Neil Osterweil

Major Finding: There was a 3.8-month increase in progression-free survival in women with advanced ovarian and related cancers who received bevacizumab as an adjunct and follow-on to standard chemotherapy.

Data Source: GOG-0218 trial.

Disclosures: Dr. Burger has served as an advisor/consultant to Genentech Inc. Dr. Eisenhauer reports no relevant disclosures.

CHICAGO — Progression-free survival in women with advanced ovarian or related female reproductive tract cancers was increased by nearly 4 months when they received frontline therapy with standard chemotherapy and concurrent bevacizumab followed by maintenance with bevacizumab alone, reported investigators from the Gynecologic Oncology Group's GOG-0218 trial.

In a randomized, placebo-controlled, phase III trial, the addition of bevacizumab (Avastin) to chemotherapy with carboplatin and paclitaxel followed by bevacizumab monotherapy resulted in a median progression-free survival (PFS) of 14.1 months, compared with 10.3 months for women on standard chemotherapy and placebo (hazard ratio 0.717, P less than .0001), reported lead investigator Dr. Robert A. Burger of the Fox Chase Cancer Center in Philadelphia.

But bevacizumab was effective only when used both as an adjunct to chemotherapy and as maintenance therapy: Women who received the angiogenesis inhibitor with chemotherapy but got a placebo during the maintenance phase had a median progression-free survival of 11.2 months, which was not significantly better than that of women who received chemotherapy and placebo only (HR 0.98, P=.16), Dr. Burger said.

“Bevacizumab is the first molecular-targeted and first antiangiogenic agent to demonstrate benefit in this population, and bevacizumab combined with chemotherapy followed by bevacizumab maintenance should be considered as one standard option for women with this disease,” said Dr. Burger.

That recommendation may be a bit premature, however, because the data so far show an effect of bevacizumab on only progression-free survival and not on overall survival, and “we cannot infer that a progression-free survival gain will mean an overall survival gain,” commented Dr. Elizabeth A Eisenhauer, the invited discussant.

“A progression-free survival gain of only 3.8 months may not be meaningful to patients. We need the mature overall survival and quality-of-life results, and ideally the results of the other frontline trial of bevacizumab in this disease, ICON-7, to understand the full story of the impact of this advance,” said Dr. Eisenhauer of the National Cancer Institute of Canada.

GOG-0218 investigators enrolled 1,873 women with stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Each group received the CT regimen, consisting of 22 3-week cycles, with the first 6 cycles consisting of intravenous paclitaxel 175 mg/m

Major Finding: There was a 3.8-month increase in progression-free survival in women with advanced ovarian and related cancers who received bevacizumab as an adjunct and follow-on to standard chemotherapy.

Data Source: GOG-0218 trial.

Disclosures: Dr. Burger has served as an advisor/consultant to Genentech Inc. Dr. Eisenhauer reports no relevant disclosures.

CHICAGO — Progression-free survival in women with advanced ovarian or related female reproductive tract cancers was increased by nearly 4 months when they received frontline therapy with standard chemotherapy and concurrent bevacizumab followed by maintenance with bevacizumab alone, reported investigators from the Gynecologic Oncology Group's GOG-0218 trial.

In a randomized, placebo-controlled, phase III trial, the addition of bevacizumab (Avastin) to chemotherapy with carboplatin and paclitaxel followed by bevacizumab monotherapy resulted in a median progression-free survival (PFS) of 14.1 months, compared with 10.3 months for women on standard chemotherapy and placebo (hazard ratio 0.717, P less than .0001), reported lead investigator Dr. Robert A. Burger of the Fox Chase Cancer Center in Philadelphia.

But bevacizumab was effective only when used both as an adjunct to chemotherapy and as maintenance therapy: Women who received the angiogenesis inhibitor with chemotherapy but got a placebo during the maintenance phase had a median progression-free survival of 11.2 months, which was not significantly better than that of women who received chemotherapy and placebo only (HR 0.98, P=.16), Dr. Burger said.

“Bevacizumab is the first molecular-targeted and first antiangiogenic agent to demonstrate benefit in this population, and bevacizumab combined with chemotherapy followed by bevacizumab maintenance should be considered as one standard option for women with this disease,” said Dr. Burger.

That recommendation may be a bit premature, however, because the data so far show an effect of bevacizumab on only progression-free survival and not on overall survival, and “we cannot infer that a progression-free survival gain will mean an overall survival gain,” commented Dr. Elizabeth A Eisenhauer, the invited discussant.

“A progression-free survival gain of only 3.8 months may not be meaningful to patients. We need the mature overall survival and quality-of-life results, and ideally the results of the other frontline trial of bevacizumab in this disease, ICON-7, to understand the full story of the impact of this advance,” said Dr. Eisenhauer of the National Cancer Institute of Canada.

GOG-0218 investigators enrolled 1,873 women with stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Each group received the CT regimen, consisting of 22 3-week cycles, with the first 6 cycles consisting of intravenous paclitaxel 175 mg/m

Major Finding: There was a 3.8-month increase in progression-free survival in women with advanced ovarian and related cancers who received bevacizumab as an adjunct and follow-on to standard chemotherapy.

Data Source: GOG-0218 trial.

Disclosures: Dr. Burger has served as an advisor/consultant to Genentech Inc. Dr. Eisenhauer reports no relevant disclosures.

CHICAGO — Progression-free survival in women with advanced ovarian or related female reproductive tract cancers was increased by nearly 4 months when they received frontline therapy with standard chemotherapy and concurrent bevacizumab followed by maintenance with bevacizumab alone, reported investigators from the Gynecologic Oncology Group's GOG-0218 trial.

In a randomized, placebo-controlled, phase III trial, the addition of bevacizumab (Avastin) to chemotherapy with carboplatin and paclitaxel followed by bevacizumab monotherapy resulted in a median progression-free survival (PFS) of 14.1 months, compared with 10.3 months for women on standard chemotherapy and placebo (hazard ratio 0.717, P less than .0001), reported lead investigator Dr. Robert A. Burger of the Fox Chase Cancer Center in Philadelphia.

But bevacizumab was effective only when used both as an adjunct to chemotherapy and as maintenance therapy: Women who received the angiogenesis inhibitor with chemotherapy but got a placebo during the maintenance phase had a median progression-free survival of 11.2 months, which was not significantly better than that of women who received chemotherapy and placebo only (HR 0.98, P=.16), Dr. Burger said.

“Bevacizumab is the first molecular-targeted and first antiangiogenic agent to demonstrate benefit in this population, and bevacizumab combined with chemotherapy followed by bevacizumab maintenance should be considered as one standard option for women with this disease,” said Dr. Burger.

That recommendation may be a bit premature, however, because the data so far show an effect of bevacizumab on only progression-free survival and not on overall survival, and “we cannot infer that a progression-free survival gain will mean an overall survival gain,” commented Dr. Elizabeth A Eisenhauer, the invited discussant.

“A progression-free survival gain of only 3.8 months may not be meaningful to patients. We need the mature overall survival and quality-of-life results, and ideally the results of the other frontline trial of bevacizumab in this disease, ICON-7, to understand the full story of the impact of this advance,” said Dr. Eisenhauer of the National Cancer Institute of Canada.

GOG-0218 investigators enrolled 1,873 women with stage III or IV epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.

Each group received the CT regimen, consisting of 22 3-week cycles, with the first 6 cycles consisting of intravenous paclitaxel 175 mg/m

Depressive symptoms in adolescents with type 1 diabetes might be a marker for poor treatment compliance, a new report shows.

Adolescents with type 1 diabetes and clinically significant symptoms of depression were more likely than their nondepressed peers to have higher glycosylated hemoglobin A_1c values, and to perform less frequent daily blood glucose monitoring (BGM), Meghan E. McGrady and Dr. Korey K. Hood wrote (Diabetes Res Clin Pract. 2010;88:e35–7 [doi:10.1016/jdiabres. 2010.03.025]).

The most commonly reported depressive symptoms among the 144 teens in the study included ineffectiveness and negative mood. These symptoms, linked to both A_1c levels at baseline and to BGM at baseline and at 6 months, might be targets for intervention, the authors wrote.

Ms. Grady and Dr. Hood, who are affiliated with the Cincinnati Children's Hospital Medical Center, looked at 144 patients, aged 13–18 years, who were treated at the hospital's pediatric diabetes clinic. Most of the participants were white (87%), female (69%), and from households with two caregivers (76%). They were asked to fill out the 27-item Children's Depression Inventory (CDI), in which individual symptoms are rated on a scale of 0 (no symptoms) to 2 (distinct symptoms). Total scores of 13 or greater on the validated scale are deemed to be portents of clinically significant depression, indicating a need for more comprehensive evaluation. The patients also filled out follow-up questionnaires 6 months after the baseline visit.

The investigators correlated the symptoms scores with data on BGM frequency obtained from downloads of blood glucose meter data taken at the time of clinic visit, and with A_1c values measured by a standard point-of-care analyzer.

At baseline, 33 patients (23%) had CDI scores of 13 or greater (mean score for all participants: 7.92 ± 7.14). The most frequently reported symptoms were ineffectiveness (mean score 0.38 ± 0.41), negative mood (0.34 ± 0.36), anhedonia (0.32 ± 0.30), negative self-esteem (0.24 ± 0.30), and interpersonal problems (0.15 ± 0.23).

Both total CDI scores (P less than .001) and all subscale scores listed above were significantly correlated with lower frequency of BGM at baseline. Higher baseline A_1c scores were significantly related to CDI total score (P less than .01), negative mood (P less than .01), interpersonal problems (P less than .05), and ineffectiveness (P less than .0001).

At 6-months' follow-up, BGM frequency retained a significant correlation with total CDI scores and with the negative mood, ineffectiveness, and negative self-esteem subscales (P less than .05 for all). No significant correlations were found between A_1c values and either total scores of any of the subscale scores at 6 months, however.

“Symptoms of negative mood include sadness and indecisiveness, while anhedonia is characterized by a loss of energy and appetite disturbances. These symptoms may inhibit adolescents from initiating and following through with diabetes management. Ineffectiveness indicates feelings of poor self-efficacy, which has been linked to decreased adherence,” the authors wrote.

The study, which the authors said was the “first to examine the responses on CDI subscales in adolescents with type 1, had several limitations. Depressive symptoms were self-reported, and it is difficult to generalize the results to other samples because of the sociodemographic characteristics of the adolescents studied. Future studies should examine depressive symptoms over time, they said.

The study was supported by a career development award to Dr. Hood. The authors reported that they had no conflicts of interest.

Depressive symptoms in adolescents with type 1 diabetes might be a marker for poor treatment compliance, a new report shows.

Adolescents with type 1 diabetes and clinically significant symptoms of depression were more likely than their nondepressed peers to have higher glycosylated hemoglobin A_1c values, and to perform less frequent daily blood glucose monitoring (BGM), Meghan E. McGrady and Dr. Korey K. Hood wrote (Diabetes Res Clin Pract. 2010;88:e35–7 [doi:10.1016/jdiabres. 2010.03.025]).

