adjustment for several factors including race, education, and current angina, depressed patients were more than twice as likely to report not taking their medication as prescribed, Dr. Whooley said.

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Low Serum Cholesterol in Non-African Americans Associated With Suspensions

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Low Serum Cholesterol in Non-African Americans Associated With Suspensions

Low total serum cholesterol is associated with an increased likelihood of school suspensions and expulsions among non-African American children, said Jian Zhang, M.D., of the University of South Carolina, Columbia, and associates.

The finding corroborates and extends existing literature linking low total cholesterol and aggressive behavior in adults. Low cholesterol may be a risk factor for aggressive behavior, a risk marker for other biologic substances or genotypes that predispose to such behavior, or a biologic marker for poor prognosis. In any case, if confirmed by prospective studies, these findings may assist pediatricians in contributing to schools and to violence prevention, the investigators said (Am. J. Epidemiol. 2005;161:691–9).

The data come from 4,852 children and adolescents aged 6–16 years (mean 10) whose mothers were interviewed for the Third National Health and Nutrition Examination Survey (NHANES III), conducted during 1988–1994. None attended special schools or classes as a result of intellectual or physical health impairment. Serum cholesterol was measured, and a variety of neuropsychiatric tests administered.

The proportion who had ever been suspended from school was 15.38% among children with serum cholesterol levels less than 145 mg/dL, compared with 6.25% among those with cholesterol levels of 145 mg/dL and above. After adjustment for age and gender, the odds ratio for school suspension for low vs. high cholesterol was 1.73.

On the other hand, serum cholesterol was not predictive of ever seeing a psychologist, being shy when meeting new persons, or having difficulty getting along with others, Dr. Zhang and his associates reported.

When broken down by race, the relationship remained significant only among the 3,167 non-African American children in the sample.

For that group, a history of school suspension or expulsion was approximately threefold higher for those with total cholesterol below the 25th percentile than for children with total cholesterol at or above the 25th percentile.

The association persisted after adjustment for many other factors, including cognitive and academic performance and nutrition status, which are known to place children's emotional and behavioral development at risk, they noted.

This study is the first to demonstrate a statistically significant, ethnicity-dependent association between serum cholesterol and aggressive behaviors from a national sample of noninstitutionalized, school-aged children.

Possible biologic mechanisms to explain the association between serum lipids and violence involve the role of cholesterol and fats in brain function and behavior through modification of membranes and through effects on neurotransmitter production, reuptake, and metabolism.

The racial difference seen in this study might have to do with differences in basal prevalence. African-American children have higher rates of school suspension, so the impact of cholesterol may be lower than in non-African Americans.

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Low total serum cholesterol is associated with an increased likelihood of school suspensions and expulsions among non-African American children, said Jian Zhang, M.D., of the University of South Carolina, Columbia, and associates.

The finding corroborates and extends existing literature linking low total cholesterol and aggressive behavior in adults. Low cholesterol may be a risk factor for aggressive behavior, a risk marker for other biologic substances or genotypes that predispose to such behavior, or a biologic marker for poor prognosis. In any case, if confirmed by prospective studies, these findings may assist pediatricians in contributing to schools and to violence prevention, the investigators said (Am. J. Epidemiol. 2005;161:691–9).

The data come from 4,852 children and adolescents aged 6–16 years (mean 10) whose mothers were interviewed for the Third National Health and Nutrition Examination Survey (NHANES III), conducted during 1988–1994. None attended special schools or classes as a result of intellectual or physical health impairment. Serum cholesterol was measured, and a variety of neuropsychiatric tests administered.

The proportion who had ever been suspended from school was 15.38% among children with serum cholesterol levels less than 145 mg/dL, compared with 6.25% among those with cholesterol levels of 145 mg/dL and above. After adjustment for age and gender, the odds ratio for school suspension for low vs. high cholesterol was 1.73.

On the other hand, serum cholesterol was not predictive of ever seeing a psychologist, being shy when meeting new persons, or having difficulty getting along with others, Dr. Zhang and his associates reported.

When broken down by race, the relationship remained significant only among the 3,167 non-African American children in the sample.

For that group, a history of school suspension or expulsion was approximately threefold higher for those with total cholesterol below the 25th percentile than for children with total cholesterol at or above the 25th percentile.

The association persisted after adjustment for many other factors, including cognitive and academic performance and nutrition status, which are known to place children's emotional and behavioral development at risk, they noted.

This study is the first to demonstrate a statistically significant, ethnicity-dependent association between serum cholesterol and aggressive behaviors from a national sample of noninstitutionalized, school-aged children.

Possible biologic mechanisms to explain the association between serum lipids and violence involve the role of cholesterol and fats in brain function and behavior through modification of membranes and through effects on neurotransmitter production, reuptake, and metabolism.

The racial difference seen in this study might have to do with differences in basal prevalence. African-American children have higher rates of school suspension, so the impact of cholesterol may be lower than in non-African Americans.

Low total serum cholesterol is associated with an increased likelihood of school suspensions and expulsions among non-African American children, said Jian Zhang, M.D., of the University of South Carolina, Columbia, and associates.

The finding corroborates and extends existing literature linking low total cholesterol and aggressive behavior in adults. Low cholesterol may be a risk factor for aggressive behavior, a risk marker for other biologic substances or genotypes that predispose to such behavior, or a biologic marker for poor prognosis. In any case, if confirmed by prospective studies, these findings may assist pediatricians in contributing to schools and to violence prevention, the investigators said (Am. J. Epidemiol. 2005;161:691–9).

The data come from 4,852 children and adolescents aged 6–16 years (mean 10) whose mothers were interviewed for the Third National Health and Nutrition Examination Survey (NHANES III), conducted during 1988–1994. None attended special schools or classes as a result of intellectual or physical health impairment. Serum cholesterol was measured, and a variety of neuropsychiatric tests administered.

The proportion who had ever been suspended from school was 15.38% among children with serum cholesterol levels less than 145 mg/dL, compared with 6.25% among those with cholesterol levels of 145 mg/dL and above. After adjustment for age and gender, the odds ratio for school suspension for low vs. high cholesterol was 1.73.

On the other hand, serum cholesterol was not predictive of ever seeing a psychologist, being shy when meeting new persons, or having difficulty getting along with others, Dr. Zhang and his associates reported.

When broken down by race, the relationship remained significant only among the 3,167 non-African American children in the sample.

For that group, a history of school suspension or expulsion was approximately threefold higher for those with total cholesterol below the 25th percentile than for children with total cholesterol at or above the 25th percentile.

The association persisted after adjustment for many other factors, including cognitive and academic performance and nutrition status, which are known to place children's emotional and behavioral development at risk, they noted.

This study is the first to demonstrate a statistically significant, ethnicity-dependent association between serum cholesterol and aggressive behaviors from a national sample of noninstitutionalized, school-aged children.

Possible biologic mechanisms to explain the association between serum lipids and violence involve the role of cholesterol and fats in brain function and behavior through modification of membranes and through effects on neurotransmitter production, reuptake, and metabolism.

The racial difference seen in this study might have to do with differences in basal prevalence. African-American children have higher rates of school suspension, so the impact of cholesterol may be lower than in non-African Americans.

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