The most commonly reported depressive symptoms among the 144 teens in the study included ineffectiveness and negative mood. These symptoms, linked to both A_1c levels at baseline and to BGM at baseline and at 6 months, might be targets for intervention, the authors wrote.

Ms. Grady and Dr. Hood, who are affiliated with the Cincinnati Children's Hospital Medical Center, looked at 144 patients, aged 13–18 years, who were treated at the hospital's pediatric diabetes clinic. Most of the participants were white (87%), female (69%), and from households with two caregivers (76%). They were asked to fill out the 27-item Children's Depression Inventory (CDI), in which individual symptoms are rated on a scale of 0 (no symptoms) to 2 (distinct symptoms). Total scores of 13 or greater on the validated scale are deemed to be portents of clinically significant depression, indicating a need for more comprehensive evaluation. The patients also filled out follow-up questionnaires 6 months after the baseline visit.

The investigators correlated the symptoms scores with data on BGM frequency obtained from downloads of blood glucose meter data taken at the time of clinic visit, and with A_1c values measured by a standard point-of-care analyzer.

At baseline, 33 patients (23%) had CDI scores of 13 or greater (mean score for all participants: 7.92 ± 7.14). The most frequently reported symptoms were ineffectiveness (mean score 0.38 ± 0.41), negative mood (0.34 ± 0.36), anhedonia (0.32 ± 0.30), negative self-esteem (0.24 ± 0.30), and interpersonal problems (0.15 ± 0.23).

Both total CDI scores (P less than .001) and all subscale scores listed above were significantly correlated with lower frequency of BGM at baseline. Higher baseline A_1c scores were significantly related to CDI total score (P less than .01), negative mood (P less than .01), interpersonal problems (P less than .05), and ineffectiveness (P less than .0001).

At 6-months' follow-up, BGM frequency retained a significant correlation with total CDI scores and with the negative mood, ineffectiveness, and negative self-esteem subscales (P less than .05 for all). No significant correlations were found between A_1c values and either total scores of any of the subscale scores at 6 months, however.

“Symptoms of negative mood include sadness and indecisiveness, while anhedonia is characterized by a loss of energy and appetite disturbances. These symptoms may inhibit adolescents from initiating and following through with diabetes management. Ineffectiveness indicates feelings of poor self-efficacy, which has been linked to decreased adherence,” the authors wrote.

The study, which the authors said was the “first to examine the responses on CDI subscales in adolescents with type 1, had several limitations. Depressive symptoms were self-reported, and it is difficult to generalize the results to other samples because of the sociodemographic characteristics of the adolescents studied. Future studies should examine depressive symptoms over time, they said.

The study was supported by a career development award to Dr. Hood. The authors reported that they had no conflicts of interest.

Depressive symptoms in adolescents with type 1 diabetes might be a marker for poor treatment compliance, a new report shows.

Adolescents with type 1 diabetes and clinically significant symptoms of depression were more likely than their nondepressed peers to have higher glycosylated hemoglobin A_1c values, and to perform less frequent daily blood glucose monitoring (BGM), Meghan E. McGrady and Dr. Korey K. Hood wrote (Diabetes Res Clin Pract. 2010;88:e35–7 [doi:10.1016/jdiabres. 2010.03.025]).

The most commonly reported depressive symptoms among the 144 teens in the study included ineffectiveness and negative mood. These symptoms, linked to both A_1c levels at baseline and to BGM at baseline and at 6 months, might be targets for intervention, the authors wrote.

Ms. Grady and Dr. Hood, who are affiliated with the Cincinnati Children's Hospital Medical Center, looked at 144 patients, aged 13–18 years, who were treated at the hospital's pediatric diabetes clinic. Most of the participants were white (87%), female (69%), and from households with two caregivers (76%). They were asked to fill out the 27-item Children's Depression Inventory (CDI), in which individual symptoms are rated on a scale of 0 (no symptoms) to 2 (distinct symptoms). Total scores of 13 or greater on the validated scale are deemed to be portents of clinically significant depression, indicating a need for more comprehensive evaluation. The patients also filled out follow-up questionnaires 6 months after the baseline visit.

The investigators correlated the symptoms scores with data on BGM frequency obtained from downloads of blood glucose meter data taken at the time of clinic visit, and with A_1c values measured by a standard point-of-care analyzer.

At baseline, 33 patients (23%) had CDI scores of 13 or greater (mean score for all participants: 7.92 ± 7.14). The most frequently reported symptoms were ineffectiveness (mean score 0.38 ± 0.41), negative mood (0.34 ± 0.36), anhedonia (0.32 ± 0.30), negative self-esteem (0.24 ± 0.30), and interpersonal problems (0.15 ± 0.23).

Both total CDI scores (P less than .001) and all subscale scores listed above were significantly correlated with lower frequency of BGM at baseline. Higher baseline A_1c scores were significantly related to CDI total score (P less than .01), negative mood (P less than .01), interpersonal problems (P less than .05), and ineffectiveness (P less than .0001).

At 6-months' follow-up, BGM frequency retained a significant correlation with total CDI scores and with the negative mood, ineffectiveness, and negative self-esteem subscales (P less than .05 for all). No significant correlations were found between A_1c values and either total scores of any of the subscale scores at 6 months, however.

“Symptoms of negative mood include sadness and indecisiveness, while anhedonia is characterized by a loss of energy and appetite disturbances. These symptoms may inhibit adolescents from initiating and following through with diabetes management. Ineffectiveness indicates feelings of poor self-efficacy, which has been linked to decreased adherence,” the authors wrote.

The study, which the authors said was the “first to examine the responses on CDI subscales in adolescents with type 1, had several limitations. Depressive symptoms were self-reported, and it is difficult to generalize the results to other samples because of the sociodemographic characteristics of the adolescents studied. Future studies should examine depressive symptoms over time, they said.

The study was supported by a career development award to Dr. Hood. The authors reported that they had no conflicts of interest.

Major Finding: The risk of acute MI was 2.69 times higher in people with metabolic syndrome (as defined by WHO criteria) than in people without the syndrome.

Data Source: The 52-nation case-control INTERHEART study involving 26,903 participants.

Disclosures: The study was funded by the Canadian Institutes of Health Research, the Heart and Stroke Foundation of Ontario, the International Clinical Epidemiology Network, and unrestricted grants from several pharmaceutical companies including AstraZeneca, Novartis, Hoechst Marion Roussel (now Aventis), Knoll Pharmaceuticals (now Abbott), Bristol-Myers Squibb, and Sanofi-Synthélabo. Dr. Mente is supported by a Heart and Stroke Foundation of Canada postdoctoral research fellowship.

As a risk factor for acute myocardial infarction, metabolic syndrome is similar in potency to diabetes or hypertension, and stronger than either abdominal obesity or an abnormal lipid profile, according to findings from INTERHEART, an international case-control study of 26,903 participants.

The presence of metabolic syndrome, as defined by World Health Organization criteria, conferred a nearly threefold higher risk of acute MI in the analysis of 12,297 cases and 14,606 controls from 262 centers in Africa, the Americas, Asia, Australia, Europe, and the Middle East. This effect was directionally similar for men and women, across all regions, and among all ethnic groups, reported Dr. Andrew Mente of McMaster University, Hamilton, Ont., and INTERHEART colleagues (J. Am. Coll. Cardiol. 2010;55:2390-8).

With International Diabetes Federation criteria, the apparent effect of metabolic syndrome was slightly less strong but still powerful, more than doubling the risk for heart attack.

“Metabolic syndrome has been fraught with definitional problems, including variation in the component factors used and differences in risk factor thresholds,” the investigators wrote. “In our analysis, the use of two different syndrome definitions (WHO and IDF) yielded a similar pattern of results relating MI to metabolic syndrome and its component factors, which is consistent with the premise that different definitions of metabolic syndrome have similar predictability in relation to coronary risk.”

Both sets of criteria include diabetes (defined as a hemoglobin A_1c of 6.5% or higher) and a history of treated or untreated hypertension. But WHO criteria define abdominal obesity broadly as a waist-to-hip ratio of at least 0.90 in men and 0.85 in women, while the IDF criteria stratify abdominal obesity by gender and ethnicity, and with categories for major geographic regions. Both sets of criteria include an abnormal lipid profile.

The MI risk conferred by metabolic syndrome as defined by WHO criteria was similar to that for diabetes and hypertension and significantly stronger than that for abdominal obesity or low HDL cholesterol.

Asians with metabolic syndrome based on WHO criteria had a fivefold higher risk compared with other regional or ethnic subgroups. For the North American population as a whole, metabolic syndrome was not significantly associated with MI risk. “However, our subanalyses by ethnicity show that metabolic syndrome is consistently associated with MI, which suggests that the null association in North America likely reflects the heterogeneity of the subjects recruited from Canada and the U.S.,” the researchers wrote.

In a comparison by age and sex that used WHO criteria, the increase in MI risk associated with metabolic syndrome was significantly higher in women than in men and in younger subjects than in older subjects.

Study limitations included the methods used to ascertain risk factors and self-reporting of diabetes and hypertension.

Major Finding: The risk of acute MI was 2.69 times higher in people with metabolic syndrome (as defined by WHO criteria) than in people without the syndrome.

Data Source: The 52-nation case-control INTERHEART study involving 26,903 participants.

Disclosures: The study was funded by the Canadian Institutes of Health Research, the Heart and Stroke Foundation of Ontario, the International Clinical Epidemiology Network, and unrestricted grants from several pharmaceutical companies including AstraZeneca, Novartis, Hoechst Marion Roussel (now Aventis), Knoll Pharmaceuticals (now Abbott), Bristol-Myers Squibb, and Sanofi-Synthélabo. Dr. Mente is supported by a Heart and Stroke Foundation of Canada postdoctoral research fellowship.

As a risk factor for acute myocardial infarction, metabolic syndrome is similar in potency to diabetes or hypertension, and stronger than either abdominal obesity or an abnormal lipid profile, according to findings from INTERHEART, an international case-control study of 26,903 participants.

The presence of metabolic syndrome, as defined by World Health Organization criteria, conferred a nearly threefold higher risk of acute MI in the analysis of 12,297 cases and 14,606 controls from 262 centers in Africa, the Americas, Asia, Australia, Europe, and the Middle East. This effect was directionally similar for men and women, across all regions, and among all ethnic groups, reported Dr. Andrew Mente of McMaster University, Hamilton, Ont., and INTERHEART colleagues (J. Am. Coll. Cardiol. 2010;55:2390-8).

With International Diabetes Federation criteria, the apparent effect of metabolic syndrome was slightly less strong but still powerful, more than doubling the risk for heart attack.

“Metabolic syndrome has been fraught with definitional problems, including variation in the component factors used and differences in risk factor thresholds,” the investigators wrote. “In our analysis, the use of two different syndrome definitions (WHO and IDF) yielded a similar pattern of results relating MI to metabolic syndrome and its component factors, which is consistent with the premise that different definitions of metabolic syndrome have similar predictability in relation to coronary risk.”

Both sets of criteria include diabetes (defined as a hemoglobin A_1c of 6.5% or higher) and a history of treated or untreated hypertension. But WHO criteria define abdominal obesity broadly as a waist-to-hip ratio of at least 0.90 in men and 0.85 in women, while the IDF criteria stratify abdominal obesity by gender and ethnicity, and with categories for major geographic regions. Both sets of criteria include an abnormal lipid profile.

The MI risk conferred by metabolic syndrome as defined by WHO criteria was similar to that for diabetes and hypertension and significantly stronger than that for abdominal obesity or low HDL cholesterol.

Asians with metabolic syndrome based on WHO criteria had a fivefold higher risk compared with other regional or ethnic subgroups. For the North American population as a whole, metabolic syndrome was not significantly associated with MI risk. “However, our subanalyses by ethnicity show that metabolic syndrome is consistently associated with MI, which suggests that the null association in North America likely reflects the heterogeneity of the subjects recruited from Canada and the U.S.,” the researchers wrote.

In a comparison by age and sex that used WHO criteria, the increase in MI risk associated with metabolic syndrome was significantly higher in women than in men and in younger subjects than in older subjects.

Study limitations included the methods used to ascertain risk factors and self-reporting of diabetes and hypertension.

Major Finding: The risk of acute MI was 2.69 times higher in people with metabolic syndrome (as defined by WHO criteria) than in people without the syndrome.

Data Source: The 52-nation case-control INTERHEART study involving 26,903 participants.

Disclosures: The study was funded by the Canadian Institutes of Health Research, the Heart and Stroke Foundation of Ontario, the International Clinical Epidemiology Network, and unrestricted grants from several pharmaceutical companies including AstraZeneca, Novartis, Hoechst Marion Roussel (now Aventis), Knoll Pharmaceuticals (now Abbott), Bristol-Myers Squibb, and Sanofi-Synthélabo. Dr. Mente is supported by a Heart and Stroke Foundation of Canada postdoctoral research fellowship.

As a risk factor for acute myocardial infarction, metabolic syndrome is similar in potency to diabetes or hypertension, and stronger than either abdominal obesity or an abnormal lipid profile, according to findings from INTERHEART, an international case-control study of 26,903 participants.

The presence of metabolic syndrome, as defined by World Health Organization criteria, conferred a nearly threefold higher risk of acute MI in the analysis of 12,297 cases and 14,606 controls from 262 centers in Africa, the Americas, Asia, Australia, Europe, and the Middle East. This effect was directionally similar for men and women, across all regions, and among all ethnic groups, reported Dr. Andrew Mente of McMaster University, Hamilton, Ont., and INTERHEART colleagues (J. Am. Coll. Cardiol. 2010;55:2390-8).

With International Diabetes Federation criteria, the apparent effect of metabolic syndrome was slightly less strong but still powerful, more than doubling the risk for heart attack.

“Metabolic syndrome has been fraught with definitional problems, including variation in the component factors used and differences in risk factor thresholds,” the investigators wrote. “In our analysis, the use of two different syndrome definitions (WHO and IDF) yielded a similar pattern of results relating MI to metabolic syndrome and its component factors, which is consistent with the premise that different definitions of metabolic syndrome have similar predictability in relation to coronary risk.”

Both sets of criteria include diabetes (defined as a hemoglobin A_1c of 6.5% or higher) and a history of treated or untreated hypertension. But WHO criteria define abdominal obesity broadly as a waist-to-hip ratio of at least 0.90 in men and 0.85 in women, while the IDF criteria stratify abdominal obesity by gender and ethnicity, and with categories for major geographic regions. Both sets of criteria include an abnormal lipid profile.

The MI risk conferred by metabolic syndrome as defined by WHO criteria was similar to that for diabetes and hypertension and significantly stronger than that for abdominal obesity or low HDL cholesterol.

Asians with metabolic syndrome based on WHO criteria had a fivefold higher risk compared with other regional or ethnic subgroups. For the North American population as a whole, metabolic syndrome was not significantly associated with MI risk. “However, our subanalyses by ethnicity show that metabolic syndrome is consistently associated with MI, which suggests that the null association in North America likely reflects the heterogeneity of the subjects recruited from Canada and the U.S.,” the researchers wrote.

In a comparison by age and sex that used WHO criteria, the increase in MI risk associated with metabolic syndrome was significantly higher in women than in men and in younger subjects than in older subjects.

Study limitations included the methods used to ascertain risk factors and self-reporting of diabetes and hypertension.

Botulinum toxin type A, celebrated by seekers of eternal youthfulness for its ability to temporarily smooth wrinkles, also might provide relief of chronic daily migraines, Brazilian investigators suggest.

A single treatment session consisting of botulinum toxin type A (OnabotulinumtoxinA, BTX-A) injections to 15 sites on the head was comparable to daily oral dosing of the tricyclic antidepressant (TCA) amitriptyline for preventing chronic daily migraine over 90 days, reported Elza Magalhães and her colleagues from the Federal University of Bahia, Brazil (Clin. Neurol. Neurosurg. 2010 April 18; [doi:10.1016/j.clineuro.2010.02.004]).

Both BTX-A injections and amitriptyline reduced the number of pain days by at least 50% in more than two-thirds of patients with chronic daily migraine, and each treatment cut the intensity of patient-rated pain approximately in half, according to the investigators.

“Considering the clinical benefits and the lack of undesirable side effects, such as weight gain and constipation, we argue that BTX-A should be considered for use in patients with chronic headaches as an alternative therapy or should be considered for use in patients who have contraindications for the use of other classes of drugs,” Ms. Magalhães and her coauthors wrote.

They enrolled 72 adults (aged 18 to 56 years) with chronic daily migraine according to International Classification of Headache Disorders-II criteria, and randomly assigned them to receive either BTX-A in a total dose of 250 units (35 patients), or 25 mg or 50 mg of amitriptyline daily (37 patients). Patients on the oral drug initially were given the 25-mg dose, and were titrated upward to the 50 mg dose if they did not have remission of symptoms from the lower dose at 30 days.

Patients assigned to BTX-A received 15 injections into pre-determined sites around the head. The injection sites included areas over sensitive innervations, including the trigeminal, C2, and C3 nerves.

Patients in both treatment groups were evaluated monthly for pain intensity, number of pain days, number of drug doses for pain, and side effects.

In all, 72% of patients treated with amitriptyline had a 50% or greater reduction in pain days, compared with 68% of the patients treated with BTX-A. The mean reported reduction in pain intensity by visual analog scale over baseline was 56% for patients on the oral drug vs. 50% for patients who received the injections. Similar percentages of patients reduced their use of pain drugs in the amitriptyline (77%) and BTX-A groups (71%).

There were no significant between-group differences in either patient or physician assessment of improvement at 90 days, with 88% of patients on the oral medication and 84% of patients on the injections reporting improvement at study end. The investigators determined that 87% of patients improved while taking the antidepressant and 88% of patients improved after receiving the toxin.

Adverse events generally were higher in the amitriptyline group, including the side effects of weight gain (58% for the oral drug vs. 12% for BTX-A), somnolence (53% vs. 4%), dry mouth (44% vs. 14%), and constipation (39% vs. 0%).

The investigators acknowledged that BTX-A is both more expensive and more invasive than oral medications, and suggested additional research to determine which subgroups of migraine sufferers might benefit from the injections compared with other means of migraine prevention.

The study is part of the doctorate of Ms. Magalhães, who received a grant from the Brazilian Federal Agency for the Support and Evaluation of Graduate Education. A coauthor received a research grant from Brazil’s National Council for Scientific and Technological Development. The authors did not report conflicts of interest.

Botulinum toxin type A, celebrated by seekers of eternal youthfulness for its ability to temporarily smooth wrinkles, also might provide relief of chronic daily migraines, Brazilian investigators suggest.

A single treatment session consisting of botulinum toxin type A (OnabotulinumtoxinA, BTX-A) injections to 15 sites on the head was comparable to daily oral dosing of the tricyclic antidepressant (TCA) amitriptyline for preventing chronic daily migraine over 90 days, reported Elza Magalhães and her colleagues from the Federal University of Bahia, Brazil (Clin. Neurol. Neurosurg. 2010 April 18; [doi:10.1016/j.clineuro.2010.02.004]).

Both BTX-A injections and amitriptyline reduced the number of pain days by at least 50% in more than two-thirds of patients with chronic daily migraine, and each treatment cut the intensity of patient-rated pain approximately in half, according to the investigators.

“Considering the clinical benefits and the lack of undesirable side effects, such as weight gain and constipation, we argue that BTX-A should be considered for use in patients with chronic headaches as an alternative therapy or should be considered for use in patients who have contraindications for the use of other classes of drugs,” Ms. Magalhães and her coauthors wrote.

They enrolled 72 adults (aged 18 to 56 years) with chronic daily migraine according to International Classification of Headache Disorders-II criteria, and randomly assigned them to receive either BTX-A in a total dose of 250 units (35 patients), or 25 mg or 50 mg of amitriptyline daily (37 patients). Patients on the oral drug initially were given the 25-mg dose, and were titrated upward to the 50 mg dose if they did not have remission of symptoms from the lower dose at 30 days.

Patients assigned to BTX-A received 15 injections into pre-determined sites around the head. The injection sites included areas over sensitive innervations, including the trigeminal, C2, and C3 nerves.

Patients in both treatment groups were evaluated monthly for pain intensity, number of pain days, number of drug doses for pain, and side effects.

In all, 72% of patients treated with amitriptyline had a 50% or greater reduction in pain days, compared with 68% of the patients treated with BTX-A. The mean reported reduction in pain intensity by visual analog scale over baseline was 56% for patients on the oral drug vs. 50% for patients who received the injections. Similar percentages of patients reduced their use of pain drugs in the amitriptyline (77%) and BTX-A groups (71%).

There were no significant between-group differences in either patient or physician assessment of improvement at 90 days, with 88% of patients on the oral medication and 84% of patients on the injections reporting improvement at study end. The investigators determined that 87% of patients improved while taking the antidepressant and 88% of patients improved after receiving the toxin.

Adverse events generally were higher in the amitriptyline group, including the side effects of weight gain (58% for the oral drug vs. 12% for BTX-A), somnolence (53% vs. 4%), dry mouth (44% vs. 14%), and constipation (39% vs. 0%).

The investigators acknowledged that BTX-A is both more expensive and more invasive than oral medications, and suggested additional research to determine which subgroups of migraine sufferers might benefit from the injections compared with other means of migraine prevention.

The study is part of the doctorate of Ms. Magalhães, who received a grant from the Brazilian Federal Agency for the Support and Evaluation of Graduate Education. A coauthor received a research grant from Brazil’s National Council for Scientific and Technological Development. The authors did not report conflicts of interest.

Botulinum toxin type A, celebrated by seekers of eternal youthfulness for its ability to temporarily smooth wrinkles, also might provide relief of chronic daily migraines, Brazilian investigators suggest.

A single treatment session consisting of botulinum toxin type A (OnabotulinumtoxinA, BTX-A) injections to 15 sites on the head was comparable to daily oral dosing of the tricyclic antidepressant (TCA) amitriptyline for preventing chronic daily migraine over 90 days, reported Elza Magalhães and her colleagues from the Federal University of Bahia, Brazil (Clin. Neurol. Neurosurg. 2010 April 18; [doi:10.1016/j.clineuro.2010.02.004]).

Both BTX-A injections and amitriptyline reduced the number of pain days by at least 50% in more than two-thirds of patients with chronic daily migraine, and each treatment cut the intensity of patient-rated pain approximately in half, according to the investigators.

“Considering the clinical benefits and the lack of undesirable side effects, such as weight gain and constipation, we argue that BTX-A should be considered for use in patients with chronic headaches as an alternative therapy or should be considered for use in patients who have contraindications for the use of other classes of drugs,” Ms. Magalhães and her coauthors wrote.

They enrolled 72 adults (aged 18 to 56 years) with chronic daily migraine according to International Classification of Headache Disorders-II criteria, and randomly assigned them to receive either BTX-A in a total dose of 250 units (35 patients), or 25 mg or 50 mg of amitriptyline daily (37 patients). Patients on the oral drug initially were given the 25-mg dose, and were titrated upward to the 50 mg dose if they did not have remission of symptoms from the lower dose at 30 days.

Patients assigned to BTX-A received 15 injections into pre-determined sites around the head. The injection sites included areas over sensitive innervations, including the trigeminal, C2, and C3 nerves.

Patients in both treatment groups were evaluated monthly for pain intensity, number of pain days, number of drug doses for pain, and side effects.

In all, 72% of patients treated with amitriptyline had a 50% or greater reduction in pain days, compared with 68% of the patients treated with BTX-A. The mean reported reduction in pain intensity by visual analog scale over baseline was 56% for patients on the oral drug vs. 50% for patients who received the injections. Similar percentages of patients reduced their use of pain drugs in the amitriptyline (77%) and BTX-A groups (71%).

There were no significant between-group differences in either patient or physician assessment of improvement at 90 days, with 88% of patients on the oral medication and 84% of patients on the injections reporting improvement at study end. The investigators determined that 87% of patients improved while taking the antidepressant and 88% of patients improved after receiving the toxin.

Adverse events generally were higher in the amitriptyline group, including the side effects of weight gain (58% for the oral drug vs. 12% for BTX-A), somnolence (53% vs. 4%), dry mouth (44% vs. 14%), and constipation (39% vs. 0%).

The investigators acknowledged that BTX-A is both more expensive and more invasive than oral medications, and suggested additional research to determine which subgroups of migraine sufferers might benefit from the injections compared with other means of migraine prevention.

The study is part of the doctorate of Ms. Magalhães, who received a grant from the Brazilian Federal Agency for the Support and Evaluation of Graduate Education. A coauthor received a research grant from Brazil’s National Council for Scientific and Technological Development. The authors did not report conflicts of interest.

Diabetic neuropathy should not be a barrier to carpal tunnel release surgery, because diabetic patients with carpal tunnel syndrome experience the same degree of neurophysiologic recovery after the procedure as do nondiabetic patients, according to Swedish investigators.

In a prospective case-control study, there were virtually no significant differences in neurophysiologic recovery after carpal tunnel syndrome (CTS) release between diabetic patients and controls, or among diabetic patients with or without peripheral neuropathy.

“We therefore recommend that diabetic patients with CTS are offered the same opportunities for surgical carpal tunnel release as nondiabetic patients,” wrote Dr. Niels O.B. Thomsen of Malm (Sweden) University Hospital and his colleagues.

The authors looked at pre- and postoperative data on 35 consecutive diabetic patients and 31 age- and sex-matched nondiabetic controls treated for CTS during 2004–2007. All cases and controls also had nerve conduction studies 1 year after surgery.

Diabetic patients were diagnosed with peripheral neuropathy if they had abnormal preoperative neurophysiologic values in sural nerve sensory conduction velocity (SCV), sensory nerve action potential (SNAP), and peroneal nerve motor conduction velocity studies.

At 1-year follow-up, there were significant differences in neurophysiologic recovery between diabetic patients and controls in only two categories: The SNAP values from digit III improved significantly more in nondiabetic patients, at a mean change from baseline of 2.1 mcV vs. 4.8 mcV, respectively. In contrast, diabetic patients had significantly greater antidromic elbow-wrist improvement, at a mean of 17.6 m/sec vs. 6.9 m/sec for nondiabetic patients.

There were no significant between-group differences in distal motor latency, motor conduction velocity, compound muscle action potential, wrist-palm SCV, or palm–digit III SCV (Clin. Neurophysiol. 2010 April 21 [doi:10.1016/j.clinph.2010.03.014]).

The investigators also looked at whether preoperative nerve conduction values could predict whether patients would improve following surgery, and found that in general, patients with the greatest presurgical disability had the highest postsurgical improvement. Still, few patients had nerve conduction values within the normal range at 1 year.

“The clinical implication … is that even though diabetic patients with CTS have significantly impaired nerve conduction parameters compared to nondiabetic patients with CTS, they obtain the same degree of neurophysiologic recovery after surgical carpal tunnel release. This result even applies to diabetic patients with evidence of peripheral neuropathy,” the researchers wrote.

The study was supported by the Swedish Research Council (Medicine), Crafoord's Fund for Medical Research, Svenska Diabetesförbundet, Diabetesföeningen Malmö, Konsul Thure Carlsson Fund for Medical Research, Region Skåne, and Funds from the Malmö (Sweden) University Hospital. The authors had no conflicts of interest to declare.

Diabetic neuropathy should not be a barrier to carpal tunnel release surgery, because diabetic patients with carpal tunnel syndrome experience the same degree of neurophysiologic recovery after the procedure as do nondiabetic patients, according to Swedish investigators.

In a prospective case-control study, there were virtually no significant differences in neurophysiologic recovery after carpal tunnel syndrome (CTS) release between diabetic patients and controls, or among diabetic patients with or without peripheral neuropathy.

“We therefore recommend that diabetic patients with CTS are offered the same opportunities for surgical carpal tunnel release as nondiabetic patients,” wrote Dr. Niels O.B. Thomsen of Malm (Sweden) University Hospital and his colleagues.

The authors looked at pre- and postoperative data on 35 consecutive diabetic patients and 31 age- and sex-matched nondiabetic controls treated for CTS during 2004–2007. All cases and controls also had nerve conduction studies 1 year after surgery.

Diabetic patients were diagnosed with peripheral neuropathy if they had abnormal preoperative neurophysiologic values in sural nerve sensory conduction velocity (SCV), sensory nerve action potential (SNAP), and peroneal nerve motor conduction velocity studies.

At 1-year follow-up, there were significant differences in neurophysiologic recovery between diabetic patients and controls in only two categories: The SNAP values from digit III improved significantly more in nondiabetic patients, at a mean change from baseline of 2.1 mcV vs. 4.8 mcV, respectively. In contrast, diabetic patients had significantly greater antidromic elbow-wrist improvement, at a mean of 17.6 m/sec vs. 6.9 m/sec for nondiabetic patients.

There were no significant between-group differences in distal motor latency, motor conduction velocity, compound muscle action potential, wrist-palm SCV, or palm–digit III SCV (Clin. Neurophysiol. 2010 April 21 [doi:10.1016/j.clinph.2010.03.014]).

The investigators also looked at whether preoperative nerve conduction values could predict whether patients would improve following surgery, and found that in general, patients with the greatest presurgical disability had the highest postsurgical improvement. Still, few patients had nerve conduction values within the normal range at 1 year.

“The clinical implication … is that even though diabetic patients with CTS have significantly impaired nerve conduction parameters compared to nondiabetic patients with CTS, they obtain the same degree of neurophysiologic recovery after surgical carpal tunnel release. This result even applies to diabetic patients with evidence of peripheral neuropathy,” the researchers wrote.

The study was supported by the Swedish Research Council (Medicine), Crafoord's Fund for Medical Research, Svenska Diabetesförbundet, Diabetesföeningen Malmö, Konsul Thure Carlsson Fund for Medical Research, Region Skåne, and Funds from the Malmö (Sweden) University Hospital. The authors had no conflicts of interest to declare.

Diabetic neuropathy should not be a barrier to carpal tunnel release surgery, because diabetic patients with carpal tunnel syndrome experience the same degree of neurophysiologic recovery after the procedure as do nondiabetic patients, according to Swedish investigators.

In a prospective case-control study, there were virtually no significant differences in neurophysiologic recovery after carpal tunnel syndrome (CTS) release between diabetic patients and controls, or among diabetic patients with or without peripheral neuropathy.

“We therefore recommend that diabetic patients with CTS are offered the same opportunities for surgical carpal tunnel release as nondiabetic patients,” wrote Dr. Niels O.B. Thomsen of Malm (Sweden) University Hospital and his colleagues.

The authors looked at pre- and postoperative data on 35 consecutive diabetic patients and 31 age- and sex-matched nondiabetic controls treated for CTS during 2004–2007. All cases and controls also had nerve conduction studies 1 year after surgery.

Diabetic patients were diagnosed with peripheral neuropathy if they had abnormal preoperative neurophysiologic values in sural nerve sensory conduction velocity (SCV), sensory nerve action potential (SNAP), and peroneal nerve motor conduction velocity studies.

At 1-year follow-up, there were significant differences in neurophysiologic recovery between diabetic patients and controls in only two categories: The SNAP values from digit III improved significantly more in nondiabetic patients, at a mean change from baseline of 2.1 mcV vs. 4.8 mcV, respectively. In contrast, diabetic patients had significantly greater antidromic elbow-wrist improvement, at a mean of 17.6 m/sec vs. 6.9 m/sec for nondiabetic patients.

There were no significant between-group differences in distal motor latency, motor conduction velocity, compound muscle action potential, wrist-palm SCV, or palm–digit III SCV (Clin. Neurophysiol. 2010 April 21 [doi:10.1016/j.clinph.2010.03.014]).

The investigators also looked at whether preoperative nerve conduction values could predict whether patients would improve following surgery, and found that in general, patients with the greatest presurgical disability had the highest postsurgical improvement. Still, few patients had nerve conduction values within the normal range at 1 year.

“The clinical implication … is that even though diabetic patients with CTS have significantly impaired nerve conduction parameters compared to nondiabetic patients with CTS, they obtain the same degree of neurophysiologic recovery after surgical carpal tunnel release. This result even applies to diabetic patients with evidence of peripheral neuropathy,” the researchers wrote.

The study was supported by the Swedish Research Council (Medicine), Crafoord's Fund for Medical Research, Svenska Diabetesförbundet, Diabetesföeningen Malmö, Konsul Thure Carlsson Fund for Medical Research, Region Skåne, and Funds from the Malmö (Sweden) University Hospital. The authors had no conflicts of interest to declare.

PHOENIX — Low-dose unfractionated heparin for thromboprophylaxis following abdominopelvic cancer surgery gives the most protection for the lowest overall cost, a cost analysis showed.

With good patient compliance, low-dose unfractionated heparin after discharge was a better bargain than even daily aspirin at preventing venous thromboembolism (VTE), Dr. Ciaran Bradley reported at a symposium sponsored by the Society of Surgical Oncology.

“Low-dose unfractionated heparin in fact saves money over the currently commonplace practice of doing nothing,” Dr. Bradley said. “It would be cost effective even if compliance with medication were low,” he noted. “Only if the cost of low-molecular-weight heparin were less than $100 would it start to compete for dominance in the model, and currently, it's seven times more expensive than that.”

Aspirin also appears to be an attractive alternative in this clinical situation because of its low cost, oral administration, and absence of heparin-induced thrombocytopenia.

“Even though aspirin has been relatively discounted as a primary agent for thromboprophylaxis for inpatients in the perioperative setting, it may have some utility after the discharge period, and further clinical studies using aspirin for this very scenario may be warranted,” said Dr. Bradley of the Medical College of Wisconsin, Milwaukee.

Patients who undergo abdominopelvic cancer resection are at high risk for VTE, with a postdischarge rate up to 25% reported in one study (BMJ 1988;297:28). Up to 4 weeks of VTE prophylaxis is recommended in guidelines published by the American College of Chest Physicians, National Comprehensive Cancer Network, and American Society of Clinical Oncology, he noted.

“However, we postulate that these guidelines are rarely followed, likely because of concerns over the costs of the agents as a result of bleeding complications and heparin-induced thrombocytopenia, as well as concern that patients may not be compliant with medications because those currently used are injectable formulations,” he said.

Dr. Bradley and his colleagues created a model using a reference case of a patient more than 40 years old who has undergone an open or laparoscopic procedure for abdominopelvic malignancy under general anesthesia and lasting at least 45 minutes. The hypothetical patient received in-hospital chemical prophylaxis for VTE, and was discharged on the seventh postoperative day.

The authors compared the relative costs of four postdischarge thromboprophylaxis strategies: 40 mg of low-molecular-weight heparin given subcutaneously once daily, 5,000 U of low-dose unfractionated heparin given subcutaneously three times daily, 325 mg of aspirin given orally daily, and no prophylaxis. The model assumed a constant risk of VTE and bleeding complications over the 3 weeks after discharge.

The model also assumed that the patient would not always be compliant with dosing. For example, the model assumes that daily compliance with injectable low-molecular-weight heparin would be 79% with once-daily dosing, and that compliance would drop to 65% with injectable low-dose unfractionated heparin dosed three times daily.

Using Medicare and Red Book 2006 data, the authors determined that the cost of VTE would be $4,715, which includes hospitalization plus 6 months of subsequent warfarin therapy and monitoring. Heparin-induced thrombocytopenia would cost $5,184, which includes 5 days of treatment with the thrombin inhibitor lepirudin followed by warfarin for 6 months. Bleeding complications, primarily minor bleeds not requiring treatment but some requiring transfusion, would cost $388.

The cost to patients would be $623 for low-molecular-weight heparin, $72 for low-dose unfractionated heparin, and $2 for aspirin.

But when the researchers factored in the VTE rates associated with each medication in the baseline analysis, they found that low-dose unfractionated heparin was the low-cost leader. The differences would translate into annual population savings relative to no prophylaxis of $50.1 million for low-dose unfractionated heparin and $28.8 million for aspirin, compared with excess costs of $81.3 million for low-molecular-weight heparin.

“This is a great paper,” Dr. Edward A. Levine commented in a postpresentation discussion. “This is something we all wrestle with, since we all work with oncology patients who have more than one risk factor for DVT or VTE,” he said. However, “there are a number of papers that I've seen showing that aspirin doesn't do anything in terms of preventing thromboembolism at all,” noted Dr. Levine, who is chief of surgical oncology at Wake Forest University Baptist Medical Center in Winston-Salem, N.C.

Dr. Bradley agreed that in the inpatient setting, aspirin does not appear to protect against immediate VTEs. “However, some studies have looked at aspirin after the point of discharge, and they do show a benefit, particularly in patients who have an increased VTE risk,” he said.

Dr. Bradley said that he has no relevant financial disclosures.

PHOENIX — Low-dose unfractionated heparin for thromboprophylaxis following abdominopelvic cancer surgery gives the most protection for the lowest overall cost, a cost analysis showed.

With good patient compliance, low-dose unfractionated heparin after discharge was a better bargain than even daily aspirin at preventing venous thromboembolism (VTE), Dr. Ciaran Bradley reported at a symposium sponsored by the Society of Surgical Oncology.

“Low-dose unfractionated heparin in fact saves money over the currently commonplace practice of doing nothing,” Dr. Bradley said. “It would be cost effective even if compliance with medication were low,” he noted. “Only if the cost of low-molecular-weight heparin were less than $100 would it start to compete for dominance in the model, and currently, it's seven times more expensive than that.”

Aspirin also appears to be an attractive alternative in this clinical situation because of its low cost, oral administration, and absence of heparin-induced thrombocytopenia.

“Even though aspirin has been relatively discounted as a primary agent for thromboprophylaxis for inpatients in the perioperative setting, it may have some utility after the discharge period, and further clinical studies using aspirin for this very scenario may be warranted,” said Dr. Bradley of the Medical College of Wisconsin, Milwaukee.

Patients who undergo abdominopelvic cancer resection are at high risk for VTE, with a postdischarge rate up to 25% reported in one study (BMJ 1988;297:28). Up to 4 weeks of VTE prophylaxis is recommended in guidelines published by the American College of Chest Physicians, National Comprehensive Cancer Network, and American Society of Clinical Oncology, he noted.

“However, we postulate that these guidelines are rarely followed, likely because of concerns over the costs of the agents as a result of bleeding complications and heparin-induced thrombocytopenia, as well as concern that patients may not be compliant with medications because those currently used are injectable formulations,” he said.

Dr. Bradley and his colleagues created a model using a reference case of a patient more than 40 years old who has undergone an open or laparoscopic procedure for abdominopelvic malignancy under general anesthesia and lasting at least 45 minutes. The hypothetical patient received in-hospital chemical prophylaxis for VTE, and was discharged on the seventh postoperative day.

The authors compared the relative costs of four postdischarge thromboprophylaxis strategies: 40 mg of low-molecular-weight heparin given subcutaneously once daily, 5,000 U of low-dose unfractionated heparin given subcutaneously three times daily, 325 mg of aspirin given orally daily, and no prophylaxis. The model assumed a constant risk of VTE and bleeding complications over the 3 weeks after discharge.

The model also assumed that the patient would not always be compliant with dosing. For example, the model assumes that daily compliance with injectable low-molecular-weight heparin would be 79% with once-daily dosing, and that compliance would drop to 65% with injectable low-dose unfractionated heparin dosed three times daily.

Using Medicare and Red Book 2006 data, the authors determined that the cost of VTE would be $4,715, which includes hospitalization plus 6 months of subsequent warfarin therapy and monitoring. Heparin-induced thrombocytopenia would cost $5,184, which includes 5 days of treatment with the thrombin inhibitor lepirudin followed by warfarin for 6 months. Bleeding complications, primarily minor bleeds not requiring treatment but some requiring transfusion, would cost $388.

The cost to patients would be $623 for low-molecular-weight heparin, $72 for low-dose unfractionated heparin, and $2 for aspirin.

But when the researchers factored in the VTE rates associated with each medication in the baseline analysis, they found that low-dose unfractionated heparin was the low-cost leader. The differences would translate into annual population savings relative to no prophylaxis of $50.1 million for low-dose unfractionated heparin and $28.8 million for aspirin, compared with excess costs of $81.3 million for low-molecular-weight heparin.

“This is a great paper,” Dr. Edward A. Levine commented in a postpresentation discussion. “This is something we all wrestle with, since we all work with oncology patients who have more than one risk factor for DVT or VTE,” he said. However, “there are a number of papers that I've seen showing that aspirin doesn't do anything in terms of preventing thromboembolism at all,” noted Dr. Levine, who is chief of surgical oncology at Wake Forest University Baptist Medical Center in Winston-Salem, N.C.

Dr. Bradley agreed that in the inpatient setting, aspirin does not appear to protect against immediate VTEs. “However, some studies have looked at aspirin after the point of discharge, and they do show a benefit, particularly in patients who have an increased VTE risk,” he said.

Dr. Bradley said that he has no relevant financial disclosures.

PHOENIX — Low-dose unfractionated heparin for thromboprophylaxis following abdominopelvic cancer surgery gives the most protection for the lowest overall cost, a cost analysis showed.

With good patient compliance, low-dose unfractionated heparin after discharge was a better bargain than even daily aspirin at preventing venous thromboembolism (VTE), Dr. Ciaran Bradley reported at a symposium sponsored by the Society of Surgical Oncology.

“Low-dose unfractionated heparin in fact saves money over the currently commonplace practice of doing nothing,” Dr. Bradley said. “It would be cost effective even if compliance with medication were low,” he noted. “Only if the cost of low-molecular-weight heparin were less than $100 would it start to compete for dominance in the model, and currently, it's seven times more expensive than that.”

Aspirin also appears to be an attractive alternative in this clinical situation because of its low cost, oral administration, and absence of heparin-induced thrombocytopenia.

“Even though aspirin has been relatively discounted as a primary agent for thromboprophylaxis for inpatients in the perioperative setting, it may have some utility after the discharge period, and further clinical studies using aspirin for this very scenario may be warranted,” said Dr. Bradley of the Medical College of Wisconsin, Milwaukee.

Patients who undergo abdominopelvic cancer resection are at high risk for VTE, with a postdischarge rate up to 25% reported in one study (BMJ 1988;297:28). Up to 4 weeks of VTE prophylaxis is recommended in guidelines published by the American College of Chest Physicians, National Comprehensive Cancer Network, and American Society of Clinical Oncology, he noted.

“However, we postulate that these guidelines are rarely followed, likely because of concerns over the costs of the agents as a result of bleeding complications and heparin-induced thrombocytopenia, as well as concern that patients may not be compliant with medications because those currently used are injectable formulations,” he said.

Dr. Bradley and his colleagues created a model using a reference case of a patient more than 40 years old who has undergone an open or laparoscopic procedure for abdominopelvic malignancy under general anesthesia and lasting at least 45 minutes. The hypothetical patient received in-hospital chemical prophylaxis for VTE, and was discharged on the seventh postoperative day.

The authors compared the relative costs of four postdischarge thromboprophylaxis strategies: 40 mg of low-molecular-weight heparin given subcutaneously once daily, 5,000 U of low-dose unfractionated heparin given subcutaneously three times daily, 325 mg of aspirin given orally daily, and no prophylaxis. The model assumed a constant risk of VTE and bleeding complications over the 3 weeks after discharge.

The model also assumed that the patient would not always be compliant with dosing. For example, the model assumes that daily compliance with injectable low-molecular-weight heparin would be 79% with once-daily dosing, and that compliance would drop to 65% with injectable low-dose unfractionated heparin dosed three times daily.

Using Medicare and Red Book 2006 data, the authors determined that the cost of VTE would be $4,715, which includes hospitalization plus 6 months of subsequent warfarin therapy and monitoring. Heparin-induced thrombocytopenia would cost $5,184, which includes 5 days of treatment with the thrombin inhibitor lepirudin followed by warfarin for 6 months. Bleeding complications, primarily minor bleeds not requiring treatment but some requiring transfusion, would cost $388.

The cost to patients would be $623 for low-molecular-weight heparin, $72 for low-dose unfractionated heparin, and $2 for aspirin.

But when the researchers factored in the VTE rates associated with each medication in the baseline analysis, they found that low-dose unfractionated heparin was the low-cost leader. The differences would translate into annual population savings relative to no prophylaxis of $50.1 million for low-dose unfractionated heparin and $28.8 million for aspirin, compared with excess costs of $81.3 million for low-molecular-weight heparin.

“This is a great paper,” Dr. Edward A. Levine commented in a postpresentation discussion. “This is something we all wrestle with, since we all work with oncology patients who have more than one risk factor for DVT or VTE,” he said. However, “there are a number of papers that I've seen showing that aspirin doesn't do anything in terms of preventing thromboembolism at all,” noted Dr. Levine, who is chief of surgical oncology at Wake Forest University Baptist Medical Center in Winston-Salem, N.C.

Dr. Bradley agreed that in the inpatient setting, aspirin does not appear to protect against immediate VTEs. “However, some studies have looked at aspirin after the point of discharge, and they do show a benefit, particularly in patients who have an increased VTE risk,” he said.

Dr. Bradley said that he has no relevant financial disclosures.

BOSTON — In patients who experience an acute pulmonary embolism, CT assessment of right ventricular ejection fraction appears useful for identifying which patients are most likely to have a good clinical outcome, investigators reported at a meeting of the International Society on Thrombosis and Haemostasis.

Among 114 patients who had an acute pulmonary embolism (PE), a right ventricular ejection fraction (RVEF) lower than 47% as assessed by ECG-synchronized multidetector-row CT (MDCT) was significantly predictive of adverse cardiac events, said Dr. Frederikus A. Klok from Leiden (the Netherlands) University Medical Center. ECG-synchronized MDCT is a novel imaging technique that allows assessment of right ventricular end-diastolic and end-systolic volumes, as well as ejection fraction.

The test had a negative predictive value approaching 100%, suggesting that it may be most useful in identifying patients with very low risk for adverse outcomes following an acute PE.

The study included consecutive inpatients and outpatients with clinical suspicion of acute PE who were hemodynamically stable and who had an indication for CT pulmonary angiography. Patients with confirmed PE underwent low-radiation-dose ECG-synchronized MDCT for assessment of right ventricular function. Right ventricular failure is the primary cause of death after acute PE, Dr. Klok noted.

Right ventricular dysfunction was defined as an ejection fraction less than 47%, which was previously established as the lower limit of the 95% confidence interval of normal RVEF in a large population-based cohort. Patients were followed for 6 weeks. End points were all-cause mortality, resuscitation, admission to an ICU with mechanical ventilation requirement and/or use of inotropic agents, and thrombolytic therapy.

Of 464 patients with suspected PE, ECG-synchronized MDCT confirmed embolism in 114 and ruled it out in 350. Of those with confirmed PE, 51 (45%) had a determination of right ventricular dysfunction and 63 (55%) were deemed to have normal ventricular function.

Of the patients with acute PE, 10 (8.8%) went on to experience an adverse event. There were four deaths, four resuscitations, one ICU admission, and one thrombolytic therapy administration. By the end of the 6 weeks of follow-up, seven of these patients had died, with four of the deaths attributable to PE.

ECG-synchronized MDCT had identified right ventricular dysfunction in 9 of the 10 patients with adverse events. The remaining patient, who had an RVEF above 47%, experienced a major bleeding complication requiring admission to an ICU, but this patient eventually recovered.

Dr. Klok acknowledged that given the low positive predictive value (18%) and high negative predictive value (98%), the test would likely be more useful for predicting outcomes in low-risk patients than in high-risk patients.

Dr. Klok said he and his colleagues did not have relevant conflicts of interest.

BOSTON — In patients who experience an acute pulmonary embolism, CT assessment of right ventricular ejection fraction appears useful for identifying which patients are most likely to have a good clinical outcome, investigators reported at a meeting of the International Society on Thrombosis and Haemostasis.

Among 114 patients who had an acute pulmonary embolism (PE), a right ventricular ejection fraction (RVEF) lower than 47% as assessed by ECG-synchronized multidetector-row CT (MDCT) was significantly predictive of adverse cardiac events, said Dr. Frederikus A. Klok from Leiden (the Netherlands) University Medical Center. ECG-synchronized MDCT is a novel imaging technique that allows assessment of right ventricular end-diastolic and end-systolic volumes, as well as ejection fraction.

The test had a negative predictive value approaching 100%, suggesting that it may be most useful in identifying patients with very low risk for adverse outcomes following an acute PE.

The study included consecutive inpatients and outpatients with clinical suspicion of acute PE who were hemodynamically stable and who had an indication for CT pulmonary angiography. Patients with confirmed PE underwent low-radiation-dose ECG-synchronized MDCT for assessment of right ventricular function. Right ventricular failure is the primary cause of death after acute PE, Dr. Klok noted.

Right ventricular dysfunction was defined as an ejection fraction less than 47%, which was previously established as the lower limit of the 95% confidence interval of normal RVEF in a large population-based cohort. Patients were followed for 6 weeks. End points were all-cause mortality, resuscitation, admission to an ICU with mechanical ventilation requirement and/or use of inotropic agents, and thrombolytic therapy.

Of 464 patients with suspected PE, ECG-synchronized MDCT confirmed embolism in 114 and ruled it out in 350. Of those with confirmed PE, 51 (45%) had a determination of right ventricular dysfunction and 63 (55%) were deemed to have normal ventricular function.

Of the patients with acute PE, 10 (8.8%) went on to experience an adverse event. There were four deaths, four resuscitations, one ICU admission, and one thrombolytic therapy administration. By the end of the 6 weeks of follow-up, seven of these patients had died, with four of the deaths attributable to PE.

ECG-synchronized MDCT had identified right ventricular dysfunction in 9 of the 10 patients with adverse events. The remaining patient, who had an RVEF above 47%, experienced a major bleeding complication requiring admission to an ICU, but this patient eventually recovered.

Dr. Klok acknowledged that given the low positive predictive value (18%) and high negative predictive value (98%), the test would likely be more useful for predicting outcomes in low-risk patients than in high-risk patients.

Dr. Klok said he and his colleagues did not have relevant conflicts of interest.

BOSTON — In patients who experience an acute pulmonary embolism, CT assessment of right ventricular ejection fraction appears useful for identifying which patients are most likely to have a good clinical outcome, investigators reported at a meeting of the International Society on Thrombosis and Haemostasis.

Among 114 patients who had an acute pulmonary embolism (PE), a right ventricular ejection fraction (RVEF) lower than 47% as assessed by ECG-synchronized multidetector-row CT (MDCT) was significantly predictive of adverse cardiac events, said Dr. Frederikus A. Klok from Leiden (the Netherlands) University Medical Center. ECG-synchronized MDCT is a novel imaging technique that allows assessment of right ventricular end-diastolic and end-systolic volumes, as well as ejection fraction.

The test had a negative predictive value approaching 100%, suggesting that it may be most useful in identifying patients with very low risk for adverse outcomes following an acute PE.

The study included consecutive inpatients and outpatients with clinical suspicion of acute PE who were hemodynamically stable and who had an indication for CT pulmonary angiography. Patients with confirmed PE underwent low-radiation-dose ECG-synchronized MDCT for assessment of right ventricular function. Right ventricular failure is the primary cause of death after acute PE, Dr. Klok noted.

Right ventricular dysfunction was defined as an ejection fraction less than 47%, which was previously established as the lower limit of the 95% confidence interval of normal RVEF in a large population-based cohort. Patients were followed for 6 weeks. End points were all-cause mortality, resuscitation, admission to an ICU with mechanical ventilation requirement and/or use of inotropic agents, and thrombolytic therapy.

Of 464 patients with suspected PE, ECG-synchronized MDCT confirmed embolism in 114 and ruled it out in 350. Of those with confirmed PE, 51 (45%) had a determination of right ventricular dysfunction and 63 (55%) were deemed to have normal ventricular function.

Of the patients with acute PE, 10 (8.8%) went on to experience an adverse event. There were four deaths, four resuscitations, one ICU admission, and one thrombolytic therapy administration. By the end of the 6 weeks of follow-up, seven of these patients had died, with four of the deaths attributable to PE.

ECG-synchronized MDCT had identified right ventricular dysfunction in 9 of the 10 patients with adverse events. The remaining patient, who had an RVEF above 47%, experienced a major bleeding complication requiring admission to an ICU, but this patient eventually recovered.

Dr. Klok acknowledged that given the low positive predictive value (18%) and high negative predictive value (98%), the test would likely be more useful for predicting outcomes in low-risk patients than in high-risk patients.

Dr. Klok said he and his colleagues did not have relevant conflicts of interest.

BOSTON — The route of hormonal contraceptive administration—transdermal or oral—does not make a difference in terms of the hormone's effect on plasma lipids and lipoproteins, according to the findings of a randomized crossover trial.

In the study, women on either a standard or extended-release contraceptive patch had higher levels of HDL cholesterol and its constituent apolipoprotein A1 (ApoA1), compared with when they were taking oral contraceptives; however, the effects of patch and oral formulations on atherogenic lipoproteins were similar, Dr. Elizabeth Chan reported at a symposium sponsored by the International Atherosclerosis Society.

“Patch contraception results in 60% higher estrogen levels than oral contraception. It is the estrogen/progestin ratio that determines the overall lipoprotein effects in hormonal contraception formulations,” according to Dr. Chan of the University of Washington division of cardiology in Seattle and her colleagues.

Thirty-five healthy premenopausal women had a 2-month phase-in period on an oral contraceptive (Ortho-Cyclen; 35 mcg ethinyl estradiol and 0.25 mg norgestimate) and were then randomly assigned in a three-way crossover design to 2 months on the oral contraceptive, a patch formulation (Ortho-Evra, approximating a daily dose of 20 mcg ethinyl estradiol and 150 mcg norelgestromin), or an extended-release patch (Extended Ortho-Evra, 7-week patch application plus 1 week off). Investigators were blinded to treatment assignment.

A total of 31 women completed all three treatments and were available for the final analysis. Lipoprotein levels were measured on the 21st day of the second month of each treatment cycle, corresponding to peak hormonal effect.

The investigators found that the use of the standard patch formulation resulted in significantly higher levels of the favorable lipids—HDL and ApoA1—compared with oral administration. The extended patch also had a significantly greater effect on HDL and ApoA1, compared with the standard patch. But for all other lipid parameters—LDL, non-HDL cholesterol, apolipoprotein B, and triglycerides—there were no significant differences among the three contraceptive formulations.

“The higher HDL cholesterol and ApoA1 seen with patch contraception may involve differences in formulation and/or reverse cholesterol transport. These mechanisms require further study.” said the researchers, who reported no conflicts of interest related to the study supported by Ortho-McNeil, maker of the contraceptives tested.

BOSTON — The route of hormonal contraceptive administration—transdermal or oral—does not make a difference in terms of the hormone's effect on plasma lipids and lipoproteins, according to the findings of a randomized crossover trial.

In the study, women on either a standard or extended-release contraceptive patch had higher levels of HDL cholesterol and its constituent apolipoprotein A1 (ApoA1), compared with when they were taking oral contraceptives; however, the effects of patch and oral formulations on atherogenic lipoproteins were similar, Dr. Elizabeth Chan reported at a symposium sponsored by the International Atherosclerosis Society.

“Patch contraception results in 60% higher estrogen levels than oral contraception. It is the estrogen/progestin ratio that determines the overall lipoprotein effects in hormonal contraception formulations,” according to Dr. Chan of the University of Washington division of cardiology in Seattle and her colleagues.

Thirty-five healthy premenopausal women had a 2-month phase-in period on an oral contraceptive (Ortho-Cyclen; 35 mcg ethinyl estradiol and 0.25 mg norgestimate) and were then randomly assigned in a three-way crossover design to 2 months on the oral contraceptive, a patch formulation (Ortho-Evra, approximating a daily dose of 20 mcg ethinyl estradiol and 150 mcg norelgestromin), or an extended-release patch (Extended Ortho-Evra, 7-week patch application plus 1 week off). Investigators were blinded to treatment assignment.

A total of 31 women completed all three treatments and were available for the final analysis. Lipoprotein levels were measured on the 21st day of the second month of each treatment cycle, corresponding to peak hormonal effect.

The investigators found that the use of the standard patch formulation resulted in significantly higher levels of the favorable lipids—HDL and ApoA1—compared with oral administration. The extended patch also had a significantly greater effect on HDL and ApoA1, compared with the standard patch. But for all other lipid parameters—LDL, non-HDL cholesterol, apolipoprotein B, and triglycerides—there were no significant differences among the three contraceptive formulations.

“The higher HDL cholesterol and ApoA1 seen with patch contraception may involve differences in formulation and/or reverse cholesterol transport. These mechanisms require further study.” said the researchers, who reported no conflicts of interest related to the study supported by Ortho-McNeil, maker of the contraceptives tested.

BOSTON — The route of hormonal contraceptive administration—transdermal or oral—does not make a difference in terms of the hormone's effect on plasma lipids and lipoproteins, according to the findings of a randomized crossover trial.

In the study, women on either a standard or extended-release contraceptive patch had higher levels of HDL cholesterol and its constituent apolipoprotein A1 (ApoA1), compared with when they were taking oral contraceptives; however, the effects of patch and oral formulations on atherogenic lipoproteins were similar, Dr. Elizabeth Chan reported at a symposium sponsored by the International Atherosclerosis Society.

“Patch contraception results in 60% higher estrogen levels than oral contraception. It is the estrogen/progestin ratio that determines the overall lipoprotein effects in hormonal contraception formulations,” according to Dr. Chan of the University of Washington division of cardiology in Seattle and her colleagues.

Thirty-five healthy premenopausal women had a 2-month phase-in period on an oral contraceptive (Ortho-Cyclen; 35 mcg ethinyl estradiol and 0.25 mg norgestimate) and were then randomly assigned in a three-way crossover design to 2 months on the oral contraceptive, a patch formulation (Ortho-Evra, approximating a daily dose of 20 mcg ethinyl estradiol and 150 mcg norelgestromin), or an extended-release patch (Extended Ortho-Evra, 7-week patch application plus 1 week off). Investigators were blinded to treatment assignment.

A total of 31 women completed all three treatments and were available for the final analysis. Lipoprotein levels were measured on the 21st day of the second month of each treatment cycle, corresponding to peak hormonal effect.

The investigators found that the use of the standard patch formulation resulted in significantly higher levels of the favorable lipids—HDL and ApoA1—compared with oral administration. The extended patch also had a significantly greater effect on HDL and ApoA1, compared with the standard patch. But for all other lipid parameters—LDL, non-HDL cholesterol, apolipoprotein B, and triglycerides—there were no significant differences among the three contraceptive formulations.

“The higher HDL cholesterol and ApoA1 seen with patch contraception may involve differences in formulation and/or reverse cholesterol transport. These mechanisms require further study.” said the researchers, who reported no conflicts of interest related to the study supported by Ortho-McNeil, maker of the contraceptives tested.

BOSTON — Nonfasting lipid status may be a better marker for impaired lipid metabolism than fasting lipids, according to a prospective study.

The findings suggest that patients need not deny themselves a good breakfast or lunch before having their blood drawn for plasma lipid testing.

Dr. István Reiber and Dr. Izabella Mezõ from the Szent György Hospital in Székesfehérvár, Hungary, compared fasting and postprandial lipid levels among 102 nondiabetic patients (44 men), and found that the only significant differences in any lipid parameters were between fasting and nonfasting triglycerides.

It is well known that there are no significant changes in total cholesterol and HDL cholesterol levels between the fasting and postprandial state. In addition, recent study findings suggest that nonfasting triglyceride concentrations in plasma are more predictive of cardiovascular events than are conventional measures of fasting triglycerides, the investigators wrote in a scientific poster presented at a symposium sponsored by the International Atherosclerosis Society.

The study participants had never received lipid-lowering drugs. They underwent separate venous blood draws following an overnight fast, 3 hours after eating their usual breakfasts, and 3 hours after their usual lunches.

Overall, total cholesterol in the fasting state was 5.51 mmol/L, 5.48 mmol/L after breakfast, and 5.69 mmol/L after lunch, a difference that was not significant.

HDL levels also were comparable between the fasting and postprandial states, at 1.12 mmol/L, 1.14 mmol/L (breakfast), and 1.20 mmol/L (lunch), respectively. Triglyceride levels, however, were significantly higher after eating, rising from 2.21 mmol/L in the fasting state, to 2.31 mmol/L after breakfast, and 2.94 mmol/L after lunch.

The researchers also found that both postprandial triglyceride measures correlated significantly with fasting triglycerides. All volunteers who had fasting triglyceride levels below 1.5 mmol/L had postprandial triglyceride levels below 2.0 mmol/L.

In addition to being more convenient, allowing patients to have their lipids measured in a nonfasting state is preferable because after all, “atherosclerosis is a postprandial story,” the researchers wrote, referring to the fact that people are in a postprandial state at least 20 hours daily.

Lipid measures 2-4 hours after meals provide a better early predictor for cardiovascular disease than do fasting lipids, concluded the investigators, who advised intervention whenever a patient has triglycerides higher than 2.0 mmol/L with elevated LDL and decreased HDL. Their suggested triglyceride treatment targets are fasting triglycerides lower than 1.0 mmol/L, or 2-4 hour postprandial triglycerides lower than 3.0 mmol/L.

Neither investigator disclosed relevant conflicts of interest.

BOSTON — Nonfasting lipid status may be a better marker for impaired lipid metabolism than fasting lipids, according to a prospective study.

The findings suggest that patients need not deny themselves a good breakfast or lunch before having their blood drawn for plasma lipid testing.

Dr. István Reiber and Dr. Izabella Mezõ from the Szent György Hospital in Székesfehérvár, Hungary, compared fasting and postprandial lipid levels among 102 nondiabetic patients (44 men), and found that the only significant differences in any lipid parameters were between fasting and nonfasting triglycerides.

It is well known that there are no significant changes in total cholesterol and HDL cholesterol levels between the fasting and postprandial state. In addition, recent study findings suggest that nonfasting triglyceride concentrations in plasma are more predictive of cardiovascular events than are conventional measures of fasting triglycerides, the investigators wrote in a scientific poster presented at a symposium sponsored by the International Atherosclerosis Society.

The study participants had never received lipid-lowering drugs. They underwent separate venous blood draws following an overnight fast, 3 hours after eating their usual breakfasts, and 3 hours after their usual lunches.

Overall, total cholesterol in the fasting state was 5.51 mmol/L, 5.48 mmol/L after breakfast, and 5.69 mmol/L after lunch, a difference that was not significant.

HDL levels also were comparable between the fasting and postprandial states, at 1.12 mmol/L, 1.14 mmol/L (breakfast), and 1.20 mmol/L (lunch), respectively. Triglyceride levels, however, were significantly higher after eating, rising from 2.21 mmol/L in the fasting state, to 2.31 mmol/L after breakfast, and 2.94 mmol/L after lunch.

The researchers also found that both postprandial triglyceride measures correlated significantly with fasting triglycerides. All volunteers who had fasting triglyceride levels below 1.5 mmol/L had postprandial triglyceride levels below 2.0 mmol/L.

In addition to being more convenient, allowing patients to have their lipids measured in a nonfasting state is preferable because after all, “atherosclerosis is a postprandial story,” the researchers wrote, referring to the fact that people are in a postprandial state at least 20 hours daily.

Lipid measures 2-4 hours after meals provide a better early predictor for cardiovascular disease than do fasting lipids, concluded the investigators, who advised intervention whenever a patient has triglycerides higher than 2.0 mmol/L with elevated LDL and decreased HDL. Their suggested triglyceride treatment targets are fasting triglycerides lower than 1.0 mmol/L, or 2-4 hour postprandial triglycerides lower than 3.0 mmol/L.

Neither investigator disclosed relevant conflicts of interest.

BOSTON — Nonfasting lipid status may be a better marker for impaired lipid metabolism than fasting lipids, according to a prospective study.

The findings suggest that patients need not deny themselves a good breakfast or lunch before having their blood drawn for plasma lipid testing.

Dr. István Reiber and Dr. Izabella Mezõ from the Szent György Hospital in Székesfehérvár, Hungary, compared fasting and postprandial lipid levels among 102 nondiabetic patients (44 men), and found that the only significant differences in any lipid parameters were between fasting and nonfasting triglycerides.

It is well known that there are no significant changes in total cholesterol and HDL cholesterol levels between the fasting and postprandial state. In addition, recent study findings suggest that nonfasting triglyceride concentrations in plasma are more predictive of cardiovascular events than are conventional measures of fasting triglycerides, the investigators wrote in a scientific poster presented at a symposium sponsored by the International Atherosclerosis Society.

The study participants had never received lipid-lowering drugs. They underwent separate venous blood draws following an overnight fast, 3 hours after eating their usual breakfasts, and 3 hours after their usual lunches.

Overall, total cholesterol in the fasting state was 5.51 mmol/L, 5.48 mmol/L after breakfast, and 5.69 mmol/L after lunch, a difference that was not significant.

HDL levels also were comparable between the fasting and postprandial states, at 1.12 mmol/L, 1.14 mmol/L (breakfast), and 1.20 mmol/L (lunch), respectively. Triglyceride levels, however, were significantly higher after eating, rising from 2.21 mmol/L in the fasting state, to 2.31 mmol/L after breakfast, and 2.94 mmol/L after lunch.

The researchers also found that both postprandial triglyceride measures correlated significantly with fasting triglycerides. All volunteers who had fasting triglyceride levels below 1.5 mmol/L had postprandial triglyceride levels below 2.0 mmol/L.

In addition to being more convenient, allowing patients to have their lipids measured in a nonfasting state is preferable because after all, “atherosclerosis is a postprandial story,” the researchers wrote, referring to the fact that people are in a postprandial state at least 20 hours daily.

Lipid measures 2-4 hours after meals provide a better early predictor for cardiovascular disease than do fasting lipids, concluded the investigators, who advised intervention whenever a patient has triglycerides higher than 2.0 mmol/L with elevated LDL and decreased HDL. Their suggested triglyceride treatment targets are fasting triglycerides lower than 1.0 mmol/L, or 2-4 hour postprandial triglycerides lower than 3.0 mmol/L.

Neither investigator disclosed relevant conflicts of interest.

BOSTON — In patients who experience an acute pulmonary embolism, CT assessment of right ventricular ejection fraction appears useful for identifying which patients are most likely to have a good clinical outcome, investigators reported at a meeting of the International Society on Thrombosis and Haemostasis.

Among 114 patients who had an acute pulmonary embolism (PE), a right ventricular ejection fraction (RVEF) lower than 47% as assessed by ECG-synchronized multidetector-row CT (MDCT) was significantly predictive of adverse cardiac events, said Dr. Frederikus A. Klok from Leiden (the Netherlands) University Medical Center.

The test had a negative predictive value approaching 100%, suggesting that it may be most useful in identifying patients with very low risk for adverse outcomes following an acute PE.

ECG-synchronized MDCT is a novel imaging technique that allows assessment of right ventricular end-diastolic and end-systolic volumes, as well as ejection fraction. After acquisition of cardiac images, the investigators digitally trace the end-diastolic and end-systolic endocardial contours for both the left and right ventricles, allowing them to determine ventricular volumes.

The study included consecutive inpatients and outpatients with clinical suspicion of acute PE who were hemodynamically stable and who had an indication for CT pulmonary angiography. The patients with confirmed PE then underwent low-radiation-dose ECG-synchronized MDCT for assessment of right ventricular function. Right ventricular failure is the primary cause of death after acute PE, Dr. Klok noted.

Right ventricular dysfunction was defined as an ejection fraction less than 47%, which was previously established as the lower limit of the 95% confidence interval of normal RVEF in a large population-based cohort.

Patients were followed for 6 weeks. End points were all-cause mortality, resuscitation, admission to an ICU with mechanical ventilation requirement and/or use of inotropic agents, and thrombolytic therapy.

Of 464 patients with suspected PE, ECG-synchronized MDCT confirmed embolism in 114 and ruled it out in 350. Of those with confirmed PE, 51 (45%) had a determination of right ventricular dysfunction and 63 (55%) were deemed to have normal ventricular function.

Of the patients with acute PE, 10 (8.8%) went on to experience an adverse event. There were four deaths, four resuscitations, one ICU admission, and one thrombolytic therapy administration. By the end of the 6 weeks of follow-up, seven of these patients had died, with four of the deaths attributable to PE.

ECG-synchronized MDCT had identified right ventricular dysfunction in 9 of the 10 patients with adverse events. The remaining patient, who had an RVEF above 47%, experienced a major bleeding complication requiring admission to an ICU, but this patient eventually recovered.

For the identification of patients at risk for adverse outcomes, ECG-synchronized MDCT evaluation of RVEF less than 47% had an associated odds ratio of 13.3, sensitivity of 90% (56–99.8%), specificity of 60% (50–70%), negative predictive value of 98% (92–99.9%), and positive predictive value of 18% (8.4–31%).

Dr. Klok acknowledged that given the low positive predictive value and high negative predictive value, the test would likely be more useful for predicting outcomes in low-risk patients than in high-risk patients.

Dr. Klok said that neither he nor his colleagues had conflicts of interest relative to the study.

BOSTON — In patients who experience an acute pulmonary embolism, CT assessment of right ventricular ejection fraction appears useful for identifying which patients are most likely to have a good clinical outcome, investigators reported at a meeting of the International Society on Thrombosis and Haemostasis.

Among 114 patients who had an acute pulmonary embolism (PE), a right ventricular ejection fraction (RVEF) lower than 47% as assessed by ECG-synchronized multidetector-row CT (MDCT) was significantly predictive of adverse cardiac events, said Dr. Frederikus A. Klok from Leiden (the Netherlands) University Medical Center.

The test had a negative predictive value approaching 100%, suggesting that it may be most useful in identifying patients with very low risk for adverse outcomes following an acute PE.

ECG-synchronized MDCT is a novel imaging technique that allows assessment of right ventricular end-diastolic and end-systolic volumes, as well as ejection fraction. After acquisition of cardiac images, the investigators digitally trace the end-diastolic and end-systolic endocardial contours for both the left and right ventricles, allowing them to determine ventricular volumes.

The study included consecutive inpatients and outpatients with clinical suspicion of acute PE who were hemodynamically stable and who had an indication for CT pulmonary angiography. The patients with confirmed PE then underwent low-radiation-dose ECG-synchronized MDCT for assessment of right ventricular function. Right ventricular failure is the primary cause of death after acute PE, Dr. Klok noted.

Right ventricular dysfunction was defined as an ejection fraction less than 47%, which was previously established as the lower limit of the 95% confidence interval of normal RVEF in a large population-based cohort.

Patients were followed for 6 weeks. End points were all-cause mortality, resuscitation, admission to an ICU with mechanical ventilation requirement and/or use of inotropic agents, and thrombolytic therapy.

Of 464 patients with suspected PE, ECG-synchronized MDCT confirmed embolism in 114 and ruled it out in 350. Of those with confirmed PE, 51 (45%) had a determination of right ventricular dysfunction and 63 (55%) were deemed to have normal ventricular function.

Of the patients with acute PE, 10 (8.8%) went on to experience an adverse event. There were four deaths, four resuscitations, one ICU admission, and one thrombolytic therapy administration. By the end of the 6 weeks of follow-up, seven of these patients had died, with four of the deaths attributable to PE.

ECG-synchronized MDCT had identified right ventricular dysfunction in 9 of the 10 patients with adverse events. The remaining patient, who had an RVEF above 47%, experienced a major bleeding complication requiring admission to an ICU, but this patient eventually recovered.

For the identification of patients at risk for adverse outcomes, ECG-synchronized MDCT evaluation of RVEF less than 47% had an associated odds ratio of 13.3, sensitivity of 90% (56–99.8%), specificity of 60% (50–70%), negative predictive value of 98% (92–99.9%), and positive predictive value of 18% (8.4–31%).

Dr. Klok acknowledged that given the low positive predictive value and high negative predictive value, the test would likely be more useful for predicting outcomes in low-risk patients than in high-risk patients.

Dr. Klok said that neither he nor his colleagues had conflicts of interest relative to the study.

BOSTON — In patients who experience an acute pulmonary embolism, CT assessment of right ventricular ejection fraction appears useful for identifying which patients are most likely to have a good clinical outcome, investigators reported at a meeting of the International Society on Thrombosis and Haemostasis.

Among 114 patients who had an acute pulmonary embolism (PE), a right ventricular ejection fraction (RVEF) lower than 47% as assessed by ECG-synchronized multidetector-row CT (MDCT) was significantly predictive of adverse cardiac events, said Dr. Frederikus A. Klok from Leiden (the Netherlands) University Medical Center.

The test had a negative predictive value approaching 100%, suggesting that it may be most useful in identifying patients with very low risk for adverse outcomes following an acute PE.

ECG-synchronized MDCT is a novel imaging technique that allows assessment of right ventricular end-diastolic and end-systolic volumes, as well as ejection fraction. After acquisition of cardiac images, the investigators digitally trace the end-diastolic and end-systolic endocardial contours for both the left and right ventricles, allowing them to determine ventricular volumes.

The study included consecutive inpatients and outpatients with clinical suspicion of acute PE who were hemodynamically stable and who had an indication for CT pulmonary angiography. The patients with confirmed PE then underwent low-radiation-dose ECG-synchronized MDCT for assessment of right ventricular function. Right ventricular failure is the primary cause of death after acute PE, Dr. Klok noted.

Right ventricular dysfunction was defined as an ejection fraction less than 47%, which was previously established as the lower limit of the 95% confidence interval of normal RVEF in a large population-based cohort.

Patients were followed for 6 weeks. End points were all-cause mortality, resuscitation, admission to an ICU with mechanical ventilation requirement and/or use of inotropic agents, and thrombolytic therapy.

Of 464 patients with suspected PE, ECG-synchronized MDCT confirmed embolism in 114 and ruled it out in 350. Of those with confirmed PE, 51 (45%) had a determination of right ventricular dysfunction and 63 (55%) were deemed to have normal ventricular function.

Of the patients with acute PE, 10 (8.8%) went on to experience an adverse event. There were four deaths, four resuscitations, one ICU admission, and one thrombolytic therapy administration. By the end of the 6 weeks of follow-up, seven of these patients had died, with four of the deaths attributable to PE.

ECG-synchronized MDCT had identified right ventricular dysfunction in 9 of the 10 patients with adverse events. The remaining patient, who had an RVEF above 47%, experienced a major bleeding complication requiring admission to an ICU, but this patient eventually recovered.

For the identification of patients at risk for adverse outcomes, ECG-synchronized MDCT evaluation of RVEF less than 47% had an associated odds ratio of 13.3, sensitivity of 90% (56–99.8%), specificity of 60% (50–70%), negative predictive value of 98% (92–99.9%), and positive predictive value of 18% (8.4–31%).

Dr. Klok acknowledged that given the low positive predictive value and high negative predictive value, the test would likely be more useful for predicting outcomes in low-risk patients than in high-risk patients.

Dr. Klok said that neither he nor his colleagues had conflicts of interest relative to the study.